Dow Jones Venture Wire
With Drugs In Doubt, Some Biotechs Are Selling Out
- By Brian Gormely
"...Numoda now plans to develop Vitreosolve in the primary indication of vitreomacular adhesion and the secondary indication of inducing a posterior-vitreous detachment in the treatment of diabetic retinopathy. The firm plans new, placebo-controlled studies and is consulting drug-makers to find other ways to groom Vitreosolve for a sale. It aims to speed the auctioning process through technology from an affiliate, Numoda Technologies Inc., that enables potential bidders to see trial data as they are generated."
Numoda: What clients think
T.S., Sponsor
I am so impressed with what you are doing for this sponsor, and I asked B. to Use Numoda on his Hep C trials, because he is killing us with his paperwork.
Investigator - Liver Transplant Specialist
Could you get our other large client to have Numoda run their trials for them? It is so much easier to do a trial with Numoda - everyone remarks on it, daily. We have had so many problems and delays with the other trial - and none on this trial. Is there any way I can help?
Good morning. It works and it is WONDERFUL!!! You have saved me hours worth of work!!! Thank you and please thank anyone who campaigned for us for this!!!
Project Manager - Cardiology
Project Manager - Cardiology
I am so impressed with what you are doing for this sponsor, and I asked B. to Use Numoda on his Hep C trials, because he is killing us with his paperwork.
Investigator - Liver Transplant Specialist
Could you get our other large client to have Numoda run their trials for them? It is so much easier to do a trial with Numoda - everyone remarks on it, daily. We have had so many problems and delays with the other trial - and none on this trial. Is there any way I can help?
Our Services
Ours is an industry of unceasing technological innovation and
deepening life sciences expertise. Our value to clients depends on the
interaction of the most sophisticated technologies with the most
experienced and dedicated personnel.
Numoda Olympian™, a Clinical Enterprise Management System, addresses the broader issues experienced by biopharma with active and often complex clinical trial pipelines by providing an integrated view through the Single Interface™ of clinical program data with flexible reporting options.
Numoda Corporation’s two divisions, Global Business Services and Global Technical Services successfully assist you with your vital trial using these patented platforms provided by our affiliate, Numoda Technologies, Inc:
Our role as The Accountable General Contractor, enables us to provide improved metrics for performance in all aspects of your trial, ranging from the clinical execution and datalock, to budget accountability. Due to the dedication and expertise of Numoda's two divisions, and our European subsidiary Numoda SAS, these capabilities are easily maintained on a global scale
Numoda Olympian™, a Clinical Enterprise Management System, addresses the broader issues experienced by biopharma with active and often complex clinical trial pipelines by providing an integrated view through the Single Interface™ of clinical program data with flexible reporting options.
Numoda Corporation’s two divisions, Global Business Services and Global Technical Services successfully assist you with your vital trial using these patented platforms provided by our affiliate, Numoda Technologies, Inc:
TruPoints®
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Financial Oversight
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Core Integrations
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SiteBook™
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Logistics Management
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Reimbursement
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Our role as The Accountable General Contractor, enables us to provide improved metrics for performance in all aspects of your trial, ranging from the clinical execution and datalock, to budget accountability. Due to the dedication and expertise of Numoda's two divisions, and our European subsidiary Numoda SAS, these capabilities are easily maintained on a global scale
A Green Trial
In addition to its commitment to bring efficiencies and reduced risk to the drug development process, Numoda is also committing to reducing the amount of unnecessary paper utilized by the pharmaceutical industry.
Numoda’s single interface provides the life science industry with a green alternative to traditional paper studies. By having one centralized location for all trial documents and reports, you can access your trial from any location, without having to print countless spreadsheets, patient diaries, etc.
You will be able to have the security of knowing that all your trial data is all in one place, and the comfort of knowing you benefit the environment. And of course travel, particularly global travel, is greatly reduced thanks to the single interface capabilities.
a leader in developing the next generation of immunotherapies for cancer and infectious diseases, reported preliminary data on the safety and clinical benefit of ADXS-HPV from an ongoing randomized Phase 2 trial of ADXS-HPV with or without cisplatin in Indian women with recurrent/refractory cervical cancer who have failed cytotoxic therapy. Dr. John Rothman, Advaxis Executive Vice President of Science and Operations, presented the preliminary data at the World Cancer Immunotherapy Conference in San Diego, California on Wednesday, January 25, 2012. The advanced cervical cancer study is being conducted at 17 sites in India, and as of January 25, 2012, 87 out of a planned 110 patients have been enrolled in the study. To be enrolled in the study, all patients must have been previously treated with radiation, and/or chemotherapy, and the cancer must have resumed growth and in most cases has metastasized, as confirmed by CT or radiologic scan. Because data are available to Advaxis in “real time”, the Company is reporting preliminary data on a periodic basis. The initial safety and objective response data for this ongoing study were presented at the AACR New Horizons in Cancer Research: Biology to Prevention to Therapy conference Gurgaon, Delhi (NCR), India on December 14, 2011.
The objectives of this Phase 2 trial are to assess the safety and efficacy of ADXS-HPV (1×109 cfu) with and without cisplatin (40 mg/m2) and to determine if ADXS-HPV can be safely administered in combination with platinum chemotherapy. As of January 20, 2012, 87 patients have received 195 doses of ADVS-HPV. 34% of patients (a total of 30) have experienced a ADXS-HPV drug-related adverse event, consisting of Grade 1 or 2 events that were transient, comprised of non-cumulative flu-like symptoms that responded to symptomatic treatment, or resolved on their own; and 1 Grade 3 event.
The primary efficacy endpoint of this Phase 2 trial is overall survival. As of January 25, 2012, the percentage of patients alive at 6 months is 62% (34/55); at 9 months is 41% (15/37) and at 1 year is 40% (6/15). Clinical responses have been observed in both treatment arms with 3 complete responses (elimination of tumor burden) and 4 partial responses (≥30% reduction in tumor burden) documented to date, which expands on the preliminary data presented at the AACR meeting in December that reported 1 complete response and 3 partial responses. “These data will change, as the study is ongoing and still enrolling. However, we are encouraged by the preliminary safety, tumor response, and survival data,” commented Dr. Rothman.
The slide presentation is available on the Advaxis website at http://www.advaxis.com/.
About Advaxis, Inc.
Advaxis is a clinical-stage biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases. Advaxis immunotherapies are based on a novel platform technology using live, attenuated bacteria that are bio-engineered to secrete an antigen/adjuvant fusion protein designed to redirect the powerful immune response all human beings have to the bacterium to the cancer itself.
Advaxis’ most advanced construct, ADXS-HPV, is being evaluated in 4 Phase 2 clinical trials for HPV-associated diseases: CIN 2/3 (US study, Clinical Trials.gov Identifier NCT01116245), locally advanced cervical cancer (GOG/NCI US study, Clinical Trials.gov Identifier NCT01266460), recurrent/refractory cervical cancer (India), and head & neck cancer (CRUK study) with over 150 patients receiving over 360 doses to date. Over fifteen (15) distinct constructs are in various stages of development, developed directly by the Company and through strategic collaborations with recognized centers of excellence such as: the National Cancer Institute, Cancer Research – UK, the Wistar Institute, the University of Pennsylvania, the University of British Columbia, and others.
The objectives of this Phase 2 trial are to assess the safety and efficacy of ADXS-HPV (1×109 cfu) with and without cisplatin (40 mg/m2) and to determine if ADXS-HPV can be safely administered in combination with platinum chemotherapy. As of January 20, 2012, 87 patients have received 195 doses of ADVS-HPV. 34% of patients (a total of 30) have experienced a ADXS-HPV drug-related adverse event, consisting of Grade 1 or 2 events that were transient, comprised of non-cumulative flu-like symptoms that responded to symptomatic treatment, or resolved on their own; and 1 Grade 3 event.
The primary efficacy endpoint of this Phase 2 trial is overall survival. As of January 25, 2012, the percentage of patients alive at 6 months is 62% (34/55); at 9 months is 41% (15/37) and at 1 year is 40% (6/15). Clinical responses have been observed in both treatment arms with 3 complete responses (elimination of tumor burden) and 4 partial responses (≥30% reduction in tumor burden) documented to date, which expands on the preliminary data presented at the AACR meeting in December that reported 1 complete response and 3 partial responses. “These data will change, as the study is ongoing and still enrolling. However, we are encouraged by the preliminary safety, tumor response, and survival data,” commented Dr. Rothman.
The slide presentation is available on the Advaxis website at http://www.advaxis.com/.
About Advaxis, Inc.
Advaxis is a clinical-stage biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases. Advaxis immunotherapies are based on a novel platform technology using live, attenuated bacteria that are bio-engineered to secrete an antigen/adjuvant fusion protein designed to redirect the powerful immune response all human beings have to the bacterium to the cancer itself.
Advaxis’ most advanced construct, ADXS-HPV, is being evaluated in 4 Phase 2 clinical trials for HPV-associated diseases: CIN 2/3 (US study, Clinical Trials.gov Identifier NCT01116245), locally advanced cervical cancer (GOG/NCI US study, Clinical Trials.gov Identifier NCT01266460), recurrent/refractory cervical cancer (India), and head & neck cancer (CRUK study) with over 150 patients receiving over 360 doses to date. Over fifteen (15) distinct constructs are in various stages of development, developed directly by the Company and through strategic collaborations with recognized centers of excellence such as: the National Cancer Institute, Cancer Research – UK, the Wistar Institute, the University of Pennsylvania, the University of British Columbia, and others.
MediQuest Therapeutics Takes Streamlined Route To VC Liquidity
MediQuest Therapeutics Inc. is taking what it hopes will be a streamlined approach to providing liquidity for its venture backers: licensing out its portfolio of drug candidates and distributing the proceeds.
Phased exit strategies such as this one are growing more common as venture firms search for ways to make returns at a time when taking a company public or selling it whole is difficult. Last year, for example, venture backers of Actimis pharmaceuticals Inc. agreed to a structured merger with Boehringer Ingelheim GmbH. The deal called for Boehringer to buy shares in the company as Actimis’ lead asthma drug reached milestones.
In its case, MediQuest decided that selling its portfolio and distributing the upfront payments, milestones and royalties would provide the most timely exit for its investors. The company, which formed in 1994 and raised its initial venture capital in 2006, hopes to complete the licensing transactions in six to nine months, said Chief Executive Frederick J. Dechow. Company backers include Integra Ventures, Janus, Masa Life Science Ventures, Novo A/S and individuals.
MediQuest, whose most advanced drug, Vascana, is in Phase III trials for the autoimmune condition Raynaud’s disease, has engaged information- and process-management company Numoda Corp. to help it run its clinical studies more efficiently. In addition, Numoda Capital Innovations, a venture arm of Numoda Corp. formed late last year, is taking part in a Series B financing that MediQuest is raising.
MediQuest in May said it had raised $23 million toward the round. Dechow declined to disclose the amount Numoda has added or to discuss other specifics. Additional new investors may also come into the Series B, he said.
MediQuest filed a New Drug Application for Vascana in April 2008, but in November, it said the Food and Drug Administration would not approve the medicine in its present form. About a month ago, it launched a new, confirmatory Phase III to answer the agency’s questions. The trial will enroll about 100 patients, Dechow said.
Numoda Corp. will help MediQuest run the confirmatory Phase III effectively by integrating the systems, people and processes of the study so that trial data are available immediately as they are generated, said CEO Mary Schaheen. This enables a company to quickly pick up on problems and correct them promptly. In the case of MediQuest, it can help ensure that only the right types of patients are enrolled, she said. In addition to investing in Numoda Corp. clients, Numoda Capital also works with these companies to help them find strategic partners. The group aims to connect MediQuest with pharmaceutical companies interested in licensing Vascana and other pipeline drugs, which include treatments for nail psoriasis and onychomycosis that have completed Phase II trials, and a preclinical treatment for actinic keratosis.
The work that Numoda Corp. does for Numoda portfolio companies helps give potential strategic partners confidence that clinical studies are being run effectively, which speeds their due diligence, according to Schaheen.
To boost its ability to help companies make these kinds of deals, Numoda Capital recently hired a managing director with investment banking as well as venture capital experience. Before joining Numoda Capital in mid-April, Terrance McGovern held senior investment banking positions with CIBC World Markets, Duff & Phelps Corp. and BMO Capital Markets Corp. He also founded and served as managing partner of Crystal Cove Capital, where he was involved in venture capital and merchant banking.
McGovern’s experience working with pharmaceutical companies should also be useful to Numoda Capital while it is raising its first fund. The group, which intends to raise $150 million for Numoda Capital Innovations LP, is talking mostly with strategic investors, McGovern said.
Investing in the fund would enable these corporations to scan Numoda Capital’s deal flow and gain insight into new drugs in development. Drug manufacturers are also expressing interest in using Numoda Corp. technologies and services to develop therapeutics in specific areas,
McGovern said. The Numoda Capital fund has not yet had a closing, so the firm is investing capital from Numoda Corp. Limited partners in the Numoda Capital fund will include Numoda Corp. and affiliate Numoda Technologies Inc., according to Schaheen. Numoda Capital is also talking with large and small drugmakers about acquiring therapeutics from them and forming virtual companies around individual products, McGovern said. Numoda Capital would then raise the money to develop these products through clinical trials with a goal of eventually licensing them out, McGovern said. The firm has also had discussions with investment banks and other health care venture investors about collaborating to execute these kinds of spinout transactions, he said.
Phased exit strategies such as this one are growing more common as venture firms search for ways to make returns at a time when taking a company public or selling it whole is difficult. Last year, for example, venture backers of Actimis pharmaceuticals Inc. agreed to a structured merger with Boehringer Ingelheim GmbH. The deal called for Boehringer to buy shares in the company as Actimis’ lead asthma drug reached milestones.
In its case, MediQuest decided that selling its portfolio and distributing the upfront payments, milestones and royalties would provide the most timely exit for its investors. The company, which formed in 1994 and raised its initial venture capital in 2006, hopes to complete the licensing transactions in six to nine months, said Chief Executive Frederick J. Dechow. Company backers include Integra Ventures, Janus, Masa Life Science Ventures, Novo A/S and individuals.
MediQuest, whose most advanced drug, Vascana, is in Phase III trials for the autoimmune condition Raynaud’s disease, has engaged information- and process-management company Numoda Corp. to help it run its clinical studies more efficiently. In addition, Numoda Capital Innovations, a venture arm of Numoda Corp. formed late last year, is taking part in a Series B financing that MediQuest is raising.
MediQuest in May said it had raised $23 million toward the round. Dechow declined to disclose the amount Numoda has added or to discuss other specifics. Additional new investors may also come into the Series B, he said.
MediQuest filed a New Drug Application for Vascana in April 2008, but in November, it said the Food and Drug Administration would not approve the medicine in its present form. About a month ago, it launched a new, confirmatory Phase III to answer the agency’s questions. The trial will enroll about 100 patients, Dechow said.
Numoda Corp. will help MediQuest run the confirmatory Phase III effectively by integrating the systems, people and processes of the study so that trial data are available immediately as they are generated, said CEO Mary Schaheen. This enables a company to quickly pick up on problems and correct them promptly. In the case of MediQuest, it can help ensure that only the right types of patients are enrolled, she said. In addition to investing in Numoda Corp. clients, Numoda Capital also works with these companies to help them find strategic partners. The group aims to connect MediQuest with pharmaceutical companies interested in licensing Vascana and other pipeline drugs, which include treatments for nail psoriasis and onychomycosis that have completed Phase II trials, and a preclinical treatment for actinic keratosis.
The work that Numoda Corp. does for Numoda portfolio companies helps give potential strategic partners confidence that clinical studies are being run effectively, which speeds their due diligence, according to Schaheen.
To boost its ability to help companies make these kinds of deals, Numoda Capital recently hired a managing director with investment banking as well as venture capital experience. Before joining Numoda Capital in mid-April, Terrance McGovern held senior investment banking positions with CIBC World Markets, Duff & Phelps Corp. and BMO Capital Markets Corp. He also founded and served as managing partner of Crystal Cove Capital, where he was involved in venture capital and merchant banking.
McGovern’s experience working with pharmaceutical companies should also be useful to Numoda Capital while it is raising its first fund. The group, which intends to raise $150 million for Numoda Capital Innovations LP, is talking mostly with strategic investors, McGovern said.
Investing in the fund would enable these corporations to scan Numoda Capital’s deal flow and gain insight into new drugs in development. Drug manufacturers are also expressing interest in using Numoda Corp. technologies and services to develop therapeutics in specific areas,
McGovern said. The Numoda Capital fund has not yet had a closing, so the firm is investing capital from Numoda Corp. Limited partners in the Numoda Capital fund will include Numoda Corp. and affiliate Numoda Technologies Inc., according to Schaheen. Numoda Capital is also talking with large and small drugmakers about acquiring therapeutics from them and forming virtual companies around individual products, McGovern said. Numoda Capital would then raise the money to develop these products through clinical trials with a goal of eventually licensing them out, McGovern said. The firm has also had discussions with investment banks and other health care venture investors about collaborating to execute these kinds of spinout transactions, he said.
Numoda Forms Cleveland Clinic Alliance; Deal Will Feed Venture Arm
Numoda Corp. will provide its clinical trials-management technology to companies studying neurological-disease drugs at the Cleveland Clinic through an alliance that will provide a flow of new deals for its venture arm.
The goal of the alliance is to speed development of new treatments for diseases affecting the health of the brain. Numoda's technology is designed to help companies run clinical trials more effectively by enabling them to integrate systems, people and processes so that trial data become accessible as they are produced.
Numoda said its technology and services can also help companies catch and fix problems that are occurring in clinical studies. Numoda will also provide researchers at Cleveland Clinic's Neurological Institute with information systems, reporting engines and administrative tools to help improve patient recruitment, budgeting and data flow.
Numoda, based in Philadelphia, also invests in private and public companies through a venture arm, Numoda Capital Innovations. It intends to invest in most of the drug companies it works with through this partnership with the Cleveland Clinic, according to Patrick Keenan, chief counsel and strategist for Numoda Capital Innovations.
Numoda is in the process of raising $150 million for Numoda Capital Innovations' fund, Keenan said. In the meantime, it has been investing capital from the management of Numoda Corp., and capital from Numoda affiliate Numoda Technologies Inc., he said.
This is the first time Numoda has formed an alliance of this type, but it may look to form other partnerships that are in the same vein, according to Keenan. The company, formed in 1997, has worked with a number of neurological-drug developers before, he said.
"Our core competency is making trials smarter, faster and less risky," Keenan said.
Numoda Capital typically invests in companies that are also clients of Numoda Corp. Portfolio companies include private companies MediQuest Therapeutics Inc. and Reata Pharmaceuticals Inc., and publicly traded Soligenix Inc. and Advaxis Inc.
The goal of the alliance is to speed development of new treatments for diseases affecting the health of the brain. Numoda's technology is designed to help companies run clinical trials more effectively by enabling them to integrate systems, people and processes so that trial data become accessible as they are produced.
Numoda said its technology and services can also help companies catch and fix problems that are occurring in clinical studies. Numoda will also provide researchers at Cleveland Clinic's Neurological Institute with information systems, reporting engines and administrative tools to help improve patient recruitment, budgeting and data flow.
Numoda, based in Philadelphia, also invests in private and public companies through a venture arm, Numoda Capital Innovations. It intends to invest in most of the drug companies it works with through this partnership with the Cleveland Clinic, according to Patrick Keenan, chief counsel and strategist for Numoda Capital Innovations.
Numoda is in the process of raising $150 million for Numoda Capital Innovations' fund, Keenan said. In the meantime, it has been investing capital from the management of Numoda Corp., and capital from Numoda affiliate Numoda Technologies Inc., he said.
This is the first time Numoda has formed an alliance of this type, but it may look to form other partnerships that are in the same vein, according to Keenan. The company, formed in 1997, has worked with a number of neurological-drug developers before, he said.
"Our core competency is making trials smarter, faster and less risky," Keenan said.
Numoda Capital typically invests in companies that are also clients of Numoda Corp. Portfolio companies include private companies MediQuest Therapeutics Inc. and Reata Pharmaceuticals Inc., and publicly traded Soligenix Inc. and Advaxis Inc.
Clinical Trials Manager Heads Into VC
An information- and process-management company that helps drug makers manage clinical trials is seeking to capture more of the upside from its clients’ success by taking equity stakes in the businesses through a new venture capital arm, reports VentureWire’s Brian Gormley.
Formed in 1997, Philadelphia-based Numoda Corp. provides biotech, diagnostic and
medical-device companies with technology and services to monitor patient recruitment, data
flow, and the financial and logistical aspects of clinical trials. It also can serve as the trial’s general contractor, hiring and overseeing contract-research organizations and other service providers.
Over the years, Numoda has used cash from its balance sheet to make small investments, usually in the low single-digit millions, in selected clients. Seeking to place larger bets in these companies, Numoda late last year formed a venture arm, Numoda Capital Innovations, and is now rounding up $150 million for its
first fund, Numoda Capital Innovations LP. The firm will soon announce the hiring of a professional with venture capital and investment-banking experience who will serve as Numoda Capital’s managing director, said Chief Executive Mary Schaheen, adding that this person would oversee fund-raising and investment activities.
While raising a first-time fund in this environment will be challenging, Schaheen said
Numoda’s track record of helping companies reduce the cost and risk of drug development should appeal to investors. Since companies these days need to stretch their cash further, services that help them run clinical trials more efficiently should be in demand, according to Numoda.
Formed in 1997, Philadelphia-based Numoda Corp. provides biotech, diagnostic and
medical-device companies with technology and services to monitor patient recruitment, data
flow, and the financial and logistical aspects of clinical trials. It also can serve as the trial’s general contractor, hiring and overseeing contract-research organizations and other service providers.
Over the years, Numoda has used cash from its balance sheet to make small investments, usually in the low single-digit millions, in selected clients. Seeking to place larger bets in these companies, Numoda late last year formed a venture arm, Numoda Capital Innovations, and is now rounding up $150 million for its
first fund, Numoda Capital Innovations LP. The firm will soon announce the hiring of a professional with venture capital and investment-banking experience who will serve as Numoda Capital’s managing director, said Chief Executive Mary Schaheen, adding that this person would oversee fund-raising and investment activities.
While raising a first-time fund in this environment will be challenging, Schaheen said
Numoda’s track record of helping companies reduce the cost and risk of drug development should appeal to investors. Since companies these days need to stretch their cash further, services that help them run clinical trials more efficiently should be in demand, according to Numoda.
Cleveland Clinic, Numoda partner to speed brain drugs to market
The Cleveland Clinic Neurological Institute is creating a hybrid
academic research organization through a partnership with Numoda Corp.
The Clinic will contribute the medical and clinical trial expertise of its doctors and researchers to the venture. Numoda in Philadelphia, Pennsylvania, will contribute its clinical trial management technology.
The goal is to speed effective neurological drugs to market and quickly weed out those that don’t work, while lowering the cost of drug development.
“This collaboration will marry advanced academic medical research center knowledge and expertise with administrative agility, allowing us to quickly develop life-enhancing and life-saving treatments,” said Mary Schaheen, Numoda’s CEO, in a Clinic release. “We want to make new treatments for neurological diseases available quickly and at lower costs.”
The “joint venture of equals” is aimed at developing a “one-stop
shop” for small and mid-sized drug companies that are sponsoring
clinical trials, said Dr. Robert Fox, the Clinic neurologist who is
co-directing the joint venture. The two organizations will start with
trials for neurological drugs but are likely to expand to other drug
types over time.
“The original concept was that large pharmaceutical companies like Merck and Johnson & Johnson typically have the expertise in-house to develop and implement clinical trials,” Fox said. “But the small- to medium-sized pharmaceutical companies often do not.
“So the idea was to match an academic medical center like Cleveland Clinic with a clinical research organization, which provides all the nuts and bolts of how a clinical trial works, to be one-stop shopping for a sponsor.”
The venture is expected to begin generating revenue to compensate Clinic researchers by Fall. Numoda is expected to benefit from a flow of new deals for its venture arm, Numoda Capital Innovations, according to Dow Jones Venture Wire (pdf).
Why start with neurological drugs?
“Neurological disorders affect millions of people around the world and represent a vast and growing need for new and improved treatment options,” Dr. Michael T. Modic, the Clinic’s chief emerging business officer, said in the release. “There is significant opportunity to develop novel treatments and therapies for neurological disorders, such as Alzheimer’s disease, and improve patient care, which is an integral part of Cleveland Clinic’s mission.”
How could the venture save money?
By shortening, streamlining and increasing the accuracy of the drug trial process, Fox said. And by ending trials of no-good drugs before drug sponsors and venture capitalists invest a lot of money in them, he said.
The venture also might act as a magnet to draw researchers to the Clinic’s medical school, Fox said. It also looks to be unique. Most academic research organizations such as the Duke Clinical Research Institute, are self-contained and don’t involve independent clinical trial IT companies like Numoda.
The Clinic will contribute the medical and clinical trial expertise of its doctors and researchers to the venture. Numoda in Philadelphia, Pennsylvania, will contribute its clinical trial management technology.
The goal is to speed effective neurological drugs to market and quickly weed out those that don’t work, while lowering the cost of drug development.
“This collaboration will marry advanced academic medical research center knowledge and expertise with administrative agility, allowing us to quickly develop life-enhancing and life-saving treatments,” said Mary Schaheen, Numoda’s CEO, in a Clinic release. “We want to make new treatments for neurological diseases available quickly and at lower costs.”
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“The original concept was that large pharmaceutical companies like Merck and Johnson & Johnson typically have the expertise in-house to develop and implement clinical trials,” Fox said. “But the small- to medium-sized pharmaceutical companies often do not.
“So the idea was to match an academic medical center like Cleveland Clinic with a clinical research organization, which provides all the nuts and bolts of how a clinical trial works, to be one-stop shopping for a sponsor.”
The venture is expected to begin generating revenue to compensate Clinic researchers by Fall. Numoda is expected to benefit from a flow of new deals for its venture arm, Numoda Capital Innovations, according to Dow Jones Venture Wire (pdf).
Why start with neurological drugs?
“Neurological disorders affect millions of people around the world and represent a vast and growing need for new and improved treatment options,” Dr. Michael T. Modic, the Clinic’s chief emerging business officer, said in the release. “There is significant opportunity to develop novel treatments and therapies for neurological disorders, such as Alzheimer’s disease, and improve patient care, which is an integral part of Cleveland Clinic’s mission.”
How could the venture save money?
By shortening, streamlining and increasing the accuracy of the drug trial process, Fox said. And by ending trials of no-good drugs before drug sponsors and venture capitalists invest a lot of money in them, he said.
The venture also might act as a magnet to draw researchers to the Clinic’s medical school, Fox said. It also looks to be unique. Most academic research organizations such as the Duke Clinical Research Institute, are self-contained and don’t involve independent clinical trial IT companies like Numoda.
Provectus Scores Points with Numoda Capital!
Just 3 days ago, Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http://www.pvct.com), signed an agreementwith Numoda Capital Innovations LLC (http://www.numodacapital.com) to license its TruPoints® strategic
partnering platform. Provectus plans to make PH-10, a therapy treatment of serious dermatological diseases,which recently showed positive Phase 2 clinical trial results in both Atopic Dermatitis and Psoriasis. In pursuit of this development, the company will use Numoda’s TruPoints to facilitate transactions with potential licensing partners for PH-10 and it will organize all due diligence material relating to the Phase 2 clinical trials.
The desired outcome of the agreement is to improve the flow of information to potential licensees. Numoda’s TruPoints platform already has an excellent reputation for helping numerous development stage biotech companies secure big pharma licensing agreements.Craig Dees, Ph.D., CEO of Provectus said, “As we actively seek to out-license PH-10, Numoda TruPoints will enable the exchange of scientific and business information between Provectus and potential partners. We expect this platform to play a critical role in the out-
licensing process when we formally engage an investment banker.” As for today, the Provectus-Numoda deal is already creating some buzz and showing consumer confidence with it's margins up by over 3% since the previous close.
partnering platform. Provectus plans to make PH-10, a therapy treatment of serious dermatological diseases,which recently showed positive Phase 2 clinical trial results in both Atopic Dermatitis and Psoriasis. In pursuit of this development, the company will use Numoda’s TruPoints to facilitate transactions with potential licensing partners for PH-10 and it will organize all due diligence material relating to the Phase 2 clinical trials.
The desired outcome of the agreement is to improve the flow of information to potential licensees. Numoda’s TruPoints platform already has an excellent reputation for helping numerous development stage biotech companies secure big pharma licensing agreements.Craig Dees, Ph.D., CEO of Provectus said, “As we actively seek to out-license PH-10, Numoda TruPoints will enable the exchange of scientific and business information between Provectus and potential partners. We expect this platform to play a critical role in the out-
licensing process when we formally engage an investment banker.” As for today, the Provectus-Numoda deal is already creating some buzz and showing consumer confidence with it's margins up by over 3% since the previous close.
JPMorgan Conference Lifts Biotech VC Hopes For Pharma Deals
Biotech venture capitalists expect a busy year of deal-making with pharmaceutical companies following a productive round of meetings at the J.P. Morgan Healthcare Conference this week.
With few companies going public, venture investors rely heavily on pharmaceutical M&A and licensing deals to secure returns and capital for portfolio companies. The J.P. Morgan conference in San Francisco, which concluded Thursday, is a key partnering event, and this year the tone of the discussions was particularly positive, venture investors said.
In 2009, drug manufacturers were consumed with consolidation and weighed down by the financial crisis. As a result, biotechs were unlikely to get full value from a deal, said Seth Harrison, managing partner of Apple Tree Partners.
But this year, pharmaceutical companies seemed ready to pay good prices for the right assets. “Now it feels like a ‘normal’ market, but [pharmas] feel like strong actors in it,” he said.
Competition is rising for these products, as smaller drug makers join Big Pharma in the bidding, some said. Even so, VCs aren’t expecting windfalls upfront. Drug manufacturers still have the upper hand, which means they’re more likely to agree to option deals in which they pay out in stages as a company’s drug proves itself in clinical trials. “No one’s expecting a
$400 million check these days,” said Christopher Ehrlich, a general partner at InterWest Partners. Pharmaceutical companies at the conference were looking to spin products out as well as bring them in, said Terrance McGovern, managing director, Numoda Capital Innovations, an investment affiliate of Numoda Corp. These companies have amassed more compounds than they can develop and are thus open to deals enabling them to monetize assets
they don’t have the resources do develop internally, he said. This can enable venture investors to piggyback on the substantial investment others have made in a program. Large drug makers, which hosted venture investors and biotech executives in hotel suites near the conference, weren’t always so hospitable to VCs or their companies. That began to change over the past few years as pharmaceutical pipelines thinned and as patent lives for top products started to run short. Now, they court VCs at conferences and venture capital events at their corporate offices.
If deal-making flourishes this year, it could help trigger the opening of a window for venture-backed biotech companies to go public, predicted InterWest’s Ehrlich. Like venture capitalists, public-market investors see more opportunity for a strong return when a company is sold than through share appreciation alone, he said.
While VCs were optimistic about the prospect for strategic deals, and even the potential of some companies to go public, they remain concerned about the venture industry’s ability to finance companies on its own. Insider rounds have
proliferated this past year and will remain common as long as venture firms struggle with their own fund-raising, some said.
“The really big question in the venture capital world is whether the window for raising new funds is going to open [soon] or not,” said David Collier, managing director of CMEA Capital.
But the best will find funding, and at good valuations this year, said Scott Minick, a former managing director of Arch Venture Partners who recently became chief executive of venture-backed Bind Biosciences Inc.
With few companies going public, venture investors rely heavily on pharmaceutical M&A and licensing deals to secure returns and capital for portfolio companies. The J.P. Morgan conference in San Francisco, which concluded Thursday, is a key partnering event, and this year the tone of the discussions was particularly positive, venture investors said.
In 2009, drug manufacturers were consumed with consolidation and weighed down by the financial crisis. As a result, biotechs were unlikely to get full value from a deal, said Seth Harrison, managing partner of Apple Tree Partners.
But this year, pharmaceutical companies seemed ready to pay good prices for the right assets. “Now it feels like a ‘normal’ market, but [pharmas] feel like strong actors in it,” he said.
Competition is rising for these products, as smaller drug makers join Big Pharma in the bidding, some said. Even so, VCs aren’t expecting windfalls upfront. Drug manufacturers still have the upper hand, which means they’re more likely to agree to option deals in which they pay out in stages as a company’s drug proves itself in clinical trials. “No one’s expecting a
$400 million check these days,” said Christopher Ehrlich, a general partner at InterWest Partners. Pharmaceutical companies at the conference were looking to spin products out as well as bring them in, said Terrance McGovern, managing director, Numoda Capital Innovations, an investment affiliate of Numoda Corp. These companies have amassed more compounds than they can develop and are thus open to deals enabling them to monetize assets
they don’t have the resources do develop internally, he said. This can enable venture investors to piggyback on the substantial investment others have made in a program. Large drug makers, which hosted venture investors and biotech executives in hotel suites near the conference, weren’t always so hospitable to VCs or their companies. That began to change over the past few years as pharmaceutical pipelines thinned and as patent lives for top products started to run short. Now, they court VCs at conferences and venture capital events at their corporate offices.
If deal-making flourishes this year, it could help trigger the opening of a window for venture-backed biotech companies to go public, predicted InterWest’s Ehrlich. Like venture capitalists, public-market investors see more opportunity for a strong return when a company is sold than through share appreciation alone, he said.
While VCs were optimistic about the prospect for strategic deals, and even the potential of some companies to go public, they remain concerned about the venture industry’s ability to finance companies on its own. Insider rounds have
proliferated this past year and will remain common as long as venture firms struggle with their own fund-raising, some said.
“The really big question in the venture capital world is whether the window for raising new funds is going to open [soon] or not,” said David Collier, managing director of CMEA Capital.
But the best will find funding, and at good valuations this year, said Scott Minick, a former managing director of Arch Venture Partners who recently became chief executive of venture-backed Bind Biosciences Inc.
events
Cowen Group 31st Annual Healthcare Conference
JP Morgan 11th Annual Healthcare Conference
Biotech Showcase 2011
One Med Forum
Rodman & Renshaw 12th Annual Healthcare Conference
Canaccord Adams Global Growth Conference
BMO Capital Markets, 10th Annual Focus on Healthcare Conference
JP Morgan 11th Annual Healthcare Conference
Biotech Showcase 2011
One Med Forum
Rodman & Renshaw 12th Annual Healthcare Conference
Canaccord Adams Global Growth Conference
BMO Capital Markets, 10th Annual Focus on Healthcare Conference
Numoda Capital Buys VitreoRetinal
Numoda Capital Innovations is reviving an effort to develop a drug for the blinding disease diabetic retinopathy that stalled in the hands of
venture-backed VitreoRetinal Technologies Inc.
The firm has acquired the assets of VitreoRetinal Technologies and will advance the company’s diabetic-retinopathy drug, Vitreosolve,
through a special-purpose entity it formed early this year, Innovations In Sight LLC.
VitreoRetinal, which raised a $9 million Series A round in 2007 from De Novo Ventures and individuals, turned its assets over to creditors
last year after clinical studies of Vitreosolve hit a snag. Numoda Capital bought Vitreosolve and other assets for an undisclosed amount
in September, said Terrance S. McGovern, Numoda Capital’s managing director. De Novo Managing Director Frederick Dotzler was not
available for comment.
Numoda Capital contends that VitreoRetinal mistakes caused its clinical studies to run aground. Through Innovations In Sight, a virtual
entity, it will either raise capital to run further clinical trials or find a corporate partner to fund them. Its ultimate goal is to sell the product or
license it out.
Innovations In Sight is funded by Numoda Capital, the venture arm of Numoda Corp., an information- and process-management company
that helps drug companies manage clinical trials.
Innovations In Sight plans to begin testing Vitreosolve in two, 225-patient Phase III trials next quarter. Numoda Corp. will be the general
contractor for the trials and will work to ensure they are carried out correctly, while technology from a Numoda Corp. affiliate, Numoda
Technologies Inc., will enable Innovations In Sight to track trial data as they are produced.
Poor study design and execution are what derailed Vitreosolve, according to Numoda, which hopes the product will emerge as the first drug
to treat diabetic retinopathy. In this disease, fragile blood vessels can grow into the back of the eye and leak blood and fluid, causing vision loss.
In Phase II clinical trials of Vitreosolve, which is injected into the eye, the drug showed that it can cause the vitreous, the eye’s transparent
inner filling, to separate from the retina, the light-sensitive tissue lining the back of the eye. This separation, known as posterior vitreous
detachment, appears to stall the disease by depriving blood vessels of nutrients.
VitreoRetinal targeted patients with severe nonproliferative diabetic retinopathy, the third of the condition’s four stages. The disease, whose
fourth and most-severe form is called proliferative diabetic retinopathy, is the most common diabetic-eye disease and is a leading cause of
blindness, according to the National Eye Institute.
VitreoRetinal ran into problems when it began Phase III studies, in which it intended to enroll a total of 450 patients. In a January 2010
interim analysis of 75 study participants, it found that control-arm patients--who got a miniscule dose of Vitreosolve--were faring almost as
well as those injected with the full dose.
Nine of the 25 control-arm subjects, or 36%, had a posterior vitreous detachment, while 26 of the 50, or 52%, of those getting the full dose
were found to have gotten that benefit, according to McGovern.
VitreoRetinal and prospective investors wanted to see a 20% or greater difference between the studies’ “active” and control arms. Unable to
raise more money, the company turned its assets over to creditors, who auctioned them off, McGovern said.
The trial results may have been diffe rent if VitreoRetinal had injected a true placebo--a dummy drug--instead of a low dose of Vitreosolve,
according to Numoda. When VitreoRetinal initiated the Phase III trial a couple years ago, it was not as common to inject drugs into the
vitreous as it is today, according to McGovern. As a result, the company feared that it wouldn’t be able to recruit patients to a study in
which some people would get a placebo, he said.
With the emergence of injected drugs such as Lucentis--a treatment for the wet form of age-related macular degeneration--intravitreal
injections are now more accepted, he said. In its Phase III studies, Innovations In Sight intends to inject saline instead of Vitreosolve into the
control-group patients. The company also plans to monitor study sites closely to ensure that the injection procedure is done correctly, he said.
Diabetic retinopathy is a slow-moving disease, and most drug companies are not keen on running long clinical trials to show that a particular
drug stops its march. Because clinicians generally agree that posterior vitreous detachment will stymie it, however, the Food and Drug
Administration has indicated that Vitreosolve can be approved if it causes vitreous detachment in Phase III trials, according to McGovern.
Innovations In Sight, based in Numoda Corp.’s Philadelphia offices, also has acquired another VitreoRetinal asset, Neurosolve, a glaucoma
drug that has yet to enter clinical trials. It will advance this drug as well, according to McGovern, who said the firm will also consider using
Innovations In Sight as a platform to acquire other ophthalmology medicines.
http://www.numodacapital.com
The firm has acquired the assets of VitreoRetinal Technologies and will advance the company’s diabetic-retinopathy drug, Vitreosolve,
through a special-purpose entity it formed early this year, Innovations In Sight LLC. VitreoRetinal raised a $9 million Series A round in
2007 from De Novo Ventures and individuals.
MichBio Expo Attendees Hear Ways to Get VC Funding for Startups
YPSILANTI -- In today's uncertain investment environment, biotech companies and venture capitalists are working together to make sure each side sees a return on its investment.
Ideas on how Michigan biotech companies can get funding from various sources and investment trends were among the subjects discussed during the 2010 MichBio Expo and Conference at the Marriott at Eagle Crest in Ypsilanti.
"There has been a decrease in number of biotech and medical investments overall," said Mary Schaheen, CEO of Philadelphia-based Numoda Corp. "But there have been a lot of very creative sources for funds: grants, alliances, high net worth investors and consolidation."
Schaheen said that companies need to think in terms of the system as a whole.
She also said that many CEOs are wearing many different hats.
"Oftentimes, you can't imagine a life-sciences CEO as a fundraiser," Schaheen said. "But they have to become a pitchman."
Getting the investment is one thing for a biotech company, she said, making sure they have a full plan from development to commercialization is something else.
"Some early-stage companies don't think about the commercialization," Schaheen said. "You always have to think about the end."
Thinking about that end is exactly what Vic Schmitt, venture partner with San Franciso-based Bay City Capital, looks at when deciding where to invest.
"When we look at investments, one of the most important things is trying to figure how we're going to get out," Schmitt said. "Getting in is easy. Getting out is hard."
From 2002-2007, venture capital investments in Michigan totaled $269 million. Despite the economic downturn in the past two years, venture capitalists are beginning to loosen their purse strings.
"In terms of traditional financing, venture capital seems to be coming back," said Mark Arizmendi, founder of Charlotte, N.C.-based Northwestern Capital Partners LLC. "You need to try to find investors, smart money people, who are in it for the long-term. There are a lot of people out there with deep pockets for young companies with great ideas."
But sometimes getting that money can be tricky.
"The pharmaceutical partners want to see data first, and the company needs money to get the data," Schaheen said. "It's a precarious place, like the chicken and the egg.
"Everybody wants the money returned for a higher amount, faster and more assured."
Greig Davis, managing member of Southfield-based Vo2 Ventures LLC, said he's seeing a lot more interest coming from individual investors who are looking for a long-term investment.
"They are a little more risk-tolerant to take a chance on a young company," he said.
Recent Stories
Zack's Investment Research(click here)
February 2012
Advaxis Reports Positive Phase II Trial Results
"...The study is designed to assess the safety and efficacy of ADXS-HPV for the treatment of CIN grade 2/3, which is late stage cervical dysplasia that requires surgery to prevent invasive cancer. Numoda Corporation is Advaxis’ strategic partner in the conduction and execution of this trial. "
One Med Place(click here)
January 2012
Advaxis CEO Tom Moore Interviewed by OneMedPlace Regarding Preliminary Data
"Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, reports that Thomas Moore, CEO & Chairman of Advaxis, was interviewed by Malini Chatterjee, Ph.D., Director of Research at OneMedPlace, to discuss the preliminary safety and survival data from the ongoing ADXS-HPV Phase 2 Trial in patients with recurrent/refractory cervical cancer in India that were presented at the World Cancer Immunotherapy Conference in San Diego on January 25, 2012.. "
About Us
Numoda Corporation is a fifteen-year-old company headquartered in Philadelphia, with operations in 50 countries.
Three organizations work in harmony and collaborate for improved clinical outcomes and investment results:
Numoda Corporation – integrates every aspect of clinical trial development under The Accountable General Contractor, with unparalleled accountability of all suppliers, groups and participants for the life sciences.
Numoda Technologies, Inc – builds and maintains the patented platforms of integrations, logistics management, and financial oversight for clinical development and efficient trial and data management.
Numoda Capital Innovations – enables life sciences companies to attract capital and partners while investing directly in companies with promising new therapies and treatments.
Three organizations work in harmony and collaborate for improved clinical outcomes and investment results:
Numoda Corporation – integrates every aspect of clinical trial development under The Accountable General Contractor, with unparalleled accountability of all suppliers, groups and participants for the life sciences.
Numoda Technologies, Inc – builds and maintains the patented platforms of integrations, logistics management, and financial oversight for clinical development and efficient trial and data management.
Numoda Capital Innovations – enables life sciences companies to attract capital and partners while investing directly in companies with promising new therapies and treatments.
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