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.
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