POSITIVE RESULTS IN GENENTECH PH II CLINICAL TRIAL OF GDC-0449 IN ADVANCED BASAL CELL CARCINOMA

On March 21, 2011 Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, reported a positive outcome from a pivotal Phase II clinical trial conducted by Roche and Genentech, Curis’ collaborator and a wholly owned member of the Roche Group, of GDC-0449, a first-in-class hedgehog pathway inhibitor, in patients with advanced basal cell carcinoma (BCC) (Press release, Cancer Research Technology, MAR 21, 2011, View Source [SID1234523524]). Genentech informed Curis that the study met its primary endpoint of achieving a target overall response rate, showing that GDC-0449 shrank advanced BCC tumors in a pre-defined percentage of people in the study. A preliminary safety assessment showed the most common adverse events were consistent with previous experience with vismodegib. A detailed safety assessment is ongoing. Roche has indicated that it anticipates making at least one regulatory submission in 2011 to seek approval to commercialize GDC-0449.

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Hedgehog was initially identified as a developmentally related gene in drosophila at the London Research Institute (Phil Ingham in collaboration with Harvard scientists). CRT subsequently licensed Hedgehog IP to Curis in 1995.

View the Curis press announcement for more information.

Apexigen Announces the Filing by its Partner, Simcere Pharmaceutical Group, of First IND

On March 11, 2011 Apexigen reported that its partner, Simcere Pharmaceutical Group filed an Investigational New Drug (IND) application with the State Food and Drug Administration (SFDA) of China to evaluate APX003 (also known as BD0801) as a potential cancer therapy (Press release Apexigen, MAR 11, 2011, View Source [SID:1234500905]). APX003 is a humanized monoclonal antibody directed against VEGF, and is intended for the treatment of multiple malignancies. Upon review and approval of the IND application by the SFDA, Simcere plans to initiate Phase 1 safety and tolerability studies in cancer patients.

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Simcere will develop and commercialize APX003 in China under a license agreement with Apexigen. In 2008, Simcere acquired rights to APX003 from Epitomics, Inc. Then in July of 2010, Epitomics created Apexigen as an independent therapeutic antibody company, licensed to Apexigen exclusive rights to the use of its antibody technologies for the development and commercialization of antibody therapeutics, and assigned to Apexigen the license and collaboration agreement with Simcere. Apexigen and Simcere collaborated on the IND enabling studies and on the completion of the IND for APX003.

The initiation of this Phase 1 clinical study will mark a significant milestone for Apexigen. APX003 will be the first humanized antibody generated through the use of its technology to be administered to humans.

"This is an exciting time for Apexigen. We are eager to see the first of our antibodies demonstrate safety, tolerability and efficacy in man as a first step toward the development of best-in-class therapeutics", said Dr. Xiaodong Yang, President & CEO of Apexigen. "The collaboration with Simcere has been very productive. We look forward to continuing to collaborate with Simcere on the clinical development program which will provide the first clinical validation of our technology."

"This IND filing is the outcome of dedicated effort and collaboration between Apexigen and Simcere," said Mr. Jinsheng Ren, chairman and chief executive officer of Simcere.

Biothera Acquires MUC1 Anti-Cancer Monoclonal Antibody from Antisoma

On March 10, 2011 Biothera reported that it has acquired the anti-cancer monoclonal antibody AS1402 from Antisoma for undisclosed terms (Press release Biothera, MAR 10, 2011, View Source [SID:1234500877]).

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AS1402 is a monoclonal antibody that targets an aberrant form of the cell-surface protein MUC1 that is widely expressed in many types of cancer. Prior to the acquisition, the experimental drug had been in Phase 2 development.

Biothera’s Imprime PGG is a novel immunotherapy that works synergistically with anti-tumor monoclonal antibodies. Imprime PGG activates the largest population of the body’s immune cells (neutrophils), enabling them to recognize and kill antibody-targeted cancer cells.

Biothera plans to study the combination therapy of Imprime PGG and AS1402 in future cancer trials. The indication(s) has (have) yet to be determined.

"We believe the combination of Imprime PGG and AS1402 could create a potent therapy to treat a wide range of cancers," said Dan Conners, President, Biothera Pharmaceutical Group.

"This deal gives Biothera the opportunity to pursue an interesting new approach with AS1402 while at the same time realising value for Antisoma," said Nicholas Adams, Vice President of Business Development at Antisoma.

Cancer Research Technology, The ICR and ZoBio BV sign deal to develop cancer drugs

On March 10, 2011 Cancer Research Technology (CRT) and The Institute of Cancer Research (ICR) reported to have signed a deal with Dutch drug discovery company, ZoBio BV, to discover and develop drugs to block a DNA repair target which may play a role in cancer cell survival (Press release, Cancer Research Technology, MAR 10, 2011, View Source [SID1234523326]).

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CRT will manage commercialisation arising from any potential drug compounds discovered through the collaboration and will share a portion of future revenues with ZoBio and the ICR.

The collaboration will combine the ICR’s expertise in drug discovery and target validation* – proving a protein’s importance as a therapeutic target – with ZoBio’s patented drug fragment screening technology called TINS**, to identify small molecules that bind to and block the DNA repair target.

DNA damage occurs during each cell division. If DNA damage is allowed to accumulate, cells will stop dividing and may eventually die.

Healthy cells use several different routes to identify and repair DNA damage. But cancer cells, which divide rapidly and accumulate more DNA damage, often have faults with a major DNA repair process. They are forced to rely on "back-up" routes.

Potential drugs developed through the new collaboration would block one of the remaining alternative repair routes. This would cause cancer cells to quickly build up DNA damage and die.***

It is also expected that these drugs would increase the effectiveness of common chemotherapies, which work by causing more DNA damage than cancer cells can repair.

Healthy cells could tolerate this type of drug as they divide more slowly and retain their main repair machinery which provides effective DNA repair.

Dr Phil L’Huillier, CRT’s director of business development, said: "Cancer Research UK and The ICR have already made strides in breast cancer treatment by blocking two DNA repair routes at once – people missing the DNA repair protein BRCA can be treated with a drug blocking PARP, an enzyme on a different DNA repair pathway.

"This approach is delivering impressive clinical trial results which could lead to better survival.

"We hope that similar drugs identified through the collaboration could also have promising results, ultimately increasing survival from a range of cancers."

The project started as a collaboration between Professor Alan Ashworth from the Breakthrough Breast Cancer Research Centre at the ICR, who completed initial validation* studies, and Professor Paul Workman from the Cancer Research UK Cancer Therapeutics Unit at the ICR, who will lead the drug discovery programme.

Professor Ashworth, Chief Executive of the ICR, says: "Collaborations such as this – that pairs our cancer expertise with cutting-edge technology – are key to developing new therapeutics which we hope will increase survival from cancer in the future."

Dr. Gregg Siegal, Chief Scientific Officer of ZoBio, said: "We are excited to work with ICR on such an exciting and novel target. We are convinced that we can provide valuable starting matter through the use of TINS where other approaches have failed."

Dr L’Huillier, added: "This innovative collaboration brings together skills and knowledge from the world’s top experts in industry and academia to beat cancer."

BIOTHERA ACQUIRES MUC1 ANTI-CANCER MONOCLONAL ANTIBODY FROM ANTISOMA

On March 10, 2011 Biothera reported that it has acquired the anti-cancer monoclonal antibody AS1402 from Antisoma for undisclosed terms (Press release, Cancer Research Technology, MAR 10, 2011, View Source [SID1234523525]).

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AS1402 is a monoclonal antibody that targets an aberrant form of the cell-surface protein MUC1 that is widely expressed in many types of cancer. Prior to the acquisition, the experimental drug had been in Phase 2 development. AS1402 was originally developed by CRT.

To find out more, visit the Biothera website.