In January 9, 2014 Five Prime Therapeutics reported a sponsored research collaboration agreement with Adimab (Press release Five Prime Therapeutics, JAN 9, 2014, View Source [SID:1234500859]). Five Prime will provide multiple targets to Adimab for the discovery and optimization of therapeutic monoclonal antibodies initially focused in cancer immunotherapy.

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Under the terms of the collaboration agreement, Adimab will use its proprietary discovery and optimization platform to identify fully-human antibodies for Five Prime. This agreement will grant Five Prime the right to develop and commercialize antibodies generated during the collaboration for potential use as therapeutic products. While financial terms were not disclosed, Adimab will be eligible to receive potential research funding, option payments, milestone payments and royalties.

"Five Prime is in an ideal position to leverage our robust protein discovery platform and our oncology experience to advance new targets and molecules for cancer immunotherapy," said Lewis T. "Rusty" Williams, M.D., Ph.D., President and Chief Executive Officer of Five Prime. "Adimab’s ability to rapidly and effectively generate therapeutic monoclonal antibody candidates should allow us to move quickly from targets to products, as we expand our research and development efforts in this promising therapeutic area."

"We are pleased to be entering into this partnership with Five Prime," said Tillman Gerngross, Co-Founder and Chief Executive Officer of Adimab. "Five Prime’s productive high-throughput protein screening capabilities, in combination with our antibody discovery platform, have the potential to lead to the development of exciting new therapeutic agents and we look forward to collaborating in this effort."

On January 9, 2014 the Avillion Group reported that it has entered into an exclusive collaborative development agreement with Pfizer Inc. to conduct a global Phase 3 clinical trial of Pfizer’s BOSULIF (bosutinib) (Press release, Avillion, JAN 9, 2014, View Source [SID:1234502188]).

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The trial, which will be conducted across multiple sites in the United States, Asia and Europe, will evaluate BOSULIF, administered at a starting dose level of 400 mg daily, as a first-line treatment for patients with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML).

Under the terms of the agreement, Avillion will provide the funding for and will conduct the trial to generate the clinical data necessary to potentially support a registration dossier for marketing authorization of BOSULIF by regulatory authorities for an indication as first-line treatment of patients with chronic phase Ph+ CML. If approved for this indication, Avillion will be eligible to receive milestone payments from Pfizer upon regulatory approval of the drug. Pfizer will retain all rights to commercialize BOSULIF globally.

"We are delighted to announce Avillion’s agreement with Pfizer, a global leader in the biopharmaceutical industry, and we look forward to working with them with the goal of advancing the development of BOSULIF and expanding its availability to a broader range of CML patients," said Lewis Cameron, CEO of Avillion. "Avillion offers pharmaceutical and biotech companies a compelling option to partner late-stage drug development projects. We have an experienced team focused on global drug development and regulatory approval, with the capability to optimise contract research organization (CRO) management."

"Chronic myelogenous leukemia remains a difficult disease to treat despite recent advances," said Garry Nicholson, president and general manager, Pfizer Oncology. "Today, the distinct tolerability profile of BOSULIF offers physicians an important therapeutic choice for their patients with Ph+ CML, as has already been shown in patients who are resistant or intolerant to prior therapy. Through our collaboration with Avillion, we plan to expand the development of BOSULIF by exploring its potential benefit as a first-line therapy for patients with CML."

BOSULIF is an oral, once-daily, TKI which inhibits the Bcr-Abl kinase that promotes CML; it is also an inhibitor of Src-family kinases. BOSULIF is currently approved in the U.S. for the treatment of adult patients with Ph+ CML with resistance or intolerance to prior therapy and offers an important treatment option for these patients. In Europe, BOSULIF was granted conditional marketing authorization for the treatment of adult patients with Ph+ CML previously treated with one or more TKIs and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

On January 8, 2014 Eddingpharm reported that an asset purchase agreement has been signed with ACT Biotech, Inc. (ACT Biotech), a biopharmaceutical company based in the United States. Eddingpharm acquired worldwide rights to three small molecule drug assets (Telatinib, ACTB1003, and ACTB1010) and other molecules from ACT Biotech (Press release, Eddingpharm, JAN 8, 2014, View Source [SID1234527684]). Eddingpharm made an upfront payment to ACT Biotech upon the closing of the transactions contemplated under the APA. ACT Biotech is also eligible to receive clinical, regulatory, and commercial milestone payments. The total consideration, including the upfront payment, may reach up to U.S. $95 million.

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The lead asset,Telatinib, is a VEGFR inhibitor ready for Phase III development for gastric cancer. The other two programs ACTB1003 (FGFR/VEGFR2 inhibitor) and ACTB1010 (Aurora kinases inhibitor) are in Phase I-ready and preclinical stages, respectively. Eddingpharm plans to initiate trials for Telatinib in China and continue the development that ACT Biotech started in the U.S. Eddingpharm also intends to take the other two assets into clinical development in either the U.S. or China.

Eddingpharm founder and CEO Xin Ni commented, "Eddingpharm is pleased to expand its oncology portfolio by acquiring global rights to these three promising compounds. We look forward to resuming ACT Biotech’s work by advancing these important drugs to the next phase of trials in the U.S., China, and beyond."

This transaction represents the next step in Eddingpharm’s growth strategy and commitment to oncology. Owning the global rights to these innovative products will allow Eddingpharm to optimize its development strategies for China and the rest of the world.

Bernard Peperstraete, MD, Acting President and Chief Executive Officer of ACT Biotech commented, "We believe that this transaction represents an attractive opportunity for ACT Biotech, its stockholders and for cancer patients, and we are delighted that ACT’s promising oncology portfolio will be further developed by such a strong and internationally well-positioned partner." John Costantino, managing partner at NGN Capital, ACT Biotech’s lead investor, noted, "Eddingpharm’s experience in commercializing oncology products promises to accelerate and further unlock the full potential of these potent cancer compounds."

Purchased Assets

Telatinib
Telatinib, is a potent and selective small molecule VEGFR inhibitor ready for Phase III in gastric cancer, a leading cause of cancer-related death in China. Telatinib stands out in the well-validated VEGFR space for its manageable safety profile and promising objective response rates across the 300 patients treated to this point. Telatinib is currently ready for Phase III with trial design supported by the FDA and EMA, and a Special Protocol Assessment (SPA) was granted by the FDA.

ACTB1003
Phase I-ready ACTB1003 inhibits both FGFR and VEGFR2. The asset has a strong pharmacological profile.

ACTB1010
ACTB1010 is an Aurora kinase inhibitor in preclinical development.

On January 7, 2014 Sutro Biopharma reported that it has entered into a collaboration agreement with Memorial Sloan-Kettering Cancer Center to use Sutro’s proprietary cell-free protein synthesis technology to produce bispecific antibodies that were discovered by Memorial Sloan-Kettering for the treatment of neuroblastoma in children (Press release Sutro Biopharma, JAN 7, 2014, View Source [SID:1234500756]).

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"Neuroblastoma is the most common extra-cranial solid tumor in children, and long-term survival for children with advanced disease diagnosed after 18 months of age is unsatisfactory despite aggressive chemotherapy," said Trevor Hallam, Ph.D., chief scientific officer of Sutro. "Sutro’s technology allows the generation, and importantly, the rapid screening of a large number of variations of bispecific antibodies. This will enable us to take bispecific antibodies with the desired characteristics faster into the clinic and potentially provide pediatric neuroblastoma patients with a much needed effective treatment option to combat this disease."

Under the collaborative agreement Sutro will use its cell free protein synthesis technology to produce four different bispecific antibodies discovered by Memorial Sloan-Kettering. These antibodies will be directed against CD3 on T-cells and, as the second target, against the ganglioside GD2, which is expressed on the surface of human neuroblastoma cells, as well as in melanoma and osteosarcoma. Nai-Kong V. Cheung, M.D., Ph.D., head of Memorial Sloan-Kettering’s Neuroblastoma program, will use preclinical models to test the bispecific antibodies manufactured by Sutro.

Dr. Cheung added, "We and others have previously shown that the use of an anti-CD3 and anti-GD2 bispecific antibody has a strong scientific rationale, and anti-GD2 monoclonal antibodies targeting the ganglioside GD2 have demonstrated efficacy in clinical trials in pediatric neuroblastoma. We hope that the use of Sutro’s technology will facilitate a more rapid, high-throughput optimization of these bispecific antibodies in the future, and allow us to investigate novel variants of these molecules quickly before bringing the winner to the clinic."

January 13, 2014 Apogenix, a clinical stage biopharmaceutical company, reported the successful completion of its phase II proof-of-concept trial with APG101 in patients with recurrent glioblastoma. All endpoints of the randomized controlled trial that compared the efficacy and safety of a combination therapy of APG101 and radiotherapy versus radiotherapy alone were achieved or exceeded. During treatment with APG101 for up to two years, no drug-related serious adverse events were observed, underlining the excellent safety profile and very good tolerability of APG101. The study’s primary endpoint – progression-free survival at six months (PFS6) – was met with a statistically significant fivefold improvement in the rate of patients reaching PFS6, as previously reported (Press release, Apogenix, JAN 7, 2014, View Source [SID1234524581]). The results demonstrate that patients having a newly-identified epigenetic biomarker associated with the CD95 ligand – the target of APG101 – experienced the greatest benefit from treatment with APG101. The trial showed a statistically significant (p=0.003) prolongation of overall survival in biomarker-positive patients treated with APG101, with a median overall survival of 16.1 months compared to 6.5 months in patients treated with radiotherapy alone. This biomarker will be validated in future clinical trials and in additional indications.
"The results of the trial have exceeded our expectations," said Harald Fricke, M.D., Chief Medical Officer of Apogenix. "Besides Temodar and Gliadel, APG101 is the first drug candidate in nearly 20 years that has demonstrated a substantial increase in overall survival in a randomized controlled phase II trial. All clinical endpoints show a clear advantage of the treatment group over the control group and thus demonstrate the clinical efficacy of APG101 in the treatment of recurrent glioblastoma."

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"We are currently developing a companion diagnostic to identify patients who will most likely respond best to treatment with APG101, so glioblastoma patients can benefit from a personalized treatment approach. Apogenix is in close consultation with the regulatory authorities EMA and FDA to agree on a development strategy toward rapid approval of APG101 for the treatment of glioblastoma," Harald Fricke added.

The complete data set will be published in a high-impact medical journal. Thomas Hoeger, Ph.D., Chief Executive Officer of Apogenix, will present a summary of the results at the Biotech Showcase in San Francisco. The presentation will take place on Tuesday, Jan. 14, at 4 p.m. PST at the Parc 55 Wyndham San Francisco – Union Square.

About the Phase II Trial in Recurrent Glioblastoma
A total of 84 patients at 25 clinical sites in Germany, Austria, and Russia participated in this randomized controlled phase II efficacy trial in recurrent glioblastoma. Patients were eligible for inclusion if they suffered from first or second relapse of glioblastoma and were refractory to standard therapy. Patients randomized into the APG101 arm were treated until further disease progression. At this time, there are still seven surviving patients in the treatment group and one patient in the control group who are being monitored in order to collect overall survival data.