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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.

(Press release, Horizon Discovery, JAN 7, 2014, View Source,%20collaboration%20and%20license%20agreement%20with%20astrazeneca [SID:1234505071])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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."