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highlights from Innate Pharma’s R&D update

On April 10, 2014 Innate Pharma reported its clinical development plan for IPH2201 (Press release Innate Pharma, APR 10, 2014, View Source [SID:1234500393]). Clinical trials are expected to begin in 2014, and three indications have been prioritized:

Head and Neck cancer:
* Single-arm single-agent Phase II trial of IPH2201 in patients with metastatic or recurrent platinum refractory squamous cell carcinoma of the Head and Neck;
* Single-arm Phase II trial of IPH2201 combined with cetuximab in patients with metastatic or recurrent platinum refractory squamous cell carcinoma of the Head and Neck;

Chronic Lymphocytic Leukemia (CLL):
* Single-arm Phase II trial of IPH2201 combined with ibrutinib in relapsed/refractory CLL patients;

Ovarian cancer:
* Single-arm single-agent Phase II trial of IPH2201 in platinum resistant ovarian cancer patients;

* Single-arm Phase II trial of IPH2201 combined with physician choice in platinum resistant ovarian cancer patients.

AVEO and Biodesix Partner to Co-Develop and Commercialize Ficlatuzumab with a Companion Diagnostic for Treatment of NSCLC

On April 10, 2014 AVEO Oncology and Biodesix announced that they have entered into a worldwide agreement to develop and commercialize AVEO’s hepatocyte growth factor (HGF) inhibitory antibody ficlatuzumab, with a Biodesix companion diagnostic test (Press release AVEO, APR 10, 2014, View Source [SID:1234500386]). This agreement and the clinical development program will leverage VeriStrat, a serum protein test that is commercially available to help physicians guide treatment decisions for patients with advanced non-small cell lung cancer (NSCLC). VeriStrat will be used as the selection assay to identify NSCLC patients most likely to benefit from ficlatuzumab.
An exploratory analysis from AVEO’s Phase 2 study in first-line NSCLC suggested that VeriStrat was prognostic for outcome in the epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI)-treated patients and predicted differential treatment benefit for the combination of ficlatuzumab plus TKI over TKI alone. The predictive effect was observed in both progression-free survival and overall survival endpoints.
Under the terms of the agreement, AVEO will conduct a proof of concept study of ficlatuzumab in combination with erlotinib in advanced NSCLC patients selected using the VeriStrat test. Biodesix will fund up to $15 million of the cost of the study. The companies expect to initiate this clinical study later this year. Any additional development, regulatory and commercial costs for ficlatuzumab beyond the proof of concept study will be shared equally as will any potential profits. Subject to regulatory approval, AVEO will lead worldwide commercialization of ficlatuzumab. Biodesix will be responsible for all development, including FDA engagement activities, sales and marketing costs for VeriStrat, and will retain total revenues for sales of VeriStrat.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Immune Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Press release Immune Pharmaceuticals, APR 9, 2014, View Source [SID1234500392]).

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Apeiron Signs Regional License Agreements for the Commercialization of its Neuroblastoma Therapy

On January 9, 2014 APEIRON Biologics reported the signing of two transactions as part of the worldwide commercialization of APN311, an antibody-based immunotherapy in development for the treatment of children suffering from high-risk neuroblastoma (Press release, Apeiron Biologics, APR 9, 2014, View Source [SID:1234502250]).

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Medison Pharma ("Medison"), Israel’s leading marketing group for innovative niche healthcare solutions, and Gen İlaç ve Sağlık Ürünleri ("Gen Ilac"), a leading supplier of orphan drugs for the treatment of rare diseases in Turkey, entered into license agreements with Apeiron, under the terms of which they receive the exclusive rights to market and sell APN311 in Israel and Turkey, respectively.

Today Apeiron announced the signing of license agreements with Medison and Gen Ilac. The two deals grant Medison and Gen Ilac exclusive rights to market and sell APN311 in Israel and Turkey, respectively. These transactions are part of Apeiron’s ongoing activities for worldwide commercialization of its immunotherapy portfolio against high-risk neuroblastoma. APN311 is the most advanced biologic in Apeiron’s development pipeline that focuses on immunologic therapies of cancer. Further details or financial terms of the transaction were not disclosed.

Hans Loibner, PhD, CEO of Apeiron, commented, "Based on very positive clinical data and the advanced development status of APN311 we are actively engaged in discussions with potential partners around the world for commercialization of this immunotherapy. After a first agreement with Paladin Labs we are pleased to now close these two deals with Medison and Gen Ilac. This represents a further important step in Apeiron’s efforts and commitment to improve therapeutic options for children suffering from life-threatening high-risk neuroblastoma."

Meir Jakobsohn, Medison’s Founder & CEO, commented, "We are proud of the new agreement with Apeiron that reflects Medison’s continuous ambition to provide breakthrough and lifesaving treatments for today’s most urgent medical needs. One of Medison’s main focuses is providing medications in the field of pediatric oncology, in niches with unmet need. Apeiron’s treatment fits exactly to Medison’s mission."

Abidin Gülmüs, CEO of Gen Ilac, added, "We are proud of our reputation as one of Turkey’s leading specialty pharma companies, but even more important to us is the difference we make to the lives of people with life-threatening conditions. We look forward to a successful partnership with Apeiron, together providing oncologists with the opportunity to treat high-risk neuroblastoma patients. We aspire to make APN311 available for Turkish patients as soon as possible."

Halozyme Announces Clinical Hold of PEGPH20 Pancreatic Cancer Trial Following Voluntary Halt of Trial by Halozyme

On April 9, 2014 Halozyme Therapeutics reported that the United States Food and Drug Administration (FDA) informed the company yesterday that a clinical hold has been placed on patient enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial (Study 202/NCT01839487) evaluating PEGPH20 in patients with pancreatic cancer (Press release Halozyme, APR 9, 2014, View Source [SID:1234500391]). According to the FDA, this action was being taken in view of the company’s recent decision to temporarily halt enrollment and dosing of PEGPH20 in the Phase 2 trial.
“As announced earlier, we are gathering information relevant to assessing the possible difference in the thromboembolic event rate between the patients treated with PEGPH20 versus the patients treated without PEGPH20 in the trial. We will be providing this information to the Data Monitoring Committee and the FDA in parallel so they can complete their respective assessments,” stated Dr. Helen Torley, President and CEO. “Pancreatic cancer has one of the lowest survival rates of any cancer. We remain committed to evaluating PEGPH20 as a possible therapy to address this devastating disease.”