On January 18, 2016 iTeos Therapeutics SA, a biotechnology company with a track record of delivering therapeutics targeting the immune tumor micro-environment, reported a new partnership for the discovery, development and commercialization of multiple, antibody-based therapeutic programs with Adimab, LLC (Press release, iTeos Therapeutics, JAN 18, 2016, View Source [SID:1234513303]). Under the terms of the agreement, Adimab will utilize its antibody discovery and optimization platform to identify fully human therapeutic antibodies against targets selected by iTeos Therapeutics. All product development, including manufacturing and clinical trials, will be coordinated by iTeos Therapeutics.

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"We are very pleased to enter into this partnership with an emerging leader in the oncology field. iTeos has a strong management team and has demonstrated the capability to quickly develop valuable therapeutic programs," said Tillman Gerngross, Chief Executive Officer of Adimab. "We are looking forward to applying the Adimab platform to discovering and engineering antibodies for iTeos."

"Adimab is clearly an excellent strategic partner for iTeos Therapeutics. The speed and the quality of Adimab’s platform has consistently generated candidate drugs that are superior to the output from competing technologies," said Christophe Quéva, Chief Scientific Officer of iTeos. "We are convinced that the Adimab platform will rapidly deliver to iTeos antibody drug candidates which will be clinically evaluated as monotherapy and in combination with leading immuno-oncology drugs to develop iTeos’ pipeline and partnering potentials for the benefit of patients with cancer."

Over the past six years, Adimab has established partnerships with multiple leading pharmaceutical companies, including Merck, Roche, Novartis, Lilly, Genentech, Biogen, Novo Nordisk, Gilead, Kyowa Hakko Kirin, and GSK. Adimab’s partnerships range from single target funded discovery projects, to larger multi-target funded discovery collaborations, as well as full transfer and enablement of the Adimab Platform to pharmaceutical companies. These collaborations focus on IgG discovery, optimization, humanization and/or bispecifics for therapeutic products.

(Filing, 10-Q, Generex, JAN 14, 2016, View Source [SID:1234508793])

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On January 14, 2016 GP Pharm reported that it has recently launched Lutrate Depot trimestral in Spain (Press release, GP Pharm, JAN 14, 2016, View Source [SID1234591043]). Lutrate Depot is a new microsphere formulation of leuprolide acetate. The product is based on the in-home based patented technology of GP Pharm and is indicated for the treatment of prostate cancer. The product complements the offer of GP Pharm in the Spanish market where the 1 month formulation was currently available.

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On January 14, 2016 Apogenix, a biopharmaceutical company developing next generation immuno-oncology therapeutics, reported that it has received Notices of Allowance from the U.S. Patent and Trademark Office for two key patents for lead immuno-oncology candidate APG101 (Press release, Apogenix, JAN 14, 2016, View Source [SID1234524580]). The so-called method of use patent covers the use of CD95 ligand inhibitors, such as APG101, for the treatment of glioblastoma. This patent is valid at least until 2029. The so-called composition of matter patent protects APG101 as a product as well as its manufacturing process at least until 2033.

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"Apogenix already has a broad patent portfolio covering APG101. These two patents greatly expand the protection of APG101 and its use in the treatment of glioblastoma," said Thomas Hoeger, Ph.D., CEO of Apogenix. "The prospective granting of these two patents in the most important pharmaceutical market further validates our innovative drug development approach and the therapeutic potential of CD95 ligand inhibitors for the treatment of malignant brain tumors, among other indications."

The efficacy, safety, and tolerability of APG101 were demonstrated in a controlled phase II proof-of-concept trial in patients with recurrent glioblastoma. Treatment with APG101 in combination with radiotherapy has shown clinical superiority in all study endpoints compared to treatment with radiotherapy alone, resulting in an overall survival benefit in glioblastoma patients treated with APG101. Interim data of a phase I trial with APG101 for the treatment of myelodysplastic syndromes further indicate the efficacy of APG101 in this hematological disease.

On January 14, 2016 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a clinical-stage pharmaceutical company, reported the initiation of Selinexor in Advanced Liposarcoma ("SEAL"), a new Phase 2/3 clinical trial with oral selinexor, the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound that inhibits exportin 1 (XPO1)(Filing, 8-K, Karyopharm, JAN 14, 2016, View Source [SID:1234508821]).

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SEAL is a multi-center, randomized, double-blind, placebo-controlled Phase 2/3 clinical trial evaluating single-agent oral selinexor in patients with advanced unresectable dedifferentiated liposarcoma. Patients will be randomized to receive either 60mg of selinexor or placebo given twice weekly per six week cycle until progression or intolerability. Fifty patients are expected to be enrolled in the Phase 2 portion of the study, with the potential to increase enrollment in the Phase 3 portion following an interim analysis. The primary endpoint of progression free survival (PFS) was acceptable to the Food and Drug Administration (FDA). Top-line data from the Phase 2 portion of this study are expected in early 2017.

"The rationale for SEAL is based on data from a Phase 1b study demonstrating durable stable disease with single-agent selinexor in patients with liposarcoma and other sarcomas," said Mrinal M. Gounder, MD, Attending Physician, Sarcoma Service and Developmental Therapeutics Service, Memorial Sloan Kettering Cancer Center, and Lead Investigator of the SEAL trial. "These data, presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2015 Annual Meeting in June, showed durable responses in liposarcoma, leiomyosarcoma and other sarcomas. Patients with liposarcoma appeared to benefit the most with selinexor, showing an improvement in progression free survival compared to previous chemotherapies." In the Phase 1b study, selinexor showed longer disease control duration compared to the patient’s most recent prior therapy, with 14 of 18 liposarcoma patients (78%) achieving stable disease, including six (43%) of these fourteen patients achieving stable disease for greater than four months.

"With a less-than-5% five-year survival rate for recurrent and high-grade forms of liposarcoma, there are few effective treatment options for these uncommon, difficult to treat tumors that arise from the body’s fat tissue," said Sant P. Chawla MD, Director, Santa Monica Oncology Center, Sarcoma Oncology Center. "Extending progression free survival is an important goal for these patients, in whom the rapid progression of disease frequently translates into early mortality. I look forward to seeing how encouraging early results from selinexor in sarcomas, in which extended disease stabilization was observed, translate to this larger outcome study."

"With our pivotal clinical strategy for selinexor in hematologic malignancies moving toward several key top line readouts, initiation of the SEAL study signals an important expansion of this strategy into solid tumors," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "We believe selinexor offers the potential to provide a still deeply underserved liposarcoma patient population with a new therapeutic option. We look forward to the advancement of this study and to the launch of additional randomized studies of selinexor in solid tumors, as well as hematologic malignancies, where high unmet medical needs persist."