iTeos Therapeutics Enters Into Therapeutic Antibody Discovery Partnership with Adimab

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.

U.S. FDA ACCEPTS FOR PRIORITY REVIEW sNDA FOR EISAI’S ANTICANCER AGENT LENVATINIB SEEKING APPROVAL FOR RENAL CELL CARCINOMA

On January 18, 2016 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) submitted by its U.S. subsidiary Eisai Inc. for Eisai’s in-house developed novel anticancer agent lenvatinib mesylate (generic name, "lenvatinib") for use in the treatment of advanced or metastatic renal cell carcinoma, and granted the sNDA Priority Review status (Press release, Eisai, JAN 18, 2016, View Source [SID:1234508800]).

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The FDA’s Priority Review designation is assigned to applications for drugs that would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. Through this process, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) of May 16, 2016, 6 months after the sNDA was submitted. Furthermore, lenvatinib has received a Breakthrough Therapy designation from the FDA. In addition, an application seeking approval for use in the treatment of renal cell carcinoma was submitted in Europe in January 2016, and Eisai intends to discuss further steps regarding submission strategies for this potential indication with the regulatory authorities in Japan as well.

This sNDA was based on a Phase II clinical study (Study 205)1 that compared the safety and efficacy among three groups including a combination of lenvatinib (18 mg) plus everolimus (5 mg), lenvatinib alone (24 mg) and everolimus alone (10 mg) in unresectable advanced or metastatic renal cell carcinoma following one prior vascular endothelial growth factor-targeted therapy. From the results of the study, the group who received the combination of lenvatinib plus everolimus demonstrated a significant extension in progression free survival (PFS), the study’s primary endpoint, compared to the everolimus alone group. Additionally, the lenvatinib alone group demonstrated an extension in PFS compared to the everolimus alone group. Both the lenvatinib plus everolimus group and the lenvatinib alone group showed an improvement in objective response rate compared to the everolimus alone group. The most common treatment-emergent adverse events (TEAEs) reported in the lenvatinib plus everolimus group were diarrhea, decreased appetite and fatigue. The most common TEAEs of Grade 3 or higher were diarrhea, hypertension and fatigue.

The number of patients with kidney cancer in the United States is estimated to be approximately 58,000,2 and renal cell carcinoma comprises more than 90% of all malignancies of the kidney.3 For advanced or metastatic renal cell carcinoma that is difficult to treat with surgery, the standard treatment is molecular targeted drug therapy, however with low 5-year survival rates, this remains a disease with significant unmet medical need.

Currently lenvatinib has been launched under the brand name Lenvima in the United States, Japan and Europe for use in the treatment of refractory thyroid cancer*. Eisai is committed to exploring the potential clinical benefits of lenvatinib in order to further contribute to patients with cancer and their families.

< Notes to editors >

1. About lenvatinib mesylate (generic name, "lenvatinib")
Lenvatinib is an orally administered multiple receptor tyrosine kinase (RTK) inhibitor with a novel binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors (VEGFR1, VEGFR2 and VEGFR3) and fibroblast growth factor (FGF) receptors (FGFR1, FGFR2, FGFR3 and FGFR4) in addition to other proangiogenic and oncogenic pathway-related RTKs (including the platelet-derived growth factor (PDGF) receptor PDGFRα; KIT; and RET) involved in tumor proliferation.
Currently, Eisai has obtained approval for lenvatinib in the United States, Japan, Europe, Korea and Canada as a treatment for refractory thyroid cancer, and is undergoing regulatory review throughout the world including in Asia, Russia, Australia, Brazil and Mexico. More specifically, Eisai has obtained approval for the agent indicated in the United States for treatment for locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer, in Japan for the treatment of unresectable thyroid cancer, and in Europe for the treatment of adult patients with progressive, locally advanced or metastatic differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine, respectively. Meanwhile, Eisai is conducting a global Phase III study of lenvatinib in hepatocellular carcinoma as well as Phase II studies of lenvatinib in several other tumor types such as endometrial carcinoma and biliary tract cancer.

2. About the Phase II Clinical Study (Study 205)1
Study 205 was a multicenter, randomized, open-label study of the combination of lenvatinib (18 mg) plus everolimus (5 mg), lenvatinib alone (24 mg), and everolimus alone (10 mg) in patients with unresectable advanced or metastatic renal cell carcinoma following one prior VEGF-targeted therapy, and was conducted in Europe and the United States. 153 patients were randomized in a 1:1:1 ratio to one of three treatment arms to compare the efficacy and safety of these three regimens.
From the results of the study, the combination of lenvatinib plus everolimus group demonstrated a significant extension in the study’s primary endpoint of progression free survival (PFS) compared to the everolimus alone group (median PFS for the lenvatinib plus everolimus group: 14.6 months vs median PFS for the everolimus alone group: 5.5 months; Hazard Ratio (HR) 0.40 [95% CI: 0.24-0.68], p=0.0005). Additionally, median PFS for the lenvatinib alone group was 7.4 months, demonstrating an extension in PFS compared to the everolimus alone group (HR: 0.61 [95% CI: 0.38-0.98]).
The study also assessed objective response rate (ORR) and overall survival (OS) as secondary endpoints. Regarding ORR, both the lenvatinib plus everolimus group and the lenvatinib alone group showed an improvement in ORR compared to the everolimus alone group (lenvatinib plus everolimus: 43%, lenvatinib alone: 27%, everolimus alone: 6%). Furthermore, regarding OS, an updated analysis carried out in December 2014 suggested that lenvatinib plus everolimus extends OS compared to everolimus alone (HR 0.51 [95% CI=0.30-0.88]).
The most common treatment-emergent adverse events (TEAEs) reported in the lenvatinib plus everolimus group were diarrhea, decreased appetite and fatigue. The most common TEAEs of Grade 3 or higher (Common Terminology Criteria for Adverse Events) were diarrhea, hypertension and fatigue.

3. About Renal Cell Carcinoma
The number of patients with renal cancer was estimated to be approximately 338,000 worldwide, including approximately 58,000 in the United States, 115,000 in Europe and 17,000 in Japan.2 Renal cell carcinoma comprises more than 90% of all malignancies of the kidney,3 and occurs when malignant cells are found in the lining of the tubules of the kidney. The incidence of renal cell carcinoma in people aged in their late 50s is rising, and is more likely to affect men than women. For advanced or metastatic renal cell carcinoma that is difficult to treat with surgery, the standard treatment method is molecular targeted drug therapy, however with low 5-year survival rates, this remains a disease with significant unmet medical need.

Loxo Oncology Announces EMA Orphan Drug Designation Granted to LOXO-101 for Treatment of Soft Tissue Sarcoma

On January 15, 2016 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that the European Medicines Agency (EMA) has granted the company orphan drug designation for LOXO-101 for treatment of patients with soft tissue sarcoma (Press release, Loxo Oncology, JAN 15, 2016, View Source [SID:1234508796]).

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Soft tissue sarcomas are cancers of the body’s connective or supportive tissues, such as cartilage, fat, muscle, fibrous tissue, and blood vessels. The EMA grants orphan drug designation to support the development of medicines for underserved patient populations, or rare disorders, that affect no more than five in 10,000 individuals in the European Union (EU). Orphan drug designation provides to Loxo certain benefits, including protocol assistance, reduced fees for regulatory activities and up to ten years of market exclusivity in the EU upon marketing approval for the designated indication.

About LOXO-101

LOXO-101 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, LOXO-101 has demonstrated encouraging preliminary efficacy. LOXO-101 is also being evaluated in a global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions. For additional information about both the LOXO-101 clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123.

Heron Therapeutics Notified by FDA That It Will Not Take Action on SUSTOL® New Drug Application by the PDUFA Date

On January 15, 2016 Heron Therapeutics, Inc. (NASDAQ:HRTX), reported that the U.S. Food and Drug Administration (FDA) has informed the Company that it has not yet completed its review of the New Drug Application (NDA) of SUSTOL (granisetron) Injection, extended release and would not be taking action by the Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016 and anticipates taking action in late February 2016 (Press release, Heron Therapeutics, JAN 15, 2016, View Source [SID:1234508795]).

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SUSTOL is a long-acting formulation of the FDA-approved 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist granisetron being developed for the prevention of both acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). SUSTOL is formulated utilizing Heron’s proprietary Biochronomer drug delivery technology, and has been shown to maintain therapeutic drug levels of granisetron for at least five days with a single subcutaneous injection.

GP Pharm has recently launched Lutrate® Depot trimestral in Spain

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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