On January 3, 2016 Kite Pharma, Inc. (Nasdaq:KITE) reported that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 trial of KITE-718, a T cell therapy engineered to express T cell receptors (TCRs) that target MAGE A3 and MAGE A6 (Press release, Kite Pharma, JAN 3, 2017, View Source [SID1234517250]). MAGE A3/A6 are frequently found in common tumors including bladder, esophageal, head and neck, lung and ovarian cancers. KITE-718 recognizes the MAGE A3 and MAGE A6 fragments bound to a Class II HLA (DPB1*04:01) and therefore has the potential to kill tumor cells both directly and indirectly through activation of the immune system given it incorporates a class II TCR. Class II HLA (DPB1*04:01) is found in 50 percent to 70 percent of Caucasians. The trial is designed to assess the safety and anti-tumor effect of KITE-718 on these solid tumors. Schedule your 30 min Free 1stOncology Demo! "Submission of this IND is an important milestone for our solid tumor strategy utilizing engineered T cell therapy based on both TCR and CAR platform technology," said David Chang, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer of Kite. "TCRs have the potential to access a broad spectrum of tumor targets and we have incorporated our next generation cell manufacturing technologies into KITE-718 to exploit targets naturally expressed in common solid tumors for which there is a great unmet medical need."
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KITE-718 is built on the proof of concept data established by the National Cancer Institute’s (NCI) MAGE A3/A6 TCR program (NCT02111850). No off-target toxicity was observed in the NCI study, and evidence of tumor regression was seen in patients with multiple types of solid tumors. KITE-718 has been optimized from the foundational work at the NCI by streamlining the manufacturing process through advanced technologies and next-generation cell manufacturing conditions.
Author: [email protected]
Eagle Pharmaceuticals’ Pemetrexed NDA Submitted for Review
On January 3, 2016 Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) ("Eagle" or "the Company") reported that the 505(b)(2) New Drug Application (NDA) for its novel pemetrexed drug product has been submitted to the U.S. Food and Drug Administration (FDA) (Press release, Eagle Pharmaceuticals, JAN 3, 2017, View Source [SID1234517249]). Schedule your 30 min Free 1stOncology Demo! This 505(b)(2) NDA requests FDA approval of Eagle’s ready-to-dilute (RTD) Pemetrexed Injection product for the treatment of Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer, and Mesothelioma (in combination with cisplatin).
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"We look forward to the FDA’s decision on this NDA this year, and to continuing to work closely with the FDA through the review process. We believe our RTD liquid formulation will be well received, adding to Eagle’s growing commercial portfolio of improved formulations, benefiting patients and shareholders alike," said Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.
Eagle’s RTD Pemetrexed Injection product is administered as an IV infusion.
Apollo Endosurgery Completes Merger with Lpath; Initiates Trading on NASDAQ as ‘APEN’
On December 29, 2016 Apollo Endosurgery, Inc. ("Apollo"), a leader in less invasive medical devices for bariatric and gastrointestinal procedures, reported that it has completed its merger transaction with Lpath, Inc. ("Lpath", Nasdaq: LPTN) (Filing, 8-K, Lpath, DEC 30, 2016, View Source [SID1234517278]).
With the completion of the merger today, Lpath was renamed Apollo Endosurgery, Inc. and will begin trading on the NASDAQ Global Market under the symbol ‘APEN’ on December 30, 2016.
Following the closing of the merger and a 1-for-5.5 reverse stock split, the combined company has approximately 10.7 million shares of common stock outstanding. The stockholders of Apollo received common stock representing approximately 95.9% of the outstanding shares and the stockholders of Lpath retained approximately 4.1% of the combined company. Concurrent with the closing of the merger, certain stockholders of Apollo invested $29 million of new equity in the combined company, which is included in the 95.9% ownership of previous Apollo stockholders.
"Apollo has an exciting product and technology portfolio from which to advance the interventional treatment of obesity through less invasive procedures. We are grateful for the continued confidence and support of Apollo’s stockholders as we take this next step in the development of our company," commented Todd Newton, Chief Executive Officer of Apollo.
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BeiGene Announces First Patient Dosing in China Phase I Trial with Investigational Anti-PD-1 Monoclonal Antibody BGB-A317
On December 30, 2016 BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported the dosing of the first patient in a Phase I clinical trial of BGB-A317, an anti-PD-1 monoclonal antibody, in mainland Chinese patients with advanced solid tumors (Press release, BeiGene, DEC 30, 2016, View Source [SID1234517240]). Schedule your 30 min Free 1stOncology Demo! "We are pleased to report that BGB-A317 is now in Phase I clinical evaluation in mainland China. To date, all four of our clinical-stage molecules are active in the clinic in China. We are enthusiastic about the agent’s therapeutic potential, with promising data from an ongoing Phase I study of BGB-A317 in Australia, New Zealand, the United States, and Taiwan recently reported at the 2016 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. We are committed to developing BGB-A317 for patients in China, where this exciting class of immuno-oncology agents is still not approved," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman.
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The Phase I open-label, multi-center study of BGB-A317 is designed to investigate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-A317 in Chinese patients with advanced solid tumors. Professor Yilong Wu from Guangdong General Hospital is the lead principal investigator of the study. The co-lead investigators are Professor Lin Shen and Professor Jun Guo, both of Beijing Cancer Hospital.
About BGB-A317
BGB-A317 is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. BGB-A317 has high affinity and specificity for PD-1, and we believe it is differentiated from the currently approved PD-1 antibodies with the ability to bind Fc gamma receptor I specifically engineered out. BGB-A317 is being developed as a monotherapy and in combination with other therapies for the treatment of various cancers.
Aptose Biosciences Provides Update on APTO-253 Development
On December 29, 2016 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, reported an update on the development of APTO-253, its investigational compound for acute myeloid leukemia (AML) (Press release, Aptose Biosciences, DEC 29, 2016, View Source [SID1234539166]). The company has successfully manufactured multiple batches of a new drug product formulation for APTO-253, including a batch that has been stable and soluble for over six months. However, Aptose will have to repeat the production of the fourth batch, a 40L batch that was the intended clinical supply, because of a correctable engineering design incompatibility during the filling process. Aptose expects the batch records and release specifications from such a new batch, along with the stability and sterility data, to be provided to the FDA during the first quarter of 2017.
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The need to strengthen the filling process is not a reflection on the drug substance or new formulation, both of which continue to perform favorably. Indeed, the new formulation demonstrates an increase of three times plasma drug exposure as compared to the prior formulation and may have the potential to create additional intellectual property for the company. Aptose also demonstrated that APTO-253 acts by inhibiting expression of the c-Myc oncogene without toxicity to normal bone marrow and blood cells, thereby potentially increasing the likelihood of application to additional cancer indications.
"We remain committed to the development of APTO-253, a small molecule agent that may provide benefit to an important patient population," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "While we have encountered delays in manufacturing activities, we also have continued mechanistic and pharmacokinetic testing of APTO-253 which heighten its viability. In parallel, we also continue to advance the development of CG’806, an exciting preclinical compound for patients with FLT3-driven AML and certain B-cell malignancies."
In November of last year, Aptose’s phase 1b trial of APTO-253 was temporarily suspended because of the report of an operational difficulty with an IV infusion pump at a clinical site. The company has spent the year identifying the root cause of the clogging issue and actively evaluating multiple formulation and production methodologies in order to improve solubility and stability characteristics and select the best approach to optimizing the delivery of the product to patients with the goal of re-entering the clinic. Aptose is currently working on submitting information requested by the FDA as a result of the development of a new drug product that does not cause filter clogging or pump stoppage during simulated infusion studies.