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ABLYNX ACHIEVES SECOND MILESTONE IN IMMUNO-ONCOLOGY COLLABORATION
WITH MERCK & CO., INC., KENILWORTH, NEW JERSEY, USA

On June 27, 2017 Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] reported that Merck & Co., Inc., Kenilworth, New Jersey, USA, known as MSD outside the United States and Canada, has started an IND-enabling toxicology study with a bi-specific Nanobody as part of the immuno-oncology collaboration between the companies (Press release, Ablynx, JUN 27, 2017, View Source [SID1234519710]). This milestone triggers a €2.5 million payment to Ablynx.

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This Nanobody is a bi-specific molecule that selectively binds to two different immune modulators, believed to be key targets for the development of potent immunotherapies. Upon successful completion of the IND package, this bi-specific Nanobody could be the first candidate to enter clinical studies as part of this collaboration.

Dr Edwin Moses, CEO of Ablynx, commented: "We are very pleased with the progress made in this collaboration. We believe that the combination of Ablynx’s Nanobody expertise with the world-leading position of our partner in the immuno-oncology area has the potential to develop important new medicines for diseases with a high unmet need. We look forward to further milestones as product candidates progress through pre-clinical and clinical development."

About the immuno-oncology collaboration between Ablynx and Merck & Co., Inc., Kenilworth, New Jersey, USA In February 2014, Ablynx entered into a research collaboration and licensing agreement with a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA. This exclusive collaboration and licensing agreement is focused on the discovery and development of several Nanobody candidates (including mono-, bi-and trispecifics) directed toward so-called immune checkpoint modulators. In July 2015, Ablynx announced an expansion of this immuno-oncology collaboration with Merck & Co., Inc., Kenilworth, New Jersey, USA to address an increased number of immune checkpoint modulator targets. The collaboration now includes up to 17 Nanobody programmes against individual protein targets and target combinations (monospecific and multi-specific Nanobodies). Ablynx has received €33 million in upfront payments and is eligible to receive research funding plus development, regulatory and commercial milestone payments of up to €340 million per programme, as well as tiered royalties on annual net sales upon commercialisation of any Nanobody products.

Merck & Co., Inc., Kenilworth, New Jersey, USA, through a subsidiary, and Ablynx have a separate collaboration in the field of ion channel drug development, announced in October 2012, with a €6.5 million upfront payment, €2 million research funding and up to €448 million in research, regulatory and commercial milestone payments associated with the progress of multiple candidates as well as tiered royalties on any products derived from the collaboration. An initial extension of this ion channel research collaboration was announced in March 2015 and a second extension in October 2016, the latter triggering a €1 million payment to Ablynx and additional research funding to September 2018.

Merck Provides Update on REVEAL Outcomes Study of Anacetrapib

On June 27, 2017 Merck (NYSE:MRK), known as MSD outside of the United States and Canada, reported that the REVEAL (Randomized EValuation of the Effects of Anacetrapib through Lipid modification) outcomes study of anacetrapib met its primary endpoint, significantly reducing major coronary events (defined as the composite of coronary death, myocardial infarction, and coronary revascularization) compared to placebo in patients at risk for cardiac events who are already receiving an effective LDL-C lowering regimen. The safety profile of anacetrapib in the early analysis was generally consistent with that demonstrated in previous studies of the drug, including accumulation of anacetrapib in adipose tissue, as has been previously reported. Merck plans to review the results of the trial with external experts, and will consider whether to file new drug applications with the U.S. Food and Drug Administration (FDA) and other regulatory agencies. The results of the REVEAL study will be presented at the European Society of Cardiology meeting on Aug. 29, 2017.

Anacetrapib is Merck’s investigational cholesteryl ester transfer protein (CETP) inhibitor. The REVEAL study is a randomized, double-blind placebo-controlled clinical trial to assess the efficacy and safety of adding anacetrapib to effective LDL-lowering treatment with atorvastatin for a median duration of at least 4 years among approximately 30,000 patients at high risk of cardiovascular events. REVEAL was designed and independently conducted by investigators at the Clinical Trial Service Unit (CTSU) at the University of Oxford, the trial’s regulatory sponsor, in collaboration with the TIMI Study Group based at Brigham and Women’s Hospital in Boston and Merck. Merck provided funding for REVEAL. Details on the REVEAL study design are available at clinicaltrials.gov: View Source

NantCell, a NantWorks Company, to Acquire Altor BioScience

On June 27, 2017 NantCell, Inc., a member of the ecosystem of NantWorks companies, reported that it has entered into a definitive merger agreement to acquire Altor BioScience Corporation (Press release, NantCell, JUN 27, 2017, View Source [SID1234519702]). Under the terms of the merger agreement, each share of Altor BioScience capital stock will be converted into the right to receive an upfront payment of $2.00 (payable in cash and/or NantCell common stock at the election of each Altor BioScience stockholder). The upfront payment alone represents over a 20 percent premium to Altor BioScience’s most recent equity financing completed in March 2017 and a 33 percent premium to equity financings in 2016. Each share will also receive two Contingent Value Rights (CVR), which entitle its holder to receive payments of up to an additional $4.00 per share (payable in cash and/or NantCell common stock at the election of each Altor BioScience stockholder) upon achievement of a regulatory milestone and a sales milestone.

The transaction has been approved by the boards of directors of both companies, including the independent directors of Altor BioScience, and is subject to customary closing conditions, including the approval of the acquisition by shareholders of Altor BioScience. The acquisition is expected to close in the third quarter of 2017.

TP Therapeutics Announces FDA Orphan Drug Designation Granted to TPX-0005 for Treatment of Non-Small Cell Lung Adenocarcinomas Harboring ALK, ROS1, or NTRK Oncogenic Rearrangements

On June 27, 2017 TP Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company focusing on addressing oncology drug resistance, announced today that U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its leading clinical compound TPX-0005 for "treatment of non-small cell lung adenocarcinomas harboring ALK, ROS1, or NTRK oncogenic rearrangements (Press release, TP Therapeutics, JUN 27, 2017, View Source [SID1234519701])."

The FDA grants orphan drug designation to investigational drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including seven years of market exclusivity upon regulatory product approval, exemptions from certain FDA application fees, and tax credits for qualified clinical trials costs.

About TPX-0005

TPX-0005 is a potent and orally bioavailable small molecule kinase inhibitor for ALK, ROS1, and TRK family. The clinical benefits of targeting ALK, ROS1, or TRK fusion kinase have been demonstrated with crizotinib, ceritinib, alectinib, and brigatinib, already approved for the treatment of ALK+ non-small cell lung cancer (NSCLC), crizotinib for ROS1+ NSCLC, and larotrectinib and entrectinib in clinical studies for TRK+ cancers. However, the successes of these therapies are overshadowed by the development of acquired resistance. The acquired solvent front mutations including ALK G1202R, ROS1 G2032R, TRKA G595R and TRKC G623R render a common clinical resistance to the current ALK, ROS1, and TRK inhibitors. TPX-0005 is a potent kinase inhibitor against wildtype and mutated ALK, ROS1 and TRK family kinases, especially the clinically significant solvent front mutations, gatekeeper mutations, and emerging compound mutations after multiple line treatments. TPX-0005 will provide new opportunities in the clinic to inhibit the abnormal signaling of ALK, ROS1, or TRK family in solid malignancies, and overcome multiple resistance mechanisms from the refractory patients. TPX-0005 is currently being evaluated in a Phase 1/2, open-label, multi-center, first-in-human study of the safety, tolerability, pharmacokinetics and anti-tumor activity in patients with advanced solid tumors harboring ALK, ROS1, or NTRK1-3 rearrangements (TRIDENT-1, NCT03093116). For additional information about TPX-0005 trial, please refer to www.clinicaltrials.gov. Interested patients and physicians can also contact the TP Therapeutics Oncology Clinical Trial Hotline at 1-858-276-0005 or email [email protected].

First in Human Administration of UCART123 in Cellectis’ AML Phase I Clinical Trial at Weill Cornell Medicine, NewYork-Presbyterian Hospital

On June 27, 2017 Cellectis (Alternext: ALCLS; Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited CAR T-cells (UCART), reported the first administration in the Phase I clinical study in Acute Myeloid Leukemia (AML) for its investigational product UCART123, one of the Company’s wholly-controlled TALEN gene-edited product candidates (Press release, Cellectis, JUN 27, 2017, View Source [SID1234519699]). This marks the first allogeneic, "off-the-shelf" gene-edited CAR T-cell product candidate targeting CD123 to be investigated in clinical trials.

This clinical research in AML is led by Principal Investigator Dr. Gail J. Roboz, Professor of Medicine at Weill Cornell Medicine and Director of the Clinical and Translational Leukemia Programs at Weill Cornell Medicine and NewYork-Presbyterian Hospital.

The clinical trial will investigate the safety and efficacy of UCART123 in patients with AML. AML is a devastating clonal hematopoietic stem cell neoplasm which is characterized by uncontrolled proliferation and accumulation of leukemic blasts in bone marrow, peripheral blood and, occasionally, in other tissues. These cells disrupt normal hematopoiesis and rapidly cause bone marrow failure. In the U.S., there are an estimated 19,950 new AML cases per year, with 10,430 estimated deaths per year. While complete response rates can be as high as 80 percent in younger patients who undergo initial induction cytotoxic chemotherapy, the majority of AML patients relapse and die from the disease. AML patients with high-risk genetic features have an especially urgent unmet medical need, as their outcomes are dismal with all existing treatment modalities, including allogeneic stem cell transplantation.

"After being granted rapid approval from Regulatory Authorities and Institutional Review Boards to initiate UCART123 studies, the enrollment and treatment of the first patient represents a major milestone for Cellectis, and we are eager to hit the ground running with the recruitment of our first patient for our second UCART123 Phase I study in BPDCN soon," said Dr. Loan Hoang-Sayag, Cellectis Chief Medical Officer. "This first program targeting CD123 will be a paradigm shift for our Company, as it will provide a wealth of valuable additional knowledge and data to drive our gene-edited allogeneic CAR T-cell platform."

"We are excited to be enrolling our first patient with UCART123 and are hopeful that this novel immunotherapy modality will prove to be a significant and effective weapon against AML," said Dr. Roboz.

The clinical trial is part of a strategic translational research alliance that was formed between Cellectis and Weill Cornell Medicine in 2015. Dr. Monica Guzman, an associate professor of pharmacology in medicine at Weill Cornell Medicine, is co-principal investigator whose work focuses on preclinical and early-stage testing to optimize the development of stem cell-targeted cancer drugs.