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.

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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.

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.

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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

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.

On June 27, 2017 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, reported the presentation of preclinical data for the Company’s AFM24 and AFM26 programs at the EACR-AACR-SIC 2017 Special Conference in Florence, Italy (Press release, Affimed, JUN 27, 2017, View Source [SID1234519711]).

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"With our NK-cell engagers AFM24 and AFM26 we are pursuing two preclinical programs which we believe are ideally suited to exploit NK-cell mediated cytotoxicity to fight cancer," said Dr. Martin Treder, Chief Scientific Officer of Affimed. "Our data for both programs show a well-differentiated profile from competitor products, addressing the need for higher efficacy and better safety."

AFM24 and AFM26 are two first-in-class tetravalent, bispecific NK-cell engagers targeting CD16A, a dominant activating receptor on NK-cells. In addition, AFM24 targets EGFR, while AFM26 binds to BCMA. Corroborating the Company’s earlier data, the studies presented at EACR-AACR-SIC 2017 provided further evidence of favorable safety profiles for both NK-cell engagers and also confirmed their ability to potently and effectively lyse tumor cells, even those with very low target expression. Furthermore, the high affinity to CD16A on NK-cells, resulting in long cell retention binding to NK-cells, and the minimal influence of serum IgG on tumor cell lysis are important differentiating factors of Affimed’s NK-cell platform compared to IgG-based monoclonal antibodies (mAbs).

In detail, AFM24 was shown to be distinguished from cetuximab in vitro and in vivo through higher potency at both high and low EGFR expression levels and in RAS mutant cells, while offering a more favorable safety profile. Single and repeat dose toxicology studies in cynomolgus monkeys demonstrated that AFM24 was well-tolerated at high doses. Further differentiating AFM24 from other therapies, no evidence of skin toxicity, a side effect commonly seen for other anti-EGFR antibodies and for tyrosine kinase inhibitors, was observed.

In addition, the Company presented further data highlighting the preclinical progress of AFM26. The NK-cell engager was able to elicit efficient tumor cell lysis in both cell lines and primary cells, even at very low BCMA expression levels. In addition, the amount of inflammatory cytokines released in vitro by cells treated with AFM26 was markedly lower than those of cells treated with a BCMA/CD3 T-cell engager. Furthermore, in contrast to approved mAb therapies such as daratumumab and elotuzumab, AFM26 did not induce NK-cell depletion in vitro.

Taken together, the results presented at EACR-AACR-SIC 2017 support the therapeutic rationale of redirecting NK-cells to tumors through bispecific tetravalent NK-cell engagers, which offers a novel mode of action addressing limitations of other therapies.

On June 26, 2017 Oxis International Inc. (OTCQB: OXIS) and (Euronext Paris: OXI.PA) reported that it has executed a binding LOI agreement to acquire Georgetown Translational Pharmaceuticals, Inc. (GTP), a deal that will add new management and a class of close-to-market Central Nervous Systems (CNS) products that will add significant value to the Oxis business model (Press release, OXIS International, JUN 26, 2017, View Source [SID1234539561]).

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Oxis has agreed to pay 33 percent of its outstanding shares to GTP to complete the transaction, which is expected to close on or before 90 days as per the agreement.

GTP, founded by Kathleen Clarence-Smith, MD, PhD, and Mark J. Silverman, JD, was incorporated in Delaware in 2015.

Dr. Clarence-Smith will become Chief Executive Officer of Oxis as part of the acquisition and will be appointed to the Oxis Board of Directors. Also joining the company’s executive management team as part of the merger will be a Chief Medical Officer (name to be disclosed upon closing), who was formerly Vice President and Chief Medical Officer and Medical Director, Oncology Clinical R&D of Pfizer, Inc. (PFE).

Anthony J. Cataldo, who has served as Chief Executive Officer of Oxis since July 2014, will become Executive Chairman of the company. Steven Weldon will continue as Chief Financial Officer.

Prior to founding GTP, Dr. Clarence-Smith co-founded Chase Pharmaceuticals Corporation in Washington D.C. and served as Chairman of the company’s Board from 2008 to 2014. Chase Pharmaceuticals was acquired by Allergan, PLC (AGN) in 2016.

Under the deal, Allergan agreed to pay $125 million upfront along with potential Regulatory and commercial milestones of up to $875 million to the shareholders of Chase.

View Source

Dr. Clarence-Smith also held executive management positions with Sanofi, Roche, Otsuka Pharmaceutical and Prestwick Scientific Capital. She is co-founder and a managing member of KM Pharmaceutical Consulting in Washington, D. C.

"The merger of Oxis and GTP will greatly accelerate the clinical development of exciting new treatments to meet the medical needs of those suffering from cancer and neurologic disease," said Dr. Clarence-Smith. "Harnessing the immune system to fight cancer has the potential to soon bring the cure for certain cancers within our reach, and our CNS pipeline includes drugs that have the potential to improve the quality of life of many patients."

Oxis’ incoming CMO said: "The drugs in the Oxis pipeline are at the forefront of targeted immunotherapeutics and represent the wave of the future. The non-clinical and clinical data is impressive and validates this approach to cancer therapy. Once approved, these agents will herald a major breakthrough in the field of immunotherapy and offer patients hope against some of the most difficult diseases to treat."

Mr. Cataldo said: "The addition of Dr. Clarence-Smith as CEO and our new incoming CMO will be instrumental in completing Oxis’ FDA phase 2 clinical trial of OXS-1550 and our plans to advance the highly-valued TriKE platform oncology assets, which are set to go into FDA clinical trials soon. Further, we are very excited with the incoming GTP product pipeline, which will add significant value as they continue to move towards a commercial license."

Oxis’ lead drug candidate, OXS-1550 (DT2219ARL), is a novel drug that binds to targets and destroys cancer cells, due to the action of the drug’s cytotoxic payload. OXS-1550 has demonstrated success in early human clinical trials in patients with relapsed/refractory B-cell lymphoma or leukemia. It is currently in a FDA-approved Phase 2 trial at the University of Minnesota.

In addition, Oxis holds the rights to commercialize OXS-3550, also known as TriKE, a targeted immunotherapy platform drug that directs Natural Killer (NK) cells to kill cancer cells without drug-related toxicity. "The first molecule called 161533 TriKE will target the CD33 antigen on acute myeloid leukemia cells. The 161533 TriKE will enable NK cells to become antigen specific and also drive the immune response through its IL-15 linker. Our existing Oncology products have now reached the point where Dr. Clarence-Smith’s experience in taking drugs through FDA approvals and into the market, will bring significant value to our shareholders," Mr. Cataldo said.

The agreement to acquire GTP marks another major value-added inflection point for the shareholders of Oxis. The company continues to progress with recently announced partnership and milestone accomplishments.