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 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 26, 2017 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company developing cancer immunotherapies, reported that the European Society of Gynaecologic Oncology (ESGO) has accepted an abstract for a poster presentation at its 2017 congress on the identification of potential baseline biomarkers indicative of survival benefit from treatment with the company’s lead immunotherapy candidate, axalimogene filolisbac (Press release, Advaxis, JUN 26, 2017, View Source [SID1234519687]). ESGO is Europe’s landmark gynecologic oncology meeting. Held biennially, ESGO congress brings together professionals to learn and discuss the latest medical and scientific developments in gynecologic cancers research, treatment and care.

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Advaxis researchers identified certain pre-treatment baseline levels of serum proteins that were strongly associated with overall survival (OS) benefit in patients with persistent or recurrent metastatic carcinoma of the cervix (PRmCC) that were treated with axalimogene filolisbac in the Phase 2 GOG/NRG-0265 study. The 12-month survival rate in this study was 38 percent (19/50), and these results were presented at a medical meeting earlier this year.

This analysis of pre-treatment baseline serum proteins of 45 patients from the study showed that levels of a group of four closely-aligned proteins were strongly correlated with OS. One cluster of patients (n=25), had relatively lower levels of all four proteins and exhibited an OS of 56 percent, while the second cluster (n=20), with relatively higher levels, exhibited an OS of 15 percent. These data are statistically significant (HR=0.23; 95% CI: 0.10-0.48; P<.001) and suggest that the baseline levels of these analytes have prognostic value for OS, and high levels of these individual proteins were negatively associated with clinical outcomes in the trial.

Importantly, it was found that much of this effect was due to levels of one particular protein, which was found to be most highly correlated with OS in the study. This particular protein was previously not known to be associated with survival in cervical cancer. Advaxis will continue to evaluate this particular protein as a potential biomarker to help identify patients most likely to benefit from treatment with axalimogene filolisbac.

"In the field of cancer immunotherapy, biomarkers have been playing an increasing role in guiding patient selection and identifying early indicators of treatment response," said Robert Petit, Chief Scientific Officer of Advaxis. "The discovery of this potential biomarker, which previously has not been known to be associated with survival in cervical cancer, is significant and could be a biomarker to predict efficacy, similar to how PD-L1 expression is used as a biomarker for checkpoint inhibitors. PD-L1 testing has become an important and routine strategy to guide treatment, and this biomarker has the promise to do the same for axalimogene filolisbac."

Sandy Hayes, PhD, Associate Director of Research and Biomarker Lead at Advaxis, is the first author and presenter of "Baseline Serum Protein Levels Associated with Survival in Axalimogene Filolisbac (Axal)-Treated Metastatic Cervical Cancer Patients: The GOG/NRG-0265 Trial." The poster will be presented at ESGO 2017, held Nov. 4 to 7 in Vienna, Austria, and will also be published in a supplement to the International Journal of Gynecological Cancer.

About Cervical Cancer

Cervical cancer is the fourth most common cancer affecting women worldwide. An estimated 13,000 cases were diagnosed in the United States in 2016, and 4,100 women will have this disease as their cause of death each year, according to the National Cancer Institute. Decades of research have shown that persistent HPV infection, particularly with high-risk virus types such as HPV-16 and HPV-18, is the most important factor in the development of cervical cancer. The prognosis for women with advanced and recurrent cervical cancer remains poor, with median survival of only six to seven months following initiation of palliative treatment with chemotherapy. According to the American Cancer Society, the five-year survival rate for stage IV disease is at 15 to 16 percent. There is no approved therapy following failure of first-line treatment, and there has been limited advancement in developing new therapeutics for advanced cervical cancer over the last 30 years.

About Axalimogene Filolisbac

Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based immunotherapy that attacks HPV-associated cancers by altering a live strain of Lm bacteria to generate cancer-fighting T cells against cancer while neutralizing the tumor’s natural protections that guard the tumor microenvironment from immunologic attack.

Axalimogene filolisbac has received Fast Track designation as an adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) patients and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac is the only active product candidate to have received the U.S. FDA orphan drug designation in cervical cancer.

Advaxis, in collaboration with Bristol-Myers Squibb, is evaluating ADXS-DUAL, the next generation immunotherapy candidate targeting HPV-associated cancers, with the PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), as a potential combination treatment option for women with metastatic cervical cancer. Expected to start by the end of 2017, the study will evaluate this combination regimen in women with PRmCC who have failed at least one prior line of systemic chemotherapy.

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.

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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.