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8-K – Current report

On March 8, 2016 Bio-Path Holdings, Inc., (NASDAQ: BPTH) ("Bio-Path"), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that it has entered a sponsored research agreement with The University of Texas MD Anderson Cancer Center ("MD Anderson") to evaluate Bio-Path’s clinical pipeline for its ability to modulate pancreatic cancer (Filing, 8-K, Bio-Path Holdings, MAR 8, 2016, View Source [SID:1234509416]).

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Included in the evaluation will be BP1001 (Liposomal Grb2 antisense), Bio-Path’s lead product candidate, which is currently in a Phase II study for blood cancers.

Jason Fleming, M.D., F.A.C.S., professor of surgical oncology within the division of surgery at MD Anderson, will serve as the study’s principal investigator. Dr. Fleming initiated and developed the first direct xenograft program in gastrointestinal cancer. These xenografts were derived from malignant pancreatic tumors that Dr. Fleming and his surgical colleagues removed from patients at MD Anderson. Dr. Fleming is also director of the tissue acquisition and biorepository core for the Pancreas Cancer Research Program at MD Anderson, and is a board certified pancreatic surgeon.

"We are honored to collaborate with Dr. Fleming," said Peter Nielsen, President and Chief Executive Officer of Bio-Path. "His experience working with pancreatic xenografts makes him uniquely qualified to lead this study. We look forward to assessing whether Bio-Path’s drug candidates work in this ex vivo model before potentially moving into animal studies."

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Scynexis has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Scynexis, 2017, MAR 7, 2016, View Source [SID1234521749]).

20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

(Filing, Annual, Compugen, 2015, MAR 7, 2016, View Source [SID:1234509392])

Data from MacroGenics’ Preclinical Studies of MGD009 Presented at Keystone Symposia’s Antibodies as Drugs (X2) Conference

On March 07, 2016 MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, reported results from preclinical studies of MGD009 were presented today by the Company in an oral presentation at Keystone Symposia’s "Antibodies as Drugs (X2)" conference held jointly with the meeting on "Cancer Vaccines: Targeting Cancer Genes for Immunotherapy" in Whistler, British Columbia, Canada (Press release, MacroGenics, MAR 7, 2016, View Source [SID:1234509403]). Paul A. Moore, Ph.D., Vice President of Cell Biology and Immunology at MacroGenics and first author, presented "MGD009, a B7-H3 x CD3 Bispecific Dual-Affinity Re-Targeting (DART) Molecule Directing T Cells to Solid Tumors."

The objectives of the studies were to evaluate the antitumor activity and pharmacokinetics of MGD009 in preclinical models. MGD009 is a DART molecule that was designed to bind to B7-H3 and CD3 simultaneously to mediate redirected T-cell activity against B7-H3-expressing cancer cells.

These studies demonstrated that MGD009 redirected T cells to kill B7-H3-expressing human cancer cell lines from a wide range of tumor types in vitro and in vivo. T-cell activation and proliferation by MGD009 is dependent upon co-engagement of B7-H3-expressing target cells with T cells. In human T cell or peripheral blood mononuclear cell (PBMC)-reconstituted mice, MGD009 demonstrated dose-dependent inhibition of growth and regression of B7-H3-expressing tumor xenografts.

In addition, Dr. Moore presented findings demonstrating linear pharmacokinetics and a prolonged half-life of MGD009 in cynomolgus monkeys, supporting dosing at biweekly intervals in humans.

These data support the evaluation of MGD009 in patients with B7-H3-positive tumors. A Phase 1 study of MGD009 in patients with B7-H3-expressing solid tumors is ongoing.

"These preclinical antitumor activity and pharmacokinetics data have provided strong rationale for the development of MGD009 in the treatment of B7-H3-expressing tumors, which encompasses a large number of cancer types," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Our Phase 1 study of MGD009 represents a very exciting milestone and important application of our DART platform technology to this compelling target."

The poster presentation at the Keystone Symposia is available for download from the Events & Presentations page on MacroGenics’ website at View Source

Background on MGD009 and B7-H3

MGD009 is a humanized DART molecule that recognizes both B7-H3 and CD3 and has a prolonged serum half-life. This product candidate is the second clinical program in MacroGenics’ B7-H3 franchise, which also includes enoblituzumab, an Fc-optimized antibody. B7-H3 is a member of the B7 family of molecules involved in immune regulation and is over-expressed on a wide variety of cancer cells, including cancer stem cells, as well as on the supporting tumor vasculature and underlying tissues, or stroma. Inhibition of certain members of the B7 family has been shown to have powerful anti-tumor effects in several solid tumor types. The primary mechanism of action of MGD009 is its ability to redirect T cells, via their CD3 component, to kill B7-H3-expressing cells.

In the fourth quarter of 2015, the Company initiated a Phase 1 dose-escalation study with MGD009. This study is designed to characterize the safety and tolerability of the product candidate administered every two weeks in patients with non-small cell lung, bladder and head and neck cancer, mesothelioma, melanoma, and certain other B7-H3 positive tumors. To learn more, please visit: View Source

Heat Biologics Presents Positive ComPACT Preclinical Data at the Keystone Symposia

On March 07, 2016 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported positive preclinical data from its next generation ComPACT platform technology, which combines a T cell priming vaccine and T cell co-stimulator in a single product, were presented as both an oral presentation and poster at the Keystone Symposia on Cancer Vaccines: Targeting Cancer Genes for Immunotherapy, held in Whistler, British Columbia, Canada on March 6-10, 2016 (Press release, Heat Biologics, MAR 7, 2016, View Source [SID:1234509402]). Data presented showed that ComPACT secreting OX40L generated the most potent immune response among other ComPACT co-stimulator variations including TL1A, 4-1BBL and ICOSL, as well as compared to systemic delivery of OX40 agonist antibody and vaccine alone.

A copy of the poster entitled "Combination Immunotherapy: T cell costimulation (OX40L, TL1A, 4-1BBL and ICOSL) secreted locally by Gp96-Ig vaccines elicits robust antigen-specific memory T cell responses and tumor elimination" will be made available in the Publications section of Heat’s corporate website.

About ComPACT

Currently in preclinical development, ComPACT represents a potential dual-acting immunotherapy, combining a pan-antigen T cell priming vaccine and a T cell co-stimulator in a single product. Heat has developed its first ComPACT product candidate, HS-120, as a potential treatment for non-small cell lung cancer (NSCLC) and anticipates filing an Investigational New Drug (IND) application by the end of 2016.