On April 18, 2018 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that data from pre-clinical studies supporting the potential of prexigebersen (BP1001, liposomal Grb2 antisense), in the treatment of solid tumors in gynecologic malignancies were presented in a poster at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), which took place in Chicago, IL (Press release, Bio-Path Holdings, APR 18, 2018, View Source [SID1234525522]).

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The poster titled, "Grabbing GRB2: The use of Liposome-incorporated Grb2 antisense oligonucleotides as a novel therapy in gynecologic malignancies," was presented by Olivia D. Lara, M.D., University of Texas MD Anderson Cancer Center, Department of Gynecologic Oncology during the Experimental and Molecular Therapeutics Poster Session. The data summarize results from studies investigating the expression of GRB2 in a series of in vitro experiments in high-grade serous (HGSC) and uterine (UC) carcinoma models. The study also examined the biological effects of prexigebersen in HGSC mice models (OVCAR 5), first in a dose-defining experiment then in combination with standard dose paclitaxel.

The data showed there was an eighty-six percent (86%) decrease in tumor burden (p<0.05), and multinodular burden (p<0.01) in the combination prexigebersen/paclitaxel group compared to control. In addition, there was no apparent toxicity with mice on combination therapy losing less weight than the paclitaxel-only group (P = 0.005).

"We are delighted to present these very encouraging findings at this year’s AACR (Free AACR Whitepaper) before an audience of the world’s leading cancer researchers and clinicians," stated Peter H. Nielsen, chief executive officer of Bio-Path Holdings. "Our research continues to suggest that prexigebersen-based combination therapy may offer an attractive method for targeting solid tumors and these findings establish the GRB2/GAB2 complex as an important target for prexigebersen. We look forward to advancing this promising therapy in gynecologic and other solid tumor cancers and plan to initiate first-in-human studies as early as the end of this year.

On April 18, 2018 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinicalstage, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported that preclinical data supporting the clinical development of its BET inhibitor CK-103 (also known as TG-1601) will be presented today in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, Illinois, at McCormick Place North/South (Press release, Checkpoint Therapeutics, APR 18, 2018, View Source [SID1234525506]). The Company’s poster is available for viewing today from 8:00 a.m. to 12:00 p.m. CT, during the Experimental and Molecular Therapeutics/Canonical Targets 2 Session in Exhibit Hall A.

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Key conclusions from the poster are as follows:
TG-1601 is a novel BET inhibitor with strong binding affinity and long-lasting effect in preclinical models
• CK-103 is a novel and potent BET inhibitor that specifically inhibits the binding of the BET subfamily of bromodomain-containing protein family;
• CK-103 potently inhibits cell growth of various multiple myeloma and lymphoma cell lines in vitro, but does not affect the growth of normal cell lines;
• CK-103 inhibits MYC and Bcl-2 expression in preclinical models; and
• CK-103 showed combinatorial effects in an in vivo model with anti-PD-1 antibodies.

James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "These data demonstrate CK103’s
potential to be a novel BET inhibitor that potently inhibits MYC expression. Elevated levels of MYC proteins are found in 60-70% of all cancers, making this family of oncogenes a promising therapeutic target. We believe the preclinical data presented today provides encouraging evidence to support the development of CK-103 as an anti-cancer agent, alone and in combination with our anti-PD-L1 antibody, and look forward to the advancement of CK-103 into a first-in-human Phase 1 trial expected to commence later this year."

The poster is available on the Publications page in the Pipeline section of Checkpoint’s website,
www.checkpointtx.com.

On April 18, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CB-839 in combination with cabozantinib for the treatment of patients with metastatic renal cell carcinoma who have received one or two prior lines of therapy, including at least one vascular endothelial growth factor tyrosine kinase inhibitor or the combination of nivolumab and ipilimumab (Press release, Calithera Biosciences, APR 18, 2018, View Source [SID1234535241]). CB-839 is a first-in-class, oral, selective, potent inhibitor of glutaminase being evaluated in the CANTATA trial. The trial is a randomized double-blind clinical study of cabozantinib in combination with CB-839 or placebo in 298 patients with clear cell renal cell carcinoma. The primary endpoint is progression free survival and the global study is open for enrollment.

"Despite a number of new therapies for the treatment of renal cell carcinoma, there remains a significant unmet need among advanced patients who have received prior treatment," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "We are pleased that CB-839 has been granted Fast Track designation, demonstrating the FDA’s commitment to facilitate the development and expedite the review of our glutaminase inhibitor as an important new therapy for patients with advanced or metastatic renal cell carcinoma who have failed prior systemic therapy."

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The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs and biologics, to treat serious or life threatening conditions, and to fill an unmet medical need. Specifically, Fast Track designation facilitates frequent interactions with the FDA review team, including meetings to discuss all aspects of development to support approval, and also provides the opportunity to submit sections of an NDA on a rolling basis as data become available. About CB-839 Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839’s onco-metabolism activity takes advantage of the unique metabolic requirements of tumor cells and cancer-fighting immune cells such as cytotoxic T-cells. It is currently being evaluated in Phase 2 clinical trials in multiple tumor types, in combination with standard of care agents.

On April 18, 2018 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies, presents a poster with promising preclinical data on a novel viral vector (pseudocowpox, PCPV) at the AACR (Free AACR Whitepaper) (American Association for Cancer Research) Annual Meeting 2018, Chicago, IL, USA, April 14 – 18 (Press release, Transgene, APR 18, 2018, View Source [SID1234525490]).

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PCPV was found to be the most promising therapeutic candidate amongst the poxviridae evaluated by Transgene:

It displayed the strongest immunogenicity, and the best ability to reduce tumor size and increase survival in immunocompetent mice carrying fast-growing tumors.
It induced a very strong cellular response and showed an attractive cytokine/chemokine profile.
It also induced a strong local secretion of IFN-α and impressive changes in the tumor micro-environment, including decreased frequency of immunosuppressive cells in the tumor.
The abstract is available on the AACR (Free AACR Whitepaper) 2018 website (#LB-287) and will be published in Cancer Research in June 2018.

Poster title: Pseudocowpox: A next generation viral vector for cancer immunotherapy. A poxviral vector selected for its remarkable ability to induce IFN-alpha.

On April 18, 2018 Grid Therapeutics, LLC, a biotechnology company developing a first-in-class, novel human-derived targeted immunotherapy for cancer, reported the closing of its Series B financing (Press release, Grid Therapeutics, APR 18, 2018, View Source [SID1234526796]). Grid will use the proceeds from the financing to accelerate and expand the development of Grid’s lead therapeutic candidate, GT103, for the treatment of solid tumors, and to prepare for clinical trials in cancer patients scheduled to commence in early 2019. Grid’s foundation is the innovative science developed by Edward F. Patz, Jr., MD, and his team of scientists at Duke University Medical Center.

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Grid’s Series B financing was led by Milestone Holdings, a California-based venture company boasting a strong history of identifying and funding companies developing disruptive technologies with revolutionary intellectual property, Paul Funk, a veteran software entrepreneur and founder of Funk Software, and Jeffery "TJ" Heyman, Founder and Chief Investment Officer of Woodbourne Capital Management International.

Grid’s unique platform is based upon a groundbreaking approach of identifying specific tumor immunoglobulin G (IgG) antibodies from cancer patients with exceptional outcomes. Grid’s unique strategy obtained the sequence and isolated its lead IgG3 antibody directly from cancer patients’ single B cells, which will modulate the immune system to kill tumors without known side effects.

"Grid Therapeutics is very excited to welcome our new investors, all of whom bring a rich history of innovation and thought leadership. With this new round of capital, we are well positioned to accelerate the development and advancement of our novel antibody into the clinic," commented Dr. Patz, CEO of Grid.