On July 30, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported the expansion of its immuno-oncology collaboration with Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada) for the support of a Phase 2a program investigating BioLineRx’s BL-8040 in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy marketed by Merck & Co., Inc., Kenilworth, N.J., USA, in patients with metastatic pancreatic cancer (Press release, BioLineRx, JUL 30, 2018, View Source;p=RssLanding&cat=news&id=2360649 [SID1234527957]). Under the expansion, a triple combination arm investigating the safety, tolerability and efficacy of BL-8040, KEYTRUDA and chemotherapy will be added to the ongoing COMBAT/KEYNOTE-202 study. The triple combination arm will focus on second-line pancreatic cancer patients. Regulatory submissions required to conduct the additional arm of the study have been made and the trial is planned to be initiated in the fourth quarter of 2018.

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BioLineRx previously disclosed partial results from the BL-8040 monotherapy portion of the COMBAT/KEYNOTE-202 study at the ASCO (Free ASCO Whitepaper) 2018 Gastrointestinal Cancers Symposium in January 2018. The partial monotherapy results showed that BL-8040 is safe and well tolerated and that BL-8040 increases infiltration of T cells into the tumor in patients with metastatic pancreatic cancer, confirming the mechanism of action of BL-8040 in this difficult-to-treat patient population. In addition, BL-8040 also induced an increase in the number of total immune cells in the peripheral blood, while the frequency of peripheral blood regulatory T cells (Tregs), known to impede the anti-tumor immune response, was decreased. Topline clinical results of the combination will be reported in H2 2018 as planned.

"We are very excited to report the expansion of our immuno-oncology collaboration with Merck and the inclusion of an additional arm in the COMBAT/KEYNOTE-202 study. The decision to investigate the combination of BL-8040 and KEYTRUDA, together with chemotherapy, stems from the encouraging results we have seen in the trial," stated Philip Serlin, Chief Executive Officer of BioLineRx. "These results continue to demonstrate the safety and tolerability of BL-8040, as well as validate its mechanism of action, namely that BL-8040 mobilizes immune cells into the peripheral blood, promotes T-cell infiltration into tumors, and has an effect on immuno-suppressive cells."

"In light of this," continued Mr. Serlin, "the addition of cytotoxic chemotherapy may be synergistic with the existing combination, due to the fact that besides helping to reduce the overall tumor burden, chemotherapy induces immunogenic cell death, thus leading to activation and expansion of new tumor-reactive T cells. Based on its demonstrated mechanism of action, BL-8040 should facilitate the infiltration of these T cells into the tumor core, alongside the restoration of T-cell activity within the tumor by KEYTRUDA. We look forward to presenting results from the dual combination arm of BL-8040 and KEYTRUDA in the COMBAT/KEYNOTE-202 study later this year, and expect to present results from the new triple combination arm of the study in the second half of next year."

About the COMBAT/KEYNOTE-202 Study

The COMBAT/KEYNOTE-202 study, a Phase 2a study, is currently an open-label, multicenter, single-arm trial designed to evaluate the safety and efficacy of the combination of BL-8040 and KEYTRUDA (pembrolizumab), an anti-PD-1 therapy marketed by Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada), in over 30 subjects with metastatic pancreatic adenocarcinoma. The study is primarily designed to evaluate the clinical response, safety and tolerability of the combination of these therapies, and is being carried out in the US, Israel and additional territories. The study is being conducted by BioLineRx under a collaboration agreement signed in 2016 between BioLineRx and MSD, through a subsidiary, to support a Phase 2a program investigating BioLineRx’s BL-8040 in combination with KEYTRUDA in patients with metastatic pancreatic cancer.

BL-8040, BioLineRx’s lead oncology platform, is a CXCR4 antagonist that has been shown in several clinical trials to be a robust mobilizer of immune cells to peripheral blood and to be effective at inducing direct tumor cell death. In addition, clinical findings have demonstrated the ability of BL-8040 to mediate infiltration of T cells into tumors that were previously immunologically "cold" and devoid of immune cell infiltrate. Immune checkpoint inhibitors (such as KEYTRUDA) produce anti-cancer effects by increasing the activity of T cells through blockade of the interaction between the immune checkpoint receptor PD-1, on T cells, and its ligand PD-L1, on tumor cells. Pancreatic cancers have very little T-cell infiltrate, making them less susceptive to checkpoint blockade than other tumors that are infiltrated by T cells. Therefore, combining BL-8040 with immune checkpoint blockade is predicted to increase the responsiveness of pancreatic cancer patients to immunotherapy. Further increase in the sensitivity of pancreatic cancer cells to BL-8040 and KEYTRUDA may be achieved by chemotherapy-mediated immunogenic cell death and exposure of new tumor antigens resulting in activation of new anti-cancer T cell clones.

About BL-8040

BL-8040 is a short synthetic peptide for the treatment of hematological malignancies, solid tumors, and stem cell mobilization. It functions as a high-affinity best-in-class antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells and immune-cells from the bone marrow, thereby sensitizing cancer cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing cell death (apoptosis). BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

On July 30, 2018 OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive liquid biopsy tests for the early detection of cancer, reported that it will release its financial and operating results for the second quarter of 2018, ended June 30, 2018, on Tuesday, August 14, 2018, after the close of the U.S. financial markets (Press release, Oncocyte, JUL 30, 2018, View Source [SID1234527958]). The Company will host a conference call on Tuesday, August 14, 2018, at 4:30 pm ET / 1:30 pm PT to discuss the results along with recent corporate developments.

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The dial-in number in the U.S./Canada is 800-458-4148; for international participants, the number is +1-323-794-2598. For all callers, please refer to Conference ID 5162879. To access the live webcast, go to the investor relations section on the Company’s website, View Source." target="_blank" title="View Source." rel="nofollow">View Source

A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling 888-203-1112 toll-free (from U.S./Canada); international callers dial 719-457-0820. Use the Conference ID 5162879. Additionally, the archived webcast will be available at View Source

On July 30, 2018 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, reported its schedule of medical conference presentations for the fall of 2018 (Press release, Aeglea BioTherapeutics, JUL 30, 2018, View Source [SID1234528358]). The three-conference schedule includes five abstract acceptances on the Company’s latest data concerning the rare genetic disease Arginase 1 Deficiency (ARG1-D), uveal and cutaneous melanoma, and human-derived enzymatic approaches to treating the metabolic disorder homocystinuria.

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"This has been an active and successful year for Aeglea," said Anthony G. Quinn, M.B Ch.B, Ph.D., Aeglea’s president and chief executive officer. "We have a busy fall conference schedule during which we will provide important data updates from our clinical and preclinical programs. The repeat dose update from our ARG1-D trials builds on the initial data presented in April 2018 that demonstrated for the first time that rapid and sustained lowering of plasma arginine levels with pegzilarginase, our lead investigational therapy, was accompanied by clinically relevant treatment effects after only eight weeks of dosing. We look forward to providing new interim data from our rare genetic disease and cancer clinical trials with pegzilarginase in the third and fourth quarters of 2018."

Conference Schedule

Event: Annual Symposium of the Society for the Study of Inborn Errors of Metabolism (SSIEM)
Date:September 4-7, 2018
Location:Athens, Greece
Title: Improvements in Arginase 1 Deficiency-related Disease Manifestations Following Plasma Arginine Reduction with Pegzilarginase

Event: American Society of Human Genetics (ASHG) Annual Meeting
Date: October 16-20, 2018
Location:San Diego, CA
Title: 1) Improvements in Arginase 1 Deficiency-related Disease Manifestations Following Plasma Arginine Reduction with Pegzilarginase (Early Phase 2 Results); 2) Clinical Features of Arginase 1 Deficiency: Review of Literature Case Series; 3) Improved Survival and Amelioration of Disease-Related Liver Pathology in a Mouse Model of Homocystinuria with a Novel Homocysteine Degrading Enzyme

Event: European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress
Date: October 19-23, 2018
Location: Munich, Germany
Title: Initial Cohort Expansion Results of Sustained Arginine Depletion with Pegzilarginase in Melanoma Patients in a Phase 1 Advanced Solid Tumor Trial

Details regarding the date and time of each abstract will be announced before each conference.

About Pegzilarginase in Arginase 1 Deficiency
Pegzilarginase is an enhanced human arginase that enzymatically degrades the amino acid arginine. Aeglea is developing pegzilarginase for the treatment of patients with Arginase 1 Deficiency, a debilitating urea cycle disorder caused by deficiency of a key arginine metabolizing enzyme that leads to severe and progressive hyperargininemia-related neurological abnormalities, hyperammonemia and early mortality. Pegzilarginase is intended for use as an enzyme replacement therapy in patients to reduce elevated blood arginine levels. The Company’s interim Phase 1/2 data demonstrated clinically relevant treatment effects and rapid and sustained lowering of plasma arginine in Arginase 1 Deficiency patients.

About Pegzilarginase in Cancer
Pegzilarginase is an enhanced human arginase that enzymatically degrades the amino acid arginine. In some cancers, tumor cells stop producing specific amino acids and must acquire them from the blood, making the tumor cells susceptible to starvation through depletion of those amino acids. Aeglea is developing pegzilarginase to exploit vulnerabilities in some cancers that lead to an increased dependency on extracellular arginine. Pegzilarginase targets these arginine dependent cancers by depleting blood arginine levels to below the normal range. Preclinical data demonstrated that the resulting arginine starvation inhibits proliferation, induces cell death, increases turnover of cell components and promotes anti-tumor immune responses. The Company’s Phase 1 data in advanced solid tumors demonstrated that pegzilarginase was well tolerated at doses that produced marked and sustained reductions in blood arginine levels below the normal range.

On July 30, 2018 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, plans to reported its second quarter 2018 financial results on Wednesday, August 8, 2018, after the close of U.S. markets (Press release, CytomX Therapeutics, JUL 30, 2018, View Source [SID1234527959]).

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The company will not be conducting a conference call in connection with this financial results press release.

On July 30, 2018 Nohla Therapeutics, a leading developer of universal, offthe-shelf cell therapies for patients with hematologic malignancies and other critical diseases, reported the hiring of Sarah Noonberg, M.D. Ph.D., as its new Chief Medical Officer (Press release, Nohla Therapeutics, JUL 30, 2018, View Source [SID1234528471]). Dr. Noonberg will oversee Nohla’s clinical and medical strategy, including clinical development, biostatistics, pharmacovigilance, regulatory and medical affairs. The company also announced today that Nohla founder, Colleen Delaney, M.D., M.S.c., has been named Chief Scientific Officer. In this role, Dr. Delaney
will oversee Nohla’s scientific and research strategy. Both Dr. Noonberg and Dr. Delaney will report to Katie Fanning, President and Chief Executive Officer and serve on Nohla’s executive leadership team. "Sarah’s broad expertise and proven track record in global clinical development will be invaluable to Nohla as we continue to advance our pipeline of universal, off-the-shelf cell therapy products toward commercialization," said Katie Fanning, President and Chief Executive Officer at Nohla Therapeutics. "Sarah joins Nohla at a significant time with data expected later this year from the Phase 2b study evaluating our lead product candidate, dilanubicel, in patients with AML and other leukemias
undergoing a myeloablative cord blood transplant."

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Dr. Noonberg is a board-certified physician-scientist that brings over 14 years of leadership experience in clinical development, from initial drug discovery to global regulatory approvals and commercialization. Prior to joining Nohla, Dr. Noonberg served as the Chief Medical Officer at Prothena, Global Head of Clinical Development at BioMarin, and Senior Vice President at Medivation where she led programs across all phases of development. She currently serves on the Board of Directors at Protagonist Therapeutics. Dr. Noonberg earned her M.D. from the University of California San Francisco, a Ph.D. in Bioengineering from the University of California, Berkeley, and a B.S. in Engineering Science
from Dartmouth College.

Ms. Fanning continued, "These changes support both the near-term opportunities and long-term growth and development of our novel pipeline. Colleen’s role as our scientific founder makes her uniquely qualified to lead Nohla’s scientific strategy as we look to expand the scope of our cell therapy platform through internal development and strategic collaborations. With the hiring of Sarah and appointment of Colleen, we have a seasoned executive leadership team that can deliver on the promise of Nohla’s innovative cell therapy technology."

Dr. Delaney is the Founder and former Chief Medical Officer at Nohla Therapeutics. She is a Member of the Fred Hutch Clinical Research Division and recipient of the Madeline Dabney Adams Endowed Chair, and a Professor at the UW Department of Pediatrics, Division of Pediatric Hematology/Oncology. Dr. Delaney’s group at Fred Hutch developed cryopreserved, non-HLA matched off-the-shelf ex vivo expanded cord blood progenitor cells – the foundation for Nohla’s technology platform. She received a B.S. in Molecular Biology and Biochemistry from Wesleyan University, an M.D. from Harvard Medical School, and an M.Sc. from Oxford University.