On October 3, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that it has entered into an agreement with Biokine Therapeutics to increase BioLineRx’s stake in its lead oncology platform, BL-8040, a CXCR4 antagonist currently in late stage clinical development in both solid tumor and hematological indications, including stem cell mobilization (SCM), acute myeloid leukemia (AML) and immunotherapy for multiple types of solid tumors (Press release, BioLineRx, OCT 3, 2018, View Source;p=RssLanding&cat=news&id=2370009 [SID1234529860]). As a result of the transaction, BioLineRx will increase its economic stake in the program to 80% from the previous level of 60%. BioLineRx licensed the exclusive worldwide rights to BL-8040 from Biokine Therapeutics in 2012.

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"We are very pleased to execute this transaction with Biokine Therapeutics, which provides us with a significantly greater share of the economics in our lead program, BL-8040, as we continue to advance this promising candidate through late-stage clinical development," stated Philip Serlin, Chief Executive Officer of BioLineRx. "In multiple clinical studies to date in a number of indications, BL-8040’s unique mechanism of action has demonstrated robust mobilization of target cells, a direct apoptotic effect, as well as the ability to induce infiltration of T cells into the core and periphery of solid tumors, while maintaining a favorable safety profile. Looking forward, we are approaching multiple important milestones over the next 6-9 months, most notably topline results from our ongoing Phase 2a pancreatic cancer study in combination with KEYTRUDA under our collaboration with Merck, which we expect later this quarter. As we work to bring novel cancer treatments to patients in need, we believe this transaction reflects our strong commitment to this program and better positions us to create significant long-term value for our shareholders."

Under the terms of the agreement, upon closing of the transaction, BioLineRx will pay Biokine Therapeutics an upfront payment of $10 million in cash plus $5 million in restricted BioLineRx shares. Biokine is also eligible to receive up to a total of $5 million in future milestone payments. The $10 million upfront payment is being financed in full via the receipt of $10 million in debt financing from Kreos Capital. See the Company’s Form 6-K filed this morning for additional details about the transaction. The transaction is expected to close within the next 10 days.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, October 3, 2018 at 10:00 a.m. EDT to discuss this transaction in more detail, as well as to preview upcoming pipeline catalysts and milestones. To access the conference call, please dial +1-888-407-2553 from the U.S. or +972-3-918-0610 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until October 6, 2018; please dial +1-888-326-9310 from the U.S. or +972-3-925-5901 internationally.

About BL-8040

BL-8040 is a short synthetic peptide for stem cell mobilization and for treatment of hematological malignancies and solid tumors. It functions as a high-affinity best-in-class antagonist for CXCR4, a chemokine receptor that is directly involved in the retention of stems cells in the bone marrow, as well as 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.

HSCs express CXCR4 and are retained in the protective bone marrow niche via binding to CXCL12 (also known as SDF-1). Blocking of the CXCR4-SDF1 interaction by BL-8040 leads to the mobilization of HSCs into the peripheral blood. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of HSCs.

Furthermore, BL-8040 induce mobilization of leukemic cells and immune-cells from the bone marrow, thereby sensitizing leukemic 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 October 3, 2018 FLX Bio, Inc., a clinical-stage, biopharmaceutical company focused on the development of oral small-molecule drugs that target drivers of cancer and other immune-related disorders, reported that it has been named by FierceBiotech as one of 2018’s Fierce 15 biotechnology companies, recognizing it as one of the most promising private biotechnology companies in the industry (Press release, FLX Bio, OCT 3, 2018, View Source [SID1234529772]).

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"We are honored to be selected as a Fierce 15 company, which we feel highlights the incredibly hard work by our team and our unique approach to targeting the immune system," said Brian Wong, M.D., Ph.D., Chief Executive Officer of FLX Bio. "We believe that our big-data and cutting-edge drug discovery capabilities permit selective control of key immuno-modulatory cells such as regulatory T cells to effectively treat cancers and other immune disorders."

The Fierce 15 celebrates the spirit of being "fierce" – championing innovation and creativity, even in the face of intense competition. Every year FierceBiotech evaluates hundreds of private companies from around the world for inclusion on its annual Fierce 15 list. Selection is based on a variety of factors including the strength of a company’s technology, partnerships, venture backers, and competitive market position.

On October 3, 2018 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported the publication of results of preclinical studies of CPI-444 demonstrating that it induces dose dependent anti-tumor responses as a monotherapy and in combination with anti-PD-1, anti-PD-L1 and anti-CTLA-4 therapies (Press release, Corvus Pharmaceuticals, OCT 3, 2018, View Source [SID1234529768]). The article, which is titled "A2AR Antagonism with CPI-444 Induces Antitumor Responses and Augments Efficacy to Anti–PD-(L)1 and Anti–CTLA-4 in Preclinical Models," is featured on the cover of and in the October issue of the journal Cancer Immunology Research, which is an official journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The article can be accessed here.

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CPI-444, Corvus’ lead product candidate, is a selective and potent inhibitor of the adenosine A2A receptor. It is currently being evaluated in clinical trials in patients with various solid tumors as a single agent and in combination with Genentech’s atezolizumab, an anti-PD-L1 antibody.

"Our carefully conducted pre-clinical studies of CPI-444 demonstrated robust, dose-dependent inhibition of cancer growth as monotherapy, and synergistic efficacy with checkpoint inhibitors, in multiple tumor models," said Stephen Willingham Ph.D., a senior scientist at Corvus and lead author of the article. "These studies indicate that CPI-444 is associated with T-cell activation, which is believed to be its main mechanism of increased cancer killing activity."

Dr. Willingham added, "In these studies we used two different models to characterize the intratumor levels of adenosine, confirming they should be easily blocked by CPI-444. We believe this is the first publication to accurately measure intratumor levels of extracellular adenosine, which is important for evaluating the potential efficacy of therapeutics aimed at this pathway."

Key takeaways from the pre-clinical studies covered in the article include:

CPI-444 is a selective and potent inhibitor of the adenosine A2A receptor and provides dose dependent inhibition of tumor growth as a monotherapy in multiple tumor models
CPI-444 is synergistic with checkpoint inhibitors (anti-PD-1, anti-PD-L1 and anti-CTLA-4), demonstrating the elimination of tumors in up to 90% of treated mice and the restoration of immune responses in mice with tumors that are resistant to anti-PD-L1 or anti-CTLA-4 monotherapy
In monotherapy and combination-therapy, CPI-444 inhibited tumor growth and enabled long-term anti-tumor immune memory
CD8+ T-cells were shown to be required for a response with CPI-444 , demonstrating a role for CD8+ T-cells in mediating primary and secondary immune responses
Intratumor adenosine levels as measured in two models were shown to be approximately 100-150 nanomolar, which is a level that is completely blocked by CPI-444
"These extensive pre-clinical studies formed the basis for our ongoing Phase 1/1b trial in renal cell cancer and Phase 1b/2 trial in non-small cell lung cancer, in each case, with CPI-444, which has now been investigated in over 250 cancer patients," said Richard A, Miller M.D., an oncologist; co-founder, president and chief executive officer of Corvus; and a senior author of the article. "We are delighted that the quality of this research led to this article being featured on the cover of the journal. We will provide an update on our ongoing human clinical studies at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November."

ABOUT CPI-444
CPI-444 is a small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity. CD39 and CD73 are enzymes on the surface of tumor cells and immune cells. These enzymes work in concert to convert ATP to adenosine. In vitro and preclinical studies have shown that dual blockade of CD73 and the A2A receptor may be synergistic.

On October 3, 2018 ArcherDX, a molecular technology company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine and Merck KGaA, Darmstadt, Germany, the vibrant science and technology company which operates its biopharmaceuticals business in the U.S. and Canada as EMD Serono, reported that they have entered into an agreement to develop and commercialize a next generation sequencing (NGS)-based companion diagnostic (CDx) assay (Press release, ArcherDX, OCT 3, 2018, View Source,-darmstadt,-germany-selects-archerdx-for-strategic-global-companion-diagnostic-assay-development-collaboration [SID1234529767]).

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Under the terms of the agreement, ArcherDX will develop and seek regulatory approval for a CDx assay that will help physicians identify patients who may benefit from treatment with a Merck KGaA, Darmstadt, Germany drug candidate, by focusing on the detection of specific genomic alterations in plasma or formalin-fixed paraffin-embedded (FFPE) tissue samples. ArcherDX will develop the CDx using the Archer diagnostic platform, which combines the patented Anchored Multiplex PCR (AMP) technology with the Illumina MiSeqDx sequencing system and Archer Analysis bioinformatics software. The CDx assay will be designed to detect multiple classes of genomic alterations across a range of genes implicated in solid malignant neoplasms and is compatible with both FFPE tissue and plasma specimen types.

"We are pleased to launch this strategic companion diagnostic initiative," stated Jason Myers, Ph.D., president and chief executive officer for ArcherDX. "The work we’ve engaged in with Merck KGaA, Darmstadt, Germany highlights the importance and potential of utilizing our proprietary profiling approach to make available to physicians an FDA-approved companion diagnostic solution for use with targeted therapies."

On October 3, 2018 Eli Lilly and Company (NYSE: LLY) reported that it will announce its financial results for the third quarter of 2018 on Tuesday, November 6, 2018 (Press release, Eli Lilly, OCT 3, 2018, View Source [SID1234529747]). Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance.

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The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.