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Immunomic Therapeutics CEO to Join Panel at 18th Annual Biotech in Europe Forum

On October 3, 2018 Tomorrow, William Hearl, Ph.D., Chief Executive Officer (CEO) of Immunomic Therapeutics, Inc., will participate in a panel discussion on advanced therapeutics for oncology at the 18th Annual Biotech in Europe Forum. Dr. Hearl will discuss the potential capabilities of Immunomic’s UNiversal Intracellular Targeted Expression (UNITE) investigational technology as a comprehensive platform for precision immuno-oncology and beyond (Press release, Immunomics, OCT 3, 2018, View Source [SID1234529955]). Immunomic’s nucleic acid vaccines have the potential to use the body’s natural biochemistry to develop a broad immune response, including antibody production, cytokine release and critical immunological memory. This approach could put UNITE at the crossroads of immunotherapies in a number of illnesses, including cancer.

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Immunomic’s lysosomal targeting technology is currently being employed in a Phase II clinical trial as a cancer immunotherapy. The company is pursuing research in the early stages of three other specific oncology applications: hepatitis B and hepatocellular carcinoma, Epstein-Barr virus driven cancers, such as nasopharyngeal carcinoma, and human papilloma virus driven cancers.

Altimmune Closes on $16.9 Million in Funding

On October 3, 2018 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported it closed the previously announced underwritten public offering of common units and pre-funded units for gross proceeds of $12 million (Press release, Altimmune, OCT 3, 2018, View Source [SID1234529905]). Together with the Company’s registered direct offering announced on September 24, the Company received aggregate gross proceeds of $16.9 million.

"We are pleased with the outcome of our fundraising efforts," said William J. Enright, President and Chief Executive Officer of Altimmune. "These proceeds strengthen our balance sheet and position us well as we continue the development of NasoVax and our other product candidates."

Altimmune intends to use the net proceeds of approximately $14.4 million from these offerings for the continued advancement of development activities for the Company’s clinical-stage product pipeline, general corporate purposes, strategic growth opportunities and repayment of the Company’s outstanding $1.5 million in aggregate principal amount of convertible notes.

Roth Capital Partners acted as sole manager for the underwritten public offering and sole placement agent for the registered direct offering.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

BioLineRx Increases Stake in BL-8040, its Lead Oncology Platform in Late Stage Development for Multiple Oncology Indications

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.

"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.

FierceBiotech Names FLX Bio as One of its “Fierce 15” Biotech Companies of 2018

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]).

"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.

Corvus Pharmaceuticals Announces Publication of Preclinical Results Highlighting Antitumor Activity of CPI-444 in Multiple Tumor Models both as Monotherapy and in Combination Studies

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.

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.