On February 5, 2019 Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the closing of an underwritten public offering of 6,571,428 shares of its common stock and warrants to purchase up to 6,571,428 shares of its common stock, as well as an additional 985,714 shares of its common stock and warrants to purchase up to 985,714 shares of its common stock pursuant to the full exercise of the underwriters’ option to purchase additional securities (Press release, Leap Therapeutics, FEB 5, 2019, View Source [SID1234533078]). Total gross proceeds to Leap from this offering were approximately $13,225,000, before deducting underwriting discounts and offering expenses payable by Leap, and excluding any proceeds Leap may receive upon exercise of the warrants.

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Raymond James & Associates, Inc. and Ladenburg Thalmann acted as book-running managers for the offering.

The shares were offered pursuant to an effective shelf registration statement on Form S-3 (File No. 333-223419) that was previously filed by Leap with the Securities and Exchange Commission (the "SEC") on March 2, 2018 and was declared effective by the SEC on March 16, 2018. A prospectus supplement and the related prospectus have been filed with the SEC and are available, for free, on the SEC’s website at View Source Copies of the prospectus supplement and the accompanying prospectus may be obtained from: Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, or by telephone at (800) 248-8863, or e-mail at [email protected]; or from Ladenburg Thalmann, 277 Park Ave, 26th Floor, New York, NY 10172, or by email at [email protected].

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.

On February 5, 2019 Personalis, Inc., a leader in advanced genomics for precision oncology, reported that they are scheduled to present at the upcoming Immuno-Oncology 360° Conference in New York on Thursday, February 7, 2019 at 3:50 PM, EST (Press release, Personalis, FEB 5, 2019, View Source [SID1234534800]).

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The presentation, entitled "A Universal Cancer Immunogenomics Solution for Biomarker Discovery," will discuss the current challenges facing investigators in immuno-oncology translational research and explore how the Personalis Platform overcomes the limitations associated with conventional NGS approaches that are used in translational research and the clinical development of new oncology therapeutics. The presentation will also introduce Personalis’ new ImmunoID NeXT Platform.

ImmunoID NeXT is the first and only platform to provide comprehensive analysis of both a tumor and its microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology; consolidating multiple oncology biomarker assays into one. This maximizes the biological information that can be generated from a precious tumor specimen.

The presentation will be delivered by Kedar Hastak, PhD, Field Applications Scientist for Personalis.

On February 5, 2019 Bolt Biotherapeutics, Inc., a biotechnology company focused on unleashing the power of the immune system to achieve anti-tumor immunity in patients, reported the completion of a $54M Series B financing led by Pivotal bioVenture Partners with additional participation from Nan Fung Life Sciences (Press release, Bolt Biotherapeutics, FEB 5, 2019, View Source [SID1234533829]). Existing investors Novo Holdings and Vivo Capital also participated in the financing. The funds will be used to advance the company’s lead Boltbody Immune-Stimulating Antibody Conjugate (ISAC) into the clinic as well as to build the company’s pipeline and further develop its technology platform.

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"We have made significant progress with our Boltbody ISAC platform that harnesses the ability of toll-like receptor (TLR) agonists to convert cold tumors into immunologically hot tumors following systemic administration. We are well positioned to bring this novel technology into clinical development and look forward to sharing more about our lead program, pipeline and platform in the months ahead," stated Peter Moldt, Ph.D., of Novo Ventures and executive chairman of the board of Bolt Biotherapeutics. "We are pleased that this group of world-class biotech investors has chosen to join us on this important mission of developing a unique class of cancer immunotherapies."

"The rapid development of Bolt’s promising targeted therapeutic platform has been very impressive," noted Ash Khanna, Ph.D., venture partner at Pivotal bioVenture Partners. "Bolt’s proprietary ISAC technology is differentiated from other immuno-oncology approaches as evidenced by the strength of the preclinical safety and efficacy data, including durable systemic anti-tumor immunity and I look forward to working with the experienced team and investors to advance the company’s programs into the clinic."

On February 5, 2019 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune disease, asthma and allergic disease, and cancer, reported it has entered into a research and license agreement with Genentech, a member of the Roche Group, to develop and commercialize novel IL-15 cytokine therapeutics, including XmAb24306. XmAb24306 is an IL-15/IL-15Rα cytokine complex engineered with Xencor’s bispecific Fc domain and Xtend Fc technology and is Xencor’s most advanced preclinical cytokine program (Press release, Xencor, FEB 5, 2019, View Source [SID1234533064]).

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"This partnership with Genentech accelerates our immuno-oncology work by enabling the exploration of novel XmAb24306 combinations with Genentech’s leading oncology portfolio and our growing internal pipeline of bispecific antibodies," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "A wide-ranging combination strategy will be critical to realize the potential of IL-15 bispecific cytokines such as XmAb24306, so we plan to explore our cytokines with a broad spectrum of leading commercial-stage and investigational cancer therapies."

"We believe cytokine therapy will play an important role in the treatment of a wide range of diseases, including cancer," said James Sabry, M.D., Ph.D., global head of Pharma Partnering, Roche. "This collaboration with Xencor will further enhance our understanding of a critical immune activation pathway and may present a potential new way to use the immune system to target cancer."

IL-15 is a highly active cytokine, or immune signaling protein, that when pre-complexed with IL-15 receptor alpha (IL-15Rα) will bind to IL-15Rβγ and stimulate the expansion and activation of natural killer (NK) cells and cytotoxic T cells, but with reduced regulatory T cell activation compared to IL-2. Xencor’s IL-15 bispecific cytokine platform provides a more druggable version of IL-15 with potentially superior tolerability, slower receptor-mediated clearance and a prolonged half-life, and is intended for development with a wide range of combination agents due to its proposed mechanism of activating tumor-killing immune cells.

Under the terms of the agreement, the companies will co-develop XmAb24306 and other potential IL-15 programs, in which the companies will share development costs and profits. Genentech will commercialize medicines worldwide, and Xencor has the option to co-promote in the United States. Additionally, the companies will engage in a two-year research program to discover new IL-15 drug candidates, including ones targeted to specific immune cell populations. Genentech will pay Xencor $120 million upfront, and Xencor will be eligible to receive up to $160 million in development milestones for the XmAb24306 program and up to $180 million in development milestones for each new IL-15 drug candidate.

The agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and closing is expected to occur in the first half of 2019

On February 5, 2019 GlaxoSmithKline plc (LSE/NYSE: GSK) and Merck KGaA, Darmstadt, Germany reported that they have entered into a global strategic alliance to jointly develop and commercialise M7824 (bintrafusp alfa*). M7824 is an investigational bifunctional fusion protein immunotherapy that is currently in clinical development, including potential registration studies, for multiple difficult-to-treat cancers (Press release, GlaxoSmithKline, FEB 5, 2019, View Source [SID1234533081]). This includes a Phase II trial to investigate M7824 compared with pembrolizumab as a first-line treatment in patients with PD-L1 expressing advanced non-small cell lung cancer (NSCLC).

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M7824 is designed to simultaneously target two immuno-suppressive pathways, transforming growth factor-β (TGF-β) trap and an anti-programmed cell death ligand-1 (PD-L1), that are commonly used by cancer cells to evade the immune system. Bifunctional antibodies aim to increase efficacy above and beyond that achieved with individual therapies or combinations of individual therapies.1 M7824 has the potential to offer new ways to fight difficult-to-treat cancers beyond the established PD-1/PD-L1 class. In addition to use as a single agent, M7824 is also being considered for use in combination with other assets from the pipelines of both companies.

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "Despite recent medical advances, many patients with difficult-to-treat cancers don’t currently benefit from immuno-oncology therapies leaving them with limited treatment options. M7824 brings together two different biological functions in a single molecule and we have observed encouraging clinical results in treating certain cancer patients, particularly those people with non-small cell lung cancer. I’m excited by the potential impact this first-in-class immunotherapy could have on the lives of cancer patients."

Dr Belén Garijo, Member of the Executive Board and CEO Healthcare of Merck KGaA, Darmstadt, Germany said: "Our bifunctional fusion protein M7824 has the potential to bring new answers to patients living with cancer. Together with GSK we aim to drive a paradigm shift in the treatment of cancer as the leader in this novel class of immunotherapies. GSK clearly emerged as the ideal partner due to their strong commitment to oncology, and the complementary talent and capabilities they will bring to our alliance. We now look forward to harnessing the full potential of M7824 across a broad range of cancer indications as we continue to advance our oncology portfolio."

Merck KGaA, Darmstadt, Germany will receive an upfront payment of €300 million (£260 million) and is eligible for potential development milestone payments of up to €500 million (£440 million) triggered by data from the M7824 lung cancer programme. Merck KGaA, Darmstadt, Germany will also be eligible for further payments upon successfully achieving future approval and commercial milestones of up to €2.9 billion (£2.5 billion). The total potential deal value is up to €3.7 billion (£3.2 billion). Both companies will jointly conduct development and commercialisation with all profits and costs from the collaboration being shared equally on a global basis.

For GSK, this alliance is a further step in the company’s priority to strengthen its pharmaceuticals pipeline. This follows the company’s recent acquisition of TESARO, an oncology-focused company based in Waltham, Massachusetts. GSK’s approach to oncology is focused on innovation in the areas of immuno-oncology, cell therapy, cancer epigenetics and, most recently, genetic medicine.

This alliance reflects Merck KGaA, Darmstadt, Germany’s strategic approach to oncology R&D, identifying those opportunities that can progress the company’s highly promising clinical stage assets as efficiently and rapidly as possible, whether through internal expertise and capabilities or external collaborations.

With this alliance, both companies have the leadership position in this new class of immunotherapies, specifically leveraging TGF-β biology.

*Bintrafusp alfa is the proposed International Nonproprietary Name (INN) for the bifunctional immunotherapy M7824. Bintrafusp alfa is currently under clinical investigation and not approved for any use anywhere in the world.

About M7824 (also now known as bintrafusp alfa)
M7824 is an investigational bifunctional immunotherapy that is designed to combine a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein. M7824 is designed to combine co-localised blocking of the two immuno-suppressive pathways – targeting both pathways aims to control tumour growth by potentially restoring and enhancing anti-tumour responses. M7824 is currently in Phase I studies for solid tumours, as well as a randomised Phase II trial to investigate M7824 compared with pembrolizumab as a first-line treatment in patients with PD-L1 expressing advanced NSCLC. The multicentre, randomised, open-label, controlled study is evaluating the safety and efficacy of M7824 versus pembrolizumab as a monotherapy treatment.

To-date, nearly 700 patients have been treated with M7824 across more than 10 tumour types in Phase I studies. Encouraging data from the ongoing Phase I studies indicates M7824’s potential safety and clinical anti-tumour activity across multiple types of difficult-to-treat cancers, including advanced NSCLC, human papillomavirus-associated cancers, biliary tract cancer (BTC) and gastric cancer. In addition, in pre-clinical studies M7824 demonstrated superior anti-tumour activity, compared with anti-PD-L1 alone or with anti-PD-L1 and TGF-β trap when co-administered. In total, eight high priority immuno-oncology clinical development studies are ongoing or expected to commence in 2019, including studies in non-small cell lung and biliary tract cancers.