On May 23, 2018 mAbxience, a company specialized in the research, development, manufacturing and global commercialization of monoclonal antibody biosimilars -part of the Insud Pharma Group- and Amneal Pharmaceuticals, Inc., an integrated specialty pharmaceutical company powered by a robust U.S. generics business, have signed an exclusive licensing and supply agreement in the United States for mAbxience´s bevacizumab, a biosimilar candidate for Avastin (Press release, mAbxience, MAY 23, 2018, View Source [SID1234611988]).

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Under the milestone based commercial agreement mAbxience will lead product, clinical development and subsequent manufacture while Amneal will guide the product through regulatory approval and have exclusive commercialisation rights in the United States.

"We are very proud to deepen our partnership with Amneal with the bevacizumab biosimilar agreement. We are passionate about increasing access and affordability of biologics in all countries around the world and this latest agreement with Amneal will be an important contribution to public health in the United States," said Emmanuelle Lepine, General Manager of mAbxience.

mAbxience is progressing its international expansion, and recently established partnerships in Europe and Australia for its bevacizumab biosimilar. Building long lasting partnerships is central to the company´s business philosophy. Biosimilars bring patients a safe, effective, efficient and affordable treatment option, which contributes to the sustainability of healthcare systems worldwide. More than 10,000 patients have now been treated with a mAbxience biosimilar.

On May 23, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell based therapies, reported the closing of a global offering of 2,070,000 ordinary shares to purchasers in the United States, Europe and certain countries outside the United States and Europe, comprised of 568,500 ordinary shares in the form of American Depositary Shares (ADSs) at a price per ADS of $26.28, and 1,501,500 ordinary shares at a price per share of € 22.29 (the "global offering") (Press release, Celyad, MAY 23, 2018, View Source [SID1234532515]). Each ADS represents the right to receive one ordinary share. The number of ADSs and ordinary shares sold in the global offering reflects the full exercise of the underwriters’ option to purchase additional shares.

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The gross proceeds to Celyad from the global offering amounted to approximately $54.4 million (approximately €46.1 million), before deducting underwriting commissions and estimated offering expenses.

Celyad’s ADSs are currently listed on the NASDAQ Global Market under the symbol "CYAD" and Celyad’s ordinary shares are currently listed on Euronext Brussels and Euronext Paris.

Wells Fargo Securities, LLC and Bryan, Garnier & Co. acted as joint bookrunning managers for the offering. Bank Degroof Petercam NV acted as a co-manager for the private placement and LifeSci Capital LLC acted as a co-manager for the global offering. Kempen & Co NV was Celyad’s advisor in connection with the offering. No stabilization activity was undertaken in connection with the global offering.

The securities were offered pursuant to an effective shelf registration statement that was previously filed with, and declared effective by, the U.S. Securities and Exchange Commission (SEC). A final prospectus supplement dated May 17, 2018 relating to and describing the terms of the offering was filed with the SEC on May 18, 2018 and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to these securities can be obtained for free from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, at (800) 326-5897 or email a request to [email protected] or Bryan, Garnier & Co., Beaufort House, 15 Saint Botolph Street, London EC3A 7BB, United Kingdom, or by telephone at +44 20 7332 2500, or by email at [email protected].

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

On May 23, 2018 INmune Bio, Inc., an immunotherapy company developing therapies that reprogram the patient’s innate immune system to treat cancer, reported that it has initiated a Phase 1 clinical trial of its drug candidate INB03 in patients with advanced solid tumors (Press release, INmune Bio, MAY 23, 2018, View Source [SID1234529236]). INB03 is a novel innate immune system checkpoint inhibitor that targets MDSCs, cells of the innate immune system which create an immunosuppressive shield around the tumor and inhibit the patient’s immune system from attacking the cancer. By preventing the proliferation and function of MDSC, the company believes patients will have a stronger immune response to their tumor and may respond better to other cancer treatments including immunotherapy such as checkpoint inhibitors (CPI).

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"MDSC are a high priority target for the next advance in immuno-oncology," said RJ Tesi, MD, CEO and co-founder of INmune Bio. "INB03 decreases proliferation and function of MDSC. By eliminating the immunosuppressive effects of MDSC in the tumor microenvironment, we hope to provide therapeutic options for patients who are resistant to immunotherapy because of elevated levels of MDSC. This Phase I trial is the first step to meeting our goal of improving the response to CPI in patients who fail therapy due to increased MDSC in their tumor."

"In less than three years, INmune Bio has developed two immunotherapy platforms, INKmune and INB03 from bench-to-bedside. Both programs will enter the clinic this year," said Tim Schroeder, CEO of CTI Clinical Trials and Consulting Services (CTI) and an INmune Bio board member. "The company has remained focused on reprograming the patient’s innate immune system to better attack their cancer. By targeting the oft-ignored innate immune system, INmune Bio has a chance to make a difference in patients’ lives."

CTI Clinical Trial & Consulting Services Australia Pty Ltd., a subsidiary of CTI, is the CRO managing the INB03 Phase I clinical trial.

MDSCs are myeloid cells that appear in patients with cancer and other chronic inflammatory diseases. In patients with cancer, the number of MDSC in the blood and/or tumor microenvironment predict the severity of the cancer and prognosis. The more MDSC, the worse the prognosis. MDSC are recognized as a risk factor in predicting failure to immunotherapy including CPI. By eliminating MDSC, INB03 should allow an improved response to immunotherapy as well as an increased ability of the patient’s own immune system to attack the tumor. The INB03 Phase I trial uses biomarkers to select patients who should benefit from treatment. There are currently no approved drugs that have been developed to target MDSC.

On May 23, 2018 Strata Oncology, a precision oncology platform company, reported the close of a $26 million USD Series B funding round (Press release, Strata Oncology, MAY 23, 2018, View Source [SID1234526890]). New investors Pfizer Ventures, Merck Global Health Innovation Fund, Deerfield Management and Renaissance Venture Capital Fund were joined by existing investors Arboretum Ventures and Baird Capital.

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Strata Oncology will use the new funding to:

Expand the Strata Precision Oncology Network, a group of leading health systems adopting Strata’s platform to systematize tumor molecular profiling and precision therapy trials.
Further develop the company’s clinical-genomic data and software solutions to streamline health system precision oncology workflows and catalyze new clinical research opportunities.
Submit the company’s tumor molecular profiling assay, StrataNGS, for approval by the US Food and Drug Administration. StrataNGS includes actionable DNA and RNA biomarkers and will be expanded to include tumor mutational load.
Launch the pan-cancer molecular analysis for cancer therapy (PATH) study, a Strata-sponsored master therapeutic protocol, to support rapid and cost-effective indication expansion studies for on-market pharma drugs.
"We are grateful to our early partners who have helped us demonstrate a new way forward in precision oncology," said Dan Rhodes, PhD, CEO of Strata Oncology, "And now with this funding, we’re eager to take our offerings to the next level so that we can further enable our health system partners and deliver a truly differentiated solution for pharma drug development."

"We believe that data is the future currency of healthcare," added Prem Tumkosit, Investment Principal at Merck Global Health Innovation Fund, "Strata’s platform will generate and leverage clinical-genomic data to drive precision trial enrollment and advance cancer care."

"We’ve been very impressed with Strata Oncology’s effort in building a comprehensive solution that meets the needs of both health systems and biopharma research," said Bill Burkoth, Executive Director at Pfizer Ventures. "We look forward to working with the company to achieve its goal of transforming precision oncology."

On May 23, 2018 Kronos Bio, Inc. (Kronos), a Two River portfolio company, reported the appointment of Norbert Bischofberger, Ph.D. as its President and Chief Executive Officer and completion of an $18 million seed financing (Press release, Kronos Bio, MAY 23, 2018, View Source [SID1234526872]). Prior to joining Kronos, Dr. Bischofberger was at Gilead Sciences for almost 30 years, where he most recently served as Executive Vice President, Research and Development and Chief Scientific Officer until April 2018.

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The financing was led by a number of industry leaders and venture capital funds, including Omega Funds, BellCo Capital, John Martin, Ph.D., Norbert Bischofberger, Ph.D., and Vida Ventures, LLC. As part of this financing, Drs. Bischofberger and Martin, as well as Rebecka Belldegrun, M.D., and Otello Stampacchia, Ph.D. joined the company’s Board of Directors.

Kronos is researching and developing first-in-class therapies against historically intractable targets. Its technology is based on over a decade of research by Kronos’ Scientific Founder, Angela Koehler, Ph.D., into high-throughput screening strategies for chemical modulators of transcription factors and other recalcitrant targets in oncology. By combining small molecule microarrays (SMM) with extensive know-how in biological assay development, Kronos’ technology platform enables high-throughput screens of chemical libraries against target proteins in a more physiologically-relevant context. This approach is ideally suited for rapid discovery of unique ligands that can be utilized in the generation of novel modulators or degraders of challenging targets such as transcription factors.

"Kronos’ technology creates the opportunity to fundamentally challenge the historic belief that certain targets should not be pursued," said Dr. John Martin. "Norbert is ideally positioned to shepherd this exciting technology into the next stage of development. I am thrilled to have the opportunity to work with Norbert again to accelerate the progress of this novel technology to generate lead compounds."

"The future of our industry belongs to companies who dare to be first," said Dr. Arie Belldegrun, Chairman of Kronos’ Board of Directors. "Angela’s innovative research combined with Norbert’s expertise and track record of success, provides Kronos the opportunity to discover first-in-class treatments for some of the most elusive targets in oncology."

Dr. Bischofberger was part of the early formation of Gilead Sciences. He joined the company in 1990 and served as Executive Vice President for Research and Development from 1999 to 2018 and Chief Scientific Officer from 2007 to 2018. Prior to joining Gilead, Dr. Bischofberger was a Senior Scientist in Genentech’s DNA Synthesis Group from 1986 until 1990. He received a Ph.D. in organic chemistry from Zurich’s Eidgenössische Technische Hochschule and performed postdoctoral research in steroid chemistry at Syntex. Dr. Bischofberger also performed additional research in organic chemistry and applied enzymology in Professor George Whiteside’s lab at Harvard University in Cambridge, Massachusetts.

"The science behind Kronos is compelling. At its core, it focuses on solutions, not limitations. It is some of the most exciting technology I’ve come across and it opens a new door for applied chemistry to solve some of the greatest challenges we face in the industry today," said Dr. Norbert Bischofberger. "When I started at Gilead, we had approximately 25 employees. I am excited to apply the wisdom and experience I’ve gained and return to my roots in early stage biotechnology."

Kronos is currently advancing two preclinical programs built upon hits identified from the SMM platform, targeting MYC and the Androgen Receptor (AR). The MYC family of transcription factors are master regulators of cell proliferation and differentiation, and MYC expression is dysregulated in a large proportion of human cancers. Kronos is currently pursuing lead compounds that have demonstrated activity in multiple MYC-driven cancer models. The Androgen Receptor (AR) is a primary driver of disease progression in prostate cancer. Kronos is progressing multiple hit series that target AR and its splice variants and have been shown to reduce viability and AR expression in treatment-resistant cell lines.

"While we can lay the framework in an academic setting, the speed with which progress can be made with the right team of commercial scientists is greatly accelerated. This next stage of development will uncover the real therapeutic potential of this research for patients," said Dr. Angela Koehler, Assistant Professor, Koch Institute for Integrative Cancer Research at Massachusetts Institute of Technology (MIT) and a Scientific Founder of Kronos. "I am thrilled to have the opportunity to work closely with Norbert and together advance our research to benefit patients with intractable cancers."