On July 1, 2020 Sumitomo Dainippon Pharma Oncology, Inc. reported that was formed today through the merger of Tolero Pharmaceuticals, Inc., and Boston Biomedical, Inc., two clinical-stage companies developing novel cancer therapeutics based in the U.S. and wholly owned subsidiaries of Sumitomo Dainippon Pharma Co., Ltd. This U.S. entity, together with the oncology research and development teams in Japan, DSP Cancer Institute and Oncology Clinical Development Unit, will collectively be known as Sumitomo Dainippon Pharma Oncology or SDP Oncology (Press release, Sumitomo Dainippon Pharma, JUL 1, 2020, View Source [SID1234561636]).

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Consolidation of the U.S. companies will combine both organizations’ passion, resources and expertise to advance science and research with the goal of bringing cancer therapies to market more rapidly. Through scientific persistence and a commitment to discovery, SDP Oncology is focused on advancing a diverse and purposeful pipeline that aims to positively impact outcomes for patients with cancer. The company’s areas of concentration will address unmet needs in oncology and encompass discovery research, external innovation, clinical development and commercialization.

"The merger of Tolero Pharmaceuticals and Boston Biomedical, and the formation of Sumitomo Dainippon Pharma Oncology, will help us achieve our vision of establishing oncology as a core driver of our business," said Hiroshi Nomura, Representative Director, Chief Executive Officer, Sumitomo Dainippon Pharma. "Over the last decade, these formerly separate organizations have expanded our oncology pipeline to include multiple advanced assets and early discovery programs. We look forward to furthering our commitment to oncology globally through the efforts of Sumitomo Dainippon Pharma Oncology."

Patricia S. Andrews has been appointed Chief Executive Officer and Global Head of Oncology. Andrews previously spent seven years at Boston Biomedical and served as Chief Executive Officer for the past three years. The global leadership team includes David Bearss, Ph.D., Chief Scientific Officer and Global Head of Research, Edgar Braendle, M.D., Ph.D., Chief Medical Officer and Global Head of Development, and Masashi Murata, Ph.D., Chief Strategy Officer, Global Strategy and Planning.

"The launch of this organization represents an exciting new beginning, bringing together distinct proficiencies and strengths from each geography into one collaborative team," said Patricia S. Andrews, CEO and Global Head of Oncology. "We operate in a unique position within the oncology landscape because we have the nimbleness of a small company combined with the support and resources of a global parent company. Working together, we strengthen our ability to embrace risks and bring forward meaningful cancer therapies that have the potential to truly advance the treatment landscape."

SDP Oncology’s discovery, research and development programs will span multiple areas, including oncogenic pathways, survival mechanisms and novel protein interactions. The company’s robust portfolio of preclinical and advanced-stage assets is currently being investigated in multiple solid tumors and hematologic malignancies, including metastatic colorectal cancer, glioblastoma, myelofibrosis and myelodysplastic syndrome. Augmenting this effort, SDP Oncology’s Global Oncology External Innovation Hub enhances collaboration with external organizations, such as academia and venture capital, to propel meaningful research in drug discovery for oncology.

The establishment of SDP Oncology will foster collaboration between colleagues across geographies from Utah to Massachusetts to Japan, encouraging innovation focused on bringing forward breakthrough therapies.

On July 1, 2020 Seeking to ignite the next major breakthroughs to treat blood cancers, The Leukemia & Lymphoma Society (LLS), The Mark Foundation, and The Paul G. Allen Frontiers Group reported more than $6.75 million awarded to nine of the most exceptional scientists in the field (Press release, The Leukemia & Lymphoma Society, JUL 1, 2020, View Source;lymphoma-society-the-mark-foundation-for-cancer-research-and-the-paul-g-allen-frontiers-group-partner-to-award-6-75m-in-new-grants-to-drive-the-next-wave-of-novel-cancer-therapies-301086643.html [SID1234561635]).

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The innovative Blood Cancer Discoveries Grant Program is designed to encourage researchers with deep experience in the blood cancers to conduct critical basic research in hopes of unleashing the next wave of novel approaches to treating leukemia, lymphoma, myeloma and myelodysplastic syndromes; together, these cancers are the 2nd leading cause of cancer deaths in the U.S.

"Over our 70-year history, The Leukemia & Lymphoma Society has been at the forefront of revolutionary cancer treatments from the early days of chemotherapy and stem cell transplantation to the leading edge discoveries of immunotherapy and precision medicine; our investment in research is nearly $1.3 billion over that time," said Lee Greenberger, LLS’s chief scientific officer. "With this new initiative, LLS maintains its role as a driver of innovation, supporting early stage research to propel discoveries that might lead to the next generation of treatments and cures, and help accelerate promising therapies to patients."

The grants are awarded to researchers seeking to understand the biological underpinnings of various blood cancers, what causes them to develop and grow, or become resistant to treatments. Each project will be supported by an award of $750,000 over a three-year period.

"In science, collaboration can accelerate the pace of achievement," said Michele Cleary, Ph.D., CEO of The Mark Foundation for Cancer Research. "Similarly, this three-way partnership among foundations will accelerate our understanding of cancer biology by empowering some of the brightest scientists to simultaneously probe unique but challenging areas of unmet need. We look forward to the discoveries that will result from these efforts."

Added Kathryn Richmond, Ph.D., MBA, director of the Frontiers Group, a division of the Allen Institute, "Our organization is committed to pushing the boundaries of bioscience and accelerating discoveries to make a difference for humankind, and we believe these grants will be a catalyst that will spark innovative new directions in blood cancer research."

"We are grateful that the Frontiers Group and Mark Foundation have aligned with us to fund some of the greatest minds in cancer discovery," said LLS’s Greenberger. "Collaborating with foundations who share a common goal of fueling leading-edge research to advance cures and better, safer treatments for cancer patients is critical to advancing our mission."

On July 1, 2020 The National Comprehensive Cancer Network (NCCN) reported the completion of the new NCCN Guidelines for Patients: Immunotherapy Side Effects series, with the publication of a book focused on chimeric antigen receptor (CAR) T-cell therapy (Press release, NCCN, JUL 1, 2020, View Source [SID1234561634]). This closely follows the publication of a separate book on immune checkpoint inhibitors, both created with support from the NCCN Foundation.

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"These guidelines explain, organize, and streamline a complex and rapidly evolving concept," said Olalekan Oluwole, MD, Vanderbilt-Ingram Cancer Center, a member of the NCCN Guidelines Panel for Management of Immunotherapy-Related Toxicities. "Traditional chemotherapy treatment affects all cells, and often fails to completely eradicate cancer. It can also leave patients with long-term complications, including other forms of cancer. CAR T-cell therapy is new in that, unlike chemotherapy, it focuses on using qualities of the immune system to target cancer. The targeting is akin to a heat seeking missile that won’t stop until it takes out any cell with the target, leading to potential long-term or permanent remission. CAR T is given one time, unlike chemotherapy, which is given over multiple cycles and could go on for months or years. However, patients are often surprised to learn that the single CAR T infusion includes a 28-day monitoring period during which they need to stay in close proximity to their treatment center."

During that monitoring period, the health care team is primarily watching for two things: cytokine release syndrome (CRS)—in which immune cells affected by the treatment release proteins called cytokines into the blood, stimulating an intense systemic inflammatory response—and immune effector cell-associated neurotoxicity syndrome (ICANS)—a range of neurological side effects. Both CRS and ICANS are generally reversible if treated promptly.

"Before starting CAR T-cell therapy two years ago, my doctor warned me and my wife that it might be a wild rollercoaster ride for a month, but then I would have an excellent chance to be in a long remission," said Brian Koffman, MDCM (retired), MSEd, Co-Founder, Executive VP, and Chief Medical Officer, CLL Society, Inc. "The NCCN Guidelines for Patients let people know CAR T-cell therapy is a powerful cell-based treatment capable of offering very durable responses in difficult to treat blood cancers, but in some cases the cancer killing can be so intense that the collateral damage may manifest as frightening symptoms. Fortunately these adverse events tend to be predictable, manageable, and short-term. I told my doctor to ‘sign me up,’ and I would say that again today."

"CRS can set in rapidly, pushing the patient’s body to very high temperatures and taking quite a toll," cautioned Dr. Oluwole. "However, we researchers are learning more about how to collaborate to predict toxicities and sharing knowledge on recognizing and treating them more quickly. The new NCCN Guidelines for Patients are yet another example of how we’re sharing this important information."

NCCN Guidelines for Patients are based on the NCCN Guidelines used by clinicians worldwide, which have been found to improve the likelihood of successful treatment and longer survival while also reducing costs, according to numerous independent studies. They cover every major type of cancer as well as prevention, supportive care, and specific patient populations. The NCCN Guidelines represent the consensus of a multidisciplinary panel of experts for each cancer type or clinical scenario based on the latest evidence. The NCCN Guidelines for Patients put the clinical recommendations into easy-to-understand language alongside illustrations, suggested questions, and a glossary of terms and acronyms.

NCCN Guidelines for Patients are available for free online at NCCN.org/patients, or via the NCCN Patient Guides for Cancer App, thanks to funding from the NCCN Foundation. Printed copies are available at Amazon.com for a nominal fee. The immunotherapy patient guidelines have been endorsed by Be The Match/National Marrow Donor Program (NMDP), Good Days, The Leukemia & Lymphoma Society (LLS), and Stupid Cancer.

Visit NCCN.org/patients to learn more or make a donation to the NCCN Foundation in support of these and other comprehensive, frequently-updated resources for people with cancer and their loved ones.

On July 1, 2020 Transcenta Holding Limited ("Transcenta"), a global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, reported that the first subject has been dosed successfully in the US Phase I clinical trial of TST001, a humanized Claudin18.2 (CLDN18.2) monoclonal antibody developed by Transcenta’s subsidiary Mabspace Biosciences (Suzhou) Co., Ltd (Press release, Transcenta, JUL 1, 2020, View Source [SID1234561633]).

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NCT04396821 is a Phase I clinical study conducted in the US to evaluate TST001 in the treatment of patients with advanced or metastatic solid tumors. The primary objectives of the study are to evaluate TST001’s safety, tolerability and recommended dose for Phase II study.

CLDN18.2, found widely expressed in gastric cancer patients, has been regarded as one of the most promising therapeutic target for gastric cancer. It is a tight junction protein with expression strictly confined to differentiated epithelial cells of the normal gastric mucosa, and its overexpression in many tumors makes it an attractive anti-cancer therapeutic target.

"Anti-cancer therapeutics is one of the key parts of Transcenta’s pipeline. As the first project entered clinical trial since merger, TST001 has shown encouraging anti-cancer activities in pre-clinical studies. Soon we’ll initiate its clinical study in China. We will continue to leverage the advantages of our fully integrated capabilities to accelerate the clinical evaluation of TST001, either as monotherapy or in combination with other drugs, bringing potentially more efficacious treatment options to cancer patients around the world," said Dr. Xueming Qian, Transcenta’s Co-Founder and Chief Executive Officer.

About TST001

TST001, developed by Transcenta’s subsidiary Mabspace Biosciences (Suzhou) Co., Ltd., is a high affinity humanized monoclonal antibody targeting CLDN18.2 positive tumors by mechanisms such as complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC) through combining CLDN18.2 with high affinity. Through bioprocess engineering, TST001 is produced with reduced fucosylation and results in significant enhancement in its activity against CLDN18.2-expressing tumors. In preclinical pharmacodynamics studies, TST001 shows better anti-cancer activity than similar molecules.

On July 1, 2020 BioLife Solutions, Inc. (NASDAQ: BLFS) ("BioLife" or the "Company"), a leading developer and supplier of a portfolio of class-defining bioproduction tools for cell and gene therapies, reported it intends to offer shares of its common stock for sale in an underwritten public offering (Press release, BioLife Science, JUL 1, 2020, View Source [SID1234561632]). In addition, BioLife expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares to be issued and sold in the public offering on the same terms and conditions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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BioLife anticipates using net proceeds from the offering for general corporate purposes, which includes, without limitation, potentially investing in or acquiring companies that are synergistic with or complementary to our technologies, and working capital.

Cowen, Oppenheimer & Co. and Stephens Inc. are acting as the joint book-running managers for the proposed offering.

The shares described above are being offered pursuant to a shelf registration statement on Form S-3, including a base prospectus, which was filed by BioLife with the Securities and Exchange Commission ("SEC") on September 24, 2019 and became effective October 4, 2019. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus may be obtained by contacting: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York, 10004, by telephone at (212) 667-8563, or by email at [email protected]; or Stephens Inc., Attn: Equity Syndicate Desk, 111 Center Street, Little Rock, Arkansas 72201, or by telephone at (800) 643-9691.

This press release shall not constitute an offer to sell or the 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.