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.

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 estimated preliminary revenue for the second quarter of 2020 of $9.6 million to $9.8 million, representing 43% to 46% growth over the same quarter in 2019 (Press release, BioLife Science, JUL 1, 2020, View Source;301087225.html [SID1234561631]).

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Mike Rice, BioLife’s CEO, commented, "Despite the continued impact of COVID-19 on the biotech industry and specifically, the cell and gene therapy market, we continued to drive revenue growth in the second quarter. In the first six months of 2020, we added 57 new customers and confirmed that our biopreservation media products have been embedded in 23 additional customer clinical trials."

The financial data presented for the second quarter of 2020 should be considered preliminary and could be subject to change as these preliminary results are based on management’s initial analysis of operations and are subject to further internal review and the Company’s independent auditor, BDO USA, LLP, who have not completed their review.

On July 1, 2020 MetVital, Inc., a privately held biopharmaceutical company developing small molecule modulators of altered glutamate metabolism for the treatment of diseases with significant unmet medical need and commercial potential, reported that the U.S. Food and Drug Administration (FDA) has notified MetVital that its lead drug candidate, "Anhydrous Enol-Oxaloacetate" (AEO) received Fast Track Designation for the treatment of patients with newly diagnosed glioblastoma multiforme (GBM) (Press release, MetVital, JUL 1, 2020, View Source [SID1234561630]).

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AEO, a patented molecule, is MetVital’s lead clinical development candidate for treatment of glioblastoma multiforme, a malicious type of brain cancer.

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions which fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.

"FDA’s Fast Track Designation for our lead drug candidate is another important milestone for MetVital, as it can potentially speed the development of this drug for glioblastoma patients," said Alan Cash, president and chief executive officer of MetVital, Inc. AEO is also being tested in Investigator-initiated clinical trials for the treatment of Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s disease and in breast cancer survivors with cognitive complaints.

Anhydrous Enol-Oxaloacetate is a molecule that has demonstrated safety and efficacy in animal models with human glioblastoma tissue implants, in animal models of ALS, and in animal models of Alzheimer’s disease. US FDA Orphan Drug Designations for oxaloacetate have been received for gliomas, ALS, and hepatocellular carcinoma.

Glioblastoma multiforme is the most aggressive of the gliomas. It is often referred to as a grade IV astrocytoma, and is the most common type of brain cancer.