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.

On July 1, 2020 Context Therapeutics LLC, a clinical-stage biopharmaceutical company dedicated to advancing medicines for hormone driven cancers, reported that results from a safety review from preclinical and two Phase 1-2 studies evaluating its drug candidate onapristone extended release (ONA-ER) for the treatment of progesterone receptor (PR) positive cancers has been published in the journal Drug Safety. ONA-ER is an investigational, potentially best-in-class oral progesterone receptor (PR) antagonist (Press release, Context Therapeutics, JUL 1, 2020, View Source [SID1234561629]). If approved, ONA-ER would be the first FDA-approved medication for PR+ cancers.

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Antiprogestins demonstrated promising activity against breast and gynecological cancers, but liver-related safety concerns limited the advancement of this therapeutic class. Onapristone was previously evaluated in Phase 2 studies for metastatic breast cancer. Due to liver enzyme elevations identified during these studies, further development was halted. Evaluation of antiprogestin pharmacology and pharmacokinetic (PK) data suggests that liver enzyme elevations might be related to off-target effects associated with serum Cmax levels. If correct, this suggests the use of pharmaceutic strategies targeting efficacious systemic dose levels, but with a diminished Cmax. One such strategy – twice-daily dosing of an extended release (ER) formulation of onapristone (ONA-ER) – was developed and clinically evaluated in two phase 1-2 studies in PR-positive malignancies. In light of renewed interest in antiprogestin therapy for treating PR-positive breast and gynecologic cancer, the publication authors assessed the hepatotoxic potential of: (a) onapristone in liver-focused preclinical toxicology models, and (b) ONA-ER based on data from two phase 1-2 studies involving breast, ovarian, endometrial, and prostate cancer patients.

"These results suggest that the extended-release formulation by reducing drug exposure may be associated with a reduced risk of hepatotoxicity, and supports the continued clinical evaluation of ONA-ER for treating PR-positive cancers," said study author James H. Lewis, MD, Director of Hepatology at MedStar Georgetown University Hospital.

In the Phase 1-2 trials, ONA-ER at escalating doses of 10 mg to 50 mg twice-a-day had a favorable safety and tolerability profile at all doses. There were no treatment-related severe adverse events among patients treated with ONA-ER. No clinical trial subject receiving ONA-ER developed liver test elevations meeting Hy’s Law criteria or other clinically significant hepatic injury considered to be drug-related.

"Poor tolerability has limited the potential of antiprogestins for cancer patients," said Martin Lehr, Chief Executive Officer of Context. "We are pleased with the results from this review, which highlight the potential of ONA-ER to meet a significant unmet need for a well tolerated treatment for PR-positive cancers."

About Onapristone ER

Onapristone ER (extended release) is a potent and specific antagonist of the progesterone receptor that is orally administered. Currently, there are no approved therapies that selectively target progesterone receptor (PR) positive cancers. Preclinical and clinical data suggest that onapristone ER has anticancer activity by inhibiting progesterone receptor binding to chromatin, downregulating cancer stem cell mobilization and blocking immune evasion. Onapristone ER is currently being evaluated in patients with PR+ rare ovarian and endometrial cancers in the ongoing Phase 2 ONWARD 220 clinical trial. Additional Phase 2 clinical trials in ER+, PR+, HER2- breast cancer and PR-positive endometrial cancers will be initiated in 2020. Onapristone ER is an investigational drug that has not been approved for marketing by any regulatory authority.