On May 25, 2021 Ascletis Pharma Inc. (HKEX code: 1672) reported that following the consultation with China National Medical Products Administration (NMPA), the clinical trial application of ASC40 combined with bevacizumab to treat patients with recurrent glioblastoma (rGBM) has been accepted for review by China NMPA (Press release, Ascletis, MAY 25, 2021, View Source [SID1234580504]).

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Lipid metabolism has been reported to play a critical role in various cancers. Fatty acid synthase (FASN) is one of the most important proteins which regulate lipid metabolism. Many solid and hematopoietic tumors overexpress FASN, including rGBM, non-small cell lung, breast, ovarian, prostate, colon, pancreatic cancers, and non-Hodgkin lymphoma.

ASC40 (known as TVB-2640 outside China) is a potent, selective and safe oral small molecule inhibitor of FASN. The positive results were demonstrated from the investigator sponsored Phase II trial of ASC40 (TVB-2640) in combination with bevacizumab in patients with first relapse of high-grade astrocytoma i.e. rGBM, which was completed in the United States (ClinicalTrials.gov Identifier: NCT03032484). The data from this Phase II trial have shown that the overall response rate (ORR) for ASC40(TVB-2640) plus bevacizumab was 65% including the complete response (CR) of 20% and partial response (PR) of 45%. Furthermore, the data indicate that the progression-free survival at six months (PFS6) observed for ASC40 (TVB-2640) plus bevacizumab was 47%, representing a statistically significant improvement in PFS6 over historical bevacizumab monotherapy (BELOB16%, P=0.01). ASC40 (TVB-2640) in combination with bevacizumab was safe and well tolerated in such patient population.

"Since the announcement on March 30 this year for investment escalation in R&D of cancer lipid metabolism and oral checkpoint inhibitors, this is a key step forward for the Company’s oncology pipeline." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.

On May 25, 2021 Bristol Myers Squibb (NYSE: BMY) reported that the company will host a virtual Investor Event on Tuesday, June 8, 2021 at 1 p.m. ET to discuss data presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Bristol-Myers Squibb, MAY 25, 2021, View Source [SID1234580523]).

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Company executives will provide an overview of data presented from the company’s oncology portfolio and address questions from investors and analysts.

Investors and the general public are invited to listen to a live webcast of the event at View Source Materials related to the webcast will be available at the same website prior to the event. An archived edition of the Investor Event will be available later that day.

On May 25, 2021 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron") reported that it has sold $150 million of senior unsecured convertible promissory notes (the "Notes") in a private placement transaction (Press release, Heron Therapeutics, MAY 25, 2021, View Source [SID1234580541]). The Notes are convertible into shares of Heron common stock at a conversion price of $15.276 per share, which represents a 13% premium over the most recent closing price of Heron’s common stock. Proceeds from the sale of the Notes will be used for the commercial launch of ZYNRELEFTM (bupivacaine and meloxicam) extended-release solution, as well as for general working capital.

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The Notes will be senior, unsecured obligations of Heron and will accrue interest at a rate of 1.5% per annum, payable semi-annually in arrears. The Notes will mature on June 1, 2026, unless earlier redeemed, converted or repurchased. Holders will have the right to convert their Notes at any time. Heron will settle conversions solely in shares of its common stock, except for payments of cash in lieu of fractional shares.

"Based on sales projections for our three commercial products, these funds allow the company to not only fully implement its launch plans for ZYNRELEF, but should also be sufficient to reach profitability," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "In the first 24 hours after announcing FDA approval, ZYNRELEF received its first formulary approval for unrestricted use. We are confident that this is the first of many formulary approvals."

The offer and sale of the Notes and any shares of common stock issuable upon conversion of the Notes have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any other securities laws, and the Notes and any such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the Notes or any shares of common stock issuable upon conversion of the Notes, nor will there be any sale of the Notes or any such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

J. Wood Capital Advisors LLC acted as financial advisor and Gibson, Dunn & Crutcher LLP acted as legal advisor to Heron on the transaction.

On May 25, 2021 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported that Selecta’s Chief Executive Officer, Carsten Brunn, Ph.D., will provide a corporate update and participate in one-on-one investor meetings at the Jefferies Virtual Healthcare Conference to be held June 1-4, 2021 (Press release, Selecta Biosciences, MAY 25, 2021, View Source [SID1234580557]).

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The presentation on Tuesday, June 1 at 9:30 a.m. ET will be available through the Jefferies conference portal and an archived webcast will also be accessible in the Investors & Media section of the company’s website at www.selectabio.com.

On May 25, 2021 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported it has entered into a technology license agreement with Bristol-Myers Squibb Company (NYSE:BMY) under which Bristol Myers Squibb will have non-exclusive access to Xencor’s Xtend Fc technology to extend the half-life of a novel antibody combination therapy that is intended to neutralize the SARS-CoV-2 virus ("SARS-CoV-2 mAb Duo") for treatment or prevention of COVID-19. SARS-CoV-2 mAb Duo was discovered by researchers at The Rockefeller University and was subsequently licensed by Bristol Myers Squibb (Press release, Xencor, MAY 25, 2021, View Source [SID1234580573]). Phase 1 clinical evaluation to assess dosing and safety of the antibody combination is being conducted by investigators at Rockefeller University Hospital, while the initial Phase 2 and 3 studies are being planned as part of the NIH ACTIV-2 trial examining treatment of infected outpatients.

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"Xencor’s Xtend Fc domains have been incorporated into more than a dozen clinical-stage programs or commercialized medicines, including two programs under investigation for the treatment of COVID-19 and five for other infectious diseases," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "This reflects the potential of Xencor’s XmAb protein engineering platforms to enhance the therapeutic performance of novel antibody candidates. By extending half-life, we improve upon a candidate’s product profile and potentially reduce costs – both of which are important features, particularly for an anti-viral therapy intended for pandemic use. We are committed to partnering with industry and the academic community to support the development of potential treatments for COVID-19, as well as other areas of urgent unmet medical need."

Under the terms of the agreement, Bristol Myers Squibb will have sole responsibility for supporting and advancing the research, development, regulatory and commercial activities for SARS-CoV-2 mAb Duo. Xencor is eligible to receive royalties from net sales of products including these antibodies.

About Xtend XmAb Fc Technology

Xencor’s Xtend XmAb Fc domains have been shown to increase circulating half-life by increasing binding affinity to the receptor FcRn. FcRn is present inside lysosomes in endothelial cells lining the blood vessels and functions to rescue antibodies from the degradation that makes most proteins short-lived in circulation. Half-life extension can be exploited to potentially improve therapeutic antibody performance in several ways, such as increasing dosing interval or decreasing drug quantities at the same dosing interval compared to a parent antibody. Xtend technology is currently in multiple clinical-stage programs and one approved therapy, Alexion’s Ultomiris (ravulizumab-cwvz).

Ultomiris is a registered trademark of Alexion Pharmaceuticals, Inc.