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FDA Issues Complete Response Letter (CRL) for UDENYCA® ONBODY™ Biologics License Application Solely Due to an Ongoing Review of Inspection Findings at a Third-Party Filler; Coherus Also Announces Completion of Toripalimab FDA Inspections

On September 25, 2023 Coherus BioSciences, Inc. ("Coherus", NASDAQ: CHRS), a commercial-stage biopharmaceutical company focused on the research, development, and commercialization of innovative immunotherapies to treat cancer, reported that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) supplement for UDENYCA ONBODY, the company’s on-body injector (OBI) presentation of UDENYCA (pegfilgrastim-cbqv), solely due to an ongoing review of inspection findings at a third-party filler (Press release, Coherus Biosciences, SEP 25, 2023, View Source [SID1234635379]). The CRL did not identify any issues with the UDENYCA ONBODY clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing, and no additional data or trials have been requested. Coherus is committed to working closely with the FDA and the third-party filler to bring UDENYCA ONBODY to cancer patients requiring pegfilgrastim treatment as quickly as possible.

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Coherus also announced completion of FDA’s toripalimab inspections
Coherus also announced today that the FDA has completed the clinical study site inspections of three clinical sites in China that enrolled subjects in the two pivotal clinical trials supporting the toripalimab BLA for the treatment of metastatic or recurrent nasopharyngeal carcinoma (NPC) as first-line treatment or as second or greater line treatment. Only one site received an FDA Form 483, with one observation noted. Coherus believes the observation is readily addressable. Coherus continues to anticipate potential approval for toripalimab by year end 2023.

"We are pleased the FDA has completed the review elements for the OBI and toripalimab applications," said Dr. Theresa LaVallee, Coherus Chief Development Officer. "We will work with the third-party filler to address the issues and resubmit the UDENYCA ONBODY application as quickly as possible. Having completed all the required review elements of the toripalimab BLA, we will continue to work collaboratively with the FDA to bring toripalimab, with its substantial improvement in survival compared to chemotherapy, to NPC patients. NPC is a rare cancer with high unmet medical need that has no drugs approved for treatment of this disease in the U.S."

BridgeBio Pharma Announces $250 Million Private Placement Equity Financing

On September 25, 2023 BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the Company), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported to have entered into a securities purchase agreement with certain existing and new accredited investors to issue and sell an aggregate of 9,167,723 shares of its common stock (Common Stock) at the Friday, September 22, 2023 closing price of $27.27 per share through a private investment in public equity (PIPE) financing (Press release, BridgeBio, SEP 25, 2023, View Source [SID1234635378]). BridgeBio anticipates the gross proceeds from the PIPE financing to be approximately $250 million, before deducting offering expenses. The PIPE financing is anticipated to close on September 27, 2023, subject to customary closing conditions.

The PIPE financing was led by Qatar Investment Authority (QIA), with significant participation from four of the largest investment management firms in the United States, as well as a number of large institutional investors and existing investors. The Company completed this targeted and strategic raise in order to provide an entry for new long-term shareholders. The Company also continues to explore additional strategic options to fund the business.

TD Cowen, Mizuho, and KKR Capital Markets LLC are acting as joint placement agents for the PIPE financing.

"We are very pleased to partner with such a strong group of investors," said Neil Kumar, Ph.D., founder and CEO of BridgeBio. "Their support will help us fund our future operations, including the launch of acoramidis and our upcoming Phase 3 readouts in achondroplasia, LGMD2I, and ADH1, and will allow us to pursue additional less dilutive financing options to optimize our cost of capital."

The securities sold in the PIPE financing are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Concurrently with the execution of the securities purchase agreement, BridgeBio and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the securities sold in the PIPE financing.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. Any offering of the Common Stock described above under the resale registration statement will only be by means of a prospectus.

Bexion Pharmaceuticals, Inc. to Participate in the 2023 Cantor Global Healthcare Conference

On September 25, 2023 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a new generation of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN), reported that the Company will participate in the 2023 Cantor Global Healthcare Conference (Press release, Bexion, SEP 25, 2023, View Source [SID1234635376]). The conference will be held in New York, NY, from September 26-28, 2023.

Scott Shively, CEO and President of Bexion Pharmaceuticals, will be presenting a company overview at the conference on September 27, 2023, at 4:45 – 5:15 p.m. ET in Track 2.

Notice of Termination of License Agreement for AAT-007 & AAT-008 (EP4 Antagonist) for Global Immunooncology

On September 25, 2023 Askat reported the termination of a license agreement for AAT-007 & AAT-008 (EP4 Antagonist) for global immuno-oncology as of March 20, 2024, which was originally signed with Ikena Oncology Inc (Headquarters: Massachusetts, USA; hereinafter referred to as "Ikena") on December 14, 2017 (Press release, AskAt, SEP 25, 2023, View Source [SID1234635375]). Clinical trials have shown that AAT-007 was effective and well tolerated in microsatellite stable colorectal cancer, as previously announced (View Source),. This termination is due to a change in Ikena’s R&D strategy. AskAt will continue to implement strategic options for AAT-007 and AAT-008, including the selection of a new partner.

Entry into a Material Definitive Agreement

In April 2023, Paragon Therapeutics, Inc. ("Paragon") and WuXi Biologics (Hong Kong) Limited ("WuXi Biologics") entered into a biologics master services agreement (the "WuXi Biologics MSA"), which was subsequently novated to Aeglea BioTherapeutics, Inc. (the "Company") by Paragon on September 19, 2023 pursuant to a novation agreement (the "Novation Agreement") among the Company, Paragon and Wuxi Biologics (Filing, 8-K, Aeglea BioTherapeutics, SEP 25, 2023, View Source [SID1234635373]). The WuXi Biologics MSA governs certain development activities and GMP manufacturing and testing for the Company’s SPY001 program, as well as potential future programs, on a work order basis. Under the WuXi Biologics MSA, the Company is obligated to pay WuXi Biologics a service fee and all non-cancellable obligations in the amount specified in each work order associated with the agreement for the provision of services.

The WuXi Biologics MSA terminates on the later of (i) June 20, 2027 or (ii) the completion of services under all work orders executed by the parties prior to June 20, 2027, unless terminated earlier. The term of each work order terminates upon completion of the services under such work order, unless terminated earlier. The Company can terminate the WuXi Biologics MSA or any work order at any time upon 30 days’ prior written notice and immediately upon written notice if WuXi Biologics fails to obtain or maintain required material governmental licenses or approvals. Either party may terminate a work order (i) at any time upon six months’ prior notice with reasonable cause, provided however that if WuXi Biologics terminates a work order in such manner, no termination or cancellation fees shall be paid by the Company and (ii) immediately for cause upon (a) the other party’s material breach that remains uncured for 30 days after notice of such breach, (b) the other party’s bankruptcy or (c) a force majeure event that prevents performance for a period of at least 90 days.

Cell Line License Agreement — WuXi Biologics (Hong Kong) Limited

In April 2023, Paragon and WuXi Biologics entered into a cell line license agreement (the "Cell Line License Agreement"), which was subsequently novated to the Company by Paragon pursuant to the Novation Agreement. Under the Cell Line License Agreement, the Company received a non-exclusive, worldwide, sublicensable license to certain of WuXi Biologics’s know-how, cell line, biological materials (the "WuXi Biologics Licensed Technology") and media and feeds to make, have made, use, sell and import certain therapeutic products produced through the use of the cell line licensed by WuXi Biologics under the Cell Line License Agreement (the "WuXi Biologics Licensed Products"). Specifically, the WuXi Biologics Licensed Technology is used in certain manufacturing activities in support of the SPY001 program.

In consideration for the license, the Company agreed to pay WuXi Biologics a non-refundable license fee of $150,000. Additionally, if the Company manufactures all of its commercial supplies of bulk drug product with a manufacturer other than WuXi Biologics or its affiliates, the Company is required to make royalty payments to WuXi Biologics in an amount equal to a fraction of a single digit percentage of global net sales of WuXi Biologics Licensed Products manufactured by a third-party manufacturer (the "Royalty"). If the Company manufactures part of its commercial supplies of the WuXi Biologics Licensed Products with WuXi Biologics or its affiliates, then the Royalty will be reduced accordingly on a pro rata basis.

The Cell Line License Agreement will continue indefinitely unless terminated (i) by the Company upon six months’ prior written notice and the Company’s payment of all undisputed amounts due to WuXi Biologics through the effective date of termination, (ii) by WuXi Biologics for a material breach by the Company that remains uncured for 60 days after written notice, (iii) by WuXi Biologics if the Company fails to make a payment and such failure continues for 30 days after receiving notice of such failure, or (iv) by either party upon the other party’s bankruptcy.