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Defence’s Accum®-MRNA Lipid Nanoparticles Elicit Antibody Response 2x Stronger Than Standard mRNA Vaccines

On September 25, 2023 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceutical company specialized in the development of immune-oncology vaccines and drug delivery technologies, reported that its encapsulation strategy used to generate Accum-mRNA lipid nanoparticles (LNPs) results in an antibody response that is twice as potent as standard mRNA LNPs (Press release, Defence Therapeutics, SEP 25, 2023, View Source;utm_medium=rss&utm_campaign=defences-accum-mrna-lipid-nanoparticles-elicit-antibody-response-2x-stronger-than-standard-mrna-vaccines [SID1234635380]). These results constitute a strong basis for conducting additional tests to optimize Defence’s mRNA vaccine pipeline.

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This in vivo study had two main objectives: testing multiple LNP formulations and comparing their induced immune responses to standard mRNA. All vaccines were delivered as part of a prime-boost vaccination protocol with animal bleeding performed every two weeks over a total period of 4 weeks and antibody titers quantified by ELISA. Amongst the tested groups, one Accum-containing LNP formulation stood-up triggering a higher antibody compared to the remaining groups.

"The use of mRNA vaccines now expanding rapidly into cancer therapeutics will expand exponentially over the next decade due to their established potency and ease of manufacturing. Defence will thus strive in applying its platform of Accum technology in mRNA vaccination opportunities, which will have a great impact on the induced immune responses", says Mr. Plouffe, CEO of Defence Therapeutics.

Defence will design additional studies, currently now being prepared to test different concentrations of the selected LNPs. Once the optimal dosing is identified, a validation study will be conducted in cancer-bearing mice to test their therapeutic potency. In this case, animals will be transplanted with a solid tumor expressing an experimental antigen followed by a prime-boost vaccination administered alone or in combination with immune-checkpoint blockers such as anti-PD-1.

Accum has been tested in various applications including protein- and cell-based vaccination modalities and was discovered to significantly boost their therapeutic potency. Defence is therefore convinced that Accum will increase the stability of mRNA molecules by enhancing structural integrity of the molecule, and augment their bio-accumulation and efficient translation in target cells resulting in a stronger immune-reactivity as shown with its latest LNP vaccination study.

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.

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.