On August 15, 2024 Stada reported Interim Report on the First Half of 2024 (Presentation, Stada, AUG 15, 2024, View Source [SID1234647165]).

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On August 15, 2024 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, reported positive feedback from its end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab to treat first-line unresectable or metastatic hepatocellular carcinoma (HCC) (Press release, Tempest Therapeutics, AUG 15, 2024, View Source [SID1234645946]).

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"We are thrilled with the positive outcome of our end-of-Phase 2 meeting with the FDA," said Sam Whiting, M.D., Ph.D., chief medical officer and head of R&D at Tempest. "Tempest and the FDA are in broad agreement on all major aspects of the proposed pivotal Phase 3 clinical trial for amezalpat in patients with hepatocellular carcinoma in the first line setting. This planned Phase 3 study closely mirrors the randomized Phase 2 study and the strongly favorable hazard ratio for overall survival observed at top-line analysis of the Phase 2, confirmed at the latest survival follow-up, give us confidence in the potential success of the Phase 3."

Key outcomes of the FDA meeting include:

Agreement on Phase 3 study design, including the standard-of-care control arm and the primary and secondary study endpoints
Agreement on appropriateness of the current amezalpat dose and schedule for the Phase 3 study
Agreement on the Phase 3 statistical plan including a pre-specified early efficacy analysis that the company currently estimates could shorten the time to primary analysis by up to 8 months
About the TPST-1120-301 Study

The planned Phase 3 study is a global, blinded, 1:1 randomized study of amezalpat plus atezolizumab and bevacizumab vs. atezolizumab and bevacizumab, the standard of care, in patients with unresectable or metastatic HCC treated in the first line setting. The company is preparing for the Phase 3 study start in the first quarter of 2025.

About Amezalpat (TPST-1120)

Amezalpat is an oral, small molecule, selective PPAR⍺ antagonist. Tempest’s data suggest that amezalpat treats cancer by targeting tumor cells directly and by modulating immune suppressive cells and angiogenesis in the tumor microenvironment. In an ongoing global randomized phase 1b/2 study of amezalpat in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC, the amezalpat arm showed clinical superiority across multiple study endpoints when compared to atezolizumab and bevacizumab alone, the standard of care. These randomized data were supported by positive results observed in the Phase 1 clinical trial in patients with heavily pretreated advanced solid tumors.

On August 15, 2024 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported the closing of its previously announced public offering of 2,000,000 shares of its American Depository Shares ("ADSs")(or pre-funded warrants in lieu thereof), together with Series G warrants ("Series G Warrants") to purchase up to 2,000,000 ADSs at a combined public offering price of $1 per ADS (or pre-funded warrant in lieu thereof) and associated Series G Warrant (Press release, TC Biopharm, AUG 15, 2024, View Source [SID1234645948]). The Series G Warrants have an exercise price of £0.78 per ADS, are exercisable upon issuance and will expire one year from the date of issuance. Each ADS represents two hundred ordinary shares of the Company.

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The gross proceeds to the Company from the offering were $2.0 million, before deducting offering expenses payable by the Company. The Company intends to use the net proceeds from this offering to support its upcoming clinical trial focusing on relapse/refractory Acute Myeloid Leukemia, and for continuing operating expenses and working capital.

A registration statement on Form F-1 (File No. 333-280659) relating to these securities described above was filed with the Securities and Exchange Commission, or the SEC, and was declared effective by the SEC on August 12, 2024. The offering was made only by means of a prospectus, which is part of the effective registration statement. A final prospectus relating to the offering was filed with the SEC. Electronic copies of the final prospectus may be obtained for free on the SEC’s website located at View Source

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On August 15, 2024 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, reported that it has entered into a Master Services Agreement with Aronnax, Inc. for its HT-KIT cancer therapeutic (Press release, Hoth Therapeutics, AUG 15, 2024, View Source [SID1234645949]).

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HT-KIT research, which was conducted at NC State University to evaluate the efficacy of HT-KIT in cancerous and non-cancerous cells, has demonstrated that HT-KIT effectively kills human mast cells that rely on signaling through the KIT receptor to survive. The effect of a single dose lasted for about two weeks, while reduced KIT expression lasted for 7 days. This result also demonstrated HT-KIT’s potential to reduce KIT expression using GIST cells and kill within 48 and 72 hours along with lower KIT expression in AML cells over 72 hours.

HT-KIT is an antisense oligonucleotide that targets the proto-oncogene cKIT being developed for the treatment of mast cell-derived cancers and anaphylaxis and previously received Orphan Drug Designation from FDA.

Aronnax will oversee the third-party provider, ITR Laboratories, conducting intravenous injection using increasing/decreasing doses for each subsequent group. A timeframe of forty-eight hours will be allowed between each dose group. This study will provide Hoth key metrics in both max dose and range finding elements which will help formulate its proposed clinical trial.

"We continue to make quick progress in moving HT-KIT from the lab to patients. This further analysis will help us with that process, finalizing the protocols in our upcoming IND-enabling study," stated Robb Knie, Chief Executive Officer. "We are pleased to further engage Aronnax and ITR Laboratories on these key studies given their reputation for IND-enabling studies."

On August 14, 2024 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 12,059,459, entitled, "Therapeutic Anticancer Neoepitope Vaccine" (Press release, Nykode Therapeutics, AUG 14, 2024, View Source [SID1234645817]).

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The newly issued patent describes Nykode’s fully individualized neoantigen based vaccine, VB10.NEO, which is in development for the treatment of locally advanced or metastatic solid tumours. The 20 year expiration date of this patent is January 5, 2037. Related patents were previously granted to the company in Russia, India, and Australia.

Michael Engsig, CEO of Nykode, said, ‘We are very pleased with the granting of this important patent in the U.S., a key market for Nykode. Continuously expanding our patent protection is a core strategy for us. The granting of this patent is a testament to the world-class innovation taking place in Nykode’s labs. We remain dedicated to pushing the boundaries of what’s possible in medicine, bringing hope to patients and their families around the globe."

About VB10.NEO

VB10.NEO is a proprietary individualized neoantigen vaccine in development for the treatment of locally advanced or metastatic solid tumors under an exclusive, worldwide clinical collaboration with Genentech, a member of the Roche Group. The vaccine is designed to be produced on-demand according to the neoantigen profile of an individual patient. Neoantigens are proteins generated by tumor-specific mutations not present in normal tissues and are thus an attractive target for cancer immunotherapy as they may be recognized as foreign by the immune system.

Nykode is currently conducting a clinical study evaluating VB10.NEO: VB N-02, an open-label Phase 1b, dose-escalation study of the safety and antigen-specific immune responses elicited by VB10.NEO in combination with Roche’s checkpoint inhibitor atezolizumab in patients with locally advanced and metastatic tumors (NCT05018273).