Sarepta Therapeutics to Present at the Morgan Stanley 22nd Annual Global Healthcare Conference

On August 30, 2024 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, reported that senior management will participate in a fireside chat at the Morgan Stanley 22nd Annual Global Healthcare Conference at the New York Marriott Marquis in New York, NY. on Friday, Sept. 6, 2024, at 9:15 a.m. E.T (Press release, Sarepta Therapeutics, AUG 30, 2024, View Source [SID1234646256]).

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The presentation will be webcast live under the investor relations section of Sarepta’s website at View Source and will be archived there following the presentation for 90 days. Please connect to Sarepta’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

InnoCure Announces ‘ICT-1402’ Research Results at US BioCentury Conference

On August 30, 2024 Innocure Therapeutics (CEO Yoo Hye-dong, Innocure), a company specializing in the development of targeted protein degradation (TPD) drugs, reported that Chief Strategy Officer (CSO) Kang Jong-seok will present the research results related to the company’s non-clinical candidate substance ‘ICT-1402’ decomposition agent at ‘BioCentury’s Grand Rounds R&D Conference 2024’ to be held in Nashville, Tennessee, USA from September 9th to 11th (local time) (Press release, InnoCure Therapeutics, AUG 30, 2024, View Source [SID1234651743]).

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This inaugural event, hosted by BioCentury, is a global conference that presents groundbreaking research, clinical insights, and innovative technologies with commercial potential for the next generation of biotech innovation.

InnoCure announced at the conference that its non-clinical non-small cell lung cancer decomposition agent ICT-1402 showed a tumor growth factor receptor (TGI) of 110% compared to the vehicle group in a patient-derived xenograft (PDX) model experiment with epidermal growth factor receptor (EGFR) exon 19 deletion and mesenchymal-to-epithelial transition (MET) amplification mutation in the 6 mpk group, and was more effective than the control drug Tepotinib 6 mpk group with a TGI of 75%.

Yoo Hye-dong, CEO of Innocure, said, "Through this event, we will promote ICT-1402, a global leading MET decomposer, and achieve business results that will accelerate future technology transfer (L/O) efforts." Meanwhile, Innocure was selected as a baby unicorn company for the ‘Global Unicorn Development Project’ last June.

Aptose Receives $10 Million Through a Facility Agreement with Hanmi; Negotiating Future Collaboration Agreement with Hanmi to Jointly Develop Tuspetinib

On August 30, 2024 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing tuspetinib, a highly differentiated oral kinase inhibitor for the treatment of patients with acute myeloid leukemia (AML), reported that it received a $10 million loan through a Facility Agreement with Hanmi Pharmaceutical Co. Ltd. ("Hanmi") (Press release, Aptose Biosciences, AUG 30, 2024, View Source [SID1234646231]). The loan is convertible as prepayment of milestone obligations under the Future Collaboration Agreement (as defined hereinafter) or repayable after the expected completion of a triple drug combination trial with tuspetinib in newly diagnosed AML patients. Aptose will use the proceeds from such loan for the development of tuspetinib.

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Beyond the $10 million Facility Agreement, Aptose and Hanmi have agreed to negotiate a new tuspetinib co-development collaboration agreement (the "Future Collaboration Agreement’), intended to provide additional funding to accelerate clinical development of tuspetinib. Aptose licensed tuspetinib from Hanmi Pharmaceutical in November 2021.

Entry into a Material Definitive Agreement

On August 29, 2024, bluebird bio, Inc. (the "Company") reported to have entered into an amendment (the "Fourth Amendment") to its Loan and Security Agreement, dated as of March 15, 2024, as amended on April 30, 2024, July 9, 2024 and August 13, 2024 (the "LSA"), by and among the Company, the several banks and other financial institutions or entities party thereto, as lenders (collectively, the "Lenders"), and Hercules Capital, Inc., as administrative agent and collateral agent (the "Agent") (Filing, 8-K, bluebird bio, AUG 30, 2024, View Source [SID1234646232]).

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Pursuant to the Fourth Amendment, the Company, the Agent and the Lenders agreed to, among other things, an extension of the deadlines by which the Company must provide to the Lenders financial statements for the year ended December 31, 2023 and for the quarter ended March 31, 2024. Further, the Fourth Amendment provides that the Company’s late delivery and filing of its Form 10-K for the year ended December 31, 2023 and Form 10-Q for the quarter ended March 31, 2024 shall not be deemed a violation of the Company’s covenant to maintain compliance with applicable law, so long as such documents are filed by the extended deadlines.

The foregoing description of the Fourth Amendment does not purport to be complete and is qualified in its entirety by the full text of the Fourth Amendment, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.

Grit Biotechnology Receives U.S. FDA Clearance of Investigational New Drug Application for GT201, a genetically engineered TIL, following its Chinese IND Approval

On August 30, 2024 Grit Biotechnology, a leading clinical-stage cell therapy company focusing on tumor-infiltrating lymphocyte (TIL) therapies, reported a major milestone with its genetically engineered TIL product, GT201 (Press release, Grit Bio, AUG 30, 2024, View Source [SID1234646258]). Following its investigational new drug (IND) approval in China in July 2023, GT201 has now also received IND clearance from the U.S. FDA, paving the way for clinical trials in the United States.

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GT201, an advanced genetically engineered TIL product developed by Grit Biotechnology’s platform StemTexp and StaViral, boosts T cell survival and function by expressing a vital membrane-bound cytokine complex. GT201 surpasses traditional TIL therapies in proliferation, tumor-killing efficacy and long-term survival with reduced dependence on IL-2. Now, GT201 IND is approved by both U.S. FDA and China Center for Drug Evaluation (CDE) to enter clinical trials in both countries for advanced solid tumor patients.

Grit Biotechnology is a clinical stage cell therapy company leading TIL therapy development based in China. Core technology platforms supporting its TIL and other cell therapy development include StemTexp (proprietary stemness TIL expansion platform), StaViral (stable virus transduction system), KOReTIL (efficient CRISPR KO system) and ImmuT Finder (genome-wide CRISPR/Cas screening platform). These platforms have enabled the development of next-generation gene-edited TIL products and other cell therapies.

In addition, Grit’s non-gene-engineered TIL program, GT101, is currently in Phase 2 (pivotal) trials and is on track to file for Biologics License Application (BLA) in 2025, making it the leading TIL pipeline in China.