Alphamab Oncology Reports 2024 Interim Results and Business Highlights

On August 16, 2024 Alphamab reported 2024 Interim Results and Business Highlights (Press release, Alphamab, AUG 16, 2024, View Source [SID1234647172]).

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Nuntius partners with Taiho to develop mRNA cancer therapies

On August 16, 2024 Nuntius Therapeutics reported a strategic collaboration agreement with Japan’s Taiho Pharmaceutical to develop next-generation messenger ribonucleic acid (mRNA) cancer immunotherapies (Press release, Nuntius Therapeutics, AUG 16, 2024, View Source [SID1234646069]).

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The partnership will leverage Nuntius’ nanocarrier technologies, which have shown potential in targeting cell types beyond the liver, a significant advancement in mRNA delivery.

This collaboration follows a successful feasibility study that demonstrated the capabilities of Nuntius’ cell-specific peptide dendrimer- and lipid-based nanocarriers.

Nuntius Therapeutics CEO and co-founder Benita Nagel said: "We are thrilled to embark on this collaboration with Taiho to improve treatments for cancer patients. Taiho is an excellent partner for us given their strong oncology-focused research and commercial capabilities."

The company’s programmable and scalable nanocarriers may work on cell types other than the liver and surpass current delivery technologies.

Agendia Achieves CE-IVDR Certification for its MammaPrint® and BluePrint® Breast Cancer Assays

On August 16, 2024 Agendia, Inc. reported that it has obtained certification from the European Union (EU) In Vitro Diagnostic Medical Device Regulation (IVDR) for three products, including its MammaPrint FFPE Microarray, BluePrint FFPE Microarray, and MammaPrint and BluePrint NGS Kit (Press release, Agendia, AUG 16, 2024, View Source [SID1234645968]). These products are classified as Class C under this regulation. This certification recognizes Agendia’s strict adherence to rigorous quality and safety standards and ensures the tests’ reliability and effectiveness in clinical settings across the EU.

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"We are very proud to receive the IVDR certification for our MammaPrint and BluePrint tests and look forward to continuing our efforts in providing accurate and effective test results to those undergoing breast cancer treatment," said Mark R. Straley, Chief Executive Officer of Agendia. "This achievement not only underscores our commitment to delivering the highest standard of care to patients, but also highlights our ability to meet the stringent regulatory requirements necessary to address the needs of breast cancer patients and clinicians around the world."

The IVDR certification marks a significant advancement in Agendia’s efforts to enhance the decision- making around treatment pathways for those with early breast cancer. For more information about the MammaPrint and BluePrint tests and Agendia’s ongoing clinical trials, please visit: www.agendia.com

BITT Announced CD40 Otsuka Research and Exclusivity Agreement and New NIH Funding for TNFR2 Clinical Trial

On August 16, 2024 Boston Immune Technologies and Therapeutics, Inc. (BITT), a clinical stage developer of novel tumor necrosis factor superfamily receptor (TNFSR) antagonist antibodies, reported a sponsored research and exclusivity agreement with the McQuade Center for Strategic Research and Development, LLC (MSRD), a member of the global Otsuka family of pharmaceutical companies (Press release, BITT, AUG 16, 2024, View Source [SID1234645967]). MSRD will finance key non-human primate studies for the pre-clinical development of BITT’s CD40 antagonist in exchange for an exclusive right to negotiate an acquisition, license or collaboration agreement related to the asset. BITT is also announcing that it has also been awarded a $4M National Institute of Health/National Cancer Institute to support the ongoing Phase I clinical trial of BITT’s lead TNFR2 antagonist.

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"Our agreement with Otsuka will provide significant resources in furtherance of our goal of filing an IND related to our CD40 antagonist program in 2025," said Russell LaMontagne, Co-Founder and Chief Executive Officer of BITT. "This is our second NIH/NCI grant to support our TNFR2 oncology program and confirmation of the novelty of our antibody and the potential of TNFR2 as a therapeutic target."

CASI PHARMACEUTICALS ANNOUNCES SECOND QUARTER 2024 BUSINESS AND FINANCIAL RESULTS

On August 16, 2024 CASI Pharmaceuticals, Inc. (Nasdaq: CASI) ("CASI" or the "Company"), a Cayman incorporated biopharmaceutical company specializing in the development and commercialization of innovative therapeutics and pharmaceutical products, reported business updates and financial results for the three months ended June 30, 2024 (Press release, CASI Pharmaceuticals, AUG 16, 2024, View Source [SID1234645966]).

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"The second quarter of 2024 was a period of significant progress for CASI as we shifted our Company’s strategy to the development of therapeutics for organ transplant rejection and autoimmune disease," said Dr. Wei-Wu He, Chairman and CEO of CASI Pharmaceuticals. "The keystone of our strategic pivot is CID-103, an anti-CD38 antibody that we believe has potential for therapeutic use across multiple areas of unmet need, including antibody-mediated rejection (AMR) and idiopathic thrombocytopenia purpura (ITP). Ultimately, we believe CID-103 has widespread therapeutic use in many immune-mediated diseases. We are structuring our resources according to this expectation and will aim to advance our anti-CD38 programs at a brisk pace."

Dr. He continued: "For both AMR and ITP, we are anticipating clinical study initiation on an efficient timeline. We are pleased that the U.S. FDA recently cleared our Investigational New Drug (IND) application for CID-103 for the treatment of adults with ITP, and we expect to initiate our planned Phase 1 study by year end. We anticipate that we will submit an IND for CID-103 in AMR in the fourth quarter of this year. We are especially pleased to have recently announced a $15 million private placement financing by Venrock Healthcare Capital Partners, Foresite Capital, and Panacea Venture in support of our strategy and its execution."

CASI’s Board of Directors has formed a special committee to evaluate Dr. He’s proposal letter dated June 21, 2024, to acquire the entire business operations of the Company in China, including all license-in, distribution and related rights in Asia (excluding Japan), for an aggregate purchase price of $40.0 million. The offer price includes assumption of up to $20.0 million of the Company’s debt.

Second Quarter 2024 Financial Highlights

Total revenue was $4.0 million for the three months ended June 30, 2024, compared to $9.8 million for the three months ended June 30, 2023.

Costs of revenues were $1.9 million for the three months ended June 30, 2024, compared to $4.0 million for the three months ended June 30, 2023. The decrease was in line with the decrease of revenues.

Research and development expenses for the three months ended June 30, 2024, were $1.3 million, compared with $2.6 million for the three months ended June 30, 2023.

General and administrative expenses for the three months ended June 30, 2024, were $5.9 million, compared with $7.7 million for the three months ended June 30, 2023.

Selling and marketing expenses for the three months ended June 30, 2024, were $4.4 million, compared with $4.8 million for the three months ended June 30, 2023.

Net loss for the three months ended June 30, 2024, was $7.0 million, compared with $10.1 million for the three months ended June 30, 2023.

As of June 30, 2024, CASI had cash and cash equivalents of $9.5 million. In July 2024, the Company received gross proceeds of $15 million from a Private Placement.
Further information regarding the Company, including its Quarterly Report for the quarter ended June 30, 2024, can be found at www.casipharmaceuticals.com.