Hot Biotech Stocks in the News- Xilio Therapeutics, Aptose, and NKGen Biotech

February 12, 2025

DENVER, Colo., Feb 12, 2025 (247marketnews.com)- 24/7 Market News, a trusted source for real-time financial news and market analysis, highlights today’s most significant stock movements and breaking developments shaping the biotech industry’s financial landscape.

AbbVie (NYSE:ABBV) and Xilio Therapeutics (NASDAQ:XLO) entered into a collaboration and option-to-license agreement aimed at developing novel tumor-activated, antibody-based immunotherapies, including masked T-cell engagers. The collaboration leverages Xilio’s proprietary tumor-activated biologics platform technology, which is designed to achieve tumor-selective activation and minimize systemic side effects.

Xilio Therapeutics developed a clinically-validated platform that enables the creation of tumor-activated biologics, including masked multispecific molecules. These molecules are designed to selectively activate within the tumor microenvironment while minimizing exposure to healthy tissues.

Theodora S. Ross, M.D., Ph.D., AbbVie’s VPt, early oncology research and development, said, “AbbVie is committed to expanding our R&D efforts in oncology. This includes investigation of novel immunotherapy approaches that aim to generate improved next-generation cancer treatments for patients in need. This partnership with the Xilio team further exemplifies our commitment.”

Masked T-cell engagers are a key component of this approach. They activate T-cells specifically within the tumor environment, potentially enhancing the effectiveness of immunotherapy with reduced toxicity.

Uli Bialucha , Ph.D., Xilio’s CSO, added, “This collaboration with AbbVie, a global leader in developing and commercializing oncology therapies, allows us to accelerate the expansion of our technology to next-generation immunotherapies, including T-cell engagers. We look forward to working with the AbbVie team to apply our deep protein engineering expertise coupled with tumor-selective activation through our novel formats for masked T-cell engagers.”

Under the agreement, Xilio Therapeutics will receive an upfront payment of $52 million, which includes a $10 million equity investment by AbbVie. Additionally, Xilio is eligible for up to approximately $2.1 billion in total contingent payments. This includes option-related fees, milestone payments, and tiered royalties based on future product sales.

Aptose Biosciences (NASDAQ:APTO) reported promising early safety and response results from its Phase 1/2 TUSCANY trial, evaluating tuspetinib in combination with venetoclax (VEN) and azacitidine (AZA) (TUS+VEN+AZA) for the treatment of newly diagnosed acute myeloid leukemia (AML). The 40 mg dose of tuspetinib combined with standard of care therapies is showing early efficacy and a manageable safety profile in patients who are ineligible for induction chemotherapy.

Rafael Bejar, M.D., Ph.D., Aptose’s CMO, commented, “These are very promising early results from the TUSCANY trial of TUS+VEN+AZA and the first indicators of the safety and efficacy we expected to see in newly diagnosed AML patients. To achieve a complete remission (CR) in Cycle 1 in a subject harboring a TP53 mutation – one of the most adverse forms of AML – is particularly encouraging. With enrollment ongoing in the TUSCANY study, we look forward to reporting additional data as it becomes available.”

The trial is focused on newly diagnosed AML patients who are ineligible for induction chemotherapy. These patients typically have limited treatment options, and the combination of venetoclax and azacitidine is already established as a standard of care for this group.

William G. Rice, Ph.D., Aptose’s Chairman, President and CEO, stated, “TUS+VEN+AZA triplet therapy has the potential to treat large AML patient populations, including those with traditionally difficult-to-treat mutations, and improve patient outcomes right from the outset of treatment. The ability to treat such diverse AML populations – including FLT3 wildtype patients – with a favorable safety profile and without having to alter the standard of care dosing, differentiates our drug from many AML drugs in development.”

Initial trial results show promising safety and response outcomes, which suggest that the triplet combination is well-tolerated by patients.

NKGen Biotech (NASDAQ:NKGN) announced that the FDA granted Fast Track designation for its investigational therapy, troculeucel, an ex vivo expanded autologous NK (natural killer) cell therapy, for the treatment of moderate Alzheimer’s disease (AD). The Fast Track designation is a process designed to facilitate the development and review of drugs that address serious conditions with unmet medical needs, potentially allowing faster access to promising treatments.

Paul Y. Song, MD, NKGen’s Chairman and CEO, said, “We are pleased with the FDA’s decision to grant Fast Track designation for troculeucel. This decision underscores the significant unmet need for effective treatments for patients with moderate AD. We specifically targeted the moderate stage population as they represent about 30% of all Alzheimer’s cases and most, if not all, of the current focus has been on early/mild patients. This designation comes after promising safety and efficacy results from our Phase 1 trial, which shows early signs of clinical benefit in patients treated with troculeucel. Receiving Fast Track designation will significantly accelerate the drug development process, bringing us one step closer to delivering this promising therapy to AD patients in need, and ensuring faster access to a potentially life-changing treatment.”

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