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Cycle Pharmaceuticals Completes Acquisition of Applied Therapeutics

On February 3, 2026 Cycle Group Holdings Limited ("Cycle") reported it has completed the acquisition of NASDAQ-listed Applied Therapeutics, Inc. (NASDAQ: APLT; "Applied"), a clinical-stage biopharmaceutical company.

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Applied’s lead drug candidate, govorestat, is a novel central nervous system (CNS) penetrant Aldose Reductase Inhibitor (ARI) for the treatment of CNS rare metabolic diseases, including Classic Galactosemia, Charcot-Marie-Tooth Sorbitol Dehydrogenase Deficiency (CMT-SORD) and phosphomannomutase 2 congenital disorder of glycosylation (PMM2-CDG), for which there are currently no FDA approved treatment options available.

"Cycle was founded with a commitment to support patients living with rare metabolic diseases. From our beginnings with NITYR, we have grown to offer three therapies for this community. With Applied Therapeutics now a part of the Cycle group, we can look to expand further in this area. Our focus remains the same: to bring meaningful, reliable treatments to the patients and families who need them most." says James Harrison, CEO of Cycle.

The transaction is to be funded from cash on hand.

For Cycle, Goodwin Procter LLP acted as legal counsel. For Applied, Aquilo Partners, L.P. provided a fairness opinion, and Ropes & Gray LLP acted as legal counsel.

(Press release, Cycle Pharmaceuticals, FEB 3, 2026, View Source [SID1234662441])

Nucleai Enables Spatial Biology Research in Nature Communications Study on Lung Cancer Treatment Response

On February 3, 2026 Nucleai, a leader in AI-powered multimodal spatial biology, reported its contribution to a collaborative international study published in Nature Communications that explores how spatial organization and metabolic characteristics of tumor cells are associated with response and resistance to immunotherapy in non-small cell lung cancer (NSCLC).

The study, led by academic researchers at The University of Queensland and Yale School of Medicine, applied multiplex immunofluorescence (mIF) and computational approaches to analyze tumor tissue at single-cell resolution. By examining how different cell populations are organized within the tumor microenvironment and how they metabolize glucose, the researchers identified distinct spatial and metabolic patterns associated with immunotherapy outcomes.

As part of the collaboration, Nucleai’s AI-powered multiplex immunofluorescence (mIF) analysis pipeline enabled accurate identification and classification of tumor and immune cell populations at scale, providing a consistent and reproducible foundation for downstream spatial and metabolic analyses conducted by the academic research teams.

"Understanding response to lung cancer treatment requires insight into the different cell states and cell-cell interactions within the tumor, not just which cells and markers are present," said Ettai Markovits, Director of Biomedical Research at Nucleai. "This study highlights the importance of spatial context in cancer biology, and we are pleased to have supported this work by enabling robust, AI-based spatial analysis applied to multiplex imaging data."

Immunotherapy has transformed the treatment landscape for lung cancer, yet only a subset of patients experience durable benefit. Findings from this study suggest that spatially defined metabolic features within tumors may help explain variability in treatment response, reinforcing the need for more nuanced approaches to characterizing tumor biology beyond traditional single-marker assessments.

This work builds on Nucleai’s broader multimodal spatial AI platform, which is designed to support scalable and rapid spatial profiling across large research cohorts. By transforming complex multiplex imaging data into structured, quantitative spatial insights, the platform supports collaborative efforts to advance precision oncology research.

"This study demonstrates the power of multiplex imaging data to shed light on nuanced spatial interactions linked to treatment response to immunotherapy," said Associate Professor Arutha Kulasinghe from UQ’s Frazer Institute. "However, translating this spatial complexity into clinical insights requires sophisticated computational analysis. Nucleai’s contributions helped connect high-dimensional spatial imaging with clinical outcomes more efficiently."

The research was conducted in collaboration with The University of Queensland’s Frazer Institute, Yale School of Medicine, Wesley Research Institute, Quanterix, and Nucleai, and is published in Nature Communications.

(Press release, University of Queensland, FEB 3, 2026, View Source [SID1234662440])

Guardant Health to Participate in Upcoming Investor Conferences

On February 3, 2026 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company will be participating in the following investor conferences.

BTIG 13th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference in Snowbird, UT
Hosting 1×1 meetings on Tuesday, February 10th
TD Cowen 46th Annual Health Care Conference in Boston, MA
Fireside chat on Wednesday, March 4th at 9:50 a.m. Eastern Time
Leerink Partners Global Health Conference in Miami, FL
Fireside chat on Tuesday, March 10th at 1:00 p.m. Eastern Time
Barclays 28th Annual Global Healthcare Conference in Miami Beach, FL
Fireside chat on Wednesday, March 11th at 1:00 p.m. Eastern Time

Interested parties may access live and archived webcasts of the sessions on the "Investors" section of the company website at: www.guardanthealth.com.

(Press release, Guardant Health, FEB 3, 2026, View Source [SID1234662439])

Biosion Announces First Patient Dosed in Investigator-Initiated Phase 1 Trial of BSI-082, a Next-Generation Anti-SIRPα Monoclonal Antibody for Advanced Solid Tumors

On February 3, 2026 Biosion, Inc. ("Biosion"), a global, clinical-stage biotechnology company developing innovative antibody-based therapeutics, reported that the first patient has been dosed in a Phase 1a/1b Investigator-Initiated Trial (IIT) evaluating BSI-082, a highly differentiated, fully human anti-SIRPα monoclonal antibody. The study is sponsored by and being conducted at the Mays Cancer Center, a National Cancer Institute (NCI)-designated Cancer Center and part of The University of Texas at San Antonio’s Health Science Center.

This clinical milestone highlights the medical community’s strong interest in Biosion’s oncology assets and follows the company’s recent transformative partnership with Aclaris Therapeutics for its immunology portfolio.

Collaborating to Unlock Innate Immunity

BSI-082 is engineered to block the CD47-SIRPα "don’t eat me" signal, a critical checkpoint tumor cells use to evade macrophage phagocytosis. Unlike other candidates in the class, BSI-082 was designed using Biosion’s proprietary H³ Antibody Discovery Platform to overcome historical development challenges.

Key differentiators of BSI-082 include:

Broad Population Coverage: High-affinity binding to SIRPα variants V1, V2, and V8, covering >90% of the human population.
Superior Safety Profile: Engineered Fc domain minimizes binding to red blood cells (RBCs) and platelets, significantly reducing the risk of anemia and thrombocytopenia often seen with anti-CD47 therapies.
Preserved T-Cell Function: No binding to SIRPγ, ensuring that adaptive immune responses remain active and uninhibited.
"The initiation of this trial by a premier institution like the Mays Cancer Center serves as powerful validation of BSI-082’s scientific rationale and therapeutic potential," said Mingjiu Chen, Ph.D., Founder and CEO of Biosion. "BSI-082’s unique profile—specifically its ability to potently block the ‘don’t eat me’ signal without compromising patient safety—positions it as an ideal combination partner for standard-of-care therapies, particularly antibody-drug conjugates (ADCs). We are honored to support Dr. Sarantopoulos and his team in this study, which represents a key step in our strategy to maximize the value of our oncology assets through high-quality clinical partnerships."

Study Design and Strategic Combinations

The Phase 1a/1b study is an open-label, dose-escalation and dose-expansion trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BSI-082 in patients with locally advanced or metastatic solid tumors.

Phase 1a: Will establish the Recommended Dose for Expansion (RDE) of BSI-082 as a monotherapy.
Phase 1b: Will evaluate BSI-082 in combination with trastuzumab deruxtecan (T-DXd) in patients with HER2-positive solid tumors. Preclinical data has demonstrated that SIRPα blockade can synergistically enhance the antitumor activity of ADCs by promoting antibody-dependent cellular phagocytosis (ADCP).
"Targeting the innate immune system via the SIRPα-CD47 axis offers a compelling therapeutic strategy for refractory tumors," said John Sarantopoulos, M.D., associate professor of medicine in the Division of Hematology and Oncology, medical oncologist, and principal investigator at the Mays Cancer Center. "We are excited to lead the clinical evaluation of BSI-082, whose design addresses key limitations of earlier generation agents. We look forward to exploring its potential to improve outcomes for patients, particularly in combination with ADCs."

(Press release, Biosion, FEB 3, 2026, View Source [SID1234662438])

Insilico Medicine Receives USD 5million Milestone Payment from Menarini Group Following First-in-Human (FIH) Achievement for MEN2501

On February 3, 2026 Insilico Medicine ("Insilico"), a clinical-stage, generative artificial intelligence (AI)-driven biotechnology company, reported that it has received USD 5 million from Menarini Group ("Menarini") as an additional milestone payment, following the completion of first-in-patient dosing in a Phase 1 study of MEN2501, which was licensed to Menarini in January 2025. MEN2501 (previously known as ISM9682) is a highly differentiated small molecule inhibitor of kinesin KIF18A motor protein with potent activity in cancers with chromosome instability.

As part of a strategic collaboration to accelerate the development and delivery of transformative cancer therapies, the asset was subsequently licensed to Stemline Therapeutics, Inc. ("Stemline"), a wholly owned subsidiary of the Menarini Group, with the combined value of the agreements exceeding USD 550 million. Pursuant to the partnership, both parties actively advanced the program transition and subsequent development activities. Following IND approval for this program, Insilico received the first development and regulatory milestone payment of USD 3 million in July 2025.

"The program rapidly advanced into a Phase I clinical trial and successfully completed first patient dosing, fully demonstrating Menarini and Stemline’s exceptional agility and clinical expertise," said Alex Zhavoronkov, PhD, Founder and CEO of Insilico Medicine. "This milestone shows our shared commitment to delivering innovative therapies for cancer treatment. We are proud to further strengthen our partnership and encouraged to see AI-discovered drug candidates reaching such a critical stage, bringing us closer to providing novel treatment options for patients worldwide."

"Getting the first patient dosed in our MEN2501 Phase 1 study is a meaningful milestone that underscores how quickly promising science can move forward through focused clinical execution," said Elcin Barker Ergun, CEO of the Menarini Group. "We value our partnership with Insilico as we translate AI-enabled discovery into clinical programs, with the goal of bringing new, transformational treatment options to patients facing aggressive cancers."

The collaboration between Insilico and Menarini has continued to expand since its inception. Prior to MEN2501, in January 2024, Insilico announced that it entered into an exclusive global license collaboration with Menarini for MEN2312, a novel KAT6 inhibitor for breast cancer and other oncology indications, with the combined value of the agreements exceeding USD 500 million. The MEN2312 program has progressed smoothly into clinical development, and Insilico has received early development milestone payments.

In addition to the collaboration pipelines, Insilico has extensive experience in AI-driven oncology, drug discovery and development. The company has established a robust oncology pipeline that targets multiple cancer indications, leveraging both moderately novel and well-established mechanisms. Among its most promising assets, the potential best-in-class pan-TEAD inhibitor ISM6331 and the MAT2A inhibitor ISM3412 are both undergoing global, multicenter Phase I clinical trials.

Harnessing state-of-the-art AI and automation technologies, Insilico has significantly improved the efficiency of preclinical drug development, setting a benchmark for AI-driven drug R&D. While traditional early-stage drug discovery typically requires an average of 4.5 years, Insilico has nominated 20 preclinical candidates from 2021 to 2024, with an average timeline—from project initiation to preclinical candidate (PCC) nomination—of just 12 to 18 months per program, with only 60 to 200 molecules synthesized and tested in each program.

(Press release, Insilico Medicine, FEB 3, 2026, View Source [SID1234662437])