Soley Therapeutics Announces Breakthrough Research Demonstrating How Cellular Stress Responses Reveal Drug Mechanisms, Enabling Entirely New and Accelerated Methods for Drug Discovery

On January 21, 2026 Soley Therapeutics reported the publication of a peer-reviewed study in Scientific Reports describing a new approach to understanding how living cells react to drug molecules, inverting traditional target-based drug discovery methods. The study shows that dynamic live-cell stress responses to drugs over time encode mechanistic information about a cell’s trajectory to survive, adapt, or die – information that is largely missed by traditional snapshot-based assays. This work establishes the scientific foundation for Soley’s platform, which enables a novel, proprietary live-cell approach to drug discovery based on how cells sense and respond to stress.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This work reflects more than a decade of foundational research into how cells sense and respond to drugs and other external signals," said Yerem Yeghiazarians, M.D., Co-founder and CEO of Soley Therapeutics. "By focusing on the dynamic flow of information inside the cell, rather than static endpoints, we can delineate biology that conventional discovery methods often miss. Live Cell Dynamics is one piece of a much larger platform that Soley has created to translate whole-cell behavior into medicines. Our growing pipeline demonstrates the real-world impact of this pathbreaking science in moving drug hits to clinical candidates faster and at lower cost than traditional approaches."

Using live, label-free cell imaging, which follows living cells over time without dyes or reporter tags, the study establishes a novel approach to extract information that describes cellular stress responses by using proprietary self-supervised machine learning methods. The authors show that subtle information extracted from cells indicates dynamic responses to a drug, providing insight into a drug’s real mechanism across multiple dimensions, including toxicity and selectivity, even when compounds have similar targets and/or produce similar outcomes such as cell death. Incorporating temporal and dose-dependent information improves detection of a drug’s biological activity and mechanism-of-action, highlighting the limitations of binary readouts and morphology-only profiling approaches, particularly in complex cellular disease states.

"Through this research, our goal was to extract dynamic information from live cells for drug discovery and development purposes," said Kurosh Ameri, Ph.D., Co-founder and Chief Scientific Officer of Soley Therapeutics. "We have now shown that live cells sense drugs dynamically and convey different mechanistic information, which is dose- and time-dependent. Our proprietary machine learning methods can extract information about drugs directly from live, unstained images. This ability to measure and interpret detailed information directly from live cells in a scalable and reproducible way demonstrates a significant advance in drug discovery. This comprehensive approach provides a more accurate understanding of complex cellular responses and a drug’s true mechanism-of-action, moving beyond single endpoint and time point assays."

These experimental principles form the scientific underpinnings of Soley’s proprietary platform, which scales this biology-first approach using automation and AI to drive drug discovery across oncology and other complex diseases. The publication adds to Soley’s growing body of peer-reviewed research supporting its differentiated approach as the company advances multiple internally discovered programs toward the clinic.

(Press release, Soley Therapeutics, JAN 21, 2026, View Source [SID1234662135])

Research to expand options for hard-to-treat cancers

On January 21, 2026 Researchers at FIU reported a personalized approach to cancer treatment that is showing increasingly promising results for patients with hard-to-treat disease, supported by new philanthropic investment that is helping expand the science behind the work.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A recent gift from the Tyler Trent Foundation is accelerating research led by Diana Azzam, whose lab is pioneering functional precision medicine — an emerging strategy that identifies the most effective therapies by testing large libraries of drugs directly on living tumor cells from individual patients.

The support comes as preliminary findings from the next phase of Azzam’s clinical research indicate even stronger responses than those observed in her original study, reinforcing the potential of drug sensitivity testing to guide treatment decisions when standard approaches fail.

"Cancer remains one of the leading causes of death, and many patients eventually run out of effective treatment options," Azzam said. "What we’re seeing in our latest work suggests that functional testing can reveal opportunities that traditional methods may miss."

Beyond genetics alone

Unlike conventional precision oncology, which relies primarily on genetic mutations to guide care, functional precision medicine evaluates how a patient’s cancer actually responds to hundreds of existing drugs. Tumor cells grown from patient samples are exposed to a wide range of compounds, allowing researchers to observe real-time drug sensitivity and resistance.

In earlier clinical research, this approach generated treatment recommendations for all participants, with many patients experiencing improved outcomes. Early data from the newest clinical phase suggest that expanding the range of drugs tested may further enhance both the effectiveness and speed of identifying viable therapies.

The method has drawn particular interest for patients with recurrent or treatment-resistant cancers, including cases where genomic testing reveals few actionable mutations.

"Our goal is to find the right drug for the right person at the right time," Azzam said. "Functional testing gives us another powerful tool to do that."

Expanding the search for effective treatments

The Tyler Trent Foundation’s gift will allow Azzam’s lab to expand its library of FDA-approved generic medications and natural compounds — a carefully curated collection of safe, widely available molecules. Many of these compounds, originally developed as antibiotics, antifungals or antiparasitic, have shown unexpected promise in cancer research and may be repurposed for oncological use.

By focusing on medications with established safety profiles, results from this study are expected to support their earlier introduction in treatment, particularly when they demonstrate synergistic effects with standard therapies. This approach could allow lower doses of conventional chemotherapy to be used, helping reduce toxicity while maintaining or enhancing treatment effectiveness and accelerating the translation from laboratory discovery to patient care.

"When we identify a drug that works, it’s often something physicians already know how to prescribe," Azzam said. "That significantly increases the potential for rapid clinical impact."

A legacy driving discovery

The Tyler Trent Foundation was established in memory of Tyler Trent, who died from osteosarcoma, a rare bone cancer. During his illness, Tyler became known nationally for his optimism and advocacy, using his platform to encourage support for cancer research. His legacy has helped raise millions of dollars to advance cancer science and patient care.

(Press release, Florida International University, JAN 21, 2026, View Source [SID1234662151])

U.S. FDA Grants to Wugen’s WU-CART-007 Breakthrough Therapy Designation for Treatment of Relapsed or Refractory T Cell Acute Lymphoblastic Leukemia / T Cell Lymphoblastic Lymphoma

On January 21, 2026 Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological malignancies, reported that it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its investigational CAR-T cell therapy, Sofi-cel.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Sofi-cel is an investigational, potential first-in-class, allogeneic, anti-CD7 CAR-T cell therapy currently under evaluation in a pivotal trial (T-RRex) for patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma (T-ALL/LBL). Breakthrough Therapy Designation is intended to expedite the development and review of medicines for serious or life-threatening conditions with evidence of a substantial clinical improvement. Sofi-cel previously received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. FDA and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of R/R T-ALL/T-LBL.

Regulators granted Wugen this designation following their review of data that included results from the global Phase 1/2 clinical trial evaluating Sofi-cel in patients with R/R T-ALL/LBL.

The pivotal Phase 2 T-RRex study is a single-arm trial designed to evaluate the safety and efficacy of Sofi-cel in patients with R/R T-ALL/LBL.

"The FDA’s Breakthrough Therapy designation underscores the promising clinical data we have generated and the potential for Sofi-cel to make a meaningful difference for patients with Relapsed or Refractory T-ALL/LBL. This recognition enables close collaboration with the FDA to accelerate development and, ultimately, help bring this innovative therapy to patients as quickly as possible," said Cherry Thomas, M.D., Wugen Chief Medical Officer.

"Our goal is to bring this investigational off-the-shelf allogeneic CAR-T treatment to patients as soon as possible," said Kumar Srinivasan, Ph.D., M.B.A., Wugen President and Chief Executive Officer. "Receiving Breakthrough Therapy Designation from the FDA is a significant milestone for our company and a testament to the potential of our therapy to address a critical unmet medical need."

About Breakthrough Therapy Designation

Breakthrough Therapy Designation is intended to expedite the review of drugs for serious or life-threatening conditions. The criteria for designation require preliminary clinical evidence that demonstrates the drug may substantially improve on at least one clinically significant endpoint over available therapy.

A Breakthrough Therapy Designation conveys intensive FDA guidance on an efficient drug development, an organizational commitment involving senior FDA leadership, FDA collaboration to optimize clinical trial design, where scientifically appropriate, including minimizing patient exposure to potentially less effective therapies, and eligibility for rolling review of a marketing application, and eligibility for rolling review and priority review.

About Soficabtagene Geleucel (Sofi-cel)

Sofi-cel is an allogeneic, off-the-shelf, CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat T-cell cancers. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T cell receptor alpha constant (TRAC) genes, thereby preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host disease (GvHD).

Sofi-cel is manufactured using healthy donor-derived T cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. Sofi-cel is currently being evaluated in a global pivotal clinical trial for relapsed or refractory T-ALL/T-LBL. More information on the pivotal trial is available at ClinicalTrials.gov, identifier NCT06514794.

Sofi-cel has received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. FDA and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of relapsed or refractory T-ALL/T-LBL. RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients in need.

(Press release, Wugen, JAN 21, 2026, View Source [SID1234662136])

Lisata Therapeutics Enters Into Term Sheet to be Acquired by Kuva Labs for $4.00 Per Share in an All-Cash Tender Offer

On January 21, 2026 Lisata Therapeutics, Inc. (Nasdaq: LSTA) ("Lisata" or the "Company"), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, reported that it has entered into a binding term sheet to be acquired by Kuva Labs, Inc. ("Kuva"), a privately-held company. Pursuant to the terms and conditions of the term sheet, Kuva and Lisata agreed to negotiate in good faith and enter into a customary purchase agreement to consummate a negotiated acquisition of Lisata by Kuva whereby Kuva will commence a tender offer to purchase all of the outstanding shares of common stock of Lisata at a price of $4.00 per share in cash. Additionally, Lisata stockholders will be entitled to receive two non-tradeable contingent value rights (CVRs), payable as follows: (1) $1.00 per share, in cash, within 12 months of the date on which rights to certepetide in the Greater China region revert to Lisata from Qilu Pharmaceutical; and (2) $1.00 per share, in cash, upon the filing of an NDA or similar registration document by Kuva for approval to commercialize certepetide in any indication in any jurisdiction. The term sheet and transaction contemplated thereby have been unanimously approved by the boards of directors of Lisata and Kuva. The Company and Kuva expect to enter into a definitive purchase agreement prior to February 27, 2026. More information is available on the Company’s Form 8-K relating to this announcement.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The $4.00 per share cash offer price represents an approximate 85% premium and, including both CVRs, an approximate 180% premium to Lisata’s most recent closing stock price and reflects the strategic value of the Company’s clinical pipeline and the breakthrough potential of its lead product candidate, certepetide. In November 2024, Kuva had licensed Lisata’s iRGD cyclic peptide product candidate, certepetide, as a targeting and enhanced delivery agent to be used with Kuva’s NanoMark platform technology and has begun development of a potentially new class of advanced magnetic resonance (MR) imaging agents that could enable the safe, non-invasive and unambiguous detection of solid tumor cancers.

About Certepetide

Certepetide (formerly LSTA1), an internalizing RGD (arginyl-glycyl-aspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively. Certepetide actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetratingand accumulating in the tumor. Certepetide also has been shown to modify the tumor microenvironment resulting in tumors which are more susceptible to immunotherapies. We and our collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. To date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to test its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer. Lisata is exploring the potential of certepetide to enable a variety of treatment modalities to treat a range of solid tumors more effectively. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma (U.S.) and osteosarcoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.).

(Press release, Lisata Therapeutics, JAN 21, 2026, View Source [SID1234662137])

Plus Therapeutics to Provide Business Update and Host Conference Call on Thursday, January 22, 2026 at 9:00 A.M. ET

On January 21, 2026 Plus Therapeutics, Inc. (NASDAQ: PSTV) (the "Company"), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, reported that the Company will provide a business update on Thursday, January 22, 2026 before the market open. Plus Therapeutics’ management team will then host a conference call and webcast at 9:00 a.m. ET to discuss and provide additional details.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Webcast and Conference Call

Date/Time: Thursday, January 22, 2026 @ 9:00 AM ET
Webcast: View Source
Participant Dial-in: 1-888-349-0106

Please dial in 15 minutes prior to the start time and ask to be joined to the Plus Therapeutics, Inc. conference call. Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.

(Press release, Plus Therapeutics, JAN 21, 2026, https://ir.plustherapeutics.com/news-releases/news-release-details/plus-therapeutics-provide-business-update-and-host-conference-0 [SID1234662138])