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Florida Cancer Specialists & Research Institute Phase 3 Trial Demonstrates Initial Clinical Benefit of Novel Immunotherapy For Advanced Non-Small Cell Lung Cancer

On April 7, 2026 Florida Cancer Specialists & Research Institute, LLC (FCS) reported key findings from stage 1 of the PRESERVE-003 Phase 3 clinical trial conducted with participation have shown that gotistobart, a novel CTLA-4 checkpoint-targeting immunotherapy, may offer improved effectiveness with fewer side effects in patients with metastatic non-small cell lung cancer (NSCLC). The global PRSERVE-003 trial is a multi-year, groundbreaking study evaluating gotistobart against the chemotherapy drug docetaxel in people with squamous NSCLC (sqNSCLC) whose disease has worsened after standard immunotherapy and chemotherapy.

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Gustavo A. Fonseca, MD, FACP, FCS director of research and clinical trials, said, "Lung cancer remains the leading cause of cancer deaths worldwide and treatment options have historically been limited. FCS clinical research is contributing to discoveries that are revolutionizing the treatment of these and other advanced cancers."

Patients with metastatic NSCLC were randomized into stage 1 of the study conducted from June 2023 to September 2024 in study centers in the U.S., Australia, China, Korea and the UK. Stage 1 aimed "to confirm the dose and assess the preliminary efficacy (primary outcome: overall survival; secondary outcomes: progression‑free survival, objective response rate and duration of response) and safety of gotistobart compared to docetaxel."

The trial has moved forward into its pivotal later stage where the findings will be confirmed in a larger population of patients with sqNSCLC. The authors note: "The primary endpoint of PRESERVE-003 is overall survival (OS), and secondary endpoints include investigator-assessed progression-free survival (PFS), objective response rate (ORR) and safety."

FCS provides ongoing access to more than 180 clinical trials within 29 FCS clinics statewide and early-phase Drug Development Units (DDUs) located in Sarasota and Central Florida. Research conducted at FCS is made possible in partnership with Sarah Cannon Research Institute, one of the world’s leading oncology research organizations conducting community-based clinical trials.

View the abstract: Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial

(Press release, Florida Cancer Specialists & Research Institute, APR 7, 2026, View Source;research-institute-phase-3-trial-demonstrates-initial-clinical-benefit-of-novel-immunotherapy-for-advanced-non-small-cell-lung-cancer-302735982.html [SID1234664215])

Phanes Therapeutics announces dose expansion in clinical study of spevatamig in combination with chemotherapy for treatment of biliary tract cancer

On April 7, 2026 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported the initiation of the dose expansion phase in their clinical study evaluating spevatamig in combination with chemotherapy for the treatment of biliary tract cancer (BTC), following dose-limiting toxicity (DLT) clearance at two dose levels.

Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with Merck’s anti-PD-1 therapy, pembrolizumab.

Phanes is conducting clinical trials with spevatamig in multiple oncology indications, including a Phase 2 study evaluating the efficacy of spevatamig in combination with chemotherapy in first-line pancreatic ductal adenocarcinoma (PDAC) patients. As of March 2026, more than 160 patients globally have been dosed with spevatamig collectively in monotherapy and combination therapy settings. Three posters on spevatamig will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 in San Diego. Presentation details can be found here: Phanes Therapeutics to present three clinical posters at AACR (Free AACR Whitepaper) 2026

(Press release, Phanes Therapeutics, APR 7, 2026, View Source [SID1234664214])

Rosalind Franklin University Incubator Company Presents Promising Glioblastoma Therapy Data at Major Brain Cancer Conference

On April 7, 2026 Rosalind Franklin University Helix 51 incubator company UP Oncolytics reported encouraging preclinical results in two studies for a novel glioblastoma therapy presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Brain Cancer, held March 23–25 in Philadelphia.

The studies highlight the potential of an oncolytic virus-based therapy to both predict treatment response and drive tumor regression in glioblastoma (GBM), one of the deadliest forms of cancer.

GBM remains highly resistant to treatment, with approximately 13,000 new U.S. cases each year and a median survival of just 14 months. Despite broader advances in oncology, no new FDA-approved therapies for GBM have emerged in the past two decades.

UP Oncolytics’ presentations focused on its lead therapy using Zika virus-based oncolytic technology for gliomas:

Predicting treatment response: In the study "Transcriptomic Prediction of Zika Virus Susceptibility in Glioblastoma Cell Lines Using Feature Selection and Machine Learning Approaches," researchers used machine learning to identify and understand genetic and molecular markers associated with tumor sensitivity or resistance to therapy.

"The ability to predict a tumor’s response to treatment ensures patients receive therapies most likely to be effective for their specific disease," said Anna Lundeen, graduate student with UP Oncolytics.

Demonstrating Therapeutic Impact: The study, "Low-neurovirulence wild-type Zika virus strains induce durable tumor regression and survival benefit in patient-derived glioblastoma models," showed complete tumor remission and prolonged survival in in vivo GBM models following treatment.

The research was conducted, in part, in collaboration with RFU’s Center for Cancer Cell Biology, Immunology and Infection, and Center for Proteomics and Molecular Therapeutics, with additional support from the university’s research cores. Ongoing collaboration with RFU is further supported by a recent Illinois Innovation Voucher Program award through the Illinois Science and Technology Coalition and the Illinois Department of Commerce and Economic Opportunity.

"We are pleased with the promising results of these two studies," said Parvez Akhtar, PhD, Chief Scientific Officer of UP Oncolytics. "They promise a new approach to effectively treating GBM tumors while minimizing impact on normal cells. We are working hard to bring this advance to patients."

Janice Urban, PhD, RFU Interim Executive Vice President for Research, added, "UP Oncolytics continues to meet key development milestones, and we are optimistic that this new approach to treating intractable cancer is on the horizon for GBM patients."

(Press release, Rosalind Franklin University, APR 7, 2026, View Source [SID1234664213])

TransCode Therapeutics Enters into Agreements for up to $20 Million Flexible Financing, Extending Company’s Runway into Late 2027/Early 2028

On April 7, 2026 TransCode Therapeutics, Inc. (NASDAQ: RNAZ, the "Company"), a clinical stage company pioneering immuno-oncology and RNA for the treatment of high risk and advanced cancer, reported that it has entered into an agreement with an institutional healthcare investor for financing of up to $20 million. The arrangement comprises pre-paid advances of up to $6 million and a three-year Standby Equity Purchase Agreement (SEPA) providing the Company the right to sell up to $14 million of its common stock to the investor, subject to certain conditions.

"The financing agreement provides TransCode with financial flexibility and ensures that TransCode can maintain operational momentum as we conduct our Phase 2a trial for our lead clinical program, TTX-MC138," said Dr. Philippe P Calais, Pharm.D., Ph.D., Chairman and CEO of TransCode. "This runway extension should enable the Company to complete the Phase 2a study and subsequently explore a strategic collaboration for the program," said Tom Fitzgerald, CFO of TransCode.

About TTX-MC138

TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b, or miR-10b, a microRNA widely believed to be critical to the emergence and progression of many metastatic cancers. TransCode’s Phase 0 clinical trial produced evidence of delivery of a radiolabeled version of TTX-MC138 to metastatic lesions and pharmacodynamic activity, even at a microdose of the drug candidate, suggesting a broad therapeutic window for TTX-MC138. In the Company’s Phase 1a clinical trial, TTX-MC138 met its safety endpoint and was well tolerated by patients. A Phase 2a clinical trial with TTX-MC138 is expected to begin in the second quarter 2026.

About the Financing Transaction

The pre-paid advance will be evidenced by convertible promissory notes priced at 95% of face value. TransCode will issue a $1 million principal amount note concurrently with the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and, subject to certain closing conditions, will issue an additional $5 million principal amount note upon shareholder approval of the transaction as required by Nasdaq rules. The advance will accrue interest at a simple annual rate of 5% and may be converted into TransCode’s common stock.

Upon conversion or repayment of the convertible notes, TransCode at its option may sell up to $14 million of its common stock to the investor under terms specified in the financing agreement.

The financing agreement can be found in TransCode’s Form 8-K filed with the U.S Securities and Exchange Commission.

Tungsten Advisors acted as the Sole Placement Agent.

(Press release, TransCode Therapeutics, APR 7, 2026, View Source [SID1234664212])

Sona Nanotech’s THT Cancer Therapy Demonstrates Strong Efficacy And Durability In Combination with Immunotherapy In Peer-reviewed Preclinical Study

On April 7, 2026 Sona Nanotech Inc. (CSE: SONA, OTCQB: SNANF) (the "Company", "Sona") reported publication of a preclinical study using its Targeted Hyperthermia Therapy ("THT") to treat cancer, in the Journal of Nanobiotechnology which demonstrated treatment durability to the end of the 45 day study period when it was given in combination with immunotherapy. Building on its prior body of preclinical research treating melanoma and breast cancer (as published in Frontiers in Immunology), this study was conducted in an immunologically ‘cold’ colorectal cancer (CT26) tumor model. In this combination protocol, CT26 tumor-bearing animals were treated with two consecutive treatments of THT plus standard PD-1 inhibitor immunotherapy followed by three additional PD-1 treatments (the "Study"). Animals were followed for 45 days following initiation of treatment as per study protocol. At completion of the Study 38% of animals given the combined therapy were alive and disease free.

Sona Nanotech CEO, David Regan commented, "We’ve all recently heard the shocking news that colon cancer is now the leading cause of cancer death for adults under 50. This timely preclinical evidence of strong immune activation in colon cancer using our THT/immunotherapy combination protocol reaffirms our confidence in pursuing Sona’s THT to spark immunity in typically immunotherapy resistant cancers. We are certainly proud of the quality of this peer-reviewed research and its acceptance in the highly respected Journal of Nanobiotechnology. This study, together with the safety and tolerability data from our recently completed, first-in-human study of THT as a monotherapy in melanoma, lays the foundation for our next trial that will combine our THT with immunotherapy."

Study principal investigator, lead author and Sona Chief Medical Officer, Dr. Carman Giacomantonio, commented, "We have focused our preclinical research on immunogenically cold cancers i.e. cancers that do not respond to today’s standard-of-care immunotherapy, to prove our hypothesis that Sona’s THT activates immunity. This is the third preclinical cancer-type in which we have confirmed our hypothesis, and our first publication delving deeply into the biology of our treatments. In this study, where no animals responded to a standard immunotherapy alone, 100% of animals in the THT treatment group responded to that same immunotherapy. This relates incredibly favorably to the less than ~15% success rate of immunotherapy when used to treat colorectal cancer in most humans due to low immunogenicity, giving us tremendous hope for its ability to change lives if translated successfully into a human therapy. Importantly, 38% (8 of 21) of those tumors completely cleared by day 24 following initiation of treatment and remained cancer-free to the end of the study. This is remarkably fast by any standard of measure, and these important findings will inform the protocol for our next clinical study."

(Press release, Sona Nanotech, APR 7, 2026, View Source [SID1234664211])