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Flashpoint Therapeutics Announces Publication Demonstrating Superior Pre-Clinical Anti-Leukemia Efficacy with its Structural Nanomedicine Platform

On November 13, 2025 Flashpoint Therapeutics, a biotechnology company pioneering a new class of structural nanomedicine, reported the publication of foundational research demonstrating the power of its proprietary Spherical Nucleic Acid (SNA) platform to create highly potent and targeted cancer therapies. The study, published in the journal ACS Nano by a team led by Flashpoint’s scientific co-founder Professor Chad A. Mirkin at the International Institute for Nanotechnology at Northwestern University, reports results of research with a new chemotherapeutic SNA that selectively targets and eliminates acute myeloid leukemia (AML) cells in preclinical models.

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The publication highlights a revolutionary approach to nanomedicine design which incorporates the chemotherapeutic agent into the shell of the nanoparticle. Unlike conventional nanocarriers that encapsulate drugs within a core, Flashpoint’s SNAs are built with oligonucleotides made from units of a chemotherapeutic drug, 5-fluorouracil (5-Fu), anchored to a nanoparticle core. This unique architecture, a key tenet of structural nanomedicine, drives the therapeutic’s biological activity, enabling preferential uptake by myeloid cells, the lineage from which AML originates.

The study reports exceptional efficacy and a promising safety profile. Key findings include:

Targeted Delivery: The SNAs were selectively taken up by myeloid cells, including AML cells, at rates up to 12.5 times higher than the free drug components.
Potent Efficacy: The SNA construct demonstrated up to a 10,000-fold enhancement in cancer cell killing in vitro compared to the free drug. In a human AML mouse model, the therapy exhibited 59-fold greater antitumor efficacy than 5-Fu.
Favorable Safety: The potent anti-leukemia activity was achieved without observable side effects in animal models, suggesting a wide therapeutic window and the potential to reduce the harsh toxicities associated with conventional chemotherapy.
"This groundbreaking research by Professor Mirkin’s laboratory validates the capability of Flashpoint Therapeutics’ technology platform to precisely control the structure of a medicine at the nanoscale, thereby unlocking unprecedented therapeutic properties," said Barry Labinger, Chief Executive Officer of Flashpoint Therapeutics. "The results in AML are a powerful demonstration of our platform’s ability to create targeted, highly potent drug candidates that overcome the limitations of conventional approaches. We are excited to advance this and other programs based on our structural nanomedicine platform to bring transformative new treatments to patients."

AML is a devastating blood cancer with low survival rates, particularly for older patients who cannot tolerate aggressive chemotherapy. Flashpoint’s approach offers the potential for a new precision medicine that can effectively eliminate cancer cells while minimizing collateral damage to the body.

"This is a new class of chemotherapeutic that is defined by its structure," said Professor Mirkin. "Today’s chemotherapeutics kill cancer cells but also a lot of healthy cells. Our structural nanomedicine preferentially seeks out the myeloid cells, where the AML resides. Instead of overwhelming the whole body with chemotherapy, it delivers a higher, more focused dose where it is needed."

The full article, titled "Chemotherapeutic Spherical Nucleic Acids," can be found in ACS Nano.

(Press release, Flashpoint Therapeutics, NOV 13, 2025, View Source [SID1234659942])

Kiyatec Secures Strategic Investment from South Korean Partner MBD to Accelerate U.S. Commercial Expansion

On November 13, 2025 Kiyatec, a leader in functional oncology testing with its proprietary 3D Predict platform, reported it has closed a strategic investment round led by MBD, a South Korea-based technology leader. This new investment solidifies a strategic commercial partnership aimed at leveraging MBD’s automated platform technology to rapidly scale Kiyatec’s U.S. testing capabilities and accelerate the launch of its diagnostic panels for multiple cancer types along with new AI tools.

The partnership represents a significant step in Kiyatec’s mission to provide clinicians with essential drug response data for cancer patients worldwide. MBD’s state-of-the-art automation will be integrated into Kiyatec’s CLIA/CAP laboratory operations in Greenville, SC, dramatically enhancing throughput and quality control as the company expands its commercial footprint.

"This strategic investment marks a pivotal moment for Kiyatec," said Eric Perreault, CEO of Kiyatec. "MBD is not just a financial partner; they are a technological force multiplier. By integrating their advanced automated platform, we can immediately enhance our scale, reduce turnaround times, and solidify our path to providing drug response results to thousands of glioblastoma patients. Crucially, this partnership will accelerate the validation and launch of our testing panels for other high-incidence cancers, including ovarian, breast, and non-small cell lung cancer."

The immediate integration of MBD’s technology is designed to optimize Kiyatec’s operational efficiency, enabling the company to meet the growing demand from physicians across the United States.

Bosung Ku, CEO of MBD, commented on the partnership: "Kiyatec’s 3D Predict technology and its compelling clinical performance data—particularly in glioblastoma—represent the future of personalized oncology. Our investment reflects our firm commitment to supporting global leaders who are advancing patient care. We look forward to seeing the immediate impact of our automated platform integration as Kiyatec scales its commercial operations and moves swiftly to bring vital functional diagnostic information to patients with brain, lung, breast and gynecological cancers."

The investment will primarily be utilized to fund the company’s commercial expansion, AI tool integration and further drive clinical evidence generation necessary for broad reimbursement coverage.

(Press release, Kiyatec, NOV 13, 2025, View Source [SID1234659941])

Singapore-based ImmunoScape Pioneers Next-Generation Cell Therapy for Solid Tumors; Announces Key Licensing Deal, New Board and SAB Appointments

On November 13, 2025 ImmunoScape Pte. Ltd., an A*STAR spin out backed by Amgen Ventures and EDBi that is developing next-generation TCR-based cancer immunotherapies, reported an exclusive in-licensing deal with Cue Biopharma Inc. (Nasdaq: CUE) to lead the development of a distinct new class of therapies to attack solid tumor cancers. The deal provides ImmunoScape with exclusive access to Cue Biopharma’s clinical-stage Immuno-STAT molecules in oncology.

By combining Cue Biopharma’s technology with its precision T cell receptor (TCR) therapy, ImmunoScape is pioneering a new "Seed-and-Boost" approach to immunotherapy, that addresses the shortcomings of current cell therapies by enabling potent in vivo expansion of infused tumor targeting T-cells—producing large numbers of highly effective tumor killing T cells in a controlled manner in the patient.

The strategy uses a minimal dose of the patient’s own T cells, engineered with a tumor-specific TCR (Seed), followed by periodic administration of TCR-matching and interleukin-2 (IL-2) carrying Immuno-STAT molecules (Boost). This combination immunotherapy enables, for the first time, the establishment of a true therapeutic index for IL-2 by selectively delivering it to tumor-reactive T cells. The potential breakthrough approach offers to eliminate systemic cytokine toxicity, streamline manufacturing, and may deliver a deeper, more durable attack on malignant cells.

ImmunoScape’s clinical program targets cancers of high unmet medical need

ImmunoScape’s first Seed-and-Boost program targets the WT1 antigen, which is expressed across many recalcitrant solid tumors — including lung, pancreatic, colorectal, ovarian, gastric, melanoma, and head and neck cancers — as well as certain hematologic malignancies that still represent significant unmet clinical needs. ImmunoScape’s Singapore lab has generated compelling preclinical data across multiple solid tumor models, which is supportive of IND-enabling studies that will enable clinical trials to commence by 2027.

"Our Singapore-based in vivo cancer models demonstrate the efficacy of this new approach in multiple solid tumors" said Dr. Kar Wai Tan PhD, ImmunoScape’s Vice President of Discovery.

The Company’s modular Seed-and-Boost platform technology has the potential to transform cell therapy, through the delivery of safe, tolerable and effective therapies against cancer while simplifying the patient journey. In addition to targeting solid tumors, the platform may also be used to enhance existing classic autologous and in vivo T cell therapies. ImmunoScape’s clinical studies will include cancers and immune types that are relevant to Asian populations.

"ImmunoScape is pioneering the next wave of cancer therapeutics," said Michael Fehlings, PhD, CEO of ImmunoScape. "Through our next-generation Seed-and-Boost strategy, we aim to deliver clinically meaningful improvements in patient outcomes in multiple cancers."

ImmunoScape Strengthens Leadership with Key Appointments

As it transitions to becoming a global leader in cancer immunotherapy development, ImmunoScape is pleased to announce additions to its leadership structure:

Usman "Oz" Azam, MD, Joins the Board of Directors: Dr. Azam, President and CEO of Cue Biopharma and former global head of Novartis’ Cell and Gene Therapy business, brings the support of Boston-based Cue Biopharma and extensive expertise in cell therapy development, manufacturing and commercialization. Dr. Azam served as Chief Executive Officer of Inspirna, Inc., a privately held clinical stage biopharmaceutical company focused on the discovery and development of novel cancer drugs and President and CEO of Tmunity Therapeutics, where he was involved in developing genetically engineered CAR-T cell therapies for solid tumor applications in cancer.
Adrian Bot, MD/PhD, Joins the Board of Directors: Dr. Bot brings 27 years of experience in discovery, development and commercialization of immunotherapies including CAR and TCR-engineered T cell products. He was the founding CSO for Capstan Therapeutics focused on in vivo CAR therapies and has held leadership positions including CSO and Global Head of Translational Medicine and Research at Kite Pharma developing groundbreaking gene engineered T cell therapies.
"Immunotherapy in solid tumors is at a juncture, when sophisticated, precision medicine tools are needed to effectively orchestrate a durable clinical response, I am convinced that the novel immunotherapeutic tools of ImmunoScape will push the boundaries towards better addressing the needs of cancer patients in a broad range of cancer types. Their innovative Seed and Boost approach is of global significance in the cancer field," said Dr. Bot.

Pamela Munster, MD, Joins Scientific Advisory Board: Dr. Pamela Munster, a distinguished medical oncologist and Director of the early-stage oncology clinical trials program at UCSF, joins and complements the existing experts on the Scientific Advisory Board, bringing unparalleled clinical insights into unmet solid tumor patient needs. Dr. Munster is the author of the award-winning book, Twisting Fate: My Journey with BRCA―from Breast Cancer Doctor to Patient and Back.

(Press release, immunoSCAPE, NOV 13, 2025, View Source [SID1234659940])

Tvardi Therapeutics Announces Third Quarter 2025 Results and Provides Business Update

On November 13, 2025 Tvardi Therapeutics, Inc. ("Tvardi") (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat ﬁbrosis-driven diseases, reported its ﬁnancial and operating results for the third quarter ended September 30, 2025, and provided a business update.

Third Quarter 2025 and Recent Highlights:

Continued to progress its Phase 2 study of TTI-101 in HCC, with topline data anticipated in the first half of 2026.
Announced that the IND for its next-generation STAT3 inhibitor, TTI-109, is in effect and that a healthy volunteer study has been initiated, results of which are anticipated in the first half of 2026.
In October, the company reported preliminary data from the Phase 2 REVERT IPF trial and concluded that the study did not meet its goals. Tvardi is conducting additional analyses to further understand these results and inform next steps.
Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, "While we continue to analyze the results from our REVERT IPF clinical trial to determine the most appropriate path forward, we remain confident in the potential of STAT3 inhibition to address fibrosis-driven diseases. We believe our lead program, TTI-101, has demonstrated encouraging clinical activity in oncology and continues to hold promise across a range of indications where STAT3 is a key driver.

"To that end, we eagerly await data from our ongoing Phase 2 REVERT Liver Cancer trial in the first half of next year. Interim results from this study have already shown clinically meaningful activity of TTI-101 both as monotherapy and in combination with established anti-cancer agents across treatment lines.

"At the same time, we are also advancing our next-generation STAT3 inhibitor, TTI-109, through a healthy volunteer study. TTI-109 is designed to rapidly convert to TTI-101 and lessen the exposure of the active drug to the intestinal lining. We believe TTI-109 strengthens our STAT3-targeted approach by providing a more efficient delivery mechanism for TTI-101 that has the potential to improve tolerability.

"With a balance sheet extending into the fourth quarter of next year, we remain focused on fully realizing the therapeutic potential of STAT3 inhibition across fibrotic diseases."

Upcoming Milestones:

Preliminary topline data from the company’s ongoing REVERT Liver Cancer Phase 1b/2 clinical trial of TTI-101 anticipated in the first half of 2026
Preliminary topline data from a healthy volunteer study of its next-generation STAT3 inhibitor, TTI-109, also anticipated in the first half of 2026
Third Quarter 2025 Financial Results

Research and development expenses for the three months ended September 30, 2025, were $3.6 million as compared to $4.8 million for the comparable period in 2024. The decrease of $1.2 million was primarily driven by lower costs associated with TTI-101, including decreases of $1.4 million and $1.0 million related to Tvardi’s HCC and IPF trials, respectively. The decrease in Tvardi’s HCC trial expense was primarily attributable to the changes in patient enrollments and estimated study costs, while the decrease in Tvardi’s IPF trial expense was attributable to the trial being completed in the second quarter of 2025. These declines were partly offset by an increase of $2.0 million related to the ongoing healthy volunteer study of TTI-109, which began in the third quarter of 2025, as well as related CMC costs.

General and administrative expenses were $2.3 million for the three months ended September 30, 2025, compared to $0.9 million for the three months ended September 30, 2024. The increase of approximately $1.5 million was primarily driven by increases in professional fees of $0.7 million, attributable to higher legal fees and ongoing accounting and audit fees. The remaining increase was attributable to higher personnel costs, insurance costs and rent and other related costs.

Net loss for the three months ended September 30, 2025 was $5.5 million, roughly flat with the comparable period in 2024.

Basic and diluted net loss per share attributable to common shareholders for the three months ended September 30, 2025 were a net loss of $0.59 on a basic and diluted basis, compared to a net loss of $2.14 on a basic and diluted basis for the comparable period in 2024.

Cash, cash equivalents and short-term investments as of September 30, 2025, were $36.5 million, as compared to $31.6 million as of December 31, 2024. Tvardi anticipates that its current cash runway is sufficient to fund operations, as currently planned, into the fourth quarter of 2026.

(Press release, Tvardi Therapeutics, NOV 13, 2025, View Source [SID1234659939])

TriSalus Life Sciences Reports Third Quarter 2025 Results and Reaffirms 2025 Revenue Guidance

On November 13, 2025 TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology company integrating novel delivery technology with standard of care therapies, and its investigational immunotherapeutic to transform treatment for patients with solid tumors, reported financial results for the quarter ended September 30, 2025, and provides an operation update.

"TriSalus continued to deliver strong commercial performance in the third quarter, underscoring the growing clinical adoption of our TriNav product suite and proprietary PEDD platform across a broad range of solid tumor indications," said Mary Szela, President and CEO of TriSalus. "We are pleased to reaffirm our full-year revenue growth guidance of 50%, reflecting the increasing market penetration of TriNav for liver-directed therapies. We continue to invest in registry and other clinical programs and are committed to building a data-driven case for the expansion of our PEDD technology platform to new embolization applications. With our strategic shift toward partnering development of nelitolimod, we are also reducing our quarterly cash burn even as we extend our platform. Our three PERIO clinical phase 1 dose escalation studies are completed, with clinical study reports under preparation for data release in Q4. We look forward to the balance of 2025 energized by our long-term vision of bringing our PEDD technology to a wider range of patients and improving their clinical outcomes."

Third Quarter 2025 Operational Highlights

Generated $11.6 million in net sales, a 57% increase year-over-year, and sequential growth of 3% over the second quarter 2025.
Lowered quarterly cash burn by approximately 50% quarter-over-quarter.
Delivered strong commercial performance, with expanding use of TriNav in liver embolization, and continued further development of new applications for new clinical settings focused on the interventional radiology call point.
Simplified the Company’s capital structure through successful completion of an exchange offering of previously issued Series A Preferred stock.
Investigator-published study in the Journal of the Endocrine Society includes results of a retrospective single-center study by Gad et al. which evaluated the safety, feasibility, and early efficacy of Pressure-Enabled Thyroid Artery Embolization (PED-TAE) using the TriNav Infusion System. This novel, minimally invasive technique targets the inferior thyroid arteries to reduce gland size and alleviate symptoms in patients who are not candidates for surgery or conventional therapies. These early results lay the foundation for a broader evaluation of pressure-enabled embolization in the management of benign thyroid disease,"
Initiated a clinical trial to evaluate genicular artery embolization (GAE) as a potential treatment for knee osteoarthritis, a condition affecting more than 30 million adults in the United States. The study aims to assess whether GAE can reduce pain and delay the need for knee replacement surgery.
Third Quarter 2025 Financial Results

Revenue, all from sales of the TriNav system, was $11.6 million for the three months ended September 30, 2025, an increase of 57% compared to the same period in 2024 and 3% sequential growth. Revenue growth was driven primarily by increased TriNav sales within liver directed applications.
Gross margins were 84% in the third quarter, compared to 86% in the same period of 2024. The year-over-year decline was primarily driven by lower manufacturing efficiency associated with newly launched products, a dynamic we continue to expect to improve as production scales and processes mature over the course of the year.
Research and Development (R&D) expenses were approximately $5.2 million, compared to $4.2 million for the same quarter of the prior year. The increase was primarily due to a one-time charge of approximately $2.1 million related to closing of our clinical studies related to nelitolimod, partially offset by the revision of approximately $0.7 million in patent-related costs to general and administrative expenses.
Sales and Marketing (S&M) expenses were approximately $6.8 million in the third quarter, compared to $6.1 million for the same quarter of the prior year. The year-over-year increase was primarily due to an increase in performance related compensation driven by the increase in sales.
General & Administrative (G&A) expenses for the third quarter were approximately $6.7 million, compared to $4.7 million for the same quarter of the prior year. The increase was primarily driven by the acceleration of approximately $1.6 million in non-cash stock-based compensation and the revision of approximately $0.7 million in patent-related expenses from research and development to general and administrative.
Operating losses were $9.0 million, compared to Operating losses of $8.7 million for the same period in the prior year. The increase was primarily driven by a one-time charge related to the close out of our clinical studies along with a one-time acceleration of non-cash stock based compensation related awards.
Net loss attributable to common stockholders was $41.3 million in the third quarter, compared to $3.2 million for the same period in the prior year, primarily driven by the conversion of our preferred stock to common stock during the third quarter of 2025, resulting in approximately $30.5 million net loss attributable to common stockholders.
The basic and diluted loss per share was $0.96 for the third quarter, compared to $0.12 for the same period in 2024. This is primarily due to the conversion of preferred stock to common stock.
As of September 30, 2025, cash and cash equivalents totaled $22.7 million providing sufficient runway to reach positive adjusted EBITDA.
The non-GAAP measure of adjusted EBITDA is reconciled in the table below as the Company believes it is an important measure of performance. Adjusted EBITDA losses were $5.4 million, compared to losses of $7.2 million for the same period in 2024. Adjusted EBITDA for the period includes approximately $2.1 million of a charge related to closing the clinical studies related to Nelitolimod. Currently, reductions in adjusted EBITDA losses are due to increased sales, reduced research and development expenses and increased stock compensation in 2025.

Conference Call

The Company will host a conference call and webcast today, November 13, 2025 at 4:30 PM eastern time to discuss its financial results for the quarter ended September 30, 2025. Parties interested in participating by phone should register using this online form. After registering for the webcast, dial-in details will be provided in an auto-generated e-mail containing a link to the conference phone number along with a personal pin. The event will also be webcast live on the investor relations section of TriSalus’ website. A replay will also be available on the website following the event.

(Press release, TriSalus Life Sciences, NOV 13, 2025, View Source [SID1234659938])