On November 13, 2025 Synthekine Inc., an engineered cytokine therapeutics company, reported that the company has dosed the first patient in the SYNERGY-101 study. SYNERGY-101 is a global, randomized Phase 2 clinical trial evaluating STK-012 combined with pembrolizumab and chemotherapy (PCT) vs. PCT in first-line, PD-L1 negative nonsquamous non-small cell lung cancer (NSCLC).

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"This marks a key milestone for Synthekine as we advance STK-012 into a randomized Phase 2 trial," said Debanjan Ray, Chief Executive Officer of Synthekine. "Our promising Phase 1b data suggest that STK-012 may lead to a meaningful improvement in outcomes in PD-L1 negative NSCLC, a population with limited benefit from current therapies."

Positive Phase 1b results presented at SITC (Free SITC Whitepaper) 2025 showed a 50% response rate in PD-L1 negative nonsquamous NSCLC patients treated with STK-012 in combination with PCT, substantially higher than the 23–32% response typically seen with standard of care alone. Notably, similarly high response rates were observed in patients with immune-resistant tumor profiles, such as those patients with STK11 or KEAP1 mutations, which have a high prevalence in PD-L1 negative NSCLC.

"PD-L1 negative patients represent 30-40% of new nonsquamous NSCLC diagnoses and typically face poor prognosis on standard-of-care therapy, highlighting the need for new treatment options in this setting," said Naiyer Rizvi, M.D., Chief Medical Officer of Synthekine. "SYNERGY-101 will help determine whether STK-012 can offer a new standard of care for this underserved population."

For additional information about the trial, please visit www.clinicaltrials.gov using the identifier NCT05098132.

About SYNERGY-101

SYNERGY-101 is a global, randomized Phase 2 study designed to evaluate the safety and efficacy of STK-012 in combination with PCT in first line, PD-L1 negative nonsquamous NSCLC patients. This trial aims to enroll approximately 105 patients, with a primary endpoint of overall response rate based on RECIST v1.1. Secondary endpoints include progression-free survival and safety.

About PD-L1 Negative Nonsquamous Non-Small Cell Lung Cancer

Lung cancer is the third-most common cancer in the United States and is a serious and life-threatening disease, which is expected to account for 20% of cancer deaths in 2025.1 Nonsquamous NSCLC is the most common form of lung cancer and PD-L1 negative patients account for 30 – 40% of these patients, who have a poor prognosis despite currently available standard-of-care therapies.

1Cancer Facts & Figures 2025, American Cancer Society (ACS), Atlanta, Georgia, 2025

About STK-012

STK-012 is a first-in-class α/β-IL-2 receptor biased partial agonist engineered to selectively stimulate antigen-activated T cells, which are associated with potent anti-tumor activity, while minimizing activation of other lymphocytes, such as natural killer (NK) cells or naïve T cells, which are associated with IL-2 related toxicity.

(Press release, Synthekine, NOV 13, 2025, View Source [SID1234659944])

On November 13, 2025 Virometix AG, a clinical-stage biotechnology company pioneering fully synthetic vaccines, reported the completion of a $15 million financing round from existing shareholders. The funds will support continued clinical and development activities for V-212, Virometix’s lead serotype-independent pneumococcal vaccine candidate, currently in Phase I clinical evaluation.

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Proceeds from the financing will be used to:

Advance the ongoing Phase I clinical trial of V-212, with topline results expected in Q1 2026.
Prepare for a planned Phase Ib combination trial evaluating V-212 with an approved pneumococcal conjugate vaccine (PCV).
Complete OPK assay validation to support immunogenicity and functional data read-outs.
Implement platform enhancements to the company’s proprietary Synthetic Virus-Like Particle (SVLP) technology.
Progress next-generation serotype-independent pneumococcal vaccine programs toward preclinical development.
"This financing demonstrates the continued confidence and commitment of our investors to Virometix’s mission and platform," said Anna Sumeray, Chief Executive Officer of Virometix. "Our fully synthetic SVLP technology enables the design of broad-spectrum, self-adjuvanted vaccines with highly scalable manufacturing. With V-212 in clinical development, we are well positioned to deliver a truly next-generation approach to pneumococcal prevention."

About V-212

V-212 is a fully synthetic, serotype-independent, peptide-based vaccine designed to prevent Streptococcus pneumoniaeinfections. The vaccine incorporates multiple conserved antigenic epitopes from key pneumococcal surface proteins conjugated to Virometix’s proprietary SVLP nanoparticles, which include built-in adjuvant elements such as T-helper epitopes and Toll-like receptor (TLR) ligands. This unique design eliminates dependence on biological carrier proteins and allows for a streamlined, fully synthetic manufacturing process.

Preclinical studies demonstrated robust and durable immunogenicity in mouse and rabbit models, protection against lethal sepsis, and cross-reactivity with multiple pneumococcal serotypes, including non-PCV-13 types—underscoring V-212’s potential for broad protection.

The ongoing Phase I clinical trial (NCT06975319) is a randomized, double-blind, placebo-controlled, first-in-human study being conducted at the Centre for Vaccinology (CEVAC), Ghent University Hospital. Sixty healthy volunteers aged 18–45 have been enrolled, and topline safety and immunogenicity data are anticipated in the first quarter of 2026.

(Press release, Virometix, NOV 13, 2025, View Source [SID1234659943])

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])

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.

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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])

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.

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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])