On October 14, 2025 Pfizer Inc. (NYSE: PFE) reported positive topline results from the Phase 3 HER2CLIMB-05 trial of first-line combination therapy with the tyrosine kinase inhibitor TUKYSA (tucatinib) in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC). HER2CLIMB-05 is evaluating TUKYSA versus placebo, both in combination with first-line standard-of-care maintenance therapy (trastuzumab plus pertuzumab) following chemotherapy-based induction. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) by investigator assessment in the TUKYSA arm versus the placebo arm. Treatment with TUKYSA in combination with trastuzumab and pertuzumab was tolerable, with a safety profile generally consistent with the established safety profiles of each individual therapy.

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"HER2+ breast cancer is a particularly challenging subtype, with many patients experiencing disease progression despite effective treatments in the first-line setting," said Erika Hamilton, M.D., principal investigator of HER2CLIMB-05 and Director, Breast Cancer Research, Sarah Cannon Research Institute (SCRI). "The HER2CLIMB-05 results demonstrate that the addition of TUKYSA to first-line maintenance therapy may further lower the risk of disease progression or death, with a treatment that has a well-established safety profile."

HER2 is overexpressed in up to 15-20% of breast cancers and is associated with poor prognosis, with an estimated five-year survival rate for HER2+ MBC of 41-47%, depending on HR status.i,ii,iii First-line standard of care maintenance treatment has remained unchanged since 2012, and the majority of HER2+ MBC patients face disease progression within two years of initiating therapy.iv Until recently, there have been limited advancements for these patients.

"Pfizer aims to help shape the future of front-line treatment for HER2+ MBC, where we see significant opportunity for a chemotherapy-free maintenance approach," said Johanna Bendell, M.D., Chief Development Officer, Oncology, Pfizer. "The positive results from HER2CLIMB-05, combined with TUKYSA’s known safety profile in later-line settings, underscore its potential to play a meaningful role in front-line maintenance, where it may benefit a broader population of patients with HER2+ disease. We are grateful to the patients and investigators who contributed to this important research."

Results from HER2CLIMB-05 will be presented at a future medical congress and discussed with regulatory authorities.

Since its initial approval in 2020, TUKYSA has become a standard of care for HER2+ MBC patients in the third-line setting and has been approved in more than 50 countries. In the United States, TUKYSA is approved by the U.S. Food and Drug Administration for use in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2+ breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. TUKYSA is not currently approved for first-line treatment.

About the HER2CLIMB-05 Trial
HER2CLIMB-05 is a randomized, double blind, placebo-controlled, pivotal Phase 3 study evaluating the efficacy and safety of TUKYSA (tucatinib) compared to placebo, both in combination with trastuzumab and pertuzumab, as maintenance therapy for patients with HER2+ metastatic breast cancer (MBC) following induction therapy in the first-line setting.

Study participants who completed induction therapy of trastuzumab, pertuzumab and a taxane with no evidence of progression were randomized to receive TUKYSA in combination with trastuzumab plus pertuzumab (n=326), or placebo in combination with trastuzumab plus pertuzumab (n=328). The primary endpoint is progression-free survival (PFS) as assessed by the investigator. Overall survival is a key secondary endpoint.

About TUKYSA (tucatinib)
TUKYSA (tucatinib) is an orally administered tyrosine kinase inhibitor of HER2. TUKYSA is approved in combination with trastuzumab and capecitabine to treat adults with HER2-positive advanced unresectable or metastatic breast cancer, including patients with brain metastases who have received one or more prior anti-HER2 breast cancer treatments in the metastatic setting.

The full U.S. Prescribing Information for TUKYSA can be found here.

IMPORTANT TUKYSA (tucatinib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION

Warning and Precautions:

Diarrhea: TUKYSA can cause severe diarrhea including dehydration, hypotension, acute kidney injury, and death. If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
In HER2CLIMB, 81% of patients who received TUKYSA experienced diarrhea, including 0.5% with Grade 4 diarrhea and 12% with Grade 3 diarrhea. The median time to onset of the first episode of diarrhea was 12 days and the median time to resolution was 8 days. Diarrhea led to dose reductions of TUKYSA in 6% of patients and discontinuation of TUKYSA in 1% of patients. Prophylactic use of antidiarrheal treatment was not required on HER2CLIMB.
Hepatotoxicity: TUKYSA can cause severe hepatotoxicity. Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatotoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
In HER2CLIMB, 8% of patients who received TUKYSA had an ALT increase > 5 × ULN, 6% had an AST increase > 5 × ULN, and 1.5% had a bilirubin increase > 3 × ULN (Grade ≥3). Hepatotoxicity led to dose reduction of TUKYSA in 8% of patients and discontinuation of TUKYSA in 1.5% of patients.
Embryo-fetal Toxicity: TUKYSA can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TUKYSA and for 1 week after the last dose.
Adverse Reactions:
In HER2CLIMB, serious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in ≥ 2% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock. Adverse reactions leading to treatment discontinuation occurred in 6% of patients who received TUKYSA. Adverse reactions leading to treatment discontinuation of TUKYSA in ≥1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions leading to dose reduction occurred in 21% of patients who received TUKYSA. Adverse reactions leading to dose reduction of TUKYSA in ≥2% of patients were hepatotoxicity (8%) and diarrhea (6%). The most common adverse reactions in patients who received TUKYSA (≥20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, hepatotoxicity, vomiting, stomatitis, decreased appetite, anemia, and rash.

Laboratory Abnormalities:
In HER2CLIMB, Grade ≥3 laboratory abnormalities reported in ≥5% of patients who received TUKYSA were decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.

(Press release, Pfizer, OCT 14, 2025, View Source [SID1234656663])

On October 14, 2025 NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, reported the presentation of assay-relevant data, including interventional therapy trials in progress, to showcase how its molecular residual disease (MRD) assay may benefit pharmaceutical partners at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, October 17–21, in Berlin, Germany. RaDaR ST, the company’s circulating tumor DNA (ctDNA) assay, is designed to accelerate and optimize oncology drug development.

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Building on NeoGenomics’ established molecular capabilities, the RaDaR ST assay uses whole-exome sequencing data from tumor samples and advanced bioinformatics to create patient-specific MRD panels. By leveraging high-depth sequencing and personalized panel design, the assay delivers highly sensitive and specific detection of ctDNA from plasma samples, providing real-time insights into tumor dynamics and treatment response.

"We stand by our commitment to clinical validation and interventional studies utilizing NeoGenomics’ MRD technology, as reflected in three new posters from our European collaborators presented at this year’s ESMO (Free ESMO Whitepaper) congress," said Tony Zook, Chief Executive Officer. "We are excited to continue our long-standing support of drug development and interventional clinical trials, now with our RaDaR ST assay. Pharmaceutical sponsors are seeking partners who can deliver both innovation and operational excellence across every stage of oncology trials. NeoGenomics meets that need with RaDaR ST, providing patient-specific insights in real time to help drive faster, more informed decisions and advance cancer research more effectively."

As MRD gains traction as a preferred solution to monitor responses to next-generation therapies, NeoGenomics’ launch of RaDaR ST strengthens its position as a partner to biopharma organizations seeking to advance precision oncology. The company will feature RaDaR ST and its broader oncology testing and research capabilities at booth #4012.

(Press release, NeoGenomics Laboratories, OCT 14, 2025, View Source [SID1234656662])

On October 14, 2025 Akamis Bio, a clinical-stage oncology company using a proprietary Tumor-Specific Immuno-Gene Therapy (T-SIGn) platform to deliver novel immunotherapeutic payloads to solid tumors, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to NG-350A for the treatment of mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC).

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NG-350A is an intravenously delivered oncolytic immunotherapy designed to drive intratumoral expression of a CD40 agonist monoclonal antibody triggering the activation of antigen-presenting cells (APCs) resident in solid tumors and their draining lymph nodes. Once activated, APCs recruit T cells into the vicinity of the tumor to deliver a potent anti-tumor immune response. NG-350A is currently being evaluated in combination with chemoradiotherapy in the actively recruiting Phase 1b FORTRESS study (NCT06459869) in pMMR LARC patients.

"The NG-350A Fast Track designation from FDA is a recognition of the significant unmet need for new therapies to treat locally advanced rectal cancer (LARC)," said Oliver Rosen, M.D., chief medical officer at Akamis Bio. "The global incidence of LARC continues to rise, with a particularly alarming increase of this cancer among younger populations. Patients with mismatch repair-proficient tumors account for approximately 90% of LARC cases, and this population has the greatest need for evolution in the standard of care to include treatments that may enable patients to avoid surgical interventions."

The FDA grants Fast Track designation to facilitate the development and expedite the review of new drugs that may fill an unmet medical need for serious or life-threatening conditions. A drug receiving the designation may be eligible for more frequent meetings and communications with the FDA to discuss development plans, ensure the collection of appropriate data needed to support approval, and enable a rolling review of an application for marketing authorization. This may lead to earlier drug approval and access for patients. Drugs receiving Fast Track designation may also be eligible for Accelerated Approval and Priority Review if relevant criteria are met.

About NG-350A
NG-350A is a clinical-stage, intravenously delivered T-SIGn therapeutic designed to drive intratumoral expression of a CD40 agonist monoclonal antibody triggering the activation of antigen-presenting cells (APCs) resident in solid tumors and their draining lymph nodes. Once activated, APCs recruit T cells into the vicinity of the tumor to deliver a potent anti-tumor immune response. Akamis Bio has evaluated NG-350A’s safety, tolerability, and preliminary efficacy as a monotherapy (FORTITUDE study) and in combination with pembrolizumab (FORTIFY study) in patients with metastatic or advanced epithelial tumors. Across these studies, NG-350A has demonstrated a consistent safety and tolerability profile, as well as strong evidence of tumor-selective delivery, replication and transgene expression.

About the FORTRESS Study
The Phase 1b FORTRESS study (NCT06459869) is an open-label, single-arm, and multicenter trial of NG-350A in combination with chemoradiotherapy (CRT) in adult patients with mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC) and at least one risk factor for local or distant recurrence or with oligometastatic disease. The FORTRESS study builds upon the Akamis Bio-supported, CEDAR study, which showed a significantly greater complete response rate in LARC patients treated with a combination of Akamis Bio’s first generation oncolytic immunotherapy and chemoradiotherapy (CRT), relative to expected outcomes using standard-of-care CRT alone. The FORTRESS study is planning to enroll approximately 30 patients aged eighteen and older with histologically confirmed adenocarcinoma of the rectum which is locally advanced (clinical stage II-III based on pelvic MRI). During the 12-week active study treatment period, patients will receive NG-350A plus CRT (oral capecitabine plus long-course intensity-modulated radiotherapy). The primary endpoint for the study will be the proportion of patients achieving a clinical complete response (cCR) at week 12. Key secondary endpoints will include the incidence and severity of adverse events, clinical response (CR) outcome, and MRI-based tumor regression grade (mrTRG). Patients recently diagnosed with pMMR LARC interested in learning more about the FORTRESS trial can visit www.FortressStudy.org.

About LARC
Colorectal cancer is the third most common cancer diagnosed in both men and women in the United States with about 145,000 people newly diagnosed each year. Amongst the incident colorectal cancer population, about 45,000 people are diagnosed specifically with rectal cancer of which approximately 60 percent have locally advanced rectal cancer (LARC). LARC is defined by the spread of the rectal cancer to nearby tissues or lymph nodes. In patients with LARC, tumors have either grown through muscle and into the outermost layers of the rectum, or in more severe cases, through the wall of the rectum where they may attach to other organs or structures and/or into the lymph nodes. Approximately 90% of LARC patients have mismatch repair-proficient (pMMR) tumors which have a functional DNA repair system.

(Press release, Akamis Bio, OCT 14, 2025, View Source [SID1234656661])

On October 14, 2025 Pilatus Biosciences Inc., a biopharmaceutical company developing novel metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, reported the granting of its foundational patent in Europe and Australia, entitled "Methods for Modulating Regulatory T Cells and Inhibiting Tumor Growth."

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Pilatus has an exclusive license on the patent from the Ludwig Institute for Cancer Research Ltd and the University of Lausanne, Switzerland, based on work by Dr. Ping-Chih Ho’s laboratory at the Ludwig Lausanne Branch. The patent covers Pilatus’ first-in-class antibody program targeting CD36, a key metabolic checkpoint expressed on regulatory T cells (Tregs) that play a critical role in suppressing anti-tumor immune responses.

This intellectual property milestone provides broad protection for the company’s pioneering work in Treg modulation through metabolic reprogramming, representing a new therapeutic strategy in immuno-oncology.

Tregs are essential for maintaining immune balance but can also enable tumor immune evasion by suppressing effector T cell activity within the tumor microenvironment. CD36, a fatty acid transporter highly expressed on Tregs acts as a metabolic gatekeeper that supports their survival and suppressive function under hypoxic and nutrient-deprived tumor conditions.

Pilatus’ antibody program is designed to disrupt CD36-mediated lipid uptake and signaling in Tregs, thereby reawakening the immune system’s ability to attack tumors without triggering systemic autoimmunity. This approach builds upon discoveries made in the laboratory of Dr. Ping-Chih Ho, Full Member at LICR Lausanne, and forms the scientific foundation for Pilatus’ proprietary pipeline of metabolic checkpoint inhibitors.

Nobel Prize Underscores the Field’s Importance

This announcement comes at a particularly timely moment: the 2025 Nobel Prize in Physiology or Medicine was awarded for groundbreaking discoveries in Regulatory T cell biology, underscoring the growing recognition of immune regulation as a cornerstone of modern medicine.

In fact, one of this year’s Nobel Laureates, Prof. Shimon Sakaguchi, the discoverer of Tregs, was a recent keynote speaker at the Ho Lab anniversary symposium in Lausanne, where he presented on "Targeting Tregs for Cancer Immunotherapy."

"The recognition of Treg biology by the Nobel Committee highlights the importance of immune regulation in health and disease," said Dr. Ping-Chih Ho, Co-Inventor and Full Professor and member at the Ludwig Institute for Cancer Research at University of Lausanne. "Our CD36 discoveries bridge metabolic control and immune suppression, paving the way for transformative treatments in oncology and beyond."

"This patent issuance solidifies Pilatus’ leadership position in metabolic checkpoint immunotherapy," said Raven Lin, Ph.D., Co-Founder and CEO, Pilatus Biosciences. "By targeting the metabolic dependencies of regulatory T cells, we are developing a new class of therapies designed to unlock potent and durable anti-tumor immunity, while demonstrating synergistic potential with PD-1 blockade to benefit patients with difficult to treat cancers."

(Press release, Pilatus Biosciences, OCT 14, 2025, View Source [SID1234656660])

On October 14, 2025 Synnovation Therapeutics, a precision medicine company focused on the discovery and development of best-in-class targeted medicines, reported that it will be presenting the initial results from a Phase 1 Trial of SNV1521, a next-generation, CNS-penetrant PARP1-selective inhibitor, at the 2025 Annual Meeting of the European Society for Medical Oncology in Berlin, Germany.

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"We look forward to sharing the first clinical dataset for our PARP-1 selective inhibitor, SNV1521, with the scientific community in Berlin," said Kevin O’Hayer, M.D., Ph.D., Senior Vice President, Head of Clinical Development at Synnovation. "We have generated encouraging anti-tumor activity and a differentiated safety and PK profile that supports best-in-class potential and further development as a monotherapy and in combination with novel targeted and cytotoxic agents."

Patricia LoRusso, D.O, Ph.D, Associate Center Director for Innovative Medicine at Yale Cancer Center, will present the initial results on Friday, October 17, 2025. The details of the presentation are below:

Oral Presentation:

Title:

First results from a phase 1 trial of SNV1521, a next generation, CNS-penetrant, PARP1-selective inhibitor in patients (pts) with molecularly selected advanced solid tumors (Abstract #923MO)

Presenter:

Patricia LoRusso, DO, PhD

Details:

Developmental Therapeutics Mini Oral Session

Friday, October 17, 2025; Heidelberg Auditorium

10:25 – 10:30 AM EST (4:25 – 4:30 PM CET)

"PARP1 selective agents offer the promise of delivering effective PARP inhibition while mitigating the hematologic and GI toxicity associated with first generation PARP inhibitors," said Patricia LoRusso, D.O., Ph.D., Associated Center Director for Innovative Medicine at Yale Cancer Center. "By optimizing PARP1 selectivity and potency, SNV1521 has the potential to emerge as a best-in-class agent with a differentiated safety profile compared to standard of care and PARP inhibitors in development."

Synnovation also announced a clinical collaboration with DualityBio to evaluate the combination of SNV1521 with Duality’s HER3-directed antibody-drug conjugate (ADC), DB-1310. DB-1310 is a novel ADC targeting HER3 developed using DualityBio’s proprietary DITAC platform. In June 2025, Dr. Aaron E. Lisberg from the University of California, Los Angeles (UCLA) presented the first-in-human Phase I/IIa clinical trial data (NCT05785741) of DB-1310 in an oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The results demonstrated encouraging efficacy and a manageable safety profile in patients with advanced solid tumors who had failed standard therapies.

"The combination of cytotoxic agents with PARP inhibitors has shown clear preclinical synergy, however, overlapping hematologic toxicity has so far hindered the successful co-development." said Wenqing Yao, Ph.D., CEO and Co-Founder at Synnovation. "This collaboration provides an exciting opportunity to evaluate the combination of two potentially best-in-class therapies—a heme-sparing, PARP1-selective inhibitor, SNV1521, and the HER3-targeting ADC, DB-1310—with the aim of demonstrating synergistic efficacy and improving patient outcomes".

(Press release, Synnovation Therapeutics, OCT 14, 2025, View Source [SID1234656659])