On October 14, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that it will host an analyst and investor event focused on lacutamab, an asset with path to potential Accelerated Approval based on existing long-term follow-up data of the Phase 2 TELLOMAK study, providing both clinical perspectives and market outlook. The event will be held in person and virtually on Tuesday, October 28, 2025, from 8:00 a.m. to 10:00 a.m. ET / 1:00 p.m. to 3:00 p.m. CET, at the Park Terrace Hotel on Bryant Park in New York.

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The program will feature Pierluigi Porcu, M.D., Division Chief for Hematology and BMT at University of Kentucky, Lexington, a world expert in T-cell lymphomas, who will provide medical perspectives on results from the Phase 2 TELLOMAK trial, which evaluated lacutamab in patients with relapsed or refractory (R/R) cutaneous T-cell lymphoma (CTCL). ZS Associates, leading experts in life sciences and healthcare markets, will describe the eligible U.S. cutaneous T-cell lymphoma patient population based on real-world claims data. Finally, Innate Pharma’s management will provide updates on the planned Phase 3 trial, regulatory pathway in CTCL, including path to potential accelerated approval in Sézary syndrome, and commercial opportunity for lacutamab.

"We look forward to engaging with the investor community in New York to share the latest updates and perspectives on lacutamab, a product which has the potential to meaningfully improve outcomes and quality of life for CTCL patients with high unmet medical needs while creating significant value for shareholders," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. Supported by strong TELLOMAK Phase 2 results, lacutamab is positioned for accelerated approval in Sézary syndrome once the confirmatory study in CTCL is underway. New real-world data showing a larger eligible CTCL population in the U.S. than previously reflected in public data further reinforce our commitment to advancing lacutamab for patients, with the confirmatory Phase 3 protocol nearing completion."

About Pierluigi Porcu, M.D.

Pierluigi Porcu, M.D. is the Ewa Marciniak Endowed Chair Professor and Division Chief for Hematology and Blood and Marrow Transplantation (Hem BMT) at the University of Kentucky College of Medicine, and Associate Director for Clinical Translation for the UK Lucille P. Markey Comprehensive Cancer Center. Dr. Porcu is an NCI-funded physician scientist and an internationally recognized expert in clinical and translational research in T-cell lymphoma. He is a former President of the United State Cutaneous Lymphoma Consortium (USCLC), and a member of the board of directors of the International Society of Cutaneous Lymphomas (ISCL). Dr. Porcu has served as global coordinating investigator or chair on numerous advisory boards and clinical trial steering committees.

Dr. Porcu earned his medical degree from the University of Torino in Italy and completed a residency in internal medicine and a fellowship in hematology-oncology at Indiana University in Indianapolis. From 1999 to 2015, he was a faculty in the Division of Hematology at The Ohio State University. From 2016 to 2025 he served as Professor and Division director of Hematologic malignancies and hematopoietic stem cell transplantation in the Department of Medical Oncology at Thomas Jefferson University in Philadelphia.

About lacutamab

Lacutamab is a first-in-class anti-KIR3DL2 antibody, developed in cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). CTCL is a group of rare non-Hodgkin lymphomas that develop in the skin and severely affect patients’ quality of life. Sezary syndrome (SS) is a rare and aggressive leukemic form with poor survival, while mycosis fungoides (MF) is the most common subtype, with advanced stages associated with poor outcomes.

Data from the Phase 2 TELLOMAK trial in CTCL demonstrated durable activity, a favorable safety profile, and improvements in patients’ quality of life. FDA provided encouraging initial feedback on Innate Pharma’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome.

The program has received Fast Track designation from the FDA, PRIME designation from the EMA for SS, and Orphan Drug designation in both the US and EU for CTCL. More recently, it has received Breakthrough Therapy Designation for SS.

A Phase 3 in CTCL is under preparation.

(Press release, Innate Pharma, OCT 14, 2025, View Source [SID1234656665])

On October 14, 2025 Iksuda Therapeutics (Iksuda), the developer of class-leading antibody drug conjugates (ADCs), reported it will present new data from its Phase 1 study of IKS014, a human epidermal growth factor receptor 2 (HER2) ADC, in patients with advanced HER2+ solid tumours, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Berlin, Germany (17-21 October).

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Poster Presentation details:

Abstract Title:

A Phase 1 Dose Escalation Trial of IKS014, a HER2-Targeting Antibody Drug Conjugate (ADC), in Participants with Advanced HER2+ Solid Tumors

Session Title:

Developmental Therapeutics

Date/Time:

19 October 2025/12:00-12:45 CET

Location:

Level 2, Hall 25

Poster Number:

936P

The Phase 1 study (NCT05872295) is a non-randomised, open-label, multicentre trial evaluating IKS014 in patients with locally advanced or metastatic solid tumours that express HER2. Data will be presented from the dose escalation portion of the trial conducted in Australia, which was designed to establish the Maximum-tolerated dose and/or Recommended Phase 2 Dose for IKS014 as monotherapy and to provide initial safety, tolerability, efficacy, PK, PD, and immunogenicity characteristics of the ADC.

About IKS014

IKS014 is a potential best-in-class antibody drug conjugate, benefiting from tumour selective activation and release of the cytotoxic agent monomethyl auristatin F (MMAF). In preclinical trials, it displayed impressive activity in high- and low-HER2 expressing tumours with a favourable Therapeutic Index compared with other HER2-directed drugs. Iksuda gained exclusive world-wide rights (excluding Greater China and South Korea) to IKS014 from LigaChem Biosciences (View Source).

(Press release, Iksuda Therapeutics, OCT 14, 2025, View Source [SID1234656664])

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])