On February 5, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported positive data in a year-end update from the ongoing Phase 2 clinical study evaluating AIM’s drug Ampligen (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the "DURIPANC" study) (see: ClinicalTrials.gov NCT05927142). This is a follow-up Phase 2 to a 57-subject early access program ("EAP") of Ampligen as a monotherapy in late-stage pancreatic cancer, where Ampligen was associated with median survival of 19.7 months, which is an extension of median overall survival of 8.6 months when compared to the standard of care. The EAP subjects also reported improved quality of life.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

AIM CEO Thomas K. Equels states: "We know all too well that metastatic pancreatic cancer is a killer. Ampligen has the potential to be a gamechanger in the treatment of this highly lethal and unmet oncological need. Quality of life for pancreatic cancer patients is extremely painful and subject to co-morbidities due to the tumor-induced immune suppressive state. Additionally, other metastatic pancreatic cancer chemotherapies and immunotherapies typically have harsh side effects. However, Erasmus has informed us that the pancreatic cancer patients who received Ampligen have reported meaningful improvements in their quality of life. This data sharply focuses our aim on late-stage pancreatic cancers, which killed more than 100,000 people in the American and European Union markets and more than 450,000 people worldwide as recently as 2022. I do not believe there is any other therapeutic in this stage of the pipeline that is producing these types of survival results combined with improvement in quality of life."

The DURIPANC study is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center ("Erasmus MC") in the Netherlands. The primary objective of the study is the clinical benefit rate of the combination therapy. The secondary/exploratory objectives include assessing overall survival (OS) and progression-free survival (PFS); exploring immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life.

Eighteen patients have been enrolled in the study. Lead investigator Marjolein Y. V. Homs, MD, PhD, Department of Medical Oncology, Erasmus MC Cancer Institute, emphasized that the promising Progression-Free Survival and Overall Survival seen in Phase 1 of the study – which supported advancement to the ongoing Phase 2 portion of the study – continue to be seen and that enrollment is ongoing. Erasmus MC expects that detailed data will be published later this year.

According to Erasmus MC, there has also been no significant toxicity – an encouraging safety profile for a post-chemo setting – and Ampligen subjects are consistently reporting "high quality of life" during treatment.

See: DURIPANC, Year-End Interim Clinical Progress Update

Prof. Casper van Eijck, MD, PhD, of Erasmus MC, states: "Erasmus MC clinicians and researchers are seeing immune system changes that suggest a coordinated activation of innate and adaptive responses – or, to put it more simply, the combination of Ampligen and Durvalumab seems to be enhancing the body’s natural immune system. This perceived mechanism of action together with the clinical results supports continued investigation of this combination in post-FOLFIRINOX patients with pancreatic ductal adenocarcinoma."

Additionally, AIM has published on its website an updated corporate presentation that emphasizes the Company’s priority goal of a new drug approval for Ampligen in the treatment of pancreatic cancer. The presentation details AIM’s research and development work in pancreatic cancer; how Ampligen is believed to work in the treatment of pancreatic cancer; and why AIM believes that pancreatic cancer research and development holds the most potential for AIM’s stockholders. The largest mergers and acquisitions deals in the biotech space often involve oncology drugs in Phase 3 clinical trials or later in development, and so AIM believes that moving Ampligen toward – and ultimately into – a Phase 3 clinical trial has great financial potential for the Company and its stockholders.

See: Ampligen Breakthroughs in Treating Late-Stage Pancreatic Cancer: Corporate Presentation – February 2026

AIM’s intellectual property portfolio includes a U.S. patent for Ampligen as an oncology treatment in combination with anti-PD-L1 therapies, similar to that seen in the DURIPANC clinical trial combining Ampligen and AstraZeneca’s durvalumab; this patent extends protection to August 9, 2039. AIM has also been awarded orphan drug designations in pancreatic cancer by both the United States and the European Union, granting years of market exclusivity to AIM for Ampligen post-commercial approval.

Equels adds: "This patent protection and the orphan drug designations’ market exclusivity have the potential to create great value for our stockholders in this large-market unmet medical need."

(Press release, AIM ImmunoTech, FEB 5, 2026, View Source [SID1234662499])

On February 5, 2026 K36 Therapeutics, Inc. ("K36"), a privately held clinical-stage biotechnology company developing novel targeted therapies for cancers with high unmet medical need, reported completion of dosing in the first patient cohort of its Phase 1 clinical trial evaluating KTX-2001, a first-in-class, orally administered, selective NSD2 inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC). This study marks the company’s second NSD2 inhibitor to enter the clinic.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase 1 clinical trial, STRIKE-001 (NCT07103018), is a multi-center, open-label dose escalation of KTX-2001 monotherapy (Part A) and in combination with darolutamide, an oral, nonsteroidal androgen receptor inhibitor (Part B).

"KTX-2001 is a first-in-class NSD2 inhibitor targeting a long-recognized epigenetic driver of prostate cancer biology," said Terry Connolly, Ph.D., President and Chief Executive Officer, K36 Therapeutics. "Despite recent therapeutic advances, many patients ultimately exhaust effective options. This trial introduces a novel epigenetic mechanism with the potential to open an entirely new treatment paradigm for men with advanced disease."

In parallel with advancing its lead clinical programs, K36 recently appointed Shinta Cheng, M.D., Ph.D., as Chief Medical Officer. Dr. Cheng brings more than 20 years of global oncology and hematology drug development experience, including leadership roles at SpringWorks Therapeutics, Johnson & Johnson, and Bristol Myers Squibb, with deep expertise in prostate cancer, including leading the development of apalutamide and niraparib.

"The advancement of KTX-2001 highlights both the urgent need for new therapies in advanced prostate cancer and the promise of a first-in-class NSD2-targeted approach. I am excited to have joined K36 Therapeutics at this pivotal moment as we advance KTX-2001, our second NSD2 inhibitor with potential across a broader range of solid tumors," said Dr. Cheng.

"Site activation is progressing ahead of schedule, with more than 75% of sites targeting activation by the end of the month and enrollment into subsequent cohorts underway. This early momentum reflects strong clinical interest in oral epigenetic modifier therapies for metastatic castration-resistant prostate cancer and underscores the urgent need for new treatment options for patients," said Jason Redman, M.D., Prostate Program Medical Director at K36 Therapeutics.

About the KTX-2001 Phase 1 Clinical Trial (STRIKE-001)
STRIKE-001 (NCT07103018) is a multi-center, open-label dose escalation evaluating KTX-2001 as a monotherapy (Part A) and in combination with darolutamide (Part B).

Part A is designed to evaluate the safety, tolerability, maximum tolerated dose, and recommended Phase 2 dose(s) of KTX-2001 monotherapy. Part B will evaluate the safety and tolerability of KTX-2001 plus darolutamide to determine the recommended Phase 2 dose(s) for the combination. Secondary objectives include assessments of pharmacokinetics, pharmacodynamics, and preliminary clinical activity. K36 expects to enroll approximately 140 patients with mCRPC who have received prior androgen receptor inhibitors and prior chemotherapy.

KTX-2001 is a small molecule, selective inhibitor of nuclear receptor binding SET domain protein 2 (NSD2, also known as multiple myeloma [MM] SET domain-containing protein [MMSET]/Wolf-Hirschhorn syndrome candidate 1 protein [WHSC1]). KTX-2001 inhibits NSD2-mediated methylation of histone H3 at lysine 36 (H3K36), disrupting aberrant NSD2-dependent oncogenic pathways.

(Press release, K36 Therapeutics, FEB 5, 2026, https://www.prnewswire.com/news-releases/k36-therapeutics-completes-dosing-of-first-cohort-in-phase-1-clinical-trial-of-ktx-2001-in-prostate-cancer-announces-new-cmo-302680429.html [SID1234662517])

On February 5, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company pioneering next-generation antibody drug conjugates (ADCs) powered by novel RNA-splicing payloads, reported that it will participate in the Corporate Connect Webinar Series hosted by Webull Financial being held virtually February 10-11, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As part of the presentation, Abizer Gaslightwala, Director, President and CEO of Akari Therapeutics, will provide a corporate overview highlighting the Company’s next-generation antibody drug conjugate platform and proprietary PH1 spliceosome-modulating payload. He will discuss Akari’s lead program, AKTX-101, a Trop2-targeting ADC designed to deliver PH1 directly to tumors with limited off-target effects, as well as ongoing IND-enabling activities targeting a first-in-human trial in late 2026 or early 2027. Mr. Gaslightwala will also provide a brief update on AKTX-102, an additional ADC program focused on GI and lung cancers.

Details of the presentation are as follows:
Date and Time: Tuesday, February 10, 2026 at 1:00 PM EST
Presenter: Abizer Gaslightwala, Director, President and CEO of Akari

(Press release, Akari Therapeutics, FEB 5, 2026, View Source [SID1234662500])

On February 5, 2026 PhotonPharma Inc., a biopharmaceutical company pioneering personalized cancer immunotherapies, reported that patient recruitment has opened for its Phase 1 clinical trial evaluating Innocell in patients with recurrent epithelial ovarian cancer. The trial for Innocell, the investigational product, is registered with ClinicalTrials.gov under identifier NCT06366490.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The clinical trial, being conducted in collaboration with City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States, with its National Medical Center ranked among the nation’s top cancer centers by U.S. News & World Report, represents a significant milestone in developing a novel therapeutic approach that harnesses patients’ own tumor cells to stimulate targeted immune responses against their cancer.

"We are excited to begin enrolling patients in this groundbreaking trial," said Raymond P. Goodrich, PhD, Chief Executive Officer and Chief Scientific Officer of PhotonPharma. "Innocell represents a fundamentally different approach to cancer immunotherapy, presenting the complete spectrum of tumor antigens to the immune system, potentially overcoming the challenge of tumor heterogeneity that limits the effectiveness of many existing treatments."

About the Clinical Trial

The Phase 1 study will assess the safety, tolerability, and immunogenicity of Innocell in patients with recurrent epithelial ovarian cancer. The trial is designed to evaluate real-time safety profiles and measure immunologic responses following treatment with the investigational autologous cellular immunotherapy.

Addressing a Critical Unmet Medical Need

Ovarian cancer represents a significant public health challenge, with approximately 20,000 new cases diagnosed annually in the United States and approximately 13,000 deaths per year. Approximately 70-80% of patients are diagnosed at Stage III or IV, and the five-year survival rate remains approximately 50%. Despite advances in surgical techniques and chemotherapy regimens, recurrence rates remain high, with approximately 50% of patients experiencing relapse within three to five years following initial treatment.

"Patients with recurrent ovarian cancer face limited curative treatment options. City of Hope is conducting translational research to address even the most challenging cancers," said Mihae Song, M.D., Assistant Professor, Division of Gynecologic Oncology, Department of Surgery at City of Hope and principal investigator for the trial. "PhotonPharma’s approach offers a promising new avenue that could potentially help these patients by activating their own immune systems to recognize and attack cancer cells."

The Innocell Technology Platform

Innocell is an autologous cellular immunotherapy that utilizes a proprietary photochemical inactivation process involving ultraviolet light and riboflavin (vitamin B2), the same technology platform originally developed for pathogen inactivation in blood products, currently used globally. This process renders tumor cells replication-incompetent while preserving their metabolic activity, and upregulating protein expression and antigen presentation capabilities.

The patented technology enables customized treatment within approximately one week at scale, significantly faster than many current autologous cell therapies. Following tumor harvest through surgery or biopsy, cells are treated with the photochemical inactivation process and combined with an adjuvant to enhance immune activation. The processed cells are then administered intradermally to stimulate comprehensive immune responses, including activation of both cellular (T-cell mediated) and humoral (antibody-mediated) immunity.

Trial Participation Information

Patients with recurrent epithelial ovarian cancer who are interested in learning more about participation in this clinical trial should contact City of Hope or visit ClinicalTrials.gov (NCT06366490) for detailed eligibility criteria and enrollment information. The study is seeking adult patients (≥18 years old) with recurrent epithelial ovarian cancer who have received at least 1 line of platinum-based systemic therapy and for whom single-agent therapy is appropriate as the next line of treatment.

(Press release, PhotonPharma, FEB 5, 2026, View Source [SID1234662518])

On February 5, 2026 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported that it will participate in two upcoming investor conferences in the first quarter of 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Citi’s 2026 Virtual Oncology Leadership Summit
Wednesday, February 18
9:15AM PT/12:15PM ET

TD Cowen 46th Annual Health Care Conference
Tuesday, March 3
8:50AM PT/11:50AM ET

Any available webcasts will be posted to the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following a live webcast, a replay will be available on the Company’s website for approximately 30 days.

(Press release, Allogene, FEB 5, 2026, View Source [SID1234662502])