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.

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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.

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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.

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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.

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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])

On February 5, 2026 HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company pioneering transformative immunotherapies, reported a robust schedule of scientific presentations at major international oncology congresses throughout Q1 2026. The selection of multiple abstracts, including four high-profile oral presentations, underscores the clinical maturity and global scientific recognition of HanchorBio’s proprietary pipeline.

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The upcoming presentations will feature clinical data from the Company’s lead programs, including the HCB101-101 Phase 1 monotherapy (NCT05892718) and the HCB101-201 Phase 1b/2a combination (NCT06771622) studies, as well as the HCB301-101 Phase 1 monotherapy (NCT06487624) study, highlighting the therapeutic potential of its CD47-SIRPα innate immune backbone and multi-functional biologics:

HCB101: A highly engineered SIRPα–IgG4 Fc-fusion protein designed to maximize phagocytosis while minimizing hematologic toxicities.
HCB301: A first-in-class multi-specific candidate targeting the CD47/SIRPα, PD-1/PD-L1, and TGFb pathways to overcome the immunosuppressive tumor microenvironment (TME).
"The concentration of oral and poster presentations at premier global forums like AACR (Free AACR Whitepaper)-IO and ESMO (Free ESMO Whitepaper)-TAT reflects the significant momentum of our clinical programs," said Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio. "By presenting data on both HCB101 and HCB301, we are demonstrating our ability to execute our complex, multi-center trials and our commitment to delivering next-generation innate immune checkpoint therapies to patients globally."

Q1 2026 Global Scientific Calendar

Following the successful presentation of the high objective response rate with HCB101 combination in second-line gastric cancer from the HCB101-201 Phase 1b/2a combination study at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January, HanchorBio continues its aggressive clinical disclosure schedule with the following upcoming presentations:

Status

Conference

Location

Date

Presentation

Completed

ASCO GI Cancers Symposium

San Francisco, USA

Jan 08-10

1 Poster

Upcoming

AACR Immuno-Oncology

Los Angeles, USA

Feb 18-21

2 Posters

Upcoming

Asia-Pacific GI Cancer Congress

Okinawa, Japan

Mar 05-06

1 Poster

Upcoming

ESMO Targeted Anticancer Therapies

Paris, France

Mar 16-18

2 Orals, 1 Poster

Upcoming

ESMO Head and Neck Congress

Seville, Spain

Mar 19-21

1 Oral

Upcoming

World Oncology Congress

Paris, France

Mar 23-25

1 Oral

About HCB101: A Next-Generation SIRPα Fc-Fusion Protein

HCB101 is a rationally engineered SIRPα–IgG4 Fc fusion protein developed on HanchorBio’s FBDB platform to selectively block the CD47–SIRPα innate immune checkpoint while minimizing hematologic toxicity. Unlike earlier anti-CD47 approaches, HCB101 is designed to preserve macrophage-mediated antitumor activity while reducing binding to red blood cells, a limitation that historically constrained the clinical utility of CD47-directed therapies.

HCB101 was engineered using AI-assisted structural modeling to achieve differentiated binding to CD47 on cancer cells while maintaining low affinity for CD47 on red blood cells. Its safety profile, receptor occupancy characteristics, and pharmacologic properties are designed to support integration with established oncology regimens without disrupting standard dosing, safety expectations, or clinical workflows. Across ongoing clinical and translational evaluation, HCB101 has demonstrated consistent target engagement and early antitumor activity as both monotherapy and in combination settings, including tumor types historically considered challenging for CD47-directed therapies.

Together, these attributes position HCB101 as a differentiated innate immune checkpoint backbone with broad potential for a wide variety of combination strategies across solid tumors and hematologic malignancies.

About HCB301: A Tri-Specific Checkpoint Immunotherapy

HCB301 is HanchorBio’s next-generation immunotherapy designed to integrate three synergistic mechanisms into a single molecule: CD47-SIRPα blockade to activate myeloid phagocytosis, PD-1 inhibition to restore exhausted T cells, and TGF-b pathway suppression to counteract immune evasion. Developed using the proprietary FBDB platform, HCB301 represents a next-generation approach to multi-checkpoint immunotherapy. Preclinical studies demonstrated enhanced immune activation and potent antitumor activity, and the results were presented at the SITC (Free SITC Whitepaper) 2025.

(Press release, Hanchor Bio, FEB 5, 2026, View Source [SID1234662519])