On February 24, 2026 K36 Therapeutics, Inc. ("K36"), a privately held, clinical-stage biotechnology company developing novel targeted therapies for cancers with high unmet medical need, reported data from its Phase 1 clinical trial of KTX-2001 will be presented in a Trial in Progress poster at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium, taking place February 26–28, 2026, in San Francisco, California. KTX-2001 is a first-in-class, orally administered, selective NSD2 inhibitor being evaluated in patients with metastatic castration-resistant prostate cancer (mCRPC) and represents the company’s second NSD2 inhibitor to enter clinical development.

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The KTX-2001 Trial in Progress poster will highlight the scientific rationale, study design, patient population, and dose-escalation study of the first-in-human Phase 1 STRIKE-001 trial. 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.

"We are pleased to present the STRIKE-001 study design evaluating KTX-2001, an oral, first-in-class NSD2/MMSET inhibitor, in metastatic castration-resistant prostate cancer," said Wassim Abida, MD, PhD, of Memorial Sloan Kettering Cancer Center. "Preclinical findings support the rationale for targeting NSD2 in prostate cancer, where it has been associated with lineage plasticity, resistance to androgen receptor pathway inhibitors, and progression to treatment-emergent neuroendocrine disease. STRIKE-001 is designed to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of KTX-2001 as monotherapy and in combination with darolutamide in this setting."

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).

ASCO Genitourinary Cancers Symposium, February 26–28, 2026
Trial in Progress Poster Details:

Title: Phase 1, dose-escalation study of KTX-2001 (an NSD2 inhibitor) alone and in combination with darolutamide for metastatic castration-resistant prostate cancer
Abstract Number: TPS276
Poster Number: N12
Session Title: Trials in Progress Poster Session A: Prostate Cancer
Presentation Time: February 26, 2026, 11:30 AM-12:45 PM; 5:45 PM-6:45 PM (PST)
Location -Moscone Center (West), San Francisco
Full abstract can be found at ASCO (Free ASCO Whitepaper) GU Meeting Website: View Source

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). 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 dimethylation of histone H3 at lysine 36 (H3K36me2), disrupting aberrant NSD2-dependent oncogenic pathways.

(Press release, K36 Therapeutics, FEB 24, 2026, View Source [SID1234662947])

On February 24, 2026 AtomVie Global Radiopharma (AtomVie), a global leading radiopharmaceutical CDMO, reported that it has supplied the successful dosing of the first patient in Radiopharm Theranostics’ First-in-Human Phase 1/2a clinical study of 177Lu‑BetaBart (RV‑01) by providing GMP manufacturing and distribution services for the radiotherapeutic drug product, after successfully developing and qualifying the radiolabeling process and analytical methods using a phase-appropriate approach that expedited IND filing.

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The Phase 1/2a clinical study is designed as a dose-escalation and expansion trial evaluating the safety, biodistribution, radiation dosimetry, and preliminary anti-tumor activity of 177Lu‑BetaBart, while also determining the recommended dose for future studies. 177Lu-BetaBart (RV‑01) is a 177Lutetium‑conjugated monoclonal antibody engineered to target the 4Ig isoform of B7‑H3, an immune checkpoint molecule overexpressed across multiple solid tumor types.

"Enabling the first patient dose of 177Lu-BetaBart reflects what matters most to us, ensuring that high‑quality radiopharmaceuticals are manufactured, released, and delivered on time so patients can access innovative therapies without delay," said Bruno Paquin, Chief Executive Officer of AtomVie. "Our team is deeply focused on operational excellence and reliability, supporting our partners from early clinical development through global supply."

"Dosing the first patient in the Phase 1/2a clinical study of 177Lu‑BetaBart represents an important milestone for Radiopharm Theranostics," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "We appreciate AtomVie’s manufacturing expertise and commitment to quality as we advance BetaBart for patients with aggressive and difficult‑to‑treat solid tumors."

About BetaBart (RV-01)

RV-01 is the first radiopharmaceutical therapeutic agent developed by Radiopharm Ventures, the Joint Venture formed between Radiopharm Theranostics and The University of Texas MD Anderson Cancer Center. 177Lu-BetaBart is a 177Lutetium-conjugated therapeutic that targets B7-H3, an immune checkpoint molecule that is overexpressed in several tumor types. Multiple preclinical studies with BetaBart have shown tumor shrinkage and prolonged survival in animals treated with the radiotherapeutic agent.

About the Phase 1/2a Clinical Trial

The FIH Phase 1/2a study (NCT07189871) is designed to establish the safety profile, biodistribution, pharmacokinetics, and radiation dosimetry of 177Lu-Betabart . The study aims to enroll 61 eligible participants who have a documented history of histopathologically confirmed castrate resistant prostate cancer, colorectal cancer, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell cancer, ovarian cancer, cervical cancer, endometrial cancer, triple negative breast cancer, or esophageal squamous cell carcinoma.

(Press release, Radiopharm Theranostics, FEB 24, 2026, View Source [SID1234662946])

On February 24, 2026 Hoth Therapeutics, Inc. (NASDAQ: HOTH) reported a significant expansion of its CLEER-001 Phase 2a clinical trial with the addition of Regis Clinical Research as a new enrolling site. Located in Miami, Florida, Regis joins the growing CLEER-001 investigational site network as surging patient demand outpaces capacity at existing sites — a direct reflection of the compelling early clinical results HT-001 has produced and the desperate unmet need it addresses.

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For the estimated 200,000 Americans who begin EGFR Inhibitor cancer therapy each year, the skin toxicities that accompany treatment are not a minor inconvenience. They are severe, often disfiguring rashes, lesions, and unrelenting itch that force up to one-third of patients to reduce or discontinue the chemotherapy keeping them alive. Today, those patients have no FDA-approved treatment option. HT-001 is designed to change that — and the data so far suggests it can.

Positive Signal

The interim CLEER-001 data is generating physician and patient interest that drives enrollment expansions like today’s announcement:

100% of open-label cohort patients achieved the primary efficacy endpoint — an ARIGA rash severity score of ≤1 — by week six
Zero patients required dose reduction or discontinuation of their life-saving EGFRi cancer therapy while on HT-001
Over 65% of patients reported meaningful reductions in pain and itching
Zero dose-limiting toxicities observed across the entire trial to date
At the American Academy of Dermatology Annual Meeting, a case study demonstrated complete lesion and symptom resolution after just one week of twice-daily application in a metastatic breast cancer patient
For a patient population that currently has no targeted treatment, results like these represent a potential paradigm shift in how oncologists can manage one of the most common and quality-of-life-destroying side effects in all of cancer care.

A New Site, A New Market, A Growing Network

Regis Clinical Research brings IRB-approved, FDA-compliant research infrastructure and a new South Florida patient population to the CLEER-001 network. For Hoth, it means faster enrollment, a faster path to a complete data set, and a faster road to the regulatory milestones that matter.

"The addition of Regis Clinical Research is a direct response to the acceleration we are seeing in enrollment demand," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "The data speaks for itself. Patients and oncologists are taking notice — and we are building the infrastructure to meet that demand and deliver the full clinical readout this program deserves."

Patients and referring physicians may visit regisclinical.com or call +1 (305) 546-3952 to learn more about participation in the CLEER-001 trial.

(Press release, Hoth Therapeutics, FEB 24, 2026, View Source [SID1234662945])

On February 24, 2026 Nektar Therapeutics (Nasdaq: NKTR) reported that company management will be participating in the TD Cowen 46th Annual Health Care Conference taking place March 2-4, 2026 in Boston and the 2026 Jefferies Biotech on the Beach Summit taking place March 9-11, 2026 in Miami.

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TD Cowen 46th Annual Health Care Conference in Boston on Wednesday, March 4, 2026 – webcast of the presentation to be available at 9:10 a.m. Eastern Time / 6:10 a.m. Pacific Time – link here
2026 Jefferies Biotech on the Beach Summit in Miami – March 9-11, 2026 – company management to be available for one-on-one meetings
The presentation will be accessible via the webcast link above as well as on the Investor Events section of the Nektar website: View Source A replay of the presentation will be available for 30 days.

If you would like to request a one-on-one meeting with company management during the conferences, please reach out to your respective representative.

(Press release, Nektar Therapeutics, FEB 24, 2026, View Source [SID1234662944])

On February 24, 2026 AbbVie (NYSE: ABBV) reported it will participate in the TD Cowen 46th Annual Health Care Conference on Tuesday, March 3, 2026. Management will participate in a fireside chat at 10:10 a.m. Central Time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

(Press release, AbbVie, FEB 24, 2026, View Source [SID1234662943])