On October 21, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH) reported FDA Orphan Drug Designation for HT-KIT and new preclinical data demonstrating >80% suppression of KIT expression and significant tumor-volume reduction by Day 8 in systemic mastocytosis and GIST models. HT-KIT, a precision antisense oligonucleotide (ASO) targeting KIT mRNA, also completed GLP-validated bioanalytical methods supporting IND-enabling studies; Japan Patent No. 7677628 extends platform protection to 2039.

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Preclinical Summary (2025):

Potent gene-level target suppression: HT-KIT achieved >80% reduction of KIT mRNA/protein across in-vitro systems and in vivo models of systemic mastocytosis and GIST.

Rapid anti-tumor activity: In xenograft models, statistically significant tumor-volume reduction by Day 8 was observed, accompanied by apoptotic signaling consistent with KIT pathway knock-down.

Favorable tolerability in early studies: No dose-limiting toxicities observed in the reported preclinical work to date.

Bioanalytical readiness: GLP-validated bioanalytical methods completed to support pharmacokinetic, biodistribution, and exposure-response analyses for IND.
Mechanistic Rationale:

Unlike small-molecule TKIs that inhibit kinase activity, HT-KIT operates upstream at the transcript level, silencing both mutant and wild-type KIT. This mechanism is designed to bypass resistance pathways (secondary mutations, compensatory signaling) and reduce off-target liabilities, potentially improving durability and tolerability in KIT-driven diseases such as aggressive systemic mastocytosis (ASM), SM-AHN, mast cell leukemia (MCL), GIST, and select leukemias.

Orphan Drug Designation (U.S.) supports development in a rare disease with incentives including potential exclusivity upon approval, tax credits, and fee waivers.
Planned Next Steps (Near-Term):

Complete GLP toxicology and CMC packages; submit IND.

Initiate Phase 1/2 dose-escalation/expansion study in advanced systemic mastocytosis and other KIT-driven tumors with translational biomarkers of target engagement (KIT knock-down, tryptase/MRK signaling) and early efficacy readouts (ORR, DCR, PFS signals).

Continue regional IP expansion and evaluate strategic partnerships for development and commercialization.
"HT-KIT’s transcript-level suppression of KIT has now produced consistent anti-tumor performance across models, with a clean preclinical tolerability profile and GLP-ready analytics," said Robb Knie, Chief Executive Officer. "With Orphan Drug Designation secured and an IND-enabling package progressing, we are preparing for a disciplined entry into first-in-human evaluation."

About HT-KIT:

HT-KIT is a precision ASO designed to silence KIT at the mRNA level, aiming to overcome resistance and off-target toxicity seen with kinase inhibitors in systemic mastocytosis, GIST, and select leukemias.

(Press release, Hoth Therapeutics, OCT 21, 2025, View Source [SID1234656883])

On October 21, 2025 Hanmi reported third quarter financial results for the year 2025 (Press release, Hanmi, OCT 21, 2025, View Source [SID1234661651]).

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On October 21, 2025 Median Technologies (FR0011049824, ALMDT, PEA-PME scheme eligible, "Median" or the "Company"), manufacturer of eyonis, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, reported the receipt of a €19 million payment under the first tranche of the financial agreement executed with the European Investment Bank (EIB) on July 11, 2025, which has a total value of up to €37.5 million.

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Fredrik Brag, CEO and Founder of Median Technologies, stated: "We have been collaborating with the European Investment Bank since 2019, and this long-standing partnership is continuing to deliver tangible results. The disbursement of the first €19 million tranche under the 2025 EIB financing facility will further accelerate the commercial launch and sales ramp-up of eyonis LCS, our AI-powered Software as a Medical Device for lung cancer screening, in both the U.S. and Europe and support the expansion of our eyonis suite towards other cancer indications. We have also proceeded with repayment of the first tranche of our 2019 loan from the EIB, which was undertaken on October 17, 2025.

After these two transactions and considering the €23.9 million capital increase successfully completed last August, our cash runway extends through Q4 2026—and potentially well beyond, assuming full exercise of the share warrants issued during the capital raise, which could generate an additional €51.7 million in cash. Consequently, Median is now financed beyond anticipated regulatory decisions in Q1 2026 for 510(k) clearance and CE marking, paving the way for the commercialization of eyonis LCS in both key markets."

As previously announced, the financial agreement with the EIB, consisting of a non-dilutive loan, provides funding in three tranches: €19 million (Tranche A), €8.5 million (Tranche B) and €10 million (Tranche C). Each of these tranches is subject to the completion of certain conditions precedent related to business performance, equity financing and issuance of warrants.

Tranche A has a maturity of six years, with a three-year grace period, and bears interest at 5%. Median has simultaneously issued 3,403,164 warrants, at an exercise price of €2.764, with a maturity of thirty years.

Median Technologies has proceeded with the repayment of €20.7 million on October 17, 2025, corresponding to the first tranche of its 2019 loan facility granted by the EIB. This tranche was drawn down in April 2020, with its maturity having been extended from April to October 2025.

(Press release, MEDIAN Technologies, OCT 21, 2025, View Source [SID1234656884])

On October 21, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ), (TSX: BCT) (" BriaCell " or the " Company "), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported a collaboration with Memorial Sloan Kettering Cancer Center’s (MSK’s) Therapeutics Accelerator Cohort program to accelerate the clinical development of Bria-OTS+, BriaCell’s next generation personalized off-the-shelf immunotherapy, for multiple cancer indications including metastatic breast cancer, prostate cancer, and other cancers.

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The collaboration starts with manufacturing, IND development and clinical protocol support for a Phase 1 clinical trial with Bria-BRES+, BriaCell’s next generation personalized immunotherapy for patients with breast cancer under the Bria-OTS+ platform. The partnership expands on BriaCell’s previously-announced selection into MSK’s accelerator program .

As one of the world’s foremost cancer research and treatment institutions, MSK has more than 135 years of leadership in patient care, education and discovery. Through the MSK Therapeutics Accelerator, MSK’s therapeutic-based strategic collaboration program, BriaCell will obtain access to MSK’s clinical and institutional expertise, including cell therapy manufacturing, Investigational New Drug (IND) preparation and submission and clinical development to expedite development of the Bria-OTS+ platform.

"We are thrilled to collaborate with MSK’s scientific and clinical experts to address the urgent unmet medical need of many thousands of metastatic breast cancer patients," stated Dr. William V. Williams, BriaCell’s President and CEO.

"We are honored to be working with the team of cancer specialists at MSK," noted Miguel Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer. "This collaboration with MSK will accelerate the development of our advanced personalized off-the-shelf immunotherapy platform, Bria-OTS+, which we believe has the potential to transform cancer care and significantly improve patients’ lives through its unique mechanism of action."

"We look forward to working with BriaCell through MSK’s Therapeutics Accelerator to help advance this next-generation personalized immunotherapy into the clinic. Collaborations like this are essential to translating promising scientific innovations into potential new treatment options for patients," commented Shanu Modi, MD, Breast Medical Oncologist and Attending Physician at MSK.

(Press release, BriaCell Therapeutics, OCT 21, 2025, View Source [SID1234656937])

On October 21, 2025 Iambic Therapeutics, a clinical-stage life science and technology company developing novel medicines using its AI-driven discovery and development platform, reported it has entered into a research collaboration and drug supply agreement with Jazz Pharmaceuticals. Under the agreement, Jazz will provide zanidatamab (Ziihera), a HER2-targeted bispecific antibody, at no cost to Iambic for evaluation in combination with IAM1363, Iambic’s brain-penetrant HER2 small-molecule tyrosine kinase inhibitor (TKI). The combination will be studied in patients with HER2-positive breast cancer that have previously been treated with trastuzumab deruxtecan (T-DXd; Enhertu).

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"We are enthusiastic to pair our potential best-in-class HER2 TKI, IAM1363, with zanidatamab, the leading HER2-targeted bispecific antibody," said Neil Josephson, M.D., Chief Medical Officer of Iambic. "Together, these agents represent a powerful new strategy with the potential to transform treatment for patients with advanced HER2-positive breast cancer whose disease has progressed following first- or second-line treatment."

As part of the Phase 1/1b IAM1363-01 study, Iambic will initiate a cohort in patients with HER2-positive breast cancer to evaluate IAM1363 in combination with zanidatamab and capecitabine.

Alongside the research collaboration announcement, Iambic has reported clinical data for IAM1363 monotherapy at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) annual meeting in Berlin, showing anti-tumor activity, safety, and tolerability. The IAM1363 clinical data show activity in patients with HER2-mutant NSCLC and HER2-positive breast and gastric cancers, as well as indications lacking approved HER2-directed TKIs or antibodies, such as HER2-mutant renal cell cancer and HER2-amplified NSCLC and ovarian cancer. IAM1363 was specifically engineered to overcome the limitations of current HER2-directed therapies, demonstrating >5,000-fold selectivity for HER2 over EGFR, ten-fold greater CNS penetration than approved TKIs, and broad activity against both wild-type and mutant HER2.

Iambic’s Phase 1/1b trial, NCT06253871, is an open-label, multi-center, dose escalation and dose optimization study, designed to evaluate tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of IAM1363 in patients with advanced HER2 cancers. The study, which has multiple sites in the U.S., recently opened in the EU and will continue to expand into additional sites across the U.S. and EU and into the UK and APAC in Q4 2025.

(Press release, Iambic Therapeutics, OCT 21, 2025, View Source [SID1234656885])