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AdvanCell’s 212Pb-ADVC001 demonstrates encouraging safety and compelling anti-tumor activity in Phase 1b in prostate cancer

On October 21, 2025 AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, reported results from the Phase 1b dose escalation of the TheraPb Phase 1/2 clinical trial (NCT05720130) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 congress. The presentation featured the first clinical results of 212Pb-ADVC001, a novel Lead-212-based PSMA-targeted alpha therapy in mCRPC.

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"We are very encouraged by the completion of the treatment period of our Phase 1 trial, which has demonstrated a favorable safety profile and compelling anti-tumor activity for 212Pb-ADVC001," said Anna Karmann, MD PhD, Chief Medical Officer of AdvanCell. "These results underscore the potential of our therapy to meaningfully impact patients’ lives and advance treatment options in metastatic prostate cancer. I want to sincerely thank the investigators, clinical teams, and most importantly the patients and their families, whose commitment has made this important milestone possible."

"The TheraPb Phase 1 trial of 212Pb-ADVC001 marks a pivotal step forward in the evolution of PSMA-targeted radioligand therapy," said Aaron Hansen, MD, Principal Investigator at Princess Alexandra Hospital. "We’ve observed a compelling therapeutic index, including marked reductions in tumor volume and PSA, alongside a promising safety and dosimetry profile. The ability to administer alpha therapy easily and efficiently in an outpatient setting is a major clinical advantage. I am excited about the potential of 212Pb-ADVC001 to redefine treatment for patients with prostate cancer."

Oliver Sartor, MD, Director of the Transformational Prostate Cancer Research Center at East Jefferson General Hospital, remarked, "The results from this Phase 1 trial demonstrate a strong efficacy signal combined with an excellent safety profile. This is an extremely promising step forward in delivering targeted alpha therapy to patients with prostate cancer."

The abstract submitted to ESMO (Free ESMO Whitepaper) was based on a data cut-off as of May 9, 2025. The presentation at ESMO (Free ESMO Whitepaper) includes updated safety and efficacy data from all seven treatment cohorts as of an October 2, 2025 cut-off.

The TheraPb Phase 1b dose escalation study enrolled 22 patients with mCRPC. Escalating doses of 60–200 MBq of 212Pb-ADVC001 were administered at prespecified schedules every 6, 4, 2 and 1 week(s) for up to six cycles. After cohort 1, six subsequent treatment cohorts were enrolled within ten months.

TheraPb Phase 1b dose escalation results as of October 2, 2025 cut-off:

Encouraging safety and tolerability

No dose-limiting toxicities, treatment-related serious adverse events or treatment-related adverse events leading to dose modification or treatment discontinuation
Xerostomia predominantly Grade 1, with evidence of reversibility
Promising anti-tumor activity

80% PSA50 biochemical response at therapeutic doses ≥ 160 MBq
100% ORR in patients with RECIST-measurable lesions, including two CRs
PSA, imaging and clinical responses within weeks of treatment start
Favorable dosimetry and kinetics

Low normal-organ radiation exposure that supports a dosing strategy beyond six cycles and enhanced dose intensity
Fast clearance and no relevant metabolic breakdown
The data represent the first clinical trial results of a 212Pb-based PSMA therapy. The findings support the further development of 212Pb-ADVC001 and may offer a new reference point in the treatment landscape for metastatic prostate cancer, both within and beyond the PSMA-targeted class.

Phase 2 expansion will evaluate 160 MBq and 200 MBq of 212Pb-ADVC001 using a randomized multi-dose-response design and adaptive dosing strategies to optimize clinical outcomes in three indications: mCRPC (chemo-naïve, and post-177Lu-PSMA) and mHSPC.

The poster presentation is available on AdvanCell’s website at: AdvanCell ESMO (Free ESMO Whitepaper) 2025 Poster.

(Press release, Advancell, OCT 21, 2025, View Source [SID1234656886])

Iambic Announces Research Collaboration with Jazz Pharmaceuticals for IAM1363 and Zanidatamab Combination Cohort in HER2-Positive Breast Cancer

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).

"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])

Median Technologies Receives €19 Million From the European Investment Bank, Corresponding to the First Tranche Under the 2025 Loan Facility

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.

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])

Hoth Therapeutics Reports FDA Orphan Drug Designation and Strong Preclinical Data for HT-KIT in Rare c-KIT-Driven Cancers

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.

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])

HanchorBio Secures US Patent for Innovative SIRPα/CD47 Fusion Protein HCB101

On October 21, 2025 HanchorBio reported that its proprietary HCB101, a SIRPα/CD47 fusion protein candidate, has been officially granted a US patent (Patent No. 12,447,195) by the United States Patent and Trademark Office (USPTO). Titled "ENGINEERED SIRPα VARIANTS AND METHODS OF USE THEREOF", the patent represents major international recognition for the company’s innovative technology for immuno-oncology.

Mechanism of Action and Novelty of HCB101: An Innovative Fusion Protein Design

Developed using HanchorBio’s proprietary FBDB (Fc-Based Designed Biologics) platform, HCB101 is an engineered SIRPα/CD47 fusion protein designed to precisely modulate the immune system’s recognition and phagocytic functions, effectively overcoming the challenge of tumor immune evasion and enhancing the clearance of cancer cells.

The molecule employs an engineered variant strategy, featuring novel amino acid substitutions at previously unclaimed and undisclosed SIRPα sites.
These innovative structural mutations significantly enhance the binding affinity and functional potency of HCB101 toward CD47 expressed on tumor cells, thereby reactivating macrophage-mediated cancer cell killing while minimizing the hematologic toxicities commonly associated with traditional CD47 monoclonal antibody therapies.

The USPTO recognized HCB101’s original mutation design and unprecedented potency as clear evidence of novelty and inventive step, distinguishing it from prior technologies and enabling the molecule to successfully pass the rigorous US patent examination process.

In addition to robust intellectual property protection, the patent also strengthens HanchorBio’s position for licensing negotiations and strategic collaborations, further enhancing its global partnership and value creation potential.

Dr. Scott Liu, Chairman of HanchorBio, commented: "The US patent grant for HCB101 is a testament to HanchorBio’s robust R&D capabilities in immunotherapy, while also illustrating the heights of innovation that Taiwan’s biotech industry is capable of reaching. Backed by a solid IP position, we are committed to further expanding global collaboration."

Why the United States: A Strategic and Symbolic First Step

HanchorBio strategically selected the United States as the first jurisdiction for patent filing and issuance, recognizing it as the world’s most influential and standard-bearing market for biopharmaceutical innovation and licensing. US patent approval often serves as a benchmark for patent examiners in other countries, amplifying both credibility and momentum for subsequent filings.

For the filing, HanchorBio worked with Fish & Richardson, one of the largest and most respected intellectual property law firms in the US. The successful approval of HCB101’s US patent demonstrates the molecule’s technical originality and therapeutic advancement, paving the way for accelerated future examinations in Europe and multiple Asian territories.

Dr. Wenwu Zhai, Chief Scientific Officer of HanchorBio, remarked:
"We prioritized the US market as the foundation of our IP strategy, as its market scale and influence align closely with our long-term growth objectives. Building on this milestone, we will further build a comprehensive global IP protection network."

Global Patent Strategy: Strengthening Licensing and Partnerships

Following this US patent grant, HanchorBio will advance patent filings across Europe, Taiwan, and other Asian countries as part of its broader global IP roadmap.
This strategy aims to consolidate the company’s leadership in immuno-oncology and fusion protein drug development, while significantly enhancing its negotiating power for international licensing and co-development opportunities.

The HCB101 patent represents not only a technological milestone but also a pivotal step in HanchorBio’s journey toward global market expansion.

(Press release, Hanchor Bio, OCT 21, 2025, View Source [SID1234656882])