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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.

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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])

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])

Atossa Therapeutics Highlights Progress in RECAST™ DCIS Platform Trial at Early Detection Research Conference; Laura Esserman, MD, MBA, to Discuss Active-Surveillance Strategy and Novel Endocrine Agents

On October 21, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines in oncology, reported that Laura J. Esserman, MD, MBA, Professor of Surgery and Radiology at the University of California, San Francisco and Principal Investigator of RECAST, will speak at the Early Detection Research Conference in Portland, OR, about the Company’s collaborative work in the RECAST platform trial for ductal carcinoma in situ (DCIS), a biologically heterogeneous, non-invasive breast condition that can progress to invasive breast cancer in a subset of patients.

RECAST is a multi-arm, Phase 2, randomized, neoadjuvant platform trial designed to identify which patients with hormone receptor–positive DCIS are best suited for active surveillance and to determine whether novel endocrine therapies can expand the population that can safely avoid surgery. The trial includes arms evaluating standard therapy (tamoxifen or aromatase inhibitor) as well as novel agents: (Z)-Endoxifen, elacestrant, and Hav-088. Efficacy is assessed with mammography and breast MRI, alongside biomarker discovery and quality-of-life endpoints. Enrollment began in January 2024; 50 patients have been enrolled toward a target of 400 across 17 activated clinical sites, with additional sites planned.

Why this matters for investors

Large, under-served market: DCIS is commonly treated like invasive cancer (surgery ± radiation ± endocrine therapy). Demonstrating that a biomarker-guided, non-surgical approach is safe and effective could reshape standard of care and expand use of oral endocrine agents in early-stage disease management.
Efficient signal-finding: The platform design enables parallel testing of multiple agents, including Atossa’s (Z)-Endoxifen, with common imaging and biomarker endpoints to generate comparative signals that can inform registration strategies.
Multiple potential catalysts: Early imaging response, biomarker correlation, and active-surveillance suitability rates by arm create interim readout opportunities that can de-risk later-stage programs and guide payer-relevant health-economic modeling.
Strategic collaborations: RECAST is sponsored by Quantum Leap Healthcare Collaborative with research support from NIH and industry partners. This shared-infrastructure model can accelerate enrollment, broaden site access, and optimize capital efficiency.
"RECAST is purpose-built to answer the question that payers, physicians, and patients care most about: who truly needs surgery and who does not," said Steven Quay, MD, PhD, Chairman and CEO of Atossa Therapeutics. "For Atossa, the trial offers a capital-efficient path to demonstrate the potential of (Z)-Endoxifen in a large early-disease setting, generate decision-grade biomarkers, and position us for value-creating milestones over the coming quarters."

RECAST Trial Objectives

Increase the fraction of DCIS patients suitable for long-term active surveillance using novel endocrine therapy.
Correlate risk of progression to invasive ductal carcinoma with risk categorization after six months of therapy.
Identify biomarkers that predict response and elucidate mechanisms of imaging response and resistance.
Assess quality of life compared with standard endocrine therapy.
Current Trial Status

Phase: 2 (platform)
Population: HR-positive DCIS (any grade)
Arms: Tamoxifen/AI (control), (Z)-Endoxifen, elacestrant, Hav-088
Assessments: Mammogram, MRI, biomarker panels, QoL
Enrollment: 50/400; 17 active U.S. sites; additional site activations planned.

(Press release, Atossa Therapeutics, OCT 21, 2025, View Source [SID1234656881])

Breakthrough clinical trial confirms that GammaTile delivers superior tumor control compared to standard of care for patients with newly diagnosed operable brain metastases

On October 21, 2025 GT Medical Technologies, a company focused on improving the lives of patients with brain tumors, reported the interim results from its ROADS clinical trial (Randomized Controlled Trial of Resection [Surgery] and GammaTile versus Standard of Care) in patients with operable, newly diagnosed brain metastases.1

The trial, which completed randomization of 230 patients over 30 leading cancer centers in the United States in August 2025, evaluated whether implanting GammaTile – a form of brain tumor radiation that begins immediately at the time of surgery, with no waiting or time lost – could improve outcomes compared with the current standard of care (surgery followed by postoperative external beam stereotactic radiation therapy [SRT]). The standard approach requires a recovery period before radiation can begin, during which remaining microscopic tumor cells may regrow.

The trial was led by Dr. Thomas Beckham, Assistant Professor, Department of Radiation Oncology, Division of Radiation Oncology, and Dr. Jeffrey Weinberg, Professor of Neurosurgery, Deputy Chair and Vice-Chair of Clinical Operations in The Department of Neurosurgery at The University of Texas MD Anderson Cancer Center. The interim data, presented at the 2025 Congress of Neurological Surgeons by Dr. Weinberg, shows significant and durable improvements in reducing tumor recurrence and increasing surgical bed recurrence-free survival (time to tumor recurrence or death) with GammaTile.

Key Interim Findings

A pre-planned interim analysis was conducted with 168 enrolled patients:1*

GammaTile showed superiority in the primary endpoint of the study. Patients who received GammaTile lived longer without tumor regrowth, and there was a greater than 50% reduction in risk of either tumor recurrence or death compared to standard of care [SRT] (hazard ratio 0.42, p=0.0024).
GammaTile showed superiority in overall protection from worrisome radiographic brain changes (either tumor recurrence or radiation-related tissue damage). At the time of analysis, more than half of GammaTile patients remained free from both tumor regrowth and radiation-related tissue damage, while in the SRT group, more than half of patients had already experienced one of these events by 16 months (hazard ratio of 0.32, p=0.018).
GammaTile demonstrated significant gains in efficacy with no increase in safety concerns. Rates of treatment-related side effects remained low and comparable between both groups proving GammaTile delivers superior outcomes without added risk.
"The interim data from the ROADS trial is the first randomized, multicenter evidence showing the superiority of starting radiation immediately at the time of tumor removal with GammaTile for operable brain metastases," says Michael Garcia, MD, MS, Chief Medical Officer at GT Medical Technologies. "These results highlight the importance of immediate, targeted radiation therapy."

"Although the ROADS trial focused on patients with operable brain metastases, the study reflects real-world treatment patterns, where many patients have a large metastasis that needs surgery and small brain metastases that can be well managed with stereotactic radiation without removal," said Weinberg. "In such cases, patients randomized to the GammaTile arm received GammaTile radiation for the operable tumor and stereotactic radiation for the small metastases. These interim results suggest that this approach not only achieves local control but does so with superiority over the existing standard of care. My colleague, Dr. Beckham, and I agree this evidence may redefine how we treat this disease."

The Brain Metastases Challenge

Brain metastases affect up to 40% of all cancer patients and significantly impact survival and quality of life.2 For patients with operable tumors, surgery followed by external beam stereotactic radiation has been the standard of care, yet its limitations are well recognized, with a 1-year tumor recurrence rate of 28%.3 In addition, up to one third of patients miss or delay postoperative radiation due to access barriers, fragmented care pathways, or logistical challenges.4 These treatment gaps leave patients vulnerable to recurrence, decline in brain function, and added burden for families.

GammaTile is designed to overcome these shortcomings by delivering immediate, targeted, and continuous radiation directly into the surgical cavity at the time of tumor removal.5 This ensures that radiation therapy begins when microscopic cancer cells are the most vulnerable—immediately after surgery, at the lowest point of tumor burden—and guarantees that every patient receives radiation treatment. By closing the treatment gap, GammaTile provides more durable tumor control, reduces recurrence risk, and streamlines the care journey for patients.1 Importantly, GammaTile also gives patients and clinicians peace of mind that treatment has started right at tumor removal.

"We are deeply encouraged by these results," said Per Langoe, Chief Executive Officer of GT Medical Technologies. "By providing immediate radiation when and where it is needed most, GammaTile is showing the potential to transform outcomes for patients with operable brain tumors."

(Press release, GT Medical Technologies, OCT 21, 2025, View Source [SID1234656880])