On October 20, 2025 Iksuda Therapeutics (Iksuda), the developer of class leading, antibody drug conjugates (ADCs), reported the presentation of new data from its Phase 1 study of IKS014, a human epidermal growth factor receptor 2 (HER2)-directed ADC, in patients with advanced HER2+ solid tumours. The data was presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Berlin, Germany.

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The Phase 1 study (NCT05872295) is a non-randomised, open-label, multicentre trial evaluating IKS014 in patients with locally advanced or metastatic solid tumours that express HER2. Part I, the dose escalation portion, is being conducted in sites in Australia and is designed to establish the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) for IKS014 and provide initial safety, tolerability, efficacy, pharmacokinetic, pharmacodynamic and immunogenicity characteristics. Part II dose expansion studies will assess IKS014 in HER2+ breast cancer in patients who have previously received Enhertu, HER2-low breast cancer, HER2+-gastric/ GEJ cancers and other HER2+ tumours and mutated HER2-NSCLC. Dose expansion studies will be conducted in sites in the US, Australia, New Zealand and Singapore.

At the data cut-off date (31 July 2025), a total of 62 patients were enrolled in the study, with 55 patients evaluable for efficacy as measured by Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Anti-tumour activity was observed across all dose levels, with partial responses and unconfirmed partial responses observed in various tumour indications including breast, lung, oesophageal, ovarian, gastric, gallbladder and gastroesophageal junction cancers and in both HER2+ and HER2-low tumours.

Amongst 11 participants with breast cancer treated at doses >90mg/m2, seven responses were seen (objective response rate (ORR) 64%), including partial responses in all four patients with HER2+ disease. Three of these patients had previously received Enhertu. Additionally, amongst 10 patients with pre-treated, HER2+ oesophageal cancer that were enrolled across all dose levels, five achieved a response, including complete regression in one patient with non-measurable disease.

Treatment with IKS014 was generally well-tolerated at doses up to 120mg/m2 (~3.2 mg/kg), with anticipated adverse events including ocular surface AEs, pneumonitis and hypokalaemia, all of which were predominately Grade 1 and Grade 2.

An MTD was not reached per the study protocol. Dose selection for further evaluation in the expansion cohorts will be based on preliminary activity, safety, pharmacokinetic, pharmacodynamic profile and overall benefit-risk assessment from the dose escalation. The Phase 1 trial is expected to complete in H2 2026.

This data follows positive data from Phase 1 clinical trials through Fosun Pharma, which is now progressing FS-1502 (IKS014) through Phase 3 trials in China.1

Dr. Dave Simpson, Chief Executive Officer, Iksuda Therapeutics, commented: "We are hugely encouraged by these data, which illustrates the potential of IKS014 to improve outcomes and address the clinical unmet need across various HER-2 positive cancers, including treatment of those patients which are refractory to prior therapy options."

About IKS014

IKS014 is a potential best-in-class antibody drug conjugate, benefiting from tumour selective activation and release of the cytotoxic agent monomethyl auristatin F (MMAF). In preclinical trials, it displayed impressive activity in high- and low-HER2 expressing tumours with a favourable Therapeutic Index compared with other HER2-directed drugs. Iksuda gained exclusive world-wide rights (excluding Greater China and South Korea) to IKS014 from LigaChem Biosciences (View Source).

(Press release, Iksuda Therapeutics, OCT 20, 2025, View Source [SID1234656850])

On October 20, 2025 Redhill Biopharma, a specialty biopharmaceutical company, reported the signing of a strategic partnership with Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) ("Cumberland"), a specialty pharmaceuticals company with a strong gastrointestinal market presence, whereby Cumberland will invest $4 million for a 30% ownership stake in RedHill’s global Talicia business. The companies will share in the financial performance and operational support for the Talicia brand with RedHill retaining 70% ownership and joint control. All other aspects of RedHill’s business remain unchanged.

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RedHill and Cumberland have also entered into a U.S. Talicia co-commercialization agreement with an equal sharing of the product’s net revenues. Cumberland commits to significant additional investment to support Talicia’s U.S. business, providing the strength of its national sales force to feature and further enhance the brand’s marketing and promotional activities. The partnership is designed to deliver economies of scale and cost reductions through shared responsibility for Talicia’s U.S. sales, marketing, manufacturing, supply, regulatory and administrative operations.

"This strategic partnership provides an excellent growth opportunity for RedHill and for Cumberland, a highly capable and driven partner with a strong gastroenterology market presence, adding a market-leading approved product to its portfolio. We believe Cumberland can help drive prescriptions and deliver revenue growth, further strengthening Talicia’s U.S. market leadership," said Dror Ben-Asher, RedHill’s CEO. "The transaction highlights the significant standalone value and commercial strength of the Talicia business, and positions RedHill to accelerate growth, reinforce its financial position and reduce costs, while continuing to advance our broader strategic objectives."

"Talicia has an outstanding product profile and represents an excellent strategic fit for Cumberland, providing us with an important growth opportunity," said A.J. Kazimi, Cumberland’s CEO. "These arrangements with RedHill provide us with the only FDA-approved all-in-one, low-dose rifabutin-based therapy to address H. pylori antibiotic resistance in support of patient care. We can build on the excellent foundation RedHill has created for the product, representing a strong growth opportunity for both companies, and we are delighted to be working with them to pursue this potential."

"There is a real problem with H. pylori antibiotic resistance, with eradication treatment failure rates of up to 40% associated with clarithromycin-containing therapies3. Leading U.S. H. pylori treatment guidelines are explicit on the need to avoid using clarithromycin as part of any H. pylori treatment regimen without prior susceptibility testing," said Rick Scruggs, RedHill’s Chief Commercial Officer. "Moreover, H. pylori is a key risk factor for gastric cancer, a cause of approximately 11,000 U.S. deaths4 a year. This is despite it being reported that eradication of H. pylori can lead to a 75% decreased gastric cancer risk.5 The need for effective H. pylori treatment designed to address antibiotic resistance is clear."

The transaction also supports RedHill’s plan to regain compliance with Nasdaq’s minimum stockholders’ equity requirement and maintain its continued listing, supporting access to capital and long-term financial stability. Accordingly, as a result of this transaction, as of the date of this press release, the Company believes it has stockholder’s equity in excess of the $2.5 million requirement for continued listing pursuant to Nasdaq Listing Rule 5550(b)(1). The Company intends to notify Nasdaq of its compliance status so that Nasdaq can make a determination as to whether the Company has regained compliance with all applicable requirements for continued listing on The Nasdaq Capital Market. However, there can be no assurance that Nasdaq will determine that the Company has regained compliance with the Nasdaq continued listing standards.

RedHill is committed to expanding patient access to Talicia globally. This month we announced the licensing of Talicia for new Middle East markets in a deal worth potentially $1.8 million plus sales royalty payments, with efforts to further broaden market access and secure additional non-dilutive ex-U.S. licensing revenue streams ongoing.

Talicia is patent protected through 2042 and received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation.

About H. pylori

H. pylori is a bacterial infection that affects approximately 35% of the U.S. adult population6 (an estimated 1.6 million U.S. patients are treated annually) rising to more than 50% globally7. Classified by the World Health Organization (WHO) as a Group 1 carcinogen, H. pylori is the strongest known risk factor for gastric cancer (between 70% to 90% of cases with more than 27,000 Americans diagnosed with gastric cancer annually8 and approximately 800,000 deaths globally per year), a major risk factor for peptic ulcer disease (90% of cases)9 and gastric mucosa-associated lymphoid tissue (MALT) lymphoma10. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics, especially clarithromycin, which is still commonly used in standard combination therapies11.

About Talicia

Approved by the FDA for the treatment of H. pylori infection in adults in November 2019, Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole). Talicia received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents extending patent protection through 2042 with additional patents and applications pending and granted in various territories worldwide. Talicia is also approved by the United Arab Emirates (UAE) Ministry of Health.

(Press release, RedHill Biopharma, OCT 20, 2025, View Source [SID1234656819])

On October 20, 2025 GlycoNex, Inc. (4168, hereinafter referred to as GNX), a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, reported that an abstract describing preclinical research on its first-in-class antibody-drug conjugate (ADC), GNX1021, has been accepted for presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), taking place October 22–26, 2025, in Boston, Massachusetts.

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The abstract, titled "Targeting branched Lewis B/Y glycans with GNX1021: A novel ADC approach for HER2-low gastric cancer," describes preclinical work characterizing GNX1021’s novel glycan-targeting mechanism. GNX1021 is engineered to recognize branched Lewis B/Y, a tumor-associated glycan highly expressed in gastric and other epithelial tumors but with limited expression in healthy tissue, potentially enabling a new level of tumor selectivity.

GlycoNex anticipates submitting an Investigational New Drug (IND) application in the first quarter of 2026 for a first-in-human clinical trial of GNX1021. The program builds on GlycoNex’s proprietary GlycoSH antibody bank and extensive expertise in glycan-directed antibody and ADC development.

Presentation Details:

Event:

American Association for Cancer Research (AACR) (Free AACR Whitepaper) NCI-EORTC
International Conference on Molecular Targets and Cancer Therapeutics
2025

Session:

Poster Session B

Abstract Title:

Targeting branched Lewis B/Y glycans with GNX1021: A novel ADC
approach for HER2-low gastric cancer

Date and Time:

Friday, October 24, 12:30-4:00 pm

Location:

Hynes Convention Center, Boston; Level 2, Exhibit Hall D

(Press release, GlycoNet, OCT 20, 2025, View Source [SID1234656835])

On October 20, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported results from the randomized, double-blind, phase 3 IMvigor011 clinical trial in muscle-invasive bladder cancer (MIBC). The findings demonstrate that Signatera can expand the adjuvant treatment window and guide the use of adjuvant atezolizumab (Tecentriq) in MIBC, resulting in improved disease-free survival (DFS) and overall survival (OS). Results will be presented today during a Presidential Symposium at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

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Bladder cancer is the sixth most common cancer in the United States1 and MIBC represents 20-25% of the newly diagnosed cases.2 Radical cystectomy (with or without neoadjuvant therapy) is curative for approximately half of these patients, but until now it has been very challenging to identify which patients are likely to recur and to offer them effective, personalized therapy while sparing the others from unnecessary treatment.3,4 The IMvigor011 trial, sponsored by Genentech, a member of the Roche Group, was designed to address that challenge.

IMvigor011 prospectively evaluated adjuvant atezolizumab versus placebo in patients with MIBC who were identified as Signatera-positive based on serial testing up to 7 times in the first year post-cystectomy.

Study highlights:

761 patients were enrolled in surveillance, of whom half tested Signatera-positive and 250 were randomized to atezolizumab vs. placebo.

Signatera-positive patients treated with atezolizumab experienced a >2x increase in median DFS compared to placebo. Median DFS was 9.9 months for patients treated with atezolizumab vs 4.8 months for placebo (HR: 0.64; P=0.005). Signatera-positive patients in the treatment arm also had a statistically significant and clinically meaningful improvement in OS (median of 32.8 months vs. 21.1 months; HR: 0.59; P=0.01).

Signatera-negative patients had excellent outcomes without adjuvant immunotherapy. Patients who remained persistently Signatera-negative during surveillance without adjuvant treatment had very low recurrence risk (DFS of 95.4% at 1 year and 88.4% at 2 years). OS outcomes were also incredibly strong, sparing patients from unnecessary treatment and potentially associated toxicity.
"IMvigor011 has delivered practice-changing evidence in bladder cancer," said Professor Thomas Powles, lead principal investigator of IMvigor011, professor of genitourinary oncology, chair of Barts Cancer Centre at St. Bartholomew’s Hospital. "Patients who tested Signatera-positive clearly benefitted from atezolizumab, while those who remained Signatera-negative had excellent outcomes without additional treatment. This is the most impactful data to date for personalized MRD testing, reinforcing Signatera’s predictive abilities to transform care."

"This is the first study to demonstrate that the adjuvant treatment decision window can be safely extended to one year post-surgery, minimizing overtreatment and allowing therapy to be precisely guided by Signatera results," said Alexey Aleshin, M.D., general manager of oncology and corporate chief medical officer at Natera. "These findings can redefine the standard of care in muscle-invasive bladder cancer and also underscore the broader potential for Signatera-guided management across multiple tumor types."

Data from IMvigor011 will support Natera’s premarket approval application to the U.S. Food and Drug Administration for Signatera as a companion diagnostic for the selection of patients with MIBC to be treated with atezolizumab after cystectomy.

(Press release, Natera, OCT 20, 2025, View Source [SID1234656851])

On October 20, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the Chinese National Intellectual Property Administration (CNIPA) has issued Patent Number ZL2020800215666, covering key aspects of the Company’s breast cancer vaccine technology.

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Anixa’s breast cancer vaccine, developed in collaboration with Cleveland Clinic, represents a novel approach to the prevention and treatment of breast cancer. Anixa’s vaccine is based on immunizing against human α-lactalbumin, a protein associated with lactation that is aberrantly expressed in certain types of breast cancer. This "retired" protein vaccine strategy aims to selectively prime the immune system to prevent tumor formation while avoiding harm to normal tissue. The vaccine was invented at Cleveland Clinic, and this patent—along with others related to this technology—has been exclusively licensed to Anixa Biosciences.

This patent issuance builds upon the Company’s broad and expanding intellectual property portfolio, extending foundational patent protection for the breast cancer vaccine program into the 2040s in multiple jurisdictions throughout the world. By reinforcing its global patent estate, Anixa is laying the groundwork for future international development and commercialization strategies.

"This newly issued patent further demonstrates the novelty and potential of our breast cancer vaccine," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "As we continue advancing clinical development in the U.S., this patent further strengthens our ability to pursue strategic global opportunities in regions with a high incidence of breast cancer."

A Phase 1 clinical trial of Anixa’s breast cancer vaccine has been recently completed and Cleveland Clinic will present full clinical results at the San Antonio Breast Cancer Symposium on December 11, 2025.

(Press release, Anixa Biosciences, OCT 20, 2025, https://www.prnewswire.com/news-releases/anixa-biosciences-announces-issuance-of-chinese-patent-covering-breast-cancer-vaccine-technology-302588477.html [SID1234656836])