Genmab Announces Net Sales of DARZALEX® (daratumumab) for 2025

On January 21, 2026 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by J&J were USD 14,351 million in 2025. Net trade sales were USD 8,266 million in the U.S. and USD 6,085 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to J&J to develop, manufacture and commercialize daratumumab.

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(Press release, Genmab, JAN 21, 2026, View Source [SID1234662129])

Defence Therapeutics Sharpens Strategic Focus On Precision Drug Delivery To Unlock The Full Potential Of Cancer Biologics

On January 21, 2026 Defence Therapeutics Inc., ("Defence" or the "Company"), a publicly traded biotechnology company, reported an evolution of its corporate positioning to reflect its focus as a precision intracellular drug-delivery company advancing its proprietary Accum platform through both internal development programs and strategic partnerships. Designed to unlock the full potential of complex cancer biologics, Accum enhances intracellular delivery to increase therapeutic potency while reducing toxicity.

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At the center of this strategy is Accum, Defence Therapeutics’ proprietary precision drug-delivery platform designed to solve one of oncology’s most persistent challenges: effective intracellular delivery. By enhancing cellular uptake and payload release, Accum increases therapeutic potency at lower doses, with the potential to reduce toxicity and improve patient access to advanced cancer treatments.

Defence is prioritizing this platform and partnering model through a dual strategy that combines internal R&D programs with strategic partnerships across the biotech and pharmaceutical ecosystem. This approach enables the enhancement of both existing and next-generation assets, including antibody-drug conjugates (ADCs), radiopharmaceuticals, and other complex biologics, transforming therapies traditionally used in later lines into safer, more effective first-line treatment options.

"Our focus is clear: solve drug delivery at the cellular level so cancer therapies, whether developed by Defence or by our partners, can reach their full potential," said Sébastien Plouffe, CEO of Defence Therapeutics. "Accum is designed to create optimal value for partners while ultimately delivering better outcomes for patients."

With this refined positioning, Defence Therapeutics reinforces its commitment to precision oncology, collaboration, and translating cutting-edge science into life-changing treatments, with a business model designed to generate scalable value for partners and long-term value for shareholders.

(Press release, Defence Therapeutics, JAN 21, 2026, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-sharpens-strategic-focus-on-precision-drug-delivery-to-unlock-the-full-potential-of-cancer-biologics [SID1234662128])

Breakpoint Therapeutics Announces Oral Presentation at the DDR Inhibitors Summit

On January 21, 2025 Breakpoint Therapeutics GmbH ("Breakpoint"), a company dedicated to the discovery and development of drugs targeting the DNA Damage Response (DDR), reported that it will present preclinical data from its polymerase theta (Pol θ / POLQ) inhibitor programme in an oral presentation at the DDR Inhibitors Summit, being held January 27-29, 2026 in Boston (MA), USA.

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DNA polymerase theta is a DNA repair enzyme that is largely absent in normal cells but displays aberrant expression in multiple cancer types which often correlates with poor prognosis. Inhibition of Pol θ is a validated therapeutic modality in certain tumour-specific contexts.

Details of the presentation are as follows:

Title: Targeting Polθ’s Dual Domains to Guide Candidate Selection & Strategic Partnering

Date: Wednesday, 28 January, 2026

Time: 11:00 – 11:30 a.m. ET

In addition, Jon will participate in a panel discussion on the topic of "Uniting Founders and Funders to Align Scientific Vision with Investment Strategy" scheduled for Thursday, 29 January, 2026 at 8:30am.

(Press release, Breakpoint Therapeutics, JAN 21, 2026, View Source [SID1234662127])

BioNTech Receives FDA Fast Track Designation for mRNA Cancer Immunotherapy Candidate BNT113 in HPV16+ Head and Neck Cancer

On January 21, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation to BNT113, an investigational mRNA cancer immunotherapy, for the treatment of patients with human papillomavirus type 16 positive ("HPV16+") head and neck squamous cell carcinoma ("HNSCC") expressing PD-L1, a distinct cancer type associated by infection with high-risk human papillomavirus.

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The FDA Fast Track process is designed to facilitate the development and expedite the review of new drugs and vaccines that are intended to treat or prevent serious conditions and have the potential to address an unmet medical need. The designation has been granted based on preliminary safety and efficacy data from the ongoing pivotal Phase 2/3 AHEAD-MERIT clinical trial (NCT04534205) evaluating BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as a first-line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1.

HNSCC is the seventh most common cancer type worldwide with increasing global incidence, mainly driven by a rise in HPV16-related oropharyngeal tumors, the most common subtype of HNSCC.2,4 About one third of HNSCC cases are HPV-positive following a HPV infection, with a rising trend, of which about 90% of oropharyngeal cancers are driven by the subtype HPV16.1,5 Despite the distinct characteristics of HPV-positive tumors, there are currently no HPV-targeted treatments approved.3 Many patients with HPV16+ HNSCC experience disease progression under current standard of care treatments with a median overall survival of 20.7 months6, underlining the unmet medical need for novel HPV-targeted chemotherapy-free treatment options that improve long-term survival. HNSCC is among BioNTech’s key tumor areas.

BNT113 is an investigational mRNA cancer immunotherapy encoding the E6 and E7 proteins of HPV16, that are frequently found in HPV16+ solid tumors. This mRNA cancer immunotherapy approach is designed to induce HPV16-specific anti-tumor immune responses, thereby aiming to enhance clinical responses in patients being treated with checkpoint inhibitor standard of care treatment.

(Press release, BioNTech, JAN 21, 2026, View Source [SID1234662126])

Amsulostat in pancreatic cancer Phase 1/2 clinical trial in collaboration with the Garvan, funded by MRFF

On January 21, 2026 Syntara Limited (ASX: SNT), a clinical-stage drug development company, reported that the Garvan Institute of Medical Research in Sydney ("Garvan Institute") has been awarded a $3 million grant under the Australian Government’s Medical Research Future Fund ("MRFF") to conduct two multicentre Australian clinical studies in advanced pancreatic cancer, one of which will evaluate Syntara’s investigational anti-fibrotic LOX inhibitor amsulostat (SNT-5505) in combination with standard-of-care chemotherapy.

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Under the collaboration, Syntara will supply the drug in addition to scientific and clinical expertise to support the program. Syntara will not be required to provide cash funding as part of the clinical study.

The inclusion of amsulostat in this MRFF-funded clinical program builds on ground-breaking preclinical research led by the Garvan Institute and published in Nature Cancer (see ASX announcement 29 August 2023). The research demonstrated that targeting tumour fibrosis weakens the dense barrier that surrounds pancreatic tumours, enabling chemotherapy drugs to penetrate more effectively and destroy more cancer cells, as well as reducing cancer cell invasion and metastasis.

Pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer, remains one of the most lethal cancers, with poor long-term survival outcomes. A key driver of treatment resistance is the fibrous "stromal" barrier that forms a fortress around tumours, limiting drug delivery and supporting tumour progression.

Professor Thomas Cox, Laboratory Head at the Garvan Institute and Conjoint Professor at St Vincent’s Clinical School, Faculty of Medicine and Health, UNSW Sydney said: "Pancreatic cancer creates a dense, scar-like barrier that diminishes patient response to therapy. Through our long-standing collaboration with Syntara, we’ve identified a promising strategy to target lysyl oxidases, the key enzymes that build and strengthen this scar tissue. The proposed phase I/II trial with amsulostat in combination with chemotherapy represents a critical step in validating and translating our laboratory findings into new treatment options for patients with advanced pancreatic cancer."

The MRFF-funded studies are expected to commence recruitment in mid-2026, enrolling patients with advanced pancreatic cancer across leading cancer centres in New South Wales, including Westmead Hospital, St Vincent’s Hospital Sydney and Wollongong Hospital. Further details regarding study design, participating sites and timelines will be announced closer to study commencement.

In addition to assessing safety and clinical activity, the studies will incorporate a precision medicine strategy, including deep molecular and genetic profiling of tumour and blood samples collected before and during treatment. This analysis aims to identify biomarkers and patient subgroups most likely to benefit, with the potential to guide more targeted therapy in future clinical development.

The approach of targeting tumour fibrosis may have broader implications for other solid cancers characterised by fibrous barriers that impede treatment delivery, including certain breast, liver and lung cancers and is supported by peerreviewed publications from academic collaborators using amsulostat.

Syntara Chief Executive Officer Gary Phillips said: "Whilst our focus remains on the treatment of haematological malignancies like MF and MDS, the pre-clinical work conducted by Professor Cox and others regarding chemotherapy resistant tumours is compelling. We are delighted that the MRFF have seen the value of translating this work into the clinic and look forward to supporting the Garvan and the clinical trial team to deliver results for pancreatic cancer patients

This MRFF supported pancreatic cancer study is now one of four Syntara clinical studies funded with non-dilutive capital, totalling more than $10m. This level of success in competitive grant processes is a very positive reflection on the quality of the pre-clinical science undertaken by Syntara and its research collaborators worldwide over a sustained period of time."

The initiation of the pancreatic cancer study later this year adds to an already rich clinical development program in 2026, which will see the SNT-4728 study in iRBD deliver top line results in Q2 2026, followed by two amsulostat studies in MDS and two skin scarring studies all due to report data later this year.

(Press release, Syntara, JAN 21, 2026, View Source [SID1234662104])