1stOncology™: Cancer Intelligence Service – Page 47 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

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.

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])

enGene Announces Expanded $125 Million Debt Facility with Hercules Capital, Inc.

On January 20, 2026 enGene Holdings Inc. (Nasdaq: ENGN, "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company, reported that it has entered into an amendment to an amended and restated loan and security agreement (as amended, the "Loan Agreement") with two of its subsidiaries and Hercules Capital, Inc. (NYSE: HTGC) ("Hercules"), as agent, for up to US$125 million. Access to the additional non-dilutive capital strengthens enGene’s balance sheet in preparation for its planned Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for detalimogene voraplasmid as a treatment for high-risk, Bacillus Calmette-Guérin ("BCG")-unresponsive non-muscle invasive bladder cancer ("NMIBC") with carcinoma in situ ("CIS") in the second half of 2026, and the potential commercial launch of detalimogene should it receive FDA approval.

"This additional access to capital strengthens our balance sheet and provides us financial flexibility as we plan for a BLA filing for detalimogene in the second half of this year and potential commercial launch in 2027," said Ron Cooper, President and Chief Executive Officer, enGene. "We’re pleased to continue our partnership with Hercules to achieve our goal of bringing detalimogene to patients with NMIBC in need of innovative, bladder-sparing treatment options."

"Hercules is proud to support enGene on its mission to improve the lives of people living with bladder cancer," said Bryan Jadot, Senior Managing Director, Hercules. "Our increased commitment underscores our approach as long-term capital partners to our portfolio companies and reflects our dedication to financing innovative life sciences companies through development and into commercialization."

Under the terms of the Loan Agreement, $25 million was funded on the execution of the amendment and will be used to refinance the Company’s existing debt facility. Three additional term loan tranches totaling up to $75 million can be drawn at enGene’s option subject to the achievement of certain clinical, regulatory and commercial milestones. The final term loan tranche of up to $25 million may be made upon request of the Company and at the discretion of Hercules. Under the terms of the Loan Agreement, the principal amount outstanding and all accrued but unpaid interest under the Loan Agreement shall be repaid on or before January 1, 2030 (or such later dates as to which the maturity date may be extended from time to time in accordance with the terms of the Loan Agreement).

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Non-muscle invasive bladder cancer (NMIBC) is a disease that poses a significant burden on both patients and clinics and has a massive economic impact on our healthcare system. NMIBC occurs when cancer cells grow in the tissues that line the interior of the bladder, but the cancer has not yet penetrated the muscle of the bladder wall. NMIBC can present as papillary outgrowths from the bladder wall, which are typically resected, or as carcinoma in situ (CIS), which consists of flat, multifocal lesions that cannot be resected. The two forms can also co-occur. About 75-80% of new bladder cancer diagnoses are NMIBC. Patients suffering from high-risk NMIBC who are unresponsive to the standard of care, Bacillus Calmette-Guérin (BCG), face high rates of disease recurrence (50-70%) and are potentially subject to full removal of the bladder (cystectomy) as a curative but life-altering next step.

About Detalimogene Voraplasmid

Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-unresponsive disease. It is designed to be instilled in the bladder and elicit a powerful yet localized anti-tumor immune response.

Detalimogene was developed using the Company’s Dually Derivatized Oligochitosan (DDX) platform, a technology designed to transform how gene therapies are accessed by patients and utilized by clinicians. Medicines developed with the DDX platform can potentially overcome the limitations of viral-based gene therapies, reduce complexities related to safe handling and cold storage, and streamline both manufacturing processes and administration paradigms.

Detalimogene has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) based on its potential to address the high unmet medical need for patients with BCG-unresponsive carcinoma in situ (CIS) NMIBC with or without resected papillary tumors who are unable to undergo cystectomy. The RMAT program is intended to expedite the development and review of regenerative medicine therapies for serious or life-threatening conditions, where preliminary clinical evidence suggests potential to address unmet medical needs. Similarly, Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Detalimogene has also been selected to participate in the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program. The FDA created the CDRP Program to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy.

About the LEGEND Trial

Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk NMIBC. LEGEND’s pivotal cohort (Cohort 1) consists of 125 patients with high-risk, BCG-unresponsive NMIBC with CIS (with or without papillary disease) and is designed to serve as the basis of the Company’s planned Biologics License Application (BLA) filing. In addition to this pivotal cohort, LEGEND includes three additional cohorts, including NMIBC patients with CIS who are naïve to treatment with BCG (Cohort 2a); NMIBC patients with CIS who have been exposed to BCG but have not received adequate BCG treatment (Cohort 2b); and BCG-unresponsive high-risk NMIBC patients with papillary-only disease (Cohort 3). The LEGEND trial is actively enrolling patients with sites participating in the USA, Canada, Europe, and the Asia-Pacific region.

(Press release, enGene, JAN 20, 2026, View Source [SID1234662107])

Peter Melnyk Joins Taiho Oncology as President & Chief Operating Officer

On January 20, 2026 Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, reported Peter Melnyk has joined the company as President & Chief Operating Officer.

Mr. Melnyk comes to Taiho Oncology with more than 30 years of proven experience in oncology commercialization and leadership across pharmaceuticals, medical devices and biotech sectors. Mr. Melnyk joined Taiho Oncology from Alpha Tau Medical, where he was the Chief Commercial Officer and former board member and led the global commercialization efforts for a novel alpha-emitting radiotherapeutic. He was also the CEO of Fortovia Therapeutics and drove the transformation and portfolio expansion in oncology supportive care. In addition, Mr. Melnyk was the Chief Commercial Officer at Novocure, where he built the global commercial infrastructure and launched Optune, a novel medical device for the treatment of glioblastoma. He also held senior leadership roles at OSI/Astellas, Pharmacia/Pfizer and Bristol-Myers Squibb and holds a Master of Science and Bachelor of Science from McGill University.

"We are excited to welcome Peter to Taiho Oncology as President & Chief Operating Officer," said Tim Whitten, CEO of Taiho Oncology. "Peter is an innovator with a demonstrated track record of success. We believe his strong leadership capabilities and ability to deliver measurable results will help guide Taiho Oncology’s continued growth and innovation as we pursue our mission of improving the lives of patients with cancer, their families and their caregivers."

"It’s a privilege to join Taiho Oncology, a company with a remarkable legacy of scientific innovation, commercial excellence, patient-centered care and an exceptional culture – one that values integrity, collaboration, and the relentless pursuit of better outcomes for patients," Mr. Melnyk said. "I’ve spent my career working to bring transformative oncology treatments to patients around the world. What excites me most about Taiho is the combination of deep scientific expertise, a mission-driven collaborative culture, and a shared commitment to making a difference for patients and their families."

(Press release, Taiho, JAN 20, 2026, View Source [SID1234662106])

Syngene International extends long-term research collaboration with Bristol Myers Squibb until 2035

On January 20, 2026 Syngene International, a global contract research, development, and manufacturing organization (CRDMO), reported the extension of its long-standing strategic collaboration with Bristol Myers Squibb through 2035. The expanded agreement broadens the scope of integrated services across the drug development lifecycle spanning discovery (chemistry, biology, drug metabolism and pharmacokinetics), translational sciences, pharmaceutical development and manufacturing, clinical trials, data and information technology services to enable seamless progression from research to commercialization. The expansion of this collaboration marks the next phase of growth, reinforcing Syngene’s position as a strategic partner delivering integrated, end-to-end scientific and manufacturing solutions.

Peter Bains, Managing Director and CEO, Syngene International Ltd., said, "Our collaboration with Bristol Myers Squibb, which now spans more than 25 years, is anchored in scientific excellence, operational reliability, and a shared commitment to advancing innovative therapies. The agreement to extend this partnership through 2035 enables us to plan together for the future in terms of building new capabilities and infrastructure with a decade long horizon. Taking a long-term perspective is a key feature of our partnership which adds strategic value to both companies. We look forward to supporting BMS with their next wave of discovery, development, and manufacturing programs that have the potential to improve patient outcomes worldwide."

Payal Sheth, Senior Vice President, Therapeutic Discovery Sciences, Bristol Myers Squibb, said, "At Bristol Myers Squibb, everything we do begins with patients. We greatly value our long-standing partnership with Syngene, which has been instrumental in advancing our scientific ambitions. This expanded collaboration reflects our commitment to advancing innovative science by effective integration of our research, development, and manufacturing capabilities to accelerate the delivery of transformative medicines and bring hope to patients around the world who are waiting for new treatment options."

The collaboration between Syngene and Bristol Myers Squibb began in 1998, culminating in the establishment of the Biocon Bristol Myers Squibb Research and Development Center (BBRC), Syngene’s first dedicated R&D Center, which was fully commissioned in 2009. Over the years, the BBRC has evolved into a major strategic R&D site for Bristol Myers Squibb, supporting integrated capabilities across target identification, lead discovery, lead optimization, pharmaceutical development, molecular and cell biology, protein sciences, assay biology and clinical biomarkers. The center, which today houses around 700 Syngene scientists working as an extension of Bristol Myers Squibb’s global research organization, contributes to discovery, preclinical development, and patent filings across therapeutic areas including cardiovascular, fibrosis, immunology, and oncology.

Since its inception, BBRC has played a pivotal role in accelerating the progression of novel compounds from early discovery to first-in-human studies, thereby helping reduce development timelines and overall costs for Bristol Myers Squibb.

(Press release, Bristol-Myers Squibb, JAN 20, 2026, View Source [SID1234662105])