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])

On January 21, 2026 Infinitopes, a clinical-stage cancer vaccine biotechnology company, reported the successful completion of the second close of its seed financing round, securing an additional $15.4 million and bringing the total raised to $35.1 million. This latest investment was co-led by Octopus Ventures and new investor Amplify Bio, with further participation from new investor Macmillan Cancer Support alongside existing investors Cancer Research Horizons and Manta Ray Ventures.

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This funding comes as the company launches its first-in-human, double-blind, randomised, placebo-controlled clinical trial of ITOP1, its leading precision therapeutic vaccine aimed at preventing recurrence in oesophageal cancer, an area where clinical need remains largely unmet. The Phase I/IIa VISTA trial is to be conducted across multiple UK NHS university cancer centres and firmly positions Infinitopes at the cutting edge of the sector.

Jonathan Kwok, Chief Executive Officer of Infinitopes, said: "I’m honoured to welcome leading US West Coast biofund Amplify Bio and ecosystem champions for better patient care, Macmillan, onto our cap table. This new funding unlocks our potentially groundbreaking Phase I/IIa trial, enabling proof-of-concept evaluation of Infinitopes’ AI/ML-precision targeted, off-the-shelf vaccine platform to prevent recurrence after surgical resection. We aim to lead the development of innovative medicines that bring hope to patients suffering from cancers with unmet medical needs. We anticipate sharing our early findings at major conferences later this year."

Elliot Hershberg, Partner at Amplify Bio, remarked: "Recent clinical evidence has made it abundantly clear that the time for cancer vaccines is now. After years of searching, Infinitopes has clearly distinguished itself as the company positioned to drive this progress forward. The combination of rigorous AI-powered immunomics profiling, a highly scalable off-the-shelf vector, and a defined clinical strategy is exactly what this field needs. Infinitopes has the potential to redefine immunotherapy and precision oncology in the years to come."

(Press release, Infinitopes, JAN 21, 2026, View Source [SID1234662143])

On January 20, 2026 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company focused on developing novel treatments for chronic diseases, including recurrent and metastatic cancer, reported that a new provisional patent application has been filed for methods of producing trypinsogen and chymotrypsinogen with IP Australia. The patent application describes an optimized expression system to produce a world-first fully synthetic recombinant version of PRP, a long-term therapy for the treatment and prevention of metastatic cancer from solid tumors. According to Emergen Research, the global metastatic cancer market is projected to be worth $111 Billion by 2027.

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A fully synthetic version of trypsinogen and chymotrypsinogen, called Rec-PRP, could have additional benefits to a global healthcare system that further capitalizes on a new therapeutic approach to treating cancer. For example, both proenzymes are synthesized by an in vivo (living organism) expression system, such as yeast cells, to produce proteins that could be maintained for long periods of time without suffering degradation in the absence of refrigeration. This is useful for a longer self-life as well as global distribution, particularly in warmer climates and developing regions where refrigeration is not available. Further, the program could produce large quantities of trypsinogen and chymotrypsinogen for commercial use that exhibits minimal variation between lots and without sourcing from animals. Therefore, management believes a fully synthetic recombinant version of PRP would have tremendous implications from a regulatory perspective, but also a practical, commercial benefit for global distribution.

"This provisional patent application is the third one filed over the past two months and will enhance our IP portfolio significantly as we enter national phase in countries worldwide for each of these patent applications," said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. "We continue to execute our strategic plan building a platform technology that could be a world-first therapeutic approach to metastatic cancer from solid tumors, but without severe or serious side effects associated with standard treatments. Further, we are expanding our research into other therapeutic indications where there is a significant unmet medical need. We are building a strong and stable future for our Company and shareholders over the long term."

(Press release, Propanc, JAN 20, 2026, View Source [SID1234662098])

On January 20, 2026 Think Bioscience ("Think Bio"), a biotechnology company focused on unlocking elusive drug targets, reported it has raised $55M in an oversubscribed Series A. The round was led by Regeneron Ventures, Innovation Endeavors, and Janus Henderson Investors with participation from T.A. Springer, CE-Ventures, MBX Capital, and YK Bioventures. Returning investors include AV8 Ventures, CU Innovations, and Buff Gold Ventures.

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Think Bioscience develops small molecule drugs for historically challenging drug targets by using synthetic biology to uncover novel footholds for medicinal chemistry (e.g., protein pockets). Their lead program targets mutants that cause Noonan syndrome, a genetic condition that affects approximately 1 in 2,500 births. Noonan patients experience life-threatening cardiac and lymphatic issues, short stature, cognitive impairment, and pain, among other chronic symptoms. There are no approved therapies that address the underlying biology of this disease.

"Our lead program has the potential to give a broad set of Noonan patients a better life," said Dr. Jerome Fox, co-founder and CEO at Think Bioscience. "We are grateful to our investors for supporting our vision to develop life-changing therapies."

Despite recent advances in computational chemistry, drug design remains exceedingly difficult. Most proteins in the human proteome are still considered undruggable—that is, they lack an obvious pocket for a drug to bind. Think Bio’s synthetic biology platform uses high-throughput functional surveys to find pockets that others miss and uses them to advance small molecules with biochemical activities previously deemed difficult, if not impossible, to achieve. They have extended their platform to a striking variety of targets, including transcription factors, protein phosphatases, kinases, proteases, and GTPases, while advancing a robust internal pipeline.

"This team is succeeding where others have failed. The lead program is the best example, but just one of many that the company is prosecuting. We are enthusiastic to double down." said Nick Olsen, Partner at Innovation Endeavors.

(Press release, Think Bioscience, JAN 20, 2026, View Source [SID1234662099])

On January 20, 2026 Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company interrogating extrachromosomal DNA (ecDNA) biology to deliver transformative therapies to patients with previously intractable oncogene amplified cancers, reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for its novel Kinesin oral degrader program, BBI-940. The Company also provided updates on the POTENTIATE clinical trial of BBI-355 and BBI-825 and its capital position.

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BBI-940 novel Kinesin degrader program

The acceptance of the BBI-940 IND enables Boundless to advance the program into a first-in-human clinical trial for patients with metastatic breast cancer, KOMODO-1 (Kinesin Oral Molecular Degrader for Oncology-1), which is expected to initiate in the first half of 2026. Boundless’s novel Kinesin oral degrader program targets a previously undrugged kinesin involved in DNA segregation, including ecDNA segregation, during mitosis. BBI-940 has demonstrated potent anti-tumor activity across a range of cancer cell lines as well as in mouse xenograft models, including single-agent tumor regressions. The Company expects to deliver initial proof-of-concept clinical data within its cash runway timeline.

"The acceptance of the BBI-940 IND marks an important milestone for our first-in-class Kinesin oral degrader program, enabling us to advance this differentiated anti-cancer approach into clinical development," said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. "In parallel, our portfolio prioritization and disciplined capital allocation sharpen our focus on BBI-940, maximizing our potential to deliver high-impact therapies for patients with high unmet need cancers."

POTENTIATE clinical trial of BBI-355 and BBI-825

Following a strategic portfolio review, Boundless Bio has elected to cease enrollment of the Phase 1/2 POTENTIATE trial evaluating the combination of BBI-355, its oral, selective CHK1 inhibitor and BBI-825, its oral, selective RNR inhibitor, in oncogene-amplified cancers. This decision reflects market considerations, clinical data, and the Company’s prioritization of programs with the greatest potential to deliver meaningful clinical impact and long-term value.

Financial Update

Based on the revised operating plan, the Company’s streamlined operations will extend its operating runway into the second half of 2028, through the anticipated initial clinical proof of concept readout for BBI-940.

(Press release, Boundless Bio, JAN 20, 2026, View Source [SID1234662100])