On December 16, 2025 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported it has entered into a 15-year contract including an option to renew with the UK Nuclear Decommissioning Authority (NDA) for access to up to 400 tonnes of reprocessed uranium (RepU). RepU continually regenerates providing a potentially sustainable supply of 212Pb. Bicycle intends to utilize the RepU provided by this agreement in its development of potential lifesaving therapies.

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In addition, Bicycle announced a collaboration with United Kingdom National Nuclear Laboratory (UKNNL), pursuant to which it plans to extract 228Th from the RepU obtained from NDA. The extracted 228Th will then be further processed into 224Ra and loaded into a bespoke 212Pb generator being developed exclusively for Bicycle by SpectronRx. 212Pb is a radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha Therapy (TAT).

Collectively, this bespoke set of arrangements is designed to support the potential discovery, development, and commercial supply of a portfolio of Bicycle Radioconjugates (BRC) containing 212Pb.

"Cancer is a disease that affects millions worldwide, and tears too many families apart. Breakthroughs in medical science are giving more cancer patients and their loved ones hope, and this unique partnership could help take that work even further. Turning nuclear material into cutting-edge cancer treatments sounds like science fiction – but thanks to the brilliance of scientists, researchers and doctors, it could be a life-saving reality. Work like this shows exactly why we’re determined to support our life sciences innovators to make groundbreaking new treatments possible," said Liz Kendall, Secretary of State.

"These new collaborations are testaments to the potential of Bicycle to advance a differentiated and exciting isotope agnostic radiopharmaceuticals portfolio. We believe we now have the resources and infrastructure we need to create the world’s first end-to-end 212Pb radiopharmaceutical ecosystem from discovery through development to commercial supply. We believe the potential of BRCs and our ability to incorporate the appropriate isotopes for specific patient needs is unique and creates significant value-creating capabilities," said Mike Hannay, D.Sc., FRPharmS, chief product and supply chain officer of Bicycle Therapeutics. "We are incredibly grateful to the UK government for their recognition of Bicycle’s potential to develop BRCs with a 15-year access agreement for reprocessed uranium, and to our partners SpectronRx with whom we are developing a bespoke 212Pb generator. We look forward to advancing these dynamic collaborations and developing our pipeline of radiopharmaceuticals with the potential of improving lives for cancer patients around the globe."

"I am delighted with the progress we are making in establishing ourselves as a potential leader in radiopharmaceutical R&D. Today’s announcement builds on our previous announcements concerning our agreement with Eckert & Ziegler to supply a range of radioisotopes for the manufacture of BRC products as well as the formation of our Research and Innovation Advisory Board (RAB) comprising some of the worlds most esteemed experts in radiopharmaceuticals," said Bicycle Therapeutics CEO Kevin Lee, Ph.D. "As we continue to advance our emerging BRC pipeline, currently with novel targets EphA2 and MT1-MMP, we look forward to presenting initial EphA2 human imaging data in the first half of 2026 and initiating our own Bicycle study in 2026."

On December 16, 2025 Illumina, Inc. (NASDAQ: ILMN) reported that members of its management team will participate at the following investor conference:

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Upcoming Investor Conference

44th Annual J.P. Morgan Healthcare Conference on January 13, 2026
The presentation is scheduled for 7:30 a.m. PT (10:30 a.m. ET), with a Q&A session to follow at approximately 7:50 a.m. PT (10:50 a.m. ET).

The webcast can be accessed through the Events & Presentations section of Illumina’s website at investor.illumina.com. A replay will be archived on Illumina’s website for at least 30 days following the event.

(Press release, Illumina, DEC 16, 2025, View Source [SID1234661465])

On December 16, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported strong operational progress in the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first line therapy for advanced/metastatic non-small cell lung cancer.

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The registrational TACTI-004 trial has enrolled 289 patients (over 38% of the trial’s targeted enrolment of 756 patients), and enrolment continues at a robust pace. Additionally, the number of activated clinical sites now exceeds 120 and 27 countries have received full regulatory approvals.

This includes the United States where the first of multiple clinical sites has received full regulatory clearance following the recent completion of the FDA’s Project Optimus initiative and subsequent receipt of local and central Institutional Review Board (IRB) approvals.

As announced on 9 October 2025, TACTI-004 had enrolled the necessary 170 patients to conduct the futility analysis that remains on track for the first quarter of CY2026. Furthermore, Immutep expects to complete patient enrolment in the third quarter of CY2026.

Immutep Chief Executive Officer, Marc Voigt, said, "We are very pleased with the strong operational progress of TACTI-004 globally and the robust pace of recruitment. Growing interest in this pivotal trial has been enhanced by the recent licensing deal for efti in emerging markets with Dr Reddy’s. The Immutep team is excited about further delivering on key milestones ahead, including the futility analysis and completion of patient enrolment."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About TACTI-004
TACTI-004 (Two ACTive Immunotherapies) is a randomised, double-blind, controlled Phase III study evaluating eftilagimod alfa (efti), a first-in-class MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer with no EGFR, ALK or ROS1 genomic tumour aberrations. The global trial will enrol approximately 756 patients regardless of PD-L1 expression and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries. Patients will be randomised 1:1 to receive either efti in combination with pembrolizumab and chemotherapy in the treatment arm or pembrolizumab in combination with chemotherapy and placebo in the control arm. The study’s dual primary endpoints are progression-free survival and overall survival.

About Eftilagimod Alfa (Efti)
Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system’s ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

(Press release, Immutep, DEC 16, 2025, https://www.immutep.com/immutep-announces-strong-operational-progress-in-global-tacti-004-keynote-f91-phase-iii-and-enrolment-continues-at-robust-pace/ [SID1234661432])

On December 16, 2025 Allink Biotherapeutics, Inc. (AllinkBio), a clinical-stage biotechnology company focusing on developing advanced antibody-drug conjugates (ADCs) and multi-specific antibody therapeutics for oncology and immunology, reported successful completion of its extension rounds of Series A, raising 47 million US dollars. The extension rounds were led by existing supporter Legend Capital and new investor Meituan Long-Z Investment, followed by other prominent returning and new investors including Lanchi Ventures, Yuanbio Venture Capital, 5Y Capital, Lapam Capital, Runzhang Venture Capital, etc.

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Advancing Global Clinical Development for Two Leading Assets

The Series A extension rounds will help advance global clinical development for the company’s two leading programs with distinct competitive advantages. ALK201, a potential first- and best-in-class FGFR2b-targeted ADC, has demonstrated encouraging efficacy signals across multiple tumor types with a favorable safety profile, supporting its development as a backbone therapy for FGFR2b-overexpressing solid tumors. In parallel, early clinical data for ALK202 have provided preliminary support of the EGFR/cMET bispecific ADC’s potential as a cornerstone therapy in non-small cell lung cancer. Furthermore, the program is being expanded into clinical evaluation of a broader range of biomarker-defined tumor types and patient populations.

AllinkBio has started developing both lead clinical assets through a biomarker-guided strategy designed to demonstrate efficacy in a broad spectrum of solid tumors. In the near term, the company plans to initiate combination therapy studies to further explore the two assets’ therapeutic potential in broader front-line patient populations. These initiatives will accelerate ALK201 and ALK202 toward pivotal trial readiness while establishing a differentiated profile in their respective target indications.

Augmenting Novel Technology Platform Capabilities

Expanding beyond its ADC technology, AllinkBio is establishing a proprietary masked T-cell engager (TCE) platform to evolve the application of TCEs for solid tumors. In the immunology space, the company is advancing a portfolio of first-in-class bi- and multi-specific antibody drug candidates. Anchored in rational biology design, these programs aim to deliver next-generation solutions for patient populations underserved by current standards of care.

"We sincerely appreciate the decisive and continued support from our investors within such a short timeframe," said Hui Feng, Ph.D., Founder and Chief Executive Officer of AllinkBio. "With this support, we are moving forward with a clear clinical roadmap to accelerate our lead programs. Beyond the two leading programs, our discovery engine is fully activated, poised to deliver new wave of innovative drug candidates that will unlock further value in the foreseeable future ."

"Our continued support is rooted in our confidence in the AllinkBio team’s efficient execution and their robust development strategy," said Tan Hong, Managing Director at Legend Capital. "The rapid clinical advancement of their two competitive lead assets is already serving as a strong validation of the company’s ADC platform and presenting significant value. We look forward to the near-term clinical readouts and seeing more innovative programs emerge from their discovery platforms."

"The AllinkBio team pairs an international mindset with best-in-class execution, setting a remarkable pace in the ADC space," said Xuejing Guo, Managing Director and Head of Healthcare at Meituan Long-Z Investment. "We are deeply impressed by the potential of their technology platform and are excited to help the team translate these original innovations into global impact, ultimately delivering life-changing therapies to patients worldwide."

(Press release, Shanghai Allink Biotherapeutics, DEC 16, 2025, View Source [SID1234661466])

On December 15, 2025 XOMA Royalty Corporation ("XOMA Royalty") (NASDAQ: XOMA), the biotech royalty aggregator, reported it has entered into an agreement to acquire Generation Bio Co. ("Generation Bio") (NASDAQ: GBIO) for a cash price of $4.2913 per share at the closing of the merger. Generation Bio stockholders also will receive one non-transferable contingent value right ("CVR") per share that entitles holders to receive potential payments of a pro rata portion of:

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100% of the amount by which net cash at closing, as finally determined pursuant to the CVR agreement, exceeds $29 million;
either 90% or 100% of any savings realized by XOMA Royalty on the Company’s Cambridge office lease obligations, subject to the timing of resolution of the lease obligations;
a share of any proceeds from Generation Bio’s existing license agreement with Moderna, which includes potential development and commercial milestones and royalties on commercial sales, calculated on a sliding scale delivering up to 90% of such payments to CVR holders; and
a share of payments from any out license or sale of the Generation Bio ctLNP delivery platform, calculated on a sliding scale delivering up to 70% of such payments to CVR holders
following the closing.

Following a thorough review process conducted with the assistance of its legal and financial advisors, Generation Bio’s board of directors has determined that the acquisition by XOMA Royalty is in the best interests of all Generation Bio stockholders and has unanimously approved the Merger Agreement.

Terms
Pursuant and subject to the terms of the Merger Agreement, a wholly owned subsidiary of XOMA Royalty will commence a tender offer (the "Offer") within 15 business days, to acquire all outstanding shares of Generation Bio common stock. Closing of the Offer is subject to certain conditions, including the tender of Generation Bio common stock representing at least a majority of the total number of outstanding shares and other customary closing conditions. Immediately following the closing of the tender offer, Generation Bio will merge with a subsidiary of XOMA Royalty, and all remaining shares not tendered in the offer, other than appraisal shares, will be converted into the right to receive the same cash and CVR consideration per share as is provided in the tender offer.

Generation Bio stockholders in possession of approximately 15% of Generation Bio common stock have signed support agreements under which such stockholders agreed to tender their shares in the Offer and support the merger. The acquisition is expected to close in February 2026.

Advisors
XOMA Royalty was represented by Gibson, Dunn & Crutcher LLP. TD Cowen served as financial advisor, and Wilmer Cutler Pickering Hale and Dorr LLP served as legal counsel, to Generation Bio.

(Press release, Xoma, DEC 15, 2025, View Source [SID1234661433])