On January 7, 2026 Curadel Pharma, a pioneer in zwitterionicity and innovator in advanced radiotherapies and imaging drugs, reported that CPI-008 (cRGD-ZW800-1), a novel integrin-targeted, zwitterionic imaging drug for margin detection of pancreatic cancer during surgery, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

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"Receiving orphan designation from both the FDA and the EMA is a profoundly important milestone for Curadel, granting us valuable incentives to fuel our development efforts," said John V. Frangioni, MD, PhD, Curadel founder and CEO. "As a pioneering company working to introduce significant advances in surgical imaging, the efficiencies of fee exemptions, credits, along with the potential for market exclusivity are vital tools to help us smartly deploy our resources and focus on delivering value to the surgical community."

In the U.S., FDA grants ODD to therapeutic candidates for conditions affecting fewer than 200,000 people in the U.S. This designation provides incentives to advance clinical development including exemption from user fees, tax credits for qualified clinical trials, and potential for up to seven years of U.S. market exclusivity if the product is approved for its designated indication. Similarly, EMA’s designation includes incentives including protocol assistance, reduced regulatory fees, and potential for early access conditional approvals, as well as market exclusivity up to 10 years if approved.

Pancreatic cancer remains one of the most challenging cancers to treat, and current imaging tools are not fully effective in helping to identify the full extent of cancerous cells to allow for full removal during surgical procedures. By enhancing surgeons’ ability to accurately visualize cancerous cells, Curadel’s technology could become an important asset in the surgical suite to optimize outcomes not only for pancreatic cancer patients, but potentially for other tumor types as well.

CPI-008 has demonstrated strong imaging capabilities in investigator-initiated Phase 2 studies in multiple cancers including pancreatic cancer, head and neck cancer, and colorectal cancer. As part of its strategic pipeline curation, Curadel is evaluating out-licensing opportunities for the program, offering a highly differentiated technology that potential partners can leverage to expand leadership in the competitive imaging market.

(Press release, Curadel Pharma, JAN 7, 2026, View Source [SID1234661829])

On January 7, 2026 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported it will present at the Biotech Showcase conference taking place from January 12-14, 2026, in San Francisco, California. CEO Helen Tayton-Martin will present Evaxion’s 2026 company milestones and provide a company update on January 13, 2026.

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The Biotech Showcase conference coincides with the J.P. Morgan Healthcare Conference and Evaxion will engage with stakeholders in San Francisco, including potential business partners, throughout the week.

Presentation details:
Date: Tuesday, January 13, 2026
Time: 2:00pm PST/11:00pm CET
Track: Yosemite C (Ballroom Level)

(Press release, Evaxion, JAN 7, 2026, View Source [SID1234661799])

On January 7, 2026 Synaffix B.V. ("Synaffix"), a Lonza company (SWX: LONN) focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, and Sidewinder Therapeutics, a precision ADC therapeutics company with a pipeline of bispecific antibodies with enhanced tumor-cell specificity and internalization, reported that they have entered into a multi-target licensing agreement to develop first-in-class bispecific ADC therapeutics to treat solid tumor indications.

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Through the agreement, Sidewinder gains access to Lonza’s clinically validated, site-specific ADC technology platform including GlycoConnect antibody conjugation technology, HydraSpace polar spacer technology, and a toxSYN linker payload. Under the terms of the agreement, Lonza is eligible to receive upfront, clinical, regulatory, and commercial milestone payments, plus royalties on net sales of resulting products. Lonza is responsible for manufacturing components that are related to its proprietary technologies, and Sidewinder is responsible for the research, development, manufacturing, and commercialization of the ADCs.

Peter van de Sande, Head of Synaffix at Lonza, commented:
"This collaboration brings together two cutting-edge platforms to enhance the therapeutic index of bispecific ADCs by minimizing impact on healthy tissue. We are confident that our technologies will help Sidewinder’s pipeline reach its full potential in maximizing tumor targeting, hence delivering new life-saving therapies for the benefit of patients with cancer."

Eric Murphy, PhD, Co–Founder and Chief Executive Officer of Sidewinder Therapeutics, said:
"The ADC field has reached an exciting moment fueled by multiple technology breakthroughs that enable the next generation of bispecific ADC innovation. Sidewinder’s bispecific antibody approach targeting tumor-specific receptor complexes combined with Synaffix’s clinically validated site-specific linker-payload platform creates an ideal synergy with the potential to greatly impact patient benefit. This collaboration advances our mission to reshape the cancer treatment landscape by improving tolerability for bispecific ADCs."

(Press release, Synaffix, JAN 7, 2026, View Source [SID1234661814])

On January 6, 2026 Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported the successful close of its acquisition of Mersana Therapeutics, Inc., (NASDAQ: MRSN) ("Mersana") following completion of all conditions of the tender offer to acquire all outstanding shares of Mersana at a price of $25 per share in cash, plus one non-tradable contingent value right ("CVR") per share to receive certain potential milestone payments of up to an aggregate of $30.25 per CVR in cash.

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"This acquisition of Mersana is a strategic fit with Day One’s mission and ambitions, allowing us to continue to expand into adult oncology while maintaining a focus on rare cancers. With promising early clinical data, Emi-Le represents a potentially transformative advancement in the treatment of ACC, and we will leverage our distinct capabilities to rapidly develop the asset and pursue registration to reach patient communities who have no approved therapies today," said Jeremy Bender, Ph.D., chief executive officer of Day One. "Building on the strong momentum of OJEMDA in the market and our continually progressing pipeline, this acquisition strengthens our overall position to expand our impact on patient communities while delivering sustainable business growth."

Through this acquisition, Day One has added a second novel ADC to the company’s clinical pipeline. Emi-Le (emiltatug ledadotin) represents an innovative and differentiated ADC directed against B7-H4, a well-characterized target in certain cancers including adenoid cystic carcinoma (ACC), a challenging rare cancer usually arising within the salivary gland with a clear unmet medical need. For additional background on Emi-Le and the acquisition, please read the announcement press release and view Day One’s investor presentation.

Terms of the Acquisition

Day One has acquired all outstanding shares of Mersana common stock at a price of $25 per share in cash, plus one non-tradable CVR per share to receive certain potential milestone payments of up to an aggregate of $30.25 per CVR in cash, for total consideration of up to $55.25 per share in cash. The CVR is payable subject to certain terms and conditions of achievement of specified milestones.

The tender offer expired as scheduled at one minute following 11:59 p.m., Eastern Time, on January 5, 2026 (the "Expiration Date"). The depositary for the tender offer, Computershare Trust Company, N.A., advised Day One that, as of the Expiration Date, a total of 3,029,135 shares of Mersana common stock were validly tendered and not validly withdrawn pursuant to the tender offer, representing 60.57% of the outstanding shares of Mersana common stock and satisfying the minimum condition to consummate the tender offer. All of the conditions of the tender offer having been satisfied, Day One accepted for payment all such tendered shares, and following a statutory merger under Section 251(h) of the Delaware General Corporation Law on January 6, 2026, Mersana became a direct wholly owned subsidiary of Day One. All remaining shares of Mersana common stock that were not tendered in the tender offer were converted into the right to receive the same per share consideration as shares that were tendered in the tender offer, as described above. With the completion of the acquisition, Mersana’s common stock will cease to trade on the Nasdaq stock exchange prior to market open on January 6, 2026 and Mersana’s common stock will be delisted from Nasdaq.

Advisors

Gordon Dyal & Co., LLC acted as the exclusive financial advisor to Day One, with Fenwick & West LLP serving as legal counsel. TD Cowen acted as financial advisor to Mersana, with Wilmer Cutler Pickering Hale and Dorr LLP serving as legal counsel.

(Press release, Day One, JAN 6, 2026, View Source [SID1234661751])

On January 6, 2026 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel allogeneic, or "off the shelf," cell therapies for serious medical conditions, reported the receipt of a novel, induced pluripotent stem cell (iPSC) line containing hypoimmunity edits, from Factor Bioscience Inc. ("Factor"). Generation of the line marks a successful milestone in the strategic collaboration between the two companies, under which Factor developed a proprietary, genetically engineered iPSC line that Lineage can utilize for differentiation into certain cell transplant product candidates. The novel cell line contains edits which are expected to support non-immune privileged and/or non-human leukocyte antigen (HLA) matched indications and includes an additional disease-specific edit with the potential to further differentiate this cell line from other cell therapies. Acceptance of the line triggered a success payment from Lineage to Factor as reimbursement for Factor’s development efforts to date. Factor remains eligible for an additional payment from Lineage subject to Lineage’s entry into an exclusive license to utilize the line. Lineage’s decision to proceed with the program will be based on further performance criteria and the outcome of additional testing, including the evaluation of the line for its ability to adapt to Lineage’s proprietary cell expansion manufacturing platform, the AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) platform.

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"Our partnership with Factor supports our plan to create novel and superior product candidates by combining our manufacturing and process development capabilities with cutting-edge cell engineering and editing technologies," stated Brian M. Culley, Chief Executive Officer of Lineage. "This achievement under our collaboration with Factor supports our plan to broaden our cell therapy platform through the addition of new technologies and indications, as we await further updates from our lead cell therapy program, OpRegen, for dry age-related macular degeneration with geographic atrophy. We look forward to leveraging the knowledge and expertise we have developed in retinal cell transplantation to additional cell therapy product candidates which may have the potential to transform the treatment of a wide range of diseases. We view the convergence of directed cell differentiation with modern gene editing technology as an exciting new branch of medicine, and we plan to continue to advance this emerging space."

"The cells we have delivered to Lineage embody the incredible potential of Factor’s gene-editing technology and represent a major milestone in the partnership between our companies," said Matt Angel, Ph.D., Chief Executive Officer and President of Factor. "We believe Factor’s state-of-the-art cell-engineering technologies have the potential to enable treatment of diseases in ways not previously possible. Factor and Lineage together are driving progress at the leading edge of engineered cell therapy development to benefit patients."

Lineage’s exclusive option and license agreement (the "Agreement") with Factor was announced in 2023. The novel hypoimmune iPSC line received by Lineage contains a set of specific edits selected in a development strategy vetted with subject matter experts in the U.S. and abroad, as well as under a broader competitive landscape analysis. The edits include: the targeted deletion of the B2M gene, designed to reduce the immunogenicity of product candidates derived from the lines by inhibiting rejection by CD8+ T cells; the targeted insertion of the HLA-E gene, designed to overexpress HLA-E and prevent adverse NK cell responses; and a third undisclosed edit intended to confer clinical differentiation and a competitive advantage in the applicable indications. The Agreement provides Lineage an option to obtain an exclusive license to utilize and sublicense the novel gene-edited cell line developed by Factor in a specific field for preclinical, clinical, and commercial purposes.

(Press release, Lineage Cell Therapeutics, JAN 6, 2026, View Source [SID1234661767])