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 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported corporate updates and highlighted upcoming milestones for 2026.

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"Heading into 2026, we are proud of the strong execution across our pipeline. Since reporting data in October from our prula-cel Phase 1 program in autoimmune diseases, enrollment has more than doubled with over 20 patients as of December 31, 2025. We have also reached regulatory alignment with the FDA to enable outpatient dosing of SLE and LN patients receiving prula-cel and are advancing our Phase 1 study in treatment-refractory RA comparing prula-cel following cyclophosphamide alone versus cyclophosphamide/fludarabine conditioning. Taken together, these accomplishments set the stage for a meaningful data readout expected in the first half of 2026," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "In parallel, we continue to advance our broader pipeline, including ADI-212, our next-generation, gene-edited and armored solid tumor candidate, which is advancing towards a regulatory filing in the first half of 2026. These achievements strongly position us as we prepare for a pivotal study and continue to advance our pipeline."

Recent Pipeline Progress and Operational Progress:

Autoimmune Diseases Clinical Programs

The prula-cel Phase 1 program is enrolling patients across seven different autoimmune diseases: LN, SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS), AAV and treatment-refractory RA. Prula-cel has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of relapsed/refractory class III or class IV LN, refractory SLE with extrarenal involvement, and SSc.
In November 2025 the Company reached alignment with the FDA to allow LN and SLE patients to be dosed with prula-cel in the outpatient setting in ongoing and future clinical trials.
In October 2025, Adicet announced the dosing of the first treatment-refractory RA patient in a Phase 1 study. The study will evaluate two conditioning regimens: cyclophosphamide alone and cyclophosphamide with fludarabine. The primary objectives of the study are to evaluate the safety and tolerability of prula-cel. Secondary objectives include measuring cellular kinetics, pharmacodynamics, and disease activity scores.
In October 2025, the Company reported positive preliminary safety and efficacy data from the Phase 1 clinical trial of prula-cel in patients with LN and SLE. The data highlighted rapid and sustained reductions in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score and Physician’s Global Assessment (PGA), improved renal function, and favorable safety and tolerability profile as of the August 31, 2025 data cut-off date.
Solid Tumor Clinical Programs

Adicet is continuing to advance preclinical development of ADI-212, a next-generation gene-edited and armored clinical candidate designed to target prostate-specific membrane antigen. ADI-212 is engineered to express a novel CAR binder designed to support enhanced tolerability and tumor-specific recognition. It integrates membrane-tethered IL-12 armoring and CRISPR/Cas9 mediated disruption of subunit 12 of the mediator complex (MED12) to enhance potency in solid tumors and deliver multiple anti-tumor mechanisms of action within the tumor microenvironment.
In October 2025, Adicet presented preclinical data from ADI-212 at the 32nd Annual Prostate Cancer Foundation Scientific Retreat supporting its design elements and functional enhancements in multiple models of disease.
Corporate Updates

In October 2025, Adicet successfully raised approximately $74.8 million in net proceeds through an underwritten registered direct offering of equity securities, extending its cash runway into the second half of 2027.
Strategic Priorities and Anticipated Key Milestones for 2026

Present new and updated clinical data from the Phase 1 study evaluating prula-cel throughout 2026.

Adicet remains on track to share a clinical update in LN, SLE, and SSc in the first half of 2026.
The Company also expects to share another clinical update from the study in the second half of 2026.
Gain alignment with the FDA on a path to registration for prula-cel.

Adicet plans to request a meeting with the FDA in the second quarter of 2026 to inform potential pivotal trial design. Subject to regulatory clearance to proceed, the Company expects to initiate a pivotal study in LN or LN and SLE patients in the second half of 2026.
Advance innovations designed to enhance patient experience and expand access.

The Company is actively enrolling patients with treatment-refractory RA in its Phase 1 study of prula-cel evaluating the potential to reduce the need for conditioning.
Adicet expects to provide a clinical update on the Phase 1 RA study in the second half of 2026.
Initiate clinical development of ADI-212 in mCRPC.

Adicet expects to submit a regulatory filing for ADI-212 for the treatment of mCRPC in the first half of 2026.
Subject to regulatory clearance to proceed with a clinical trial, the Company expects to initiate clinical startup activities in the second quarter of 2026.

(Press release, Adicet Bio, JAN 7, 2026, View Source [SID1234661828])

On January 7, 2026 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported that its Phase Ib/II study of FL115 (IL-15 Superagonist) in combination with anti-PD-1 antibody for patients with advanced solid tumor has been activated at the first clinical study site, Sun Yat-sen University Cancer Center; separately, its IND for FL115 Subcutaneous Injection has been accepted by Chinese NMPA.

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The Phase Ib/II study (NCT07131202) is an open-label, multicenter study to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, and pharmacodynamics of FL115 in combination with an anti-PD-1 monoclonal antibody through IV infusion in patients with advanced solid tumors. The first clinical study site, Sun Yat-sen University Cancer Center, is now open and actively screening eligible participants.

FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein, aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. FL115 monotherapy via IV infusion has been assessed in two Phase I studies in patients with advanced solid tumors, showing good safety profile with preliminary clinical efficacy (DCR 41% with PR 7%) supported by significant and sustainable expansion of NK and CD8+ T cells as well as strong transient induction of IFN-g. Clinical benefit have been observed in patients continuing on treatment, including 1 patient with Stable Disease over 68 weeks, and 2 patients with confirmed PR at 32 and 24 weeks respectively. Based on mechanism of action and literature, FL115 expects to be synergistic with anti-PD-1 antibody and the combination therapy expects to significantly enhance clinical efficacy especially for patients resistant or refractory to PD-1 therapy.

FL115, currently formulated at 20 mg/ml with stability over 3 years, especially fits for subcutaneous formulation development. Compared to IV infusion, FL115 subcutaneous injection has been shown to lower Cmax by over 20 fold while significantly increasing the meaningful exposure duration, with bioavailability at 60% or more. FL115 subcutaneous formulation expects to significantly enhance NK and T cell stimulation and clinical efficacy while improving safety profile by lowering release of certain cytokines. An abstract, "Development of FL-115, a novel IL-15 superagonist, as subcutaneous injection for cancer immunotherapy" has been accepted for presentation at the upcoming AACR (Free AACR Whitepaper) Annual Meeting 2026.

"FL115 monotherapy via IV infusion has demonstrated safety/tolerability with early signs of potent anti-tumor activity in Ph1 in patients with advanced solid tumors," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology, "FL115 in combination with anti-PD-1 antibody via IV infusion expects to significantly enhance clinical efficacy through synergy of mechanisms of actions while F115 subcutaneous formulation expects to further improve safety and efficacy profile as well as convenience. Such continuing clinical development activities will further establish FL115 as potential Best-in-class IL-15 superagonist, and bring new treatment options for cancer patients in need."

About FL-115

FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein, aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. FL115 has demonstrated significant anti-tumor activities as a monotherapy or as part of combination therapy in vivo, and can be manufactured by a robust and efficient process with excellent product stability. Clinically, FL115 has demonstrated favorable safety profile and preliminary clinical responses as a monotherapy, and has the best-in-class potential to synergize with current and emerging T cell-targeting immunotherapies through combination therapy to significantly improve the treatment outcome for patients. It is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial to evaluate safety and preliminary efficacy in patients with nonmuscle invasive bladder cancer (NMIBC) and in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial to evaluate safety and preliminary efficacy in patients with advanced solid tumors. An IND of FL115 Subcutaneous Formulation has been accepted by Chinese NMPA.

(Press release, Forlong Biotechnology, JAN 7, 2026, View Source [SID1234661827])

On January 7, 2026 SAGA Diagnostics, a pioneer in blood-based cancer detection and precision medicine redefining the standard for ultrasensitive and early molecular residual disease (MRD) detection, reported collaborators from the Karolinska Institutet to present new clinical data showcasing the ultrasensitive detection of ctDNA in colorectal cancer (CRC) using Pathlight at the 2026 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, January 8-10 in San Francisco, CA.

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The CIrculating Tumour DNA (ctDNA) as a Prognostic and Predictive Marker in Colorectal CAncer (CITCCA) study is one of the largest CRC ctDNA studies conducted to date, particularly in rectal cancer. Within the larger multicenter, prospective study, Pathlight retrospectively analyzed ctDNA from 377 patients with stage I–III colorectal cancer (25% of patients were stage 1), including 232 (~60%) patients with colon cancer and 145 (~40%) patients with rectal cancer, who received standard-of-care treatment and follow-up across seven centers in Sweden between October 2020 and January 2024. The primary objective was to evaluate the association between ctDNA status and recurrence-free interval (RFI), defined as the time from surgery to first radiological confirmation of recurrence.

Analysis of the data demonstrated:

Patients who were ctDNA-positive following treatment experienced significantly higher rates of recurrence compared to ctDNA-negative patients. Overall, the hazard ratio was 38.5; 33.8 for colon cancer patients and 93.5 for rectal cancer patients.
Three-year RFI was ~30% for ctDNA-positive patients versus ~90% for ctDNA-negative patients, highlighting the strong prognostic value of ultrasensitive ctDNA detection using Pathlight.
42.5% of ctDNA-positive patients at the clinical landmark (4-6 weeks post-surgery) had ctDNA levels in the ultrasensitive range (<100 ppm), indicating that a substantial proportion of high-risk patients would only be identified using an ultrasensitive assay.
Recurrence risk was markedly higher in ctDNA-positive patients who did not receive adjuvant chemotherapy (ACT), demonstrating that ctDNA may help guide ACT treatment decisions.
"The CITCCA study provides compelling prospective evidence that ctDNA is a powerful predictor of recurrence in patients with stage I–III colorectal cancer," said Professor Anna Martling, MD, Karolinska Institutet, Stockholm, Sweden and principal investigator of the study. "The striking difference in three-year recurrence-free interval between ctDNA-positive and ctDNA-negative patients highlights the clinical value of structural-variant-based ultrasensitive MRD detection. Tools like Pathlight have the potential to meaningfully improve how we risk-stratify patients and tailor treatment and follow-up strategies."

Poster details:

Abstract #208/Poster #H20: Ultrasensitive Structural Variant-based ctDNA detection of MRD in Colorectal Cancer – the CITCCA study
Date: January 10, 2026; Times: 7:00-7:55 AM PST and 12:00 PM-1:30 PM PST
Presenter: Cecilia Merk, MD, Karolinska Institutet, Stockholm, Sweden

"Data from the CITCCA study reinforce the critical role of ctDNA as a prognostic biomarker in early-stage colorectal cancer," said Wendy Levin, MD, MS, Chief Clinical Officer, SAGA Diagnostics. "Importantly, more than 40% of ctDNA-positive patients had residual disease at levels only detectable with ultrasensitive methods, as enabled by Pathlight’s structural-variant-based approach. This finding underscores that test sensitivity matters – not just for identifying patients at highest risk of recurrence, but for informing more personalized decisions around adjuvant therapy and follow-up. We are proud to collaborate with the Karolinska Institutet on a study of this scale and quality, which advances the clinical evidence base for MRD-guided decision making for patients with colorectal cancer."

The poster presented at ASCO (Free ASCO Whitepaper) GI will be available on SAGA’s website after the presentation.

(Press release, SAGA Diagnostics, JAN 7, 2026, View Source [SID1234661826])

On January 7, 2026 Volastra Therapeutics, a clinical-stage biotechnology company pioneering first-in-class therapies targeting chromosomal instability (CIN) in cancer, reported a significant expansion of its clinical development program driven by encouraging clinical data from its lead KIF18A inhibitor (KIF18Ai), a key investigational CIN-targeted cancer therapy. The company also highlighted continued advancement across its strategic pipeline and the appointment of Timothy Bowler, M.D., Ph.D., as its new Chief Medical Officer, strengthening its leadership team as it executes on key value-inflection milestones.

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"These developments represent a meaningful step forward for Volastra as we continue to build a differentiated oncology company focused on chromosomal instability," said David Southwell, Chief Executive Officer of Volastra Therapeutics. "The strength of the emerging clinical data from our KIF18Ai program reinforces our conviction in CIN as a compelling therapeutic target and supports the expansion of our clinical strategy. With continued progress across our pipeline and the addition of our highly experienced Chief Medical Officer, we are well-positioned to execute on key upcoming milestones and create long-term value for patients and shareholders."

In addition to the company’s progress with its KIF18Ai ovarian cancer clinical program:

Expansion into New Tumor Types: It is also extending its Phase 1/2 program beyond ovarian cancer, with additional efficacy data from expansion cohorts expected in the first half of 2026.
KIF18Ai Combination Trials: The company is advancing new combination therapy studies with standards of care based on synergistic efficacy with taxanes in preclinical studies. Volastra plans to initiate its first combination trial in the first quarter of 2026, evaluating a KIF18Ai in combination with standard-of-care chemotherapy in patients with ovarian, lung, and breast cancers. Initial safety data are anticipated in the second quarter, with efficacy data expected to emerge in the second half of the year.
Biomarker Approach: In parallel, the company will continue to advance its biomarker identification strategy to predict KIF18Ai response, with results expected throughout the first half of 2026.
FDA Regulatory Update: Volastra also anticipates an End-of-Phase meeting with the FDA in the second half of 2026 to discuss potential registrational trials, reflecting the continued clinical momentum of the program.
These initiatives build on VLS-1488’s Phase 1 clinical results and follow the program’s FDA Fast Track designation in platinum-resistant ovarian cancer. To date, more than 120 patients have been treated with VLS-1488, which has been well tolerated across all dose levels with no dose-limiting toxicities observed. The company has demonstrated a clear dose-response across dose levels, with strong early efficacy and a favorable safety profile in platinum-resistant ovarian cancer. Notably, VLS-1488 has also demonstrated durable clinical benefit, with approximately half of patients with squamous non-small cell lung cancer remaining on therapy beyond six months.

To support its pipeline growth, Volastra has appointed Timothy Bowler, M.D., Ph.D., as Chief Medical Officer. He will oversee the expanded clinical program and drive the execution of the company’s development strategy. Dr. Bowler succeeds Dr. Scott Druttman, who is leaving Volastra to pursue other opportunities.

"Tim has been instrumental in driving our clinical progress, and we are delighted to have him step into the CMO role," said Mr. Southwell. "His expertise in oncology drug development will be invaluable as we advance our pipeline and strive to deliver CIN-targeted therapies to patients."

Dr. Bowler, a board-certified medical oncologist and experienced drug developer, previously served as Volastra’s Vice President of Clinical Development. Prior to joining Volastra in 2023, Dr. Bowler was Global Clinical Lead in oncology at Pfizer, and previously served at Regeneron and Memorial Sloan Kettering Cancer Center. In his new role, he will spearhead all clinical strategy and operations, guiding the KIF18Ai program through its next phase of growth and advancing Volastra’s broader clinical portfolio.

"Volastra’s innovative approach to targeting chromosomal instability has tremendous potential to benefit patients," said Timothy Bowler, M.D., Ph.D., Chief Medical Officer of Volastra. "Our focus now is executing a disciplined development plan that builds on monotherapy activity while expanding the reach of KIF18Ai through combinations and biomarker-guided approaches."

(Press release, Volastra Therapeutics, JAN 7, 2026, View Source [SID1234661825])