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])

On January 7, 2026 InduPro, Inc., a biotechnology company defining membrane protein spatial relationships to create novel therapeutics for the treatment of cancer and autoimmune diseases, reported a global strategic collaboration and licensing agreement, and equity investment, with Eli Lilly and Company ("Lilly") to discover novel oncology treatments using InduPro’s proximity-guided platform.

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Under the terms of the agreement, the two companies will collaborate on up to three targets, for a total deal value of up to approximately $950M. Lilly will also make an equity investment in InduPro.

By leveraging Tumor Associated Proximity Antigens (TAPAs), surface antigens that are spatially co-localized and often functionally linked to tumor-associated antigens (TAAs) within the tumor microenvironment, the companies will use InduPro’s proximity-based platform to discover novel, disease-specific protein-target pairs. This strategy is designed to enable new therapeutic approaches for bispecific antibody drug conjugates (ADCs) and multispecific T-cell engagers, offering improved safety, potency, and tumor selectivity.

"Our partnership with Lilly underscores a shared commitment to advancing a new generation of tumor-selective medicines guided by the spatial biology of cancer," said Prakash Raman, PhD, CEO of InduPro. "TAPAs represent a fundamentally new way to think about tumor antigens, and we’re thrilled that Lilly shares our vision of leveraging proximity-based biology to enable precision multi-specific therapeutics. We believe this partnership reflects growing confidence in our differentiated, proximity-guided approach to tumor targeting and its promise to improve the design and performance of ADCs and TCEs."

Through the agreement, Lilly will gain access to InduPro’s proprietary AI/ML-enabled membrane interactomics (MInt) platform. InduPro will lead early discovery efforts, applying its proximity-guided platform to identify co-target pairs and advance bispecific and multispecific antibody programs emerging from the collaboration.

(Press release, InduPro, JAN 7, 2026, View Source [SID1234661824])

On January 7, 2026 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules for patients with cancer and inflammatory and autoimmune diseases, reported its 2026 priorities for casdatifan and its emerging inflammation and immunology (I&I) programs.

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"As we enter 2026, the highest priorities for Arcus will be the rapid enrollment of PEAK-1, our Phase 3 study evaluating casdatifan in immunotherapy (IO)-experienced ccRCC patients, and the initiation of a 1L Phase 3 study evaluating casdatifan informed by data from multiple ongoing and soon-to-be initiated Phase 1 combination studies," said Terry Rosen, Ph.D., chief executive officer of Arcus. "This year, we also expect to advance our first small molecule for inflammatory disease into the clinic."

Casdatifan (HIF-2a inhibitor for ccRCC)

Upcoming Data Presentations:

Arcus expects to have at least three data readouts for casdatifan, its potential best-in-class HIF-2a inhibitor, during 2026:

In February 2026, Arcus plans to present updated data from the four cohorts of the Phase 1/1b ARC-20 study evaluating casdatifan monotherapy in late-line ccRCC at a medical conference. These data will include updated progression-free survival (PFS) data for the 100mg once-daily (QD) cohort of casdatifan and for all four monotherapy cohorts combined (n=121), as well as updated biomarker data correlating erythropoietin suppression with clinical outcomes.
Mid-year, Arcus expects to present updated data for approximately 45 patients treated in ARC-20 with casdatifan plus cabozantinib in IO-experienced ccRCC; this cohort evaluates the same combination in the same setting as PEAK-1, an ongoing Phase 3 study, which represents Arcus’s "fast-to-market" strategy in ccRCC.
In the second half of the year, Arcus expects to present data from multiple ARC-20 cohorts evaluating casdatifan in early-line metastatic settings, including data from the cohort evaluating casdatifan plus the anti-PD-1 antibody, zimberelimab, in 1L ccRCC.
This will be the first presentation of data for a tyrosine kinase inhibitor (TKI)-sparing HIF-2a inhibitor-based regimen in the 1L setting. Data from this cohort are expected to show an acceptable safety profile and early efficacy, including a low rate of primary progression, which is essential in this setting. The cohort is designed to de-risk Arcus’s strategy to displace TKIs as an early-line treatment.
Development Strategy:

Arcus’s development plan is designed to establish casdatifan as a foundational standard of care across multiple settings of ccRCC, which represents a potential global market opportunity of $5 billion or more.

Arcus’s ongoing Phase 3 study for casdatifan in IO-experienced ccRCC, PEAK-1, is evaluating casdatifan plus cabozantinib, the most widely used TKI in this setting. Similar Phase 3 trials in this setting have completed enrollment in 18 months or less, and Arcus’s goal is to achieve a similar timeline.

Arcus’s strategy in 1L ccRCC is focused on TKI-free regimens, which are enabled by the consistently low rate of primary progression observed with casdatifan across all cohorts and settings evaluated to date. This strategy has the potential to bring about a highly desirable paradigm shift with a first-in-class regimen that delays treatment with TKIs and their associated toxicities to later lines of therapy. The following cohorts are designed to efficiently determine the optimal 1L registrational strategy for casdatifan:

Casdatifan plus zimberelimab (Arcus’s anti-PD-1 antibody): This combination is currently being evaluated in ARC-20, and this cohort has completed enrollment. Arcus plans to present data from this cohort in the second half of 2026.
Casdatifan plus anti-PD-1-containing regimens: Arcus is planning to initiate new cohorts to evaluate two other TKI-free casdatifan plus anti-PD-1-containing regimens in the 1L setting.
Casdatifan plus volrustomig (AstraZeneca’s anti-PD-1/CTLA-4 bispecific antibody): This combination is being evaluated in the eVOLVE-RCC02 study (which is being operationalized by AstraZeneca).
Data from these cohorts will inform and enable the initiation of a Phase 3 study for a casdatifan-containing, TKI-free regimen in the 1L setting. Arcus is targeting initiation of this study by year-end 2026.

Small-Molecule Inflammation & Immunology Programs

Arcus’s I&I strategy leverages the company’s demonstrated capabilities in small-molecule drug discovery, focusing on indications currently dominated by blockbuster injectable biologics and on highly validated targets. Arcus’s I&I portfolio currently includes several oral small molecules, including an MRGPRX2 antagonist and inhibitors of TNF, CCR6 and CD40L. The company is also developing an anti-CD89 antibody that has potential in patients with a type of rheumatoid arthritis that is currently difficult to treat.
Arcus expects to advance its lead inflammation program, a potential best-in-class oral MRGPRX2 antagonist for atopic dermatitis and chronic spontaneous urticaria, into clinical development in 2026. The molecule was designed to have exquisite potency, enabling substantially lower-dose target coverage relative to the most advanced MRGPRX2 antagonist in clinical development, thereby avoiding potential exposure-limiting toxicities.
Arcus also expects to advance an oral small-molecule TNF inhibitor, a potential treatment for rheumatoid arthritis, psoriasis and inflammatory bowel disease (such as ulcerative colitis), into the clinic in late 2026 or early 2027.
Quemliclustat (CD73 inhibitor for pancreatic cancer)

Arcus’s oncology portfolio also includes quemliclustat, a small-molecule CD73 inhibitor, which is being evaluated in PRISM-1, a registrational Phase 3 study in 1L pancreatic cancer that completed enrollment in September 2025. Results from this study are expected in the first half of 2027.
Runway Guidance

Arcus has approximately $1 billion of cash and investmentsi and expects to be able to fund its planned operations until at least the second half of 2028. This guidance includes a rapid wind down of the Phase 3 STAR-221 and Phase 2 EDGE-GASTRIC studies. In the first quarter of 2026, Arcus and Gilead expect to conduct an analysis of STAR-121, a Phase 3 study evaluating domvanalimab plus zimberelimab and chemotherapy in 1L non-small cell lung cancer. Depending on the outcome of this analysis, Arcus could realize additional cost savings.

Presentation at 44th Annual J.P. Morgan Healthcare Conference

Arcus will present at the 44th Annual J.P. Morgan Healthcare Conference at 3:00 pm PT on Wednesday, January 14, 2026. A live webcast of the presentation will be available on the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay will be available following the live event.

Domvanalimab, zimberelimab and quemliclustat are investigational molecules, and neither Arcus nor Gilead has received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established. Casdatifan is also an investigational molecule, and Arcus has not received approval from any regulatory authority for any use globally, and its safety and efficacy have not been established.

About RCC

According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 80,980 Americans will be diagnosed with kidney cancer in 2025. Clear cell RCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 18%. In 2022, approximately 32,200 patients with advanced kidney cancer required systemic therapy in the U.S., with over 20,000 patients receiving first-line treatment.

About Casdatifan (AB521)

Casdatifan is a small-molecule inhibitor of HIF-2a, a master switch that turns on hundreds of genes in response to low oxygen levels. In a majority of people with the most common form of kidney cancer (clear cell renal cell carcinoma), genetic anomalies result in the dysregulation of this master switch and transformation of normal kidney cells into cancerous ones. Casdatifan was designed to provide deep and durable inhibition of the HIF-2a pathway. Early clinical studies have shown high response rates and a low primary progression rate relative to clinical benchmarks, warranting further investigation in late-stage studies. Casdatifan, which is administered in pill form once daily, has a safety profile that allows it to be investigated in combination with other treatments.

About Zimberelimab

Zimberelimab is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody that binds PD-1, with the goal of restoring the antitumor activity of T cells. Zimberelimab has demonstrated high affinity, selectivity and potency in various tumor types. Zimberelimab is being evaluated in the U.S. and globally as a foundational anti-PD-1 treatment option in multiple ongoing clinical studies in combination with other immunotherapies. Guangzhou Gloria Biosciences Co. Ltd., which holds commercialization rights for zimberelimab in greater China, has obtained approval for zimberelimab for the treatment of recurrent or metastatic cervical cancer and for relapsed or refractory classical Hodgkin’s lymphoma. Zimberelimab is not approved for any use in the U.S. or other regions outside of China. Gloria conducts its development and commercialization activities independent of Arcus and Gilead.

(Press release, Arcus Biosciences, JAN 7, 2026, View Source [SID1234661823])