On January 12, 2026 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ ) T cell therapies for cancer and autoimmune diseases, reported updated clinical data from its INB-200 Phase 1 and INB-400 Phase 2 trials in newly diagnosed glioblastoma (GBM). The prior results were presented at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting. The data continue to demonstrate meaningful and durable improvements in progression-free survival when compared with both historical standard-of-care (SOC) Stupp protocol data and concurrently enrolled SOC treated patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Patients in both the Phase 1 and 2 who received repeated doses of the Company’s investigational therapy, DeltEx Drug-Resistant Immunotherapy gamma-delta (γδ) T cells (DeltEx DRI) (N=14), experienced substantial improvements in both median progression-free (mPFS) and median overall survival (mOS) across multiple clinical centers. This data is put into greater context compared to contemporaneously enrolled patients treated only with SOC at the same clinical trial sites (N=10), forming a concurrently treated control cohort:

Median progression-free survival (mPFS): DeltEx DRI 13.0 months vs. 6.6 months with SOC (a +97% improvement).
Median overall survival (mOS): DeltEx DRI, not yet reached, currently 17.2+ months and rising, compared with 13.2 months (final mOS) for SOC.
Durability: DeltEx DRI, eight of fourteen patients (57%) remained progression-free longer than their expected overall survival (OS) based on age and MGMT status (a biomarker used to stratify GBM patients and impacting response to chemotherapy), compared with just a single patient (10%) in the control group.
Long-term benefit: Several DeltEx DRI treated patients remain progression-free beyond two years without experiencing any significant DRI related SAEs or DLTs.
William Ho, CEO and Co-founder of IN8bio, commented, "GBM is an extremely aggressive and devastating brain cancer, with a short median survival of only ~12 months and no meaningful innovation in over twenty years. The contrast between our repeat-dose DeltEx DRI patients and the SOC controls treated at the same centers demonstrates a profound improvement. The increase in mPFS, particularly in the newly diagnosed GBM setting, is meaningful time for these patients. The durability of these mPFS results, combined with a well-tolerated safety profile, underscore the potential of our γδ T cell therapy to meaningfully improve newly diagnosed GBM treatment and patient outcomes."

For the first time, IN8bio presented data from a control group of patients that were contemporaneously enrolled and treated only with the SOC protocols at the same clinical centers with the same treating physicians as the DeltEx DRI cohorts. The SOC control patients performed in-line with expectations based on historical GBM mPFS of 6.9 months, despite a greater number of patients receiving gross total resections. This demonstrates both the aggressive nature of GBM, even with SOC treatment, and the significant need for new treatment options. The funds received from IN8bio’s recent financing announced late in 2025 will support further discussions with the FDA on potential clinical pathways, including any potential for accelerated approval.

Across both Phase 1, INB-200, and Phase 2, INB-400, trials at multiple centers, DeltEx DRI γδ T cells continued to demonstrate a well-tolerated safety profile, with:

No DLTs
No cytokine release syndrome (CRS)
No immune effector cell-associated neurotoxicity (ICANS)
No unexpected infections or SAEs
Kate Rochlin, PhD, Chief Operating Officer, IN8bio, added, "These results show a consistent biological and clinical story. In the DeltEx DRI treated patients, we observed persistent and elevated levels of γδ T cells in circulation, immune cell infiltration within the tumors, and broader systemic immune activation. This is significant in understanding the immune impact in patients treated with this therapy, particularly in a setting traditionally considered a "cold" tumor combined with long-term lymphodepleting chemotherapy. Furthermore, these findings indicate that localized intracranial delivery of DeltEx DRI can drive systemic immune responses, an aspect that could be important in fighting GBM. This is a disease marked by profound treatment-induced lymphodepletion, rapid progression, and poor outcomes.

The data presented at SNO was the first time IN8bio had presented multi-center DeltEx treated and control SOC patient data from the both 1 and Phase 2 trials. Across all sites, early trends in mPFS and mOS were consistent with the original INB-200 trial, reinforcing:

Reproducibility across clinical centers
Scalability of the repeated-dose approach
A strong foundation for further development

(Press release, In8bio, JAN 12, 2026, View Source [SID1234661954])

On January 12, 2026 Tscan therapeutics presented its corporate presentation.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

(Presentation, TScan Therapeutics, JAN 12, 2026, View Source [SID1234661972])

On January 12, 2026 AbbVie (NYSE: ABBV) and RemeGen reported an exclusive licensing agreement for the development, manufacturing and commercialization of RC148, a novel investigational Programmed Cell Death-1 (PD-1)/Vascular Endothelial Growth Factor (VEGF)-targeted bispecific antibody. RC148 is currently being developed by RemeGen as a monotherapy and in combination regimens across multiple advanced solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

PD-1/VEGF-targeted bispecific antibodies represent a new class of cancer therapies that aim to help the immune system fight tumors more effectively and potentially overcome tumor resistance mechanisms by blocking both PD-1 and VEGF simultaneously. Additionally, given their potential to modulate both immune suppression and foster a favorable tumor microenvironment for antibody-drug conjugate (ADC) activity, PD-1/VEGF bispecific antibodies are also being explored in combination with ADCs. In early clinical studies, RC148 has shown initial favorable antitumor activity in combination with an ADC.

RC148 further strengthens AbbVie’s diverse oncology portfolio. In particular, it may offer new opportunities to explore combination regimens with AbbVie’s ADCs such as investigational telisotuzumab adizutecan (Temab-A), across multiple solid tumors with high unmet need including non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).

"Our partnership with RemeGen reflects AbbVie’s commitment to not only advance novel oncology treatments, but also to build strong collaborations with biopharmaceutical innovators globally as an increasingly important source of scientific and clinical progress," said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology at AbbVie. "By combining the immune checkpoint inhibition and anti-angiogenic activity of RC148 together with the targeted cytotoxic activity of ADCs, we have the potential to identify meaningful options for patients across a range of solid tumors."

"This collaboration is a significant milestone for RemeGen, highlighting the innovative potential of RC148 in addressing critical unmet medical needs in cancer treatment," said Dr. Jianmin Fang, chief executive officer of RemeGen. "The deal further underscores RemeGen’s commitment to bringing cutting-edge therapies to patients worldwide. Working with AbbVie, we look forward to maximizing RC148’s clinical and commercial potential in China and globally."

Under the terms of the agreement, AbbVie will receive exclusive rights to develop, manufacture, and commercialize RC148 outside of the Greater China territory. RemeGen will receive an upfront payment of USD $650 million and is eligible to receive up to USD $4.95 billion in aggregate development, regulatory, and commercial milestone payments, along with tiered, double-digit royalties on net sales outside the Greater China territory.

(Press release, AbbVie, JAN 12, 2026, View Source [SID1234661988])

On January 12, 2026 Eureka Therapeutics, Inc., a clinical-stage biotechnology company advancing next-generation T-cell therapies for cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to ECT204, a GPC3-targeting ARTEMIS CAR T-cell therapy, for the treatment of patients with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The RMAT designation followed the FDA’s review of data from the completed Phase I cohort, together with additional clinical data, from Eureka’s ongoing Phase I/II ARYA-3 trial evaluating ECT204, an autologous ARTEMIS CAR T-cell therapy based on the AbTCR (Antibody-T Cell Receptor) architecture, in adult patients with GPC3-positive advanced HCC. RMAT designation, granted based on preliminary clinical evidence of potential to address unmet medical needs, provides the benefits of Breakthrough Therapy designation for regenerative medicines, including enhanced FDA interaction, alignment on development and manufacturing strategy, discussion of surrogate or intermediate clinical endpoints that may support accelerated approval, and eligibility for priority review of a future biologics license application (BLA).

"This represents an important inflection point for Eureka and for cell therapy in solid tumors," said Dr. Cheng Liu, Founder and Chief Executive Officer of Eureka Therapeutics. "ARTEMIS was designed to overcome the limitations of conventional CAR T-cell therapies in solid tumors, and early clinical observations with ECT204 in liver cancer reinforce our belief that the ARTEMIS architecture can meaningfully expand the therapeutic reach of cell therapy."

HCC is among the most biologically resistant solid tumors in oncology, characterized by an immunosuppressive tumor microenvironment that has posed significant challenges to the effectiveness of cell-based therapies. Unlike conventional CAR T cells that rely on a synthetically fused CD3-zeta (ζ) signaling domain linked to co-stimulatory molecules, which may contribute to constitutive activation and limited persistence in solid tumors, ARTEMIS CAR T cells were engineered using the AbTCR architecture and incorporate dual receptors that leverage human gamma delta (γ/δ) T cell receptor (TCR) signaling with co-stimulation delivered through separate receptors. This more natural TCR signaling design combines the precision of antibody-redirected tumor targeting with balanced and sustained T-cell activation, which may explain the improved tumor infiltration, persistence, and functional activity of the engineered T cells in hostile solid tumor environments.

The advantages of ARTEMIS CAR T cells over conventional CAR T cells have been validated by independent research conducted in collaboration with the National Cancer Institute, including NCI-led, peer-reviewed studies published in Cell Reports Medicine. In preclinical solid tumor models, ARTEMIS CAR T cells demonstrated significantly greater tumor infiltration and anti-tumor activity than conventional CAR T cells using the same antigen-binding domain, including in low antigen density settings that typically limit conventional CAR T efficacy.

ECT204 previously received FDA Orphan Drug Designation (ODD) in January 2022, reflecting the significant unmet need in advanced HCC. With RMAT designation in place, Eureka will work closely with the FDA to advance ECT204 through the ongoing ARYA-3 trial while continuing to build on the broader applicability of the ARTEMIS platform across different cancer indications.

About ECT204

ECT204 is an autologous T-cell therapy engineered with Eureka’s proprietary ARTEMIS CAR platform. Unlike conventional CAR T cells, ARTEMIS T cells are designed to mimic the natural biological regulation of T-cell activation, potentially improving safety, tumor infiltration, and persistence in solid tumors. ECT204 targets GPC3 (Glypican-3), an oncofetal antigen found on more than 70% of HCC cells but rarely on healthy tissues. The GPC3 protein is also expressed in other solid tumors, including ovarian and lung cancer. ECT204 is currently being investigated in Eureka’s ongoing ARYA-3 study, an open-label, dose escalation, multi-center Phase I/II clinical trial in adult patients with GPC3-positive HCC.

(Press release, Eureka Therapeutics, JAN 12, 2026, View Source [SID1234661999])

On January 12, 2026 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 2025 accomplishments and strategic priorities for 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In 2025, we remained steadfast in our goal of helping patients live longer and live well, making meaningful advancements to our pipeline and strengthening the operational capabilities that support our strategic priorities. In addition to the progress we continue to make with zelenectide pevedotin and BT5528, our recently announced collaborations with the United Kingdom Nuclear Decommissioning Authority, United Kingdom National Nuclear Laboratory and SpectronRx provide us with the potential for an end-to-end supply chain for 212Pb, building on the existing supply chains we have established for 177Lu and 68Ga. In summary, by combining these supply collaborations with our proprietary Bicycle technology we have established a unique radiopharmaceutical capability from the identification of Bicycle targeting agents to the potential commercial supply of the radiotherapeutic across multiple radioisotopes," said Bicycle Therapeutics CEO Kevin Lee, Ph.D. "We look forward to providing updates on the potential approval pathway for zelenectide pevedotin and dose selection from the Phase 2/3 Durvelo-2 trial in the first quarter of 2026."

2025 Key Accomplishments

Reported updated topline Phase 1 Duravelo-1 combination data for zelenectide pevedotin plus pembrolizumab in first-line cisplatin-ineligible patients with metastatic urothelial cancer (mUC). The data continue to show zelenectide pevedotin’s promising anti-tumor activity and differentiated safety profile.
Initiated Phase 1/2 Duravelo-3 trial for zelenectide pevedotin in NECTIN4-amplified breast cancer.
Initiated Phase 1/2 Duravelo-4 trial for zelenectide pevedotin in NECTIN4-amplified non-small cell lung cancer.
Reported first human imaging data for an early Bicycle Radioconjugate (BRC) molecule targeting EphA2 at the Targeted Radiopharmaceuticals Summit Europe. The data supports the potential of EphA2 as a novel cancer target and demonstrates the positive properties of BRC molecules for radiopharmaceutical use.
Presented additional human imaging data for an early Bicycle Radioconjugate (BRC) molecule targeting MT1-MMP at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025. The company believes this data further supports the potential of MT1-MMP as a novel target in the treatment of cancer, demonstrates the translatability of BRC preclinical data and highlights the potential of Bicycle molecules for targeted radionuclide therapies and radiopharmaceutical imaging.
2026 Strategic Priorities and Anticipated Milestones

Nectin-4 Pipeline (zelenectide, BT7480)

Provide an update on dose selection for Phase 2/3 Duravelo-2 pivotal trial and zelenectide pevedotin’s potential approval pathway in mUC following meetings with multiple regulatory agencies in the first quarter of 2026.
Report dose selection data from Phase 2/3 Duravelo-2 pivotal trial evaluating zelenectide pevedotin in combination with pembrolizumab in patients with mUC at a scientific conference in the first half of 2026.
Report additional Phase 1 Duravelo-1 combination data with pembrolizumab in first-line cisplatin-ineligible mUC at a scientific conference in the first half of 2026.
Report longer-term follow-up Phase 1 Duravelo-1 monotherapy data in late-line mUC at a scientific conference in the first half of 2026.
Report initial data for Phase 1/2 Duravelo-3 trial for zelenectide pevedotin in NECTIN4-amplified breast cancer at a scientific conference in the second half of 2026.
Report Phase 1 BT7480 combination data with nivolumab at a scientific conference in the first half of 2026.
EphA2 Pipeline (BT5528, EphA2 imaging)

Report Phase 1 BT5528 combination data with nivolumab in mUC patients at a scientific conference in the first half of 2026.
Provide an update on future clinical development plans for BT5528 in the first half of 2026.
Report additional EphA2 human imaging data in the first half of 2026.

(Press release, Bicycle Therapeutics, JAN 12, 2026, View Source [SID1234661939])