On January 12, 2026 Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, reported preliminary unaudited net product revenue from sales of AUCATZYL (obecabtagene autoleucel; obe-cel) for the fourth quarter and full year of 2025. The Company also announced pipeline advancement updates and anticipated future milestones.

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!

AUCATZYL 2025 Preliminary Unaudited Net Product Revenues, Commercial Updates and 2026 Revenue Guidance

Dr. Christian Itin, Chief Executive Officer of Autolus, said: "We had a successful launch of AUCATZYL in the US with full year sales well above expectations and more than 60 centers offering treatment. We established reliable, high-quality product delivery with short and consistent turn-around time. Parallel to the launch and independent from the Company, the ROCCA consortium collected real-world data for AUCATZYL in adult r/r B-ALL patients and presented initial data at ASH (Free ASH Whitepaper) 2025. The real-world data confirmed a high level of clinical activity and a favorable safety profile for AUCATZYL consistent with prior clinical trial results, and we believe this positive customer experience will be a key driver for the future growth of AUCATZYL in 2026.

"In addition to our launch of AUCATZYL in the US, we obtained regulatory approvals in the UK and EU. We successfully navigated the challenging pricing and reimbursement process with NICE, establishing cost effectiveness of AUCATZYL for the NHS and initiating our commercial launch in the UK in December under routine commissioning – a first for a CAR T therapy in the UK."

Based on preliminary unaudited financial information, Autolus expects net product revenue from sales of AUCATZYL to be approximately $24 million1 for the fourth quarter of 2025. Net product revenues for the full year of 2025, the first year of commercial sales, are expected to be approximately $75 million1. The Company plans to report its fourth quarter and full year 2025 financial results in March 2026.

For 2026, the Company projects net product revenue for AUCATZYL of between $120 million to $135 million.

Pipeline Updates and Upcoming Clinical Milestones

Dr. Matthias Will, Chief Development Officer of Autolus, said: "In 2025 we reported strong initial clinical data for the Phase 1 CATULUS trial in pediatric r/r B-ALL patients and in the Phase 1 CARLYSLE trial in patients with severe lupus erythematosus. Both data sets form a compelling basis for progressing those studies in pediatric B-ALL and in lupus nephritis to Phase 2. With this strong foundation of clinical data, Phase 2 studies enrolling and demonstrated commercial and manufacturing capabilities, we believe Autolus is well positioned to drive growth with obe-cel in additional and significant indications."

Obe-cel data in pediatric r/r B-ALL

Preliminary data from the CATULUS Phase 1 trial of obe-cel in pediatric relapsed or refractory (r/r) B-ALL patients were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Obe-cel demonstrated high remission rates in pediatric patients with high-risk r/r B-ALL with overall response rate (ORR) of 95.5%. Low rates of high-grade cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were observed, consistent with obe-cel’s adult safety profile. Autolus is now advancing obe-cel into the Phase 2 portion of the trial and expects to have the trial fully enrolled in the first half of 2027.
Obe-cel in lupus nephritis (LN)

Data from the ongoing Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus (srSLE) were reported at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. All patients show deep B-cell depletion after infusion, suggesting an immune reset. No ICANS or high-grade CRS were observed in the nine patients evaluable for safety.
Data support progressing obe-cel as a treatment for LN and 50 million cells was selected as the recommended Phase 2 dose. Autolus has previously aligned with the US Food and Drug Administration (FDA) on a Phase 2 trial design in LN and potential registrational path to approval. The LUMINA trial is now enrolling.
Obe-cel in progressive multiple sclerosis (MS)

Autolus is advancing obe-cel into initial clinical development to explore treatment in progressive MS. The first patient in the BOBCAT trial was dosed in October 2025. The Phase 1 trial, expected to include up to 18 adult patients, will determine the safety, tolerability, and preliminary efficacy of obe-cel in participants with refractory progressive forms of MS. Initial data from the trial are expected to be reported at the end of 2026.
AUTO8 in light-chain amyloidosis

The first patient was dosed in the Phase 1 ALARIC trial in AL amyloidosis and initial data is expected to be reported at the end of 2026.
Operational Updates & 2026 Outlook

Dr. Christian Itin concluded: "Our 2026 commercial focus for AUCATZYL is to build on the strong center presence and positive physician experience to drive top line growth, while improving margins by reducing our manufacturing costs per batch. Our development focus is on progressing our pivotal pediatric ALL CATLULUS and lupus nephritis LUMINA studies and the exploratory BOBCAT study in progressive multiple sclerosis. Our plans for innovation will focus on manufacturing technology and European market access."

Increasing patient numbers in 2026 will improve manufacturing plant utilization and together with operational efficiencies, Autolus expects a shift from previously reported negative gross margin to positive gross margin in 2026.

Autolus has initiated an overall manufacturing life cycle plan to facilitate additional cost reductions and gross margin improvements as the Company plans to expand obe-cel into new indications and pursue larger market opportunities. The initiatives are focused on: 1) optimizing the Company’s current manufacturing operating model; 2) enhancing automation opportunities for the Company’s existing manufacturing process; and 3) developing a next-generation manufacturing platform with a step change in the cost and capacity profile. The Company plans to provide a detailed update on these plans in mid-2026.

Based on current operating plans, including anticipated AUCATZYL net revenues, Autolus expects that its current and projected cash, cash equivalents and marketable securities will be sufficient to fund the Company’s operations into Q4 2027.

(Press release, Autolus, JAN 12, 2026, View Source [SID1234661938])

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])