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Nurix Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update

On July 9, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported financial results for the fiscal quarter ended May 31, 2026, and highlighted significant corporate updates including Nurix’s entry into a global license and collaboration agreement with Roche for Nurix’s potential best-in-class BTK degrader bexobrutideg (NX-5948), continued advancement of its registrational program in chronic lymphocytic leukemia (CLL), expansion into immunology and neurology, and progress across its broader pipeline.

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"The second quarter of 2026 was a defining period for Nurix and the targeted protein degradation field," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "Our global collaboration with Roche, an industry leader, validates both the differentiated clinical profile of bexobrutideg in malignant hematology and its broader potential in immunology and inflammation. The co-development, co-commercialization structure of the agreement allows Nurix to pursue multiple opportunities in significant markets in both oncology and autoimmune disease with financial strength and global reach."

Program Highlights*
Bexobrutideg Global Partnership with Roche
•Nurix announced a global collaboration agreement with Roche to co-develop and co-commercialize bexobrutideg across malignant hematology, immunology and neurology. Within 30 days following the effectiveness of the agreement, Nurix expects to receive a $700 million upfront payment and will be eligible to receive development, regulatory and commercial milestone payments for potential total payments of up to $2.3 billion, inclusive of the upfront payment. Development costs will be shared 40% by Nurix and 60% by Roche. Profits and losses in the United States will be shared equally and Nurix is eligible to receive tiered royalties on ex-U.S. sales.
•The collaboration includes a comprehensive development strategy spanning multiple hematologic malignancies and expansion into immune-mediated diseases, including planned Phase 2 studies in multiple sclerosis (MS) and chronic spontaneous urticaria (CSU).
•The collaboration agreement is subject to customary closing conditions, including expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and other required antitrust clearances.
Bexobrutideg Clinical Data Presented at EHA (Free EHA Whitepaper) 2026
•Nurix reported new and updated clinical data from the ongoing NX-5948-301 Phase 1a/1b study demonstrating durable responses and a favorable tolerability profile in patients with relapsed/refractory CLL/SLL.
•Updated Phase 1a results demonstrated
◦Median progression-free survival of 22.1 months
◦Objective response rate (ORR) of 83%
◦Responses observed across difficult-to-treat patient populations, including patients with BTK resistance mutations, high-risk molecular features and central nervous system involvement
•New Phase 1b results demonstrated:
◦ORR of 92.9% among evaluable patients with 18 of 19 patients remaining on treatment at data cutoff in Cohort 5, evaluating patients previously treated with a BTK inhibitor but naïve to BCL2 inhibitor therapy

◦ORR of 84.2% among evaluable patients with 19 of 20 patients remaining on treatment at data cutoff in Cohort 15, evaluating BTKi-naïve patients including treatment-naïve patients
Bexobrutideg Clinical Development Program
•Enrollment continues in DAYBreak CLL-201, the pivotal Phase 2 trial designed to support a potential Accelerated Approval submission in patients with relapsed/refractory CLL whose disease has progressed following treatment with a covalent BTK inhibitor, a BCL2 inhibitor and a non-covalent BTK inhibitor.
•Preparations continue for DAYBreak CLL-306, the global randomized Phase 3 confirmatory trial evaluating bexobrutideg versus pirtobrutinib in patients with relapsed/refractory CLL following prior BTK inhibitor therapy with the dosing of the first patient anticipated in mid-2026.
•Preparations continue for the Phase 1b/2 Study Basket Combination Study to define optimal treatment regimens to support the initiation of combination pivotal trials in CLL and potentially mantle cell lymphoma (MCL) and Waldenstrom’s macroglobulinemia (WM).
•Nurix continues to enroll select cohorts in the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) in patients with relapsed or refractory B cell malignancies. The Phase 1b study includes cohorts testing the safety and efficacy of the 600 mg dose of bexobrutideg in earlier lines of therapy in CLL patients and in NHL patients. Updated data from this study are anticipated to be presented at upcoming medical meetings throughout 2026. More information on the ongoing Phase 1a/1b trial of bexobrutideg is available at www.clinicaltrials.gov.
Expansion of Bexobrutideg Development into Immunology and Neurology
•Presented new preclinical and Phase 1 translational data from healthy volunteers at the 2026 Society for Investigative Dermatology Annual Meeting supporting the potential of bexobrutideg in chronic spontaneous urticaria. Data demonstrated potent and selective BTK degradation across key immune cell populations, robust degradation in blood and skin following oral administration of the new tablet formulation, and enhanced suppression of FcεRI-driven biology compared with BTK inhibition.
•Continued advancement of a healthy volunteer SAD/MAD study evaluating the new tablet formulation of bexobrutideg to support potential future development in immunology and neurology indications with planning underway for the initiation of Phase 2 trials in CSU and MS.
Broader Pipeline Highlights
Preclinical Oncology Pipeline
•Presented new data at the 2026 AACR (Free AACR Whitepaper) Annual Meeting highlighting progress across multiple targeted protein degradation programs, including pan-mutant BRAF degrader NRX-0305, CBL-B program NX-1607 and AURKA degrader NRX-4972.
•Data reinforced the potential for targeted protein degradation to overcome key limitations of conventional therapeutic approaches, including treatment resistance and incomplete pathway suppression.
NX-1607
•Nurix has completed enrollment of current Phase 1a dose escalation cohorts of NX-1607, an investigational oral CBL-B inhibitor, across multiple solid tumor oncology indications and is reviewing the data to determine next steps.
Zelebrudomide
•Zelebrudomide is an orally bioavailable degrader of BTK and the cereblon neosubstrates IKZF1 (Ikaros) and IKZF3 (Aiolos) designed for the treatment of relapsed or refractory B-cell malignancies. Nurix has completed enrollment in the current dose escalation cohorts of the Phase 1 trial (NCT04830137) and is reviewing the data to determine next steps.
Strategic Collaborations
•In addition to the Roche collaboration, Sanofi continues to advance the STAT6 degrader, NX-3911, in IND-enabling studies. Nurix retains the right to opt-in after clinical proof of concept to a 50/50 U.S. profit share and co-development agreement. Gilead continues to advance the IRAK-4 degrader, GS-6791, in an ongoing first-in-human Phase 1 study in healthy volunteers. Nurix retains the right to opt-in after Phase 1 to a 50/50 U.S. profit share and co-development, `subject to certain restrictions. Nurix and Pfizer continue to progress multiple preclinical degrader antibody conjugate (DAC) programs. In the second fiscal quarter of 2026, Nurix earned a $2 million milestone payment from Sanofi.
*Expected timing of events throughout this press release is based on calendar year quarters.

Fiscal Second Quarter 2026 Financial Results
Revenue for the three months ended May 31, 2026, was $9.0 million compared with $44.1 million for the three months ended May 31, 2025. The decrease was primarily due to $30 million of license revenue from two Sanofi license extensions in the prior year. During the three months ended May 31, 2026, Nurix achieved a research milestone under its collaboration with Sanofi of $2 million.
Research and development expenses for the three months ended May 31, 2026, were $87.7 million compared with $78.1 million for the three months ended May 31, 2025. The increase was primarily related to clinical costs and contract manufacturing costs as Nurix continued to accelerate the enrollment of patients in the ongoing Phase 2 trial of bexobrutideg and to enable the initiation of Phase 3 trials.
General and administrative expenses for the three months ended May 31, 2026, were $15.6 million compared with $14.3 million for the three months ended May 31, 2025. The increase was primarily due to an increase in legal costs for collaboration and business development activities.
Net loss for the three months ended May 31, 2026, was $89.5 million or ($0.81) per share compared with $43.5 million or ($0.52) per share for the three months ended May 31, 2025.
Cash, cash equivalents and marketable securities were $443.5 million as of May 31, 2026, compared to $592.9 million as of November 30, 2025. In addition, we expect to receive the $700 million upfront payment from Roche in the third fiscal quarter of 2026.

About Bexobrutideg
Bexobrutideg (NX-5948) is an investigational, orally bioavailable, brain-penetrant, highly selective small-molecule degrader of Bruton’s tyrosine kinase (BTK) being developed by Nurix and Roche as a potential best-in-class therapy across oncology, immunology and neurology.
Bexobrutideg is currently being evaluated in the DAYBreak CLL-201 clinical trial (NCT07221500), a pivotal single-arm Phase 2 study in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), and in the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) in patients with relapsed or refractory B-cell malignancies. A new tablet formulation of bexobrutideg is also being evaluated in a first-in-human single-ascending-dose and multiple-ascending-dose study in healthy volunteers (NCT06717269) to support future development in immunology and neurology indications. Additional information about ongoing clinical trials can be found at clinicaltrials.gov.

(Press release, Nurix Therapeutics, JUL 9, 2026, View Source [SID1234669123])

Greenwich LifeSciences Announces European Approval for Use of Commercially Manufactured GP2 in FLAMINGO-01

On July 9, 2026 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported the following update on the use of commercially manufactured GP2 in FLAMINGO-01 in Europe.

All European and US Sites to Treat Patients with Commercially Manufactured GP2

The Company previously announced that the first three commercial lots of GP2 active ingredient were manufactured in 2023 in an approved commercial facility, which could be used to prepare approximately 200,000 doses of GP2. In 2024, the first commercial lot filling GP2 into vials for commercial sale or for clinical use was manufactured in a commercial facility. In addition, drug stability programs were initiated for all four lots. Data on these commercial lots was submitted to the FDA, and after review, the first commercial lot of GP2 vials was approved for use in FLAMINGO-01 in the US in early 2026. All approximately 40-50 US sites have been supplied with commercially manufactured GP2 vials and have begun treating patients with these vials. We were able to efficiently distribute the GP2 vials and communicate with the US pharmacists working with our warehouse partners and through our clinical team, which we internalized in Q4 2025.

The European Medicines Agency (EMA) has completed their review and will also allow use of the same commercially manufactured GP2 lot in FLAMINGO-01 in Europe. Thus, all clinical sites in the US and Europe, which have increased from 160 sites to approximately 170-180 sites, are expected to be using the same lot with shipments to European pharmacies already under way. We are now seeking approval to use this lot in the UK and Canada in separate and independent regulatory processes.

About FLAMINGO-01 Open Label Phase III Data

More than 1,300 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
The AACR (Free AACR Whitepaper) Meeting 2026 delayed-type-hypersensitivity (DTH) poster and the ASCO (Free ASCO Whitepaper) Meeting 2026 injection site reaction (ISR) poster can be seen and downloaded at the bottom of the Phase III clinical trial tab on the Company’s website here.
As shown in both posters the frequency of DTH and ISR reactions increased statistically significantly over time.
As reported in Table 1 of each poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline.
Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A*02 only patients are being vaccinated.

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb posters and results can be summarized as follows and can be seen here:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 170-180 sites globally.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

(Press release, Greenwich LifeSciences, JUL 9, 2026, View Source [SID1234669122])

Alchemab Therapeutics announce biggest ever life sciences investment from British Business Bank to advance its AI-enabled clinical pipeline of next generation human-derived antibodies

On July 9, 2026 Alchemab Therapeutics reported to have extended its series A financing with a £25 million (USD $34m) investment from the British Business Bank – the Bank’s largest investment in a life sciences company to date. The funding will enable the company to build its clinical pipeline and grow its proprietary unique antibody dataset to more than a billion sequences.

Alchemab is discovering and developing first-in-class drugs from its unique Resiliome platform which uses complex AI derived algorithms to identify naturally occurring antibodies present in humans with unusual resistance to a range of hard-to-treat diseases.

This investment builds on the success of the company’s first asset, ATLX-1282 – a first-in-class antibody therapeutic in clinical development for amyotrophic lateral sclerosis (ALS) which was licensed to Eli Lilly and has provided robust validation of the potential of the Resiliome platform approach.

The additional funding brings Alchemab’s total Series A investment to date to £109 million and will enable the company to enhance its antibody database from 500 million to a billion antibody sequences and advance additional clinical candidates into development

Dr Jane Osbourn, CEO and Co-Founder of Alchemab, said "We are delighted that British Business Bank has recognised the importance of enabling Alchemab to grow and thrive here in the UK. This investment provides further validation of the sustainable, long-term potential of our drug discovery platform and will enable us to further accelerate our pipeline of first-in-class antibody therapeutics for conditions with significant unmet need."

Dame Kate Bingham, Managing Partner at SV Health Investors and Chair of Alchemab’s board of directors, said, "The UK life sciences sector has the expertise, creativity and commercial potential to build globally significant biotech companies, and Alchemab is determined to be one of them. This investment by the British Business Bank demonstrates the importance of providing capital to allow innovative biotechs to scale here, and we are proud to be building the company’s future in the UK."

Charlotte Lawrence, Managing Director of Direct Equity at British Business Bank said, "Alchemab sits at the cutting edge of UK scientific capability, integrating deep sequencing and lab-based validation to harness the body’s natural defences against disease. This landmark £25m investment demonstrates our commitment to providing the long-term capital necessary for the UK’s most innovative biotech firms to advance complex pipelines in the UK."

Dr Carmine Circelli, Senior Investment Director, Life Sciences at British Business Bank said, "Alchemab is yet another example of the UK’s strength in leveraging technology in life sciences. By combining one of the world’s largest proprietary antibody datasets with advanced AI, the company has developed a powerful platform with the potential to unlock new treatments. Our investment will help convert promising results into high value medical discoveries."

(Press release, Alchemab Therapeutics, JUL 9, 2026, View Source [SID1234669121])

MAIA Biotechnology Reports Strong Initial Efficacy Data in Third-Line Non-Small Cell Lung Cancer from Phase 2 THIO-101 Part C Expansion Trial

On July 8, 2026 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported positive initial efficacy data from its Phase 2 THIO-101 clinical trial expansion, Part C, evaluating its lead candidate, ateganosine, a dual mechanism of action drug incorporating telomere targeting and immunogenicity, as a third-line (3L) therapy for patients with advanced non-small cell lung cancer (NSCLC).

Initial data from the THIO-101 Part C 3L studies1 show a disease control rate (DCR) of 90.5% (19 out of 21 patients) in the efficacy evaluable population who had at least one tumor scan after starting treatment. Patients are treated with ateganosine followed by cemiplimab (Libtayo) in cycles of 21 days. Current chemotherapy treatments deliver an approximate 25-35% disease control rate.2

"The initial efficacy data from the Part C studies are consistent with the encouraging efficacy signals we previously reported for Parts A and B of THIO-101, including an 88% disease control rate in third-line NSCLC patients. This measure of efficacy is close to triple the reported outcome for standard-of-care chemotherapy treatment," said Vlad Vitoc, Founder and Chief Executive Officer of MAIA Biotechnology. "Importantly, patients enrolled in Part C of our trial represent a more heavily pre-treated population, with all patients having previously received docetaxel in addition to demonstrating resistance to both immunotherapy and other chemotherapies."

MAIA recently announced that it has completed international enrollment in Part C of the Phase 2 THIO-101 expansion trial. Treatment with ateganosine followed by cemiplimab has shown an acceptable safety profile to date in a heavily pre-treated population.

About Ateganosine
Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101 Phase 2 Clinical Trial
THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

(Press release, MAIA Biotechnology, JUL 8, 2026, View Source [SID1234669115])

Allotera Therapeutics (Formerly Wugen) Closes $35 Million Financing to Advance Off-the-Shelf CAR-T Therapies for T-Cell Cancers

On July 8, 2026 Allotera Therapeutics, Inc. (formerly Wugen, Inc.), a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies for hematological malignancies, reported the successful closing of a $35 million financing round comprising equity and venture debt. The company also introduced its new name, Allotera Therapeutics, reflecting its sharpened focus on advancing off-the-shelf CAR-T cell therapies for patients with T-cell cancers.

The financing brings Allotera’s total capital raised to $150 million, building on the company’s $115 million Series C announced in late 2025. Proceeds will primarily support the ongoing global pivotal T-RRex clinical trial of Soficabtagene Geleucel, also known as Sofi-cel, in relapsed or refractory T-ALL/T-LBL, as well as advance platform capabilities, operational scale-up, and continued team growth.

"Allotera reflects who we are becoming as a company: a pivotal-stage cell therapy company focused on bringing off-the-shelf CAR-T therapies to patients with T-cell cancers," said Kumar Srinivasan, Ph.D., M.B.A., Chief Executive Officer of Allotera Therapeutics. "With Sofi-cel advancing in T-RRex, a global pivotal study, this financing strengthens our ability to execute across clinical development, manufacturing, and patient-community engagement as we work to address diseases where treatment options remain limited."

T-cell cancers are among the most difficult settings for CAR-T therapy development because many therapeutic targets are also present on the T cells used to manufacture the therapy. Allotera is developing Sofi-cel as an allogeneic, healthy donor-derived CAR-T cell therapy intended to address these challenges and provide an off-the-shelf treatment approach for patients with aggressive T-cell malignancies.

The Series C was led by Fidelity Management & Research Company, with participation from all existing investors. The current extension includes additional participation from Lightchain Capital and BioGenerator, as well as new investors, including Blood Cancer United’s Therapy Acceleration Program (TAP) and others. The venture debt was provided by Banc of California.

In connection with the financing, Allotera has also entered into a strategic partnership with Blood Cancer United, through which TAP will provide ongoing access to its scientific and drug development expertise, facilitate engagement with key opinion leaders, and connect Allotera to critical resources, including clinical trial support, patient education, and community engagement capabilities.

"Our partnership with Blood Cancer United reflects an important part of Allotera’s next chapter," said Srinivasan. "As we advance Sofi-cel through pivotal development, we are committed not only to building the clinical and manufacturing capabilities needed to bring off-the-shelf cell therapies forward, but also to engaging with the communities most affected by these diseases."

About Soficabtagene Geleucel (Sofi-cel)

Sofi-cel is an allogeneic, off-the-shelf, CD7-targeted CAR-T cell therapy being developed for T-cell cancers. Allotera uses CRISPR/Cas9 gene editing to delete CD7 and the T-cell receptor alpha constant (TRAC) genes, an approach intended to prevent CAR-T cell fratricide and mitigate the risk of graft-versus-host disease.

Sofi-cel is manufactured in the United States using healthy donor-derived T cells, which is intended to avoid malignant cell contamination that can occur in the autologous CAR-T setting. Sofi-cel is currently being evaluated in a global pivotal clinical trial for relapsed or refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. More information on the pivotal trial is available at ClinicalTrials.gov, identifier NCT06514794.

Sofi-cel has received Breakthrough Therapy, Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration for the treatment of relapsed or refractory T-ALL/T-LBL, as well as Priority Medicines, or PRIME, designation in the European Union. RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients with medical need. Sofi-cel was also selected to participate in the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program.

(Press release, Allotera Therapeutics, JUL 8, 2026, View Source [SID1234669114])