On August 20, 2026 Cerenome, Inc. (Nasdaq: CNSY) ("Cerenome" or the "Company") reported data from two scientific posters presented at the 2026 Society for Neuro-Oncology/American Society of Clinical Oncology (SNO/ASCO) CNS Metastases Conference, held August 13–15 in Boston. One presentation featured updated pharmacokinetic (PK), pharmacodynamic (PD), dosimetry, safety and activity data for REYOBIQ (rhenium-186 obisbemeda) in patients with leptomeningeal metastases (LM), including emerging safety data from the ongoing repeated-dosing program. The second was an update of a previously reported health economics analysis evaluating the impact of CNSide-enabled earlier LM detection and therapeutic management.

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"The data presented at SNO/ASCO underscore the rationale behind Cerenome’s integrated approach to leptomeningeal metastases – from earlier and more definitive detection and quantitative disease monitoring with CNSide, to targeted local therapy with REYOBIQ," said Marc H. Hedrick, M.D., Cerenome President and Chief Executive Officer. "The REYOBIQ findings provide additional support for broad CSF distribution, limited systemic exposure in most patients, and the continued evaluation of repeat dosing. The CNSide analysis reinforces the potential economic value of earlier, information-rich disease management. Together, these data demonstrate the potential of connecting diagnostics, therapeutics and longitudinal data to improve the management of CNS cancers."

As previously announced, both posters will be available on the Publications page of Cerenome’s website following the conclusion of the conference.

REYOBIQ ReSPECT-LM and ReSPECT-LMM Data

A poster titled, "ReSPECT-LM: Pharmacokinetic and Pharmacodynamic Assessment of Rhenium Obisbemeda in Leptomeningeal Metastases with Emerging Data from Repeated Dosing (ReSPECT-LMM)" was presented by Andrew Brenner, M.D., Ph.D., of The University of Texas Health Science Center at San Antonio. The analysis included updated safety, activity, PK and dosimetry findings from the single-administration study, along with emerging data from the ongoing repeated-dosing program.

Key findings included:

In the ongoing repeated-dosing ReSPECT-LMM study, Cohort 1a cleared with no dose-limiting toxicities, with enrollment ongoing in additional cohorts.
PK showed rapid ( ̴24 hours) redistribution of drug within the CSF with clearance of the REYOBIQ from the lateral ventricle at a half-life of 1.7 hours. By clearing the ventricles quickly, drug remains available at high doses in the cerebral spinal fluid.
Bulk RNA-Seq demonstrated rapid ( ̴5 hours) induction of cell-death (apoptosis) genes, with peak activity occurring at 24 hours. Data promoting cell-death supports REYOBIQ’s established radiopharmaceutical mechanism of action and highlights its rapid onset target activity.
CNSide Cost-of-Care Analysis

The second poster, titled, "Economic Impact of Earlier Detection and Therapeutic Management of Leptomeningeal Metastases Using CNSide: A Cost-of-Care Analysis," was presented by Kelly Kreitzburg Ondrasek, Ph.D., Medical Science Liaison at CNSide Diagnostics. The analysis evaluated the potential economic and clinical impact of a CNSide-enabled care pathway incorporating earlier definitive LM diagnosis, targeted treatment, and quantitative disease monitoring.

The model estimated average LM-related treatment costs of approximately $119,550 per month, or approximately $717,300 over six months. Under modeled scenarios incorporating earlier LM confirmation and optimized management, a CNSide-enabled pathway was estimated to reduce monthly LM-related costs by approximately 33-47%.

(Press release, Cerenome, AUG 20, 2026, View Source [SID1234670254])

On August 20, 2026 Nykode Therapeutics ASA (OSE: NYKD), a clinical stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 12,697,377 B2, entitled "Therapeutic anticancer neoepitope vaccine" related to its individualized neoantigen therapy pipeline candidate, VB10.NEO.

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The newly issued patent relates to Nykode’s fully individualized neoantigen based cancer vaccine, VB10.NEO but also to similar modular neoantigen based cancer vaccines comprising alternative targeting units and/or dimerization units. The 20 year expiration date of this patent is January 5, 2037.

Michael Engsig, CEO of Nykode, said: "This new patent broadens the intellectual property protecting VB10.NEO and our wider neoantigen platform, and it arrives at a pivotal moment for the field. Merck and Moderna’s positive Phase 3 INTerpath-001 data is an important clinical validation of individualized neoantigen cancer vaccines. The question now moves from whether the modality works to which asset can be delivered reliably, and economically, across many indications. With a differentiated APC-targeted design, a neoantigen selection algorithm validated in patients, and an established attractive manufacturing supply chain, we believe VB10.NEO is well positioned to move into a larger set of indications."

Nykode presented data on the VB10.NEO program at the Neoantigen Summit in Amsterdam on July 22, 2026. Further details are available in the Company’s press releases: View Source

Nykode is actively exploring partnerships to advance VB10.NEO across a broad range of tumor types.

(Press release, Nykode Therapeutics, AUG 20, 2026, View Source [SID1234670252])

On August 20, 2026 NovaBridge Biosciences (Nasdaq: NBP) ("NovaBridge" or the "Company"), a global biotechnology company that identifies differentiated innovation and applies disciplined development, financing, and partnering strategies to create value, reported financial results for the six months ended June 30, 2026, and provided a business update. During the first half of 2026, the Company continued executing its strategic priorities by progressing key clinical milestones for its lead programs. The Company also strengthened leadership, governance, and capital allocation to support long-term value creation.

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"Significant innovation exists across geographies and organizations, yet many promising therapies never reach their full potential," said Srishti Gupta, MD, MPP, Chief Executive Officer of NovaBridge. "NovaBridge was built to identify those opportunities, advance them efficiently and create value through the path best suited to each asset. The progress of givastomig and VIS-101 reflects our ability to both identify differentiated science and to achieve meaningful development milestones, positioning NovaBridge to continue creating value for patients and shareholders."

"NovaBridge is building the capabilities required to succeed over the long term. The progress of givastomig and VIS-101, together with the continued strengthening of the organization, reflects deliberate execution against that objective," said Fu Wei, Chairman of the Board of NovaBridge.

Pipeline Overview and Potential Upcoming Milestones

NovaBridge’s two lead programs illustrate the complementary capabilities at the core of its strategy. Givastomig, a potential first-in-class Claudin 18.2-Targeted Immuno Amplifier ("CTIA"), reflects NovaBridge’s ability to efficiently execute differentiated science toward registrational development. VIS-101, a purpose-designed tetravalent VEGF-A × ANG-2 peptibody for retinal vascular diseases, developed through NovaBridge’s majority-owned subsidiary leading its ophthalmology platform, Visara, Inc. ("Visara"), reflects NovaBridge’s ability to identify and acquire differentiated therapeutic assets that others have overlooked.

Givastomig

Givastomig is a potential first-in-class CTIA. It is a bispecific Claudin 18.2 × 4-1BB antibody targeting Claudin 18.2-positive tumor cells being developed for the treatment of first-line metastatic gastric cancer.

In January 2026, NovaBridge reported positive data from the givastomig Phase 1b dose expansion combination study in patients with first-line ("1L") gastric cancer. The data showed that givastomig produced a 77% ORR at 8 mg/kg and 73% ORR at 12 mg/kg (among 52 evaluable subjects), and a 16.9-month median progression-free survival at 8 mg/kg (among 27 evaluable subjects), with responses observed across a range of PD-L1 and Claudin 18.2 expression levels. Givastomig demonstrated favorable overall tolerability in combination with immunochemotherapy without dose-dependent toxicity.

In February 2026, NovaBridge initiated a global, randomized Phase 2 study of givastomig combined with immunochemotherapy in patients with HER2-negative, 1L metastatic gastric cancer.

In March 2026, NovaBridge reported givastomig’s potential eligibility for the U.S. Food and Drug Administration’s (FDA) Accelerated Approval Pathway in first-line HER2-negative, Claudin 18.2-positive, PD-L1-positive patients with gastroesophageal adenocarcinoma ("GEA").

In June 2026, the FDA granted Fast Track Designation to givastomig for the treatment of previously untreated HER2-negative advanced or metastatic GEA in combination with nivolumab and chemotherapy.

NovaBridge estimates that approximately 180,0001 patients are diagnosed with first-line GEA in the U.S., France, Germany, Italy, Spain, the United Kingdom and Japan, of which approximately 105,0002,3 cases are HER2-negative and Claudin 18.2-positive, the population givastomig targets. The Company also believes givastomig has broad potential across other Claudin 18.2-positive gastrointestinal malignancies, including biliary tract cancer and pancreatic ductal adenocarcinoma.

Upcoming Givastomig Milestones:

•
October 25, 2026: Poster presentation of Phase 1b combination dose expansion data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026
•
As early as YE 2026: Initiate Phase 3 registrational study under a potential Accelerated Approval Pathway
VIS-101

VIS-101 is a potential best-in-class VEGF-A × ANG-2. It is a purpose-designed tetravalent peptibody being developed for neovascular retinal diseases. Positive Phase 2a data reported in March 2026 demonstrated favorable safety and tolerability results, meaningful visual acuity improvements, and encouraging durability in neovascular (wet) age-related macular degeneration ("nAMD") patients. VIS-101 is being developed for nAMD, diabetic macular edema ("DME"), and retinal vein occlusion ("RVO"), which together affect more than 57 million people globally.4

VIS-101 is being advanced through Visara. Consistent with NovaBridge’s operating model, Visara combines specialized ophthalmology expertise with NovaBridge’s strategic oversight, capital allocation, and business development capabilities to support focused execution and future growth of the ophthalmology franchise.

Upcoming VIS-101 Milestones:

•
H2 2026: Initiate Phase 2b program in nAMD
•
2027: Initiate global Phase 3 program in nAMD
1H Execution Highlights

During the first half of 2026 and subsequent period, NovaBridge continued to strengthen its leadership team to support the Company’s next phase of growth. NovaBridge appointed Srishti Gupta, MD, MPP, as Chief Executive Officer to lead corporate strategy, capital allocation, business development, and operational execution. The Company also appointed Mark Hagler as Chief Commercial Officer, adding commercial and portfolio planning expertise to support future development and partnership opportunities. At Visara, Jeffrey Nau, PhD, MMS, was appointed President and Chief Executive Officer to lead the advancement of VIS-101 and the continued build-out of the ophthalmology franchise. With these additions, NovaBridge continued executing its strategy to identify, develop, and create value from differentiated therapeutic assets. During the period, the Company advanced key pipeline programs toward important development milestones while continuing to evaluate opportunities to expand its portfolio and create long-term value for patients and shareholders.

In addition, NovaBridge is implementing enhancements to its segment disclosure and half-year reporting structure, expected to provide shareholders with clearer visibility into the performance of the Company and its operating subsidiaries.

First Half 2026 Financial Results

Cash Position

As of June 30, 2026, the Company had cash, cash equivalents, short-term investments, and equity investment at fair value of $215.9 million. Based on its current operating plan, the Company believes its cash position is sufficient to support the advancement of its portfolio through multiple anticipated clinical and strategic milestones, including givastomig’s planned Phase 3 interim data read-out in 2028.

Research & Development Expenses

Research and development expenses were $14.3 million for the six months ended June 30, 2026, compared to $4.1 million for the six months ended June 30, 2025. The increase was primarily driven by investment in clinical development activities for givastomig and the continued build-out of NovaBridge’s development capabilities to support current and future portfolio programs.

Administrative Expenses

Administrative expenses were $26.4 million for the six months ended June 30, 2026, compared to $8.3 million for the six months ended June 30, 2025. The increase was primarily driven by higher share-based compensation expense associated with equity awards granted in 2025, increased personnel-related costs as the Company expanded its organizational capabilities, and a one-time write-off of deferred offering costs related to the previously proposed HKEx dual primary listing.

Net Loss

Net loss was $37.9 million for the six months ended June 30, 2026, compared to $8.7 million for the prior-year period. Net loss per share attributable to ordinary shareholders was $0.14 compared to $0.05 in the prior-year period.

About Givastomig

Givastomig (TJ033721 / ABL111), a potential first-in-class CTIA, is a Claudin 18.2 × 4-1BB bispecific antibody. Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed for potential treatment of gastric cancer, its current lead indication. Givastomig also has potential applicability across other Claudin 18.2+ gastrointestinal malignancies including biliary tract cancer and pancreatic ductal adenocarcinoma. Givastomig is being evaluated in a global, randomized Phase 2 study (NCT07432295), following positive topline results from a Phase 1b, multicenter, open-label study in first-line gastric cancer. NovaBridge expects to initiate a Phase 3 registrational study under a potential Accelerated Approval Pathway as early as year end 2026.

Givastomig is being jointly developed through a global partnership with ABL Bio, Inc. ("ABL Bio"). NovaBridge is the lead party and shares worldwide rights equally with ABL Bio, excluding Greater China and South Korea.

About VIS-101

VIS-101 (ASKG712/AM712) is a tetravalent VEGF-A × ANG-2 peptibody purpose-designed to be best-in-class. It targets retinal vascular diseases, including nAMD, DME, and RVO, which together affect more than 57 million people globally.⁴ VIS-101 is the only intravitreal therapeutic with two binding sites for each of VEGF-A and ANG-2, and carries the molecular weight of a full-length monoclonal antibody, a structural design intended to deliver a rapid, robust, and durable treatment response for patients with neovascular retinal diseases.

VIS-101 has completed initial safety and dose-escalation studies in both the U.S. and China, along with a randomized, dose-ranging Phase 2a study in China (NCT05456828). It is expected to advance to a randomized, controlled, dose-determining Phase 2b study in the second half of 2026, with anticipated initiation of a global Phase 3 program in 2027.

NovaBridge is the majority shareholder of Visara, which controls global rights to VIS-101 outside of Greater China and certain countries in Asia.

References:

1.
Markets include U.S., France, Germany, Italy, Spain, the United Kingdom, and Japan in 2025 based on Data Monitor Biomed Tracker, based on 1L treatment
2.
HER2-negative status of 78%. Van Cutsem E, Bang YJ, Feng-Yi F, et al. HER-2 screening data from ToGA: targeting HER2 in gastric and gastroesophageal junction cancer. Gastric Cancer 2015;18(3):476-84
3.
CLDN18.2 positive status of ~70%. Kohei Shitara, et al, 2023 ASCO (Free ASCO Whitepaper) Annual Meeting (June 2-6), poster #4035
4.
Invest Ophthalmol Vis Sci. 2021 Nov 24; 62 (14): 26. doi: 10.1167/iovs.62.14.26
Webcast/Conference Call Details:

NovaBridge will hold a webcast on Thursday, August 20, 2026 at 9:00 AM ET/9:00 PM China Standard Time to discuss recent corporate progress and financial results for the six months ended June 30, 2026.

Webcast Information:

·
Date: Thursday, August 20, 2026
·
Time: 9:00 AM ET/9:00 PM China Standard Time
·
Web Access – China: Click here
·
Webcast Access – All other locations: Click here
The live and archived webcast can also be accessed by visiting the NovaBridge Biosciences website on the Upcoming Events section of the Investors page. A replay of the webcast will be archived for at least 30 days after the event.

(Press release, NovaBridge Biosciences, AUG 20, 2026, View Source [SID1234670251])

On August 20, 2026 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology platform, reported business update and announces second quarter 2026 financial results.

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Business highlights (since last quarterly update)
Evaxion is making steady progress towards completing its strategic milestones for 2026. Highlights include:

Announcing the upcoming presentation of three-year clinical data for personalized cancer vaccine candidate EVX-01 at the ESMO (Free ESMO Whitepaper) Congress 2026
Presentation of new data for EVX-04, an off-the-shelf cancer vaccine for acute myeloid leukemia (AML)
Expansion and refocusing of our R&D pipeline with EVX-05, a novel off-the-shelf therapeutic cancer vaccine program for glioblastoma
Presentation of new data for cytomegalovirus (CMV) vaccine candidate EVX-V1
Winning the 2026 Prix Galien UK Award for Best digital health solution for AI-Immunology
Cash runway unchanged with cash at hand to fund operations into the second half of 2027
"Progress remains strong in recent months, particularly regarding the expansion and progression of our R&D pipeline. Both EVX-04 and EVX-05 represent completely new concepts in targeting hard-to-treat cancers and are great examples of what we can do with AI-Immunology to identify novel, conserved cancer targets for off-the-shelf vaccines. The same is true for EVX-V1 in the infectious disease space and we are excited by the successful progress of this next-generation, multi-component CMV-vaccine program. These programs and the combined R&D pipeline show how our AI-Immunology platform can truly deliver product candidates, which is crucial in validating our platform and for partnerships," says Helen Tayton-Martin, CEO of Evaxion.

Conference call and webcast
Evaxion’s executive management will host a conference call and webcast at 8.30 ET/14.30 CET today, presenting the business update and financial results as well as taking questions.

To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event.

To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event.

Research & Development (R&D) update
Evaxion has a R&D pipeline of innovative vaccine candidates for both cancer and infectious diseases. In future, this is expected to be supplemented by programs for autoimmune diseases following application of AI-Immunology in this space in the second half of 2026.

We are looking forward to presenting three-year clinical efficacy data for personalized cancer vaccine EVX-01, our most advanced pipeline asset, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 in October.

Developed with AI-Immunology, EVX-01 is designed to target multiple neoantigens; cancer unique proteins arising from mutations. We completed the initially planned two-year treatment in the phase 2 trial with EVX-01 in patients with advanced melanoma (skin cancer) last year with unprecedented results presented at ESMO (Free ESMO Whitepaper) in 2025.

Following on with a one-year extension of the phase 2 trial, the upcoming data will provide additional insights into potentially enhanced treatment effects and durability of the EVX-01-induced immune response. It will also offer insights into the vaccine’s effect also as stand-alone treatment of these patients with advanced melanoma, in comparison to the prior administration in combination with pembrolizumab in the first two years of the trial.

In addition to the personalized approach, we are leveraging AI-Immunology’s capabilities to develop novel off-the-shelf cancer vaccines, including EVX-04 targeting AML. Developed with AI-Immunology, EVX-04 targets multiple non-conventional endogenous retrovirus (ERV) tumor antigens from the dark genome.

ERV antigens are present in tumors but absent in normal tissue, making them highly attractive targets for cancer vaccines. AI-Immunology has unique capabilities in identifying ERVs and this opens a whole new source of antigens, which can potentially greatly improve patient outcomes.

We are progressing preclinical activities with EVX-04 as planned and presented new data at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress. The data demonstrates EVX-04’s complete expression in human cells, including correct transcription and translation. Further, EVX-04 is secreted in human cells, enabling immune recognition and activation.

The data also shows that all ERV antigens included in EVX-04 drive specific immune responses both in mice (in vivo) and human cells (in vitro) across different human immune profiles. These vaccine-induced immune cells mediate targeted cell-killing, highlighting EVX-04’s potential as a new effective therapeutic cancer vaccine.

In parallel with preclinical studies, we are preparing the regulatory filing for clinical testing of EVX-04, which is expected to be submitted before the end of the year.

We have also leveraged our capabilities to identify clinically relevant ERVs to expand our pipeline with EVX-05, a novel off-the-shelf cancer vaccine candidate for the deadly brain cancer glioblastoma.

Partly based on data analysis done in collaboration with leading experts from Duke University School of Medicine, EVX-05 targets endogenous retrovirus (ERV)-derived antigens shared between glioblastoma patients. The use of such antigens could potentially be highly effective for glioblastoma patients, who generally have few neoantigens to target due to low mutational burden.

We also carry out preclinical activities for infectious disease programs and presented new data for CMV vaccine program EVX-V1 at the International Herpesvirus Workshop 2026 in July. EVX-V1 is a next-generation, multi-component CMV vaccine program designed with AI-Immunology. It combines novel AI-Immunology identified protective B-cell antigens and T-cell epitopes complemented by known optimized structural B-cell antigens.

This broader multi-targeted strategy is expected to strengthen the protective potential of a future vaccine. The concept represents a scalable strategy for rational vaccine development across other herpesviruses. The new data demonstrates the potential to improve control of acute infection, latency, and viral reactivation, further supporting the concept behind EVX-V1.

Business development update
We remain active in several parallel partnership discussions based on external interest in both our AI-platform and R&D pipeline as we continue to pursue our strategy of strengthening our platform and building value through multiple partnerships.

We were honored to receive the Prix Galien UK Award for Best digital health solution for AI-Immunology in June. The award is another strong external validation and recognition of the AI-Immunology platform and as such supporting our partnering efforts, alongside the new data we continuously generate to further validate the fact that AI-Immunology is a platform that deliver product candidates. This is an important proposition to potential business partners.

Second quarter 2026 financial results
The financial results for the second quarter 2026 were in line with expectations with a net loss of $3.7 million, compared to $3.6 million in the first quarter 2026 and $4.8 million in the second quarter 2025. The reduced loss compared to same period last year primarily relates to lower capital market transaction costs and financial expenses from significantly reduced derivative liability.

Research and development (R&D) expenses were $2.3 million for the second quarter 2026, aligned with first quarter 2026, and a slight increase compared to second quarter last year, as we progress our pipeline according to plan.

General and administrative (G&A) expenses were $1.5 million for the quarter, which was at same level with first quarter 2026, and compared to $2.2 million in second quarter 2025. Compared to last year the reduced cost is primarily driven by lower capital market costs.

Net financial expense of $0.1 million for the second quarter 2026 compared to net financial expense of $0.7 million same quarter last year, a reduction of net expense mainly due to reduced derivative liability and the thereof related remeasurement.

Cash and cash equivalents as of June 30, 2026, were $14.0 million, compared to $18.4 million as of March 31, 2026, and confirm our current cash runway until second half of 2027.

Total equity amounts to $9.5 million as of June 30, 2026, reflecting the net loss of the first six months of 2026 when compared to $17.0 million as of December 31, 2025.

Evaxion A/S
(Unaudited) Consolidated statement of financial position data
(USD in thousands)

Jun 30,
2026 Dec 31,
2025
Cash and cash equivalents 14,000 23,234
Total assets 19,380 28,408
Total liabilities 9,849 11,369
Share capital 15,791 15,791
Other reserves 127,343 127,492
Accumulated deficit (133,603) (126,244)
Total equity 9,531 17,039
Total liabilities and equity 19,380 28,408

Evaxion A/S
(Unaudited) Consolidated statement of comprehensive loss data
(USD in thousands, except per share data)

Three Months Ended
June 30, Six Months Ended
June 30,
2026 2025 2026 2025
Revenue - 37 - 37
Research and development (2,334) (2,165) (4,631) (4,321)
General and administrative (1,512) (2,212) (3,034) (3,924)
Operating loss (3,846) (4,340) (7,665) (8,208)
Finance income 147 546 405 4,305
Finance expenses (234) (1,232) (519) (2,895)
Net loss before tax (3,933) (5,026) (7,779) (6,798)
Income tax benefit 204 195 420 387
Net loss for the period (3,729) (4,831) (7,359) 6,411
Net loss attributable to shareholders of Evaxion A/S (3,729) (4,831) (7,359) 6,411
Loss per share – basic and diluted (0.01) (0.02) (0.02) (0.02)
Number of shares used for calculation (basic and diluted) 417,010,756 315,828,608 417,010,756 275,434,522

(Press release, Evaxion, AUG 20, 2026, View Source [SID1234670250])

On August 20, 2026 BioOra Limited reported a commercial manufacturing supply agreement with Miltenyi Biotec, a global leader innovating technologies and services for patient-specific cell and gene therapies. Under the agreement, Miltenyi Biotec’s CDMO division, Miltenyi Bioindustry, will provide commercial manufacturing and supply of lentiviral vectors for atlacabtagene autoleucel (Atla-cel), BioOra’s lead CD19-directed CAR T cell therapy. The agreement builds on a long-standing relationship between the two companies and supports the therapy’s continued development and potential commercialization.

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Atla-cel, currently in Phase II clinical development, is a third-generation autologous CD19-targeted CAR T therapy being developed for patients with B-cell non-Hodgkin lymphoma and other B-cell malignancies. Originating from research at the Malaghan Institute of Medical Research, the therapy has generated encouraging early clinical results and is advancing into registration-directed clinical development. John Robson, our Managing Director at BioOra, said:"BioOra was established to expand patient access to CAR T therapies through a scalable manufacturing approach. Partnering with Miltenyi Biotec strengthens our ability to deliver novel therapies such as Atla-cel to patients while supporting our long-term vision of building a globally relevant cell therapy manufacturing ecosystem from New Zealand."

Miltenyi Biotec will produce the lentiviral vectors for Atla-cel at its FDA-approved facility in Gaithersburg, Maryland. Since receiving approval in 2024, the site has delivered more than 500 GMP batches at 50L and 200L scale, supporting more than 100 clinical trials across 28 countries. "As Atla-cel advances toward pivotal development, we are pleased to contribute the expertise, quality standards, and supply reliability needed to help bring innovative therapies to patients," said Boris Stoffel, Managing Director of Miltenyi Biotec.

About Atla-cel
Atla-cel is a third-generation autologous CD19-targeted CAR T cell therapy being developed for the treatment of B-cell malignancies, including B-cell non-Hodgkin lymphoma. Developed initially by the Malaghan Institute of Medical Research and commercialized through BioOra, Atla-cel is designed to combine potent anti-tumor activity with an improved tolerability profile while enabling more efficient manufacturing and delivery of therapy. The program has completed initial clinical evaluation and is advancing through registration-directed development.

(Press release, BioOra, AUG 20, 2026, https://bioora.com/our-stories/miltenyi-biotec-to-support-commercial-manufacturing-of-biooras-cd19-car-t-therapy-candidate-atla-celnbsp [SID1234670249])