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Allink Biotherapeutics and Akeso Announce Clinical Collaboration to Evaluate FGFR2b ADC Plus Ivonescimab for Squamous Cell Lung Cancer

On July 29, 2026 Shanghai Allink Biotherapeutics Co., Ltd. ("AllinkBio") ,a clinical-stage biotechnology company focused on developing differentiated antibody-drug conjugates (ADCs) and multispecific antibody therapies, reported that it has entered into a clinical trial collaboration agreement with Akeso, Inc. (9926.HK) ("Akeso") .

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Under the terms of the agreement, AllinkBio will perform a multi-center, open-label Phase II clinical study evaluating the efficacy and safety of ALK201, a first-in-class/best-in-class FGFR2b-targeted ADC, in combination with Akeso’s PD-1/VEGF bispecific antibody, ivonescimab. The study is designed to assess the potential benefits of this combinatory approach as a first-line treatment for patients with locally advanced or metastatic SqNSCLC.

The IND application for this combination study was recently approved by the NMPA in China. AllinkBio will be fully responsible for the advancement and execution of the clinical study, while Akeso will supply the ivonescimab required for the trial.

Dr. Hui Feng, Founder and Chief Executive Officer at AllinkBio stated
"We are very pleased to partner with Akeso on this clinical collaboration, which received rapid IND clearance from China’s NMPA – a testament to the strong execution of both teams and the clear clinical rationale of this combination.Discovered and developed in-house on our proprietary ADC platform, ALK201 is a first-in-class FGFR2b-targeting ADC that has demonstrated precise and potent tumor cell killing with a favorable therapeutic window in preclinical studies. Ivonescimab, the world’s first PD-1/VEGF bispecific antibody, has redefined first-line NSCLC treatment with positive head-to-head Phase III results. Together, the deep, durable responses of IO 2.0 and the targeted cytotoxicity of ADCs offer the potential to break through the current efficacy ceiling in biomarker-positive squamous NSCLC.

This collaboration marks an important milestone for ALK201 and a strong validation of our platform-driven strategy. We look forward to working closely with Akeso to bring a superior first-line option to patients worldwide.

"We are delighted to see that ivonescimab, in collaboration with Allink Bio’s innovative FGFR2b-targeting ADC, is advancing combination therapy exploration for first-line lung cancer treatment. This represents yet another important validation of ivonescimab’s global value as a cornerstone drug in the Immuno-Oncology 2.0 (IO2.0) era," stated Dr. Xia Yu, Founder, Chairwoman, President, and CEO of Akeso. "Ivonescimab is the world’s first PD-1/VEGF bispecific antibody. Across multiple Phase III studies, it has demonstrated significant clinical breakthrough value over PD-1-based therapies, supported by robust evidence-based data. In the NSCLC field, ivonescimab has achieved multiple positive Phase III results, including head-to-head superiority versus pembrolizumab monotherapy in PD-L1-positive NSCLC and head-to-head superiority versus PD-1 inhibitor plus chemotherapy in first-line squamous NSCLC, redefining the gold standard of first-line treatment for NSCLC. Today, ivonescimab serves as the cornerstone of Akeso’s IO2.0 + ADC2.0 strategy. It is powering a series of high-potential, differentiated combination therapies that continue to drive the upgrade and evolution of global treatment paradigms for major malignancies, including lung cancer and breast cancer. This includes extensive combination explorations with our in-house next-generation ADCs and bispecific ADCs, as well as partnerships with numerous global high-potential ADC assets. We look forward to the ivonescimab plus ALK201 regimen delivering more efficacious and safer next-generation treatment options for patients worldwide."

About ALK201
ALK201 is an innovative, in-house developed ADC targeting FGFR2b. It is designed to exploit multiple synergistic anti-tumor mechanisms, including specific payload delivery, the bystander effect, ligand blockade, and antibody-dependent cellular cytotoxicity (ADCC), effectively countering FGFR2b overexpression associated with poor clinical prognoses. Based on the positive efficacy and favorable safety profile demonstrated in early-stage studies, ALK201’s therapeutic potential is actively being expanded from gastric cancer to a broader range of solid tumors. A clinical study (NCT06656390) evaluating ALK201 in patients with FGFR2b-overexpressing advanced solid tumors is currently underway.

About Ivonescimab
Ivonescimab is Akeso’s first-in-class PD-1/VEGF bispecific antibody. By simultaneously targeting PD-1 and VEGF, ivonescimab exerts synergistic anti-tumor effects and effectively addresses multiple clinical challenges that single-target therapies cannot overcome. In multiple Phase III trials, ivonescimab has demonstrated significant clinical advantages over PD-1 monotherapy, PD-1 plus chemotherapy, and anti-VEGF therapies. Notably, the HARMONi-A study is the first Phase III trial to achieve statistically significant and clinically meaningful improvements in both overall survival (OS) and progression-free survival (PFS) in patients with EGFR-TKI progressed non-squamous NSCLC. Ivonescimab is also the first innovative drug to outperform a blockbuster therapy in a head-to-head Phase III trial. As monotherapy in PD-L1-positive NSCLC, it extended median PFS beyond 11 months and reduced the risk of disease progression or death by 49% compared with PD-1 inhibitors. In the HARMONi-6 study, ivonescimab plus chemotherapy demonstrated statistically significant and clinically meaningful improvements in both PFS and OS compared with PD-1 inhibitor plus chemotherapy, redefining the first-line treatment standard for squamous NSCLC.

Ivonescimab is currently being evaluated in dozens of clinical trials, including 15 ongoing Phase III studies, many of which are international multicenter trials. Two NSCLC indications for ivonescimab have been included in China’s National Reimbursement Drug List (NRDL).

(Press release, Shanghai Allink Biotherapeutics, JUL 29, 2026, View Source [SID1234670858])

Second quarter 2026 results

On July 29, 2026 Boston Scientific reported second quarter 2026 results.

(Presentation, Boston Scientific, JUL 29, 2026, View Source [SID1234670607])

Entry Into A Material Definitive Agreement.

On July 29, 2026, Northwest Biotherapeutics (OTCQB:NWBO) (the "Company" or "NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported to have entered into a $4.9 million convertible Promissory Note financing with YA II PN, Ltd., an investment fund managed by Yorkville Advisors Global, LP ("Yorkville"). The term of the Note is 12 months. No payments by the Company are due until maturity. The Note carries an Original Issue Discount of five percent but no interest. Repayment of all outstanding amounts is due at maturity. The Note includes customary default provisions. During the term of the Note, it is convertible at the option of the holder, at a small discount to the then prevailing market price. The Company plans to use the proceeds for general corporate purposes, including both its lead product and its in-licensed portfolios.

The Company and Yorkville also entered into a standby equity subscription agreement (the "Subscription Agreement") which the Company may use after the Note is repaid or converted. The prior standby equity subscription agreement was cancelled. Under this Subscription Agreement, NW Bio has the option, in its discretion, to require Yorkville to subscribe for up to $50 million of common shares in the Company at any time during the 24-month term of the Subscription Agreement at a small discount to the then prevailing market price, after the Note is repaid or converted. The Company has no obligation to make any such use of this arrangement, and the Company can cancel the arrangement at any time after the Note is repaid or converted. The Company has no current plans to draw upon this standby facility; however, the Company believes it will be useful to have this facility available for special funding needs in connection with certain key potential upcoming milestones.

Yorkville also acquired a warrant to purchase up to $2 million of shares at $0.205 per share pursuant to the above transaction.

(Filing, Northwest Biotherapeutics, JUL 29, 2026, View Source [SID1234669577])

VERAXA Biotech Strengthens Patent Portfolio to Protect Core Technology Platforms and Product Candidates

On July 29, 2026 VERAXA Biotech AG (NASDAQ: VRXA; "VERAXA"), an emerging leader in designing novel cancer therapies, reported an update on its core patent portfolio. During the first half of 2026, first patent applications were filed to cover the Company’s new generation of technologies including its T cell engager (BiTAC-TCE) and antibody-drug-conjugate (BiTAC-ADC) platforms and therapeutic programs derived from them. Additionally, previously granted patents covering auxiliary technology modules have now cleared the opposition period. Overall, VERAXA now has a portfolio of more than 50 granted owned or exclusively licensed patents in 14 countries, which are spread across 26 patent families. Once the recently filed patent applications are granted, they are expected to protect VERAXA’s core technology suite through at least 2047.

"Patentable innovations are at the heart of any biotechnology company, and we are very pleased to provide an update on recent developments. Our IP strategy mirrors the breadth of novel concepts and innovations we are pursuing with regard to our BiTAC-TCE and BiTAC-ADC platforms, novel payload strategies, and the conjugation technologies and click chemistry enabling such therapies," commented Christoph Antz, Ph.D., CEO and Co-Founder of VERAXA. "Overall, we are building toward a strong IP portfolio protecting our core technology platforms and product candidates."

VERAXA is reimagining key aspects of bispecific T cell engager (TCE) and antibody-drug-conjugate (ADC) biology through its BiTAC (Bi-targeted Tumor-Associated Cytotoxicity) strategy. This novel approach relies on a dual-component molecular architecture to enhance tumor selectivity and safety via a true "AND-gate" mechanism. For T cell engagers (BiTAC-TCEs), the platform uses two split antibody constructs. Each targets a distinct tumor-associated antigen and carries one half of the T cell binding motif. Only when both precursors bind to the same cancer cell do they form a functional molecule—a mechanism that restricts T cell activity to cells displaying both tumor markers, sparing healthy tissue. For antibody-drug conjugates (BiTAC-ADCs), the technology delivers a systemically inactive prodrug and a cell-impermeable proactivator through two separate antibodies, each targeting a defined tumor-associated antigen. The payload is only released inside the cancer cell through a rapid, highly efficient chemical reaction called ‘click-to-release’. VERAXA’s click chemistry leverages the ultra-fast reaction between trans-cyclooctenes (TCOs) and tetrazines—one of the fastest in nature. The reaction kinetics and other proprietary improvements enable VERAXA to avoid the premature payload release during systemic circulation, as seen with past ADC approaches, and unlock cost savings in BiTAC-ADC manufacturing. In addition, VERAXA applies proprietary conjugation, linker, and hydrophilic payload technologies across its BiTAC and non-BiTAC pipelines, further enhancing the safety, efficacy, and manufacturability of its next-generation therapies.

(Press release, Veraxa Biotech, JUL 29, 2026, https://www.globenewswire.com/news-release/2026/07/29/3335104/0/en/veraxa-biotech-strengthens-patent-portfolio-to-protect-core-technology-platforms-and-product-candidates.html [SID1234669516])

TScan Therapeutics Announces First Patient Dosed in Phase 3 ALLOHA-2™, a Pivotal Trial Evaluating TSC-101 in Patients with Heme Malignancies

On July 29, 2026 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, reported that the first patient has been infused with TSC-101 in the pivotal Phase 3 ALLOHA-2 trial (NCT07702578). The patient, who was enrolled in June, has now received their first infusion of TSC-101 following successful stem cell engraftment. The trial is investigating the efficacy and safety of TSC-101 for the treatment of residual disease to prevent relapse following allogeneic hematopoietic cell transplantation (allo-HCT) in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

"Dosing our first patient in the ALLOHA-2 study is a significant milestone for TScan. Having been a part of TScan as we moved TSC-101 from an idea to Discovery, through Phase 1 clinical development, and now to a Phase 3 study, I want to acknowledge all the hard work that went into bringing TSC-101 to this integral step and congratulate all current and previous members of the TScan team," said Gavin MacBeath, Ph.D., Chief Executive Officer. "I would also like to thank the investigators, the patients, and their families for participating in our Phase 1 ALLOHA trial. In June, we reported initial data from Cohort C of that study, in which patients were treated with our commercial-ready manufacturing process. The strong clinical efficacy and positive safety profile observed in this cohort gives us added confidence in our Phase 3 trial and future clinical development plans."

"TSC-101 has demonstrated a safety profile and clinical results that continue to excite the transplant community," said Chrystal U. Louis, M.D., Chief Medical Officer. "The pace of Cohort C enrollment highlights the growing interest in TSC-101 as a potential therapeutic option for people with AML or MDS, and we look forward to working with our investigators to address residual disease and improve survival in patients after allo-HCT."

The Phase 3 ALLOHA-2 pivotal trial is a study evaluating TSC-101 administered after standard of care HCT vs HCT alone in patients with AML or MDS. Treatment is based on biological assignment (genetic randomization), with A*02:01-positive subjects with an appropriate donor assigned to the treatment arm, and A*02:01-negative subjects, or A*02:01-posititve subjects without an appropriate donor, assigned to the control arm. All subjects will receive HCT with reduced intensity conditioning. Subjects in the treatment arm will receive two infusions of TSC-101 following engraftment. The primary endpoint for the study is relapse-free survival, and key secondary endpoints include overall survival and event-free survival.

To learn more about the ALLOHA-2 clinical trial, visit clinicaltrials.gov (identifier: NCT07702578).

(Press release, TScan Therapeutics, JUL 29, 2026, View Source [SID1234669515])