On July 8, 2026 STEMCELL Technologies and the Centre for Commercialization of Regenerative Medicine (CCRM) reported a partnership to expand access to high-quality human induced pluripotent stem cell (iPSC) starting materials, giving cell therapy developers worldwide a faster, lower-risk path from research to the clinic. Under the agreement, STEMCELL will manufacture and distribute research-use-only (RUO) iPSC lines derived directly from LineaBio’s Good Manufacturing Practices (GMP) iPSC lines, and will offer the matched GMP lines to developers worldwide.

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For developers of iPSC-derived cell therapies, the starting cell line is a foundational choice that shapes the entire path to the clinic. A 2026 review in Stem Cell Reports identified 126 human iPSC lines available for clinical applications, but few offer the full set of attributes that reduce development risk: donor consent for commercial and therapeutic use, cleanroom-based GMP manufacturing, comprehensive genomic characterization, and clear freedom to operate. A shortfall in any of these may not surface until late in development, when a change of starting material can trigger a new regulatory filing, adding significant time and cost.

"As a company of Scientists Helping Scientists, STEMCELL is committed to providing cell therapy developers with iPSC starting materials they can rely on as they move from research toward the clinic," said Dr. Allen Eaves, President and CEO, STEMCELL. "By offering LineaBio’s GMP iPSC lines alongside matched RUO lines manufactured from the same material, we are giving scientists a dependable foundation for their work and helping to accelerate the development of new cell therapies."

"LineaBio was founded to give cell therapy developers off-the-shelf GMP iPSC lines backed by the documentation, characterization, and regulatory support they need," said Dr. Michael May, President and CEO, CCRM. "Working with STEMCELL and its reach into research laboratories worldwide, we can expand access to these lines across the research community and help accelerate the next generation of cell therapies for patients. We are proud to advance this work with a fellow Canadian company, expanding access to these tools for scientists worldwide."

LineaBio’s iPSC lines are manufactured under controlled GMP conditions from donor-eligible source material and characterized extensively, including by whole genome sequencing. The flagship line, Linea 1, is certified by the Human Pluripotent Stem Cell Registry (hPSCreg) and supported by a U.S. FDA drug master file, giving developers a standardized chemistry, manufacturing, and controls (CMC) data package they can reference in their own regulatory submissions to shorten their path to GMP and reduce cell line development costs. STEMCELL generates matched RUO counterparts directly from this GMP material and qualifies them using established comparability and genomic assessment frameworks. Because the RUO and GMP lines share the same donor and origin, developers can begin their research on the RUO line with confidence that it is comparable to the GMP material. The partnership will expand to include future GMP iPSC lines, including a hypoimmune line for allogeneic therapies.

The companies will present comparability and genomic concordance data for Linea 1 during the STEMCELL and CCRM Innovation Showcase at the 2026 International Society for Stem Cell Research (ISSCR) Annual Meeting in Montréal, "Accelerating Cell Therapy Development with GMP-Manufactured Human iPSC Lines and Matched RUO Equivalents," presented by Dr. Andrew Gaffney (STEMCELL) and Dr. Janet Rothberg (CCRM) on Wednesday, July 8, at 12:30 p.m. ET in Room 511a, Palais des congrès de Montréal. To learn more about the iPSC lines, visit www.stemcell.com/gmp-ipscs.

(Press release, CCRM, JUL 8, 2026, View Source [SID1234669105])

On July 8, 2026 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, and Hemispherian AS, a clinical-stage oncology company developing novel small molecule therapeutics, reported highly encouraging new preclinical data demonstrating strong synergy between GLIX1 and PARP inhibitors in a patient-derived xenograft (PDX) model of ovarian cancer.

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Ovarian cancer remains a major therapeutic challenge, particularly in homologous recombination (HR)-proficient disease where PARP inhibitors (PARPi) presently have limited efficacy, as well as for patients with platinum-resistance.

GLIX1 in combination with PARPi is expected to result in synthetic lethality, a mechanism in which GLIX1-induced single-stranded DNA breaks overcome PARP inhibitors’ requirement for HR-deficiency, enabling synergistic activity in HR-proficient cancers. This effect was first observed in vitro, where GLIX1 showed reproducible synergy across different PARP inhibitors and multiple HR-proficient ovarian cancer cell lines, with very high ZIP synergy scores.

"We are very excited to observe, in a patient-derived ovarian cancer model, the synergistic effect as we anticipated based on the mechanistic rationale and as demonstrated by in vitro data" said Philip Serlin, Chief Executive Officer of BioLineRx. "GLIX1 has the potential to sensitize patients to PARP inhibitors as well as to potentially address the huge unmet need for patients with platinum-resistance. Based on these highly encouraging data, we plan to include an ovarian cancer arm in the expansion part of our ongoing Phase 1/2a study."

Today’s results represent a compelling in vivo confirmation of GLIX1 and PARPi synergy from an HR-proficient ovarian cancer PDX model.

· The study included six arms: cisplatin, GLIX1 monotherapy and olaparib monotherapy (all at doses expected to be optimal), low-dose GLIX1, a low-dose GLIX1/olaparib combination arm, and a control arm

· Results show substantially better efficacy in the combination arm versus the control arm and versus the monotherapy arms, despite using lower doses in the combination arm

· The low-dose GLIX1/olaparib combination tumor reduction was similar to cisplatin, the current chemotherapy benchmark

BioLineRx and Hemispherian plan to present the data from this study at one or more future medical conferences.

About Ovarian Cancer

Ovarian cancer is the deadliest gynecologic malignancy in the United States, with an estimated approximately 21,000 new cases and 12,450 deaths projected in 2026. Standard first-line treatment consists of cytoreductive surgery and platinum-based chemotherapy, with PARP inhibitors used as maintenance therapy in selected patients, particularly those with BRCA-mutated or homologous recombination (HR)-deficient disease. However, PARP inhibitors are markedly less effective in patients with HR-proficient tumors, which account for approximately 50% of high-grade serous ovarian cancers and are associated with primary platinum resistance and shorter survival. This leaves a substantial and currently underserved patient population in need of new treatment strategies capable of extending the benefits of PARP inhibitors.

About GLIX1

GLIX1 is a first-in-class, orally administered, brain penetrating, small molecule activator of the Ten-Eleven Translocation 2 (TET2) pathway that is commonly inhibited in cancer. Activating the novel TET2 pathway by GLIX1 overwhelms the DNA repair capacity of cancer cells, resulting in apoptotic cancer cell death.

About the Phase 1/2a Trial with GLIX1

The Phase 1/2a trial is an open-label, multicenter trial. Part 1 of the trial is a dose escalation study where patients receive GLIX1 daily as monotherapy. This part is expected to recruit up to 30 patients with recurrent and progressive GBM and other high-grade gliomas. The primary objective is to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. Updates to the Phase 1/2a trial are anticipated during H2 2026, with full results on the dose escalation part expected in 2027.

The Phase 2a expansion part of the trial is planned to include additional indications, including newly diagnosed GBM, as well as select cancers, with GLIX1 as monotherapy or in combination with standard of care (including in combination with PARP inhibitors). These cohorts are expected to identify preliminary efficacy, PD assessments and dose optimization data, serving as the basis for a rapid and effective advanced clinical development plan.

For more information on the Phase 1/2a trial, please visit NCT07464925.

(Press release, BioLineRx, JUL 8, 2026, View Source [SID1234669104])

On July 8, 2026 Cellis reported to have participated in the International Conference on Precision Medicine and the STRIKE Scientific Meeting, held on 2–4 July 2026 in Messina, Italy. The event brought together leading researchers, clinicians, and industry representatives to discuss the latest advances in precision medicine and translational research.

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As an invited speaker, our Chief Scientific Officer, Prof. Magdalena Król, presented the lecture titled "Turning Macrophages into Therapeutic Effectors: Immune Reprogramming via the Macrophage Drug Conjugate Platform."

During her presentation, Prof. Król introduced Cellis’ innovative Macrophage Drug Conjugate (MDC) platform, which harnesses macrophages as active therapeutic effectors capable of delivering anti-cancer payloads directly to the tumor microenvironment. The lecture highlighted how immune cell reprogramming can overcome key limitations of conventional drug delivery and open new opportunities for precision oncology.

The conference provided an excellent opportunity to exchange ideas with scientists, clinicians, and innovators working across cancer biology, immunotherapy, nanomedicine, and targeted drug delivery. The discussions reinforced the growing interest in next-generation cell-based therapies and the importance of interdisciplinary collaboration in accelerating their clinical translation.

We thank the organizers for the invitation and the opportunity to present Cellis’ scientific achievements on an international stage. We look forward to building new collaborations and continuing to advance macrophage-based precision therapies for patients with cancer.

(Press release, Cellis, JUL 8, 2026, View Source [SID1234669103])

On July 7, 2026 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for PADCEV (enfortumab vedotin) in combination with Keytruda (pembrolizumab) as neoadjuvant treatment (before surgery), and then continued after cystectomy (surgery) as adjuvant treatment (after surgery), for adults with muscle-invasive bladder cancer (MIBC), regardless of their eligibility for cisplatin-containing chemotherapy.

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The BLA is supported by results from the Phase 3 EV-303 and EV-304 clinical trials (KEYNOTE-905 and KEYNOTE-B15, respectively). In EV-303, neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab was compared with surgery alone in MIBC patients ineligible for or who declined cisplatin-containing chemotherapy. In the Event-Free Survival (EFS) analysis, the combination reduced the risk of tumor recurrence, progression, or death by 60%.1 In the Overall Survival (OS) analysis, the combination reduced the risk of death by 50%.1

In EV-304, neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab was compared with standard of care neoadjuvant gemcitabine and cisplatin chemotherapy in MIBC patients eligible for cisplatin-containing chemotherapy. In the EFS analysis, enfortumab vedotin plus pembrolizumab reduced the risk of tumor recurrence, progression, or death by 47%.2 In the OS analysis, enfortumab vedotin plus pembrolizumab reduced the risk of death by 35%.2

In EV-303 and EV-304, the safety profile of enfortumab vedotin plus pembrolizumab was consistent with prior experience with the combination, and no new safety signals were observed.1,2 Across both trials, the most common (≥30%) adverse events (AEs) related to treatment with neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab include pruritus (itching), alopecia, diarrhea, and anemia.1,2

According to the latest data from the China National Cancer Center, bladder cancer has an estimated incidence rate of 3.44 per 100,000 people, with more than 480,000 people affected in China.3,4 MIBC represents approximately 30% of bladder cancer cases, and despite curative-intent surgery, approximately half of MIBC patients experience recurrence.5,6

Astellas has already reflected the impact from this acceptance in its financial forecast of the current fiscal year ending March 31, 2027.

About PADCEV (enfortumab vedotin)
PADCEV (enfortumab vedotin) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.7 Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).7

Enfortumab vedotin in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph is approved as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy in the United States.

Additionally, enfortumab vedotin plus pembrolizumab is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) regardless of cisplatin eligibility in the United States, Japan, and a number of other countries around the world. In the European Union, the combination is approved for the treatment of adult patients with la/mUC who are eligible for platinum-containing chemotherapy.

About the EV-303/KEYNOTE-905 Trial
The EV-303 trial (also known as KEYNOTE-905) is an ongoing, open-label, randomized, three-arm, controlled, Phase 3 study evaluating neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab or neoadjuvant and adjuvant pembrolizumab versus surgery alone in patients with MIBC who are either not eligible for or declined cisplatin-based chemotherapy. Patients were randomized to receive either neoadjuvant and adjuvant pembrolizumab (arm A), surgery alone (arm B) or neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab (arm C). Enfortumab vedotin in combination with pembrolizumab was administered as a planned total of 9 cycles of enfortumab vedotin and 17 cycles of pembrolizumab, split before and after surgery.

The primary endpoint of this trial is EFS between arm C and arm B, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy (RC) or failure to undergo RC in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence based on imaging, blinded independent central review (BICR), and/or biopsy or death due to any cause. Key secondary endpoints include OS and pCR rate between arm C and arm B, as well as EFS, OS and pCR rate between arm A and arm B.

For more information on the global EV-303 trial, go to clinicaltrials.gov.

About the EV-304/KEYNOTE-B15 Trial
The EV-304 trial is an ongoing, open-label, randomized, controlled, Phase 3 study evaluating neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab versus neoadjuvant chemotherapy (gemcitabine and cisplatin) in patients with MIBC who are eligible for cisplatin-based chemotherapy. Patients were randomized to receive either neoadjuvant and adjuvant (before and after surgery) enfortumab vedotin in combination with pembrolizumab (arm A) or neoadjuvant chemotherapy (arm B). Curative-intent surgery (cystectomy) was performed in both arms. Enfortumab vedotin in combination with pembrolizumab was administered as a planned total of 9 cycles of enfortumab vedotin and 17 cycles of pembrolizumab, split before and after surgery.

The primary endpoint of this trial is EFS, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC or failure to undergo RC in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence based on BICR or death due to any cause. Key secondary endpoints include OS and pCR rate.

For more information on the global EV-304 trial, go to clinicaltrials.gov.

(Press release, Astellas, JUL 7, 2026, View Source [SID1234670181])

On July 7, 2026 Imugene Limited ("Imugene", the "Company", "ASX:IMU") , a clinical-stage immuno-oncology company, reported it has received firm commitments from sophisticated, professional and institutional investors for a two-tranche placement to raise approximately $11.12 million (before costs) ( the "Placement") through the issue of approximately 117.1 million new fully paid ordinary shares ("New Shares") at an issue price of $0.095 per New Share ("Offer Price"). The Placement was strongly supported by new and existing institutional investors, including long-only global investors and a global pharmaceutical company.

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The Placement includes a placement to Directors of Imugene to raise approximately $0.12m (before costs) through the issuance of ~1.3m New Shares ("Directors Placement") subject to shareholder approval. Managing Director and Chief Executive Officer, Leslie Chong said: "The first two evaluable patients in our concurrent BTKi combination cohort have both achieved complete responses, providing a strong early clinical signal for azer-cel in a therapeutic class worth more than US$12 billion annually. This Placement funds a series of important clinical data readouts over the next 6–12 months, including presentations at ASH (Free ASH Whitepaper) and ASCO (Free ASCO Whitepaper), while supporting our ongoing business development activities and continued discussions with potential pharmaceutical partners. We thank our shareholders, new investors and Directors for their ongoing support as we advance azer-cel towards a registrational pathway"

About the Placement
Under the terms of the Placement, the Company has secured firm commitments for approximately $11.1 million and proposes to issue approximately 117.1 million New Shares to Placement participants at an issue price of $0.095 per New Share, representing a discount of:
• 17.7% to the 30-day VWAP of $0.115 up to and including Thursday, 2 July 2026; and
• 29.6% to the last closing price of $0.135 on Thursday, 2 July 2026. Shares under the Placement will be issued as follows:
• Tranche 1 Placement to raise A$7.0 million (before costs) through the issuance of approximately 73.7 million New Shares ("Tranche 1 Placement") pursuant to the Company’s placement capacity under Listing Rules 7.1 and 7.1A; and
• Tranche 2 Placement to certain investors, including Directors of Imugene to raise $4.1m (before costs) through the issuance of 43.4m New Shares, with any shares in excess of the company’s placement capacity under Listing Rules 7.1 and 7.1A ("Tranche 2 Placement") and the issue of shares under the Directors Placement subject to shareholder approval at the EGM

Placement participants include an international, commercial-stage biopharmaceutical company, which subscribed for approximately 14% of the Placement, subject to shareholder approval.

(Press release, Imugene, JUL 7, 2026, View Source [SID1234669281])