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])

On July 7, 2026 MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicines company, reported that it has entered into an agreement with Oberland Capital Management LLC (Oberland Capital) for an investment of up to $400 million in the Company, including up to $375 million in non-dilutive capital for capped royalty payments on certain products and up to $25 million in equity.

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"We are very pleased to partner with Oberland Capital as we move towards potential commercialization of our late-stage programs for XLRP and radiation-induced xerostomia," said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. "The size and terms of Oberland Capital’s investment demonstrate exceptional confidence in the strength of the data for these programs to date as well as the large commercial potential for both bota-vec and AAV2-hAQP1."

Dr. Forbes continued, "Having multiple late-stage products allowed for a creative structure with low royalties on more than one product, which provides substantial non-dilutive capital while preserving business development flexibility in all aspects of the Company."

Michael Bloom, Partner at Oberland Capital, added, "MeiraGTx is in the rare position of having three potentially approvable therapies within the next 12 to 24 months, two of which have significant commercial potential. Each of these would be first to market in areas of complete unmet need where there are a large number of patients waiting for these potential treatments. We are excited to partner with the MeiraGTx team and provide substantial investment to enable robust commercialization and launch efforts globally."

Transaction Overview:
The investment by Oberland Capital provides for up to $400 million in total capital to MeiraGTx, including up to $375 million in non-dilutive royalty funding and up to $25 million in equity, as follows:

The initial $135 million funded includes $125 million in exchange for low single-digit royalties on the included products, and a $10 million equity investment
An additional $50 million will be available at the Company’s option tied to AAV2-hAQP1 positive data readouts from the Phase 2 AQUAx2 study in 2027
An additional $50 million will be available at the Company’s option tied to regulatory approval of bota-vec in 2027
An additional $50 million will be available at the Company’s option tied to regulatory approval of AAV2-hAQP1 in 2028
A further $100 million is available upon mutual agreement for new products or business development
Oberland Capital has the right to purchase an additional $15 million in equity in MeiraGTx

The agreement with Oberland Capital includes flexible provisions for potential change of control, with the ability for the Company to buy back the entire funded royalty note at any time by paying certain specified amounts.

Royalty payments are capped at a multiple of the amounts funded.

Additional details regarding the agreement with Oberland Capital can be found in the Current Report on Form 8-K filed by the company today with the U.S. Securities and Exchange Commission.

(Press release, MeiraGTx, JUL 7, 2026, View Source [SID1234669102])

On July 7, 2026 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported the publication of its primary result analysis of the Phase 3 COMPETE trial in The Lancet. The clinical data demonstrated that non-carrier-added (n.c.a.) 177Lu-edotreotide (also known as 177Lu-edotreotide or ITM-11) significantly improved progression-free survival (PFS) compared to everolimus in patients with Grade 1 or Grade 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

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The publication, titled "[177Lu] Lu-edotreotide versus everolimus for gastroenteropancreatic neuroendocrine tumours (COMPETE): a phase 3, multicentre, randomised, open-label, superiority trial," appeared online on July 2, 2026, and can be accessed via the following link: doi.org/10.1016/S0140-6736(26)00604-5.

"COMPETE provides the first high-level evidence directly comparing peptide receptor radionuclide therapy (PRRT) with everolimus, a commonly used systemic standard-of-care therapy, in the treatment of advanced GEP-NETs," said Jaume Capdevila, MD, PhD, last author, study investigator and senior medical oncologist at Vall d’Hebron University Hospital, Barcelona. "The efficacy and safety results observed with 177Lu-edotreotide support its consideration as a potential treatment option for appropriate patients, including those whose disease has progressed following somatostatin analog (SSA) therapy."

"Publication of these data in a peer-reviewed journal underscores the scientific importance of the COMPETE study and provides an important forum for dissemination of the results," added Thomas Walter, MD, PhD, first author, study investigator and professor of gastroenterology, Hospices Civil of Lyon, France. "These findings offer additional insights into PRRT and support 177Lu-edotreotide as a potential therapeutic option in advanced GEP-NETs, where a high unmet need remains."

COMPETE Trial Results
The randomized, open-label Phase 3 COMPETE trial evaluated n.c.a. 177Lu-edotreotide versus everolimus in 309 patients with advanced, progressive, Grade 1 or Grade 2 SSTR-positive GEP-NETs across 49 global sites. Patients were randomized 2:1 to receive 177Lu-edotreotide every three months for up to four cycles or everolimus daily for up to 30 months. Patients were not required but permitted to receive SSAs at the investigator’s discretion for symptom control only. Overall, 21% of patients received concomitant SSA treatment during the study, with similar proportions receiving SSAs in each treatment arm. Top line results of the trial were initially presented at ENETS 2025 and ESMO (Free ESMO Whitepaper) 2025.

Key findings from the COMPETE trial include:

Median PFS was significantly longer in the 177Lu-edotreotide arm compared to everolimus (23.9 vs. 14.1 months; p=0.022; HR 0.67, 95% CI [0.48–0.95])
Objective response rate (ORR) was significantly higher in the 177Lu-edotreotide arm compared to everolimus in central review (22% vs. 4%; p<0.0001)
Safety data demonstrated a lower incidence of Grade 3/4 treatment-related adverse events in patients receiving 177Lu-edotreotide compared to everolimus (18% vs. 40%)
The most common treatment-related adverse events in the 177Lu-edotreotide arm were diarrhea and nausea (both 36%) and asthenia (33%), whereas those in the everolimus arm were diarrhea (45%), asthenia (36%), and anemia (27%)

Notably, a substantial proportion of patients enrolled in COMPETE had pancreatic neuroendocrine tumors (n=178, 57.6%), where treatment options remain limited. ITM will continue to monitor patients for up to five years after the end of the study to gather additional safety and overall survival data.

"The COMPETE results add to the evidence base of PRRT in advanced GEP-NETs and help address an important evidence gap, given the limited prospective, head-to-head trials versus active therapies in this setting," said Dr. Celine Wilke, chief medical officer of ITM. "These data support the potential role of investigational 177Lu-edotreotide as a treatment option in this indication, if approved."

ITM-11 is currently under regulatory review by the U.S. Food and Drug Administration and is not approved by any regulatory authority for any use.

About GEP-NETs
Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are a heterogeneous group of rare tumors arising from neuroendocrine cells in the gastrointestinal tract and pancreas. Many patients present with advanced disease, and treatment options are often limited following progression on first-line therapies.

About the COMPETE Trial
The COMPETE trial (NCT03049189) evaluated 177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular standard-of-care therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177Lu-edotreotide is also being evaluated in COMPOSE (NCT04919226), a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, SSTR-positive GEP-NET tumors, and in KinLET (NCT06441331), a Phase 1 trial in pediatric patients with SSTR-positive tumors.

(Press release, Isotopen Technologien München, JUL 7, 2026, https://www.globenewswire.com/news-release/2026/07/07/3322956/0/en/itm-announces-primary-results-from-the-phase-3-compete-trial-published-in-the-lancet-comparing-lu-edotreotide-itm-11-vs-everolimus-in-advanced-gep-nets.html [SID1234669101])