Sapu Nano Expands International Development of Sapu003 and Appoints Global Clinical Trials (GCT) as Lead CRO for Phase 1b Program

On June 3, 2026 Sapu Nano and Oncotelic Therapeutics (OTCQB:OTLC) reported the expansion of its Phase 1b clinical development program for Sapu003 (Everolimus for Injection) and the appointment of Global Clinical Trials (GCT) as the lead contract research organization supporting international execution of Study SP-03-B101.

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The announcement follows recent regulatory approvals supporting the study expansion and CRO transition and represents an important milestone in the evolution of the Sapu003 clinical program from its initial Australian clinical footprint toward a broader multinational clinical program.

GCT was selected following a competitive evaluation process that assessed international oncology expertise, regulatory capabilities, operational execution, clinical quality systems, and global logistics infrastructure. Following its appointment, GCT successfully completed key regulatory submissions ahead of schedule and has initiated clinical operations, regulatory coordination, site activation activities, investigational product logistics, and study management functions.

The appointment supports the expansion of the SP-03-B101 study beyond Australia into Europe and represents an important step in establishing the clinical, operational, and regulatory infrastructure necessary to support future multinational Phase 3 development. By building an international clinical network early in development, Sapu Nano aims to position Sapu003 for efficient advancement into global registrational studies following successful completion of ongoing clinical evaluation.

SP-03-B101 is an open-label Phase 1b dose-escalation study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of Sapu003 in patients with advanced mTOR-sensitive solid tumors.

"Sapu003 has progressed from concept through formulation development, manufacturing, regulatory approval, and clinical evaluation in a remarkably short period of time," said Dr. Vuong Trieu, Chief Executive Officer. "The expansion of the program beyond Australia and the appointment of GCT provide the international infrastructure necessary to support continued clinical development. We believe these milestones position Sapu003 for broader global evaluation and future registrational studies while expanding access for patients with advanced cancers."

Sapu003 is a proprietary intravenous formulation of everolimus developed using Sapu Nano’s Deciparticle platform technology. The program is designed to address limitations associated with oral everolimus administration, including variable absorption, food effects, and first-pass metabolism, while providing more predictable systemic drug exposure through intravenous delivery.

The Company expects the expanded international footprint and integrated clinical operations platform established through GCT to support continued enrollment, future site expansion, and long-term global development objectives for the Sapu003 program.About Deciparticle

Deciparticle is Oncotelic’s proprietary nanomedicine platform designed to formulate highly water-insoluble therapeutics into ultra-small nanoparticles for intravenous administration. The platform utilizes amphiphilic polymer architectures intended to improve aqueous compatibility, stability, manufacturability, and translational flexibility across multiple therapeutic classes.

(Press release, Sapu Bioscience, JUN 3, 2026, View Source [SID1234666413])

Alpha Tau and Tolmar Announce Strategic Collaboration to Bring Alpha DaRT® Therapy to U.S. Urological Cancer Patients

On June 3, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW), developer of the innovative alpha-radiation cancer therapy Alpha DaRT, and Tolmar International Ltd., one of the strongest commercial players in the U.S. urology, oncology, endocrinology and pediatric endocrinology markets, reported a strategic collaboration agreement to develop and commercialize Alpha DaRT for the treatment of prostate cancer in the United States.

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According to the American Cancer Society, prostate cancer is the second-leading cause of cancer death in American men, behind only lung cancer, with over 330,000 new cases expected this year and about 1 in 44 men dying from the disease. More than half of men who undergo a radical prostatectomy experience long-term complications, including erectile dysfunction and urinary incontinence, highlighting the need for new alternatives that may potentially avoid such surgeries.

Through the collaboration, Tolmar will hold exclusive rights to commercialize Alpha DaRT in the United States for prostate cancer indications for a term that is expected to extend for 20 years from first commercial sale, subject to the terms and conditions of the Collaboration Agreement. Tolmar also holds an option, exercisable upon achievement of specified clinical criteria, to expand commercially into bladder cancer in the United States.

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) represents a paradigm shift in the treatment of solid tumors. While traditional radiation therapies face limitations of efficacy and focused targeted delivery, Alpha DaRT is designed to deliver highly potent and conformal therapy directly inside the tumor, by means of recoiling radioisotopes that release alpha particles with high energy and short diffusion. Alpha DaRT therefore has the potential to destroy cancer cells with precision and spare the surrounding healthy tissue, offering patients a new and highly localized treatment modality to maximize their quality of life.

Alpha Tau Chief Executive Officer, Uzi Sofer, remarked, "Our clinical exploration of prostate cancer is already well underway, having treated patients in Israel and secured an IDE from the FDA for a U.S. trial. Working alongside Tolmar, a top commercial leader with a keen understanding of this market, unlocks a vital channel with the potential to reach tens of thousands of patients per year in this first urological indication alone. Alongside our core clinical programs to date in glioblastoma, pancreatic cancer, and squamous cell carcinoma, expanding into prostate cancer allows us to extend the reach of our platform technology exponentially and builds upon our deep commitment to advancing innovative therapies across multiple oncology settings. This partnership will also spur additional expansion of our U.S. manufacturing capacity, advancing our commitment to deliver this groundbreaking science to patients as quickly as possible."

"Alpha DaRT represents a meaningful advancement in oncology, with the potential to make a significant difference for patients facing prostate cancer," said Anil D’Souza, Chief Executive Officer of Tolmar. "By combining innovative science with Tolmar’s proven capabilities and deep experience supporting providers, we are focused on expanding access to new treatment options for patients and the clinicians who care for them. Throughout our extensive due diligence of Alpha Tau, we were consistently impressed with Uzi and the talent of the Alpha Tau leadership team, thinking strategically through all aspects of this unique therapy, from manufacturing to supply chain, and into clinical settings, as we were increasingly convinced of the promise of the technology, the market opportunity, and the commercial prospects. Together, we are mobilized to work to accelerate its development and bring this therapy to patients across the United States as efficiently as possible."

Tolmar Chief Medical Officer, Anjan Chatterjee, MD, MPH, MBA, added, "From a clinical perspective, Alpha DaRT’s localized mechanism of action is incredibly promising for urological oncology. For clinicians treating prostate cancer, the ability to deliver potent alpha-radiation precisely to the tumor while minimizing radiation-induced damage to nearby healthy tissue (off-target activity) can address a profound unmet medical need. We are eager to collaborate with Alpha Tau’s medical team to advance the U.S. clinical development program and bring this solution to patients and their physicians in the oncology community."

Alpha Tau Chief Financial Officer, Raphi Levy, commented, "We are very excited about the potential for this collaboration. We have long identified the prostate cancer market as compelling, and with our concentration also on other cancers, we stand to benefit greatly from Tolmar’s focus and deep industry expertise in this sector, and we will be excellently positioned towards introducing a much-needed therapy in a seamless and integrated fashion. It has been a pleasure working with Tolmar to get to this moment, though we know the work is only just beginning."

Key Terms of the Collaboration

Tolmar will hold exclusive rights to commercialize Alpha DaRT in the United States for prostate cancer indications for a term that is expected to extend for 20 years from first commercial sale, subject to the terms and conditions of the Collaboration Agreement. Tolmar also holds an option to expand the agreement to include bladder cancer commercialization in the U.S., exercisable upon achievement of specified clinical criteria.

Alpha Tau will lead clinical development of the Alpha DaRT for these indications, working in close collaboration with Tolmar and subject to joint governance under the collaboration agreement. Alpha Tau will be responsible for manufacturing and supply of the product, while Tolmar will have full responsibility and control over commercialization, including pricing, customer engagement, and sales execution in the United States. The supply price to Tolmar is based on a percentage of net sales (set at 60%, subject to certain adjustments as defined in the Supply Agreement).

At closing, Tolmar will make a $20M equity investment in Alpha Tau at $11.99 a share, a 25% premium to the 30-trading day volume-weighted average price (VWAP) prior to signature, and will pay $15M towards the construction of a new Alpha DaRT production facility in the U.S. Certain payments have also been agreed for future clinical development and U.S. regulatory approval work, which total up to $96.5M in development and regulatory milestone payments for the initial indication, and up to $65M in commercial milestone payments, subject to achievement of specified milestones.

Should Tolmar exercise the U.S. bladder cancer option, Tolmar will invest another $5M at a 25% premium to the then-prevailing 30-trading day VWAP and pay an additional $5M for expanded manufacturing capacity, as well as similar payments of up to $96.5M for future clinical development and U.S. regulatory approval work for the first bladder cancer indication to be pursued jointly by the parties.

Under the terms of the agreement, Tolmar receives a right of first negotiation on new Alpha Tau products for U.S. urological cancers covered by the agreement, as well as a right of first negotiation for certain additional products and geographic opportunities, as specified in the Collaboration Agreement. Alpha Tau retains all rights to Alpha DaRT outside of the prostate and bladder markets in the U.S., as well as all global rights outside the U.S.

(Press release, Alpha Tau Medical, JUN 3, 2026, View Source [SID1234666429])

Juncell Therapeutics’ GC101 TIL Therapy Achieves Primary Endpoint in the Pivotal Phase II Trial for PD-1 Antibody Failed Advanced Melanoma

On June 3, 2026 Shanghai Juncell therapeutics, reported a Late-Breaking Abstract (LBA) oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Professor Lu Si from Peking University Cancer Hospital presented the results of a Pivotal Phase 2 clinical study (MIZAR-003) conducted in China evaluating the efficacy and safety of GC101 TIL therapy (Nolgileucel), developed by Shanghai Juncell Therapeutics Co., Ltd. for PD-1 antibody failed patients with advanced melanoma. Comparing with the control group who received chemotherapy, GC101 TIL therapy demonstrated statistically significant and clinically meaningful efficacy improvement, potentially to benefit patients with advanced melanoma who failed PD-1 antibody.

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Addressing the Unmet Need in the Treatment of Advanced Melanoma

Unlike cutaneous melanoma which is predominant in Western population, melanoma in East Asia is primarily composed of acral melanoma and mucosal melanoma. The differences in subtypes result in distinct patient outcomes. For instance, the objective response rate (ORR) and duration of response (DoR) of PD-1 antibody as the first treatment setting for advanced melanoma in China are only around 1/3 of those in Western population.

Conventional TIL therapies can offer deep and durable clinical benefits, but the requirements of high-intensity lymphodepletion chemotherapy and high-dose IL-2 administrations may lead to severe adverse events and even mortality.

The MIZAR-003 study selected for this ASCO (Free ASCO Whitepaper) LBA is an open-label, randomized, active-controlled, multicenter pivotal Phase II clinical trial. Initiated in December 2024 and led by Professor Jun Guo of Peking University Cancer Hospital. The trial was conducted across 25 leading cancer centers in China. The study aims to evaluate the efficacy and safety of GC101 in patients with advanced melanoma who have failed prior PD-1 antibody therapy, with the primary endpoint being progression-free survival (PFS).

Juncell’s GC101 TIL Therapy Demonstrates Exceptional Efficacy

All enrolled patients in MIZAR-003 had advanced melanoma that failed prior PD-1 antibody therapy. The median number of prior systemic therapy lines was 2, acral and mucosal melanoma accounted for 81.8% of patients, the median sum of the diameters (SOD) of target lesions was 68.4 mm, 89.9% of patients had distant metastasis, with more than half of the patients having metastases involving ≥ 3 organs. Among these, 66.7% had metastases to vital organs including the liver, lungs, and bones. After randomization, baseline characteristics were balanced between the GC101 treatment group and the control group.

As the first registrational randomized controlled trial (RCT) of a TIL therapy in late-line melanoma globally, MIZAR-003 met its primary endpoint, achieving clinical trial success. According to the data presented, the median progression-free survival (PFS) in the GC101 treatment group was 4.3 months, which was significantly superior to 1.6 months in the chemotherapy control group (HR=0.43,95% CI 0.26~0.68,P=0.0002), representing a 57% reduction in the risk of progression or death. Overall survival (OS) data are not yet mature but have shown a clear trend of benefit.

The ORR in the GC101 treatment group was 42.0%, representing a substantial improvement over the 6.1% observed in the control group. Moreover, some patients in the treatment group converted from long-term partial response (PR) to complete response (CR), demonstrating excellent efficacy.

Juncell’s GC101 TIL Therapy Exhibits Favorable Safety Profile

Unlike conventional TIL therapy which requires high-intensity lymphodepletion chemotherapy and high-dose IL-2 administration, GC101 TIL therapy adopts an innovative regimen featuring low-intensity preconditioning and no IL-2 administration, thereby reducing related adverse events.

In terms of safety profile, compared with conventional TIL therapies, adverse events following GC101 treatment were substantially lower in both incidence and grade, with shorter duration. The median duration was 8 days.

(Press release, Juncell Therapeutics, JUN 3, 2026, View Source;juncell-therapeutics-gc101-til-therapy-achieves-primary-endpoint-in-the-pivotal-phase-ii-trial-for-pd-1-antibody-failed-advanced-melanoma-302790931.html [SID1234666414])

CytomX Announces Expansion of Strategic Research Collaboration with Regeneron in the Field of Conditional Bispecific Therapeutics for the Treatment of Cancer

On June 3, 2026 CytomX Therapeutics, Inc. (NASDAQ: CTMX) reported an expansion of its collaboration and licensing agreement with Regeneron Pharmaceuticals, Inc. to create conditionally-activated bispecific cancer therapies utilizing CytomX’s Probody therapeutic platform and Regeneron’s Veloci-Bi bispecific antibody development platform.

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The Regeneron and CytomX collaboration, initially entered into in 2022, is strategically focused on applying CytomX’s biologic masking strategies in combination with Regeneron’s bispecific antibodies to develop investigational bispecifics that remain inactive until activated by proteases in the tumor microenvironment. This technology has the potential to widen the therapeutic window and help minimize off-target effects for next-generation T-cell engaging therapies, potentially addressing tumor types that have historically been challenging for immunotherapy.

"Cancer necessitates innovative treatment approaches, and with this expanded collaboration with CytomX, we are advancing bispecific treatments where we see the most promise. Our complementary oncology expertise with CytomX – including application of our proprietary VelociSuite technologies developed to accelerate drug discovery and development – make us uniquely suited to work together on this endeavor to bring new medicines to patients in need," said John Lin, M.D., Ph.D., Senior Vice President of Oncology & Antibody Technology Research at Regeneron.

"Our ongoing research collaboration with Regeneron is based on a shared commitment to cutting edge science and a vision to push the boundaries of cancer immunotherapy. At CytomX, we are applying our deep understanding of masking and protease biology to unlock new opportunities uniquely enabled by our technology," said Sean McCarthy, D. Phil, CEO and Chairman of CytomX. "Regeneron’s deep expertise in bispecific immunotherapies has made them an ideal partner in expanding the reach of the PROBODY platform, and we look forward to building on our alliance momentum to collectively make a meaningful difference for people with cancer."

Under the expanded agreement, Regeneron and CytomX will continue to collaborate on discovery activities to identify and validate conditionally active bispecific antibodies. Regeneron will be responsible for funding preclinical and clinical development and commercialization activities. CytomX will receive a target nomination payment of $37 million for two additional targets that have been selected, and Regeneron has the option to select up to 6 additional future targets. Total potential target nomination payments, preclinical, clinical, regulatory and commercial milestones covered under the scope of the expanded collaboration could reach up to approximately $4 billion. CytomX is also eligible to receive tiered global net sales royalties on products covered under the collaboration.

(Press release, CytomX Therapeutics, JUN 3, 2026, View Source [SID1234666430])

TransCode Therapeutics Successfully Completes Phase 1a Clinical Trial, Reports Safety and Stabilization Data for TTX-MC138 in Metastatic Cancer

On June 3, 2026 TransCode Therapeutics, Inc. (NASDAQ: RNAZ) a clinical stage company pioneering immuno-oncology and RNA for the treatment of high risk and advanced cancer, reported further results of the Phase 1a dose escalation clinical trial. The trial met its primary endpoint of safety, with positive tolerability, combined with disease stabilization in multiple patients, and the absence of dose-limiting toxicities with its lead therapeutic candidate TTX-MC138. TTX-MC138, an investigational inhibitor of the key metastatic driver, microRNA-10b, has shown durable disease control. These findings support advancing TTX-MC138 into Phase 2a clinical development to assess efficacy in patients with circulating tumor DNA (ctDNA) positive colorectal cancer following curative–intent therapy.

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TTX-MC138 has been administered to 16 patients who received 86 doses. The median treatment duration was 11.3 weeks, with a range of four to 52.4 weeks, representing 2 to 20 cycles of treatment.
Notably, three patients remain on trial, and continue to receive TTX-MC138. One patient is at 21 cycles of treatment, another is at 16 cycles, and the third one is at 14 cycles of treatment. (Table 1)

Table 1: Trial demographics, met safety primary endpoint

Cohort

Dose

Number of Patients

DLT’s1

1

0.8mg/kg

3

0

23

1.6mg/kg

3

0

33

3.2mg/kg2

7

0

43

4.8mg/kg

3

0

1 No significant treatment-related safety events or dose limiting toxicities were observed.
2 Optional backfill 3 with additional patients.
3 One patient in each of cohort 2, 3 and 4 currently on study.

TransCode believes these results support its selection of the recommended Phase 2a dose (RP2D) of 4.8mg/kg.

In addition, the assessment of the trial patient population underscored the potential for durable disease control in participants with metastatic cancer.

Based on Response Evaluation Criteria in Solid Tumors (RECIST) standardized criteria to measure tumor response to treatment using imaging to categorize lesions and assess changes in size over time, 9 out of 14 (64%) of evaluable patients achieved stable disease lasting six months, demonstrating a durable disease activity.

"From a clinical perspective, it is quite encouraging to see how well tolerated this agent has been at the exposures achieved through the Phase 1a dose-escalation study, without any dose-limiting toxicities. That, combined with the observation of disease stabilization in a population with such advanced disease supports continued clinical development" noted Keith Flaherty, MD, Director of Clinical Research at the Massachusetts General Hospital Cancer Center, Professor of Medicine at Harvard Medical School and TransCode’s Advisory Board member.

The pharmacokinetics profile from the analysis of plasma from patients receiving TTX-MC138 demonstrated evidence of drug bioavailability consistent with earlier preclinical studies.

One patient diagnosed with metastatic thyroid cancer was noted to have a dramatic decrease in their thyroglobulin levels, a tumor marker associated with cancer progression. The patient has now had demonstrated stable disease for the last 12 months and is one of the three patients who remain on study. We believe that the patient’s continued participation in the study, together with the decline in their thyroglobulin levels, provides further evidence of therapeutic activity from TTX-MC138.

A clinical study report is in process. Several presentations are planned at future scientific congresses.

"As the safety and tolerability primary objectives of the trial were met, the encouraging rates of disease stabilization provide the rationale to advance TTX-MC138 clinical development in our recently initiated Phase 2a trial. We continue to believe that TTX-MC138 may offer a promising therapeutic option, if approved, for patients with metastatic disease who have limited treatment alternatives," said Daniel Vlock, MD, TransCode Consulting Clinician.

Further information about the trial is available at www.clinicaltrials.gov, (NCT Identifier: NCT06260774).

About TTX-MC138

TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b (miR-10b), a microRNA widely believed to be critical to the emergence and progression of many metastatic cancers. TransCode’s Phase 0 clinical trial produced evidence of delivery of a radiolabeled version of TTX-MC138 to metastatic lesions.

(Press release, TransCode Therapeutics, JUN 3, 2026, View Source [SID1234666415])