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])

On July 7, 2026 CoRegen, Inc., a biopharmaceutical company pursuing novel treatments for patients living with some of the most aggressive forms of cancer, reported the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CRG-150, a novel, adoptive cell therapy that has been shown to impact multiple immune checkpoint targets, including PD-1, PD-L1, CTLA-4, LAG3, and CCR4, as a master gene regulator.

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The IND clearance enables CoRegen to initiate a Phase 1/2a study that will evaluate CRG-150’s safety and help determine optimal dosing. The Phase 1/2a first-in-human study will enroll patients diagnosed with metastatic triple negative breast cancer, metastatic HR+ HER2− breast cancer and metastatic prostate cancer populations, to assess safety, tolerability, cellular kinetics, and antitumor activity of CRG-150. For patients, this study represents an important first-ever step in evaluating a new immune-based approach designed to harness the body’s own defenses against some of the most difficult-to-treat cancers.

CRG-150 is being developed based on the discovery that steroid receptor coactivator 3 (SRC-3) is a key gene that enables cancer cell immune evasion. By targeting SRC-3, which is overexpressed in most human cancers, CRG-150 disrupts the tumor-protective function of regulatory T cells (Treg cells), restoring the immune system’s ability to recognize and eliminate cancer. In preclinical studies, this approach led to complete tumor eradication in a range of mouse models of hard-to-treat solid cancers and provided durable protection against recurrence, without evidence of systemic autoimmunity.

"Acceptance of our IND application is a defining milestone, transitioning CoRegen into a clinical-stage company, and one made possible by the extraordinary dedication of our team," said Suneet Varma, Chairman of the Board, CoRegen. "Their sheer rigor and scientific depth have brought us to this moment – the initiation of our first-in-human clinical studies – advancing an approach we believe could fundamentally change the practice of medicine for patients with cancer."

Sonal Gupta, MD, Ph.D., Chief Medical Officer, added, "Moving into the clinic is a pivotal step, and we are doing so alongside globally renowned major academic cancer centers that will serve as sites for our Phase 1 study. Grounded in the vast volumes of preclinical work our team has conducted at Baylor College of Medicine, we are optimistic about what lies ahead. While CRG-150 will initially be evaluated in patients with three selected tumor types, we believe the potential of this product and our broader pipeline could address critical needs across numerous cancers."

CoRegen remains on track to initiate its Phase 1 trial this year and plans to expand into additional indications in the future, including glioblastoma and pancreatic cancer.

CoRegen has partnered with Lonza, one of the world’s largest and most established contract development and manufacturing organizations (CDMOs), to support manufacturing for its first-in-human clinical study. Through this partnership, CoRegen gains access to world-class cell therapy development and manufacturing expertise, established quality systems, and proven regulatory capabilities, streamlining clinical execution and strengthening CoRegen’s path into the clinic.

(Press release, CoRegen, JUL 7, 2026, View Source [SID1234669100])

On July 7, 2026 Biocartis, an innovative molecular diagnostics company, and Discovery Life Sciences ("Discovery"), a global leader in biomarker specialty laboratory services and biospecimen solutions, reported a strategic collaboration to deliver seamless, end-to-end precision oncology solutions to pharmaceutical and biotech customers worldwide.

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The collaboration pairs Discovery’s global clinical laboratory network and industry leading biorepository with the Idylla Platform, a fully automated, sample-to-result, real-time PCR (Polymerase Chain Reaction) based system that delivers in-house molecular biomarker results in only 3 hours, with more than 2,500 placements in over 95 countries. This collaboration expands access to ultra-fast biomarker testing, allowing pharmaceutical companies to rapidly identify and enroll patients in clinical trials.

The collaboration enables Discovery as a preferred testing laboratory, which includes joint companion diagnostic (CDx) and clinical trial assay (CTA) support, custom assay development, rapid access to prospective and banked biospecimens, biomarker discovery programs, and co-promotion to pharmaceutical partners. As a first priority, the companies will replicate their rapid KRAS testing program from Discovery’s Kassel, Germany location at their Newtown, PA, US facility.

Installing the Idylla Platform at both Kassel, Germany and Newtown, PA, US sites allows rapid molecular testing on both continents, giving global pharma programs harmonized results regardless of where samples are collected or tested. Discovery’s Kassel laboratory holds Health Institution status, which supports in-house device testing under Article 5(5) of the EU-IVDR. Using this approach, Discovery can move new biomarkers from project start to first patient sample in as little as six to seven months. Extending testing capability to the Newtown site gives sponsors a harmonized US and EU testing footprint and a faster path to companion diagnostic readiness to support global clinical trials.

"By combining Discovery’s biomarker expertise and specialty laboratory capabilities with the speed of the Idylla Platform, we can offer pharma partners a faster, more cost-effective path from sample to actionable biomarker insight", said Anthony Green, EVP of Corporate & Business Development at Biocartis. "We are excited to build on our KRAS collaboration in Germany and bring this platform to the United States."

"Pharma teams running global oncology trials face a real constraint. A biomarker result generated in Europe has to hold up against one generated in the US, or the data doesn’t translate. Installing Idylla at both Kassel and Newtown lets us run the same rapid assay on both continents and stand behind the comparability. That is what makes Newtown a genuine hub for this work, not just another testing site," said T. Scott Reid, VP, Companion Diagnostics and Scientific Affairs at Discovery Life Sciences.

The companies will jointly develop curated pharma service bundles and cross-train their commercial and scientific teams to support a unified offering to pharmaceutical and biotech partners.

(Press release, Biocartis, JUL 7, 2026, View Source [SID1234669099])

On July 7, 2026 Oncotelic (OTCQB:OTLC), an AI/Robotic native biotechnology company, and its 45% owned subsidiary- Sapu Nano (US) LLC, a clinical-stage biotechnology company developing the proprietary Deciparticle nanomedicine platform, reported that the independent Safety Review Committee (SRC) has completed its review of the initial safety cohort in the Company’s ongoing SP-03-B101 Phase 1b clinical trial evaluating Sapu003, an investigational intravenous formulation of everolimus.

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Following completion of the protocol-defined 28-day dose-limiting toxicity (DLT) evaluation period for the initial three-patient cohort, the SRC concluded that no dose-limiting toxicities (DLTs) were observed and recommended advancing the study to the next planned dose level in accordance with the study protocol.

Sapu003 is currently being evaluated in the SP-03-B101 Phase 1b clinical trial, an open-label, multicenter, Bayesian Optimal Interval (BOIN) dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of weekly intravenous Sapu003 in patients with advanced mTOR-sensitive solid tumors. The study is registered on ClinicalTrials.gov (Identifier: NCT07369505).

Following successful completion of the initial safety cohort, the Company has initiated expansion of the SP-03-B101 clinical program into Europe. Additional European clinical sites are expected to participate in the study, broadening patient access, accelerating enrollment, and supporting the global clinical development strategy for Sapu003.

"Successful completion of the initial safety cohort represents an important milestone for the Sapu003 development program," said Dr. Vuong Trieu, CEO of Sapu Nano. "The independent Safety Review Committee’s recommendation to advance to the next dose level provides important clinical validation of the program’s progress. Combined with the expansion of SP-03-B101 into Europe, we believe these milestones position Sapu003 for accelerated clinical development while broadening access for patients with advanced mTOR-sensitive solid tumors."

Peer-Reviewed Publication Supports Clinical Development

The clinical milestone follows the Company’s recent peer-reviewed publication describing the scientific foundation of Sapu003 and the proprietary Deciparticle nanoparticle platform.

Min SH, Forero K, Putnam W, Anderson J, Hoff R, Lopp J, Trieu V, Ho K, Lee C. Intravenous Everolimus Formulation (Sapu003) for Clinical Trials. International Journal of Molecular Sciences. 2026;27(13):5775. doi: 10.3390/ijms27135775.

The publication provides the first comprehensive description of the Deciparticle platform, including formulation discovery, scalable cGMP manufacturing, physicochemical characterization, stability, and preclinical evaluation supporting the ongoing clinical development of Sapu003.

The published work demonstrated:

Development of a stable intravenous everolimus nanoparticle formulation with a mean particle size below 20 nanometers.
Development of a robust, scalable cGMP manufacturing process suitable for clinical production.
Excellent product reproducibility and stability following lyophilization and refrigerated storage.
Broad compatibility of the Deciparticle platform with multiple hydrophobic therapeutic compounds, supporting potential future pipeline expansion.
Potent preclinical antitumor activity supporting advancement into clinical development.

"The progression from peer-reviewed publication to successful completion of our first clinical safety cohort highlights the maturity of both the Sapu003 program and the Deciparticle platform," added Dr. Trieu. "We believe Deciparticle represents a differentiated nanomedicine platform capable of enabling intravenous delivery of numerous poorly water-soluble therapeutic compounds while supporting scalable commercial manufacturing."

Clinical Trial Information

Study Title: SP-03-B101: A Phase 1b Study of Sapu003 (Intravenous Everolimus) in Patients with Advanced mTOR-Sensitive Solid Tumors

ClinicalTrials.gov Identifier: NCT07369505

About Sapu003

Sapu003 is an investigational intravenous formulation of everolimus developed using Sapu Nano’s proprietary Deciparticle nanoparticle platform. Sapu003 is designed to overcome the formulation limitations associated with oral everolimus by enabling intravenous administration with a scalable cGMP manufacturing process. The program is currently being evaluated in the Phase 1b SP-03-B101 clinical trial in patients with advanced mTOR-sensitive solid tumors.

About Deciparticle

Deciparticle is Sapu Nano’s proprietary nanomedicine platform designed to formulate poorly water-soluble therapeutic compounds into stable intravenous formulations. The platform combines amphiphilic polymer technology with scalable cGMP manufacturing to enable the clinical development of challenging hydrophobic therapeutics. In addition to Sapu003, the platform has demonstrated compatibility with multiple classes of hydrophobic molecules, supporting future pipeline expansion and potential strategic collaborations.

(Press release, Oncotelic, JUL 7, 2026, View Source [SID1234669098])

On July 7, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has started a phased review of data on daraxonrasib, the company’s investigational RAS(ON) multi-selective inhibitor. A phased review aims to accelerate the assessment of a medicine by evaluating the data in phases as they become available, ahead of the submission of a full marketing authorization application. Daraxonrasib was designated by the EMA as an orphan medicinal product for the treatment of pancreatic cancer and has been recognized as a high priority under EMA’s Cancer Medicines Pathfinder project based on its potential to address a high unmet medical need.

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In addition, the company continues to make significant progress on its rolling submission of a New Drug Application (NDA) for daraxonrasib to the U.S. Food and Drug Administration (FDA) under the Commissioner’s National Priority Voucher pilot program, which is intended to accelerate the development and review of therapies aligned with U.S. national health priorities.

"As our rolling submission of an NDA to the FDA nears completion, we are encouraged by the strong engagement we’ve received from health authorities around the world," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "The EMA’s decision to include daraxonrasib in its new phased review process is an important step toward making this medicine available to patients globally as quickly as possible. We believe this milestone underscores both the significant unmet medical need in pancreatic cancer and the potential of daraxonrasib to address that need."

The company continues to engage in discussions with regulatory authorities around the world as it prepares for submissions in additional territories. The ongoing FDA review and planned regulatory submissions in other territories are supported by the positive results from the pivotal Phase 3 RASolute 302 trial, which demonstrated unprecedented improvements in overall survival and progression-free survival compared to standard of care cytotoxic chemotherapy in patients with previously treated metastatic PDAC, with or without an identified tumor RAS mutation. In the trial, daraxonrasib exhibited a manageable safety profile and patients treated with daraxonrasib reported significantly delayed deterioration in cancer-related pain, overall global health status and quality of life, compared to those treated with chemotherapy.

About Daraxonrasib

Daraxonrasib is an investigational, oral RAS(ON) multi-selective, non-covalent tri-complex inhibitor. The U.S. Food and Drug Administration (FDA) granted daraxonrasib Breakthrough Therapy Designation and Orphan Drug Designation for the treatment of patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) harboring G12 mutations. In addition, daraxonrasib was selected for the FDA Commissioner’s National Priority Voucher pilot program, which is intended to accelerate the development and review of therapies aligned with U.S. national health priorities.

Daraxonrasib is designed to target cancers driven by a broad range of common RAS mutations, including PDAC, non-small cell lung cancer (NSCLC), and colorectal cancer. Daraxonrasib is being advanced through a global Phase 3 registrational program comprising four trials, including the completed RASolute 302 trial and three additional trials in patients with PDAC and metastatic RAS mutant NSCLC.

Daraxonrasib works by suppressing RAS signaling through inhibition of the interaction between both wild-type and mutant RAS(ON) proteins and their downstream effectors.

About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma

Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. Pancreatic ductal adenocarcinoma, or PDAC, is the most common form of pancreatic cancer.1

Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. PDAC is the most commonly RAS-driven malignancy of all major cancers, with more than 90% of patients having tumors that harbor RAS mutations.2 Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%.

(Press release, Revolution Medicines, JUL 7, 2026, View Source [SID1234669097])