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Biocartis and Discovery Life Sciences Announce Strategic Collaboration to Advance Precision Oncology Diagnostics

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])

Oncotelic Successfully Completes Initial Safety Cohort of Phase 1b SP-03-B101 Trial; Independent Safety Review Committee Recommends Dose Escalation and European Expansion Underway

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.

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])

European Medicines Agency Expedites Assessment of Revolution Medicines’ Daraxonrasib Under Phased Review Process

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.

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])

Biocytogen and Whitehawk Therapeutics Enter Global Collaboration for Bispecific Antibody ADC Development

On July 7, 2026 Biocytogen (SSE: 688796; HKEX: 02315) and Whitehawk Therapeutics, Inc. ("Whitehawk," Nasdaq: WHWK) reported a global collaboration to develop bispecific antibody-drug conjugates (BsADC). Biocytogen will provide access to up to five bispecific antibodies using its proprietary RenLite platform, and Whitehawk will evaluate these in combination with its ADC linker-payload platform technologies. Whitehawk then has the option to advance any resulting BsADC candidates as part of its pipeline.

Based on a common light-chain design, RenLite supports the discovery, screening, and optimization of fully human bispecific antibodies across diverse target combinations, while reducing the risk of light-chain mispairing and providing a robust molecular foundation for subsequent BsADC development. By bringing together the complementary capabilities of Biocytogen and Whitehawk, the collaboration aims to identify BsADC candidates with differentiated targeting profiles and therapeutic potential.

"Whitehawk has established strong expertise in ADC technology and oncology drug development," said Dr. Yuelei Shen, President and CEO of Biocytogen. "This collaboration further expands the application of Biocytogen’s fully human bispecific antibodies in ADC development. We look forward to supporting the efficient advancement of multiple programs by contributing high-quality antibody molecules and integrated research capabilities to identify differentiated therapeutic candidates and ultimately bringing new treatment options to patients with cancer."

"Bispecific antibodies are a promising approach to broadening our targeting strategies, and Biocytogen’s established platform provides a robust framework for exploring this modality in combination with our ADC platform," said Dave Lennon, PhD, Chief Executive Officer of Whitehawk Therapeutics. "We are excited about the potential of this collaboration to expand our pipeline opportunities and support our ambition to deliver new ADC INDs in the next 12-24 months."

Under the financial terms of the agreement, Biocytogen will receive an upfront payment and is eligible for development, regulatory, and commercial milestone payments, as well as low single-digit royalties on net sales. Additional financial terms were not disclosed. If Whitehawk exercises its option to advance any resulting BsADC candidates, Whitehawk will hold global rights and full program control of the BsADCs.

(Press release, Biocytogen, JUL 7, 2026, View Source [SID1234669096])

LTZ Therapeutics Announces FDA Clearance of IND Application for LTZ-232 to Treat Advanced Metastatic Colorectal Cancer and Other Solid Tumors

On July 7, 2026 LTZ Therapeutics, a clinical-stage, immunotherapy-focused biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to evaluate LTZ-232 to treat patients with advanced metastatic colorectal cancer (mCRC) and other solid tumors.

LTZ-232 is the second asset in the company’s platform to enter clinical trials, leveraging its Universal Myeloid Cell Engager (U-MCETM) Platform to treat pan solid tumor indications that are epithelial cell adhesion molecule positive (EpCAM+). Building on the clinical progress of LTZ-301, already in clinical development for hematologic malignancies, the advancement of LTZ-232 reflects the company’s strategic expansion into broad solid tumors. LTZ expects to initiate its Phase 1, open-label, multicenter study for LTZ-232 in Q4 2026.

"Advancing LTZ-232 into the clinic represents another significant milestone for LTZ as it highlights the therapeutic potential of our U-MCE Platform for broad disease areas beyond our initial program," said Robert Li, Ph.D., founder and chief executive officer of LTZ. "We are excited to initiate our second first-in-class myeloid engager immunotherapy, delivering novel therapeutic options for patients."

LTZ’s clinical development strategy for LTZ-232 initially prioritizes colorectal cancer supported by disease biology and internal data demonstrating consistent EpCAM expression alongside a myeloid-rich tumor microenvironment (TME). The program is designed with the flexibility to explore potential therapeutic activity across other tumor types.

"Advanced metastatic colorectal cancer remains a significant unmet need in oncology, particularly since it’s typically an ‘immunologically cold’ tumor microenvironment, limiting the effectiveness of many existing immunotherapies," said William Grossman, M.D., Ph.D., chief medical officer of LTZ. "Our differentiated and novel approach is designed to redirect myeloid cells to drive anti-tumor activity in these challenging tumor microenvironment settings. We believe LTZ-232 has the potential to expand the reach of immunotherapy into cold solid tumors, and that we can meaningfully improve patients’ lives."

About LTZ-232

LTZ-232 is a first-in-class bispecific antibody designed to activate tumor-associated macrophages (TAMs) to phagocytose and eliminate tumor cells in solid tumors with high EpCAM+ expression. Preclinical studies demonstrated potent pharmacology across in vitro and in vivo models, supported by a favorable safety profile. LTZ-232 transitions the company’s pipeline strategy into solid tumor indications, with an initial primary focus on advanced mCRC.

LTZ’s Scientific Approach

LTZ’s approach focuses on the fusion of reverse translational science, with a deep understanding of TME biology – especially myeloid biology. Macrophages appear to be one of the most prevalent immune cell populations in TME of various hematologic and solid tumors. Therefore, effectively engaging and activating macrophages to kill cancer cells offers significant therapeutic potential for patients. LTZ is developing its own U-MCE Platform to primarily enhance the phagocytic function of monocytes and macrophages of different polarization states to foster anti-tumor immunity and offer potential therapeutic benefit for other non-oncology diseases.

(Press release, LTZ Therapeutics, JUL 7, 2026, View Source [SID1234669094])