First Quarter Financial Results for Fiscal Year Ending March 31, 2026

On August 5, 2025 Eisai reported the First Quarter Financial Results for Fiscal Year Ending March 31, 2026 (Presentation, Eisai, AUG 5, 2025, View Source [SID1234655503]).

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10-Q – Quarterly report [Sections 13 or 15(d)]

Cogent Biosciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Immutep Receives Positive Feedback from FDA on Late-Stage Clinical Development of Eftilagimod Alfa in Head and Neck Cancer with CPS <1

On August 5, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported it has received positive and constructive feedback from the US Food and Drug Administration (FDA), regarding future clinical development of its first-in-class MHC Class II agonist, eftilagimod alfa ("efti"), for first line treatment of recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients who have PD-L1 expression below 1 (Combined Positive Score [CPS] <1) (Press release, Immutep, AUG 5, 2025, View Source [SID1234654981]).

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Based on its review of the encouraging data in 1L HNSCC with CPS <1 from the TACTI-003 (KEYNOTE-C34) Phase IIb trial evaluating efti in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 KEYTRUDA (pembrolizumab), the FDA agreed on the potential of efti in combination with KEYTRUDA to address the high unmet need in this CPS <1 patient segment and is supportive of the combination’s further development.

Paths for future clinical development and potential accelerated approval in light of the FDA’s Project FrontRunner include a randomised registrational trial evaluating efti in combination with KEYTRUDA against standard-of-care therapy or alternatively a smaller single-arm study (e.g. 70 – 90 patients) with safety, response rate, and duration of response as key endpoints, followed by a confirmatory randomised study that builds on the existing data.

"We are pleased with the FDA’s feedback and guidance that underscores the high unmet need of head and neck cancer patients whose PD-L1 expression level is below one. The FDA feedback positions Immutep to evaluate options for future collaborative clinical development paths to bring a new, effective and safe treatment option to this underserved patient population," said Marc Voigt, CEO of Immutep.

"Our primary focus clearly remains the pivotal TACTI-004 Phase III evaluating efti as first line therapy for non-small cell lung cancer and we are excited with its progress to date and the consistent, encouraging feedback we hear from physicians. This focus and additional considerations will be reviewed internally and discussed with stakeholders and potential strategic partners in regards to forward paths in head and neck cancer," added Mr Voigt.

Project FrontRunner is an FDA Oncology Center of Excellence (OCE) initiative to encourage drug sponsors to consider when it may be appropriate to develop and seek approval of cancer drugs for advanced/metastatic disease, in an earlier clinical setting rather than the usual approach to develop and seek approval of a drug for treatment of patients who have received numerous prior lines of therapies or have exhausted available treatment options. In this setting, advancing new effective therapies has the greatest potential to significantly improve quantity and quality of patients’ lives.

Patients with CPS <1 in 1L HNSCC represent a treatment population with high unmet medical need. Up to 20% of 1L HNSCC patients have CPS <1 and despite immunotherapy’s progress in fighting cancer, anti-PD-1 therapy alone (without chemotherapy) is only approved for patients who express PD-L1 (CPS >1). All currently available treatment options for patients with PD-L1 CPS <1 include chemotherapy.

Janux Therapeutics Announces Clinical Milestone Achievement in TRACTr Collaboration With Merck

On August 5, 2025 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technologies to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, reported the dosing of the first patient in its TRACTr collaboration with Merck, known as MSD outside of the United States and Canada. Under the terms of the collaboration that was entered in December 2020, Janux is eligible to receive development and commercial milestone payments and royalties (Press release, Janux Therapeutics, AUG 5, 2025, View Source [SID1234654890]).

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"This milestone underscores the strength of our approach to generating value through both internal innovation and strategic partnerships, and it reflects the growing promise of our TRACTr pipeline—precision engineered to selectively modulate T cells to fight cancer," said David Campbell, Ph.D., President and CEO of Janux.

"We’re thrilled to mark this pivotal achievement with the first clinical program emerging from our collaboration with Merck. This event displays strong collaboration with our partner and the ability to advance novel therapeutics derived from our underlying platforms from discovery into clinical trials," said Janeen Doyle, Chief Corporate and Business Development Officer of Janux.

Janux’s TRACTr, TRACIr and ARM Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC. Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. Janux is also advancing additional CD3-based TRACTr and CD28-based TRACIr programs for future clinical development, including a PSMA-TRACIr for use in combination with our PSMA-TRACTr JANX007, and a TROP2-TRACTr for the treatment of TROP2+ solid tumors. Janux is advancing its first ARM platform program candidate, a CD19-ARM for the potential treatment of autoimmune diseases toward clinical trials. Janux is also generating a number of additional TRACTr, TRACIr and ARM programs for potential future development.

Mission Bio Secures Equity Financing to Accelerate Single-Cell Tri-omics Platform Expansion

On August 5, 2025 Mission Bio, a leader in single-cell multi-omics solutions for precision medicine, reported the successful completion of equity financing led by Ally Bridge Group (Press release, Mission Bio, AUG 5, 2025, View Source [SID1234654819]). The investment will fund new innovations, commercial partnerships, and clinical adoption. The company’s vision is to accelerate clinical adoption of the company’s Tapestri Platform across multiple cancer segments by providing crucial insights into treatment decision-making. This effort will be supported by the broadening of the platform’s single-cell tri-omics capabilities, which recently added targeted gene expression analysis to genotype analysis in a single assay.

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The funding follows Mission Bio’s strong traction with biopharma customers and continued platform innovation. The Tapestri Platform has long been the leading technology for simultaneously generating DNA and protein data from a single cell, allowing researchers and clinicians a unique window into disease development and therapeutic response. Last month, Mission Bio launched its Single-Cell Targeted Genotype and Gene Expression assay, a custom service supporting KOL protocols to profile DNA and – for the first time in one assay – RNA from over 10,000 single cells, an unprecedented leap forward for single-cell multi-omics. In its next phase, Mission Bio will expand its offerings, enabling a variety of uses for characterizing tri-omics – the simultaneous profiling of DNA, RNA, and protein for single cells – at high resolution.

"This strong support from Ally Bridge Group and other investors validates our leadership position in single-cell multi-omics and enables us to take the next step in our mission of transforming precision medicine," said Brian Kim, CEO. "We are now positioned to expand our commercial footprint while advancing our technology to address critical unmet needs in cancer research and treatment."

The funding will support three key initiatives:

Commercial Expansion and Partnerships: Mission Bio will broaden its customer reach to support growing demand from pharmaceutical companies developing next-generation cancer therapies. Recent partnerships, including a collaboration with Integrated DNA Technologies (IDT), a Danaher company, demonstrate industry confidence in the Tapestri Platform’s ability to deliver comprehensive insights for drug development. Furthermore, Mission Bio will expand its commercial reach through distribution agreements that help access new market opportunities.
Development of Single-Cell Tri-omics Capabilities: The company will advance its platform to include targeted RNA analysis alongside existing DNA and protein capabilities. This enhancement responds to consistent customer demand for integrated genotype and gene expression data, enabling researchers to understand mechanisms of action and resistance in cancer therapies. The tri-omics capability will support applications beyond patient stratification, including patient safety assessments.
Accelerated Clinical Adoption: Mission Bio will expand the clinical utility of Tapestri across multiple cancer segments, including multiple myeloma, myeloid malignancies, and CAR-T cell therapy applications. The platform’s ability to provide comprehensive sample-to-answer solutions empowers clinicians to accelerate personalized treatment guidance. One promising initiative is using Mission Bio’s Tapestri Single-cell Myeloid Multiomics Assay to correlate relapse with complex clonal architecture, surpassing the limitations of existing methods like NGS or FLO and revealing novel biomarkers for therapeutic targets.
Mission Bio is well known for breakthrough innovation in single-cell analytics that has unlocked novel insights for its customers. In addition to its latest tri-omics offering, the Tapestri Platform was recently featured in a publication where its single-cell Myeloid Multi-omics solution was used as a highly sensitive molecular test to confirm long-term remission for patients with IDH1-mutant AML who received olutasidenib, the latest demonstration of how the industry is using Tapestri as a high-resolution MRD assay leading to actionable insights.

"Mission Bio’s single-cell tri-omics platform represents exactly the type of transformative life science innovation we seek to support," said Kevin Reilly, Managing Director at Ally Bridge Group. "This investment reflects our continued conviction that Mission Bio’s technology will become essential infrastructure for precision medicine, particularly as the industry shifts toward more complex cell and gene therapies requiring comprehensive characterization at the individual cell level."

Mission Bio has also expanded its leadership team with the addition of Matthew H. Cato as the company’s new Chief Commercial Officer. Cato has held senior marketing and business development positions with the company since 2017, and will help expand the company’s commercial leadership in the multi-omics space.