On July 9, 2024 Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to OBX-115, a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15), for the treatment of patients with metastatic or locally advanced melanoma that is refractory to or has relapsed after PD-1/PD-L1–based immune checkpoint inhibitors (ICI) (Press release, Obsidian Therapeutics, JUL 9, 2024, View Source [SID1234644762]).

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"FDA Fast Track Designation underscores the ongoing unmet need for patients with melanoma that has progressed on or after ICI therapy, agnostic of mutational status, and that OBX-115 may have the potential to address that unmet need," said Madan Jagasia, M.D., Chief Executive Officer of Obsidian. "OBX-115 is poised to be a transformative treatment option due to its patient-centric focus, including compatibility with core needle biopsy tumor tissue procurement and positively differentiated safety and tolerability profile relative to non-engineered TIL cell therapy. We are highly encouraged by the most recent safety and efficacy data presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting. With this designation, we look forward to continued collaborative interaction with the FDA as we advance OBX-115 clinical development in the broad post-ICI setting."

Fast Track Designation is intended to facilitate development and expedite the review of new drug candidates that address serious and life-threatening conditions so that an approved product can reach the market expeditiously. Features of Fast Track Designation include frequent interactions with the FDA review team, and if relevant criteria are met, eligibility for Priority Review and Rolling Review.

OBX-115 is being investigated in a multicenter trial in advanced or metastatic melanoma and non-small cell lung cancer (NSCLC) (NCT06060613). Enrollment has been completed for the first-in-human, single-center study of OBX-115 (NCT05470283).

About OBX-115

Obsidian’s lead investigational cytoTIL15 program, OBX-115, is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). OBX-115 has the potential to become a meaningful therapeutic option for patients with advanced or metastatic melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process to enhance persistence, antitumor activity, and clinical safety of TIL cell therapy. OBX-115 is being investigated in two ongoing clinical trials in advanced or metastatic melanoma and non-small cell lung cancer (NSCLC) (NCT05470283 and NCT06060613).

On July 9, 2024 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumorally injected cancer therapies intended to kill tumors directly and increase immune system recognition of cancers, reported that the first U.S. patient has been dosed in the Company’s Phase 3 study to treat metastatic sarcoma (NCT06263231) (Press release, Intensity Therapeutics, JUL 9, 2024, View Source [SID1234644761]). The trial is a superiority study testing INT230-6 as monotherapy compared to the investigator’s choice of three current standard-of-care systemic chemotherapy drugs in second or third-line metastatic, recurrent, or inoperable soft tissue sarcomas ("STS").

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The global Phase 3 study is expected to enroll approximately 333 patients. The primary endpoint is overall survival. For every three patients treated, two will receive INT230-6, and one will receive the standard of care. STS subtypes being enrolled are leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma. The Phase 3 initiation follows reported data from the Company’s Phase 1/2 trial, where INT230-6 showed tumor-killing and immune-activating properties with increased survival in metastatic disease.

"We have now dosed our first patient in the U.S. and have filed regulatory documents to initiate this trial in Canada and Europe. Over the next several months, we anticipate initiating sites in eight countries. Sarcoma is a deadly cancer with a median overall survival following second and third-line drug treatments of between 10 and 15 months," said Intensity Therapeutics’ Founder, Chairman, and CEO, Lewis H. Bender. "During our phase 1/2 metastatic dose escalation study, in a sarcoma population that had progressed following a median of 3 lines of therapy, we reported a median overall survival of 21.3 months with our drug alone. Patients, their caregivers, and physicians worldwide desperately need improved treatment options and we are excited to have finally begun testing our new approach in Phase 3. I want to take this opportunity to thank our dedicated team for getting us to this tremendous milestone."

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug comprises two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct killing of the tumor, INT230-6 releases a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

About Sarcoma

Soft tissue sarcoma is a rare type of cancer that starts with the growth of cells in the body’s soft tissue, such as muscle, fat, blood vessels, nerves, tendons, and linings of the joints. The disease mostly occurs in the arms, legs and belly. There are 197,000 patients in the US living with sarcoma and more than 50 types of soft tissue sarcoma, the treatment of which first involves surgery. Other treatments might include radiation therapy and then chemotherapy. Using the U.S. SEER database, the Company estimated that 14,337 patients have regional or distal (metastatic) leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma.

On July 9, 2024 iOnctura, a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers, reported expansion of the clinical trial program for lead pipeline asset, roginolisib. Via clinical collaboration agreements with the ETOP IBCSG Partners Foundation and GSK, roginolisib will be evaluated in combination with dostarlimab in NSCLC (Press release, iOnctura, JUL 9, 2024, View Source [SID1234644759]).

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Roginolisib is an allosteric modulator of PI3Kδ, widely recognized as a ‘master switch’ of cancer. Inhibition of PI3Kδ unleashes a multi-pronged anti-tumor and immune response to combat the tumor1 . Roginolisib has demonstrated an unprecedented clinical profile in solid and liquid cancers2, with 44 patients treated to date.

Emerging clinical and translational biomarker data supports the hypothesis that combining roginolisib with a programmed death receptor-1 (PD-1) targeting agent, with or without docetaxel, may prevent or reverse drug resistance in NSCLC and may show synergistic anti-tumor immune activity without significant addition of toxicity3.

Dostarlimab is a PD-1-blocking antibody approved for certain patients with endometrial cancer, which has also demonstrated clinical activity in combination with chemotherapy in NSCLC4. Under the terms of the agreement with iOnctura, GSK will supply dostarlimab for use in a randomized Phase II clinical trial in NSCLC patients resistant to first-line checkpoint inhibitor therapy, with or without docetaxel. iOnctura will retain worldwide rights to roginolisib.

The ETOP IBCSG Partners Foundation is a leading organization performing international clinical and translational research in thoracic malignancies and breast cancer. Through the clinical collaboration, iOnctura will be provided access to a network of highly experienced investigators for the Phase II study. Professor Solange Peters, MD, PhD, Chair of Medical Oncology and the Thoracic Malignancies Programme in the Department of Oncology at the University Hospital of Lausanne will be the primary coordinating investigator of the study.

Catherine Pickering, Chief Executive Officer of iOnctura, said: "As iOnctura moves into the next phase of clinical development, we are thrilled to be able to assess the effectiveness of roginolisib in combination with dostarlimab for the treatment of NSCLC. The successful uveal melanoma data reported so far, combined with a rich preclinical data package, support the rationale to expand our development program with potentially synergistic combinations in NSCLC."

Solange Peters, Professor and Chair of Medical Oncology & Thoracic Malignancies Programme in the Department of Oncology at the University Hospital of Lausanne in Lausanne, Switzerland, commented: "On behalf of the ETOP IBCSG Partners Foundation, we are intrigued by the benefit/risk profile of roginolisib. In patients who no longer respond to current therapies, we wish to investigate whether roginolisib in combination with dostarlimab provides a novel treatment option. ETOP IBCSG Partners Foundation is committed to investigate novel treatment options to help our patients."

On July 9, 2024 SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory, and infectious diseases, reported the successful enrollment of the MERLIN_001 study (Press release, SkylineDx, JUL 9, 2024, View Source [SID1234644758]). This study is the largest independent multicenter prospective investigation to date into the role of Gene Expression Profiling (GEP) testing in melanoma care. This milestone marks the conclusion of enrollment with the final patient now included in this groundbreaking prospective registry study [1].

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MERLIN_001 was designed with the aim of prospectively validating the Merlin Assay – a clinicopathologic GEP model – in an independent multicenter cohort of clinically node negative primary cutaneous melanoma patients, who are undergoing lymphatic mapping and sentinel lymph node biopsy (SLNB) per current clinical guidelines. The primary objective of this study is to evaluate the ability of the Merlin Assay to predict risk of sentinel node metastasis in melanoma patients who are candidates for SLNB. Spanning 9 centers across the US, the study enrolled 1,640 eligible patients over the past 3 years, reflecting a comprehensive real-world cross-section of the melanoma patients referred for SLNB.

Independent prospective validation is crucial for GEP testing to show its clinical value and establish their cost-effectiveness [2]. Previous prospective data from the Netherlands affirmed the performance metrics published from multiple independent international retrospective cohorts. All of these publications conclude that the Merlin Assay can accurately identify patients at low risk for nodal metastasis.

Dharminder Chahal, CEO of SkylineDx, commented: "The successful completion of patient enrollment in the MERLIN_001 study represents a monumental achievement in our melanoma research efforts. We are immensely grateful to all the patients who participated and to our dedicated team of researchers and collaborators. This study underscores our commitment to advancing personalized medicine and improving outcomes for melanoma patients worldwide."

Vernon K. Sondak, MD, Chair of the Department of Cutaneous Oncology at Moffitt Cancer Center in Tampa, FL, and Principal Investigator of the MERLIN_001 study, added: "The importance of this large multicenter investigation cannot be overstated. The collaboration among leading institutions across the country has been instrumental in driving the success of this study. The diverse patient population and the rigorous methodology employed have provided a robust dataset that will significantly advance our understanding of the potential role of gene expression profiling in melanoma, and the results will enhance patient care."

SkylineDx extends heartfelt thanks to all the patients who participated in the MERLIN_001 study. Their confidence and willingness to contribute to this innovative research are invaluable. We also thank our collaborators, healthcare professionals, and research teams for their unwavering support and dedication.

As we move forward, SkylineDx remains committed to analyzing the data collected and sharing comprehensive results with the medical community. The insights gained from the MERLIN_001 study will pave the way for more precise and personalized melanoma care, ultimately benefiting patients globally.

About CP-GEP

CP-GEP is a non-invasive prediction model for cutaneous melanoma patients that combines clinicopathologic (CP) variables with gene expression profiling (GEP). This model is able to assess metastatic potential in cutaneous melanoma patients, thus identifying those at low risk for nodal metastasis who may potentially safely forgo the sentinel lymph node biopsy (SLNB) procedure. The CP-GEP model was developed by Mayo Clinic and SkylineDx BV and it has been clinically validated in multiple studies. More information (including references) may be obtained at www.falconprogram.com. The test has been launched in the United States and Europe as the Merlin Assay. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase access. In the United States, Tempus is commercializing Tempus Merlin test.

Quest Diagnostics launched their own LDT version of the CP-GEP model in the United States under the brand name MelaNodal Predict.

On July 9, 2024 Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, reported that it has acquired Fluent BioSciences, developer of an emerging and highly differentiated single-cell technology (Press release, Illumina, JUL 9, 2024, View Source [SID1234644757]).

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"The addition of Fluent BioSciences to Illumina will provide significant and new capabilities to our customers in a key growth area and advances our multiomics growth strategy," said Steven Barnard, chief technology officer of Illumina. "Single-cell research opens doors to new areas of discovery, and Fluent’s innovative, accessible, and flexible single-cell method will accelerate our ability to deliver full multiomics solutions for our customers."

Fluent’s single-cell analysis technology eliminates the need for complex, expensive instrumentation and microfluidic consumables. This novel approach removes many of the barriers and limitations of current methods, making single-cell analysis accessible for a broader set of customers, and catalyzing new experiments enabled by the ability to perform that assay at the point of sample collection. Fluent’s latest release, PIPseq V, delivers exceptional performance, with the ability to detect cell types often missed with current methods, and the highest scalability, capable of processing a range from 100 cells up to 1 million.

Fluent’s unique technology combined with Illumina’s leading sequencing and informatics solutions including Partek Flow, which enables single-cell multiomic analysis, will provide customers with a complete solution and single point of support so that researchers can advance discovery faster and more economically.

The Fluent team will join Illumina, and PIPseq V will be integrated into Illumina’s product portfolio. The company plans to build on Fluent’s technology to develop full end-to-end solutions for single-cell analysis.

Illumina will remain an open NGS platform and is committed to maintaining and supporting its existing single-cell partnerships. "Our goal is to continue to develop the sequencing eco-system and support the best multiomics solutions like single-cell analysis," Barnard said. "We want customers to have the flexibility to adopt the tools that best fit their needs."

The acquisition closed on July 9, 2024, and has been funded with cash on hand.