On July 01, 2024 Foundation Medicine, Inc. reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneLiquid CDx to be used as a companion diagnostic for AKEEGA (niraparib and abiraterone acetate) from Janssen Biotech, Inc, a Johnson & Johnson company, the first and only FDA-approved dual-action tablet combining PARP inhibition and hormone therapy for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) (Press release, Foundation Medicine, JUL 1, 2024, View Source [SID1234644640]). This decision from the FDA follows the approval of FoundationOneCDx, Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) test, for the same therapy and indication in August 2023.

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Prostate cancer is one of the most common cancers in men.2 BRCA1- or BRCA2-mutated mCRPC is a particularly aggressive form of the disease,3 occurring in approximately 11% of diagnoses.4 Despite progress in developing new treatment options for this condition, BRCA1- or BRCA2-mutated mCRPC remains difficult to treat and patients often face a poor prognosis.5

While some BRCA1 and BRCA2 mutations are germline, somatic mutations are more common.4 While tumor tissue testing is the gold standard for identifying patients with BRCA1 or BRCA2 mutations in prostate cancer, not all patients with mCRPC have sufficient tumor tissue available for testing.6 With this approval, healthcare providers can now leverage a minimally invasive liquid biopsy to identify additional patients with BRCA mutations who may benefit from AKEEGA.

"We know how challenging it can be to obtain a tissue sample for testing in advanced cancers such as mCRPC, making liquid biopsy an incredibly important tool in a provider’s toolbox for the development of personalized treatment plans for their patients," said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. "The approval of our liquid biopsy test, along with the previous approval for our tissue biopsy test, will enable more patients to access this important therapy option. Additionally, with the ability to leverage a liquid-based test and reflex to a tissue-based test if needed, healthcare providers can feel confident they have accurate genomic information at their fingertips to guide treatment decisions for patients."

From a simple blood sample, FoundationOne Liquid CDx analyzes more than 300 cancer-related genes to provide genomic insights. The test has several companion diagnostic indications across non-small cell lung cancer (NSCLC), prostate cancer, breast cancer, and colorectal cancer, plus a pan tumor indication specific to NTRK1/2/3 fusions.

With today’s approval, Foundation Medicine is the only company that has five FDA-approved companion diagnostic indications for prostate cancer.7 Foundation Medicine is the global leader in companion diagnostic approvals. The company has 60% of all U.S. companion diagnostic approvals for next-generation sequencing (NGS) testing.8

"Men with aggressive prostate cancer need and deserve more options," said Courtney Bugler, President and CEO of ZERO Prostate Cancer. "We applaud Foundation Medicine’s liquid biopsy test because it empowers patients and families with more tools that can potentially help them lead longer, fuller lives."

Foundation Medicine and FoundationOne are registered trademarks of Foundation Medicine, Inc.

On July 01, 2024 KaliVir Immunotherapeutics, Inc., a biotech company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy programs, reported that the FDA has cleared the Investigational New Drug (IND) application for the STEALTH-001 study of VET3-TGI in patients with incurable, advanced solid tumors (Press release, KaliVir Immunotherapeutics, JUL 1, 2024, View Source [SID1234644639]).

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VET3-TGI is a novel oncolytic immunotherapy which in nonclinical studies specifically targets and preferentially kills tumor cells directly while stimulating anti-cancer immunity by expressing its therapeutic payload consisting of the transgenes for interleukin-12 and a TGFbeta inhibitor. The Phase 1/1b study (ClinicalTrials.gov ID NCT06444815) will evaluate the safety profile and efficacy of VET3-TGI when administered through intravenous infusion or intratumoral injection in patients with advanced, incurable solid tumors. The trial will assess VET3-TGI both as a monotherapy and in combination with checkpoint inhibitor therapy.

"The initiation of this Phase 1/1b clinical study marks a pivotal moment in our continued journey to redefine cancer treatment with oncolytic virus therapy and combat advanced, unresectable or metastatic solid tumors," said Helena Chaye, Ph.D., CEO of KaliVir Immunotherapeutics. "This marks our second initiation of a clinical trial from the VET platform, having announced in 2023 the progress with ASP1012 exclusively licensed to Astellas. We remain fully committed to pushing the boundaries on what is possible with cancer therapies and develop safer, more effective options that have the potential to transform the treatment landscape of oncology."

On July 1, 2024 Radionetics Oncology, a biotechnology company discovering and developing novel small molecule G protein coupled receptor (GPCR) targeted radiopharmaceuticals to treat a broad range of solid tumors, reported the formation of a strategic relationship with Eli Lilly and Company to take forward Radionetics’ proprietary GPCR targeting small molecule radiopharmaceuticals (Press release, Radionetics Oncology, JUL 1, 2024, View Source [SID1234644638]).

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Under the terms of the agreement, Radionetics received a $140 million upfront cash payment. As part of the strategic arrangement, Lilly obtained the exclusive right to acquire Radionetics upon conclusion of an exercise period for $1 billion. During the exercise period, Radionetics will continue to build out a proprietary pipeline of therapeutic assets. These will include small molecule radioligand therapeutics targeting GPCRs using the Radionetics proprietary discovery platform and associated intellectual property.

"We are fortunate to have entered into an agreement with Lilly given its global development capability, oncology expertise, and the radiopharmaceutical experience and capabilities Lilly is building following the acquisition of POINT Biopharma," said Paul Grayson, CEO of Radionetics Oncology.

"Furthering our commitment to radiopharmaceutical therapies, this relationship provides access to novel GPCR targets and the discovery capabilities of Radionetics Oncology," said Jacob Van Naarden, Executive Vice President and President, Lilly Oncology.

"Our platform uniquely pairs the power of radiopharmaceuticals with the precision of small molecule targeting to novel GPCRs. We have a specialized team that is focused on rapidly advancing each of our promising programs to bring these much-needed new therapies to patients," said Brett Ewald, Chief Operating Officer.

Cooley LLP is acting as legal advisor to Radionetics. Ropes & Gray LLP is acting as legal advisor to Lilly.

On July 1, 2024 Signet Therapeutics, a biotech company using organoid disease models and AI to advance targeted cancer therapy, reported that the FDA has granted its IND application for sigx1094 as a potential treatment for diffuse gastric cancer (DGC) (Press release, Signet Therapeutics, JUL 1, 2024, View Source [SID1234644637]). This marks a significant milestone as sigx1094 is the first targeted drug candidate for DGC, a disease currently lacking effective treatments. The company is poised to commence a Phase I clinical trial to assess the safety and efficacy of sigx1094 in patients with DGC and other advanced solid tumors.

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"The FDA’s IND approval for sigx1094 marks a significant step forward in addressing the critical unmet medical needs in DGC. This milestone fuels our optimism for a new era where AI and organoid disease models become the catalysts for more fruitful drug discovery efforts, propelling the transformation of biological discoveries into innovative, life-saving treatments," said Dr. Haisheng Zhang, Founder and CEO of Signet Therapeutics.

Accelerating Drug Discovery with Organoid Disease Models and AI

In leveraging its proprietary organoid disease model platform and through a strategic collaboration with XtalPi, XtalPi (2228.HK), a leading drug R&D platform company driven by artificial intelligence (AI) and robotics, Signet nominated pre-clinical candidate sigx1094 in just over six months, and received FDA’s IND approval in under four years, significantly accelerating the drug discovery and design process. For efficacy evaluation, Signet used its proprietary organoid disease models developed from real-world cancer genomics data to simulate drug effects in 3D tissues that resemble human biology, allowing for more accurate predictions of patient responses. Sigx1094 is the first of a series of pipeline projects that was discovered by AI and validated by organoid disease models. By designing and evaluating candidate molecules using data of higher clinical relevance, the company hopes such innovative R&D approach will increase the likelihood of clinical trial success. The company’s novel organoid disease model platform not only supports its own drug pipeline but also provides external services, including drug efficacy evaluation, target screening, and model animal experiments, ensuring a consistent revenue stream.

Signet Therapeutics’ Origins and Vision

Before establishing the company, Dr. Haisheng Zhang was part of a team led by Dr. Adam Bass at Dana-Farber Cancer Institute at Harvard Medical School. Their groundbreaking research, published in Nature, classified gastric cancer into four distinct molecular subtypes, with diffuse gastric cancer (DGC) identified as a genomically stable cancer. This subtype is particularly challenging due to its high invasiveness and poor response to conventional treatments like chemotherapy and radiotherapy and the current targeted therapies.

Driven by these insights, Dr. Zhang established Signet Therapeutics in late 2020 and led a team dedicated to identifying novel targets and developing effective therapies for cancers. The team is driven by the urgent need for new treatments for cancers where traditional therapies have often been ineffective. They have established unique organoid disease models using transgenic mice to study DGC, leading to the discovery of potent targets such as FAK and YAP.

Broad Potential of sigx1094

Apart from treating DGC, sigx1094 has shown promise in preclinical studies for treating various cancers, including ovarian, triple-negative breast, and pancreatic cancers. The drug candidate also demonstrated potential in combination therapies, particularly with chemotherapy and targeted treatments for KRAS-mutated and EGFR-mutated cancers. As clinical studies progress, Signet hopes to further investigate and validate sigx1094’s potential as treatment in a broader range of therapeutic areas.

On July 1, 2024 NH TherAguix (NHT), a phase II clinical-stage biotechnology company specializing in the development of novel nanomedicine solutions for precision radiotherapy in oncology, reported the transition to the Phase II randomized part of the NANOSMART study in the cohort of patients with pancreatic tumors (Press release, NH TherAguix, JUL 1, 2024, View Source [SID1234644636]). The NANOSMART study, titled "An adaptive phase I–II trial of AGuIX gadolinium-based nanoparticles with stereotactic magnetic resonance-guided adaptive radiation therapy (SMART) for locally advanced unresectable pancreatic ductal adenocarcinoma and centrally located lung tumors," is currently ongoing to assess safety, biodistribution and radio-enhancement efficacy of the combination of AGuIX intravenous injections.

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AGuIX: A Nanodrug Capable of Improving the Precision and Effectiveness of Radiotherapy
The culmination of over a decade of research, AGuIX nanoparticles are designed to meet the critical medical need for more effective cancer treatments, including pancreatic cancer. These gadolinium-based nanoparticles enhance MRI contrast, allowing for precise tumor visualization, and significantly amplify the radiation dose delivered to tumor tissues, thereby improving the efficacy of radiotherapy.

NANOSMART: A Monocentric, Randomized, Open-Label Phase Ib/II Trial Conducted with the Dana-Farber Cancer Institute/Brigham & Women’s Hospital Team
The aim of the dose escalation Phase I was to determine the recommended dose of the experimental drug to be evaluated in Phase II. Two dose levels of AGuIX (75mg/kg and 100mg/kg) have been tested on twenty patients treated in the pancreas cohort during Phase I. These patients with locally advanced unresectable pancreatic ductal adenocarcinoma have received two injections of AGuIX in combination with SMART (40 Gy in 5 fractions of 8 Gy). AGuIX injections were well-tolerated. Additionally, MRI analysis has confirmed that AGuIX nanoparticles selectively accumulated in pancreatic tumors.

A good safety profile of AGuIX in combination with SMART was confirmed.
"The transition to the Phase II randomized stage of the study in the cohort of patients with pancreatic cancer was approved by the institutional review board and the FDA at the recommended dose of AGuIX at 100mg/kg," said Dr Jonathan Leeman, the study P.I., from Brigham & Women’s Hospital and The Dana-Farber Cancer Institute.

The Phase II part of NANOSMART study will be randomized within two arms: an experimental arm in which patients will be treated with AGuIX at a dose of 100 mg/kg in combination with SMART (10 patients), and a control arm in which patients will be treated with SMART alone (20 patients).

The primary endpoint of this Phase II is local control at 12 months. Secondary endpoints include progression-free survival, overall response rate, disease-specific survival, quality of life and overall survival.

Dr. Olivier de Beaumont, CMO of NH TherAguix, emphasized the significance of this step: "AGuIX Orphan Drug Designation was already granted by FDA and EMA for pancreatic tumors in 2021, and we are very happy to be able to continue the evaluation of AGuIX in combination with SMART after confirmation of the good safety profile and biodistribution in patients with pancreatic tumors. I would like to thank Dr. Jonathan Leeman very much for his strong commitment to enrolling patients in the two cohorts (locally advanced/unresectable pancreatic ductal adenocarcinoma (LAPC) and centrally located non-small cell lung cancer lesions."

Vincent Carrère, CEO of NH TherAguix, commented: "We are thrilled to announce this important next step of transition to the NANOSMART Phase II randomized part in pancreatic tumors. I would like to thank Dr Jonathan Leeman and the Dana-Farber Cancer Institute/Brigham & Women’s Hospital team for this remarkable clinical and translational work. It highlights the transformative potential of AGuIX in enhancing radiotherapy for pancreatic cancer patients. This promising next step reinforces our commitment to advancing innovative cancer treatments and improving patient outcomes in difficult-to-treat indications."