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SOPHiA GENETICS and the Spanish Lung Cancer Group Team Up to Explore the Predictive Potential of Multimodal Health Data in Resectable Stage IIIA Non-Small Cell Lung Cancer

On February 8, 2021 SOPHiA GENETICS, a global leader in Data-Driven Medicine, reported a clinical research partnership initiative with the Spanish Lung Cancer Group to apply its radiomics and multimodal analysis capabilities to predict response to neoadjuvant chemoimmunotherapy in resectable stage IIIA non-small cell lung cancer (NSCLC) (Press release, Sophia Genetics, FEB 8, 2021, View Source [SID1234574766]).

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SOPHiA GENETICS and the Spanish Lung Cancer Group Team Up to Explore the Predictive Potential of Multimodal Health Data in Resectable Stage IIIA Non-Small Cell Lung Cancer
The collaboration with the Spanish Lung Cancer Group (Grupo Español de Cáncer de Pulmón — GECP), a Spanish cooperative group for the research on lung cancer, is to show the potential of SOPHiA Radiomics — a groundbreaking application that analyzes medical images for research use — put to use in an additional retrospective analysis of the data from the phase 2 NADIM clinical trial (NCT03081689) (the NADIM trial).

The NADIM trial, funded by Bristol-Myers Squibb and part of the European Union’s Horizon 2020 research and innovation program, aimed to assess the antitumor activity and safety of neoadjuvant chemoimmunotherapy for resectable stage IIIA NSCLC. The important results recently published in The Lancet Oncology supported the addition of neoadjuvant nivolumab to platinum-based chemotherapy in patients with resectable stage IIIA NSCLC. This very aggressive type of cancer is unfortunately terminal in most patients with locally advanced staged disease; these results could therefore support a change of perception of locally advanced lung cancer as a potentially lethal disease to one that is curable.

Additional data are expected to be generated through the analysis of the radiology images of NADIM patients through the SOPHiA Radiomics Platform. These data will then be combined with clinical, biological, and genomics data, and multimodal machine learning models will be developed to predict response to neoadjuvant treatment, using baseline and pre-surgery data. The predictive analysis will also aim to stratify patient cohorts with regard to progression-free and overall survival.

"We are very happy to collaborate in this innovative and revolutionary project that opens the door to a new precision medicine. Certainly, this partnership will improve the knowledge relating to the treatment for this group of patients and will allow to approach the best prospects for curing early-stage non-small cell lung cancer (NSCLC)," said Dr. Mariano Provencio, Head of the Medical Oncology Department at Puerta de Hierro University Hospital in Madrid and lead investigator of the NADIM trial.

"We are very excited to apply our radiomics and multimodal analytics capabilities to such an important clinical question," said Prof. Thierry Colin, Vice-President of Radiomics Research at SOPHiA GENETICS. "In the Spanish Lung Cancer Group, we have found visionary partners that clearly see the promise of next-generation health data such as radiomics being married with tech-enabled solutions in artificial intelligence to generate entirely novel clinical insights for the benefit of oncology patients."

"Unlocking the synergistic potential of multimodal health data through artificial intelligence holds revolutionary promise for the future of personalized medicine in oncology and many other health conditions. We are inspired by the potential to positively impact on patients by supporting their care providers in predicting the best course of treatment," said Dr. Philippe Menu, Chief Medical Officer at SOPHiA GENETICS.

The NADIM trial involved 18 centers from the Spanish Lung Cancer Network that will contribute their data to the joint project.

Results from the additional analysis of NADIM trial data are expected to be available later this year.

IDEAYA Announces IDE397 IND Clearance by U.S. FDA to Initiate Phase 1 and Appointment of Matthew Maurer, M.D., as Vice President, Head of Clinical Oncology and Medical Affairs

On February 8, 2021 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported the effectiveness of the Investigational New Drug (IND) application for a Phase 1 clinical trial to evaluate IDE397, a potential best-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor (Press release, Ideaya Biosciences, FEB 8, 2021, View Source [SID1234574764]).

IDE397 is IDEAYA’s most advanced synthetic lethality program, and being developed in the clinic for cancer patients harboring methylthioadenosine phosphorylase (MTAP) deletion, which is prevalent in approximately 15% of all solid tumors. IDEAYA is targeting a Q1 2021 First-Patient-In for the Phase 1 clinical trial of IDE397 in patients having solid tumors harboring MTAP deletion.

IDEAYA also announced that Matthew Maurer, M.D., has joined the company as Vice President, Head of Clinical Oncology and Medical Affairs. "Matt brings extensive clinical development and oncology experience in both the pharmaceutical industry and academia. His background in clinical oncology will be invaluable as we advance IDE397 clinically in MTAP-deletion and target to select the Development Candidate for our wholly-owned PARG program in 2021," said Yujiro S. Hata, President and Chief Executive Officer at IDEAYA Biosciences.

Dr. Maurer has over 15 years of experience in oncology and previously worked at Bristol Myers Squibb (BMS) where he most recently led the clinical development of nivolumab and ipilimumab late phase studies in renal cell carcinoma and prostate cancer. Prior to BMS, Dr. Maurer was a physician investigator and Assistant Professor of Medicine at Columbia University College of Physicians and Surgeons, where he served as a breast cancer specialist. Dr. Maurer obtained his undergraduate degree from Princeton University and his medical degree from Mount Sinai School of Medicine, and then completed his residency at Columbia University Medical Center.

"I am thrilled to join the IDEAYA team and look forward to advancing the IDE397 clinical program and the broader Synthetic Lethality pipeline, including the PARG program, which has a potential application in breast cancer, an indication in which I have clinical experience as an oncologist," said Matthew Maurer, M.D., Vice President, Head of Clinical Oncology and Medical Affairs at IDEAYA Biosciences.

Enzychem Lifesciences Announces Poster Presentation At AACR Virtual Annual Meeting 2021

On February 8, 2021 Enzychem Lifesciences (KOSDAQ: 183490), a biopharmaceutical company developing innovative medicines to improve the lives of patients with cancer and inflammatory diseases, reported it will present new study data regarding its lead drug candidate, EC-18 in combination with immune checkpoint inhibitor (ICI) therapy, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting, held virtually, April 10-15 and May 17-21 (Press release, Enzychem Lifesciences, FEB 8, 2021, View Source [SID1234574763]).

ICI is approved and used in the treatment of various cancers. However, some carcinomas are refractory to ICI and the treatment effect diminishes through drug resistance. Adenosine-induced tumor progression and drug resistance are major obstacles to ICI therapy. Effective removal of adenosine surrounding the tumor can improve the ICI effect and suppress tumor progression.

"We are excited to present our in vitro cell analysis results at AACR (Free AACR Whitepaper), that support EC-18’s unique mechanism of action and synergistic therapeutic effect in combination with immune checkpoint inhibitors," said Ki Young Sohn, CEO & Chairman, Enzychem Lifesciences. "Based on these results, EC-18 has an anti-tumor effect by quickly eliminating eAdo extracellular adenosine (eAdo), which is a key factor for successful ICI therapy. PLAG, the active pharmaceutical ingredient of EC-18, may help cancer cells absorb and remove eAdo, thereby, effectively inhibiting tumor growth and changing the tumor microenvironment. PLAG may enhance the therapeutic effect of ICI in the treatment of LLC-1 lung carcinoma cells."

Details of the virtual poster presentation are below:
Abstract Title: Suppressive effect of PLAG on tumor progression and its synergistic therapeutic effect with ICI therapy through adenosine clearance.
Date: Saturday, April 10, 2021
Abstract Number: 1447
Session: Targeting the Tumor Microenvironment in Drug Development

The virtual abstract is available in the program section of the virtual AACR (Free AACR Whitepaper) annual meeting website: View Source

Longevity Acquisition Corporation Announces 4D pharma Clinical Trial Collaboration and Supply Agreement for the Treatment of Locally Advanced or Metastatic Urothelial Carcinoma

On February 8, 2021 Longevity Acquisition Corporation (NASDAQ: LOAC) (the "Company"), a publicly-traded special purpose acquisition company, reported that on February 8, 2021, 4D pharma plc (AIM: DDDD) ("4D pharma"), a pharmaceutical company leading the development of Live Biotherapeutic products ("LBPs") – a novel class of drug derived from the microbiome, and a business combination target of LOAC, has announced a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. for BAVENCIO (avelumab), the first and only immunotherapy approved as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma (Press release, Longevity Biotech, FEB 8, 2021, View Source [SID1234574762]). BAVENCIO is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc.

Under the collaboration, 4D pharma intends to commence a clinical trial in 2021 to evaluate BAVENCIO in combination with MRx0518 as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.

"With this second clinical trial collaboration for MRx0518 with a leading immune checkpoint inhibitor, 4D is able to evaluate MRx0518 in a new combination and earlier treatment setting. Following the promising data already generated in combination with checkpoint inhibitor pembrolizumab in refractory patients, and MRx0518 monotherapy data demonstrating single agent immuno-modulation presented last year at SITC (Free SITC Whitepaper), this collaboration allows us to continue to build a broad understanding of the safety and efficacy of MRx0518 across a range of solid tumors and stages of disease," said Duncan Peyton, Chief Executive Officer, 4D pharma. "The combination of MRx0518 with BAVENCIO has the potential to further enhance the positive clinical outcomes achieved by BAVENCIO for the significant number of patients in this treatment setting."

About MRx0518

MRx0518 is single strain Live Biotherapeutic product in development for the treatment of cancer. It is delivered as an oral capsule and stimulates the body’s immune system, directing it to produce cytokines and immune cells that are known to attack tumours. It is currently being evaluated in three clinical trials in patients with cancer. MRx0518-I-001 is a neoadjuvant monotherapy study in a variety of solid tumours and is being conducted at Imperial College (London, UK). MRx0518-I-002 is in combination with KEYTRUDA (pembrolizumab) in patients whose disease has previously progressed on anti-PD-1 therapies. The Coordinating Investigator of the study is at The University of Texas MD Anderson Cancer Center, Houston, USA, with multiple additional sites in the US. The study is being conducted in collaboration with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA. MRx0518-I-003 is in combination with preoperative radiotherapy in resectable pancreatic cancer. A fourth clinical trial of MRx0518 in combination with BAVENCIO (avelumab) in the first-line maintenance setting for urothelial carcinoma, conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc., is expected to initiate in 2021.

Avelumab Approved Indications

Avelumab (BAVENCIO) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Avelumab in combination with axitinib is approved in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis including fatal cases, colitis, endocrinopathies, nephritis, and other immune-mediated adverse reactions as a single agent or in combination with axitinib which can be severe and have included fatal cases), infusion-related reactions, hepatotoxicity in combination with axitinib, major adverse cardiovascular events (MACE) in combination with axitinib which can be severe and have included fatal cases, and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 hematology laboratory value abnormalities reported in at least 10% of patients with Merkel cell carcinoma treated with BAVENCIO monotherapy include lymphopenia; in patients receiving BAVENCIO in combination with axitinib, grade 3-4 clinical chemistry abnormalities include blood triglyceride increased and lipase increased.

Catapult Therapeutics receives FDA Clearance of Investigational New Drug (IND) Application for CAP-100, an innovative first-in-class humanized anti-CCR7 antibody

On February 8, 2021 Catapult Therapeutics, a biopharmaceutical company developing novel cancer treatments, reported the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its lead product candidate CAP-100, an innovative first-in-class humanized anti-CCR7 antibody for treatment of hematological malignancies (Press release, Catapult Therapeutics, FEB 8, 2021, View Source [SID1234574760]).

Catapult Therapeutics is now poised to initiate a Phase 1 clinical trial in patients with relapsed or refractory CLL (chronic lymphocytic leukemia). Expected to begin in the second quarter of 2021, the clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of CAP-100. The study will be performed at Dana-Farber Cancer Institute in Boston, where startup activities are currently underway, and two other leading clinical sites in the USA.

"The FDA clearance of the IND for CAP-100 represents another important milestone for Catapult Therapeutics, and we look forward to initiating the clinical trial shortly," said Wim Mol, PhD, Chief Executive Officer of Catapult Therapeutics. "We are excited to take the next step in the development of an antibody we believe will fulfill a significant unmet medical need: an effective treatment of hematological malignancies with the potential to change the treatment paradigm and provide new treatment options for patients."

About the study

The planned Phase I clinical trial (clinicaltrials.gov #NCT04704323) will investigate the safety and efficacy of increasing doses of CAP-100 in relapsed or refractory patients to at least two prior standard systemic treatment regimens for CLL or SLL (small lymphocytic lymphoma) and having no available therapies known to provide clinical benefit. The trial will be divided into two phases. The aim of the Phase Ia (dose escalation) is to define the Recommended Phase 2 Dose (RP2D). Phase Ib of the trial (expansion phase) will evaluate the safety and preliminary clinical benefit of CAP-100 at RP2D, to support the design of future trials investigating CAP-100 either as monotherapy or in a combination setting with approved treatments for CLL.

About CCR7 & CAP-100

The chemokine receptor CCR7 is essential for migration of immune cells to lymphoid organs. This pivotal receptor is over-expressed in hematological malignancies with lymph node involvement, such as CLL and diffuse large B-cell lymphoma (DLBCL) amongst others. Anti-hCCR7 antibody CAP-100 offers a unique and biologically independent therapeutic mechanism to treat these hematological cancers at a fundamental point, by interrupting tumor cell migration to lymph nodes. In addition, CAP-100 provides strong cell killing (ADCC) and inhibition of survival of tumor cells in the lymph nodes.

About CLL

Despite advances in therapy and improved outcome, in most instances CLL is an incurable disorder, and most patients relapse or become refractory to their treatment. CLL is the most common type of leukemia in Western countries, predominates in the elderly, and the incidence of the disease increases exponentially with age. Thus, the number of CLL patients is expected to rise in the future, given the increase in the aging population, bringing to light new clinical challenges and public health issues.