On December 21, 2022 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported that the U.S. Food and Drug Administration (FDA) has approved its FoundationOneLiquid CDx as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitutions and are appropriate for treatment with a group of current and future EGFR tyrosine kinase inhibitors (TKI) approved by the FDA for this indication (Press release, Foundation Medicine, DEC 21, 2022, View Source [SID1234625518]). Group approvals are granted when evidence is sufficient to conclude that a companion diagnostic is appropriate for use with a specific group of therapies, rather than specific products.1

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Specific segments of the DNA molecule, called exons, contain information that helps to code proteins. EGFR mutations seen in NSCLC patients are due to mutations within two specific exons—deletions in exon 19 and substitutions in exon 21.2 Since EGFR mutations are the second most common drivers of tumor growth in NSCLC patients, the ability to pinpoint two of the largest catalysts of cancer growth in these patients provides oncologists with more insight for their targeted treatment planning.

"For NSCLC patients whose tumors have EGFR exon 19 deletions or exon 21 substitutions, this approval opens new access avenues for targeted treatment options," says Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. "Following three recent group companion diagnostic approvals for Foundation Medicine’s tissue-based test, FoundationOneCDx, this first group approval for FoundationOne Liquid CDx builds upon the momentum for more efficient and innovative regulatory approaches to the companion diagnostic approval process. These efforts help to maintain the high-quality standards and rigor of the process, while streamlining the approach to developing TKIs to get these treatments to patients faster."

As a companion diagnostic for all therapies in this group targeting these mutations in NSCLC, FoundationOne Liquid CDx offers oncologists flexibility when selecting the right therapy for their patients and ensures all FDA approved treatment options are considered within this group of therapies.

The current therapies for which FoundationOne Liquid CDx is a companion diagnostic under the group approvals are Tarceva (erlotinib), Tagrisso (osimertinib) and Iressa (gefitinib). Moving forward, FoundationOne Liquid CDx will automatically become a companion diagnostic for future TKIs within this group for NSCLC that are approved by the FDA.

About FoundationOne Liquid CDx
FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.

About FoundationOne CDx
FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit www.f1cdxlabel.com.

On December 21, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, and Susan G. Komen, the world’s leading breast cancer organization, reported that they have entered into a partnership to bring the patient perspective to the development of clinical studies that help identify early-stage breast cancer patients who are at high risk of disease recurrence and may benefit from additional monitoring or therapy (Press release, Guardant Health, DEC 21, 2022, View Source [SID1234625517]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The focus of the partnership will be to support the development of clinical utility data for Guardant Reveal, a blood test for the detection of minimal residual disease (MRD) in patients with early-stage breast cancer. The test detects circulating tumor DNA (ctDNA) in the blood as a measurement of MRD, the presence of which indicates a high risk for disease recurrence.

A critical element of the partnership is the use of input from patient advocates to guide the research study design. These advocates, who serve as Susan G. Komen Advocates in Science, will provide a first-hand perspective of what matters most to patients with early-stage breast cancer in the development of research to find more effective approaches to their care.

"Susan G. Komen’s partnership with Guardant will help us achieve our goal of conquering deadly and aggressive breast cancers and saving lives by moving us towards personalized treatment through identifying which patients are at higher risk for recurrence," said Victoria Wolodzko Smart, SVP of Mission at Susan G. Komen. "By involving patient advocates in study design, we can achieve truly patient-centric research, clinical trials and treatment, bringing us closer to the goal of improving care and outcomes for all patients."

"We’re excited to partner with Susan G. Komen to help ensure a patient-centered approach to research for breast cancer patients," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "Leveraging their knowledge and resources will help us accelerate the understanding of the clinical value of MRD monitoring and how to personalize care to the specific needs of each patient with early-stage breast cancer to help improve outcomes."

On December 21, 2022 Guided Therapeutics, Inc. or the "Company" (OTCQB: GTHP), the maker of LuViva, a rapid and painless cervical cancer detection system based on the Company’s patented biophotonic technology, announced today it had executed a Clinical Trial Agreement with a prestigious academic medical institution (Press release, Guided Therapeutics, DEC 21, 2022, View Source [SID1234625516]). The clinical trial is aimed at achieving FDA approval for LuViva and is expected to involve approximately 400 women at up to three medical institutions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Negotiating and signing the Clinical Trial Agreement is the final step prior to starting the study," said Gene Cartwright, CEO of Guided Therapeutics. "We look forward to the start of the study early next year and planned completion before the end of 2023."

On December 21, 2022 Osmol Therapeutics, reported that it is presenting at BIOTECH SHOWCASE 2023, a leading investor conference focused on driving advances in therapeutic development taking place in San Francisco from January 9-11, 2023 (Press release, Osmol Therapeutics, DEC 21, 2022, View Source [SID1234625514]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presentation details:
Bob Linke, Chief Executive Officer, Osmol Therapeutics
January 9, 2023, at 9:00 a.m. PST
Hilton Union Square, 333 O’Farrell Street, Franciscan B (Ballroom Level), San Francisco CA

Registered attendees can view Osmol’s presentation live and access a recorded version beginning November 29th – six weeks prior to the actual event. With 24×7 on-demand access, attendees can view recorded presentations at their convenience when scheduling does not allow viewing during the main event week.

"There are currently no FDA-approved treatments for chemo-induced peripheral neuropathy (CIPN), a debilitating side effect most commonly associated with microtubule therapies such as taxanes," said Bob Linke. "Based on the research of Dr. Barbara Ehrlich of Yale University, Osmol ’s lead drug candidate, OSM-0205, is designed to prevent the occurrence of CIPN. Our initial focus is on breast cancer where up to 80% of patients treated with taxanes develop CIPN. Half of these patients have their dose of chemotherapy reduced to address their CIPN since there are no disease modifying treatments available today, potentially negatively impacting patient outcomes. There is an urgent need for a therapy to prevent CIPN and we expect to begin a Phase 1 clinical trial of OSM-0205 in the first half of 2023."

BIOTECH SHOWCASE, produced by Demy-Colton and EBD Group, is an investor conference focused on driving advances in therapeutic development by providing a sophisticated networking platform for executives and investors that fosters investment and partnership opportunities. The conference takes place each year during the course of one of the industry’s largest gatherings and busiest weeks.

"We are delighted that Osmol Therapeutics will be joining us in San Francisco and present at BIOTECH SHOWCASE this year," said Sara Demy, CEO of Demy-Colton. "BIOTECH SHOWCASE is a prime occasion for life science entrepreneurs and investors to come together to discover the potential of innovative technologies that will drive the future of drug discovery."

About OSM-0205 and CIPN

Osmol’s lead drug, OSM-0205, is based on Dr. Barbara Ehrlich’s research in neuronal calcium sensor-1 (NCS1) at Yale University and is designed to prevent the off-target calcium surge caused by taxanes and potentially other chemotherapy treatments associated with peripheral nerve damage. Data from preclinical studies conducted by Osmol show that pre-treatment with OSM-0205 prevents the pathologic damage caused by these chemotherapy agents. Further, preliminary data in preclinical models suggests OSM-0205 may have utility in preventing chemotherapy induced cognitive impairment, an indication that will also be assessed by Osmol.

Osmol expects to initiate a Phase 1 bioavailability trial for the treatment of chemotherapy induced peripheral neuropathy in the first half of 2023.

On December 21, 2022 Gradalis, a late-stage biotechnology company developing personalized immunotherapies for ovarian and other cancers, reported that it has received clearance by the U.S. Food and Drug Administration (FDA) to proceed with the registrational Phase 3 VITAL-V study for Vigil (gemogenovatucel-T) in patients with advanced ovarian cancer (Press release, Gradalis, DEC 21, 2022, View Source [SID1234625513]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This clearance by the FDA to initiate the pivotal VITAL-V Phase 3 clinical trial of Vigil in HRP ovarian cancer is a major milestone for Gradalis," said Steve Engle, Gradalis’ chief executive officer. "We look forward to initiating this pivotal study so that we can bring a much-needed new treatment option to patients as quickly as possible."

The VITAL-V study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate Vigil in newly diagnosed advanced stage ovarian cancer patients with tumor profiles that are homologous recombination proficient (HRP) undergoing maintenance therapy who achieve a complete clinical response following surgery and frontline chemotherapy. Upon completion of front-line chemotherapy, patients will be randomized to receive either Vigil plus bevacizumab or bevacizumab alone. The study’s primary endpoint is progression-free survival (PFS); overall survival (OS) is a key secondary endpoint. The study is planned to enroll approximately 300 patients in the U.S. Gradalis plans to begin enrolling patients in the second half of 2023.

"Cancer represents a failure of immune response. The current single modality attempts to engage the immune system do not solve the problem, especially for solid tumors like ovarian cancer," said John J. Nemunaitis, M.D., co-founder and chief scientific officer of Gradalis. "We have built upon earlier single modality approaches to develop a Trifecta of anti-cancer activity –tumor target identification, immune activation, and immune evasion. Utilizing the patient’s own tumor as the antigen source, Vigil provides the full repertoire of personal neoantigen targets that naturally educate circulating immune effector cells."

"HRP ovarian cancer represents a major unmet medical need because of its greater resistance to platinum chemotherapy and the limited role of PARPi therapy," said Rodney Rocconi, M.D. FACOG, professor, Division of Gynecologic Oncology, University of Alabama at Birmingham and principal investigator of the VITAL-V trial. "Preliminary clinical testing of Vigil has demonstrated an effective mechanism of action and consistent efficacy and safety."

About Vigil (gemogenovatucel-T)
Vigil (gemogenovatucel-T) is a novel, personalized immunotherapy platform designed to achieve a Trifecta of immune anticancer activity using a unique bi-shRNA DNA-based plasmid and the patient’s own tumor tissue. The Trifecta of systemic activity involves knock down of TGFβ1 and TGFβ2 which function as tumor suppressor cytokines, increased GM-CSF expression to enhance local immune function, and presentation of the patient’s clonal neoantigen epitopes via use of autologous cancer tissue. By utilizing the patient’s own tumor as the antigen source, Vigil is designed to elicit an immune response that is specifically targeted and broadly relevant to each patient’s unique "clonal" tumor neoantigens. Vigil therapy has been well tolerated in Phase 1, 2a and 2b clinical studies.