On October 10, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will report financial results for the third quarter 2022 after market close on Thursday, November 3, 2022 (Press release, Guardant Health, OCT 10, 2022, View Source [SID1234621869]). Company management will be webcasting a corresponding conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.

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Live audio of the webcast will be available on the "Investors" section of the company website at: www.guardanthealth.com. The webcast will be archived and available for replay after the event.

On October 10, 2022 Bluestar Genomics, Inc., an early cancer detection company leading the development and commercialization of next-generation liquid biopsy tests focused on non-invasive detection of high-mortality cancers in high-risk patient populations, reported it received accreditation for its clinical laboratory from the College of American Pathologists (CAP) (Press release, Bluestar Genomics, OCT 10, 2022, View Source [SID1234621868]). The certification enables the company to serve physicians and patients globally as it works towards broad commercialization of its first test for the detection of pancreatic cancer.

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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

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CAP Accreditation is an internationally recognized program that awards laboratories that meet stringent requirements of quality, accuracy, and consistency. This milestone further solidifies Bluestar Genomics’ commitment to providing the highest standards of testing results. The company’s proprietary approach to detecting cancer early is anchored in epigenomic process of tracking dynamic changes in cells in the body by measuring levels of the biomarker 5-hydroxymethylcytosine (5hmC) in a person’s blood.

"This accreditation—on the heels of our CLIA certification and combined with our growing body of scientific evidence supporting the utility of our 5hmC-based epigenomic testing—positions us to become the first cancer detection company to offer non-invasive epigenomic blood-based testing for early pancreatic cancer detection," said David Mullarkey, chief executive officer of Bluestar Genomics. "These milestones are a testament to our focus on preparing our company to serve customers around the world, helping millions of patients avoid late-stage, untreatable cancer diagnosis."

Bluestar Genomics’ pancreatic cancer early detection test has been analytically validated and previously received FDA Breakthrough Device Designation. It is designed to analyze a person’s changing biology and uses novel 5hmC-based epigenomic analysis to detect when cells become cancerous. The company has a prospective, large clinical validation study underway to further study its test.

On October 10, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported that it is presenting data highlighting its portfolio of skin cancer gene expression profile (GEP) tests at the 2022 American Society for Dermatologic Surgery (ASDS) Annual Meeting, being held Oct. 6-10 in Aurora, Colorado, including new data highlighting impactful changes in risk-aligned patient management strategies after clinicians received DecisionDx-SCC test results (Press release, Castle Biosciences, OCT 10, 2022, View Source [SID1234621867]).

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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

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DecisionDx-SCC is Castle’s prognostic 40-GEP test designed to use a patient’s tumor biology to predict individual risk of metastasis for patients diagnosed with cutaneous squamous cell carcinoma (SCC) who have one or more high-risk factors. The test stratifies patients into one of three classes based on their biologic risk of metastasis: Class 1 (low risk), Class 2A (moderate risk) or Class 2B (high risk).

"Incorporating DecisionDx-SCC test results into existing risk-assessment frameworks can give clinicians confidence that they are making informed and risk-appropriate decisions regarding the overall treatment intensity of their high-risk SCC patients," said study investigator Sarah T. Arron, M.D., Ph.D., board-certified dermatologist and Mohs surgeon with Peninsula Dermatology in Burlingame, California. "In the study, 42% of Mohs surgeons reported greater confidence in their patient management decisions when using the personalized, risk-stratification information provided by DecisionDx-SCC test results."

The study data is available in a pre-recorded oral presentation given by Dr. Arron and titled "How Mohs surgeons utilize prognostic testing for high-risk cutaneous squamous cell carcinoma (SCC): a clinical impact study."

Study highlights:

A clinical impact survey was distributed to current American College of Mohs Surgery (ACMS) members; a total of 39 members provided responses to a variety of questions, including their familiarity with DecisionDx-SCC and their approach to a number of treatment modalities for a high-risk SCC patient, pre- and post-DecisionDx-SCC test results.
97% of respondents were at least somewhat familiar with or had used the DecisionDx-SCC test.
Several National Comprehensive Cancer Network (NCCN) high- or very-high risk factors, such as perineural involvement, lymphatic or vascular involvement, poor differentiation and more, that the clinicians believed were the most influential in the development of metastasis were also considered reasons to use DecisionDx-SCC.
Additionally, the survey highlighted a risk-appropriate trend where respondents’ overall approach to patient management intensity increased as the DecisionDx-SCC test results indicated an increased risk of metastasis and decreased when test results indicated a lower risk.
42% of Mohs surgeons reported increased confidence in management decisions when DecisionDx-SCC test results were provided.
Overall, the study demonstrates how DecisionDx-SCC test results can assist Mohs surgeons in making risk-aligned management plans and increase confidence in their treatment decisions.
Additionally, the study suggests that DecisionDx-SCC can focus treatment options in the most risk-appropriate manner, allowing for an optimization of healthcare resources and improved patient outcomes.
The following pre-recorded oral presentations highlighting Castle’s other GEP tests for skin cancer are also available during the ASDS annual meeting:

DecisionDx-Melanoma

"Incorporating the 31-gene expression profile test stratifies survival outcomes and leads to improved survival compared to clinicopathologic factors alone: a Surveillance, Epidemiology, and End Results (SEER) collaboration" will be presented by Sarah J. Kurley, Ph.D., director of evidence development at Castle Biosciences.
"The 31-gene expression profile test stratifies the risk of recurrence in patients with T1 cutaneous melanoma" will be presented by Abel Jarell, M.D., board-certified dermatologist and dermatopathologist with Northeast Dermatology Associates, P.C., in Portsmouth, New Hampshire.
DecisionDx-SCC

"Integration of the 40-gene expression profile (40-GEP) for management and treatment of high-risk cutaneous squamous cell carcinoma (cSCC)" will be presented by Gaurav Singh, M.D., M.P.H., F.A.A.D., board-certified dermatologist and Mohs surgeon.
Diagnostic GEP Tests, MyPath Melanoma and DiffDx-Melanoma

"A clinical impact study of dermatologists’ use of MyPath Melanoma and DiffDx-Melanoma: diagnostic gene expression profile tests guide surgical excision and enhance management plan confidence" will be presented by Aaron S. Farberg, M.D., F.A.A.D., board-certified dermatologist and Mohs surgeon with Derm Texas and Baylor Scott & White Health System in Dallas, Texas.
About DecisionDx-Melanoma

DecisionDx-Melanoma is a risk stratification gene expression profile test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 9,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 35 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through June 30, 2022, DecisionDx-Melanoma has been ordered 105,239 times for patients diagnosed with cutaneous melanoma.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

About MyPath Melanoma and DiffDx-Melanoma

MyPath Melanoma and DiffDx-Melanoma are Castle’s two gene expression profile tests designed to provide an accurate, objective result to aid dermatopathologists and dermatologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately two million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. For these cases, the treatment plan can also be uncertain. Obtaining accurate, objective ancillary testing can mean the difference between a path of overtreatment or the risk of undertreatment. Interpreted in the context of other clinical, laboratory and histopathologic information, MyPath Melanoma and DiffDx-Melanoma are designed to reduce uncertainty and provide confidence for dermatopathologists and help dermatologists deliver more informed patient management plans.

On October 10, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, reported that Michele Korfin, Chief Operating Officer and Chief Commercial Officer, will present its corporate highlights at the annual Cell & Gene Meeting on the Mesa to be held October 11-13, 2022 in Carlsbad, California and livestreamed globally (Press release, Gamida Cell, OCT 10, 2022, View Source [SID1234621866]).

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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

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Ms. Korfin will discuss 2022 catalysts and potential milestones including the U.S. market opportunity for omidubicel upon potential U.S. Food and Drug Administration (FDA) approval. Additional topics include, accelerating the development of its first-in-class NAM-enabled natural killer (NK) cell therapy candidate, GDA-201, as a potential new approach for patients with follicular and diffuse large B-cell lymphomas, and expansion of its NAM-enabled cell therapy pipeline with multiple next-generation, genetically-engineered NK cells.

Organized by the Alliance for Regenerative Medicine, the Cell & Gene Meeting on the Mesa is a three-day conference featuring more than 90 dedicated company presentations by leading public and private companies, highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering and broader regenerative medicine technologies, as well as over 100 panelists and featured speakers.

Virtual attendance is available which includes a live webcast of Gamida Cell’s presentation and the ability to view all conference sessions on-demand. Please visit View Source for full information including registration.

Complimentary attendance at this event is available for credentialed investors and members of the media only. Investors should contact Laura Stringham at [email protected] and interested media should contact Stephen Majors at [email protected].

About NAM Technology

Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.

About Omidubicel

Omidubicel is an advanced cell therapy candidate developed as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multi-center, randomized Phase 3 study (NCT0273029) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU.

The BLA for omidubicel has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2023. If approved, omidubicel will be the first allogeneic advanced stem cell therapy donor source for patients with blood cancers in need of a stem cell transplant.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit View Source

About GDA-201

Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy candidate for the potential treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical study data. Preclinical studies have shown that GDA-201 may address key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, these data suggest GDA-201 may improve antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. There are approximately 40,000 patients with relapsed/refractory lymphoma in the US and EU, which is the patient population that will be studied in the currently ongoing GDA-201 Phase 1/2 clinical trial.

For more information about GDA-201, please visit View Source For more information on the Phase 1/2 clinical trial of GDA-201, please visit www.clinicaltrials.gov.

GDA-201 is an investigational cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority.

On October 10, 2022 Scandion Oncology (Scandion), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, reported that it has as planned initiated part 3 of the CORIST phase II trial studying Scandion’s lead compound SCO-101 as a combination treatment in patients with metastatic colorectal cancer (mCRC) (Press release, Scandion Oncology, OCT 10, 2022, View Source,c3645573 [SID1234621863]). The first of up to 36 patients has been enrolled as the development of SCO-101 seamlessly continues with the momentum from the ongoing part 2 of the trial maintained.

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CORIST part 3 expands the development program to best exploit SCO-101’s potential in mCRC, adding a new schedule for combining SCO-101 and chemotherapy (FOLFIRI), which will be evaluated in patients with both RAS wild-type and RAS mutated tumors. Part 2 of the trial only includes patients with RAS wild-type tumors.

The new optimized dosing schedule for CORIST part 3 is based on evidence about safety and pharmacokinetics gathered so far from part 2 of the trial. This schedule is expected to provide a potentially improved modality for combining SCO-101 and FOLFIRI.

"We are pleased to initiate part 3 of CORIST in accordance with our plans and communicated timeline. SCO-101 has potential to improve treatment options in mCRC and we are excited to continue the work to best harness this potential to the benefits of patients, health care professionals and Scandion", says Johnny Stilou, acting Chief Executive Officer of Scandion.

New administration schedule

CORIST part 3 will evaluate the safety and tolerability of SCO-101 in combination with FOLFIRI when administered once daily on day 1 to day 6 and FOLFIRI administered on day 2 to day 4 of each treatment cycle. Based on pharmacokinetics and pharmacodynamics data this new schedule is expected to be better both in term of efficacy and tolerability.

CORIST part 3 is planned to include up to 36 patients, however the number of patients will vary according to the observed tolerance. Topline results from CORIST part 3 are currently expected in the third quarter of 2023, but timelines may change depending on number of patients enrolled.

Following completion of part 3, Scandion expects to expand the CORIST trial with a part 4. Here, up to 24 patients will be enrolled to assess the preliminary activity of SCO-101 in combination with FOLFIRI administered at the optimal dose found in part 3. After completion of part 4, the overall study results will be analyzed to choose the best schedule and the appropriate patient population for further development of SCO-101 in mCRC.