On October 10, 2022 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, reported it has entered into a clinical trial collaboration and supply agreement with BeiGene to evaluate Immune-Onc’s first-in-class myeloid checkpoint inhibitors, IO-108 and IO-202, in combination with BeiGene’s anti-PD-1 antibody, tislelizumab, as part of its clinical development programs in China (Press release, Immune-Onc Therapeutics, OCT 10, 2022, View Source [SID1234621871]).

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"We are delighted to partner with BeiGene. The preclinical and clinical data to date of our first-in-class LILRB antagonists IO-108 and IO-202 have shown that there is great potential in combining our myeloid checkpoint inhibitors with T cell checkpoint inhibitors, such as tislelizumab, to potentially improve clinical outcomes," said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "By expanding our reach with BeiGene in China, we have an opportunity to treat a broader array of patients with significant unmet medical needs."

"We are thrilled to partner with Immune-Onc to evaluate the combination of tislelizumab with their novel myeloid checkpoint inhibitors IO-108 and IO-202," added Lai Wang, Ph.D., Global Head of R&D of BeiGene. "Based on strong preclinical and emerging clinical data, we believe there is good synergy between PD-1 and LILRB antagonists for the treatment of solid tumors. We look forward to working with Immune-Onc to explore the possibility of combination therapy with our products, which may bring more treatment options to cancer patients in China."

Under the terms of the collaboration, Immune-Onc will sponsor and fund the IO-108 and IO-202 clinical trials in China, and BeiGene will provide tislelizumab. Immune-Onc retains global development and commercial rights to IO-108 and IO-202.

ABOUT IO-108

IO-108 is a fully human IgG4 monoclonal antibody with high affinity and specificity towards LILRB2 (also known as ILT4). It blocks the interaction of LILRB2 with multiple ligands that are involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A and CD1d. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s annual meeting and the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrate that IO-108 functions as a myeloid checkpoint inhibitor and promotes innate and adaptive anti-cancer immunity.

The ongoing Phase 1 study of IO-108 in adult cancer patients in the U.S. (NCT05054348) has completed dose escalation. To date, IO-108 has been well tolerated with demonstrated clinical activity in multiple tumor types, both as a monotherapy and in combination with pembrolizumab, an anti-PD-1 antibody. The company is actively enrolling a Phase 1 clinical trial in China to evaluate IO-108 in solid tumors.

ABOUT IO-202

IO-202 is a humanized IgG1 monoclonal antibody with high affinity and specificity towards LILRB4 (also known as ILT3). It blocks the interaction of LILRB4 with multiple ligands, including ApoE and Fibronectin, and has broad potential as an immunotherapy in both blood cancers and solid tumors. In hematologic malignancies, preclinical studies showed that IO-202 converts a "don’t kill me" to a "kill me" signal by activating T cell killing and converts a "don’t find me" to a "find me" signal by inhibiting infiltration of blood cancer cells. In the context of solid tumors, preclinical data presented at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrate that IO-202 enhances dendritic cell function and T cell activation in vitro and inhibits tumor growth in an immune competent model in vivo.

IO-202 has two ongoing clinical studies in the U.S.: Its first Phase 1 trial is currently enrolling patients with acute myeloid leukemia (AML) or chronic myelomonocytic leukemia (CMML) as a monotherapy and in combination with azacitidine (NCT04372433). The U.S. Food and Drug Administration granted IO-202 Orphan Drug designation for treatment of AML in 2020 and Fast Track designation for relapsed or refractory AML in 2022. The second Phase 1 trial of IO-202 is currently enrolling patients with advanced solid tumors to evaluate IO-202 as a monotherapy and in combination with an anti-PD-1 (NCT05309187).

On October 10, 2022 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a leading late-stage biotechnology company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders with high unmet need, reported that Raj Prabhakar, M.B.A., Chief Business Officer, will deliver an in-person company presentation at the 2022 Cell & Gene Meeting on the Mesa on Tuesday, October 11, at 2:30 p.m. PT in Carlsbad, CA (Press release, Rocket Pharmaceuticals, OCT 10, 2022, View Source [SID1234621870]).

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A live audio webcast of the presentation will be available to registered attendees within the conference virtual platform and the video will be available for on-demand viewing within 24 hours of the Rocket presentation.

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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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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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.