On January 23, 2023 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported that the Company’s medical director, Matthew Goldberg, M.D., F.A.A.D., board-certified dermatologist and dermatopathologist, will present at the Precision Medicine World Conference (PMWC) 2023, being held Jan. 25-27 in Santa Clara, California (Press release, Castle Biosciences, JAN 23, 2023, View Source [SID1234626475]).

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Dr. Goldberg’s presentation, titled "Using Molecular Diagnostics to Inform Cancer Management Decisions," will take place on Wednesday, Jan. 25, at 2:30 p.m. Pacific time as part of Track 3: Diagnostics and Molecular Profiling in the Clinic. Dr. Goldberg will highlight several tests within Castle’s skin cancer and gastroenterology portfolios, including DecisionDx-Melanoma, DecisionDx-SCC and the TissueCypher Barrett’s Esophagus test, and demonstrate how the personalized information the tests provide can help clinicians make more informed treatment decisions in the care of their patients to potentially improve patient outcomes.

"Castle Biosciences is a leading company in the precision medicine space that is committed to transforming disease management for skin cancers and Barrett’s esophagus," said Dr. Goldberg. "By focusing on disease states with significant unmet clinical need, we leverage our innovative in-house testing platforms to provide meaningful improvements to diagnostic or risk stratification approaches across the various disease states where we offer molecular testing.

"While there is much discussion about the promise of personalized medicine, Castle’s tests have the potential to improve patient outcomes and reduce costs to the healthcare system. I am looking forward to sharing concrete examples during my discussion of how molecular testing technologies can be clinically accessed for the benefit of patient care today."

Dr. Goldberg has served as Castle’s medical director since 2020 and supports Castle’s commercialized and pipeline tests. He graduated summa cum laude from Princeton University and received his medical degree from the Icahn School of Medicine at Mount Sinai. Dr. Goldberg completed his dermatology residency at the University of California, San Francisco, and completed a dermatopathology fellowship at the University of Texas Southwestern.

Conference presentation content will be available to registered attendees only. Visit View Source for more information and registration details.

About Precision Medicine World Conference

PMWC, the "Precision Medicine World Conference," is the largest and original annual conference dedicated to precision medicine. PMWC’s mission is to bring together recognized leaders, top global researchers and medical professionals, and innovators across healthcare and biotechnology sectors to showcase practical content that helps close the knowledge gap between different sectors, thereby catalyzing cross-functional fertilization and collaboration in an effort to accelerate the development and spread of precision medicine.

Since 2009, PMWC has been recognized as a vital cornerstone for all constituents of the health care and biotechnology community, providing an exceptional forum for the exchange of information about the latest advances in technology, in clinical implementation, research and in all aspects related to the regulatory and reimbursement sectors.

On January 23, 2023 Agilent Technologies Inc. (NYSE: A) reported an agreement with Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services (Press release, Agilent Technologies, JAN 23, 2023, View Source [SID1234626474]). The alliance will enable providers and patients throughout the United States to access the Agilent Resolution ctDx FIRST liquid biopsy next-generation sequencing (NGS) test. Healthcare providers can order the test beginning today.

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The agreement between Quest and Agilent will enable broad adoption for ctDx FIRST, a single-site premarket approved (ssPMA) test performed at the Resolution Bioscience CLIA laboratory in Kirkland, Washington. ctDx FIRST is the first liquid biopsy test approved by the U.S. Food and Drug Administration (FDA) as a companion diagnostic (CDx) to identify advanced non-small cell lung cancer (NSCLC) patients who may benefit from treatment with KRAZATI. KRAZATI (adagrasib) received accelerated approval as a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. ctDx FIRST is also FDA-approved for tumor profiling of the epidermal growth factor receptor (EGFR) gene in accordance with professional guidelines in oncology for patients with advanced non-small cell lung cancer (NSCLC).

As a professional service, the ctDx FIRST test report* includes comprehensive genomic profiling on 109 genes across four types of alterations: single nucleotide variants, indels, copy number amplifications, and fusions.

"We are looking forward to the Quest Diagnostics alliance facilitating broad access to ctDx FIRST, our liquid biopsy solution," said Paul Beresford, vice president and general manager of Agilent’s Companion Diagnostics Division. "This expands the testing options available for NSCLC patients as patients don’t always have tissue available for molecular analysis."

"The addition of the ctDx FIRST test to our oncology menu underscores our commitment to providing access to precision medicine innovations to improve care for patients with cancer," said Kristie Dolan, vice president and general manager, Oncology Franchise, at Quest Diagnostics. "It also reflects our ability to optimize our national physician and patient access network to extend access to important medical innovations with the potential to improve patient outcomes."

Under the terms of the agreement, Quest will offer ctDx FIRST to healthcare providers in the United States seeking a minimally invasive liquid biopsy test option as a CDx for KRAZATI. Healthcare providers can order the test electronically through the Quest connectivity platform, which connects to hundreds of electronic medical records (EMRs). Healthcare providers may direct patients to provide specimens at one of Quest’s 2,100 patient service centers across the United States. Integrating Quest’s electronic health record (EHR) platform and access to its national patient center network will make it easier for healthcare providers to incorporate ctDx FIRST as part of regular clinical care.

Agilent and Quest have previously collaborated on Ki-67 IHC MIB-1 pharmDx and PD-L1.

* CLIA validated, not FDA approved

About NSCLC

There are two primary types of lung cancer, non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Named initially for how the cancer cells look under the microscope, these two account for 230,000 newly diagnosed cases of lung cancer in the U.S. each year. The vast majority (85 percent) of lung cancers fall into the non-small cell lung cancer category. Though this form of lung cancer progresses more slowly than SCLC, 40 percent of NSCLCs will have spread beyond the lungs by the time it is diagnosed.

On January 23, 2023 Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound mocravimod reported that the first patients have been enrolled in the pivotal MO-TRANS global Phase 2b/3 study evaluating mocravimod in AML patients undergoing allogeneic hematopoietic cell transplant (HCT) (Press release, Priothera, JAN 23, 2023, View Source [SID1234626473]).

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Mocravimod, a sphingosine 1 phosphate (S1P) receptor modulator which has been previously tested in multiple autoimmune indications, is being developed to enhance the curative potential of allogeneic HCT. Mocravimod has shown a clinically relevant benefit in an early clinical study in patients with hematologic malignancies undergoing allogeneic HCT.

Priothera is initiating the pivotal MO-TRANS global Phase 2b/3 study in Europe, Israel, the US and in additional Asian and Latin American countries, to assess the efficacy and safety of mocravimod as an adjunctive and maintenance therapy in AML patients undergoing allogeneic HCT. The double-blind, placebo-controlled study assesses relapse-free and overall survival of two dose levels of mocravimod in comparison to placebo. Topline data from this study are expected in 2025.

Marcos de Lima, M.D., is the Principal Investigator for the MO-TRANS global Phase 2b/3 trial. Dr. de Lima is professor of medicine at The Ohio State University College of Medicine and a hematologist-oncologist at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.

Prof de Lima said: "We are excited to be part of the important MO-TRANS global Phase 2b/3 study to investigate mocravimod, a potential new adjunctive and maintenance therapy for patients with Acute Myeloid Leukemia undergoing allogeneic Hematopoietic Cell Transplant. Maintenance therapy is fast becoming the new frontier in the treatment of AML and we are committed to bringing forth new innovative therapies to AML patients."

Elisabeth Kueenburg, M.D., Chief Medical Officer at Priothera, commented: "This MO-TRANS global Phase 2b/3 study builds on pre-clinical and clinical proof of concept studies which demonstrated mocravimod’s ability to improve survival outcomes for patients with hematological malignancies requiring allogeneic HCT. The mode of action has been well-established in autoimmune indications, but never in hematology. Mocravimod has the potential to be a first-in-class therapy in maintaining the graft-versus-leukemia effect, while preventing graft-versus-host disease, one of the most serious complications of allogeneic HCT. We expect this trial to deliver important clinical data supporting the registration of mocravimod in this indication."

Florent Gros, Co-Founder and CEO of Priothera, said: "Having successfully enrolled the first AML patients undergoing allogeneic HCT in our MO-TRANS global study represents a significant milestone for Priothera as we believe mocravimod has the potential to address a significant unmet need. Furthermore, we anticipate a strong uptake in patient enrollment with a significant number of patients currently being identified. We look forward to seeing topline results in 2025."

About mocravimod

Mocravimod (also known as KRP203) is a synthetic, sphingosine 1-phosphate receptor (S1PR) modulator. This novel investigational drug has been assessed in Phase 1 and Phase 2 trials for safety and tolerability, as well as for efficacy in several autoimmune indications. Promising data from a Phase 1b/2a clinical study in patients with hematological malignancies led Priothera to further develop mocravimod for the treatment of blood cancers and the improvement of CAR-T cell therapy.

Mocravimod is currently being investigated as an adjunctive and maintenance treatment in a Phase 2b/3 study for patients with Acute Myeloid Leukemia (AML) receiving allogeneic hematopoietic cell transplantation (HCT). Allogeneic HCT is the only potentially curative approach for AML patients, but current treatments have unacceptably high mortality and morbidity rates.

Priothera leverages mocravimod’s unique mode of action to maintain the beneficial graft-versus leukemia (GVL) activity, while reducing tissue damage resulting from graft-versus-host disease (GVHD), both a consequence of allogeneic HCT. This novel treatment approach – mocravimod being the only S1PR modulator treating blood cancers – tackles a high unmet medical need and aims to improve patients’ quality of life.

On January 23, 2023 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that it has initiated enrollment into a company-sponsored Phase 2 clinical trial to evaluate darovasertib as monotherapy in neo-adjuvant and adjuvant settings in primary, non-metastatic uveal melanoma (UM) patients (Press release, Ideaya Biosciences, JAN 23, 2023, View Source [SID1234626472]). The company also provided guidance for an update on its Phase 2 clinical trial evaluating darovasertib in combination with crizotinib in metastatic uveal melanoma (MUM) patients in 2023.

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"We are excited to clinically evaluate darovasertib as a neoadjuvant and an adjuvant treatment in uveal melanoma patients. This is a paradigm-shifting opportunity, as there are no approved systemic therapies in these settings. The preliminary clinical data shows clear evidence of anti-tumor activity and supports further clinical evaluation of darovasertib to determine its potential to either save the eye by avoiding enucleation, or to reduce the tumor thickness in the eye, enabling treatment with less radiation to preserve vision," said Dr. Carol Shields, M.D., Chief, Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University.

"The primary tumor shrinkage we are observing from just a single month of therapy in our investigator-sponsored NADOM study is very promising. We are looking forward to seeing even greater benefits in the IDEAYA-sponsored Phase 2 study where the protocol provides for neoadjuvant treatment to maximum response," said Professor Anthony Joshua, MBBS, PhD, FRACP, Head Department of Medical Oncology, Kinghorn Cancer Centre, St. Vincent’s Hospital Sydney.

"We are taking a comprehensive approach to treatment of ocular tumors. We plan to treat primary UM with darovasertib monotherapy as neoadjuvant therapy prior to enucleation or radiation treatments, and then as follow-up adjuvant therapy after the primary interventional treatment. We are also preparing to initiate a registrational clinical trial to treat patients who develop metastatic uveal melanoma, which predominantly presents as liver metastasis, with darovasertib in combination with crizotinib," said Dr. Darrin M. Beaupre, M.D., Ph.D., Senior Vice President and Chief Medical Officer, IDEAYA Biosciences.

Darovasertib is a potent, selective small molecule inhibitor of protein kinase C (PKC). Mutations in GNAQ or GNA11 (GNAQ/11) or related proteins occur in approximately 95% of patients with uveal melanoma (UM) and activate the PKC signaling pathway, driving tumor progression. The FDA has designated darovasertib as an Orphan Drug in Uveal Melanoma. As presented at IDEAYA’s Investor R&D Day in December 2022, Darovasertib has demonstrated tumor shrinkage and clinical benefit in 5 of 5 patients with an ocular tumor, including 3 UM patients from the IST as measured by ultrasound, and 2 MUM patients with an ocular lesion from IDEAYA’s ongoing IDE196-001 clinical trial, including 1 MUM patient as measured by PET scan, and 1 MUM patient as measured by MRI.

Uveal melanoma is a rare, lethal form of melanoma that arises from melanocytes of the iris, the ciliary body, or most commonly the choroid, with an annual potential incidence of approximately 8,700 patients aggregate in US and Europe. Current approaches for treatment of primary UM depend on tumor size and location – enucleation of the eye for large tumors and radiation therapy (e.g., plaque brachytherapy) for small or medium tumors, which consequential vision impairment.

IDEAYA has initiated a company-sponsored Phase 2 clinical trial evaluating darovasertib as monotherapy in neoadjuvant and adjuvant UM. Pursuant to the protocol, in one cohort UM patients with large tumors will be treated with darovasertib until maximum benefit or six months, at which time they will undergo a primary interventional treatment. The endpoint for this large-tumor cohort is eye preservation – e.g., a patient who would otherwise have undergone enucleation is instead eligible for radiation treatment. In another cohort, UM patients with small or medium tumors will be treated with darovasertib until maximum benefit or six months, at which time they will undergo radiation therapy. Endpoints for this small- or medium-tumor cohort include (i) reducing the radiation dose that the patient received, relative to the radiation dose they would have otherwise received without the neoadjuvant treatment, and (ii) functional vision preservation. Each of the two cohorts will include up to six months of follow-up adjuvant therapy after the primary interventional treatment to evaluate relapse-free survival and useful vision.

In addition to IDEAYA’s Phase 2 clinical trial, the company is also continuing to support the ongoing investigator sponsored trial (IST), captioned as "Neoadjuvant / Adjuvant trial of Darovasertib in Ocular Melanoma" (NADOM), led by St. Vincent’s Hospital in Sydney with participation of Alfred Health and the Royal Victorian Eye and Ear Hospital in Melbourne.

IDEAYA owns or controls all commercial rights in darovasertib, subject to certain economic obligations under its exclusive, worldwide license with Novartis.

IDEAYA is also evaluating darovasertib in combination with crizotinib in MUM patients in a Phase 2 clinical trial. The company is targeting a clinical data update on the darovasertib and crizotinib combination in MUM in 2023, including overall survival (OS) data.

On January 23, 2023 Regen BioPharma, Inc. (OTC PINK: RGBP) and (OTC PINK: RGBPP), a biotechnology company advancing a diverse pre-clinical pipeline spanning cell therapies, RNA vaccines, RNA and DNA therapeutics and small molecule drugs, reported that it will be presenting at the Emerging Growth Conference on January 25, 2023 (View Source) (Press release, Regen BioPharma, JAN 23, 2023, View Source [SID1234626471]).

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This live interactive online event will give existing shareholders and the investment community the opportunity to interact with the Company’s CEO, Dr. David Koos, in real time. Please ask your questions during the event and Dr. Koos and his team will do their best to address as many of them as possible.

"We plan to use this time to update our stakeholders on recent intellectual property and answer shareholder questions," says Dr. David Koos, CEO and Chairman of the Company.

Regen BioPharma, Inc. will be presenting from 3:30 – 3:40 Eastern time on Wednesday, January 25, 2023. Please register here to ensure you are able to attend the conference and receive any updates that are released View Source;tp_key=9111d280ed&sti=rgbp.

If attendees are unable to join the event live on the day of the conference an archived webcast will also be made available on EmergingGrowth.com.

About the Emerging Growth Conference

The Emerging Growth conference is an effective way for public companies to present and communicate their new products, services and other major announcements to the investment community from the convenience of their office, in a time efficient manner.

The Conference focus and coverage includes companies in a wide range of growth sectors, with strong management teams, innovative products & services, focused strategy, execution, and the overall potential for long term growth. Its audience includes potentially tens of thousands of individual and institutional investors, as well as investment advisors and analysts.