On February 13, 2023 Angiocrine Bioscience, Inc., a clinical-stage biopharmaceutical company, reported that it has been selected by the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) for a poster presentation on its Phase 3 registration study AB-205-301 (E- CELERATE), a multi-center, randomized, double-blind, placebo-controlled study of AB-205 in adults with lymphoma undergoing high-dose chemotherapy (HDT) and autologous hematopoietic cell transplantation (AHCT) (Press release, Angiocrine Bioscience, FEB 13, 2023, View Source;cellular-therapy-meetings-of-astct-and-cibmtr-301743676.html [SID1234627135]). AB-205 is an intravenous investigational engineered cell therapy product being developed for multiple indications.

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"Our investigators and Angiocrine are honored to be selected by ASTCT & CIBMTR to present at its annual meeting this February," commented Paul Finnegan, MD, Angiocrine CEO. "We look forward to Dr. Michael Scordo’s presentation on the trial design of our AB-205 Phase 3 multi-center study (E-CELERATE)." E-CELERATE has been designed to evaluate the efficacy and safety of AB-205 as a treatment for damaged organ stem cell vascular niches caused by off-target cytotoxicity of HDT and prevent the progression of severe multi-organ complications, which can be life threatening and prolong hospitalization. The US Food and Drug Administration has conferred special regulatory status to AB-205 via the Regenerative Medicine Advanced Therapy and Orphan Drug designations for this indication. Additionally, the California Institute for Regenerative Medicine (CIRM) has approved investing $15M in this Phase 3 registration study.

Tandem Meetings Info

Poster Session: Acute Regimen-Related Toxicity and Supportive Care
Session Date: Thursday, February 16, 2023
Session Time: 5:45 PM – 6:45 PM EST
Poster Number: 184
Poster Title: A Phase 3 Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of AB-205 Plus Standard of Care (SOC) Versus Placebo Plus SOC in Adults with Lymphoma Undergoing High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (E–CELERATE; NCT05181540): Trial in Progress

About AB-205

AB-205 is an experimental engineered cell therapy consisting of allogeneic E4ORF1+ human umbilical vein endothelial cells (E-CEL cells). AB-205 is currently being studied in a single, pivotal Phase 3 registration trial, designed to evaluate the efficacy and safety of AB-205 in the treatment of severe multi-organ complications related to systemic, diffuse injury to the stem cell vascular niches of multiple organs sustained during high-dose chemotherapy. More information about the E-CELERATE trial and participating sites may be found at the National Institute of Health’s ClinicalTrials.gov website – NCT05181540.

About Severe Toxicities and Complications during High-Dose Chemotherapy (HDT) and Autologous Hematopoietic Cell Transplant (AHCT)

HDT followed by AHCT is a curative treatment option for eligible patients with aggressive systemic lymphoma. Although highly effective in eradicating aggressive cancer cells, HDT also causes collateral damage to healthy tissue. The initial damage can quickly progress to serious and expensive complications despite state-of-the-art prophylactic measures. Most frequent complications involve the gastrointestinal and immune systems (low blood counts, infections); vital organ involvement can be life-threatening and prolong hospital stay.

About the California Institute for Regenerative Medicine (CIRM)

CIRM was created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission.

To meet this challenge, CIRM’s team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies.

With $5.5 billion in funding and more than 150 active stem cell programs in its portfolio, CIRM is one of the world’s largest institutions dedicated to helping people by bringing the future of cellular medicine closer to reality.

For more information go to www.cirm.ca.gov.

On February 13, 2023 Cleveland Diagnostics, Inc., a commercial-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, reported an agreement designed to expand patient access to Cleveland Diagnostics’ novel prostate cancer test, IsoPSA (Press release, Cleveland Diagnostics, FEB 13, 2023, View Source [SID1234627133]).

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Through an agreement with Quest Diagnostics (NYSE: DGX), the nation’s leading provider of diagnostic information services, patients will be able to access IsoPSA and, once ordered by their physician, provide a blood specimen for testing at one of over 2,100 Quest Diagnostics patient service center locations nationwide later this year. With its national logistics network, Quest will transport the specimens to Cleveland Diagnostics’ laboratory for testing. The parties expect physicians will be able to begin offering the test to patients through Quest Diagnostics in the second quarter of 2023.

IsoPSA is a blood-based prostate cancer test used in triaging patients at risk for high-grade prostate cancer to biopsy. For patients with elevated levels of prostate-specific antigen (PSA), IsoPSA provides additional insight into whether patients’ elevated PSA levels are due to high-grade cancer or a different condition, thereby empowering physicians and patients with insights for deciding whether to undergo prostate biopsy.

PSA is a protein produced by cells of the prostate gland. While the PSA test measures the level of PSA in the blood, which is often elevated in people with prostate cancer, several benign conditions can also cause a person’s PSA level to rise.1 Moreover, PSA testing is unable to identify cases of prostate cancer that may be rapidly progressing and therefore require urgent treatment. By comparison, the IsoPSA test helps predict risk by interrogating the partitioning behavior of isoforms of PSA that are linked to cancer. In a large, prospective, multi-center clinical study, the IsoPSA test demonstrated significant improvement in detecting high grade prostate cancer.2 A separate and robust clinical utility study confirmed that IsoPSA could reduce unnecessary biopsies by as much as 55%.3

"We are very pleased to collaborate with Quest Diagnostics to expand patient access to IsoPSA. We believe Quest’s broad reach and extensive laboratory services expertise will provide patients and their physicians with unparalleled access to transformative clinical insights," said Arnon Chait, CEO of Cleveland Diagnostics. "As the leader in oncology testing, Quest is aligned with Cleveland Diagnostics’ vision of providing physicians and their patients exceptional and more definitive understanding of their prostate conditions."

"Prostate cancer is a leading cause of cancer – and cancer deaths – among men, and physicians are eager for improved tools to diagnose, stage and monitor this disease," said Kristie Dolan, vice president and general manager of Oncology at Quest Diagnostics. "We believe IsoPSA holds great promise to better inform physicians’ diagnostic and treatment decisions for their patients being evaluated for prostate cancer, and we are pleased to work with Cleveland Diagnostics to expand access to this important new test, ultimately bettering patient outcomes by improving the diagnostic process."

According to the American Cancer Society, prostate cancer increased by 3% per year from 2014 through 2019 after two decades of decline, driven primarily by the diagnosis of advanced disease.4 A recent Quest Diagnostics Health Trends study suggests this trend could continue or even worsen: two years after the COVID-19 pandemic began, the rate of new diagnoses of prostate cancer continued to lag behind pre-pandemic levels, suggesting delays in care may contribute to more advanced prostate cancers in the future.

About IsoPSA

IsoPSA is a non-invasive, blood-based test that demonstrated in a large, multicenter study superior diagnostic accuracy compared to prostate-specific antigen (PSA), the current standard of care in prostate cancer diagnosis. Cleveland Diagnostics currently offers IsoPSA as a laboratory-developed test conducted at its high-complexity, CLIA-certified, CAP-accredited laboratory in Cleveland, Ohio. For the time being, tests ordered through the Quest network will be processed in Cleveland Diagnostics’ laboratory in Cleveland, OH.

On February 13, 2023 Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has cleared Gracell’s Investigational New Drug (IND) application for GC012F, an autologous CAR-T therapeutic candidate, for the treatment of relapsed/refractory multiple myeloma (RRMM) (Press release, Gracell Biotechnologies, FEB 13, 2023, View Source [SID1234627132]).

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Gracell plans to initiate a Phase 1/2, single-arm, open-label, multi-center trial in China in the third quarter of 2023 to further evaluate GC012F in RRMM patients. Following the U.S. FDA’s clearance of Gracell’s IND application announced on Feb. 3, Gracell also plans to initiate a Phase 1b/2 clinical trial in the U.S. in the second quarter of 2023.

GC012F is an autologous CAR-T therapeutic candidate dual-targeting B cell maturation antigen (BCMA) and CD19, and utilizes Gracell’s proprietary FasTCAR next-day manufacturing platform. In November 2021, the FDA granted GC012F Orphan Drug Designation for the treatment of multiple myeloma. GC012F is currently being studied in multiple investigator-initiated trials (IIT) evaluating its safety and efficacy in RRMM, newly-diagnosed multiple myeloma, and B-cell non-Hodgkin’s lymphoma (B-NHL). At the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress, Gracell presented longer-term follow-up clinical data of GC012F in RRMM that showed a 100% minimal residual disease (MRD) negativity rate in all patients treated.

"This milestone marks successful regulatory clearances to commence key clinical trials for Gracell’s lead asset, GC012F, in both China and the United States," said Dr. William (Wei) Cao, founder, Chairman, and CEO of Gracell. "We believe GC012F has vast potential to meaningfully improve cancer care, including the faster delivery to patients enabled by Gracell’s FasTCAR next-day manufacturing and a novel approach of BCMA and CD19 dual-targeting in multiple indications. Gracell is committed to developing innovative cell therapies to transform patients’ lives, and we look forward to launching the Phase 1/2 IND trial in China to further study GC012F."

About GC012F

GC012F is a FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T product candidate that is currently being evaluated in IIT studies in China for the treatment of multiple myeloma and B-cell non-Hodgkin’s lymphoma. GC012F simultaneously targets CD19 and BCMA to drive fast, deep and durable responses, which can potentially improve efficacy and reduce relapse in multiple myeloma and B-NHL patients.

About FasTCAR

CAR-T cells manufactured on Gracell’s proprietary FasTCAR platform appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next-day manufacturing, FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, and, together with fast release time, enables enhanced accessibility of cell therapies for cancer patients.

On February 13, 2023 Caris Life Sciences(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, reported that the company and partners within the Caris Precision Oncology Alliance (POA) will collectively present five studies across three tumor types at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium, February 16-18, 2023 in San Francisco (Tabletop #50) (Press release, Caris Life Sciences, FEB 13, 2023, View Source [SID1234627130]).

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"We are proud of the growing number of collaborative abstracts accepted for presentation at ASCO (Free ASCO Whitepaper) GU, demonstrating the power of Caris’ comprehensive molecular profiling and the large-scale collaboration between POA sites," said Chadi Nabhan, M.D., MBA, FACP, Chairman of the Caris Precision Oncology Alliance. "The findings represent important observations in prostate, urothelial, and renal cancers, which could lead to novel treatment strategies and knowledge that improve patient outcomes."

"At Caris, our goal is to enable clinicians to make the best treatment choices for their patients, researchers to discover new targets, and the biopharmaceutical industry to develop the next breakthrough medicines," said David Spetzler, M.S., Ph.D., MBA, President and Chief Scientific Officer of Caris. "These presentations show how our physicians, scientists and partners in the POA are leveraging real-world clinical evidence from over 455,000 lifetime cases in Caris’ unique AI-driven platform to deepen our understanding of cancer. These foundational discoveries provide key insights into advanced cancer and support the development of precision oncology approaches in advanced genitourinary tumors to better serve cancer patients."

Poster presentations include:

Clinical and Molecular Features of ATM and BRCA2 Mutations in Metastatic Prostate Cancer. (Poster Number: J8)
February 16, 11:30 AM – 1:00 PM PST
The Genomic Landscape of Urothelial Carcinoma with High and Low ERBB2/HER2 Expression. (Poster Number: M18)
February 17, 12:30 – 2:00 PM PST
Characterization and Impact of Wnt5A Signaling on Outcomes of Urothelial Carcinoma. (Poster Number: N3)
February 17, 12:30 – 2:00 PM PST
Exploration of Immunosuppressive Features of the Tumor Microenvironment within Hepatic and Non-Hepatic Tumors of Urothelial Origin. (Poster Number: N5)
February 17, 12:30 – 2:00 PM PST
Characterization of FOLH1 Expression in Renal Cell Carcinoma (RCC). (Poster Number: K8)
February 18, 7:00 – 8:00 AM PST
Poster and abstract summaries highlighting this research will be available onsite at Caris’ Tabletop #50. The full abstracts will be available through the official ASCO (Free ASCO Whitepaper) website February 13.

The Caris Precision Oncology Alliance includes 77 cancer centers and academic institutions in the United States and beyond. These institutions have early access to the extensive database and artificial intelligence platform within Caris to establish evidence-based standards for cancer profiling and molecular testing in oncology. By leveraging the comprehensive genomic, transcriptomic and proteomic data available through Caris molecular profiling, Caris seeks to provide this network with the ability to prioritize therapeutic options and determine which clinical trial opportunities may benefit their patients. POA members are also able to integrate with a growing portfolio of biomarker directed trials sponsored by biopharma. Additionally, as a member of the POA, institutions have access to Caris CODEai, the most comprehensive data solution in the industry with cancer treatment information and real-world clinical outcomes evidence for over 350,000 patients covering over 1 million data points per patient.

On February 13, 2023 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported that further analyses of initial clinical data from two Phase 1 studies of EPI-7386 in patients with metastatic castration-resistant prostate cancer ("mCRPC") will be presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium ("ASCO GU"), taking place February 16-19, 2023, in San Francisco, California and online (Press release, ESSA, FEB 13, 2023, View Source [SID1234627129]). EPI-7386 is a first-in-class N-terminal domain androgen receptor ("AR") inhibitor that suppresses androgen activity through a novel mechanism of action. The two poster presentations are available on the ASCO (Free ASCO Whitepaper) GU Digital Program and the "Publications" section of the Company’s website at www.essapharma.com.

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"We are encouraged that EPI-7386 has continued to be well-tolerated and safe as well as demonstrate initial anti-tumor activity both as a monotherapy and in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer," said David Parkinson, MD, President and CEO of ESSA. "Although the clinical data is still in the early stages, with longer follow-up we observe that EPI-7386 in combination with enzalutamide continues to show deep and sustained prostate-specific antigen ("PSA") declines, which may indicate the potential for long-term treatment benefits. We look forward to further exploring the potential clinical benefit of EPI-7386 in combination with enzalutamide as we look to enroll patients in the final cohort of the dose escalation study and prepare to enroll approximately 120 patients in the randomized Phase 2 study at clinical sites across the U.S., Canada, and Australia."

Presentation Details:
Abstract #179
Title: Phase 1/2 Study of EPI-7386 in Combination with Enzalutamide (Enz) Compared with Enz Alone in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Presenting Author: Andrew Leonard Laccetti, MD, MS, Memorial Sloan Kettering Cancer Center
Format: Poster

The Phase 1/2 multicenter, open-label clinical trial is enrolling mCRPC patients on androgen deprivation therapy who are naïve to second-generation antiandrogens but may have been treated previously with one line of prior chemotherapy in the metastatic hormone-sensitive prostate cancer setting. The current presentation of data is an update on the first two cohorts of patients which was previously presented at the Prostate Cancer Foundation Scientific Retreat in October 2022. In this update, EPI-7386 in combination with enzalutamide continues to be safe and well-tolerated at the doses tested with clinically relevant drug exposures of both enzalutamide and EPI-7386 with deep and durable PSA reductions continuing through 13 cycles of dosing in some patients. Five of six evaluable patients achieved a PSA90 (≥90% decline in PSA) during the study with these PSA responses being maintained or further deepening during the course of the study. These rapid and deep PSA declines occurred both in patients who have and have not received prior chemotherapy. A further analysis shows that four of six evaluable patients’ PSA levels reached <0.2 ng/mL, one of the most stringent measures of PSA decline.

Abstract #177
Title: Oral EPI-7386 in Patients with Metastatic Castration-Resistant Prostate Cancer
Presenting Author: Russell Kent Pachynski, MD, Washington University School of Medicine
Format: Poster

The data reported are from 45 heavily pretreated mCRPC patients from both the phase 1a and 1b patient populations. Updated results of EPI-7386 as a monotherapy demonstrate that EPI-7386 continues to be safe and well-tolerated with clinically relevant drug exposures reached at all dose levels tested. Similar to what was reported previously at the Prostate Cancer Foundation Scientific Retreat in October 2022, clinically important signals of anti-tumor activity of EPI-7386 were observed in a subset of these patients (those with less than 3 lines of treatment for mCRPC, lack of visceral disease, no prior chemotherapy and lack or few non-AR mutations).

Part 1b of the study is open with enrollment focused on pre-chemotherapy, post-second-generation antiandrogen treated mCRPC patients in one cohort, and treatment-naïve non-mCRPC patients in a window of opportunity proof-of-concept second cohort. Two doses will be evaluated based on FDA Project Optimus recommendations.

About EPI-7386
EPI-7386 is an investigational, highly-selective, oral, small molecule inhibitor of the N-terminal domain of the androgen receptor. EPI-7386 is currently being studied in a Phase 1 clinical trial (NCT04421222) in men with CRPC whose tumors have progressed on standard-of-care therapies. The U.S. FDA has granted Fast Track designation to EPI-7386 for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA is also conducting a Phase 1/2 clinical trial (NCT05075577) of EPI-7386 in combination with enzalutamide in metastatic CRPC patients who have not yet been treated with second-generation antiandrogen therapies. ESSA retains all rights to EPI-7386 worldwide.