On June 3, 2021 Resverlogix Corp. ("Resverlogix") (TSX:RVX) and EVERSANA, the pioneer of next generation commercial services to the global life sciences industry, reported a partnership to support planned commercialization of apabetalone in the United States, Canada (where authorization has been granted to conduct clinical studies of apabetalone for COVID-19) and/or potentially expanding to additional global markets, as Emergency Use Authorization and/or a New Drug Application or equivalent is issued or approved (Press release, EVERSANA, JUN 3, 2021, View Source [SID1234583447]).

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In preparation for launch, Resverlogix will utilize EVERSANA’s fully integrated commercialization services that include market access, agency services, clinical and commercial field teams, medical science liaisons, channel management, patient services, health economics and outcomes research, and compliance, with each service optimized by data and predictive analytics.

Apabetalone is an investigational, phase 3 clinical candidate with safety data in more than 4,200 man years of treatment. As previously published, apabetalone has the potential to combat COVID-19 through a unique dual mechanism. First, apabetalone treatment prevents SARS-CoV-2 from infecting human cells; and second, it reduces the inflammation and cytokine storm response, which can result in organ damage and long-term negative impacts. Apabetalone is also being studied for important benefits for patients with high-risk cardiovascular disease, chronic kidney disease and other indications while maintaining a well-described safety profile.

"With EVERSANA’s integrated commercialization solution, we are poised to swiftly and efficiently deliver apabetalone to patients who desperately need it," said Donald McCaffrey, President and CEO of Resverlogix. "We are proud to be on the front line with the global scientific medical community as we fight the ongoing threat of this and future pandemics."

"We believe in apabetalone’s potential to save the lives of patients still facing the tragic impact of COVID-19 and its numerous growing variants as well as the millions of patients facing multiple diseases that have the potential to be treated by this much-needed therapy," said Jim Lang, Chief Executive Officer of EVERSANA. "Our COMPLETE end-to-end commercialization engine is mobilized and ready to move swiftly in anticipation of authorizations and approvals."

There can be no assurance that regulatory approval will be obtained.

On June 3, 2021 Crown Bioscience (CrownBio), a JSR Life Sciences Company, reported that they have entered into separate, yet complementary, portfolio license agreements with the ATCC and the U.S. Department of Health and Human Services, as represented by the National Cancer Institute (NCI) of the National Institute of Health (NIH) (Press release, Crown Bioscience, JUN 3, 2021, View Source [SID1234583446]). By entering into five-year agreements with these premier biomaterial resource providers, CrownBio clients will directly benefit from a priority status that will make cell lines more readily available with simplified logistics.

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Through its XenoSelect and OmniScreen panels, CrownBio already offers its clients highly customizable, broad in vitro screening panel services, paired with industry-leading bioinformatics capabilities and a breadth of established "matched" downstream in vivo models. CrownBio clients will now have access to an extended and unrivaled portfolio of cell lines, with the knowledge and peace of mind that all necessary licensing is in place.

The license agreement with ATCC grants CrownBio expedited access to more than 140 cell lines and associated datasets, as well as future access to an additional 4000 cell lines through an umbrella licensing structure. Similarly, to meet CrownBio’s ongoing global client needs for supplies of NIH cell lines, a new portfolio license has been signed with the NIH. With this agreement, CrownBio will provide access to 100 cell lines available through the NCI Repository of Tumors and Tumor Cell Lines and other sources, that were developed in NCI labs.

Henry Li, PhD, CSO of CrownBio said, "We greatly value our relationships with both ATCC and NIH, which are two of CrownBio’s largest cell line partners. We are excited that these new agreements will enable us to offer our clients expanded and prioritized cell line availability and supply. Together, these agreements exemplify CrownBio’s dedication to ensuring our clients have easy access to an industry-leading range of in vitro and in vivo models for drug discovery."

On June 3, 2021 Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, reported an update on its pipeline focus following a strategic evaluation of its regenerative medicine platform technology development programs with the goal of focusing on high value orthopedic indications, creating pipeline synergies and maximizing resources in an effort to further drive long-term shareholder value (Press release, Conatus Pharmaceuticals, JUN 3, 2021, View Source [SID1234583445]).

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Development Program Updates

HST 001 – we completed our strategic evaluation of the HST 001 program taking into consideration the results from our Phase 1b/2a clinical trial of HST 001 as announced earlier this year, and as a result, we will suspend development of this program. While HST 001 has demonstrated a favorable safety and tolerability profile in androgenic alopecia in men, the development resources required to potentially achieve an acceptable efficacy threshold are substantial in terms of cost and time. Therefore, we believe the best business decision at this time, is to redirect these resources towards our high value orthopedic programs.
HST 003 – we are on track to initiate our Phase 1/2 clinical study of HST 003 in June 2021. The upcoming study is designed to evaluate the safety and efficacy of human extracellular matrix (hECM) implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure. Patients will be enrolled at three sites: Oasis MD in San Diego, CA, The Steadman Clinic in Vail, CO, and Walter Reed Medical Center in Bethesda, MD.
HST 004 – We recently initiated an investigational new drug application (IND) enabling activities for HST 004, a CCM solution intended to be administered through an intradiscal injection for spinal disc repair. Our initial preclinical research has shown that HST 004 stimulates stem cells from the spinal disc to proliferate and secrete aggrecan and collagen II, regenerate normal matrix and cell tissue structure, and restore disc height. HST 004 was also shown to both reduce inflammation and protease activity and upregulate aggrecan production in an ex vivo spinal disc model. We anticipate filing an IND in the second half of 2022.

Emricasan – In May, we, along with our partner Amerimmune, completed enrollment of the Phase 1 study of emricasan for the treatment of mild-symptomatic COVID-19 patients. A total of 13 patients have been enrolled at our single site in New York City versus the initially targeted 40 patients. The decision to stop enrollment with a lesser number of patients was based solely upon the overall decline in COVID-19 cases in New York City and its negative impact on patient recruitment. To date, there have been no reports of serious adverse events, and we anticipate top-line safety, biomarker and patient reported outcomes data to be available in June 2021.
"Following the completion of our HST 001 Phase 1a/2b study in androgenic alopecia in men in the first quarter of this year, we embarked upon a strategic pipeline evaluation with the goal of determining the optimal value-creating opportunities for our regenerative medicine technology platform," said Richard W. Pascoe, President and Chief Executive Officer. "As a result of our evaluation, we have charted a new course for Histogen with a focus on orthopedic indications that we believe sit at the crossroads of pre-clinical and clinical proof of concept, significant commercial opportunity, and unmet medical needs. Moreover, we believe that by developing products that are therapeutically synergistic, we can be more efficient with our resources and create a strategic pipeline of novel therapeutics that has the potential to create long-term value for the benefit of our shareholders."

On June 3, 2021 Cardinal Health Specialty Solutions reported that Four years after the approval of the first CAR-T cell therapies, oncologists are referring more patients for treatment and becoming more comfortable with the cost (Press release, Cardinal Health, JUN 3, 2021, View Source [SID1234583444]). However, payer approvals and cumbersome administrative processes are still key barriers.

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Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

CAR-T cell therapy uses the body’s own immune system to fight cancer. It works by taking blood from patients and separating out the T cells, then genetically engineering them to produce chimeric antigen receptors (CARs) on their surface, which can target and kill cancer cells. Today, there are five CAR-T products approved in the United States (U.S.) for seven different indications including various lymphomas and multiple myeloma.

The perceptions and current use of CAR-T therapy by oncologists are explored in the latest edition of Oncology Insights, a biannual research-based report series authored by Cardinal Health (NYSE: CAH), analyzing surveys of more than 300 U.S. oncologists. The surveys were conducted between February – April 2021, culminating in the report’s publication today.

"The innovative science behind cell therapies like CAR-T is transforming the long-term outlook for many cancer patients. Our latest research shows that, despite some barriers to access, oncologists are embracing these new therapies and are optimistic about their continued use in the future of oncology care," said Heidi Hunter, President of Cardinal Health Specialty Solutions.

The study finds 60% of participating oncologists say that CAR-T therapy costs are either "reasonable" or "not inappropriate" versus just 39% of respondents in a similar 2017 study1. In addition, 91% of oncologists have referred at least one patient for CAR-T therapy over the past 12 months, up from 54% and 71% in surveys2 conducted in 2019.

In addition to assessing views about CAR-T, the report also explores the continued impact of COVID-19 on oncology and discusses performance in value-based care. These key findings identified:

About two-thirds of participating oncologists report delays in routine cancer screening due to the COVID-19 pandemic;
89% of participants expect to continue using telemedicine after the end of the COVID-19 pandemic; and
Nearly four in 10 participants said it is difficult or very difficult to perform well under value-based care models, and just one in four participating oncologists agree that current technologies support success in value-based care.

On June 3, 2021 Novartis reported that results of the Phase III VISION study evaluating 177Lu-PSMA-617, a targeted radioligand therapy, plus best standard of care (SOC) demonstrated significant improvement in overall survival (OS) compared to SOC alone, in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC)1 (Press release, Novartis, JUN 3, 2021, View Source [SID1234583443]). The difference in OS between study arms was statistically significant (one-sided p<0.001), with an estimated 38% reduction in risk of death in the 177Lu-PSMA-617 arm (n=551) compared to the best standard of care only arm (n=280) (hazard ratio: 0.62 with 95% confidence interval (CI): (0.52, 0.74))1. These results will be presented during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting plenary session on June 6.

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Patients receiving 177Lu-PSMA-617 also demonstrated a statistically significant (one-sided p<0.001) 60% risk reduction for radiographic progression-free survival or death (rPFS), compared to the best standard of care only arm (hazard ratio: 0.40 with 99.2% CI: (0.29 0.57))1. There was a higher rate of drug-related treatment emergent adverse events reported in the 177Lu-PSMA-617 treatment arm (85.3%) compared to standard of care alone (28.8%)1.

Across both arms of the study, rates of treatment discontinuation associated with treatment-emergent adverse events occurred as follows: In the 177Lu-PSMA-617 plus standard of care (SOC) arm, 11.9% of patients discontinued 177Lu-PSMA-617 and 8.5% discontinued SOC; while in the SOC alone arm 7.8% of patients discontinued treatment1.

"Patients suffering from metastatic CRPC who have progressed through contemporary hormonal treatments and chemotherapy have few meaningful therapeutic options," said Michael J. Morris, MD, who chaired the study’s Scientific Committee and is the Prostate Cancer Section Head, Genitourinary Oncology Service, Division of Solid Tumor Oncology at Memorial Sloan Kettering Cancer Center. "The study demonstrated that 177Lu-PSMA-617 improves disease progression and prolongs survival, which are key measures of clinical benefit in the mCRPC population. I am grateful to be a part of this study that may lead to additional therapeutic options for these patients."

"Men with metastatic prostate cancer have an approximately 3 in 10 chance of surviving 5 years2. These data from the first Phase III study of a radioligand therapy in this advanced prostate cancer setting confirm the potential of 177Lu-PSMA-617 targeted therapy to improve clinical outcomes," said John Tsai, Head of Global Drug Development and Chief Medical Officer for Novartis. "Our comprehensive development program for this targeted therapy seeks to reach eligible patients with advanced prostate cancer, who express the PSMA biomarker1,3-6. And, we won’t stop with prostate cancer, our team is exploring next generation RLT across a number of tumor types."

Two additional studies with 177Lu-PSMA-617 radioligand therapy in earlier lines of treatment for metastatic prostate cancer are planned to start in the first half of 2021, investigating potential clinical utility in the mCRPC pre-taxane setting (PSMAfore) and in the metastatic hormone-sensitive setting (PSMAddition).

Additional VISION data
Median OS (95% CI) for the 177Lu-PSMA-617 plus best standard of care arm in the VISION study was 15.3 months (14.2, 16.9), compared to 11.3 months (9.8, 13.5) in the best standard of care arm only1. The median rPFS (99.2% CI) was 8.7 months (7.9, 10.8) for the 177Lu-PSMA-617 arm compared to 3.4 months (2.4, 4.0) for the best standard of care only arm1.

Key secondary endpoints were also met. The median time to first symptomatic skeletal event was 11.5 months (95% CI: 10.3, 13.2) in 177Lu-PSMA-617 arm compared to 6.8 months (95% CI: 5.2, 8.5) in the best standard of care only arm (hazard ratio: 0.50 (95%CI: 0.40, 0.62)); two-sided p-value: <0.0011. Significant differences were also seen in overall response rate in patients with measurable or non-measurable disease at baseline (29.8% partial or complete response in the 177Lu-PSMA-617 arm compared to 1.7% partial response in the best standard of care only arm (two-sided p-value: <0.001)) and disease control rate (89.0% in 177Lu-PSMA-617 arm compared to 66.7% in the best standard of care only arm (two-sided p-value: <0.001))1.

Grade ≥3 drug-related treatment emergent adverse events occurred in 28.4% of the 177Lu-PSMA-617 arm compared to 3.9% in the best standard of care only arm1. The most common treatment emergent adverse events regardless of drug relatedness (above 2% respectively for the 177Lu-PSMA-617 and best standard of care arm) were anemia (12.9% vs. 4.9%), thrombocytopenia (7.9% vs. 1%), lymphopenia (7.8% vs. 0.5%), fatigue (5.9% vs. 1.5%), urinary tract infection (3.8% vs 0.5%), neutropenia (3.4% vs 0.5%), hypertension (3.2% vs 1.5%), back pain (3.2% vs. 3.4%), acute kidney injury (3.0% vs 2.4%), leukopenia (2.5% vs. 0.5%), bone pain (2.5% vs. 2.4%), hematuria (2.5% vs 0.5%), and spinal cord compression (1.3% vs. 5.4%)1.

Serious drug-related treatment emergent adverse events occurred in 9.3% of patients in the 177Lu-PSMA-617 arm compared to 2.4% in the best standard of care only arm1.

Visit View Source for the latest information from Novartis, including our commitment to the Oncology community, and access to our ASCO (Free ASCO Whitepaper)21 Virtual Scientific Program data presentations (for registered participants).

About Advanced Prostate Cancer
Prostate cancer is a form of cancer that develops in the prostate gland, a small walnut shaped gland in the pelvis of men. In castration resistant prostate cancer (CRPC), the tumor shows signs of growth, such as rising Prostate Specific Antigen (PSA) levels, despite the use of hormone treatments that lower testosterone7. In metastatic CRPC (mCRPC), the tumor spreads to other parts of the body, such as neighboring organs or bones and remains unresponsive to hormone treatment7. The five-year survival rate for patients with metastatic prostate cancer is approximately 30%2.

About Phenotypic Precision Medicine in Advanced Prostate Cancer
Despite advances in prostate cancer care, there is a high unmet need for new targeted treatment options to improve outcomes for patients with mCRPC. More than 80% of prostate cancer tumors highly express a phenotypic biomarker6 called Prostate Specific Membrane Antigen (PSMA) 3-5,8-9, making it a promising diagnostic (through positron emission tomography (PET) scan imaging) and potential therapeutic target for radioligand therapy10. This differs from ‘genotypic’ precision medicine which targets specific genetic alterations in cancer cells6.

About 177Lu-PSMA-617
177Lu-PSMA-617 is an investigational PSMA-targeted radioligand therapy for metastatic castration-resistant prostate cancer. It is a type of precision cancer treatment combining a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle)11-13. After administration into the bloodstream, 177Lu-PSMA-617 binds to prostate cancer cells that express PSMA14, a transmembrane protein, with high tumor-to-normal tissue uptake11,15,16. Once bound, emissions from the radioisotope damage tumor cells, disrupting their ability to replicate and/or triggering cell death17-19. The radiation from the radioisotope works over very short distances to limit damage to surrounding cells10,11,15.

About VISION
VISION is an international, prospective, randomized, open-label, multicenter, phase III study to assess the efficacy and safety of 177Lu-PSMA-617 (7.4 GBq administered by intravenous infusion every 6 weeks for a maximum of 6 cycles) plus investigator-chosen best standard of care in the investigational arm, versus best standard of care in the control arm20. Patients with PSMA PET-scan positive mCRPC, and progression after prior taxane and androgen receptor pathway inhibitors, were randomized in a 2:1 ratio in favor of the investigational arm20. The alternate primary endpoints were rPFS and OS20. The study enrolled 831 patients1.