On January 30, 2020 Bayer reported that results from the preplanned final overall survival analysis of the Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated NUBEQA (darolutamide) in men with non-metastatic castration-resistant prostate cancer (nmCRPC) show a significant improvement in overall survival (OS) in patients receiving NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT (Press release, Bayer, JAN 30, 2020, View Source [SID1234553712]). Results of ARAMIS previously published show a statistically significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) of darolutamide plus ADT compared to placebo plus ADT; however OS data were not yet mature at the time of the MFS analysis. Detailed data on the updated OS and other additional endpoints as well as an update on longer term safety will be presented at an upcoming scientific meeting.

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NUBEQA, an oral androgen receptor inhibitor (ARi), has been approved in the U.S., Brazil, and Japan, and filings in the European Union and other regions are underway or planned. The compound is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

About NUBEQA (darolutamide)

On July 30th, 2019, the FDA approved NUBEQA (darolutamide) based on the ARAMIS trial, a randomized, double-blind, placebo-controlled, multi-center Phase III study, which evaluated the safety and efficacy of oral NUBEQA in patients with nmCRPC who were receiving a concomitant gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of NUBEQA orally twice daily or placebo plus ADT. The primary efficacy endpoint was MFS, defined as the time from randomization to the time of first evidence of blinded independent central review (BICR)-confirmed distant metastasis or death due to any cause within 33 weeks after the last evaluable scan, whichever occurred first. NUBEQA plus ADT demonstrated a statistically significant improvement in MFS, with a median MFS of 40.4 months versus 18.4 months with placebo plus ADT [HR=0.41, 95% CI (0.34, 0.50), p<0.0001].

Adverse reactions occurring more frequently in the NUBEQA arm (≥2 % over placebo) were fatigue (16% versus 11%), pain in extremity (6% versus 3%) and rash (3% versus 1%). NUBEQA was not studied in women and there is a warning and precaution for embryo-fetal toxicity.

NUBEQA is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.1 A Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS) is ongoing. Information about this trial can be found at www.clinicaltrials.gov.

INDICATION

NUBEQA is approved for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).1

IMPORTANT SAFETY INFORMATION

Embryo-Fetal Toxicity: Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions

Adverse reactions occurring more frequently in the NUBEQA arm (≥2% over placebo) were fatigue (16% vs. 11%), pain in extremity (6% vs. 3%) and rash (3% vs. 1%).

Serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥ 1 % of patients who received NUBEQA were urinary retention, pneumonia, and hematuria. Overall, 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo died from adverse reactions, which included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%) for NUBEQA.

Clinically significant adverse reactions occurring in ≥ 2% of patients treated with NUBEQA included ischemic heart disease (4.0% vs. 3.4% on placebo) and heart failure (2.1% vs. 0.9% on placebo).

Drug Interactions

Effect of Other Drugs on NUBEQA – Concomitant use of NUBEQA with a combined P-gp and strong or moderate CYP3A4 inducer decreases darolutamide exposure, which may decrease NUBEQA activity. Avoid concomitant use of NUBEQA with combined P-gp and strong or moderate CYP3A4 inducers.

Concomitant use of NUBEQA with a combined P-gp and strong CYP3A4 inhibitor increases darolutamide exposure, which may increase the risk of NUBEQA adverse reactions. Monitor patients more frequently for NUBEQA adverse reactions and modify NUBEQA dosage as needed.

Effects of NUBEQA on Other Drugs – NUBEQA is an inhibitor of breast cancer resistance protein (BCRP) transporter. Concomitant use of NUBEQA increases the exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use with drugs that are BCRP substrates where possible. If used together, monitor patients more frequently for adverse reactions, and consider dose reduction of the BCRP substrate drug. Consult the approved product labeling of the BCRP substrate when used concomitantly with NUBEQA.

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

On January 30, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported the following upcoming presentations at medical meetings (Press release, Advaxis, JAN 30, 2020, View Source [SID1234553711]):

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ASCO – Genitourinary Cancers Symposium February 12-15, 2020, San Francisco, California
Title: "KEYNOTE-046 (Part B): Effects of ADXS-PSA in combination with pembrolizumab
on survival in metastatic, castration-resistant prostate cancer patients with or without
prior exposure to docetaxel"
Presenter: Dr. Mark N. Stein, Associate Professor, Division of Hematology/Oncology, Columbia University Medical Center
Abstract: 126, Poster number F6
Date: Thursday, February 13, 2020
Time: 11:30AM – 1:00 PM, 5:30PM – 6:30 PM PT

IASLC 2020 Targeted Therapies of Lung Cancer Meeting February 19-22, 2020, Santa Monica, California
Session: Immunotherapy Combinations
Title: A Phase 1 Study of ADXS-503 Alone and in Combination with Pembrolizumab in
Subjects with Metastatic Squamous or Non-Squamous Non-Small Cell Lung Cancer
Presenter: Dr. Jennifer Carlisle, Assistant Professor, Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University
Date: Saturday, February 22, 2020
Time: 7:00 am PT

Immuno-oncology 360° February 26-28, 2020, New York, New York
Session: IO Novel Technologies
Title: "Clinical Updates for Advaxis’ Pipeline of Lm-based Immunotherapies in
Oncology"
Presenter: Andres A. Gutierrez MD PhD – Advaxis’ Chief Medical Officer and Executive Vice President
Date: Thursday, February 27, 2020
Time: 11:00 am ET

On January 30, 2020 Acceleron Pharma Inc. (Nasdaq:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, reported that John Quisel, J.D., Ph.D, Executive Vice President and Chief Business Officer, is leaving the Company to become Chief Executive Officer of a venture-backed startup biotechnology company (Press release, Acceleron Pharma, JAN 30, 2020, View Source [SID1234553709]). Dr. Quisel’s departure from Acceleron is effective as of February 24.

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"John has been a valued colleague and trusted leader at Acceleron, contributing meaningfully to the Company’s growth and success," said Habib Dable, President and Chief Executive Officer of Acceleron. "During his nearly 14 years here, John has lent his scientific, business, and legal acumen to many important corporate initiatives. I’ve personally enjoyed working alongside him and am delighted for him to take this next natural step in his career."

Dr. Quisel joined Acceleron in 2006 and has held a variety of roles spanning legal, intellectual property, business development and corporate strategy. During his time with the organization, he supported venture capital financings, the company’s 2013 initial public offering, subsequent public offerings, and a range of collaboration and licensing agreements, including Acceleron’s longstanding development and commercialization agreements with Celgene Corp., now Bristol-Myers Squibb.

"I’m enormously grateful for my time at Acceleron and proud of all that we accomplished throughout the years," said Dr. Quisel. "Although my decision to depart was a difficult one, the opportunity to lead another organization on what I believe will be a similarly successful path was too enticing to ignore. I leave Acceleron with cherished memories and the knowledge that the Company is on the right track, steered by a talented leadership team."

On January 30, 2020 Mammoth Biosciences, the company behind the world’s first CRISPR-based disease detection platform, reported an oversubscribed round of $45 million in its Series B (Press release, Mammoth Biosciences, JAN 30, 2020, webwire.com/ViewPressRel.asp?aId=254210 [SID1234553708]). The raise is led by Decheng Capital and has participation from Mayfield, NFX, Verily, Brook Byers, Plum Alley, Pacific 8, aMoon, and others. The capital will fuel the company’s further development of CRISPR diagnostics and next-generation CRISPR products as it extends its platform to include gene-editing and therapeutics as well. Mammoth is also exploring deep partnerships with biotech and pharmaceutical companies to leverage the Mammoth CRISPR platform to transform healthcare and deliver benefits to patients.

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CRISPR holds enormous promise for treating disease, with clinical trials for Cas9 already underway — a crucial step in bringing CRISPR out of the lab and into everyday life. But while this enzyme has shown first signs of success in the ex-vivo setting, challenges remain for in vivo applications, limiting the broad use of Cas9 for a wide field of diseases. Further, Cas9 cannot be used for CRISPR-based diagnostics, an emerging and ground-breaking application for Cas systems.

Mammoth is uniquely positioned to overcome these obstacles with its extensive portfolio of novel Cas systems that serve as a toolbox for applications in diagnostics, gene-editing, and therapeutics. The $45 million Series B will fuel the development of the CRISPR platform with a particular focus on the Mammoth-discovered and characterized Cas14. Cas14 is a unique enzyme that opens up new possibilities due to its extremely small size, diverse targeting ability and high-fidelity. These properties will enable Mammoth to achieve next-generation editing with a broader target range for both ex-vivo and in-vivo applications and is a foundation for enabling advanced CRISPR modalities such as targeted gene regulation, precision editing, and beyond.

Recently, industry veterans including Peter Nell, previously a co-founder of Casebia (a joint venture between Bayer and CRISPR Therapeutics) and Ted Tisch, previously an executive at Synthego and Bio-Rad, have joined the company to accelerate its growth as Chief Business Officer and Chief Operating Officer, respectively. Grail co-founder and previous Illumina board member Jeff Huber has joined the company’s board as an independent director and the Dean of the Stanford University School of Medicine, Lloyd Minor, has joined the Mammoth advisory board.

"As a team on the frontlines of discovery in CRISPR, we’ve seen firsthand the need for new tools to deliver on the therapeutic and diagnostic promise that this technology has to offer," explained Trevor Martin, CEO and Co-founder of Mammoth Biosciences. "In powering new products in addition to diagnostics, we’re enabling the full potential of our platform to read and write the code of life and to fully transform how we interact with biology."

Beyond Mammoth’s own initiative to develop the next generation of CRISPR products for gene-editing and therapeutics, the company has already seen significant traction in enabling access to its robust and expansive CRISPR IP. As a testament to its proprietary data and powerful CRISPR platform, Mammoth has partnered with Horizon Discovery, a global leader in bioproduction to develop best in class CRISPR tools for CHO cell line editing.

"One of our missions is to identify and develop the next wave of innovative healthcare companies and support them through investment and inclusion in our Partner’s Space program on Verily’s campus. Mammoth is clearly one of these companies, driving the next-generation of CRISPR products that researchers at the forefront of gene-editing and diagnostics truly need," remarked Andrew Harrison, head of business and corporate development at Verily. "With an experienced leadership team and the guidance of CRISPR pioneer Jennifer Doudna, Mammoth is well-positioned to close the gap between the discovery of new CRISPR systems and their application in diagnostics and therapeutics."

Mammoth is currently evaluating partnerships with companies adding complementary skills to leverage these new proteins in gene editing, therapeutic, and diagnostic applications to deliver on the promise of this groundbreaking CRISPR technology. For more information visit View Source

On January 30, 2020 Black Diamond Therapeutics reported unveiled technology that analyzes genetic data to discover new cancer drugs (Press release, Xconomy, JAN 30, 2020, View Source [SID1234553707]). The company has $201 million from an IPO to advance the development of drugs stemming from that technology.

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Black Diamond priced its IPO late Wednesday, selling 10.5 million shares for $19 apiece. That tops the company’s earlier target of 8.9 million shares in the range of $16 to $18 each. Those shares are expected to begin trading Thursday on the Nasdaq exchange under the stock symbol "BDTX."

Black Diamond’s technology, called Mutation Allostery Pharmacology (MAP), analyzes population-level genetic sequencing data in order to find mutations that drive cancer growth. These mutations are grouped into families, the company says in its IPO filing. Black Diamond aims to treat cancer, regardless of the type of tumor, by targeting specific families of mutations with small molecule drugs.

Lead Black Diamond drug BDTX-189 was designed to target the ErbB family of enzymes, specifically mutations in two proteins from this family: EGFR and HER2. These mutations are prevalent in breast, bladder, endometrial, gastric and colon cancers, as well as non-small cell lung cancer. In animal tests, Black Diamond reported that the drug stopped tumors from growing and also shrank them. The company expects to start a Phase 1/2 study testing BDTX-189 in the first half of this year.

Black Diamond’s pipeline also includes a preclinical drug in development for glioblastoma, an aggressive cancer affecting the brain or spinal cord. The company says in the filing that it is completing preclinical work on glioblastoma candidate leads and expects to select a candidate later this year.

The new IPO cash will be deployed across Black Diamond’s programs. According to the filing, $50 million is earmarked for completing the Phase 1 portion of the BDTX-189 Phase 1/2 study. Another $20 million is set aside for the glioblastoma program. Black Diamond plans to spend $25 million more to continue its drug discovery work.

Black Diamond was founded in 2014 by David Epstein and Elizabeth Buck. Three years later, they began working with venture capital firm Versant Ventures to develop the technology underpinning the company, according to the filing. Black Diamond was incubated in a drug discovery unit established by Versant before unveiling its technology in late 2018. Last January, the company closed an $85 million Series B round of financing. Prior to the IPO, Versant was Black Diamond’s largest shareholder, owning a 42 percent stake in the company, the IPO filing shows.