On April 28, 2020 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported financial results for the three months ended March 31, 2020 (Press release, Odonate Therapeutics, APR 28, 2020, View Source;2020-aee1c48c-90a1-4e1f-bc46-c7bb2ab697ed [SID1234556702]).

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As of March 31, 2020, Odonate had $153.1 million in cash, compared to $180.5 million as of December 31, 2019. Net cash used in operating activities for the three months ended March 31, 2020 was $27.8 million, compared to $27.1 million for the same period in 2019. Odonate’s net loss for the three months ended March 31, 2020 was $30.2 million, or $0.99 per share, compared to $28.6 million, or $1.16 per share, for the same period in 2019.

"We continue to expect to report top-line results from CONTESSA, Odonate’s Phase 3 study investigating tesetaxel, an investigational, orally administered chemotherapy, as a potential treatment for patients with metastatic breast cancer, in the third quarter of 2020," said Kevin Tang, Chief Executive Officer of Odonate.

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. Tesetaxel currently is the subject of three studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with metastatic breast cancer, known as CONTESSA.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 600 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients with central nervous system (CNS) metastases are eligible. The primary endpoint is progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC.

About CONTESSA 2

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA 2 is investigating tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 125 patients with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC not previously treated with a taxane. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients with central nervous system (CNS) metastases are eligible. The primary endpoint is objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are duration of response (DoR) as assessed by the IRC, progression-free survival (PFS) as assessed by the IRC, disease control rate (DCR) as assessed by the IRC and overall survival (OS).

About CONTESSA TRIO

CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). In Cohort 1, approximately 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus either: (1) nivolumab at 360 mg by intravenous infusion on the first day of each 21-day cycle; (2) pembrolizumab at 200 mg by intravenous infusion on the first day of each 21-day cycle; or (3) atezolizumab at 1,200 mg by intravenous infusion on the first day of each 21-day cycle. Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are immuno-oncology (IO) agents approved for the treatment of multiple types of cancer. One of these agents, atezolizumab, in combination with the intravenously delivered taxane, nab-paclitaxel, was recently approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with metastatic TNBC. The dual primary endpoints for Cohort 1 are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include duration of response (DoR) and overall survival (OS). Efficacy results for each of the three PD-(L)1 inhibitor combinations will be assessed for correlation with the results of each of the three approved PD-L1 diagnostic assays. In Cohort 2, approximately 40 elderly patients (with potential expansion to up to 60 patients) with human epidermal growth factor receptor 2 (HER2) negative MBC will receive tesetaxel monotherapy dosed orally at 27 mg/m2 on the first day of each 21-day cycle. The primary endpoint for Cohort 2 is ORR. Secondary endpoints include PFS, DoR and OS. Patients with central nervous system (CNS) metastases are eligible for both cohorts.

On April 28, 2020 BioEclipse Therapeutics (BioEclipse), a private clinical-stage biopharmaceutical company developing first-in-class, curative immuno-oncology therapeutics, reported that the U.S. Food and Drug Administration has cleared the Investigational New Drug (IND) application for the Company’s lead drug candidate, CRX100 (Press release, BioEclipse Therapeutics, APR 28, 2020, View Source [SID1234556722]). This multi-mechanistic cancer immunotherapy is delivered intravenously to target and destroy multiple cancer types and to prevent disease recurrence. BioEclipse plans to initiate a Phase 1 clinical trial of its patented CRX100 in therapy-refractory solid tumors in 2020.

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Pamela Contag, Ph.D., founder and CEO of BioEclipse, stated, "Our first IND clearance represents a significant milestone for BioEclipse, and validates the groundbreaking potential of our cancer immunotherapy, CRX100. This first-in-class immunotherapy may conquer the challenges of resistant and recurrent cancers by both killing primary tumors and metastatic disease along with the generation of a durable immune response against the patient’s tumor. With funds raised in the Series A-1 financing, we plan to initiate the first clinical trial of CRX100 and take further steps to achieve our mission to bring a new generation of targeted therapies to cancer patients with few treatment options."

Dr. Contag continued, "These are exciting times for our team and our company. However, as we prepare to advance CRX100 into the clinic, we must acknowledge that we do so amid extraordinary circumstances with the COVID-19 outbreak placing immense pressure on our healthcare system. As we move ahead with the CRX100 clinical trial, the safety and well-being of the patients, and their families, as well as the medical personnel administering the trial is paramount."

CRX100 was developed with technology exclusively licensed from Stanford University, and has the potential to provide a curative therapy to patients with hard-to-treat malignancies that span a broad range of both solid and liquid tumors. The drug combines activated immune cells with a tumor selective oncolytic virus. When used separately in patients, these two approaches display limited efficacy as cancer therapies, as described by previous clinical research. By combining these two approaches, CRX100 is designed so the immune cells carry the virus to the cancer cells and then the two work synergistically to eradicate the tumors. An additional element of the combination CRX100 therapy is mediation of an immune response against the patient’s tumor cells that can potentially limit the growth of new disease.

The BioEclipse activated immune cells preinfected with a selective oncolytic virus have been studied extensively in animal models using mice across several cancer indications, including ovarian, breast, prostate, Non-Hodgkin’s Lymphoma, hepatocellular carcinoma, colon, glioblastoma, neuroblastoma and lung. Data from these nonclinical studies demonstrate that the therapy appears to work in both solid and liquid tumors, and that a long-term immune response was generated against even hard-to-kill metastatic cancers.

"We have an urgent need for more effective treatments especially for patients with disease refractory to standard treatments," said Oliver Dorigo, M.D., Ph.D., Director of Gynecologic Oncology at Stanford University Medical Center. "CRX100 has the potential to be effective not only in women with ovarian cancer, but in many other tumor types with an otherwise poor prognosis. This new immunotherapy is based on meticulous scientific studies and brings new hope to our patients and their families."

The planned open-label Phase 1 dose-escalation study is designed to determine the safety, tolerability and pharmacokinetic (PK) properties of CRX100 in adult subjects with solid tumors that are relapsed, refractory or intolerant to standard care, or refusing standard therapies. The study may include patients with multiple cancer types and can enroll up to 24 patients. The study’s primary endpoint will measure the frequency of treatment-emergent adverse events and dose-limiting toxicities in each subject following dose administration. More information on the study can be accessed at www.clinicaltrials.gov (NCT04282044).

BioEclipse will collaborate with Spannerwerks, LLC, a professional services firm focused on assisting biopharmaceutical companies with the development and launch of new products, to prepare for the upcoming Phase 1 clinical trial for CRX100. The firm worked with BioEclipse to complete the IND filing for CRX100.

"CRX100 is an important step forward in cancer immunotherapy and we are proud to work with BioEclipse as it advances this technology out of the laboratory and into the clinic," said Dara Lockert, Executive Director of Spannerwerks.

On April 28, 2020 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported that it will host a conference call and webcast in conjunction with its first quarter 2020 update and financial results on Tuesday, May 5 at 4:30 p.m. ET (Press release, Acorda Therapeutics, APR 28, 2020, View Source [SID1234556667]).

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To participate in the conference call, please dial (833) 236-2756 (domestic) or (647) 689-4181 (international) and reference the access code 7999873. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 8:30 p.m. ET on May 5, 2020 until 11:59 p.m. ET on June 5, 2020. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 7999873. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

On April 28, 2020 Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, reported that data from across its portfolio will be presented at the ASGCT (Free ASGCT Whitepaper) annual meeting, to be held May 12-15, 2020 (Press release, Magenta Therapeutics, APR 28, 2020, View Source [SID1234556687]).

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"Magenta’s pipeline continues to deliver new results and continues our progress toward our goal of allowing all patients who can benefit to receive curative stem cell gene therapy or transplant. Our ASGCT (Free ASGCT Whitepaper) presentations demonstrate the far-reaching potential of our programs to widen availability of and improve the patient experience with stem cell gene therapy and transplant," said John Davis Jr., M.D., M.P.H., M.S., Head of Research & Development and Chief Medical Officer, Magenta Therapeutics. "We are particularly encouraged by the new results on our first-line mobilization and conditioning medicines for patients."

Data from MGTA-145 First-Line Stem Cell Mobilization Program:

Magenta is developing MGTA-145 as the new first-line standard of care for stem cell mobilization in a broad range of diseases, including autoimmune diseases, blood cancers and genetic diseases, such as sickle cell disease. MGTA-145, a CXCR2 agonist, works in combination with plerixafor, a CXCR4 antagonist, to rapidly and robustly mobilize stem cells for collection and transplant.

These data provide further confirmation that MGTA-145, in combination with plerixafor, enables the same-day mobilization of functional hematopoietic stem cells (HSCs) that can be gene-modified and engrafted.

Title: MGTA-145, in Combination with Plerixafor, Rapidly Mobilizes Large Numbers of HSCs in Humans That Can Be Gene Edited with CRISPR/Cas9 and Mediate Superior Engraftment to Standard-of-Care (Abstract #123)
Presenter: Kevin Goncalves, Ph.D., Magenta Therapeutics, Cambridge, Mass.
Date and Time: Tuesday, May 12, 2020 – 3:45-5:30pm

This abstract demonstrates that MGTA-145 plus plerixafor is a rapid, reliable, efficient medicine to obtain high numbers of HSCs that can be gene edited with CRISPR/Cas9 and mediate durable engraftment in preclinical models.

Title: MGTA-145/Plerixafor-Mediated HSC Mobilization and Intravenous Gene Therapy in Mice Allows for Efficient in vivo HSC Transduction and Stable Gene Marking in Peripheral Blood Cells (Abstract #810)
Presenter: Chang Li, Ph.D., Division of Medical Genetics, Department of Medicine, University of Washington
Date and Time: Wednesday, May 13, 2020 – 5:30-6:30pm

This abstract shows, for the first time, that MGTA-145 plus plerixafor can enable robust mobilization of large numbers of stem cells in animals that can be efficiently modified in vivo by gene therapy without transplant.

Data from CD117-ADC Gene Therapy Conditioning Program

Targeted, disease-modifying antibody drug conjugates (ADCs) are designed to precisely and rapidly remove disease-causing cells in the body and enable immune and blood system reset and long-term engraftment, without the need for chemotherapy or radiation. The results to be presented at ASGCT (Free ASGCT Whitepaper) use a tool CD117-ADC molecule to demonstrate the first-ever successful transplant of gene-modified cells in non-human primates without the use of chemotherapy or radiation. Magenta has built on these results to declare its clinical candidate, MGTA-117, for targeted patient preparation for stem cell gene therapy and transplant. Magenta is on track to deliver initial clinical data on MGTA-117 in 2021.

Title: A Single Dose of Fast Half-Life CD117 Antibody Drug Conjugate Enables Hematopoietic Stem Cell-Based Gene Therapy in Nonhuman Primates (Abstract #533)
Presenter: Naoya Uchida, M.D., Ph.D., Cellular and Molecular Therapeutics Branch; National Heart, Lung, and Blood Institute; National Institutes of Health
Date and Time: Wednesday, May 13, 2020 – 3:45-5:30pm

This abstract demonstrates that a single dose of a tool CD117-ADC selectively depleted HSCs in non-human primates while sparing immune cells, which are important for recovery following transplant. A single dose of CD117-ADC in non-human primates enabled successful transplant and long-term engraftment of HSCs modified with a lentiviral vector encoding the β-globin gene, the gene that causes sickle cell disease and β-thalassemia, with none of the side effects associated with busulfan conditioning.

Additional Posters and Presentations

Title: Expansion with E478 Significantly Increases the Rate of CRISPR-Mediated Homology Directed Repair (HDR) and Improves Engraftment of Human Hematopoietic Stem Cells (Abstract #10)
Presenter: Kevin Goncalves, Ph.D., Magenta Therapeutics, Cambridge, Mass.
Date and Time: Tuesday, May 12, 2020 – 10:15am-12:00pm

Title: MGTA-456, A Cell Therapy Utilizing an Aryl Hydrocarbon Receptor Antagonist (AHRa) Culture, Promotes Expansion of CD34+CD90+Cord Blood (CB) Hematopoietic Stem Cells (HSC), Resulting in Rapid Hematopoietic Recovery, Uniform Engraftment and Better HLA Matched Grafts for Larger Recipients (Abstract #120)
Presenter: John Wagner, M.D., Executive Medical Director, Bone Marrow Transplant Program, University of Minnesota, Minneapolis, Minn.
Date and Time: Tuesday, May 12, 2020 – 3:45-5:30pm

Title: High Dose Hematopoietic Stem Cell Therapies, like MGTA-456, Enable Complete Neural, Peripheral and Skeletal Disease Cross-Correction Through Rapid and Robust Engraftment (Abstract #248)
Presenter: Sharon Hyzy, M.S., Magenta Therapeutics, Cambridge, Mass.
Date and Time: Tuesday, May 12, 2020 – 5:30-6:30pm

Title: A Phase 2 Trial of MGTA-456 Cell Therapy Demonstrates Rapid and Durable Long-Term Improvement in Disease-Specific Outcomes in Inherited Metabolic Disease (IMD) Patients (Abstract #1302)
Presenter: John Wagner, M.D., Executive Medical Director, Bone Marrow Transplant Program, University of Minnesota, Minneapolis, Minn.
Date and Time: Friday, May 15, 2020 – 8:00-9:45am

On April 28, 2020 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported that it will release its financial results for first quarter 2020 after the close of trading on Tuesday, May 5, 2020 (Press release, Quanterix, APR 28, 2020, View Source [SID1234556704]). Company management will host a conference call at 4:30 p.m., EDT to discuss Quanterix’ financial results and provide a business update. The call will be hosted by Kevin Hrusovsky, Chief Executive Officer, President and Chairman, Quanterix.

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Individuals interested in listening to the conference call may do so by dialing (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 4994882. A live webcast will also be available at: View Source The webcast will be available on the Company’s website, View Source, for one year following completion of the call.