On October 5, 2020 Odonate Therapeutics reported that the results of CONTESSA, a Phase 3 study of tesetaxel in the treatment of patients with metastatic breast cancer, have been selected for an oral presentation at the 2020 SABCS, to be held virtually December 8-11, 2020 (Press release, Odonate Therapeutics, OCT 5, 2020, View Source;a-phase-3-study-of-tesetaxel-in-the-treatment-of-patients-with-metastatic-breast-cancer–to-be-presented-at-the-2020-san-antonio-breast-cancer-symposium–sabcs–1463cc93-7e13-40a3-9d02-80a22baa098d [SID1234568109]).

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The presentation details are as follows:

Date: December 11, 2020

Time: 9:00am CT

Session: General Session 4

Title: Results from CONTESSA: A phase 3 study of tesetaxel plus a reduced dose of capecitabine versus capecitabine alone in patients with HER2-, hormone receptor + (HR+) metastatic breast cancer (MBC) who have previously received a taxane

For more information, please visit View Source

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 685 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. 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.

On October 5, 2020 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported a two-year strategic partnership with Xilio Therapeutics (Press release, Applied BioMath, OCT 5, 2020, View Source [SID1234568125]). Applied BioMath will provide a variety of services related to mathematical modeling, simulation, analysis, and visualization, which include systems pharmacology, quantitative systems pharmacology, experiment prioritization and design, and traditional and mechanistic pharmacokinetic (PK) / pharmacodynamic (PD) modeling, in support of Xilio’s preclinical and clinical drug development projects. "We are thrilled to announce this next phase of our partnership with Xilio Therapeutics," said John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "We really enjoy being part of the project teams, working on exciting projects and science, and helping to better inform decisions. We take pride in partnerships such as these as they are evidence that our prior collaborations with our partners provided high value."

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Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Applied BioMath’s approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis. "Our previous collaborations with Applied BioMath informed the advancement of our preclinical candidates," said Jennifer O’Neil, PhD, Vice President, Translational Oncology at Xilio Therapeutics. "We look forward to continuing to work closely with Applied BioMath and incorporate their approach into more of our projects."

On October 5, 2020 ImmunoGen, Inc., (Nasdaq: IMGN) a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for IMGN632 for the treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN) (Press release, ImmunoGen, OCT 5, 2020, View Source [SID1234568093]).

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"We are pleased FDA has granted Breakthrough Therapy designation for IMGN632, our novel CD123-targeted ADC, as it underscores the urgent need for effective and well-tolerated treatments for patients with this rare and aggressive cancer," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "We look forward to continuing to work with FDA to further define the development path for IMGN632 in BPDCN, in addition to pursuing our ongoing evaluation of IMGN632 in AML and other hematological malignancies."

According to FDA guidelines, Breakthrough Therapy designation is designed to expedite the development and review of drugs that are intended to treat a serious condition and have generated preliminary clinical evidence that the drug may demonstrate substantial improvement over available therapy. Breakthrough Therapy designation was granted for IMGN632 based on the findings from the BPDCN cohort of the first-in-human study of IMGN632, for which initial data were presented in an oral session at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in 2019. Updated data from the IMGN632 monotherapy BPDCN dose expansion cohort will be presented at ASH (Free ASH Whitepaper) this December.

ABOUT IMGN632
IMGN632 is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and acute lymphocytic leukemia (ALL). IMGN632 is currently being evaluated in multiple cohorts, including monotherapy for patients with BPDCN and minimal residual disease positive (MRD+) AML following frontline induction therapy and in combinations with Vidaza (azacitidine) and Venclexta (venetoclax) for patients with relapsed/refractory AML. IMGN632 uses one of ImmunoGen’s novel indolino-benzodiazepine (IGN) payloads, which alkylate DNA without crosslinking. IGNs have been designed to have high potency against AML blasts, while demonstrating less toxicity to normal marrow progenitors than other DNA-targeting payloads.

ABOUT BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM
BPDCN is a rare form of blood cancer that has features of both leukemia and lymphoma, with characteristic skin lesions, lymph node involvement, and frequent spread to the bone marrow. This aggressive cancer requires intense treatment often followed by stem cell transplant. Despite the recent approval of a CD123-targeting therapy, the unmet need remains high for patients, particularly in the relapsed/refractory setting.

On October 5, 2020 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported that its Chief Executive Officer, Steven Engle, will present a company update at the BIO Investor Forum, being held virtually on October 13-15, 2020 (Press release, CohBar, OCT 5, 2020, View Source [SID1234568110]). This presentation will be available on demand for BIO Investor attendees.

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BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

On October 5, 2020 Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that the database for the Phase III trial of DCVax-L for Gliobastoma has been locked (Press release, Northwest Biotherapeutics, OCT 5, 2020, View Source [SID1234568126]).

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With the database now locked, the independent service firms managing the Clinical Trial are arranging for the independent statisticians to have access to the unblinded raw data from the Trial. Neither the Company nor any party other than the independent statisticians will have access to any unblinded data at this stage.

The statisticians will proceed as quickly as possible with analyses of the raw data and prepare summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, who will analyze the data with the statisticians in preparation for public announcement and scientific publication.

"We are excited to be so close to the finish line now, after such a long road" commented Linda Powers, the Company’s CEO. "We are hopeful that DCVax-L can become an important new treatment option for patients who urgently need more and better treatments for Glioblastoma brain cancer."

"We are grateful to the independent service firms and the clinical trial sites who have worked so hard to complete the data collection and confirmation during many months of COVID restrictions and challenges," Ms. Powers continued. "We are also very grateful to our shareholders for their patience and support, which has made all this possible."