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Transcenta Received IND Clearance from FDA for Initiating Clinical Trials for its Novel Humanized Claudin 18.2 Monoclonal Antibody TST001

On April 20, 2020 Transcenta Holding Limited. ("Transcenta"), a global biotherapeutics company that fully integrates antibody-based biotherapeutics discovery, R&D and manufacturing, reported that its subsidiary Mabspace Biosciences (Suzhou) Co., Limited has received clearance of its IND from FDA for its novel humanized Claudin 18.2 (CLDN18.2) monoclonal antibody (internal project number TST001) (Press release, Transcenta, APR 20, 2020, View Source;301043268.html [SID1234556442]). It is developed jointly by Mabspace Biosciences and HJB, another Transcenta’s subsidiary focusing on CMC and manufacturing.

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The unique expression profile of Claudin 18.2 in normal tissue and its aberrant expression in multiple tumor types make Claudin 18.2 an attractive anti-cancer therapeutic target. TST001 is a humanized high affinity anti-Claudin 18.2 antibody and kills tumor cells via antibody-dependent cellular cytotoxicity (ADCC). Through bioprocess engineering, TST001 is produced with reduced fucosylation and results in significant enhancement in its ADCC inducing activity against Claudin 18.2 expressing tumors. In preclinical studies, TST001 is efficacious in multiple tumor animal models, and well tolerated in GLP toxicology studies. As of today, TST001 has received clearance from both FDA and China National Medical Products Administration (NMPA) to initiate clinical trials in patients with metastatic solid tumors.

"The FDA’s clearance of our IND is an important milestone for TST001 project transition into clinical-stage. Our team is very excited to have the opportunity to test this differentiated Claudin 18.2 antibody in cancer patients. Our ongoing development of companion diagnostic antibody will help us to identify patients with Claudin 18.2 expression. We hope to expedite the development of this agent to bring potentially more efficacious treatment options to cancer patients around the world," said Dr. Xueming Qian, Transcenta’s Co-Founder and Chief Executive Officer.

Sutro Biopharma to Host Conference Call on April 27, 2020, to Provide Clinical Update on its STRO-002 Antibody-Drug Conjugate

On April 20, 2020 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported that it will host a conference call and live audio webcast on Monday, April 27, at 8 a.m. EDT to discuss updated dose escalation safety and efficacy data from the company’s ongoing Phase I study of STRO-002 in ovarian and endometrial cancer that is being presented as a virtual poster at the AACR (Free AACR Whitepaper) Virtual Annual Meeting (Press release, Sutro Biopharma, APR 20, 2020, https://www.prnewswire.com/news-releases/sutro-biopharma-to-host-conference-call-on-april-27-2020-to-provide-clinical-update-on-its-stro-002-antibody-drug-conjugate-301043688.html [SID1234556441]). The virtual poster will be accompanied by a video presentation from Dr. Wendel Naumann of The Levine Cancer Institute.

STRO-002 is a novel antibody-drug conjugate (ADC) targeting the clinically validated folate receptor-α (FolRα), an antigen known to be overexpressed in ovarian cancer. Sutro discovered, developed and manufactures STRO-002 using its proprietary XpressCF+ cell-free protein synthesis technology.

Conference Call Information:

To access the conference call and live audio webcast on Monday, April 27, at 8 a.m. EDT, please dial (833) 729-4781 (domestic) or (830) 213-7705 (international) and refer to conference ID 2699785.

The conference call will be webcast via the Investors page on the Company’s website at ir.sutrobio.com. Approximately two hours following the live event, a webcast replay of the conference call will be available through the Company Presentation page of the Investor section of the company’s website at www.sutrobio.com for approximately 30 days.

Poster Presentation Details:

STRO-002-GM1, a First in Human, Phase 1 Study of STRO-002, an anti-Folate Receptor-alpha (FRα) Antibody Drug Conjugate (ADC), in Patients with Advanced Platinum-Resistant/Refractory Epithelial Ovarian Cancer (OC), including Fallopian Tube or Primary Peritoneal Cancers

Date & Time:

Monday, April 27, 2020, 9:00 a.m. to 6:00 p.m. EDT

Location:

The AACR (Free AACR Whitepaper) Virtual Meeting at aacr.org

Poster Number:

CT125

The submitted abstract and the virtual poster presentation will also be accessible through the Clinical/Scientific Presentation and Publication Highlights page of the News section of the company’s website at www.sutrobio.com on the day of the presentation.

McKesson Corporation to Announce Fourth Quarter Fiscal 2020 Results on May 20, 2020

On April 20, 2020 McKesson Corporation (NYSE:MCK) reported that it will release its fourth quarter fiscal 2020 financial results before market open on Wednesday, May 20, 2020 (Press release, McKesson, APR 20, 2020, View Source [SID1234556440]). The company will host a conference call for investors at 8:00 AM Eastern Time to review its financial results.

A live audio webcast of the conference call will be available on McKesson’s Investor Relations website at View Source, along with the company’s earnings press release, financial tables and slide presentation. The conference call can also be accessed by dialing 786-815-8297. The password is ‘McKesson’.

Alpine Immune Sciences Announces Poster Presentation at AACR Virtual Annual Meeting I

On April 20, 2020 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported the company will present a poster at the AACR (Free AACR Whitepaper) Virtual Annual Meeting I, taking place April 27-28, 2020 (Press release, Alpine Immune Sciences, APR 20, 2020, View Source [SID1234556439]).

Details of the presentation are as follows:

Presentation Title: NEON-1: A first-in-human phase I open-label study of ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor, in advanced malignancies
Session Title: VPO.CT07.01 – Phase I Trials in Progress
Date: Monday, April 27, 2020
Presentation Location: Virtual Meeting
Session Type: Virtual Poster Session
Poster Number: CT245
An abstract of the presentation will be available on the AACR (Free AACR Whitepaper) Virtual Annual Meeting I website.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. A phase 1 trial of ALPN-202 in advanced malignancies (NEON-1, NCT04186637) is open for enrollment.

TUKYSA™ (tucatinib) Approved for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer, Available from Onco360

On April 20, 2020 Onco360, the nation’s largest independent Oncology Pharmacy, reported that it has been selected by Seattle Genetics to be a specialty pharmacy partner for TUKYSA (tucatinib), a new oral treatment used in combination with capecitabine and trastuzumab for adult patients with HER2-positive metastatic breast cancer who have received one or more prior anti-HER2-based regimens in the metastatic setting (Press release, Onco360, APR 20, 2020, View Source [SID1234556438]).

"The approval of TUKYSA for patients with HER2-positive metastatic breast cancer is an important advancement in fighting this devastating disease," said Paul Jardina, President and CEO, Onco360. "As a specialty pharmacy dedicated to serving people with cancer, Onco360 is honored to be selected as a distribution partner for TUKYSA. We are committed to improving the lives of patients suffering from HER2-positive metastatic breast cancer."

According to the National Cancer Institute (NCI), approximately 276,480 patients are diagnosed with breast cancer annually, with corresponding 42,170 deaths. The five-year overall survival for breast cancer, regardless of stage, is 90%. Approximately 20% of breast cancer patients are found to be HER2-positive, an aggressive histological subtype of breast cancer. Unfortunately, about 25-30% of patients with HER2-positive breast cancer experience disease recurrence with metastatic disease.

TUKYSA is manufactured by Seattle Genetics, an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer. The FDA’s approval of TUKYSA in combination with capecitabine and trastuzumab is based on the results of the Phase II HER2CLIMB clinical trial, which demonstrated a 34% improvement in overall survival for the triplet regimen compared to capecitabine + trastuzumab doublet therapy. For full prescribing information, visit TUKYSA.com.

Community and hospital-based oncologists can immediately place prescription orders with Onco360 for TUKYSA, as well as other cancer and supportive care medications, including capecitabine and trastuzumab. Referral forms and information on how to order can be found at Onco360.com/Order.