NovalGen presents data at American Society of Clinical Oncology for novel ROR1xCD3 bispecific antibody for non-Hodgkin lymphoma

On May 20, 2021 NovalGen Ltd ("NovalGen"), a biopharmaceutical company developing breakthrough cancer therapies, reported the company will give a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual meeting 2021, taking place June 4-8, 2021 (Press release, UCLB, MAY 20, 2021, View Source [SID1234580421]).

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NovalGen has developed an ROR1xCD3 bispecific antibody T cell engager, NVG-111, that is currently entering Phase 1/2 development for patients with non-Hodgkin lymphoma; initially focused on Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia (CLL), but with the potential to target >20 different hard-to-treat solid and liquid cancers. NVG-111 is a first in class bispecific antibody T cell engager targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1). ROR1 is a tumor-associated antigen that is overexpressed in a broad range of cancers, but has negligible expression in healthy adult tissues, making it an ideal candidate for novel, targeted cancer therapies.

"These data presented in our poster at ASCO (Free ASCO Whitepaper) show preclinical data supporting our Phase 1/2 first in human study for NVG-111," said Professor Amit Nathwani, CEO of NovalGen. "The data demonstrates NVG-111 eliciting potent killing at low concentrations of the drug. Additionally, cytokine release appears lower than other T cell engagers. Overall, it advances the scientific understanding of the potential of NVG-111 in a range of hard-to-treat cancers."

Poster Presentation Details:

Abstract Number for Publication: 7549

Abstract Title: NVG-111, a novel ROR1xCD3 bispecific antibody for non-Hodgkin lymphoma

Session Title: Poster Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

The abstract is available on the ASCO (Free ASCO Whitepaper) meeting library.

Nordic Nanovector ASA: Invitation to First Quarter 2021 Results Presentation and Webcast

On May 20, 2021 Nordic Nanovector ASA (OSE: NANOV) reported that it will report its results for the first quarter 2021 on Wednesday, 26 May 2021 (Press release, Nordic Nanovector, MAY 20, 2021, View Source [SID1234580411]).

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A presentation by Nordic Nanovector’s senior management team will be webcast live the same day at 8:30am CET.

The webcast can be accessed from www.nordicnanovector.com in the section: Investors & Media and a recording will also be available on this page after the event.

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2021 from 7:00am CEST the same day.

Oncopeptides AB: Invitation to presentation of the Q1 2021 results

On May 20, 2021 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported that it will publish its report for the first quarter 2021 on May 26. Investors, financial analysts and media are invited to participate in a webcast with a QnA session on the same day at 12:00 CEST (Press release, Oncopeptides, MAY 20, 2021, View Source [SID1234580410]). The event will be hosted by CEO, Marty J Duvall and members of the Oncopeptides’ Leadership team. The presentation will be held in English.

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The webcast will be streamed via this link which can also be found on the website: www.oncopeptides.com.

Everest Medicines Announces China NMPA Has Granted Priority Review for Sacituzumab Govitecan-hziy in Metastatic Triple-Negative Breast Cancer

On May 20, 2021 Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products in Greater China and other parts of Asia, reported that sacituzumab govitecan-hziy (SG) was granted Priority Review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) (Press release, Everest Medicines, MAY 20, 2021, View Source [SID1234580409]).

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This marks another progress following the Company’s announcement published on 17 May 2021 that the NMPA accepted its Biologics License Application (BLA) for SG for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.

"We are very pleased by the NMPA’s decision to grant Priority Review for SG, reinforcing its potential to serve as a novel and important treatment option to people in China suffering the devastating effects of metastatic triple-negative breast cancer," said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. "We look forward to working closely with local regulatory bodies to bring this innovative treatment to patients in China as quickly as possible."

"This exciting milestone is one of many recent global clinical and regulatory advances that further enables us to accelerate the pace at which we work to bring this first-of-its-kind therapy to patients in need," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines.

In October 2020, SG was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer, compiled by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, and the Cancer Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association.

Under the trade name Trodelvy, the U.S. Food and Drug Administration (FDA) previously granted accelerated approval to SG in April 2020 and full approval to SG in April 2021 for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.

About Triple-Negative Breast Cancer

Triple-negative breast cancer (TNBC) is a highly aggressive disease and accounts for approximately 15% of all breast cancer types worldwide. The median age of breast cancer diagnoses tends to be younger in Asian than western countries, and the percentage of the TNBC molecular subtype has been increasing in the past 10 years. TNBC cells lack sufficient estrogen, progesterone or HER2 receptor expression to benefit from the use of hormonal or HER2-directed therapy. Overall survival among patients with this form of breast cancer has not changed in the past 20 years, which highlights the need for advances in therapeutic options for these patients.

About Sacituzumab Govitecan-hziy

Sacituzumab govitecan-hziy (SG) is a first-in-class, antibody and topoisomerase inhibitor conjugate directed at TROP-2, a protein frequently expressed in multiple types of epithelial cancers. SG is approved in the United States under the trade name Trodelvy.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize SG for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries.

The Ministry of Food and Drug Safety (MFDS) in South Korea has granted Fast Track Designation and Orphan Drug Designation (ODD) to SG for the treatment of metastatic TNBC. In addition, Everest announced in January 2021 that it submitted a New Drug Application (NDA) to the Health Sciences Authority (HSA) of Singapore for SG for the treatment of patients with metastatic TNBC who have received at least two prior therapies for metastatic disease. That application is currently under review.

RedHill Biopharma to Host First Quarter 2021 Financial Results and Operational Highlights Webcast on May 27, 2021

On May 20, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it will report its first quarter 2021 financial results and operational highlights on Thursday, May 27, 2021 (Press release, RedHill Biopharma, MAY 20, 2021, View Source [SID1234580408]).

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The Company will host a webcast on Thursday, May 27, 2021, at 8:30 a.m. EDT, during which it will present key highlights for the first quarter of 2021.

The webcast including slides will be broadcast live on the Company’s website, View Source, and will be available for replay for 30 days.