On September 8, 2022 Genor Biopharma (Stock code: 6998.HK) reported that the first patient has been successfully dosed in a Phase I/II clinical trial of GB261(CD20/CD3, bispecific antibody) in China (Press release, Genor Biopharma, SEP 8, 2022, View Source [SID1234619243]).

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The clinical trial application was approved by the National Medical Products Administration (NMPA) on 23 May for the treatment of patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (B-NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The trial was then achieved first China patient dosed on September 8.

GB261 (a novel and innovative CD20/CD3 bispecific antibody) is in process of the dose escalation in the FIH (First in Human) study in Australia, and has demonstrated preliminary clinical efficacy, good safety and pharmacokinetic profile.

About GB261 (CD20/CD3, BsAb)

GB261 is the first T-Cell Engager with ultra-low affinity to bind CD3 and has Fc-enabled functions (ADCC and CDC). GB261 significantly inhibits rituximab-resistant cancer cell proliferation in both in vitro assays and in vivo models; meanwhile with T-cell activation, GB261 induces less cytokine release compared with compound in the same class. Thus, GB261 is a highly potent bispecific therapeutic antibody for B cell malignancies. It has potential to be a better and safer T-cell engager with competitive advantages over other CD3/CD20 agents.

On September 8, 2022 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to elicit a potent and durable immune response in the tumor microenvironment, reported that it will host a virtual webinar to review the latest clinical trial data for BCA101, a first-in-class EGFR/TGFβ-trap bifunctional antibody designed to deliver superior anti-tumor efficacy with an improved therapeutic window to solid tumors (Press release, Bicara Therapeutics, SEP 8, 2022, View Source;utm_medium=rss&utm_campaign=bicara-therapeutics-to-host-webinar-to-review-latest-clinical-trial-data-for-bca101 [SID1234619242]). The webinar will be held Monday, September 12, 2022 at 10:30 a.m. ET.

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During the webinar, Dr. Glenn Hanna, principal investigator from Dana-Farber Cancer Institute, will review the Phase 1 data presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022. Management will then discuss the development program in more detail, followed by a Q&A session. Presenters for the event are:

Claire Mazumdar, Ph.D., Chief Executive Officer, Bicara Therapeutics
Glenn J. Hanna, M.D., Director of the Center for Salivary and Rare Head and Neck Cancers, Dana-Farber Cancer Institute and Principal Investigator in the Phase 1 trial for BCA101
Liviu Niculescu, M.D., Chief Medical Officer, Bicara Therapeutics
To register for the live event, please visit the Online Experiences website. Following the live webcast, an archived replay will be available on the Company’s website, www.Bicara.com.

About BCA101

BCA101 is a first-in-class EGFR / TGF-β-trap bifunctional antibody designed to enhance both innate and adaptive immune responses directly at the site of the tumor by binding to the well-validated EGFR antigen and disabling TGF-β, a signaling molecule that plays a key role in suppressing the immune response in the tumor microenvironment. Promising preclinical data suggest that BCA101 is superior to the anti-EGFR antibody cetuximab in preventing tumor recurrence, as well as in restoring immune activation. An ongoing Phase 1/1b clinical trial of BCA101, initiated in July 2020, has enrolled cohorts of patients in a dose-escalation study with BCA101 as a single agent, as well as in combination with pembrolizumab, a PD-1 inhibitor and a recommended dose for expansion has been declared. Enrollment in the dose expansion arm of the study in first-line head and neck in combination with pembrolizumab is currently ongoing. For more information, please visit study number NCT04429542 at www.clinicaltrials.gov.

On September 8, 2022 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing novel synthetic lethality-based cancer therapeutics targeting DNA damage response (DDR) pathways, reported that Oren Gilad Ph.D, President and Chief Executive Officer, will present a corporate overview at the H.C. Wainwright 24th Annual Global Investment Conference on Monday, September 12, 2022 at 12:30 p.m. ET (Press release, Aprea, SEP 8, 2022, View Source [SID1234619241]).

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The presentation will discuss Aprea’s discovery program and development pipeline in synthetic lethality and DDR, including:

ATRN-119, the Company’s Phase 1-ready small molecule ATR inhibitor
ATRN-W1051, the Company’s WEE1 inhibitor in preclinical development
Repli-Biom, the Company’s discovery platform to identify both new precision oncology targets and patient populations most likely to benefit from treatment
Eprenetapopt, the Company’s clinical-stage small molecule p53 reactivator
A copy of the presentation will be accessible from the "Events Calendar" in the News and Events section of the Aprea website.

On September 8, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) (‘Applied DNA’ or the "Company"), a leader in polymerase chain reaction ("PCR")-based technologies, and the Cornell University College of Veterinary Medicine ("CUCVM") reported the signing of a research agreement (the "Agreement") to advance LinearDNA-based vaccine research and discovery for animal diseases with agricultural biosecurity implications (Press release, Applied DNA Sciences, SEP 8, 2022, View Source [SID1234619240]). Primarily, the Agreement seeks to combine LinearDNA as a platform for rapid drug development with CUCVM’s expertise in viral vector design to advance a differentiated approach to animal vaccine development for infectious diseases.

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The Agreement builds on the strong, existing collaboration between Applied DNA’s biotherapeutics subsidiary, LineaRx, and Dr. Diego Diel, D.V.M, M.S., PhD., Associate Professor of Virology at the Cornell University College of Veterinary Medicine’s Department of Population Medicine and Diagnostics. Dr. Diel is the lead investigator for veterinary clinical trials sponsored by the Company for the LinearDNA-based COVID-19 vaccine candidate and other therapeutic candidates in the Company’s pipeline.

Recently, Applied DNA announced the successful administration and expression of a lipid nanoparticle-encapsulated (LNP) LinearDNA construct in mice via routine intramuscular (IM) injection. Based on this positive data, the Company is currently advancing several LNP LinearDNA vaccine designs that will be utilized in upcoming preclinical animal studies. Data generated by these preclinical animal studies will advance the LinearDNA platform toward the commercialization of LNP-LinearDNA vaccines for both prophylactic and therapeutic applications and will inform the final design of the Company’s LNP-LinearDNA canine cancer vaccine candidate that is currently slated to begin an initial clinical trial during 1H calendar 2023.

"The Agreement is an opportunity to expand our work with Dr. Diel and his talented team to accelerate the application of the LinearDNA platform to the animal health market," stated Dr. James A Hayward, president and CEO of Applied DNA and LineaRx. "Veterinary DNA vaccines present an attractive opportunity for us, and these animal studies should generate additional key validation data for our platform relevant to veterinary health. There is a continuing need for better veterinary therapies and we believe an LNP-LinearDNA product has the strong potential to offer enhanced ease of administration and improved clinical outcomes."

Dr. Diel said, "Vaccinology research and clinical trials are crucial to developing new prevention strategies that could have transformative applications in animal health. This partnership will help to advance research and development of novel vaccine candidates for emerging infectious diseases in ways that can benefit us all, including human and animal patients."

On September 8, 2022 Amgen (NASDAQ:AMGN) reported that it will present at Morgan Stanley’s 2022 Global Healthcare Conference at 9:10 a.m. ET on Tuesday, Sept. 13, 2022 (Press release, Amgen, SEP 8, 2022, View Source [SID1234619239]). Robert A. Bradway, chairman and chief executive officer at Amgen will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.