On September 8, 2022 Silence Therapeutics plc, Nasdaq: SLN ("Silence" or "the Company"), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapeutics for the treatment of diseases with significant unmet medical need, reported that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation to SLN124, a novel siRNA targeting the TMPRSS6 gene, for the treatment of polycythemia vera ("PV") (Press release, Silence Therapeutics, SEP 8, 2022, View Source [SID1234619247]). The Company plans to start a phase 1/2 study in PV patients this year.

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SLN124 is designed to address a range of hematological diseases by targeting TMPRSS6 to increase endogenous hepcidin, the body’s master regulator of iron balance and distribution. SLN124 demonstrated proof of mechanism and was well tolerated in a healthy volunteer study completed last year.

"The granting of Fast Track Designation represents an important recognition by the FDA of SLN124’s potential to address a significant unmet need in the treatment of PV," said Craig Tooman, President and Chief Executive Officer of Silence. "We plan to leverage Fast Track to expedite our development path as we seek to provide an important new treatment option to those suffering from this very serious and chronic genetic disease."

Fast Track designation aims to facilitate the development and accelerate the review of new therapeutics that are intended to treat serious or life-threatening conditions and that potentially address an unmet medical need. Drugs that are granted this designation are given the opportunity for more frequent interactions with the FDA, as well as potential pathways for expedited approval.

In addition to PV, SLN124 is being evaluated in a phase 1 study in patients with thalassemia. SLN124 has orphan disease designations for PV, thalassemia, and myelodysplastic syndrome as well as a rare pediatric disease designation for thalassemia.

On September 8, 2022 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, reported that Ryan Spencer, Chief Executive Officer, will participate in a virtual fireside chat at the H.C. Wainwright 24th Annual Global Investment Conference, being held September 12-14, 2022 (Press release, Dynavax Technologies, SEP 8, 2022, View Source [SID1234619245]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The on demand presentation will be available, beginning Monday, September 12, 2022 at 7:00 a.m. E.T. and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source

On September 8, 2022 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), reported that company management will present a corporate overview at the H.C. Wainwright 24th Annual Global Investment Conference being held September 12-14, 2022, both virtually and in-person at the Lotte New York Palace Hotel (Press release, Crinetics Pharmaceuticals, SEP 8, 2022, https://crinetics.com/hc-wainwright-24th-annual-investment-conference/ [SID1234619244]).

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Details of the Crinetics presentation are as follows:

The presentation may be accessed from the H.C. Wainwright platform or from the Events & Presentations page in the Investors section on the Company’s website. A replay of the presentation will be accessible for 90 days.

In addition, if you are interested in arranging a virtual 1×1 meeting with members of the Crinetics management team, please contact your bank/conference representative.

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.