On September 2, 2022 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported that the company’s Current Good Manufacturing Practice (CGMP) manufacturing facility located at the Research Triangle Park (RTP) in North Carolina, the United States of America ("The RTP GMP Manufacturing Facility") has started GMP production of autologous CAR T-cell products and successfully released the first GMP batch for the clinical trials (Press release, Carsgen Therapeutics, SEP 2, 2022, View Source [SID1234618953]).

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The RTP GMP Manufacturing Facility, with a total gross floor area of approximately 3,300 sq.m, will provide CARsgen additional manufacturing capacity of autologous CAR T-cell products for 700 patients annually to support clinical studies and early commercial launch in North America and Europe. "I am very pleased to announce that the RTP Manufacturing Facility has achieved the company’s target of releasing the clinical batches for the U.S. patient use in Q3, 2022," said Mr. Richard Daly, President of CARsgen Therapeutics Corporation. "CARsgen is rapidly expanding the in-house capacity of manufacturing and quality testing in the United States. The company will accelerate the ongoing clinical studies by providing more promising CAR T-cell products to the global patients."

"The successful release of the first U.S. patient product at the RTP GMP Manufacturing Facility is a remarkable milestone for CARsgen and our trusted partners," added by Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited. "By taking the advantage of the vertically integrated production at CARsgen, our world-class CMC team could complete the global technology transfer from our China manufacturing facility and then advance to the clinical manufacturing effectively. The commencement of clinical production at the RTP GMP Manufacturing Facility will greatly reduce current risks of global supply chain shortage and strengthen the value chain of CARsgen."

Apart from several ongoing clinical studies in China, the company has two active INDs, including a Phase 2 pivotal study of CT053 for relapsed/refractory multiple myeloma and a Phase 1b study of CT041 for advanced gastric and pancreatic cancers, both cleared by the U.S. FDA and the Health Canada. In fact, CARsgen is the only CAR T company to have received RMAT and PRIME designations for both heme (CT053) and solid (CT041) tumor therapies.

On September 2, 2022 Myovant Sciences (NYSE: MYOV), a biopharmaceutical company that aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy, reported that David Marek, Chief Executive Officer of Myovant Sciences, Inc., and Uneek Mehra, Chief Financial and Business Officer, will participate in the following upcoming investor conferences (Press release, Myovant Sciences, SEP 2, 2022, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-participate-upcoming-investor-conferences [SID1234618950]):

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Citi’s 17th Annual BioPharma Conference on Thursday, September 8, 2022. Management will participate in one-on-one investor meetings.
Baird 2022 Global Healthcare Conference on Tuesday, September 13, 2022 at 12:15 p.m. Eastern Time, Mr. Marek and Mr. Mehra will participate in a fireside chat. Management will also participate in one-on-one investor meetings on September 13.
Investors and the general public are invited to listen to the Baird fireside chat, which will be accessible on the Events page under the Investors & Media section of the Myovant website at www.myovant.com.

On September 2, 2022 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported that the Company’s management will participate in the following investor conferences in September 2022 (Press release, MacroGenics, SEP 2, 2022, View Source [SID1234618949]):

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Citi 17th Annual BioPharma Conference (Boston). MacroGenics’ President & Chief Executive Officer, Scott Koenig, M.D., Ph.D., will participate in the Bispecific Panel on Wednesday, September 7, 2022, at 2:40 pm ET. Management will also participate in one-on-one meetings.
H.C. Wainwright 24th Annual Global Investment Conference (New York). MacroGenics’ President & Chief Executive Officer, Scott Koenig, M.D., Ph.D. will provide a corporate overview on Monday, September 12, 2022, at 10:30 am ET. MacroGenics’ management will also participate in one-on-one meetings.
Guggenheim Nantucket Therapeutics Conference. MacroGenics’ President & Chief Executive Officer, Scott Koenig, M.D., Ph.D., will participate in a fireside chat on September 28, 2022, at 2:30 pm ET and participate in one-on-one meetings.
Webcasts of the above will be made available under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company maintains archived replays of webcasts on its website for 30 days after the conference.

On September 2, 2022 LamKap Bio beta reported to present data on NILK-2401 ± NILK-2301 programs SITC (Free SITC Whitepaper) 37th Annual Meeting 2022 (Press release, LamKap Bio Group, SEP 2, 2022, View Source [SID1234618948])

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The SOCIETY FOR IMMUNOTHERAPY OF CANCER (SITC) (Free SITC Whitepaper) will host the 37th Annual Meeting & Pre-Conference Programs November 8-12, 2022. LamKap Bio beta is very pleased to present for the first time preclinical data on the development of NILK-2401 (CEAxCD47) ± NILK-2301 (CEAxCD28) bispecific antibodies for immunotherapy of patients with carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5 aka CEA) expressing solid tumors.

"Novel CEAxCD47 (NILK-2401) and CEAxCD3 (NILK-2301) kl bispecific antibodies for multimodal immunotherapy of CEA-expressing solid cancer" will be presented on site in the Poster Hall on November 10 (abstract no. 853).

A pdf file will be made available for download after presentation at the meeting.

On September 2, 2022 Crinetics Pharmaceuticals reported that Monica R. Gadelha, MD, PhD, professor of endocrinology at the Medical School of the Universidade Federal do Rio de Janeiro and a principal investigator in the Phase 2 ACROBAT program, will be presenting data from a planned two-year interim analysis from the ACROBAT Advance open label extension (OLE) study at the 35th Brazilian Congress of Endocrinology and Metabolism (CBEM) being held in São Paulo, Brazil from September 3-7, 2022 (Press release, Crinetics Pharmaceuticals, SEP 2, 2022, View Source [SID1234618942]).

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DETAILS OF THE ORAL PRESENTATION IS AS FOLLOWS:
Congress: Brazilian Congress of Endocrinology and Metabolism (CBEM)
Title: Paltusotine shows long-term safety and IGF-1 maintenance in the ACROBAT Advance study
Date/Time: September 4, 2022 at 3:30 pm BST / 2:30 pm EDT
Enrollment in the Advance OLE study was offered to participants from the Phase 2 ACROBAT Evolve and Edge studies of acromegaly patients who were under a variety of degrees of baseline biochemical control as defined by insulin-like growth factor-1, or IGF-1, levels when treated with regimens that included an injected somatostatin receptor ligand (SRL).

ABOUT ACROMEGALY
Acromegaly is a serious disease generally caused by a pituitary adenoma, a benign tumor in the pituitary that secretes growth hormone. Excess GH secretion causes excess secretion of IGF-1 from the liver. Together, excess of these hormones leads to the symptoms and physical manifestations of acromegaly, including abnormal growth of hands and feet, alteration of facial features, arthritis, carpal tunnel syndrome, joint aches, deepening of voice due to enlarged vocal cords, fatigue, sleep apnea, enlargement of heart, liver and other organs, and changes in glucose and lipid metabolism. Surgical removal of pituitary adenomas, if possible, is the preferred initial treatment for most acromegaly patients. Pharmacological treatments are used for patients that are not candidates for surgery, or when surgery is unsuccessful in achieving treatment goals. Approximately 50% of patients with acromegaly prove to be candidates for pharmacological treatment. Long-acting somatostatin-receptor ligands (SRLs) are the most common initial pharmacologic treatment; however, these drugs require monthly depot injections with large gauge needles that are commonly associated with pain, injection site reactions, and increased burden of therapy on the lives of patients.

ABOUT PALTUSOTINE
Paltusotine is an investigational, orally available nonpeptide agonist that is designed to be highly selective for the somatostatin receptor type 2 (SST2). It was designed by the Crinetics discovery team to provide a once-daily oral option for patients with acromegaly and neuroendocrine tumors. A previously completed Phase 1 trial of paltusotine showed clinical proof of concept by providing evidence of potent suppression of the growth hormone axis in healthy volunteers. In Phase 2 trials, paltusotine maintained IGF-1 levels in acromegaly patients who switched from injectable depot medications to once-daily paltusotine. IGF-1 is the primary biomarker endocrinologists use to manage their acromegaly patients.