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.

On September 2, 2022 The National Institute of General Medical Sciences (NIGMS) reported that has awarded $1,729,532.72 to Collaborations Pharmaceuticals, Inc. (CPI) and the University of Arizona to generate in vitro data and develop MegaTransÒ machine learning software for drug discovery (Press release, Collaborations Pharmaceuticals, SEP 2, 2022, View Source [SID1234618941]).

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"The objective of MegaTrans is to develop a new computational system and tools for integrating human transporter data into drug discovery pipelines, as well as enabling its analysis and visualization. It will also assist with developing computational tools for quantitatively modeling drug-drug interactions of xenobiotics. We will generate data for transporters which currently have a paucity of data in the public domain, use validated machine learning algorithms, access the latest curated datasets and develop a user-intuitive interface and visualization system to enable predictions. MegaTrans will be developed as commercial quality software and then commercialized by licensing to companies, as well as used in fee-for-service consulting projects. In Phase I of this project, we have collaborated with Dr. Steven Wright and Dr. Nathan Cherrington at the University of Arizona to generate numerous models for important human drug transporters. CPI have also developed the prototype for MegaTransÒ, curating numerous transporter datasets then generating and tested the resulting models. This Phase II award will allow us to perform additional in vitro testing (at the University of Arizona) to expand our models and develop MegaTransÒ further as a commercial product available for licensing by pharmaceutical and other groups so they can benefit from our expertise." said Sean Ekins, CEO, CPI.

Drs. Stephen Wright and Nathan Cherrington of the University of Arizona are long-term collaborators with Collaborations Pharmaceuticals, Inc. This joint effort builds upon extensive experience and extends the mechanistic understanding of drug disposition to the whole patient by accurately predicting functional disposition. This collaboration is now poised at the forefront of understanding xenobiotic disposition and predicting the mechanistic features that determine human exposure and response to drugs.

We are not aware of any other company pursuing such an approach to both generate new high value datasets or models, performing testing of their own models and creating a wide array of transporter models. MegaTrans can be applied in these various companies or organizations to aid in decision making or in regulatory submissions.

On September 2, 2022 Neukio Biotherapeutics, a company committed to developing novel cell therapy products, reported it has closed $50 million in a Series A-1 funding round (Press release, Neukio Biotherapeutics, SEP 2, 2022, View Source [SID1234618940]). The investment round was led by CD Capital, with the participation of Alwin Capital and Surplus Capital as new investors. Existing shareholders Lilly Asia Ventures, Sherpa Healthcare Partners and IDG Capital have continued to support the company with additional funding. G&G Capital served as the exclusive financial adviser. The funds raised will play important roles in accelerating the preclinical and clinical validation of induced pluripotent stem cell (iPSC)-derived off-the-shelf CAR-NK cell therapy products, and supporting team recruitment and expansion.

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Neukio, founded at the Simbay Park in Shanghai Pilot Free Trade Zone (China) in June 2021, is an innovative biotherapeutic company focusing on the development and commercialization of next generation immune cell therapy. Leveraging its significant experience in the R&D, CMC and commercialization of autologous CAR-T cell therapy, Neukio’s management team has established an iPSC-CAR-NK-based pipeline development strategy, aiming to launch allogenic off-the-shelf cell therapy products that can be produced in scale for treating solid tumors. The company focuses on both in-house R&D innovation and global collaboration with leading partners, to provide valuable clinical solutions for cancer patients worldwide. Since its establishment just over one year ago, the company has made remarkable progress in talent recruitment, facility construction, R&D pipeline advancement and quality management system establishment, exceeding all expectations.

Dr. Richard Liqun Wang, founder, chairman and CEO of Neukio and former founding CEO of Fosun Kite Biotechnology Co., Ltd., has successfully brought China’s first CAR-T cell therapy product Yescarca (Axicabtagene Ciloleucel) to the market in less than four years, laid foundation for the cell therapy industry in China. To address the challenges in manufacturing, clinical application, and patient access of autologous cell therapy, Dr. Wang and the Neukio team are aiming high to create novel cell therapies for the benefit of cancer patients by exploiting the clonality and unlimited replication capability of iPSCs in conjunction with cutting-edge gene editing technologies.

Dr. Wang commented: "In as little as 10 months since the operation of our new laboratories, not only have we completed several signaling pathway modifications and CAR designs tailored for solid tumors, but also we have made significant progress in the development of innovative manufacturing processes of NK differentiation and expansion. In today’s challenging environment of capital market, we are honored to have received recognition from CD Capital, Alwin Capita, Surplus Capital, and previous investors of Sherpa Healthcare Partners, Lilly Asia Ventures and IDG Capital on our R&D strategy, development capabilities and project progress. I am very grateful to all investors and to G&G Capital and Silkroad Law Firm for their support in this round of financing, and we will reward them with rapidly moving forward in the preclinical and clinical validation of our R&D platform and products. The field of cell therapy is rapidly advancing with a promising future and a huge market potential, and iPSC-CAR-NK therapy has the potential to become one of the brightest stars of next generation cell therapy."

"The transition from traditional small molecules and antibodies to the era of cell therapy is a great leap in drug design and manufacturing capabilities of human being," said CD Capital, the leading investor in this round of financing. "With the commercialization of autologous CAR-T cell products, more and more improvement opportunities have emerged and need to be taken urgently. In the field of cell therapy, CD Capital continues to focus on innovations and breakthroughs in allogenic products to conquer solid tumors. Neukio has been deeply committed to iPSC-CAR-NK cell therapy. Within a short time of its establishment, Neukio has built up global leading technology platforms efficiently in both scientific innovation and process development, demonstrating its strong execution capability and efficiency. We hope that the company, under the leadership of Dr. Wang, will adhere to pragmatism, efficiency, and innovation, leading the advancement of the industry, and bringing a new generation of allogenic cell therapy products to the clinical application as soon as possible for the benefit of patients."

On September 2, 2022 Amgen (NASDAQ:AMGN) reported that it will present at Wells Fargo’s 2022 Global Healthcare Conference at 9:45 a.m. ET on Thursday, September 8, 2022 (Press release, Amgen, SEP 2, 2022, View Source [SID1234618938]). David M. Reese, M.D., executive vice president of Research and Development and Peter H. Griffith, executive vice president and chief financial 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.