Cogent Biosciences to Host Virtual R&D Investor Event

On March 29, 2022 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported details for its planned Virtual R&D Investor Event on Friday, April 8, 2022, beginning at 4:05 PM EDT (Press release, Cogent Biosciences, MAR 29, 2022, View Source [SID1234611086]). Attendees can register HERE for the event.

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Cogent will share updates on recent progress, including additional nonclinical data demonstrating the potential of bezuclastinib as a best-in-class KIT mutant inhibitor, outline its strategy and focus to create best-in-class small molecules for genetically defined diseases, and present early data from its growing pipeline of novel, small molecule targeted therapy programs, including Fibroblast Growth Factor Receptor 2 (FGFR2).

Featured speakers include:

Andrew Robbins, President and Chief Executive Officer
John Robinson, PhD, Chief Scientific Officer
Jessica Sachs, MD, Chief Medical Officer
Access to the webcast will be available on the investor relations section of Cogent’s website, including an archived replay of the webcast at View Source

The Virtual Investor R&D Event will coincide with the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, taking place April 8-13 at the Ernest N. Morial Convention Center in New Orleans, Louisiana, at which Cogent will share data from two poster presentations. The first poster presentation (Abstract 147) will highlight new nonclinical data on the unique properties of bezuclastinib that differentiate it from other KIT inhibitors. Bezuclastinib is currently under clinical investigation in Advanced Systemic Mastocytosis (NCT04996875), Nonadvanced Systemic Mastocytosis (NCT05186753), and imatinib-resistant Gastrointestinal Stromal Tumors (GIST) (NCT05208047). A second poster presentation (Abstract 167) will reveal in vitro and in vivo characteristics of a novel series of FGFR inhibitors with potency against clinically relevant mutations. The AACR (Free AACR Whitepaper) poster presentations will be made available through the AACR (Free AACR Whitepaper) conference website on Friday, April 8 at 1:00 PM EDT, and the in-person poster presentations will occur Sunday, April 10, 1:30 – 5:00 PM CDT.

Biodesix Announces Publication Further Validating the use of Liquid Biopsies and NGS Techniques to Provide Clinical Information for Patients with Cancer

On March 29, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that new data were published in the peer-reviewed journal, Diagnostics (Basel), in an article titled, "Analytic and Clinical Validation of a Pan-Cancer NGS Liquid Biopsy Test for the Detection of Copy Number Amplifications, Fusions and Exon Skipping Variants (Press release, Biodesix, MAR 29, 2022, View Source [SID1234611085])." This peer-reviewed publication further validates the GeneStrat NGS test and the use of multiple classes of tumor markers in circulating free nucleic acid analysis as a surrogate for tumor tissue biopsies. [i]

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"These data extend on Biodesix’ testing of plasma for somatic nucleotide variants and indels in circulating nucleic acids by detecting amplifications, fusions and exon skipping. We can broadly assay for the major variant classes which includes actionable mutations in support of comprehensive molecular testing in lung cancer," said Gary Pestano, Ph.D., Chief Development Officer, Biodesix.

Additionally, Biodesix will present data associated with the GeneStrat ddPCR and NGS blood tests in a poster presentation focused on reporting validation studies of key actionable mutations in NSCLC entitled: Analytic and clinical validation of a new pan-cancer NGS liquid biopsy test for the detection of copy number variations, fusions/exon skipping, somatic variants and indels (Abstract number 5323), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from April 8-13, 2022. The full abstract can be found on the official AACR (Free AACR Whitepaper) website here. Poster presentations will be viewable after April 8th, 2022.

The company believes that the coupling of highly sensitive, rapid stand-alone droplet digital PCR (ddPCR) and the NGS techniques offers more comprehensive blood-based testing support for patients with non-small cell lung cancer (NSCLC) and provides clinically relevant information both before and after targeted treatment of patients with cancer.

Apeiron Closes $17.5 Million Series A and Launches Strategic Partnerships

On March 29, 2022 GT Apeiron Therapeutics (‘Apeiron’) reported it has completed a $17.5 million Series A financing (Press release, GT Apeiron Therapeutics, MAR 29, 2022, View Source [SID1234611079]). Panacea Venture led the investment round with participation from Viva BioInnovator and existing investors. This is the company’s second round of financing in the last year following a Pre-A+ round in May 2021. The investment will enable the company to advance its lead CDK7 program to enter clinical trials, as well as several earlier stage programs. In conjunction with the financing, James Huang, Founding Managing Partner at Panacea Venture joined the Apeiron Board of Directors.

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Apeiron, in collaboration with Exscientia (NASDAQ: EXAI), is developing a pipeline of novel CDK therapies. Its leading asset, GTAEXS617, an orally bioavailable, highly potent and selective small-molecule inhibitor of CDK7, is currently in IND-enabling studies and pre-clinical data will be presented at this year’s AACR (Free AACR Whitepaper).
Apeiron also announced a strategic partnership with Viva Biotech (HK: 01873) under which Viva Biotech provides world-leading structure-based drug discovery expertise to enhance Apeiron’s AI-empowered innovative drug discovery and development platform.

"We are excited to welcome a group of visionary investors, embracing our journey and mission to deliver breakthrough therapies to cancer patients globally," said Dr. Mingxi Li, Co-Founder and CEO of Apeiron, "Over the past two years, our team has built a unique pipeline of precision oncology therapies, focusing on CDKs and synthetic lethality. We will continue strengthen our integrated drug discovery platform with AI and structural biology."

Kati Medical completed over 70 million yuan in Series A+ financing, accelerating the IND filing and pipeline development of leading products

On March 28, 2022 Nanjing Kati Medical Technology Co., Ltd., a cutting-edge domestic solid tumor CAR-T cell therapy company, reported in early February 2022, the company completed an A+ round of financing totaling more than 70 million yuan (Press release, CART Medical, MAR 28, 2022, View Source [SID1234639848]). This round of financing was jointly completed by Nanjing Chengyi Investment, Qiandao Group, Suzhou Guanya Investment and Haihui Investment. This round of financing will be mainly used to promote IND filing for Kati Medical’s leading product.

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Kati Medical was established in 2017 and is headquartered in the Nanjing Biopharmaceutical Valley, a national-level Jiangbei New Area in Nanjing. It is a key enterprise in the genetic and life health fields and a national high-tech innovation enterprise in Jiangbei New Area. Kati Medical focuses on the development of new CAR-T cell drugs for solid tumors. Focusing on the solid tumor microenvironment, the proprietary technology platform has significant potential. Kati Medicine was founded by Dr. Wang Enxiu, a core member of Carl June’s team at the University of Pennsylvania. The company’s core leadership team comes from the Chinese Academy of Sciences, Tsinghua Union Medical College, Nanjing Medical University, and MD Anderson Cancer Center in the United States. Center and other top institutions have rich experience and high professionalism in oncology, drug research and development, commercial operations, etc. Dr. Wang Enxiu has achieved breakthrough results in CAR-T flexible activation design, and the core patent has been authorized by European, American and Chinese patents. Immune cell CAR-T drugs currently show significant efficacy in the clinical treatment of hematological tumors, but most current CAR-T products have poor efficacy against solid tumors. Dr. Wang pointed out that this is mainly related to the structural design of CAR. Solid tumors have a more complex microenvironment than hematological tumors. Without technological innovation, it is difficult to apply the structural design of traditional CAR to bring clinical efficacy. Cati Medical has identified this need and pain point, concentrated its efforts, designed the CAR-T architecture for the solid tumor microenvironment, and independently developed a new DAP-CAR-T solid tumor CAR-T technology platform. The DAP-CAR-T technology platform based on flexible activation can effectively improve the adaptability of CAR-T cells to the tumor microenvironment, reduce clinical side effects and have good durability. Kati Medical relies on its own technology platform to develop a series of new candidate R&D drugs with independent intellectual property rights. It has 5 R&D pipelines including KT030, KT032, KT095, KT081, and KT051. Among them, KT032 treats pancreatic cancer, ovarian cancer, and mesothelial cancer. Cancer and other solid tumors are designated as indications, and it is the leading research and development pipeline of Kati Medicine. KT032 is a solid tumor CAR-T product targeting Mesothelin. Early IIT data show that among 8 patients with mesothelin-positive solid tumors (one of which was pancreatic tumor and the rest were ovarian cancer), the best curative effect after treatment was PR (4/7), SD (3/7), and the overall response rate ( ORR) was 57.5%, the disease control rate (DCR) was 100%, the median progression-free survival was 7 months, and the longest progression-free survival was 17 months; the median survival was 11.625 months, and the longest survival The term is 17 months. Kati Medical is currently carrying out in-depth cooperation with top domestic hospitals. The number of patients enrolled in the trial continues to increase, forming a trial progress rate of one case recovery, one case preparation, and one case blood collection, and continues to collect trial data. Dr. Wang Enxiu, founder of Kati Medical, said: "Our vision is to be the most innovative cell drug company in China. Currently, Kati Medical has built a third-generation signaling platform for the "activation end" of CAR, which can realize target replacement at any time. , thereby expanding different indications. In the future, we will use our own innovative platform to open a richer product pipeline and achieve more diversified product transformation." Wang Yuan, partner of Nanjing Chengyi Investment, said: "Kati Medical The founder of Penn made a significant contribution to the collaboration between Penn and Novartis to promote the launch of the world’s first CAR-T drug. He has more than ten years of experience and accumulation in the field of CAR-T technology and is a trustworthy partner. In addition, , we attach great importance to Kati Medical’s own technology platform, based on which Kati Medical can establish a rich product pipeline for different solid tumors." Jiang Yu, investment director of Qiandao Investment Fund, said: "There are many fields in the field of gene and cell therapy. Opportunities for layout, CAR-T has shown good clinical efficacy in the treatment of hematological tumors, but there is still room for breakthrough in solid tumors. We recognize the accumulation and experience of Kati Medical and founder Dr. Wang Enxiu in the CAR-T field, and are optimistic about it The layout and prospects of the company’s product pipeline." About Chengyi Investment Chengyi Investment was founded in 2015, based in Nanjing and radiating to the Yangtze River Delta region. Focus on equity investment and value-added services in early and growth stages, with a core focus on biomedicine and technological innovation. At present, the scale of Chengyi Investment Management Fund is nearly 2 billion yuan. In the field of biomedicine, we have invested in a number of outstanding companies that represent the future development direction, including Zhonghui Biotech, Bioxin Biotech, and Kewang Pharmaceuticals. In addition to capital assistance, Chengyi Investment also provides all-round and multi-level help and support to each invested enterprise to promote enterprise innovation and growth, so that they can eventually develop into industry leaders and beneficially promote industrial change and social progress. About Gandao Group Gandao Group was founded in 2011. Adhering to the concept of "technology empowers finance, financial services industry, and industry serves the motherland", it is deeply involved in China’s economic development and industrial upgrading, and is committed to becoming a comprehensive holding company that leads innovation with technology and serves the real economy. group. Qandao focuses on multiple asset management and investment businesses such as equity investment, industrial investment, and special opportunity investment. The group owns Qandao Investment Fund Management Co., Ltd., which focuses on medicine and medical technology, advanced manufacturing, and new energy, as well as a subsidiary of a state-owned enterprise under mixed ownership reform— —China Emerging Asset Management Co., Ltd. and many other member companies. Qandao’s pharmaceutical and medical investment focuses on innovative drugs including biomedicine, in vitro diagnostics, innovative medical devices, medical services and technology. About Suzhou Crown Asia Investment Suzhou Guanfengyu Venture Capital Center (Limited Partnership) is a private equity investment fund managed by Crown Asia Investment. Crown Asia Investment is established by professionals with senior professional background, work experience and independent judgment. , has rich investment experience and resource accumulation in the fields of biomedicine and equipment, semiconductors and new energy. Guided by industrial development needs, based on hard-core technology investment, and relying on rich industrial resources, the company continuously discovers and cultivates outstanding innovative enterprises with growth potential, creates long-term value for investors, and supports the growth of innovative enterprises. Protect and protect. About Haihui Investment

Haihui Investment was established in 2007 and is headquartered in Guangzhou. It is the first venture capital fund in Guangzhou to obtain national registration and management. It is a venture capital institution (VC) that has long been focused on start-up companies. It has worked with Jiete Biotech, Hongya CNC, Boyun New Materials, Gaolan Shares, Lushan New Materials, etc. have dozens of successful IPO exit cases as early investors. The cumulative assets of its managed funds are tens of billions. It is the national technology-based small and medium-sized enterprise guidance fund recognized management agency, and has been continuously It has received key support from the National Venture Capital Guidance Fund Project for more than ten years.

Immorna Biotherapeutics, Inc. Receives IND Clearance to Conduct FIH Study of JCXH-211, the First-in-Class Self-replicating mRNA

On March 28, 2022 Immorna Biotherapeutics, Inc. (Immorna), a rapidly-expanding biotechnology company developing both self-replicating and conventional mRNA-based therapeutics and vaccines, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for JCXH-211, a novel self-replicating mRNA encoding human interleukin (IL)-12 protein (Press release, Immorna, MAR 28, 2022, View Source [SID1234619633]).

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This IND clearance allows Immorna to initiate a Phase 1, multi-center, open-label, First-in-Human (FIH) dose escalation and expansion study of JCXH-211 in patients with malignant solid tumors, administered via intratumoral injection. The goal of the study is to establish a recommended dosing regimen, and assess the safety, tolerability and preliminary efficacy of JCXH-211 in cancer patients.

JCXH-211 is the first-in-class lipid nanoparticle (LNP) encapsulated self-replicating mRNA, using Immorna’s proprietary technology, encoding the human IL-12 protein. The strong anti-viral innate response triggered by RNA replicon together with the potent anti-cancer immunity stimulated by IL-12 conferred JCXH-211 superior tumor-eradicating potency in multiple preclinical animal and patient-derived xenograft (PDX) models, which was better than similar investigational drug employing conventional (non-replicating) mRNA. JCXH-211 was manufactured by Immorna’s robust CMC process and showed very favorable safety profiles in comprehensive GLP toxicology studies.

IL-12 is a naturally occurring cytokine that plays a key role in the body’s immune response against cancer. Despite consistently showing potent antitumor activity in preclinical studies, the efficacy of IL-12 treatment at tolerable doses in humans failed to provide clinical benefit. One key challenge for IL-12 treatment is the delivery method. IL-12 given through bolus injection was unstable and had a short half-life, and frequent intravenous administration of recombinant human IL-12 protein was challenging due to unacceptable toxicities. Alternate localized delivery systems, such as intratumoral injection, could potentially help to overcome this hurdle by directly targeting the tumor microenvironment whilst limiting systemic exposure and thereby minimizing adverse effects.

"IL-12 is crucially important in providing the immune antitumor response," said NgocDiep Le, M.D., Ph.D., Global Chief Medical Officer of Immorna. "Immorna is excited to have received FDA clearance to initiate this FIH study of JCXH-211, the first-in-class LNP-encapsulated self-replicating mRNA encoding human IL-12 protein, in patients with malignant solid tumors. We look forward to working with the investigators and patients to bring this potential novel therapy to patients who are in dire need of new and effective treatments."

"Our RNA encodes innovation. With this IND clearance, we are thrilled that Immorna is now transitioning into a clinical-stage biotech," said Zihao Wang, Ph.D., Co-Founder and Chief Executive Officer of Immorna. "Since its founding, Immorna has established robust processes that can efficiently and consistently produce high quality and potent cell-replicating as well as conventional mRNA. Immorna has also developed an arsenal of mRNA delivery vehicles, including thermal-stable ones. This IND clearance of JCXH-211 marks Immorna’s first Oncology investigational drug to be tested in humans and, more importantly, FDA’s acceptance of our mRNA platform technology. We expect to bring more potentially life-saving drugs and vaccines to the clinic in the near future."