Eli Lilly & Co.

ROCKVILLE, Md. and SUZHOU, China, April 7, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that preclinical data on multiple novel bispecific antibodies as well as antibody-drug-conjugates (ADCs) from its oncology pipeline are presented at the American Association for Cancer Research (AACR) Annual Meeting 2024. Late-Breaking Research: Experimental and Molecular Therapeutics 1 Topic: IBI3001: a potentially first-in-class site-specific glycan-conjugated B7-H3/EGFR bispecific ADC for multiple solid tumors Abstract Number: LB055 Presentation Form: Poster Presentation Time : Sunday Apr 7, 2024 1:30 PM - 5:00 PM Location: Poster Section 53 Presenting Author: Dr. Kaijie He IBI3001 is a potentially first-in-class bispecific ADC against B7-H3 and EGFR that is site-specifically glycan-conjugated using the clinically validated SYNtecanE® platform. IBI3001 has multiple anti-tumor mechanisms of action: (1) enhanced EGFR signaling blockade; (2) EGFR- and B7-H3-aided payload internalization and cytotoxicity; and (3) potent bystander killing effects of ADC. The optimized B7-H3 arm not only enhances the EGFR signaling blockade but also reduces EGFR on-target toxicities. IBI3001 showed strong anti-tumor efficacy in vitro and in vivo across multiple solid tumors and is well tolerated with the therapeutic index at 40. Topic: IBI334, a novel ADCC-enhanced B7-H3/EGFR bispecific antibody, demonstrated potent pre-clinical efficacy in solid tumors Abstract Number: LB056 Presentation Form: Poster Presentation Time : Sunday Apr 7, 2024 1:30 PM - 5:00 PM Location: Poster Section 53 Presenting Author: Dr. Kaijie He IBI334 is an afucosylated bispecific antibody against B7-H3 and EGFR that is constructed using Innovent's proprietary Innobody platform. With the aid of B7-H3, IBI334 showed better tumor growth inhibition in vitro and in vivo than EGFR monoclonal antibody and c-met/EGFR bispecific antibody benchmarks. IBI334 has a favorable safety profile with the highest non-severely toxic dose (HNSTD) in cynomolgus monkeys at 120 mg/kg and a large therapeutic window of > 200 folds. As a promising bispecific antibody against multiple solid tumors, IBI334 is currently under clinical evaluation. Topic: Discovery and preclinical characterization of IBI343, a site-specific glycan-conjugated anti-Claudin18.2 ADC for treating solid tumors Abstract Number: LB057 Presentation Form: Poster Presentation Time : Sunday Apr 7, 2024 1:30 PM - 5:00 PM Location: Poster Section 53 Presenting Author: Dr. Kaijie He IBI343 is a potentially first-in-class anti-Claudin 18.2 ADC that is site-specifically glycan-conjugated to cytotoxin exatecan via Synaffix's GlycoConnect® technology. It demonstrated Claudin 18.2-specific in vitro cytotoxicity on a series of cancer cell lines at varying levels of target expression, and potent in vivo efficacy in multiple xenograft models. The glycan-based conjugation technology leads to enhanced stability of the ADC molecule. IBI343 displayed good safety profile in GLP toxicology study in rhesus monkey and was well tolerated up to 30 mg/kg. IBI343 has favorable pre-clinical efficacy and safety, and it is currently in preparation for Phase 3 clinical trial for Claudin-18.2-positive HER2-negative gastric cancer. Dr. Kaijie He, Vice President of Innovent, stated: "We are pleased that the pre-clinical studies of our novel anti-cancer drugs are accepted for Late-Breaking Research poster presentation at the 2024 AACR conference. This is the result of dedicated work from scientists at Innovent Academy with the aim to tackle cancers with innovative drugs that are more effective and safer. With careful design and optimization, our molecules can achieve favorable therapeutic windows of 40 to more than 200 times. We look forward to their performance in clinical settings and hope that these innovations can eventually benefit cancer patients." Poster Session: Immunology - Single Target and Bispecific Antibodies Topic: A novel TROP2-targeted immune stimulating antibody conjugate (ISAC) with potent anti-tumoral activity and acceptable safety Abstract Number: 2718 Presentation Form: Poster Presentation Time: Monday Apr 8, 2024 1:30 PM - 5:00 PM Location: Poster Section 6 Poster Board Number: 9 Presenting Author: Dr. Huizhong Xiong Immune stimulating antibody conjugates (ISACs) are a unique class of ADC in which antibodies recognizing tumor antigens are conjugated with immune agonists. ISACs target tumor tissue and specifically activate intra-tumoral myeloid cells, unleashing downstream immune response. Like the other immune agonists, balance between efficacy and safety remains a challenge for ISACs. Here we describe a potential first-in-class TROP2 ISAC with rationally selected antibody and TLR7/8 agonist linker-payload. The anti-TROP2 antibody elicited robust ADCP of TROP2+ tumor cells by macrophages. In-vitro, TROP2 ISAC mildly activated myeloid cells only in the presence of TROP2+ tumor cells. In-vivo, the molecule potently suppressed tumor growth in different TROP2+ xenograft tumors, and effectively enhanced killing of an ADC. In terms of safety, the ISAC was tolerated in both WT and hTROP2KI mice, and, importantly, in monkeys. Taken together, our data demonstrate a novel TROP2 ISAC with outstanding efficacy and manageable safety profile, which may benefit patients with TROP2+ tumors. Poster Session: Immunology - Immune Modulation Employing Agonist or Co-Stimulatory Approaches Topic: Tumor targeted-CD28 bispecific antibody with optimized potency, robust anti-tumoral activity and stringent CD3-dependence Abstract Number: 5295 Presentation Form: Poster Presentation Time: Tuesday Apr 9, 2024 1:30 PM - 5:00 PM Location: Poster Section 3 Poster Board Number: 4 Presenting Author: Dr. Huizhong Xiong We reported a rationally screened CD28 agonist antibody and its PSMAxCD28 bispecific format, IAR038. IAR038 has minimal activity in the absence of CD3, even under stringent conditions, different from benchmark antibody in clinical development. It demonstrated moderate activity in vitro in a CD3-dependent and PSMA-dependent manner. Notably, IAR038 elicited superior tumor killing in vivo and combined effectively with anti-PD1 antibody. In addition, it had an improved half-life compared with the Benchmark antibody. These features may translate to a wider therapeutic window and improved safety for CRPC patients. Dr. Huizhong Xiong, Senior Director of Immunology of Innovent, stated: "We keep pushing for deeper understanding and more rational design of agonistic and costimulatory molecules. Our work on tumor targeted TLR7/8 agonist and tumor targeted CD28 antibody demonstrates the capability of our biology-driven drug development to achieve better balance between efficacy and safety, made possible by our advanced technology platforms." About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 3 new drug applications under the NMPA review, 5 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. SOURCE Innovent Biologics

Gala honors Pioneer in Dermatology, Emma Guttman-Yassky, MD, PhD and Global Pharmaceutical Leader Eli Lilly and Company NEW YORK, April 5, 2024 /PRNewswire/ -- On Thursday evening, at The Plaza Hotel, American Skin Association (ASA) held their Spring Gala. They presented awards to two outstanding honorees and celebrated another successful year of funding research and educating youth on skin health. The gala was attended by ASA's loyal supporters and donors, including philanthropists, business leaders, and renowned physicians from the field of dermatology. Howard P. Milstein, Chairman of ASA, said, "ASA is proud to present Dr. Emma Guttman-Yassky and Eli Lilly and Company these much-deserved awards for their dedication to the field of dermatology. Both Dr. Guttman-Yassky and Lilly share in our mission and we look forward to continuing to partner as we work towards finding cures for skin diseases." This year, awards were presented to the following: Emma Guttman-Yassky, MD, PhD, System Chair of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai, was presented ASA's Inaugural Therapeutic Innovation Award for her tireless work towards discovering new dermatological therapies which bring hope to patients. The award was presented by ASA Chairman, Howard P. Milstein, who praised Dr. Guttman-Yassky's continuing dedication to dermatological research, her care for patients, and her mentorship of the next generation of dermatologists. She is one of the world's leading experts in inflammatory skin diseases and the first woman to chair a dermatology department in New York. Global pharmaceutical leader, Eli Lilly and Company, received ASA's 2024 Distinguished Corporate Leadership Award. The award was presented by Mark G. Lebwohl, MD and was accepted by Lilly's Head of Dermatology Global/US Medical Affairs, Maria Jose Rueda, MD. Eli Lilly and Company has a nearly 150-year legacy of pioneering life-changing discoveries. Dr. Lebwohl shared that the company is committed to delivering innovative clinical trials that reflect the diversity of our world and continue to work to ensure their medicines are accessible and affordable. Their status as a leading, global medicine company turning science into healing to make life better for more than 51 million people around the world, was applauded. "I congratulate Dr. Guttman-Yassky and Eli Lilly and Company on their honors this evening. We look forward to continuing our long-standing work with physicians like Dr. Guttman-Yassky and organizations like Lilly as we work together to provide hope to patients and their families," said President of ASA, Dr. David A. Norris. For nearly four decades, ASA and its affiliates have funded over $50 million in grants to support the work of more than 300 promising young scientists. Recipients, who work on breakthrough efforts to prevent, detect, and treat skin cancer and other skin diseases, have gone on to become top researchers in dermatology. The critical research funded by ASA addresses not only the causes and treatments of melanoma, vitiligo, psoriasis, atopic dermatitis, and other skin diseases, but also promises remarkable breakthroughs in the search for long-sought-after cures. ASA's educational mission is no less crucial. The organization continues to support the SPOTS (Sun Protection Outreach Teaching by Students) program, a free community outreach program designed to teach students from preschool through high school about the importance of early detection and prevention of skin cancer. ASA's educational contributions are part of a growing worldwide understanding of the importance of skin health awareness. The event's Master of Ceremonies was NBC's Emmy-winning weather anchor Dave Price. Mr. Price has emceed the event in previous years and was once again a wonderful addition to the festivities. ABOUT AMERICAN SKIN ASSOCIATION A unique collaboration of patients, families, advocates, physicians and scientists, ASA has evolved over nearly four decades as a leading force in efforts to defeat melanoma, skin cancer and other skin diseases. Established as a 501(c)(3) organization to serve the now more than 100 million Americans – one-third of the U.S. population – afflicted with skin disorders, the organization's mission remains to: advance research, champion skin health – particularly among children, and drive public awareness about skin disease. For more information, visit americanskin.org. American Skin Association has earned Candid's 2023 Seal of Platinum Transparency and Four-Star Rating from Charity Navigator. SOURCE American Skin Association

Pictured: U.S. and Chinese flags in concrete, broken in the middle/iStock, ffikretow If it hasn’t become painfully obvious yet with the BIOSECURE Act in the news, China is aggressively pursuing a strategy to become the world’s leader in biotechnology, which poses a significant threat to U.S. national security. In recent months, members of Congress and U.S. intelligence officials have warned that Chinese biotech companies may be collaborating with Beijing with the latest example being Wuxi AppTec, a China-based biotech reported to have allegedly transferred a U.S. client’s intellectual property (IP) to the Chinese government without consent. In its annual threat assessment in February 2024, the Office of the Director of National Intelligence (ODNI) warned that Beijing is prioritizing biotech and is trying to fast track its science and technology development through intellectual property (IP) theft and other means for economic, political and military advantage. “China now rivals the United States in DNA-sequencing equipment and some foundational research. Beijing’s large volume of genetic data potentially positions it to lead in precision medicine and agricultural biotechnology applications,” according to the ODNI. Last month, the National Security Commission on Emerging Biotechnology (NSCEB) issued a white paper laying out policy options for the federal government, including requiring the President to conduct a competitive analysis of the state of biotech infrastructure and technological advancement in the U.S. compared to its strategic adversaries. “If the United States does not lead, others will, and we risk a future in which biotechnology undermines, rather than supports, U.S. national security. The People’s Republic of China intends to win the age of biology and is making significant investments and shrewd policy decisions with the intent to outpace the United States,” warned the NSCEB. John Crowley, the new CEO of the industry lobby Biotechnology Innovation Organization (BIO), in an opinion piece in STAT News on Thursday made a similar case that the U.S. must maintain its biotech dominance in the interests of national security. “The country must never be at risk of losing access to safe and effective medicines. That’s why BIO, the organization I lead, supports the BIOSECURE Act, which is aimed at securing America’s domestic biomanufacturing supply chain,” Crowley wrote. “We also announced [March 13] that WuXi AppTec, one of the Chinese companies regulated by the bill, would be ending its relationship with us.” What a difference a week makes! Just last month, BIO said it didn’t support the BIOSECURE Act. Then in a March 5 letter to Attorney General Merrick Garland, Rep. Mike Gallagher (R-Wisc.), chair of the House Select Committee on the Chinese Communist Party, requested that the Department of Justice investigate lobbying by BIO on behalf of WuXi and against the BIOSECURE Act—actions that would raise “concerns that [BIO] is operating as an unregistered agent of a foreign principal while advancing the interests of the People’s Republic of China government.” BIO’s about-face on WuXi and the BIOSECURE Act is mind-boggling. It certainly begs the question why it took a showdown with a member of Congress for BIO to support the BIOSECURE Act and for the lobbying group to part ways with WuXi. Other Companies in Crosshairs The BIOSECURE Act specifically names the BGI Group, MGI, Complete Genomics and WuXi, and it isn’t the only congressional bill targeting these companies. In the Senate, the Prohibiting Foreign Access to American Genetic Information Act of 2024 also seeks to implement a fast-track ban applied to the same four firms, as well as their subsidiaries, from receiving U.S. taxpayer dollars through federal contracts, grants and loans. “The U.S. intelligence community has cited the Chinese Communist Party’s concerted efforts to acquire human genetic and related data through biotechnology companies, such as the BGI Group, as a serious threat to U.S. national security,” according to Senators Gary Peters (D-Mich.) and Bill Hagerty (R-Tenn.), who authored the legislation. And the list of targeted Chinese biotech companies continues to grow. In the House of Representatives, Gallagher and Rep. Raja Krishnamoorthi (D-Ill.) wrote a March 29 letter to Defense Secretary Lloyd Austin urging the Department of Defense to add seven Chinese biotechs to DoD’s 1260H list of “problematic People’s Republic of China” companies, including Innomics, STOmics, Origincell, Vazyme Biotech and Axbio. How will a crackdown on WuXi and other Chinese biotechs affect U.S.-based biopharma companies? Merck, Iovance Biotherapeutics and Kyverna Therapeutics have detailed interactions with the SEC about potential impacts on their future programs. A Kyverna spokesperson in an email statement to BioSpace said it is aware of the “ongoing concerns related to the BIOSECURE Act” and is “closely monitoring the developments.” If that weren’t enough, another area of collaboration that could suffer from these high-pro between the U.S. and China is in the hot area of antibody-drug conjugate (ADC) technology. However, Jake Van Naarden, president of Eli Lilly’s Loxo Oncology division, told BioSpace that nearly all major pharma companies have contract relationships in China and cautioned against “[throwing] the baby out with the bathwater” by shutting down cooperation on ADC and other drug development. Hopefully, cooler heads will prevail. Greg Slabodkin is the news editor at BioSpace. You can reach him at greg.slabodkin@biospace.com. Follow him on LinkedIn.