LIV-1

SHANGHAI, Nov. 7, 2023 /PRNewswire/ -- BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as BioRay) announced that the first patient has been dosed in the Phase I Clinical trial of BRY812, a third-generation antibody-drug conjugate (ADC) targeting LIV-1 for the treatment of advanced malignant tumors. The leading institution of this clinical trial is Sun Yat-sen Memorial Hospital of Sun Yat-sen University, and the principal investigators are academician Song Erwei and Professor Yao Herui. LIV-1, also known as SLC39A6 or ZIP6, is a multipass transmembrane protein belonging to the ZIP superfamily of zinc transporters, possesses zinc transporter and metalloproteinase activities. LIV-1 directly participates in the homeostasis metabolism of intracellular zinc ions, facilitating the transport of zinc ions from the extracellular space or intracellular organelles to the cytoplasm, influencing cell growth. To date, there are no approved drugs worldwide that target LIV-1, making BioRay's BRY812 the first LIV-1 ADC in China and the second to enter clinical trials globally. BRY812 uses the proprietary CysLink™ irreversible chemical conjugation technology platform and highly stable linker to conjugate the antibody with the toxin. BRY812 has shown significant tumor growth inhibition in preclinical studies, and demonstrated excellent anti-tumor activity that is potentially superior to similar drugs. Compared to other drugs of the same class, it exhibits higher circulation stability, effective release of the payload within the tumor while significantly reducing toxin shedding and exchange in serum. This provides BRY812 with a great safety profile and an improved therapeutic window. Furthermore, BRY812 can also induce immunogenic cell death (ICD) and enhance the anti-tumor effects of immunotherapies such as anti-PD-(L)1. Dr. Zhu Wei, CMO of BioRay, stated, " The significant market potential of ADCs requires differentiation in the market competition and expanding coverage to a broader patient population. As the first domestic ADC targeting LIV-1 to enter clinical trials, BRY812 is expected to treat various advanced malignant tumors, meet more clinical medication needs, and provide more treatment options for patients." About BioRay BioRay is a pioneer in China's biopharmaceutical industry focusing on immune-mediated diseases. Its extensive autoimmune and oncology portfolio includes six marketed products and over 10 clinical-stage drug candidates. Operating a fully integrated platform with end-to-end capabilities across drug discovery, clinical development, manufacturing, and commercialization, BioRay has over 1,500 employees globally, with main sites in Taizhou, Hangzhou, Shanghai, and San Diego. SOURCE BioRay Pharmaceutical Co., Ltd

ZUG, Switzerland and BOSTON, Sept. 27, 2023 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today announced poster presentations of preclinical data at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting, taking place in San Diego, CA or virtually from November 1 to 5, 2023. Title: Development of CTX112 a next generation allogeneic multiplexed CRISPR-edited CAR T cell therapy with disruptions of the TGFBR2 and Regnase-1 genes for improved manufacturing and potency Abstract Number: 274 Location: Exhibit Halls A and B1 Date and Time: Saturday, November 4, 2023, 9:00 a.m. – 8:30 p.m. Title: Allogeneic CAR T cells targeting Liv-1 for Breast Cancer Abstract Number: 324 Location: Exhibit Halls A and B1 Date and Time: Saturday, November 4, 2023, 9:00 a.m. – 8:30 p.m. Title: Development of allogeneic, potency-edited, anti-GPC3 CAR-T cells for the treatment of hepatocellular carcinoma Abstract Number: 264 Location: Exhibit Halls A and B1 Date and Time: Saturday, November 4, 2023, 9:00 a.m. – 8:30 p.m. About CRISPR Therapeutics CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom. For more information, please visit . CRISPR THERAPEUTICS® word mark and design logo and CTX112™ are trademarks and registered trademarks of CRISPR Therapeutics AG. All other trademarks and registered trademarks are the property of their respective owners. Investor Contact: Susan Kim +1-617-315-4600 susan.kim@crisprtx.com Media Contact: Rachel Eides +1-617-315-4493 rachel.eides@crisprtx.com

Ladiratuzumab vedotin uses Seagen’s ADC technology—the gem of the Pfizer deal—to target LIV-1, which is expressed on most metastatic breast cancers. Seagen is putting a phase 2 Merck & Co.-partnered antibody-drug conjugate on the shelf for now, nearly three years after signing on to a $1.6 billion partnership for the asset. The company—which is in the process of being acquired by Pfizer—briefly noted in a second-quarter earnings filing Thursday that ladiratuzumab vedotin, or LV, is being deprioritized. Merck confirmed in an email Thursday afternoon that the company is in the process of discontinuing the program.  "LV has been shown to be clinically active with a tolerable safety profile, however, the emerging treatment landscape with newer therapeutics introduces a higher efficacy threshold," Seagen said in a statement to Fierce Biotech.  Merck in September 2020 ponied up $600 million for the ADC, alongside a $1 billion investment in Seagen, at the time known as Seattle Genetics. The companies planned to co-develop LV in combination with Keytruda for breast cancer and other solid tumors. The therapy was in phase 2 testing at the time but little has been detailed about the clinical program since. LV could have been a rival to Gilead Sciences’ Trodelvy. "Several attempts have been made to optimize the profile of LV through combination therapy and varying the dosing regimens, which were insufficient to elevate the efficacy profile of LV to justify moving to a pivotal trial whether as a monotherapy or in combination with Keytruda," the Seagen statement said.  LV uses Seagen’s ADC technology—the gem of the Pfizer megadeal—to target LIV-1, which is expressed in most metastatic breast cancers as well as in melanoma, prostate, ovarian, uterine and cervical cancers. Merck was rumored to be in the running to buy Seagen last year, but the deal—reportedly valued around $40 billion—stalled when the parties could not agree on the right price. Pfizer came out the victor with a $43 billion offer. The Seagen statement noted that the collaboration agreement signed in 2020 is still active.  Merck did not return a request for comment on the future of the LV program as of publication.