PARP7 inhibitors(Azkarra)

BEIJING, SHANGHAI and BOSTON, March 28, 2024 Jacobio/PRNewswire/ -- Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced its 2023 annual results. The revenue was RMB63.5 million, the R&D investment was RMB372 million, the cash and cash equivalent at the end of 2023 was RMB 1.2 billion. Jacobio Pharma also announced its recent business progress and expected milestones. Dr. Wang Yinxiang, Chairman and CEO of Jacobio Pharma, said: "In the past year, Jacobio continued to make progress in our projects. We received approval for registrational phase III clinical trial of the combination therapy between our SHP2 inhibitor JAB-3312 and KRAS G12C inhibitor glecirasib. Our JAB-3312 became the first SHP2 inhibitor to enter into registrational trial. This milestone is consistent with our mission of 'drugging the undruggable'. Meanwhile, the patient enrollment for pivotal trial of our core product glecirasib has been completed, and the NDA application expected to be submitted in the first half of 2024. This marks that Jacobio will enter into the commercial stage." Development of core clinical stage products KRAS G12C inhibitor Glecirasib (JAB-21822) Non-small cell lung cancer (NSCLC) The patient enrollment for pivotal trial of glecirasib monotherapy in ≥2L NSCLC patients harboring KRAS G12C mutation was completed. The NDA application is expected to be submitted to CDE (Center for drug evaluation, NMPA) in Q2 2024 as planned. 1L NSCLC is in combination with SHP2 inhibitor JAB-3312. The phase III registrational trial was approved by CDE. Pancreatic cancer (PDAC) The pivotal trial of glecirasib monotherapy in ≥2L PDAC patients was activated in China. The results were presented at the 2024 American Society of Clinical Oncology (ASCO) GI Annual Meeting. The cORR was 41.9% (13/31) and the DCR was 93.5% (29/31). The median progression-free survival (mPFS) was 5.6 months. Colorectal cancer (CRC) The clinical results of glecirasib monotherapy and glecirasib combined with cetuximab in advanced colorectal cancer were presented at the Second JCA- AACR Precision Medicine International Conference. Phase III pivotal trial design of glecirasib monotherapy or glecirasib in combination with cetuximab is expected to be approved by CDE in Q2 2024. Multi-tumors basket Multi-tumors basket includes biliary tract cancer, gastric cancer, small bowel cancer, appendices cancer, etc. The results were presented at the 2024 American Society of Clinical Oncology (ASCO) GI Annual Meeting. The cORR was 57.9%（11/19), DCR was 84.2%（16/19), mPFS was 7.0 months. A phase II single arm pivotal trial is under communication with CDE. SHP2 inhibitor JAB-3312 The Phase III pivotal trial of JAB-3312 in combination with glecirasib to treat 1L NSCLC patients has been approved by CDE, and this study in China is expected to initiated in Q3 2024. JAB-3312 is the very first SHP2 inhibitor entering a phase III registrational trial worldwide. The clinical data of glecirasib in combination with JAB-3312 was published at the 2023 European Society for Medical Oncology Congress (ESMO 2023). Glecirasib (800mg once daily) + JAB-3312 2mg (once daily for 1 week on, then 1 week off) dosage yielded ORR of 86.7% (13/15) and DCR of 100% (15/15). Long term safety and efficacy data have submitted to the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Development of other clinical products P53 Y220C activator JAB-30355: The IND has been approved by U.S. FDA (Food and Drug Administration), and phase I clinical trial is expected to be initiated in the second half of 2024. Preclinical data will be presented at the AACR Annual Meeting 2024. BET inhibitor JAB-8263: A Phase II trial of JAB-8263 monotherapy or combination therapies is planned to be initiated in the second half of 2024. Clinical data will be published at the 2024 European Hematology Association (EHA) Congress. Aurora A inhibitor JAB-2485: RP2D is anticipated to be determined in Q2 2024. The preclinical study of JAB-2485 was presented at the 2023 AACR. Anti-CD73 humanized monoclonal antibody JAB-BX102: RP2D is anticipated to be determined in Q2 2024. The preclinical study of JAB-2485 was presented at the 2023 AACR. PARP7 inhibitor JAB-26766: Preclinical data will be presented at the AACR Annual Meeting 2024. We are optimizing the clinical development strategy for PARP7 inhibitor JAB-26766, GUE (glutamine-utilizing enzyme) inhibitor JAB-24114, and LIF mAb JAB-BX300 considering the current treatment landscape and our resources available. Development of other pre-clinical products KRASmulti inhibitor JAB-23E73: The IND application is expected to be submitted in Q2 2024. Clinical candidate for HER2-STING iADC JAB-BX400 is expected to be nominated in the second half of 2024. As of December 31, 2023, Jacobio owned 340 patents or patent applications that are filed globally, of which 82 patents have been issued or allowed in major markets globally. During the performance period, Jacobio raised HKD159 million through public placing, and obtained RMB150 million from Beijing E-town Capital. As of December 31, 2023, Jacobio has RMB 1.2 billion cash and cash equivalent, providing sufficient cash reserves for R&D investment in the next 30-36 months. Jacobio repurchased and canceled 1.807 million shares, continuing to increase shareholder value. Conference Call Information Jacobio Pharma will hold a live conference call at 10:30 AM March 29 2024 Beijing time. Participants please register in advance through . About Jacobio Jacobio Pharma (1167.HK) is committed to developing and providing new and innovative products and solutions to improve people's health. Our pipeline revolves around novel molecular targets on six major signaling pathways: KRAS, immune checkpoints, tumor metabolism, P53, RB and MYC. We aim for our key projects to be among the top three in the world. Our vision is to become a global leader recognized for our impact in drug R&D together with our partners. Jacobio has R&D centers in Beijing, Shanghai and Boston with our Induced Allosteric Drug Discovery Platform (IADDP) and our iADC Platform. SOURCE Jacobio Pharma

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Ribon Therapeutics, a clinical-stage biotechnology company developing therapeutics to target stress support pathways, today announced dosing the first patient in the open-label cohort of patients with moderate-to-severe atopic dermatitis to measure the pharmacodynamic activity of RBN-3143 and evaluate the safety and preliminary efficacy of 28 days of administration of RBN-3143 in this target population. “As a first-in-class, oral, small molecule inhibitor of PARP14, RBN-3143 has the potential to treat a range of inflammatory diseases, including but not limited to atopic dermatitis, asthma and ulcerative colitis. Following the successful completion of the single and multiple ascending dose assessment in healthy subjects to assess safety and pharmacokinetics, we are pleased to be advancing this study into patients with moderate-to-severe atopic dermatitis, the first therapeutic area of focus for the RBN-3143 program,” said Prakash Raman, Ph.D., President and Chief Executive Officer, Ribon Therapeutics. “As a leading company focused on novel targets in the field of cellular stress response, the initiation of the atopic dermatitis portion of our Phase 1 study marks an important advancement in evaluating NAD+-utilizing enzymes as targets for inflammatory diseases.” “In preclinical models, RBN-3143 suppresses markers of disease, demonstrating its potential as an oral alternative to biologics in a broad range of inflammatory diseases of the skin, lung and the gastrointestinal system,” said Sudha Parasuraman, M.D., Chief Medical Officer, Ribon Therapeutics. “RBN-3143 has demonstrated a favorable safety and pharmacokinetic pro healthy subjects and we look forward to its evaluation in patients with moderate-to-severe atopic dermatitis and to demonstrate proof-of mechanism.” About PARP14 PARP14 is a NAD+-utilizing monoART (mono-ADP-ribosyltransferase) controlling cell signaling and regulating protein function. PARP14 expression is elevated in tissues of various inflammatory diseases, but it is not highly expressed in normal tissues. Elevated PARP14 expression leads to higher levels of first order cytokines, specifically alarmins, and second order cytokines, Th2 and Th17 cytokines, in the inflammatory lesion, and ultimately the increase in disease tissue eosinophils and neutrophils which drive pathology. About RBN-3143 RBN-3143, a first-in-class, oral small molecule inhibitor of PARP14, has the potential to be a differentiated therapy for the treatment of numerous inflammatory diseases. This is the second program emerging from the BEACON+ platform to enter clinical development. Selective inhibition of PARP14 leads to a decrease in alarmins and dampening of the IL-17 and IL-4/13 signaling pathways. Ribon has demonstrated efficacy in multiple preclinical models of inflammatory disease. RBN-3143 is currently being evaluated in a Phase 1 clinical study in healthy volunteers and atopic dermatitis patients. About Ribon Therapeutics Ribon Therapeutics is a clinical-stage biotechnology company developing therapeutics targeting novel enzyme families activated under cellular stress conditions that contribute to disease. Ribon’s portfolio includes two oral, first-in-class clinical programs, RBN-2397 (a PARP7 inhibitor) and RBN-3143 (a PARP14 inhibitor), targeting broad indications in oncology and inflammatory diseases, respectively. The company explores novel areas of biology with the goal of developing effective treatments for patients with limited therapeutic options. Leveraging its proprietary BEACON+ (Blocking the Enzyme Activity Component of NAD+) platform, Ribon is building a pipeline of selective, small molecule inhibitors to numerous NAD+-utilizing enzymes, beginning with monoARTs (mono-ADP-ribosyltransferase), which have applications across multiple therapeutic areas. Ribon is located in Cambridge, Massachusetts. For more information, visit .