BCMA CAR-T Cell(Shenzhen Puruijin Biological Pharmaceutical)

Plus, news about NewAmsterdam, Rocket, ImmunityBio, CG Oncology, Spruce Biosciences, Pharming, Veradermics, Noema Pharma, Ambrosia Biosciences, EsoBiotec, Cellectar Biosciences and Hepion: BenevolentAI’s overhaul: The struggling AI biotech said it plans to lay off staff, consider delisting from the Euronext Amsterdam stock exchange, partner its early-stage assets and undergo other additional organizational shifts as co-founder Ken Mulvany returns . Its Amsterdam-listed stock was down 10% on Wednesday. — Kyle LaHucik Cimeio Therapeutics, Kyowa Kirin make a deal: The Japanese drugmaker is paying up to $300 million as part of an agreement to develop new cell therapies. Additional financial terms were not disclosed. — Jaimy Lee At least three public offerings have been disclosed over the past day, including NewAmsterdam ’s bid to raise $300 million; Rocket ’s upsized $165 million offering ; ImmunityBio ’s $100 million financing ; and CG Oncology ’s offering , which has yet to be priced. — Jaimy Lee Spruce’s Phase 2b fail for endocrine disorder drug: The South San Francisco biotech said tildacerfont administered once daily did not meet the primary endpoint of glucocorticoid reduction in a mid-stage study of people with adult congenital adrenal hyperplasia. But the trial’s principal investigator said the data suggest twice daily dosing may be more effective. Its stock $SPRB was down about 25% on Wednesday morning. — Ayisha Sharma Pharming’s rare disease med passes Phase 3 test in kids: The Dutch drugmaker’s Joenja for activated phosphoinositide 3-kinase delta syndrome (APDS) met the primary endpoints in a late-stage trial of patients aged four to 11 years old. Joenja won FDA approval for APDS patients aged 12 and older in March 2023. Pharming plans to submit global regulatory filings in children starting in 2025. — Ayisha Sharma Veradermics’ $75M Series B: The Connecticut-based dermatology and aesthetics biotech raised the financing as it begins a Phase 2/3 study in hair loss. — Kyle LaHucik Noema adds $35M from EQT Life Sciences: A second close of a Series B first announced in March of last year brings the total for the round to CHF 130 million, which is about $147 million. The cash will fund Noema’s four ongoing Phase 2 trials: mGluR5 negative allosteric modulator basimglurant in trigeminal neuralgia and seizures in tuberous sclerosis complex; gemlapodect, a PDE10a inhibitor, in Tourette syndrome; and NOE-115, a monoamine modulator, in menopause symptoms. — Elizabeth Cairns Merck backs Ambrosia: The New Jersey pharma giant invested in the biotech’s Series A, which now totals $25 million. Ambrosia previously announced plans to take over a former Pfizer site in Boulder as it builds out an oral small-molecule pipeline for obesity and metabolic disorders. — Kyle LaHucik EsoBiotec scores €22M: The Belgian cell therapy specialist raised the equivalent of $23 million from backers that include Thuja Capital, UCB Ventures and Invivo Partners. The company’s immune-shielded lentiviral vector, which is called ESO-T01, is designed to reprogram T lymphocytes into BCMA CAR-T cells in vivo . It will enter an investigator-initiated trial in multiple myeloma in China, its first in humans, and data are expected in the second half of 2025, which could allow expansion to indications including autoimmune diseases. — Elizabeth Cairns Cellectar lays off 60% of its workers: The biotech is prioritizing its pipeline and letting go of staff. Cellectar had 20 employees at the end of 2023. Its stock price $CLRB sank 62% in pre-market trading on Wednesday. — Kyle LaHucik Hepion Pharmaceuticals ends merger plans with Pharma Two B. — Jaimy Lee

82.4% of patients without prior CAR-T achieving Complete Response (CR) or better ROCKVILLE, Md. and SUZHOU, China, Sept. 28, 2023 /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, metabolic, autoimmune, ophthalmology and other major diseases, and IASO Bio, a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, today announced updated long-term follow-up data from two studies for BMCA CAR-T: ( 1) Results from phase 1b/2 study (FUMANBA-1) in patients with relapsed/refractory multiple myeloma (RRMM) treated with Equecabtagene Autoleucel (Abstract Code P-290) and (2) A model to predict the risk of prolonged thrombocytopenia recovery in relapsed/refractory multiple myeloma patients after anti-BCMA CAR-T Treatment (Abstract Code P-288) at the 2023 International Myeloma Society (IMS) Annual Meeting in Vienna on September 27-30, 2023. Poster Presentation #1 Overview Presentation Title: Updated long-term follow-up results of a phase 1b/2 study (FUMANBA-1) in patients with relapsed/refractory multiple myeloma (RRMM) treated with Equecabtagene Autoleucel Session Title: Treatment of Relapsed/Refractory Multiple Myeloma Abstract Code: P-290 Session Date and Time: Saturday, September 28, 2023, 12:30 PM - 1:30 PM EEST Equecabtagene Autoleucel is a chimeric antigen receptor T-cell (CAR-T) therapy featuring fully human B-cell maturation antigen (BCMA)-targeting single-chain fragment variable (scFv) antibody. The updated data showed long-term follow-up efficacy, safety, and persistence of the phase 1b/2 study (FUMANBA-1) conducted in 14 clinical sites in China. This study enrolled RRMM patients who had received ≥3 prior lines of therapy containing at least one proteasome inhibitor and one immunomodulator and whose disease had progressed after the last line of therapy (CTR20192510, NCT05066646). As of the data cutoff date of December 31, 2022, a total of 105 participants received Equecabtagene Autoleucel at 1.0×106 CAR-T cells/kg with a median follow-up of 18.07 months (IQR 12.6~21.8) and median prior four lines of therapy (range 3~23). Among the 105 patients, 69.5% (73/105) had high-risk cytogenetic abnormalities per mSMART 3.0, 13.3% (14/105) had extramedullary disease (EMD), and 11.4% (12/105) had received prior BCMA CAR-T therapy. Efficacy: Among the 103 evaluable patients, the overall response rate (ORR) was 96.1% (99/103), with 91.3% (94/103) of those participants achieving a very good partial response (VGPR) or deeper response, and the stringent complete response/complete response (sCR/CR) rate was 77.7% (80/103). In 91 participants without prior CAR-T therapy, ORR was 98.9% (90/91), 82.4% (75/91) of patients reaching sCR/CR, the 12-month PFS rate was 85.5% (95% CI: 75.75, 91.51). Among the 103 evaluable participants, the median time to response (mTTR) was 16 days (range 11, 179). The 12-month PFS rate was 80.0% (95% CI: 70.33,86.76). 94.2% (97/103) of patients achieved minimal residual disease (MRD) negativity, and all sCR/CR patients achieved MRD negativity. 80.8% (95% CI: 69.59,88.24) of patients sustained MRD negativity over 12 months and the median duration of MRD negativity was not reached. Equecabtagene Autoleucel demonstrated favorable efficacy in patients with multiple myeloma (MM) who had received prior CAR-T therapy. Among the 12 MM patients who previously received CAR-T therapy, the ORR was 75.0% (9/12), with 41.7% (5/12) of those patients achieving sCR. Safety: Among the 105 participants, 93.3% (98/105) experienced cytokine release syndrome (CRS). The majority experienced Grade 1-2 CRS, with only one experiencing ≥ Grade 3 CRS. The median time to CRS onset was 6.0 days (range 1, 13) post- infusion, and the median duration of CRS was 5.0 days (range 2, 30). Only 1.9% (2/105) of the patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS), including one grade 1 and one grade 2 ICANS, with no ≥ grade 3 ICANS. All patients with CRS or ICANS have recovered. Expansion and Persistence: Equecabtagene Autoleucel in peripheral blood reached the peak at a median of 12 days post-infusion, with a median Cmax of 88001.13 copies/ug DNA. CAR Transgenes were still detectable in 50% (32/64) and 40% (4/10) of patients who completed follow-ups 12-month and 24-months after infusion. Anti-CAR antibodies developed in only 20 (19.2%) patients after infusion. Poster Presentation #2 Overview Presentation Title: A model to predict the risk of prolonged thrombocytopenia recovery in relapsed/refractory multiple myeloma patients after anti-BCMA CAR-T treatment Conference Session Title: Treatment of Relapsed/Refractory Multiple Myeloma Abstract Code: P-288 Session Date and Time: September 28, 2023, 12:30 PM - 1:30 PM EEST Patients with RRMM treated with BCMA CAR-T cell therapy frequently experience hematologic toxicity of persistent thrombocytopenia. This presentation showcases a model that was developed to distinguish between patients at high and low risk for prolonged thrombocytopenia. The model was established after analyzing the baseline clinical characteristics of the participants, PLT, C reaction protein, plasma cells in bone marrow, hemoglobin, and Ig Ferritin—which were ultimately determined to be associated with the recovery of thrombocytopenia. Patients with a model score of 5 or higher post-infusion are at a higher risk for prolonged thrombocytopenia. The principal investigators Prof. Lugui Qiu ， MD ， from the Chinese Academy of Medical Science Hematology Hospital, and Prof. Chunrui Li, MD, PhD, from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, stated, "Multiple myeloma is a hematology malignant disease with a high incidence rate, and relapse and refractory are almost inevitable after current treatments. There's an urgent unmet need for treatments that are well-tolerated and with long persistence. Equecabtagene Autoleucel, a fully human targeted BCMA CAR-T injection, has demonstrated long-lasting efficacy with a durable response. In comparison to the clinical data released at the ASCO 2023 Annual Meeting, the updated study data at IMS shows that among patients without prior CAR-T therapy, ORR remains consistently high at 98.9%. The sCR/CR rate and 12-month PFS rate also significantly improved. This suggests that with longer follow-up periods and larger groups of participants, Equecabtagene Autoleucel continues to show excellent efficacy and safety. These results are encouraging and entail a promising opportunity to reshape RRMM treatment and bring forth new hopes to patients." About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to discover and develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to discovering and developing, manufacturing and commercializing high-quality innovative medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, and ophthalmology diseases to enhance the quality of the patients' lives. Innovent has 10 products in the market, including TYVYT® (Sintilimab Injection), BYVASDA® (Bevacizumab Injection), SULINNO® (Adalimumab Injection), HALPRYZA® (Rituximab Injection), Pemazyre® (Pemigatinib Oral Inhibitor), olverembatinib, Cyramza® (Ramucirumab Injection), Retsevmo® (Selpercatinib Capsules), FUCASO® (Equecabtagene Autoleucel Injection) and SINTBILO® (Tafolecimab Injection). Additionally, we have 1 assets under NMPA NDA review, 7 assets in Phase III or pivotal clinical trials, and 18 more molecules in early clinical stage. Innovent has also entered into 30 strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. We strive to work with many collaborators to help advance the biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. About IASO Bio IASO Bio is a biopharmaceutical company engaged in the discovery and development of novel cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercial production. The pipeline in the company includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of RR MM. Leveraging its strong management team, innovative product pipeline, GMP production, as well as integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China as well as around the world. For more information, please visit or . Forward-Looking Statements 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, are intended to identify certain of such forward-looking statements. Innovent 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 Innovent 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 Innovent'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, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent 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 materialize or turn out to be incorrect. SOURCE Innovent Biologics