On August 29, 2024 Noetik, an AI-native biotech company leveraging self-supervised machine learning and high-throughput spatial data to develop next-generation cancer therapeutics, reported that it closed an oversubscribed $40 million Series A financing round (Press release, Noetik AI, AUG 29, 2024, View Source [SID1234646219]).

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The financing was led by Polaris Partners and managing partner Amy Schulman, who will join the board of directors, with participation from new investors Khosla Ventures, Wittington Ventures and Breakout Ventures. The round was supported by all existing investors DCVC, Zetta Venture Partners, Catalio Capital Management, 11.2 Capital, Epic Ventures, Intermountain Ventures and North South Ventures. The round also included AI funds ApSTAT Technologies, Linearis Labs and Ventures Fund, supported by leading AI expert Yoshua Bengio and metabolomic expert David Wishart, Element AI co-founder Jean-Francois Gagne, and current and former Recursion executives.

Funds from the Series A financing will be used to expand Noetik’s spatial omics-based atlas of human cancer biology (already one of the world’s largest) together with its high throughput in vivo CRISPR Perturb-Map platform. Additionally, the investment will enable the company to scale training of its multi-modal cancer foundation models such as OCTO. The company will leverage these platform capabilities to advance an innovative pipeline of cancer therapeutics candidates to the clinic.

"We are thrilled to have the support of incredible investors who share our vision of combining deep patient data and artificial intelligence to build the future of cancer therapeutics. This significant financing will enable us to accelerate our progress toward turning biological insights into a portfolio of therapeutic candidates" said Ron Alfa, M.D., Ph.D., CEO & Co-Founder, Noetik.

Noetik was founded to solve critically important challenges in bringing effective new therapeutics to patients: improving target discovery and biomarker development to increase the probability of clinical success. To address these, the company has built a discovery and development platform that pairs human multimodal spatial omics data purpose-built for machine learning with a massively multiplexed in vivo CRISPR perturbation platform (Perturb-Map). Together these data are used to train self-supervised foundation models of tissue and tumor biology that power the company’s discovery efforts.

"We are excited to partner with Noetik and support their mission to build a pipeline of potentially transformative cancer programs," said Amy Schulman, Managing Partner, Polaris Partners. "We have been investing in the most innovative life science technologies for decades and have been excited about the potential of AI. Noetik impressed us both with the sophistication of their platform and the team’s dedication to make an impact for patients."

The company aims to establish strategic partnerships and collaborations with leading academic institutions, health care providers, and pharmaceutical companies. The company recently appointed Shafique Virani, M.D. as the company’s Chief Business Officer to spearhead these partnering efforts.

"We are thrilled to continue backing Noetik. The team’s speed of execution in building one of the most sophisticated AI-enabled oncology discovery engines in less than two years is unprecedented, and their deep experience and demonstrable progress have only strengthened our conviction," said James Hardiman, General Partner, DCVC.

Noetik is committed to advancing the field of precision oncology and improving outcomes for cancer patients worldwide. This Series A funding marks a significant milestone in the company’s journey and reinforces its position as a leader in the development of AI-driven cancer therapies.

To learn more about our comprehensive patient dataset, visit View Source

On August 29, 2024 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that James Porter, Ph.D., Chief Executive Officer, and Alexandra Balcom, Chief Financial Officer, will participate in a fireside chat during the Morgan Stanley 22nd Annual Global Healthcare Conference on Thursday, September 5, 2024, at 1:05 p.m. ET in NYC (Press release, Nuvalent, AUG 29, 2024, View Source [SID1234646218]).

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A live webcast will be available in the Investors section of the company’s website at www.nuvalent.com, and archived for 30 days following the presentation.

On August 29, 2024 Transcenta Holding Limited ("Company"; stock code: 6628.HK) reported the unaudited consolidated results of the Company and its subsidiaries (collectively, the "Group") for the six months ended June 30, 2024 (the "Reporting Period") (Press release, Transcenta, AUG 29, 2024, View Source [SID1234646217]).

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In the first half of 2024, the Company continued to accelerate clinical progress across both the oncology and non-oncology pipelines.

For company’s lead oncology asset, the Claudin18.2-targeting antibody osemitamab (TST001, A Humanized ADCC Enhanced Claudin18.2 mAb for Solid Tumors), reached key milestones for the treatment of gastric or gastroesophageal junction (G/GEJ) cancer. Company published the encouraging Phase II data of osemitamab (TST001) in combination with checkpoint inhibitor and standard chemotherapy as first-line treatment of G/GEJ cancer at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (ASCO) (Free ASCO Whitepaper), showing that high/medium Claudin18.2 expression is associated with a median PFS of 12.6 months. At the same period, Company published the safety and PK data of TranStar101 study at the 2024 AACR (Free AACR Whitepaper) annual meeting. The safety and pharmacokinetic profile of osemitamab (TST001) in the U.S. patients, is consistent with the profile reported in Chinese patients from TranStar102 study.

Worked with Agilent Technologies, Inc. (Agilent), a world leader in CDx development, and developed a Claudin18.2 companion diagnostic test that can fully support the global pivotal trial of osemitamab (TST001). Successfully received regulatory clearances from the U.S. Food and Drug Administration (FDA), China Center for Drug Evaluation (CDE) and South Korea Ministry of Food and Drug Safety (MFDS). All the achievements validate and further support strategy for the Global Phase III trial (TranStar301). Osemitamab (TST001) is on track to become the first global therapy that delivers the next wave of innovation in the first-line treatment of patients with Claudin18.2 expressing locally advanced or metastatic G/GEJ cancer. Company also plans to explore several Claudin18.2 expressing advanced solid tumors other than G/GEJ cancer.

For lead non-oncology asset, the anti-sclerostin antibody blosozumab (TST002, A Humanized Sclerostin mAb for Osteoporosis), published Single Ascending Dose (SAD) study result in the 2024 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO Congress) in April. After a single dose of blosozumab (TST002) up to 1,200 mg, the average increase of lumbar spine BMD at day 85 (D85) ranged from 3.52% to 6.20% and total hip BMD from 1.30% to 2.24% across dose cohorts. The lumbar spine BMD increase exceeded the least significant difference level (2.77%) and was clinically meaningful.

In addition, Company has completed the enrolment of patients in the dose-escalation part for the First-in-Human (FIH) trial of first-in-class anti-GREMLIN-1 antibody TST003 and the trial is ongoing at multiple clinical centers in the U.S. and China. Have presented one Trial in Progress (TiP) poster of TST003-1001 study at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April.

Furthermore, progress had been made in improving the continuous bioprocessing platform technology HiCB (Highly Intensified Continuous Bioprocessing) and the technology was successfully implemented in the GMP manufacturing of osemitamab (TST001).

Research/Early Development Update:

TST013 (An ADC Candidate Targeting a Validated Tumor Antigen)- TST013 displayed significantly improved anti-tumor activity relative to benchmark ADC and improved tolerability profile which warrants further development
TST808 (A Humanized Antibody Neutralizing One of the Validated Key Targets Regulating B/Plasma Cell Proliferation and Survival) – TST808 has the potential to treat multiple autoimmune renal disorders including IgA nephropathy. Company has obtained the lead molecules and initiated the IND-enabling studies
Business Development Achievements:

Company has continued the collaboration with Agilent for the Claudin18.2 specific IHC CDx Assay to support TranStar301 global Phase III pivotal trial of osemitamab (TST001) in combination with checkpoint inhibitor and chemotherapy
Company has continued the clinical trial collaboration with BMS, and completed the enrolment with osemitamab (TST001),checkpoint inhibitor and chemotherapy combination in TranStar102 in China and in TranStar101 in the U.S.
Technology Partnership & Advancement:

Company has formed a strategic alliance with a company specialized in siRNA drug substance synthesis, to provide CDMO services in siRNA formulation development and F&F
Company’s in-house cell culture media ExcelPro CHO are being evaluated for its performance against market standards for fed-batch, intensified fed-batch and perfusion processes by several external partners including a global leading company of media. This is part of potential collaboration for global commercialization of ExcelPro CHO

On August 29, 2024 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that management will present virtually at the H.C. Wainwright 26th Annual Global Investment Conference (Press release, Compugen, AUG 29, 2024, https://www.prnewswire.com/news-releases/compugen-to-present-at-the-hc-wainwright-26th-annual-global-investment-conference-302233882.html [SID1234646216]). The presentation will be available on demand on the Investor Relations section of Compugen’s website at www.cgen.com from Monday, September 9, 2024, 7:00 AM ET for 30 days.

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On August 29, 2024 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported its 2024 Interim Results (Press release, Carsgen Therapeutics, AUG 29, 2024, View Source [SID1234646215]).

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Business Highlights

Zevor-cel was approved by NMPA in China.
Patient enrollment for the confirmatory Phase II trial of satri-cel (CT041) in China has been completed.
Multiple adjuvant studies for solid tumor CAR T-cell therapies are underway.
Clinical data on satri-cel, zevor-cel, and CT071 were presented at academic conferences.
Rapid development of differentiated allogeneic CAR T-cell product pipelines.
Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "In the past six months, we have made significant progresses in technological innovation, product development, and business operations. Zevor-cel was successfully launched in China and has been included in nearly 20 provincial and municipal healthcare plans. The pivotal Phase II trial of satri-cel in China has completed patient enrollment. We are also actively exploring the potential of satri-cel in adjuvant therapy, aiming for greater clinical benefit for patients. Additionally, we are rapidly advancing CT071, which is manufactured with our CARcelerate platform, while continuing to develop multiple allogeneic CAR T-cell products based on the THANK-uCAR platform."

1. Zevor-cel Market Launch and Commercialization Progress in China

Zevor-cel (zevorcabtagene autoleucel, CT053) is a fully human autologous CAR T-cell product targeting B-cell maturation antigen (BCMA). It was approved by the National Medical Products Administration (NMPA) on February 23, 2024 for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have progressed after at least three lines of therapy, (including a proteasome inhibitor and an immunomodulatory agent). CARsgen has been collaborating with Huadong Medicine for the commercialization of zevor-cel in mainland China. As of July 31, 2024, zevor-cel had been included in nearly 20 provincial or municipal government-subsidized insurance programs and private health insurance products; certification and regulatory filings had been completed in over 100 healthcare institutions across 19 provinces or cities nationwide; we had received a total of 52 orders from Huadong Medicine.

The Group’s revenue was over RMB6 million for the six months ended June 30, 2024 mainly from zevor-cel in which the primary revenue of zevor-cel was calculated on the basis of ex-works price, rather than on the basis of end-of-market prices. Our revenue is recognized upon completion of ex-works delivery of products. Besides, the Company received a milestone payment of RMB75 million from Huadong Medicine for zevor-cel for the six months ended June 30, 2024. Due to the inherent time cycle of CAR-T manufacturing, this results in a discrepancy between the number of orders obtained from Huadong Medicine and number of ex-works deliveries.

2. Progresses in Development of Differentiated CAR T Pipeline

Satricabtagene autoleucel (CT041) is an autologous humanized CAR T-cell product targeting Claudin18.2. Patient enrollment for the confirmatory Phase II trial (NCT04581473) in China for the treatment of gastric cancer/gastroesophageal junction cancer (GC/GEJ) has been completed. Our collaboration with Moderna, Inc. is ongoing to investigate Moderna’s investigational Claudin18.2 mRNA product in combination with satri-cel in preclinical studies.

CARsgen is actively expanding the application of CAR T-cell therapies in post-surgery treatments for solid tumors, including an ongoing Phase I clinical trial for pancreatic cancer (CT041-ST-05, NCT05911217), an investigator-initiated trial that is currently in the start-up phase for GC/GEJ, and a Phase I clinical trial for hepatocellular carcinoma (CT011-HCC-03, NCT06560827).

In the hematological malignancies field, the focus of the pipeline includes CT071, a fully human autologous CAR T-cell product targeting GPRC5D. CT071 was developed using CARsgen’s CARcelerate platform for the treatment of MM and primary plasma cell leukemia (pPCL). CARcelerate is a proprietary platform developed by CARsgen that shortens the manufacturing time to approximately 30 hours, resulting in younger and potentially more potent CAR T cells compared to conventional manufacturing processes. An investigator-initiated trial (NCT05838131) for R/R MM and R/R PCL and another investigator-initiated trial (NCT06407947) for the treatment of newly diagnosed multiple myeloma (NDMM) are currently underway in China. An IND was cleared by the FDA in November 2023 for the treatment of patients with R/R MM and R/R pPCL.

In addition to autologous products, CARsgen is also advancing differentiated allogeneic CAR T-cell products based on the THANK-uCAR platform. These include: CT0590, for the treatment of R/R MM and PCL; KJ-C2320, for the treatment of acute myeloid leukemia (AML); KJ-C2219, targeting CD19 and CD20, for the treatment of B-cell-related hematologic malignancies and autoimmune diseases; and KJ-C2114, for the treatment of solid tumors.

3. Clinical Data Disclosure

Updated results of the pivotal Phase II registrational trial of zevor-cel in China were reported as an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2024 annual meeting. Updated data from the investigator-initiated trial (CT041-CG4006, NCT03874897) of satri-cel were published in Nature Medicine in June and presented orally at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. A summary of safety and efficacy in patients with refractory metastatic pancreatic cancer (PC) (CT041-CG4006 & CT041-ST-01 Ib) was published in Journal of Clinical Oncology. The results from the satri-cel phase 1b clinical trial (CT041-ST-02, NCT04404595) in the U.S. were presented at the 2024 ASCO (Free ASCO Whitepaper) GI meeting. Results from the investigator-initiated trial (NCT05838131) of CT071 for the treatment of R/R MM were presented as a poster at the EHA (Free EHA Whitepaper) 2024 annual meeting. Data updates for CT071 and CT0590 are to be disclosed in the second half of 2024.