On August 29, 2024 Bayer reported that the first patient has been enrolled in the global Phase III SOHO-02 trial, an open-label, randomized, multicenter clinical trial, assessing the efficacy and safety of investigational agent BAY 2927088 as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC), whose tumors have activating HER2 mutations (Press release, Bayer, AUG 29, 2024, View Source [SID1234646222]).

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Beyond the SOHO-02 trial, investigational agent BAY 2927088 is also being assessed for its potential as a second-line therapy in adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy. Late-breaking results from the phase I/II SOHO-01 trial will be presented in the presidential symposium at the World Conference on Lung Cancer (WCLC) in San Diego on Monday, September 9th, 2024.

"Our commitment to precision medicine is not just a promise but a mission to address the critical unmet needs of individuals battling HER2-mutant NSCLC, a variant of the most prevalent form of lung cancer," said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. "By advancing innovative research, we are dedicated to improving survival rates for those affected by this devastating disease. This endeavor underscores our commitment to pioneering precise and personalized healthcare solutions for those in direct need."

Investigational agent BAY 2927088 is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA.

Lung cancer is the leading cause of cancer-related deaths worldwide. Currently there are no approved targeted first-line therapies for patients with NSCLC harboring HER2 activating mutations.

BAY 2927088 has received Breakthrough Therapy designation in the second-line setting from the U.S. Food and Drug Administration (FDA) in February 2024. In June 2024, the Center for Drug Evaluation (CDE) in China also granted investigational agent BAY 2927088 Breakthrough Therapy designation for the same patient population.

About the SOHO-02 Study
SOHO-02 is a global Phase III, open-label, randomized, multicenter clinical trial, assessing the efficacy and safety of investigational agent BAY 2927088 as first-line therapy for adult patients with advanced non-small cell lung cancer (NSCLC), whose tumors have activating HER2 mutations. Participants will be randomized to either investigational agent BAY 2927088 or the current standard of care (cisplatin/carboplatin + pemetrexed + pembrolizumab). The primary endpoint of the study is progression free survival (PFS) measured by a blinded, independent, central review. Additional endpoints include overall response rate (ORR), duration of response (DoR) and evaluating the safety of investigational agent BAY 2927088. More information can be found at View Source

About Investigational Agent BAY 2927088
BAY 2927088 is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential new targeted treatment option for patients with NSCLC harboring HER2 activating mutations. BAY 2927088 is an oral, reversible tyrosine kinase inhibitor (TKI) that potently inhibits mutant human epidermal growth factor receptors 2 (HER2), including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR), with high selectivity for mutant vs wild-type EGFR.

About Non-Small Cell Lung Cancer (NSCLC)
NSCLC is the most common type of lung cancer, accounting for more than 85% of cases. Activating HER2 mutations are found in 2% to 4% of advanced NSCLC. 80% of people diagnosed with NSCLC have already progressed to advanced stages, which makes it more difficult to treat.

On August 29, 2024 OS Therapies Incorporated (NYSE American: OSTX) ("OS Therapies" or "the Company"), an ADC and Immunotherapy research and clinical-stage biopharmaceutical company, reported that the last patient (Patient #41) enrolled in the AOST-2121 clinical trial (NCT04974008) of OST-HER2 in recurred, resected Osteosarcoma (OS) – has received its last treatment dose (Press release, OS Therapies, AUG 29, 2024, View Source [SID1234646221]). This last patient is expected to complete its final radiological imaging evaluation as part of the 12-month Event Free Survival primary endpoint analysis by early in the fourth quarter of 2024. Concurrently, the Company will close all clinical trial sites and lock the database in preparation for data analysis and topline data readout that is expected to be announced in the fourth quarter of 2024.

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OST-HER2, a biologic therapeutic candidate, is a Lm (Listeria monocytogenes) vector-based off-the-shelf immunotherapeutic vaccine designed to prevent metastasis, delay recurrence, and increase overall survival in patients with Osteosarcoma. The AOST-2121 study is designed to demonstrate efficacy in patients who have already had recurrent disease and are highly likely to recur. A total of 16 OST-HER2 doses are administered once every three weeks, with a follow-up approximately four weeks after the final dose is administered, for a total of 52 weeks study. Radiographic evaluation of recurrence is evaluated throughout treatment. The proposed OST-HER2 mechanism of action is based on innate and adaptive immune stimulating responses activated by the Lm vector. This treatment generates T-cells that can eliminate or slow potential micro-metastases that can grow into recurrent Osteosarcoma. T-cell responses target HER2 expressed by the tumor and then kill the cell, releasing additional tumor targets. There are currently no approved adjuvant treatments for recurrent Osteosarcoma in the United States.

AOST-2121 has achieved full enrollment of 41 patients treated with OST-HER2 at 21 clinical trial sites across the United States. The primary endpoints for the AOST-2121 study are Event Free Survival ("EFS"’, defined as absence of recurrence of primary tumor or metastasis) at 12 months and Overall Survival at 36 months, with interim Overall Survival endpoints at 12 months and 24 months. Topline EFS data, interim 2-year OS data, as well as additional secondary data analyses are expected to be reported in the fourth quarter of 2024. We believe there have not been any novel therapeutic interventions approved by the FDA that have improved the clinical outcomes for patients with Osteosarcoma in over 40 years.

The addition of the data from this final patient, along with Patient #40, will enhance interim data announced in conjunction with ASCO (Free ASCO Whitepaper) 2024. This is in addition to previously reported Phase I clinical data in Breast cancer, which the Company plans to target after Osteosarcoma. We thank the patients, families, clinicians, researchers, assistants and the entire Osteosarcoma community for supporting this important and ground-breaking trial.

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