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Bayer Championing Advancements in Radiology Pipeline and Accelerating AI Innovation

On November 22, 2023 Bayer reported to advance its comprehensive Radiology portfolio with progress in the development pipeline for an investigational contrast agent as well as new innovations in the area of Artificial Intelligence (AI) (Press release, Bayer, NOV 22, 2023, View Source [SID1234637948]). The company announced that new clinical data for gadoquatrane, Bayer’s investigative macrocyclic gadolinium-based compound currently in Phase III development, will be presented at the 2023 Radiological Society of North America (RSNA) Annual Meeting – taking place from November 26 to 30 in Chicago, USA. In addition, Bayer announced four collaboration agreements, adding additional applications to its digital platform Calantic Digital Solutions and will announce the publication of a Bayer funded health economic modeling analysis that evaluated cost effectiveness of supplemental imaging for screening breast cancer in women with dense breasts.

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The activities at RSNA reflect Bayer’s commitment as a leading company in key areas of radiology to accelerate innovation and address today’s industry challenges for the benefit of patients and their clinicians.

New clinical data for investigational contrast agent gadoquatrane being presented at RSNA 2023:

International Multicenter Phase 2 Dose Finding Study of Gadoquatrane: A Dose of 0.04 mmol Gd/ kg body weight (bw) of Gadoquatrane compared to 0.1 mmol Gd/kg bw of Gadobutrol

Background: Gadoquatrane, Bayer’s investigative macrocyclic gadolinium-based compound is currently in Phase III of development.
The Purpose of this Phase II study was to establish a dose of gadoquatrane in comparison to gadobutrol.
The Phase II results supported the further development of gadoquatrane in a broad Phase III program.
Session Number W7-SSNR13
Fostering innovation in Radiology AI

In more than 30 sessions, Bayer’s AI team composed jointly of experts from both Calantic Digital Solutions and Blackford Analysis, will share their insights to help customers advance their AI strategy – by offering various tech talks, including "Spark Tank Sessions" where early-stage app companies can learn new ways to refine their value proposition and market their AI. Bayer will also host thought leadership panel discussions with topics like regulatory challenges in the field of AI in medical imaging, app selection and leverage clinical utility frameworks to assess ROI.

Building on technology from Blackford and adding additional workflow and analytics components, Bayer’s own platform Calantic Digital Solutions delivers access to applications for medical imaging, including those enabled by AI. Calantic SPARK, Bayer’s accelerator program for medical imaging app developers to further foster innovation in radiology AI, will showcase Imagine Software and Scanslated. Bayer’s Calantic Spark is a targeted program to help radiology AI startups of all stages get to market faster by offering advice spanning medical, regulatory, reimbursement expertise, and market access. Acting as a fast-track pathway to commercialization and distribution through Calantic Digital Solutions.

New Insights into Cost Effectiveness of Supplemental Screening Modalities for Dense Breasts

During RSNA Bayer will announce the publication of a novel health economic model in the Journal of Medical Economics, funded by Bayer, analyzing cost effectiveness of supplemental imaging modalities for women with dense breasts at average and intermediate risk of breast cancer.

Bayer is also hosting an immersive tour of a radiology clinic of the future through the eyes of a patient.

Boehringer Ingelheim expands immuno-oncology portfolio with the acquisition of bacterial cancer therapy specialist T3 Pharma

On November 22, 2023 Boehringer Ingelheim reported the acquisition of privately-held T3 Pharmaceuticals AG ("T3 Pharma"), a clinical stage Swiss biotech company, for an amount of up to 450 million CHF (Press release, Boehringer Ingelheim, NOV 22, 2023, View Source [SID1234637947]). T3 Pharma has developed a proprietary therapy platform that uses live bacteria to deliver immune-modulating proteins to cancer cells and tumor micro-environments.

Despite the significant transformation of the cancer treatment landscape by immunotherapies, long-term remissions only occur in 15-20% of cancer patients. Boehringer Ingelheim aims to considerably increase this rate by utilizing complementary immuno-oncology platforms such as T-Cell Engagers (TcEs), oncolytic viruses, and cancer vaccines, which have the potential to turn cold tumors into hot ones, extending the benefits of immunotherapy to more patients in need.

T3 Pharma’s pioneering technology will bolster Boehringer Ingelheim’s array of novel immune-modulatory cancer treatments, reinforcing the company’s oncology strategy to transform the lives of people affected by cancer.

"The acquisition of T3 Pharma will significantly expand our immuno-oncology pipeline portfolio and is synergistic with many of our existing R&D programs. This will bring us closer to achieving our vision of driving a paradigm shift in cancer care treatments," said Michel Pairet, Member of the Board of Managing Directors at Boehringer Ingelheim with responsibility for the Innovation Unit.

"We are extremely proud of the work of T3 Pharma’s team and very excited to continue and accelerate the successful development of our bacterial delivery platform as part of Boehringer Ingelheim. Being integrated with our partners at Boehringer will enable us to realize the full potential of our platform to fight solid cancers," said Simon Ittig, CEO of T3 Pharma.

T3 Pharma has developed a unique platform using engineered Yersinia enterocolitica bacteria to deliver bioactive proteins directly and selectively into the tumor micro-environment, while sparing healthy tissues. The bacteria can be loaded with multiple immune-modulatory proteins of choice, enabling the design of immuno-oncology combination therapies in one single agent.

Boehringer Ingelheim is adopting a comprehensive approach to cancer therapy development including both cancer cell-directed and immuno-oncology approaches. This strategy aims to enable smart combinations that deliver life-changing and best-in-class treatments that may offer the greatest benefit for people affected by cancer. To make this ambition a reality, the company is constantly exploring emerging science cooperating with a growing global network of leading academic and industry partners and by investing in startup companies via its Boehringer Ingelheim Venture Fund, which was among the main investors of T3 Pharma.

T3 Pharma is headquartered in Allschwil near Basel, Switzerland, where it was founded with financial backing from both corporate and institutional investors. Operations of T3 Pharma will be kept in the Basel region following the acquisition.

Carisma Therapeutics to Participate in Evercore ISI HealthCONx Conference

On November 22, 2023 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that Steven Kelly, President and Chief Executive Officer, will participate in a fireside chat at the 6th Annual Evercore ISI HealthCONx Conference on Wednesday, November 29 at 2:35 pm ET (Press release, Carisma Therapeutics, NOV 22, 2023, https://www.prnewswire.com/news-releases/carisma-therapeutics-to-participate-in-evercore-isi-healthconx-conference-301995316.html [SID1234637946]).

An audio webcast of the event will be available on the Company’s Investor Events section of the Investor Relations webpage and will be archived for a limited time following the event.

Elevation Oncology to Present at the Piper Sandler 35th Annual Healthcare Conference

On November 22, 2023 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported that Joseph J. Ferra, Chief Executive Officer of Elevation Oncology, will participate in a fireside chat at the Piper Sandler 35th Annual Healthcare Conference on Wednesday, November 29, 2023, at 8:30 am ET (Press release, Elevation Oncology, NOV 22, 2023, View Source [SID1234637945]).

A live webcast and replay of the event will be available on the Events page of the Company’s Investor Relations website at View Source

Innovent and AnHeart Therapeutics Announce the National Medical Products Administration of China Has Accepted the New Drug Application for Taletrectinib (ROS1 Inhibitor)

On November 22, 2023 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 AnHeart Therapeutics ("AnHeart"), a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, reported that the New Drug Application (NDA) for taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor (TKI), has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs (Press release, Innovent Biologics, NOV 22, 2023, View Source [SID1234637944]).

The NDA acceptance are based on positive results from the Phase 2 TRUST-I trial (NCT04395677), a multicenter, open-label, single-arm trial that evaluated taletrectinib in Chinese ROS1-positive NSCLC patients. Results from an interim analysis of the TRUST-I trial were presented at the European Lung Cancer Congress (ELCC) 2023.[Link]

Professor Caicun Zhou, Principal Investigator and Oncologist at Shanghai Pulmonary Hospital, stated: "We have extremely limited options for our patients with ROS1-positive NSCLC, especially those with brain metastases who represent more than one-third of patients, and those who go on to develop resistant mutations, which is more than half of patients. Once patients progress on the current options, there are no approved treatments. I hope this NDA represents a step towards making another option available to the ROS1-positive NSCLC patient community in China."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are encouraged by the best-in-class efficacy and safety profile that taletrectinib demonstrated in the TRUST-I trial, and are excited about the NDA acceptance in China. Together with our partner AnHeart, we will work closely with the NMPA to bring this precision therapy to NSCLC patients who are in need of novel treatment options, especially those with acquired resistant mutations or with brain metastases."

Bing Yan, MD, Chief Medical Officer of AnHeart, stated: "Acceptance of our China NDA marks an important milestone for AnHeart and is the first regulatory submission for taletrectinib globally. We would like to thank all the doctors and patients who participated in the clinical trials that support this submission. We look forward to working with our partner Innovent and the regulatory authorities in China to hopefully make taletrectinib available to patients in need as soon as possible."

In June 2021, Innovent and AnHeart entered into an exclusive license agreement for the co-development and commercialization of taletrectinib in Greater China, including mainland China, Hong Kong, Macau and Taiwan.

About ROS1-positive Non-small Cell Lung Cancer

More than one million people globally are diagnosed with NSCLC annually, the most common form of lung cancer. It is estimated that approximately 3% of people with NSCLC in China are ROS1-positive. There are approved first-generation TKIs for people with newly diagnosed advanced or metastatic ROS1-positive NSCLC and no approved therapies for people whose ROS1-positive NSCLC has progressed following treatment with these medicines. Up to 35% of people newly diagnosed with metastatic ROS1-positive NSCLC have tumors that have spread to their brain (brain metastases), the number increases to approximately 55% for those whose cancer has progressed following initial treatment.

About Taletrectinib

Taletrectinib is an oral, potent, brain penetrant, selective, next-generation potential best-in-class ROS1 inhibitor being evaluated for the treatment of ROS1-positive NSCLC.

Taletrectinib was evaluated in ROS1-positive NSCLC patients in two Phase 2 trials, TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global pivotal trial. Positive interim results from TRUST-II trial were reported at the ELCC 2023, and positive interim results from TRUST-II trial were reported at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023.[Link]

Taletrectinib was granted Breakthrough Therapy Designation (BTD) by the CDE of NMPA in 2022 for the treatment of adult patients with advanced or metastatic ROS1-positive NSCLC who have previously been treated with a ROS1 TKI as well as those who have not previously been treated by a ROS1 TKI (TKI-naïve). In addition, taletrectinib has also been granted BTD for the treatment of ROS1-positive NSCLC by the U.S. Food and Drug Administration in the United States in 2022.