On November 1, 2022 Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company focused on the discovery and development of proprietary, first-in-class immune-based cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported that three abstracts have been selected for presentation at key upcoming clinical oncology conferences: the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting and the Connective Tissue Oncology Society (CTOS) 2022 Annual Meeting in November (Press release, Intensity Therapeutics, NOV 1, 2022, View Source [SID1234622750]).

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November 10-12: Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting being held at the Boston Convention and Exhibition Center, Boston, MA. Two poster presentations have been selected.

Presentation 1
Abstract Number: 545
Title: A Phase II Randomized Window of Opportunity Trial Evaluating Cytotoxic and Immunomodulatory effects of Intratumoral INT230-6 (Cisplatin, Vinblastine) in Early Stage Breast Cancer: the INVINCIBLE Trial
First Author: Angel Arnaout, M.D., FACS
Session Date and Time: Thursday, November 10, 2022, 9:00 am – 9:00 pm EST
Location: Hall C; In-Person & On Demand

Presentation 2
Abstract Number: 710
Title: Safety and Survival Results From a Phase 1/2 Trial of Intratumoral Agent INT230-6 (cisplatin vinblastine) Induces Immunological Cancer Cell Death Alone or With Pembrolizumab in Patients with Refractory, Metastatic Cancers
First Author: Jacob Stephen Thomas, M.D.
Session Date and Time: Friday, November 11, 2022, 9:00 am – 9:00 pm EST
Location: Hall C; In-Person & On Demand

November 16-19: Connective Tissue Oncology Society (CTOS) 2022 Annual Meeting being held at the Vancouver Convention Center, Vancouver BC, Canada. An oral podium presentation will be made by Matthew Ingham, M.D., Assistant Professor of Medicine in the Division of Hematology and Oncology at New York Presbyterian Hospital/Columbia University Medical Center.

Oral presentation
Abstract ID: 1301741
Title: Intratumoral INT230-6 (Cisplatin, Vinblastine, Shao) Alone or with Ipilimumab Prolonged Survival with Favorable Safety in Adults with Refractory Sarcomas (NCT03058289)
Session: Session 9: Immunology & Immunotherapy
Session Date Friday, November 18, 2022
Time: 3:30 PM – 5:00 PM PST
First Author: Matthew Ingham, M.D.

Each of the above presentations will be accessible on the "Publications, Papers and Posters" page of Intensity’s website at: View Source

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, discovered using Intensity’s proprietary DfuseRx℠ technology platform, is designed to cause tumor necrosis following direct intratumoral injection. INT230-6 contains two proven, potent anti-cancer agents, cisplatin and vinblastine, with a penetration enhancer molecule, SHAO, that helps disperse the potent cytotoxic drugs throughout tumors and enable diffusion into cancer cells. Importantly, each of the active drug agents remain in the tumor causing local disease control and tumor necrosis, leading to a favorable safety profile and the induction of an anti-cancer systemic immune response, resulting in shrinkage of uninjected tumors. Immunosuppression, often seen when dosing intravenous chemotherapy, is absent when treating with INT230-6.

Study IT-01 consists of a dose escalation and several Phase 2 expansion cohorts (NCT03058289) to evaluate INT230-6 in patients with various advanced solid tumors. In 2019, the Company signed a clinical collaboration agreement with Merck Sharpe & Dohme (Merck) to evaluate the combination of INT230-6 and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced pancreatic, colon, squamous cell and bile duct malignancies, as part of study IT-01. In 2020, the Company executed a clinical collaboration agreement with Bristol-Myers Squibb Company to evaluate the combination of INT230-6 with Bristol-Myers Squibb’s anti-CTLA-4 antibody, Yervoy (ipilimumab), in patients with advanced liver, breast and sarcoma cancers, as a separate cohort in study IT-01. In 2021, the Company executed agreements with the Ottawa Hospital Research Institute and the Ontario Institute of Cancer Research to study INT230-6 in a randomized controlled neoadjuvant phase 2 study in women with early stage breast cancer (the INVINCIBLE study) (NCT04781725). Over 200 patients have been enrolled in Intensity’s studies to date.

On November 1, 2022 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs), reported that the Avidity management team will be participating at the following upcoming conferences (Press release, Avidity Biosciences, NOV 1, 2022, View Source [SID1234622748]):

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31st Annual Credit Suisse Healthcare Conference on November 8 at 11:00 a.m. PT/2:00 p.m. ET
5th Annual Evercore ISI HealthCONx Conference on November 29 at 7:30 a.m. PT/10:30 a.m. ET
Live webcasts of each event, up-to-date event details and an archived replay of the webcasts following each event, will be available on the "Events and Presentations" page in the "Investors" section of Avidity’s website at View Source

On November 1, 2022 Shanghai Henlius Biotech, Inc. (2696. HK) reported that its first self-developed innovative anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (generic name: serplulimab injection), in combination with carboplatin and albumin-bound paclitaxel for the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC), has been approved by the National Medical Products Administration (NMPA), providing an alternative treatment option for patients (Press release, Shanghai Henlius Biotech, NOV 1, 2022, View Source [SID1234622745]). HANSIZHUANG had already been approved for the treatment of Microsatellite Instability-High (MSI-H) solid tumors, and it covers a wide variety of indications to benefit a broader population of patients.

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Wenjie Zhang, Chairman, Executive Director, and CEO of Henlius, said, "the approval marks that HANSIZHUANG steps into the clinical practice of lung cancer, benefiting patients with its world-class quality, and actively expands its presence. Lung cancer is a kind of cancer with high incidence in China and world, which has a huge demand for clinical treatment. Henlius has a sound indication plan in a diverse variety of lung cancer, in which many clinical studies are forging ahead. We will fully tap the potential of HANSIZHUANG and look forward to more positive study results to make further contributions in cancer treatment."

Prof. Caicun Zhou, the leading principal investigator and Chief of Oncology Department of Shanghai Pulmonary Hospital Affiliated to Tongji University and Director of Cancer Institute of Tongji University School of Medicine, said, "sqNSCLC accounts for about 25%-30% of non-small cell lung cancer (NSCLC), with the 2nd highest incidence rate among NSCLC, and has a large demand for clinical treatment. In terms of the study, this is the largest sqNSCLC MRCT (Multi-Regional Clinical Trials) led by Chinese researchers, with more than 500 subjects enrolled globally. The study results demonstrate that serplulimab injection has reached the predefined primary study endpoint and extended progression-free survival (PFS) significantly. It is another key achievement of immunotherapy and is ready to benefit more patients."

Fulfill the clinical medication needs with world-class quality

The approval was primarily based on a randomized, double-blind, global multi-center Phase 3 clinical trial (ASTRUM-004) initiated in many countries around the world, including China, Poland, Turkey, etc., of which more than 30% are white. Its global clinical trial data will support NDAs in overseas markets and lay a foundation for clinical practice all over the world in the future. The results indicate that HANSIZHUANG in combination with carboplatin and albumin-bound paclitaxel could bring significant benefits in the treatment of previously untreated locally advanced or metastatic sqNSCLC patients, which meets the primary endpoint and has good safety and tolerability.

Lung cancer is one of the most common cancers in the world, and it is the malignant tumor with the highest morbidity and mortality in China. According to the latest national cancer statistics released by the National Cancer Center, there are 828,000 new cases of lung cancer, with a total death toll of 657,000 [1], in which NSCLC accounts for about 80% – 85% of all lung cancers [2], and about 50% of NSCLC patients are in local advanced stage that is not suitable for surgical resection or have metastasized at the time of diagnosis. The advanced sqNSCLC, making up about 30% of the advanced NSCLC, is given first place to a platinum-based doublet chemotherapy, which has limited efficacy, and the median survival time (MST) is quite short, many of which are less than 1 year. Therefore, there are huge unmet medical needs. In recent years, immune checkpoint inhibitors have made breakthroughs in NSCLC treatment, especially, the anti-PD-1 mAb combined with carboplatin and albumin-bound paclitaxel have been recommended by domestic and international authoritative guidelines for the treatment of advanced or metastatic sqNSCLC, which push forward the treatment of the advanced NSCLC into the era of immunotherapy. Furthermore, the approval of HANSIZHUANG brings a new option for sqNSCLC, promoting immunotherapy in clinical treatment of lung cancer, and boosting innovation-driven development.

Keep innovating in the first-line treatment of lung cancer

As the first innovative monoclonal antibody developed by Henlius, HANSIZHUANG covers a wide variety of indications and has initiated more than 10 clinical studies on immuno-oncology combination therapies around the world, including many high-incidence cancers such as lung cancer, hepatocellular carcinoma, esophageal cancer, head and neck squamous cell carcinoma and gastric cancer. As of now, the company has enrolled more than 3,100 subjects worldwide and HANSIZHUANG is also an anti-PD-1 mAb with one of the largest global clinical data pools, which speed up the commercial expansion in overseas markets. Notably, HANSIZHUANG covers the full range of first-line treatment of lung cancer, including sqNSCLC, non-squamous non-small cell lung cancer (nsqNSCLC) and small cell lung cancer (SCLC), etc., in which HANSIZHUANG achieved positive results in the phase 3 clinical trial of extensive-stage small cell lung cancer (ES-SCLC) and it is also the first anti-PD-1 mAb in the world gaining positive results in the first-line treatment of ES-SCLC. Its NDA is under review and potentially to be the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. In terms of NSCLC, HANSIZHUANG has initiated many clinical studies, such as in combination with innovative anti-EGFR mAb HLX07 for the first-line treatment of sqNSCLC with EGFR overexpression, in combination with HANBEITAI (bevacizumab) for the first-line treatment of nsqNSCLC. The company has devoted itself to lung cancer with a sound indication plan and makes explorations in combination therapies, aiming for a higher quality of life and long-term survival in patients.

Henlius has consistently adhered to the principle of patient-centered care and keeps innovating to address the difficulties and pain points in clinical treatment, while HANSIZHUANG will explore more in lung cancer and other tumors to bring confidence and hope to patients.

On November 1, 2022 Carisma Therapeutics Inc. (Carisma Therapeutics), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, announced today the acceptance of multiple abstracts to be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Anniversary Annual Meeting in Boston, Massachusetts, which is being held November 8 to November 12, 2022 (Press release, Carisma Therapeutics, NOV 1, 2022, View Source [SID1234622744]). Accepted abstracts include: two abstracts of clinical trial data, including one for oral presentation; four abstracts of pre-clinical study data; and one abstract overviewing the design of a Phase 1 clinical trial for CT-0508.

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"We are excited to participate at the SITC (Free SITC Whitepaper) 37th Anniversary Annual Meeting so we can share the latest updates from our landmark CT-0508 trial," said Steven Kelly, Chief Executive Officer of Carisma Therapeutics. "Across the seven abstracts we will be presenting, we are eager to share the promising clinical and pre-clinical updates and the advances within the Carisma Therapeutics pipeline."

Presentation and posters will be available on the SITC (Free SITC Whitepaper) 37th Anniversary Annual Meeting portal for registered attendees. Details of the presentations are as follows:

Oral Presentation:
Title: Characterization of CT-0508, an anti-HER2 chimeric antigen receptor macrophage (CAR-M), manufactured from patients enrolled in the phase 1, first in human, clinical trial of CT-0508
Oral Presentation Abstract Number: 315
Date/Time: November 11, 2022, 12:18pm EST – 12:26pm EST
Poster Presentations:
Title: Chimeric antigen receptor macrophages (CAR-M) sensitize solid tumors to anti-PD1 immunotherapy
Poster/Abstract Number: 371
Date: November 10, 2022
Title: A Phase 1, First in Human (FIH) study of autologous macrophages containing an anti-HER2 chimeric antigen receptor (CAR) in participants with HER2 overexpressing solid tumors.
Poster/Abstract Number: 633
Date: November 10, 2022
Title: A phase 1, first-in-human (FIH) clinical trial of the anti-HER2 CAR macrophage CT-0508 in participants with HER2 overexpressing solid tumors.
Poster/Abstract Number: 634
Date: November 11, 2022
Title: Macrophages Engineered to Express Synthetic Cytokine Switch Receptors Act as Living Microenvironment Converters
Poster/Abstract Number: 376
Date: November 11, 2022
Title: Pre-clinical development of a CAR Monocyte platform for cancer immunotherapy
Poster/Abstract Number: 318
Date: November 11, 2022
Title: Pre-clinical development of CT-1119, a mesothelin targeting chimeric antigen receptor macrophage (CAR-M), for solid tumor immunotherapy
Poster/Abstract Number: 194
Date: November 11, 2022

On November 1, 2022 Applied BioMath (www.appliedbiomath.com), the industry-leader in providing model-informed drug discovery and development (MID3) support to help accelerate and de-risk therapeutic research and development (R&D), reported their collaboration with SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, for the development of a systems pharmacology model in multiple myeloma (Press release, Applied BioMath, NOV 1, 2022, View Source [SID1234622743]).

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In this collaboration, Applied BioMath is developing a model of SpringWorks’ investigational oral selective small molecule gamma secretase inhibitor (GSI), nirogacestat, in combination with an agent that targets B-cell maturation antigen (BCMA) for the treatment of multiple myeloma.

"Our goal is to lead the scientific understanding of the pharmacodynamic interactions between nirogacestat and BCMA-targeted agents in order to advance therapies more efficiently to help patients with multiple myeloma," said Todd Shearer, PhD, Vice President, Clinical Pharmacology at SpringWorks Therapeutics. "We are pleased to work with Applied BioMath given their expertise in building systems pharmacology models for biopharmaceutical companies and we look forward to working with them to further advance our BCMA efforts."

Applied BioMath offers software and services to help de-risk and accelerate drug R&D. Their solutions, which focus on quantitatively integrating knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms, are leveraged across the entire R&D spectrum from early research through to clinical trials. Their approach involves working with clients to develop the appropriate mathematical strategy for each unique project, with common strategies encompassing systems pharmacology, mechanistic modeling. bioinformatics, biosimulation, and clinical pharmacology.

"Applying mathematical and engineering approaches to translational medicine allows us to integrate knowledge about the therapeutic with an understanding of its mechanism of action in the context of human disease mechanisms," said John Burke, PhD, Co-founder, President and CEO at Applied BioMath. "This enables project teams developing therapeutics to answer more questions earlier and advance programs more efficiently."