On October 27, 2023 Oncoinvent AS, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, reported that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for the phase 2b study for Radspherin in patients with peritoneal carcinomatosis from colorectal cancer (Press release, Oncoinvent, OCT 27, 2023, https://www.oncoinvent.com/press-release/oncoinvent-announces-u-s-fda-clearance-of-investigational-new-drug-ind-application-for-radspherin-in-colorectal-cancer-patients/ [SID1234636416]).

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"We are excited to announce the IND clearance for Radspherin for colorectal cancer patients following the promising indications of safety and efficacy from the RAD-18-002 Phase 1/2a clinical trial, " said Anders Månsson, Chief Executive Officer of Oncoinvent. "This is an important corporate milestone for Oncoinvent, allowing us to clinically advance Radspherin and expand to the U.S. landscape. Today’s announcement, in conjunction with the positive clinical data supporting Radspherin, continues to reinforce our belief in its transformative potential, and we look forward to advancing its clinical development."

In the ongoing phase 1/2a clinical trials with Radspherin, all dose levels have to date been well tolerated and 7MBq was selected as the recommended dose. Oncoinvent recently presented preliminary 18-month safety and efficacy data from the ongoing RAD-18-002 study in patients with peritoneal carcinomatosis from colorectal cancer at the 13th International Congress on Peritoneal Surface Malignancies (PSOGI). At 18 months, none of the 12 patients who received the recommended dose of 7 MBq experienced peritoneal recurrences.

Only 2.6% of all adverse events reported were considered to be related to Radspherin, all of which were grade 1-2.

The planned trial, for which we have now received FDA clearance, is a randomized controlled phase 2b trial, assessing efficacy and safety of Radspherin in patients with peritoneal carcinomatosis from colorectal carcinoma following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The primary objective for the trial, planned to start in Q2 of 2024, is to compare progression-free survival (PFS) between patients following CRS and HIPEC and Radspherin versus CRS and HIPEC.

On October 27, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported that two poster presentations taking place at SITC (Free SITC Whitepaper) 2023, the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), in San Diego from November 3-5 will demonstrate the potential for using the company’s novel tools to help advance the development of immuno-oncology drugs (Press release, Veracyte, OCT 27, 2023, View Source [SID1234636415]). These tools allow for better characterization of the tumor microenvironment (TME), which can enable new insights into drug response and mechanisms of resistance.

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"While immunotherapy drugs such as immune checkpoint inhibitors have been shown to induce remarkable, long-term responses in many cancer types, they remain ineffective for a majority of patients. There is a pressing need to understand drug response so scientists can develop treatments that will be effective for many more patients and types of cancer," said Corinne Danan, Veracyte’s general manager of Biopharma and IVD Services. "These conference presentations will show that Veracyte’s Brightplex and Immunoscore IC tools can offer scientists a clearer view of the tumor microenvironment, as well as data that could inform immuno-oncology drug development."

The following posters will be presented at the SITC (Free SITC Whitepaper) 2023 meeting on Saturday, November 4, 2023:

Title: Deciphering the relationship between lymphocytes and macrophages within the tumor micro-environment using a workflow combining RNA transcripts detection and multiplex IHC on Brightplex
Presenter: Jacques Fieschi, Ph.D., VP, research and development, Veracyte
Abstract: #70
Location: Exhibit Halls A and B1

Title: Regulatory T-cell tumor infiltration improves advanced NSCLC patients’ outcome under ≥ 2nd line anti-PD1/L1monotherapy in The PIONeeR Project
Presenter: Florence Monville, Ph.D., Scientific Head of Collaborative Research Projects at Veracyte
Abstract: #782-C
Location: Exhibit Hall B

In addition, Veracyte will host the following corporate symposium on Friday, November 3, 2023, from 5:10 p.m. to 6:40 p.m. PT:

Title: A Promising Biomarker of Tumor Immunogenicity: Unveiling the Potential of Immunoscore IC (CD8/PDL1)
Presenters: Jérôme Galon, Ph.D. (scientific executive director, Veracyte); Jacques Fieschi, Ph.D. (VP, research and development, Veracyte)
Location: Presentation Stage (Exhibition Floor)

On October 27, 2023 Sairopa B.V., a clinical-stage company that develops novel treatments for cancer by modulating the patient’s immune system, reported its poster presentation at the SITC (Free SITC Whitepaper) 38th Annual Meeting taking place November 3-5, 2023 in San Diego, California (Press release, Sairopa, OCT 27, 2023, View Source [SID1234636413]). The presentation, taking the form of a poster, presents early clinical data with encouraging early safety signals on ADU-1604, Sairopa’s anti-CTLA-4 antibody. ADU-1604 is being studied in Phase 1 clinical trials in PD-1 relapse/refractory melanoma patients. Data obtained from the dose-escalation stage will be presented and will provide further specifics about the safety, efficacy of ADU-1604, as well as modulation of pharmacodynamic markers supporting its potential use in future clinical applications. sairopa.com

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Poster information:

Title: ADU-1604, a novel CTLA-4 blocking antibody modulates pharmacodynamic markers in PD1 relapse/refractory melanoma patients
Date: Saturday, November 4
Poster Hall Hours: 9:00 a.m. – 8:30 p.m. (Reception: 5:10 p.m. – 6:40 p.m.)
Onsite Location: Exhibit Halls A and B1 – San Diego Convention Center
Number: 770

On October 27, 2023 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that members of its senior management team are scheduled to participate in upcoming investor conferences, detailed below (Press release, Innate Pharma, OCT 27, 2023, View Source [SID1234636410]).

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Jefferies London Healthcare Conference
Event Date: November 15, 2023, London, UK
6th Annual Evercore ISI HealthCONx Conference
Event Date: November 28, 2023, Miami, USA
Investir Day
Event Date: November 28, 2023, Paris, France

On October 27, 2023 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for mirvetuximab soravtansine (ELAHERE) for the treatment of patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (Press release, ImmunoGen, OCT 27, 2023, View Source [SID1234636409]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"The acceptance of our MAA is another important regulatory milestone in the next chapter of ELAHERE’s story as we work diligently to deliver this new treatment option to patients with platinum-resistant ovarian cancer globally," said Michael Vasconcelles, MD, ImmunoGen’s Executive Vice President, Research, Development, and Medical Affairs. "As the first novel medicine to have demonstrated an overall survival benefit in platinum-resistant ovarian cancer compared to chemotherapy in a Phase 3 clinical trial, we are pleased to initiate the review process that moves us one step closer to providing access to ELAHERE for eligible patients in Europe. We look forward to working closely with the EMA throughout the review process and to potentially bring this novel ADC to Europe as early as 2024."

The MAA is supported by positive data from the Phase 3 MIRASOL trial of ELAHERE in platinum-resistant ovarian cancer, which was disclosed in May 2023 and subsequently presented as a late-breaking abstract at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In the MIRASOL trial, ELAHERE demonstrated statistically significant and clinically meaningful improvements in progression-free survival, objective response rate, and overall survival compared to investigator’s choice (IC) of single-agent chemotherapy. ELAHERE demonstrated a tolerable safety profile compared to IC chemotherapy consisting predominantly of low-grade ocular and gastrointestinal events.

ELAHERE was approved by the US Food and Drug Administration in November 2022.

ABOUT OVARIAN CANCER

Ovarian cancer is the leading cause of death from gynecological cancers worldwide. Each year, more than 66,000 patients are diagnosed and 45,000 patients will die in the United States and Europe combined. Most patients present with late-stage disease and will typically undergo surgery followed by platinum-based chemotherapy. Unfortunately, the majority of patients eventually develop platinum-resistant disease, which is difficult to treat.