Intensity Therapeutics to Present Data on Safety, Tumor Regression and Immune Activation of INT230-6 at ASCO 2019

On May 16, 2019 Intensity Therapeutics, Inc., a clinical-stage biotechnology company pioneering a novel, immune-based approach to treat solid tumor cancers through direct injection of its proprietary therapeutic agents, reported that a poster highlighting the safety profile, tumor regression activity and immune activation of the company’s lead product candidate, INT230-6, will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 31 to June 4, 2019 in Chicago (Press release, Intensity Therapeutics, MAY 16, 2019, View Source [SID1234536420]).
Details of the poster presentation are as follows:

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Title: Safety profile of INT230-6, a novel intratumoral (IT) formulation, during injections into a variety of refractory deep and superficial tumors with evidence of tumor regression and immune activation

Abstract Number: 2602

Date/Time: Saturday, June 1, 2019, 8-11 a.m. CDT

Poster Session: Developmental Immunotherapy and Tumor Immunobiology

Presenter: Jacob Stephen Thomas, MD, Assistant Professor of Clinical Medicine, University of Southern California

About INT230-6

INT230-6, Intensity’s lead product candidate designed for direct intratumoral injection, is comprised of two proven, potent anti-cancer agents and a penetration enhancer molecule that helps disperse the drugs throughout tumors and diffuse into cancer cells. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor kill and recruitment of dendritic cells to the tumor micro-environment that induced anti-cancer T-cell activation. Treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-inoculations of the initial cancer and resistance to other cancers. In mouse models, INT230-6 has shown strong synergy with checkpoint blockage, including anti-PD-1 and anti-CTLA4 antibodies. INT230-6 was discovered from Intensity’s DfuseRxSM platform.

Inovio and QIAGEN Establish Collaboration to Develop Diagnostic Test for VGX-3100, Inovio’s Novel Immunotherapy Targeting Advanced Cervical Pre-Cancer

On May 16, 2019 Inovio Pharmaceuticals Inc. (NASDAQ: INO) and QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported a collaboration to co-develop a diagnostic test to identify patients most likely to respond to VGX-3100, Inovio’s immunotherapy to treat advanced cervical dysplasia associated with the human papillomavirus virus (HPV) (Press release, Inovio, MAY 16, 2019, View Source [SID1234536419]). This precision medicine partnership focuses on Inovio’s VGX-3100, a late-stage product candidate currently in two pivotal Phase 3 clinical trials (REVEAL 1 and 2) with potential to become the first treatment for HPV infection of the cervix and the first non-surgical treatment for precancerous cervical lesions associated with the virus. Financial arrangements were not disclosed.

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Dr. J. Joseph Kim, Inovio’s President & CEO, said, "As we advance our Synthetic Nucleics platform we are always looking for ways to drive innovation within our own technology or via a creative partner like QIAGEN. QIAGEN is bringing their extensive track record of commercially developing and marketing novel diagnostic tests to this important collaboration. Inovio is developing VGX-3100 as a non-surgical treatment for women with cervical pre-cancer and pre-treatment biomarkers we have discovered could provide a targeted way to identify patients most likely to respond to treatment with VGX-3100, increasing absolute efficacy of the product."

"We are pleased to support Inovio by developing a liquid biopsy-based companion diagnostic to identify patients who would benefit from VGX-3100, which has potential to make a dramatic difference in the treatment of HPV infections and precancerous disease. Our Sample to Insight workflows and experience in developing diagnostic solutions for Precision Medicine in immuno-oncology are well-suited to help Inovio address this large unmet medical need," said Peer M. Schatz, Chief Executive Officer of QIAGEN. "Our team has deep experience in HPV-related molecular testing and cervical cancer and is looking forward to applying this expertise in partnership with Inovio, This project is also a case study of a collaboration that started in the discovery phase, when Inovio selected QIAGEN Genomic Services to work on the discovery of novel microRNA biomarkers that now contribute to the power of this unique molecular assay. The project progressed into development and Inovio now aims to make regulatory submissions for VGX-3100 in 2021."

HPV is the most common viral infection of the reproductive tract and the major cause of cervical cancer, the fourth most common cancer among women. The World Health Organization (WHO) reported an estimated 570,000 new cases of cervical cancer and 311,000 deaths in 2018. Almost 300 million women globally are estimated to be infected with HPV, and about 30 million additional cases have progressed to the precancerous stage. The high-risk HPV 16 and HPV 18 genotypes are estimated to cause at least 70% of cervical cancers.

Inovio’s VGX-3100 is a novel immunotherapy under clinical investigation for the treatment of infection with HPV 16 and HPV 18 and advanced cervical dysplasia (Phase 3), and the vulva and anus (Phase 2). VGX-3100 propels the patient’s own immune system to clear the HPV 16 and HPV 18 infections and precancerous lesions without the increased risks associated with surgery.

About Inovio Pharmaceuticals Inc.
Inovio is an innovative biotechnology company focused on the discovery, development, and commercialization of its synthetic nucleic technology targeted against cancers and infectious diseases. Inovio’s proprietary technology platform applies antigen sequencing and delivery to activate potent immune responses to targeted diseases. The technology functions exclusively in vivo, and has been demonstrated to consistently activate robust and fully functional T cell and antibody responses against targeted cancers and pathogens. Inovio’s most advanced clinical program, VGX-3100, is in Phase 3 for the treatment of HPV-related cervical pre-cancer. Also in development are Phase 2 immuno-oncology programs targeting HPV-related cancers, bladder cancer, and glioblastoma, as well as platform development programs in hepatitis B, Zika, Ebola, MERS, and HIV. Partners and collaborators include AstraZeneca, Regeneron, Roche/Genentech, ApolloBio Corporation, GeneOne Life Science, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations, Defense Advanced Research Projects Agency, National Institutes of Health, National Institute of Allergy and Infectious Diseases

Infinity Pharmaceuticals To Present At B. Riley FBR Institutional Investor Conference

On May 16, 2019 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that Adelene Perkins, Infinity Pharmaceutical’s Chief Executive Officer, will present at the B. Riley FBR Institutional Investor Conference on Thursday, May 23, 2019, at 2:00 p.m. PT (5:00 p.m. ET) at The Beverly Hilton, Beverly Hills, CA (Press release, Infinity Pharmaceuticals, MAY 16, 2019, View Source [SID1234536417]). A live webcast of the presentation will be available on the Investors/Media section of Infinity’s website at www.infi.com, and will be available for 30 days following the event.

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Incyte Announces Abstracts Accepted for Presentation at the 2019 ASCO Annual Meeting and the 24th Congress of EHA

On May 16, 2019 Incyte Corporation (Nasdaq:INCY) reported that multiple abstracts highlighting data from its oncology portfolio will be presented at the upcoming 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held from May 31-June 4, 2019, in Chicago, Illinois; and the 24thCongress of the European Hematology Association (EHA) (Free EHA Whitepaper), to be held June 13-16, 2019, in Amsterdam, the Netherlands (Press release, Incyte, MAY 16, 2019, View Source [SID1234536416]).

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Abstracts accepted for presentation at ASCO (Free ASCO Whitepaper) feature genomic profiling data from Incyte’s ongoing Phase 2 FIGHT-202 trial evaluating its selective fibroblast growth factor receptor (FGFR) inhibitor, pemigatinib, in patients with cholangiocarcinoma, as well as efficacy and safety data from the Novartis-sponsored GEOMETRY mono-1 trial of capmatinib, the investigational selective MET inhibitor licensed to Novartis by Incyte. Additionally, data to be presented at EHA (Free EHA Whitepaper) will showcase the continued study of Incyte’s JAK1/JAK2 inhibitor, ruxolitinib, in myeloproliferative neoplasms (MPNs).

"Our presence at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) illustrates Incyte’s ongoing commitment to discovering and developing therapeutic options that address significant unmet medical needs for patients," said Steven Stein, M.D., Chief Medical Officer, Incyte. "We are pleased to highlight new data on two investigational medicines – pemigatinib and capmatinib – that were discovered by Incyte scientists and for which we anticipate applications for initial U.S. regulatory approvals later this year, as well as data that furthers our understanding of the treatment of MPNs."

Key ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) abstracts include:

ASCO Abstracts

Oral Presentation

Capmatinib (INC280) in METΔex14-mutated advanced non-small cell lung cancer (NSCLC): efficacy data from the phase 2 GEOMETRY mono-1 study (Abstract #9004, oral abstract session)

Monday, June 3, 2019, 9:12 – 9:24 a.m. CT, Hall B1
Poster Presentation

Comprehensive genomic profiling in FIGHT-202 reveals the landscape of actionable alterations in advanced cholangiocarcinoma (Abstract #4080, poster session)

Monday, June 3, 2019, 8:00 – 11:00 a.m. CT, Hall A
EHA Abstracts

Poster Presentations

Impact of myeloproliferative neoplasms (MPNS) and perceptions of treatment goals amongst physicians and patients in 6 countries: an expansion of the MPN Landmark Survey(Abstract #PF681, poster presentation)

Friday, June 14, 2019, 5:30 – 7:00 p.m. CEST, Poster area
Real-world safety data from a non-interventional long-term post authorization safety study of ruxolitinib in myelofibrosis (Abstract #PF679, poster presentation)

Friday, June 14, 2019, 5:30 – 7:00 p.m. CEST, Poster area
Safety and efficacy of ruxolitinib (RUX) in patients with myelofibrosis (MF) and anemia (hemoglobin <10g/dL):Results at Week 24 of the REALISE trial (Abstract #PS1465, poster presentation)

Saturday, June 15, 2019, 5:30 – 7:00 p.m. CEST, Poster area
For full session details and data presentation listings, please see the ASCO (Free ASCO Whitepaper) (View Source) and EHA (Free EHA Whitepaper) (View Source) online programs.

Where the use of compounds described herein is either investigational or being studied for (a) new use(s), efficacy and safety have not been established, and there is no guarantee that such compounds will become commercially available for the use(s) under investigation.

ImaginAb Enrolls First Patient in Phase II Clinical Trial at a World-Leading Cancer Center in Los Angeles County

On May 16, 2019 ImaginAb Inc., a clinical stage immuno-oncology imaging company, reported it has enrolled its first patient for the Phase II clinical trial of its lead product, CD8 tracer 89Zr-Df-IAB22M2C, at City of Hope in Los Angeles County (Press release, ImaginAb, MAY 16, 2019, View Source [SID1234536415]). City of Hope is a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases based in Duarte, California, where ImaginAb co-founder Anna Wu, Ph.D., is currently Chair of Molecular Imaging and Therapy.

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89Zr-Df-IAB22M2C is a first in class imaging agent that visualizes the immune system using non-invasive, whole-body in vivo PET imaging of CD8 T cells. Using its ‘Minibody’ platform, ImaginAb’s technology targets and visualizes CD8+ T-cells to provide highly-specific, quantitative assessment of the immunological status of each cancer lesion within a patient, potentially enabling treatment to be tailored quickly and specifically to the needs of that patient.

City of Hope is one of ImaginAb’s active clinical sites conducting Phase II baseline/on-treatment clinical trials investigating the utility of 89Zr-Df-IAB22M2C to image CD8 T cells prior to (baseline) and after (on-treatment) cancer patients receive immunotherapy-based treatment. Kim Margolin, M.D., clinical professor in the Department of Medical Oncology & Therapeutics Research at City of Hope, is the study’s principal investigator.

Ian Wilson, CEO of ImaginAb, said: "ImaginAb’s goal is to provide target-specific imaging agents to predict, inform, monitor and enable treatment of cancer disease more effectively. We are delighted to have enrolled and imaged our first patient in this ongoing clinical study at City of Hope, a world-class cancer center."

The trial will enroll metastatic cancer patients and will study the correlation of imaging signals observed using ImaginAb’s CD8 T-cell ImmunoPET imaging agent, standard-of-care scans, and immunohistochemistry analysis of CD8 in biopsied tissues. The trial will also measure changes in CD8+ T-cell distribution before and after immuno-oncology therapies.

For further information please contact:

ImaginAb

Ian Wilson
Email: [email protected]
Phone: +1 310 645 1211

Optimum Strategic Communications

Mary Clark, Supriya Mathur, Manel Mateus
Email: [email protected]
Phone: +44 20 3950 9144