On May 18, 2021 Imugene Ltd (ASX:IMU), an immuno-oncology company and City of Hope, a world-renowned independent cancer research and treatment center near Los Angeles, reported they have entered into a licensing agreement for the patents covering a novel combination immunotherapy (Press release, Imugene, MAY 18, 2021, View Source [SID1234580224]). The therapy unleashes a CD19-expressing oncolytic virus to enable CD19-directed chimeric antigen receptor (CAR) T cell therapies to target solid rumors, which are currently otherwise difficult to treat with CAR T cell therapy alone.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Our City of Hope team designed this CF33 oncolytic virus to do what it does so well. It enters the cancer cell, uses the cell’s own machinery to replicate itself, and engineers the cancer cells to express the well-known CAR T cell target, CD19"

Tweet this
The worldwide exclusive license of the patents covering the cell therapy technology, which includes CF33-CD19, known as onCARlytics, or an agent that tags cancer cells for CAR T cell destruction, was developed at City of Hope.

City of Hope scientists led by Saul Priceman, Ph.D., have combined two potent immunotherapies. Imugene’s CD19 oncolytic virus and CD19 CAR T cell therapy — with the goal of targeting and eradicating solid tumours that are otherwise difficult to treat with CAR T cell therapy alone.

"Our research demonstrates that oncolytic viruses are a powerful and promising approach that can be combined strategically with CAR T cell therapy to effectively target solid tumours in patients," said Priceman, assistant professor in City of Hope’s Department of Hematology & Hematopoietic Cell Transplantation."This therapeutic platform addresses two major challenges that make solid tumors so difficult to treat with immunotherapy. There are limited solid tumor targets that T cells can be redirected against with CARs. Solid tumors are surrounded by a brick wall — a so-called immunosuppressive tumour microenvironment. When a CAR T cell attempts to enter the tumor, survive and kill cancer cells, it can’t effectively because of this barrier."

Imugene’s managing director and CEO, Leslie Chong said, "This platform opens up the entire field of use to cellular therapy for the CF33 OV. Supercharging CF33 with CD19 is a revolutionary new paradigm in combination therapy with any CD19 binding therapies to include bi-specifics, antibody drug conjugates and CAR T, cell therapy for solid tumors. The CAR T cell field currently only treats ~10% of all cancers such as blood or liquid tumors, whereas this technology has the potential to open up the solid tumor market."

City of Hope scientists genetically engineered an oncolytic virus to enter tumor cells and force the expression of CD19 on the cell surface. The scientists were then able to use CD19-directed CAR T cells to recognize and attack these solid tumors. The preclinical research was published recently and featured on the front cover of the prestigious journal Science Translational Medicine [1].

CD19-CAR T cell therapy is approved by the U.S. Food and Drug Administration to treat certain types of blood cancers, namely B cell lymphomas and acute lymphoblastic leukemia. This new research may expand the use of CD19-CAR T therapy with onCARlytics to the treatment of patients with potentially any solid tumor.

This discovery highlights a City of Hope research collaboration, including Priceman, Anthony Park, Ph.D., postdoctoral research fellow in Priceman’s lab, Stephen Forman, M.D., director of City of Hope’s Hematologic Malignancies Research Institute and T Cell Therapeutics Research Laboratory, and Yuman Fong, M.D., professor and Sangiacomo Family Chair in Surgical Oncology at City of Hope. "Our City of Hope team designed this CF33 oncolytic virus to do what it does so well. It enters the cancer cell, uses the cell’s own machinery to replicate itself, and engineers the cancer cells to express the well-known CAR T cell target, CD19," Fong said.

A separate four year sponsored research agreement with City of Hope and the research team led by Priceman to further develop the technology​ has also been executed.

Under the terms of the licence agreement, Imugene acquires the exclusive worldwide rights to develop and commercialize the patents covering the CF33-CD19 for which it has agreed to pay City of Hope license fees comprising upfront, annual maintenance fees which are creditable against future royalty payments, performance-based consideration linked to the achievement of certain value-inflection development milestones and commercial outcomes, as well as net sales based on single digit royalty payments, and sublicencing fees.

All upfront cash payments under the license agreement will be funded through Imugene’s existing cash reserves.

1 Effective combination immunotherapy using oncolytic viruses to deliver CAR targets to solid tumours.
Park AK, Fong Y, Kim SI, Yang J, Murad JP, Lu J, Jeang B, Chang WC, Chen NG, Thomas SH, Forman SJ, Priceman SJ.Sci Transl Med. 2020 Sep 2;12(559):eaaz1863. doi: 10.1126/scitranslmed.aaz1863.PMID: 32878978

OnCARlytics

Researchers first created an oncolytic virus (CF33-CD19) in Fong’s lab to get into tumor cells and start producing CD19. They did this successfully in triple-negative breast, pancreatic, prostate, ovarian, head and neck, and brain cancer cell lines. CF33-CD19 oncolytic virus was then combined with CD19-CAR T cells in vitro and in vivo mice studies. Researchers showed significant activity with mice being cured of their cancer with the CF33-CD19 and CAR T cell combination, as well as prolonged protective anti-tumor immunity. Solid tumors don’t express CD19 on their cell surface, therefore introducing the CF33-CD19 allowed for CD19 to be present on the solid tumor cell surface, as well as helped to reverse the tumor’s harsh microenvironment, making it receptive to receiving CAR T cell therapy. The first clinical trial is anticipated to start in 2022 and will evaluate the safety and efficacy of CF33-CD19 in combination with CAR T therapy in patients with solid tumors.

On May 18, 2021 Elevar Therapeutics, Inc. ("Elevar"), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported the presentation of data from a systematic literature review characterizing the burden and unmet medical needs associated with Cremophor-based cancer treatments at the 2021 Virtual International Society for the Pharmacoeconomic and Outcomes Research (ISPOR) conference (Press release, Elevar Therapeutics, MAY 18, 2021, View Source [SID1234580356]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Cremophor EL is an additive used to improve the solubility of paclitaxel, an effective and widely used chemotherapy for the treatment of a variety of cancers such as lung, breast and ovarian cancer. Unfortunately, many patients experience increased adverse events and hypersensitivity reactions caused by the additive rather than the active drug," said Diana I. Brixner, R.Ph., Ph.D., FAMCP, executive director of the Pharmacotherapy Outcomes Research Center at University of Utah Health. "While the clinical burden of Cremophor EL is well documented, this literature review confirms that it is also associated with a high economic and quality of life burden, demonstrating the need for non-Cremophor containing therapy."

The systematic literature review evaluated 31 studies that met the eligibility criteria for a qualitative synthesis of literature on the safety, humanistic, and economic burden of burden of treatment with Cremophor EL (CrEL) among patients with ovarian cancer, triple negative breast cancer, pancreatic cancer, and cervical cancer. Key findings include:

Safety and tolerability associated with CrEL-containing therapy on cancer patients, specifically ovarian cancer patients, result in significant patient burden across clinical and humanistic metrics
Most patients need substantial medication to preemptively, or during chemotherapy, mitigate adverse events (AEs) associated with CrEL-containing therapy
Despite pre-medication, patients reported experiencing these AEs with CrEL-containing therapy
Additionally, the published literature describes challenges associated with infusion of CrEL-containing therapy, including longer infusion times and the need for specialized medical devices to handle the viscous medications.

"Today, healthcare providers must consider not only the direct clinical impact of treatment options for patients, but also the potential impact to a patient’s quality of life and the healthcare costs and resources required to manage treatment with Cremophor-based agents," said Mark Gelder, M.D., chief medical officer of Elevar Therapeutics. "This systematic literature review is the first to evaluate the current evidence on the clinical, economic, and humanistic burdens related to Cremophor EL based therapies among multiple tumor types. We are pleased to share these results with the global oncology community which we hope promote a better understanding of the impact of Cremophor EL on patients and help inform optimal treatment selection."

About Ovarian Cancer

Ovarian cancer is one of the most common female cancers affecting the primary reproductive organs 1. Globally, it is the third most common cancer among women and has the highest mortality rate 2,3. Although ovarian cancer has a lower prevalence in comparison with breast cancer, it is three times more lethal, and it is predicted that, by the year 2040, the mortality rate of this cancer will rise significantly 4,5. About half of the women who are diagnosed with ovarian cancer are 63 years or older and many of these patients are predisposed to age-related comorbidities, such as diabetes, which can influence treatment response and prognosis 6.

About Apealea (paclitaxel micellar)

Apealea is a patented, water-soluble, intravenously injectable, non-Cremophor based formulation of paclitaxel. Paclitaxel is a well-known chemotherapy agent used to treat breast, ovarian, lung, bladder, prostate, melanoma, and esophageal cancer, as well as other types of solid tumor cancers.Cremophor EL, is a formulation vehicle used for various poorly-water soluble drugs, including the anticancer agent paclitaxel, and is known to cause serious hypersensitive allergic reactions.

In December 2020, Elevar Therapeutics announced that it had entered into an exclusive agreement with Inceptua Group for the distribution and commercialization of Apealea (paclitaxel micellar) in Europe. Apealea received marketing authorization by the European Commission in November 2018, making it Europe’s first non-Cremophor EL formulation of paclitaxel approved for use in ovarian cancer. Apealea has been authorized by European regulatory authorities for use in the European Economic Area in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. It has also been granted Orphan Drug Designation by the U.S. Food and Drug Administration.

On May 18, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that its management team will participate at the Oppenheimer MedTech, Tools & Diagnostics Summit on Wednesday, May 26, 2021 (Press release, Personalis, MAY 18, 2021, View Source [SID1234580225]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Interested parties may access the pre-recorded and archived webcast of the presentation for 90 days following the conference through the "Events" section of Personalis’ website at View Source

On May 18, 2021 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage precision oncology company developing targeted therapies to inhibit frontier targets in RAS-addicted cancers, reported that the company will participate in the upcoming Cowen 2nd Annual Virtual Oncology Innovation Summit (Press release, Revolution Medicines, MAY 18, 2021, View Source [SID1234580193]). Steve Kelsey, M.D., president, research and development, will be the featured speaker in a fireside chat at the event.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Details of the company’s participation are as follows:

Cowen 2nd Annual Virtual Oncology Innovation Summit
Conference Date: May 20-21, 2021
Fireside Chat Time/Date: 12:40 p.m. Eastern on Friday, May 21, 2021
Format: Virtual conference

On May 18, 2021 InterSystems, a leader in healthcare data management, and Oncodesign (Paris:ALONC), a biopharmaceutical company specializing in precision medicine, reported the signing of a strategic partnership aimed at advancing research for new treatments in the field of oncology (Press release, Oncodesign, MAY 18, 2021, View Source [SID1234580210]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

In a context characterized by an exponential growth of data volumes over the last 20 years, the quality and use of health and research data have become two critical issues for all healthcare stakeholders. The current health crisis has only reinforced the importance of an agile and decompartmentalized strategy for health data governance.

As part of this partnership, Oncodesign has chosen to combine its proprietary platform for the identification and validation of new therapeutic targets, called OncoSNIPER, with InterSystems’ unified health data management platform, known as InterSystems IRIS for Health. This alliance will allow both companies to develop and optimize essential synergies between the two platforms.

The InterSystems IRIS for Health data platform will be integrated into Oncodesign’s recently established Artificial Intelligence (AI) Business Unit for the storage and management of various preclinical and clinical data sources, which are highly valuable to each of the businesses involved in the drug discovery process. By analyzing and better exploiting the data consolidated through InterSystems IRIS for Health, Oncodesign’s AI BU will optimize the development of OncoSNIPER, notably through more accurate functioning of its algorithms. In addition, InterSystems will provide Oncodesign with the benefit of its international network of strategic academic partners generating health data (hospitals and universities), particularly in North America.

For InterSystems, this partnership is part of a strategic approach to healthcare players through its access to Oncodesign’s solid expertise in drug discovery and reflects its historical commitment to oncology. With a solid domestic network, InterSystems has been working for many years with major cancer centers (known as CLCC in France) through its patient administrative and clinical management solution, InterSystems TrakCare (especially in Dijon, Nice and Reims), as well as with the Toulouse University Cancer Institute – Oncopole (IUCT-O) with InterSystems HealthShare, for comprehensive patient management and better coordination of the various private and public players in the region. The company has also made its expertise in health data exploitation available to innovative partners such as the start-up MyPL and the Guerbet Group.

For Michel Amous, Regional Director EMEA at InterSystems: "We are delighted to begin this partnership with Oncodesign, which has been a major player in the biotechnology industry for 25 years. Our goal is to provide them with our expertise in optimizing data platforms to build a new intelligent architecture for oncology research. The pooling of health data – scattered, heterogeneous but so valuable – is not just a simple operational consolidation. It is a project with strategic scope aimed at aggregating the various sources of data available to Oncodesign in order to improve communication between them. This dynamic governance will enable Oncodesign to remain at the forefront of biopharmaceutical innovation and ultimately to commercialize new therapeutic solutions to better serve the public interest. "

For Oncodesign, this partnership is the second step in its strategic development based around AI after the launch in 2017 of the OncoSNIPER project (clinical trial of 600 patients with 3 oncology indications and 16 partners). After generating large amounts of heterogeneous clinical data, the company needs to structure the available data using the InterSystems IRIS for Health data platform, before implementing the algorithms needed to select sub-populations of patients with treatment-resistant cancers.

Philippe Genne, Chairman and CEO of Oncodesign, stated: "We have known the InterSystems teams well for several years, and we are therefore very pleased to formalize our collaboration through this ambitious partnership. Our expertise at Oncodesign is in developing new treatments and InterSystems’ is in leveraging data to accelerate the digital transformation of companies. Together, we will be able to pool our respective fields of expertise in order to make our drug discovery process in precision medicine more reliable and even faster. Traditionally, the lead optimization phase alone can last up to 3 years and cost between 10 and 12 million euros with random results in the medium term (1/10 success rate). Today, artificial intelligence is changing the game: the exploitation of data gives us the possibility to make more informed choices in increasingly rapid timeframes. "

This collaboration will bring together several distinct and complementary fields of expertise, including data science, artificial intelligence, pharmacology, chemistry, biology and clinical research. The two companies share a common goal: to harness the power of data to develop and industrialize new therapeutic solutions in the field of oncology.

On May 21st next, Oncodesign will inaugurate its new headquarters in Dijon (Bâtiment Jean Mermoz – 18 rue Jean Mazen), which will house its AI teams. On the same day, the company will also launch its new development strategy based on AI approaches.