August 2020 – Page 19 – 1stOncology™: Cancer Intelligence Service

Sarah Cannon and Lyell Immunopharma Announce Collaboration to Advance Development and Patient Access to T-Cell Therapies

On August 27, 2020 Sarah Cannon, the Cancer Institute of HCA Healthcare, and Lyell Immunopharma reported a strategic collaboration for the advancement of oncology-focused immune-effector, or T-Cell, therapies (Press release, Sarah Cannon Research Institute, AUG 27, 2020, View Source [SID1234564108]). This partnership brings together Lyell’s research and development of cell-based immunotherapies and Sarah Cannon’s expertise in designing and optimizing clinical trials to expand treatment options and access for patients.

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"We look forward to partnering with Lyell Immunopharma to accelerate development and access to innovative T-Cell therapies for patients who could potentially benefit from these treatment options," said Howard A. "Skip" Burris, MD, President, Clinical Operations and Chief Medical Officer, Sarah Cannon. "By bringing together Lyell Immunopharma’s scientific expertise with Sarah Cannon’s experience and expansive network, we can pursue an innovative approach to bring these cutting-edge treatment options into the community more rapidly and affordably for patients."

Sarah Cannon is one of the world’s leading clinical research organizations conducting community-based clinical trials throughout the United States and United Kingdom. Additionally, Sarah Cannon’s Blood Cancer Network is one of the largest providers of hematopoietic cell transplants, offering patients access to complex blood cancer care, including clinical trials and innovative therapies such as CAR T-Cell therapy.

Since 2015, Sarah Cannon has activated T-Cell therapy studies, which are overseen by immune cell therapy committees that advise on the coordination and standardization of research processes across centers for both blood cancer and solid tumor indications.

"Lyell is very excited to be partnered with Sarah Cannon," said Tina Albertson, MD, PhD, Chief Medical Officer of Lyell. "This collaboration should result in the ability to more rapidly and efficiently initiate clinical trials and thus bring Lyell’s innovative cell therapy treatments to patients more quickly once trials are authorized to commence."

Lyell Immunopharma, Inc. is a cellular therapy company dedicated to mastering immune cell functionality by focusing on advancing the science of T-Cell differentiation, functionality, and specificity to develop curative treatments.

T-Cell therapies have become an effective approach for treating many forms of blood cancers, with CAR T-Cell therapies currently approved in acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL), as well as hundreds of additional trials for both blood cancer and solid tumors.

"There are challenges in developing and providing access to the latest T-Cell therapies due to care fragmentation and related barriers for integrating these novel therapies into clinical settings," said Fred LeMaistre, MD, Senior Vice President, Market Operations and Physician-in-Chief, Blood Cancers for Sarah Cannon. "By collaborating, Sarah Cannon and Lyell Immunopharma will work to create a more cohesive approach to introducing new T-Cell therapy standards of care into clinical practice, and developing strategies for these innovative therapies."

Through Sarah Cannon Development Innovations, its full-service, oncology-focused contract research organization (CRO), Sarah Cannon will provide comprehensive clinical development services and operational delivery for the collaboration.

OncoSec Announces Initiation of a Phase 2 Study at the Moffitt Cancer Center to Evaluate the Combination of TAVO plus OPDIVO® as Neoadjuvant Therapy for Melanoma

On August 27, 2020 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a company developing late-stage intratumoral cancer immunotherapies, reported the commencement of an investigator-initiated Phase 2 study led by Senior Member and Professor Ahmad A. Tarhini, M.D., Ph.D. of the H. Lee Moffitt Cancer Center and Research Institute and the University of South Florida Morsani College of Medicine to evaluate its lead product candidate, TAVO (interleukin-12 or IL-12 plasmid) immunotherapy as neoadjuvant treatment (administered before surgery) in combination with intravenous OPDIVO (nivolumab) in up to 33 patients with operable locally/regionally advanced melanoma (Press release, OncoSec Medical, AUG 27, 2020, View Source [SID1234564107]).

Anti-PD-1 immune checkpoint therapies, such as OPDIVO, are an established first-line treatment for advanced melanoma, and encouraging clinical data suggest that they have clinically meaningful activity in the neoadjuvant setting as well. This investigator-initiated Phase 2 study has been designed to evaluate whether the addition of TAVO can increase the published anti-tumor response observed with monotherapy OPDIVO, an anti-PD-1 checkpoint inhibitor, in patients with locally/regionally advanced melanoma prior to surgical resection of tumors.

Recent trials with anti-PD-1 and anti-PD-1 combinations have shown significant advantages in both relapse free survival (RFS) and overall survival (OS) when administered as neoadjuvant therapy as compared to adjuvant therapy (administered after surgery) alone for metastatic melanoma. The TAVO-specific immunological signatures associated with coordinated innate and adaptive cellular responses were identified in earlier TAVO monotherapy trials and continue to be essential in driving the clinical efficacy in late-stage, anti-PD-1-refractory metastatic melanoma patients. These immunological pathways that sensitize lesions to checkpoint therapy in a late-stage setting are likely to be highly active in an earlier disease setting, which along with TAVO’s excellent safety record, provides a strong rationale to leverage this therapeutic combination within the neoadjuvant setting.

"Patients with locally/regionally advanced melanoma present a major challenge for surgical and medical management," said Dr. Tarhini, who is Director, Cutaneous Clinical & Translational Research and Senior Member in the Departments of Cutaneous Oncology and Immunology at H. Lee Moffitt Cancer Center & Research Institute. "Following surgical treatment, these patients continue to have a high risk of relapse and death despite the use of standard adjuvant therapy. Neoadjuvant therapy with an effective immunotherapeutic agent, such as TAVO, combined with the anti-PD-1checkpoint inhibitor nivolumab, has the potential to improve overall outcomes such as operability, pathologic tumor response and long-term disease control. This, combined with the excellent safety and tolerability profile TAVO has demonstrated with hundreds of patients to-date, leaves me very encouraged and eager to evaluate TAVO-nivolumab combination treatment in the neoadjuvant setting."

"This Phase 2 study will highlight the advantages of bringing TAVO into an earlier disease setting. It will be an important validation of the broad utility of TAVO, and is anticipated to build on its excellent safety and efficacy profile to date," commented Kellie Malloy Foerter, OncoSec’s Chief Operating Officer. "We look forward to collaborating with Dr. Tarhini’s team and to supporting other potential investigator-initiated studies that can further the understanding of TAVO’s capabilities in treating cancer. We also want to express our appreciation of the patients and their families who participate in clinical trials."

Seattle Genetics to Receive Milestone Payment Under ADC Collaboration with GlaxoSmithKline Following European Commission Approval of BLENREP (belantamab mafodotin)

On August 27, 2020 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that it will receive a milestone payment from GlaxoSmithKline (GSK) triggered by European Commission conditional marketing authorisation for GSK’s BLENREP (belantamab mafodotin), an antibody-drug conjugate (ADC) targeting B-cell maturation antigen (BCMA) that utilizes Seattle Genetics’ proprietary technology (Press release, Seattle Genetics, AUG 27, 2020, View Source [SID1234564106]). BLENREP was developed and will be commercialized by GSK. In addition to the milestone payment, Seattle Genetics is entitled to royalties on BLENREP product sales. BLENREP was approved as monotherapy for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

"This is the second collaborator program utilizing our ADC technology to receive European Commission approval in 2020, and rapidly follows the FDA approval of BLENREP earlier this month, highlighting the potential of these novel therapies in the treatment of cancer patients globally," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Our ADC collaborator progress, along with the growth of Seattle Genetics’ marketed ADCs, ADCETRIS and PADCEV, and recent positive results of tisotumab vedotin from our ADC pipeline, underscore our leadership in ADCs to treat cancer."

BLENREP was granted PRIME (PRIority MEdicines) designation in 2017 and the application was reviewed under the European Medicines Agency’s (EMA) accelerated assessment procedure, which is given if the Committee for Medicinal Products for Human Use of the EMA determines the treatment is of major interest from a public health perspective and represents a therapeutic innovation.

Seattle Genetics’ ADC technology combines the specificity of monoclonal antibodies, innovative linker systems and potent cell-killing agents to treat cancer. The technology has been licensed to several companies. Under the terms of these agreements, each licensee company has rights to use the technology with antibodies against specified targets. The licensee is responsible for research, product development, manufacturing and commercialization. Seattle Genetics is entitled to receive fees, progress-dependent milestone payments and royalties on worldwide net sales of any resulting ADC products.

TRACON Pharmaceuticals Announces $5.0 Million Private Placement

On August 27, 2020 TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that it has entered into a definitive securities purchase agreement with an institutional health care focused fund to raise aggregate gross proceeds of approximately $5.0 million through a private placement of its common stock and pre-funded warrants (Press release, Tracon Pharmaceuticals, AUG 27, 2020, View Source [SID1234564105]). The closing of the private placement is expected to occur on or about August 27, 2020.

TRACON will sell approximately 3.1 million shares of common stock, or in lieu of common stock, pre-funded warrants to purchase common stock, for aggregate gross proceeds of approximately $5.0 million. The purchase price of each share of common stock (or pre-funded warrant) is approximately $1.64. The pre-funded warrants will have a per share exercise price of $0.01 and will expire seven years from the date of issuance.

TRACON intends to use the net proceeds from the private placement to conduct the ENVASARC pivotal study of envafolimab in sarcoma and for working capital and general corporate purposes. As previously announced, the ENVASARC trial was cleared by the U.S. Food and Drug Administration on August 14th, 2020.

The securities being sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. TRACON has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable in connection with the private placement, including upon exercise of the pre-funded warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Seattle Genetics Highlights Data from Broad Oncology Portfolio During ESMO Virtual Congress 2020

On August 27, 2020 Seattle Genetics, Inc. (Nasdaq:SGEN) reported the presentation of new data from its broad pipeline of marketed and investigational therapies at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, taking place September 19-21 (Press release, Seattle Genetics, AUG 27, 2020, View Source [SID1234564104]). Twelve abstracts, including a late-breaking abstract accepted for oral presentation featuring data from the positive tisotumab vedotin phase 2 innovaTV 204 clinical trial in recurrent or metastatic cervical cancer, will highlight the company’s continued progress in advancing research in cancers that have a significant unmet need.

"At the ESMO (Free ESMO Whitepaper) Virtual Congress, we will be sharing important updates from our broad oncology portfolio of both marketed and investigational therapies, including an oral presentation of full data from the phase 2 trial evaluating tisotumab vedotin in recurrent or metastatic cervical cancer," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "In addition, we will present data describing real-world outcomes for patients with HER2-positive breast cancer with brain metastases, as well as additional analyses of the impact of TUKYSA on clinical outcomes and quality of life for patients in the HER2CLIMB trial. As illustrated by several trials in progress presentations, we continue to advance the development of our programs across a range of unmet medical needs."

The abstract titles published in advance of the ESMO (Free ESMO Whitepaper) Congress can be found here. All data presentations will be available via on-demand view starting on Thursday, September 17, 2020.

Details of Key Seattle Genetics Presentations at ESMO (Free ESMO Whitepaper) Virtual Congress 2020:

Abstract Title

Abstract # / Presentation #

Presentation
Type / Date

Presenter

Completed Clinical Trials

Tisotumab Vedotin

Tisotumab vedotin (TV) in previously treated recurrent or metastatic cervical cancer (r/mCC): results from the phase 2 innovaTV 204/GOG-3023/ENGOT-cx6 study

#3435/#LBA32

Late-breaking oral presentation / Monday, Sept. 21 at 17:04 CET

RL. Coleman

Tucatinib (TUKYSA)

Impact of Tucatinib on Health-Related Quality of Life (HRQoL) in Patients with HER2+ Metastatic Breast Cancer (MBC) with and without Brain Metastases (BM)

#2067/#275O

Oral presentation / Monday, Sept. 21 at 12:42 CET

V. Mueller

Impact of Tucatinib on Progression-Free Survival in Patients with HER2+ Metastatic Breast Cancer and Brain Metastases

#2073/#293P