On April 1, 2021 City of Hope, a world-renowned independent research and treatment center for cancer and diabetes, reported that it will extend its leading-edge cancer expertise to South America via an education agreement with Hospital Israelita Albert Einstein, a top cancer center in Latin America (Press release, City of Hope, APR 1, 2021, View Source [SID1234577511]).

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The three-year agreement calls for City of Hope to share its specialized cancer expertise with Hospital Israelita Albert Einstein’s oncology residents and clinical staff. City of Hope will provide educational experiences and host multidisciplinary tumor boards. Both institutions will explore potential innovative collaborations in precision oncology and research.

"This agreement marks another milestone moment, allowing City of Hope to extend its mission to eliminate cancer to a new continent," said Harlan Levine, M.D., president of strategy and business ventures at City of Hope, which is headquartered near Los Angeles.

"Hospital Israelita Albert Einstein has an exceptional medical team," Levine added. "City of Hope will offer our best-in-class expertise as a comprehensive cancer center to both their residents in training and clinical staff. We hope to collaborate with our Latin American colleagues to improve cancer care outcomes not only in São Paulo, but also throughout Brazil and Latin America."

Among other services, City of Hope will provide a virtual multidisciplinary tumor board that will initially focus on gastrointestinal, genitourinary, lung and brain cancers. Hospital Israelita Albert Einstein physicians will share specific patient cases with complex issues involving molecular diagnostics, immunotherapy and innovations in cancer care delivery for review and discussion. City of Hope will also provide educational webinars and offer professional training on topics such as genetic testing, supportive care services and nursing.

Sidney Klajner, M.D., Ph.D., president of Hospital Israelita Albert Einstein, said, "We will incorporate City of Hope’s multidisciplinary approach to oncology precision medicine to address the cancer burden in Brazil. Together with City of Hope, we hope to collaborate on molecular diagnostics and innovative care advancements for the benefit of patients in Latin American and beyond."

Hospital Israelita Albert Einstein has been ranked as the best hospital in Latin America by the America Economia Business Intelligence Unit for 12 years in a row. Additionally, it is positioned 36th overall globally and 21st for specialized oncology on Newsweek’s ranking of the World’s Best Hospitals 2021.

This collaborative agreement was made possible through efforts by City of Hope’s Center for International Medicine (CIM), which seeks to collaborate with international organizations to improve cancer and diabetes care for more people worldwide. CIM works with governments, hospitals, private companies and investors, and offers a range of services in the areas of clinical research and innovation, education and professional development.

On April 1, 2021 McKesson Corporation (NYSE: MCK) reported that it will release its fourth quarter fiscal 2021 financial results after market close on Thursday, May 6, 2021 (Press release, McKesson, APR 1, 2021, View Source [SID1234577509]). The company will host a live webcast of the earnings conference call for investors at 4:30 PM Eastern Time to review its financial results.

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The live webcast will be available on McKesson’s Investor Relations website at View Source, along with the company’s earnings press release, financial tables and slide presentation.

On April 1, 2021 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, announced today that it has successfully completed the twelve-months product stability testing required by the U.S. Food and Drug Administration (FDA) for its CypCaps final clinical trial product (Press release, PharmaCyte Biotech, APR 1, 2021, View Source [SID1234577508]). This product will be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer upon the FDA lifting the clinical hold on PharmaCyte’s Investigational New Drug Application (IND).

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the completed twelve-month stability study, "We are pleased that our CypCaps product successfully completed all of the required stability tests and that the product has now shown itself to be stable and active after being stored for 1 year at -80oC. The study will continue in order to determine the maximum shelf life of the CypCaps product. It should be noted that this data is exceptional for a product of this kind."

As reported previously, the ongoing stability study is designed to determine the shelf life of the Cell-in-a-Box encapsulated cell product, CypCaps, stored frozen at -80oC. Upon analysis after 12 months in storage at -80oC, the unfrozen CypCaps product passed all of the specified tests, including cell viability, enzyme activity and cell potency as well as pH, label check, capsule appearance, and integrity. This twelve-month data, as well as all future longer-term time points of the shelf life analyses, such as the next time point to be evaluated after 18-months of storage at -80oC, will be reported to the FDA. This ongoing stability study was initiated prior to the submission of the company’s IND to the FDA, and the information and data will form part of the package of information together with data from additional studies requested by the FDA.

In a survey of European biotech/biomedical companies developing advanced therapeutic medicinal products (i.e., products containing living cells like CypCaps), shelf life issues were reported to be one of the major challenges that such products face (ten Ham et al., 2018, Molecular Therapy: Methods & Clinical Development vol. 11, pp121-130). Laboratory data on non-GMP produced encapsulated cells have suggested that the shelf life of Cell-in-a-Box products stored at -80oC is even longer than 1 year.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On April 1, 2021 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it has received PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA) for AUTO1, the company’s CAR T cell therapy being investigated in the ongoing FELIX Phase 1b/2 study in relapsed / refractory (r/r) adult B-Acute Lymphocytic Leukemia (ALL) (Press release, Autolus, APR 1, 2021, View Source [SID1234577507]).

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"We are pleased to have received PRIME designation for AUTO1 as it will accelerate the review of a promising therapy targeting unmet medical need," said Dr. Christian Itin, chairman and chief executive officer of Autolus. "The designation comes soon after we presented compelling activity and safety data from the ALLCAR Phase 1 clinical trial at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. We believe AUTO1 could change standard of care by offering a potentially curative therapy for r/r ALL."

About PRIME
The PRIME program aims to optimize development plans and speed up evaluation of medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options. The PRIME designation is awarded by the EMA to promising medicines that target an unmet medical need. To be eligible and accepted for PRIME, a medicine has to show its potential to benefit patients with unmet medical needs based on early clinical data coupled with non-clinical data. Through the PRIME program, the EMA offers enhanced support to medicine developers including early interaction and dialogue, and a pathway for accelerated evaluation by the agency. The program is intended to optimize development plans and expedite the review and approval process so that these medicines may reach patients as early as possible.

On April 1, 2021 Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, reported that a poster highlighting the Company’s ongoing Phase I/II OVATION 2 Study with GEN-1 in advanced ovarian cancer was presented last week at the Virtual Annual Meeting on Women’s Cancer, sponsored by the Society of Gynecologic Oncology (Press release, Celsion, APR 1, 2021, View Source [SID1234577506]). The poster, titled "A Phase I/II Study Evaluating Intraperitoneal GEN-1 in Combination with Neoadjuvant Chemotherapy [NACT] in Patients with Newly Diagnosed Advanced Epithelial Ovarian Cancer (EOC)," can be viewed here.

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GEN-1 is Celsion’s DNA-mediated interleukin-12 (IL-12) immunotherapy designed using TheraPlas, its proprietary, synthetic, non-viral nanoparticle delivery system platform. The poster was presented by Premal Thaker, MD, Study Chair of the OVATION 2 Study and Professor of Obstetrics and Gynecology, Director of Gynecological Oncology Clinical Research, Division of Gynecologic Oncology, Washington University School of Medicine. Additional authors were R.W. Holloway, L. Kuroki, S. E. DePasquale, W.H. Bradley, A. ElNaggar, M.C. Bell, R.P. Rocconi, A. Bregar, M.D. Indermaur, C. Gunderson, B. Pothuri, R. Agajanian, D. Warshal, D. Provencher, M. McHale, V. John, M. Bergman, S. Lau, L. Musso, K. Anwer, N. Borys and C.A. Leath III.

"Currently advanced ovarian cancer has a low survival rate and a lack of effective therapies. PARP inhibitors have made an important contribution in a subset of patients. For the majority of patients there is hope that an immunotherapy such as GEN-1 will provide a valuable new treatment option to improve both the quality of life and the life expectancy for these women," commented Dr. Thaker. "OVATION 2 Study data now show R0 resections in 14 of 17 patients, or 82%, in the GEN-1 + NACT arm, compared with seven of 12 patients, or 58%, in the NACT alone arm. We view R0 resections as a good predictor of survival, and R0 resections in the GEN-1 + NACT arm are encouraging thus far," Dr. Thaker added.

The poster describes the OVATION 2 Study, which combines GEN-1 with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the cancer as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three adjuvant cycles of chemotherapy and up to nine additional weekly GEN-1 treatments, the goal of which is to delay progression and improve overall survival. The OVATION 2 Study is an open-label, 1-to-1 randomized trial, 80% powered to show the equivalent of a 33% improvement in progression-free survival (PFS) (HR=0.75), the primary endpoint, when comparing the treatment arm (standard of care + GEN-1) with the control arm (standard of care alone).

The Company recently announced that it has enrolled approximately 40% of the anticipated 110 patients to be enrolled into the OVATION 2 Study. To date, 29 patients have had their interval debulking surgery with the following results:

14 of 17, or 82%, of patients treated with GEN-1 had a R0 resection, which indicates a microscopically margin-negative complete resection in which no gross or microscopic tumor remains in the tumor bed.
7 of 12 patients, or 58%, of patients in the control arm had an R0 resection.
This interim data represents a 41% improvement in R0 resection rates for GEN-1- patients compared with control arm patients and is consistent with the reported improvement in resection scores noted in the encouraging Phase I OVATION 1 Study, the manuscript of which has been submitted for publication in a peer-reviewed journal.
Celsion also recently announced that GEN-1 had received Fast Track designation from the U.S. Food and Drug Administration (FDA). This designation is intended to facilitate the development and expedite the regulatory review of drugs to treat serious conditions and fill an unmet medical need.

About GEN-1 Immunotherapy

GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company has previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy or a combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer, and recently completed a Phase Ib dose-escalation trial (OVATION 1 Study) of GEN-1 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer.

About the Virtual Annual Meeting on Women’s Cancer

The Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women’s Cancer will be a fully virtual meeting, allowing participants to access high-quality content and engage remotely from around the world in a platform that will be designed explicitly for this meeting. SGO is working hard to provide a great virtual experience with the latest gynecologic cancer research and education you have come to expect at the Annual Meeting on Women’s Cancer. All education sessions will be recorded and available through the virtual platform for attendees who register for the meeting by March 25, 2021.