On November 11, 2019 IBM (NYSE: IBM), American Cancer Society (ACS), the National Comprehensive Cancer Network (NCCN) and the Clinton Health Access Initiative (CHAI), reported a new alliance to help improve access to high-quality cancer care and treatment in Sub-Saharan Africa called Allied Against Cancer (Press release, IBM – Initiate Systems, NOV 11, 2019, View Source [SID1234550879]). The Alliance will support a network of African oncology experts and technical assistance partners to help improve the quality of cancer care, including collaborating closely with the African Cancer Coalition to establish priorities and execute these initiatives locally.

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There are more than 800,000 new cancer cases each year in Sub-Saharan Africa and incidence is projected to double by 2040. And as these countries address the growing cancer epidemic, data and emerging technologies can play a significant role in cancer treatment control and care. The need for more affordable cancer treatment and strong systems for their delivery are crucial to help improve patients’ survival.

To address gaps in access to cancer medicines, ACS and CHAI teamed up in 2016 to bring lower prices for 16 common chemotherapy drugs to a half-dozen countries in Sub-Saharan Africa. And top American oncologists have supported the African Cancer Coalition — comprising of 110 African oncologists representing 34 hospitals from 13 countries in Sub-Saharan Africa—to adapt cancer-treatment guidelines for use in African hospitals. The African Cancer Coalition, working with experts from NCCN, adapted the 46 NCCN Guidelines and NCCN Framework for Resource Stratification of NCCN Guidelines (NCCN Framework) to create the NCCN Harmonized Guidelines for Sub-Saharan Africa specifically to be used by oncologists across Sub-Saharan Africa. These guidelines have been endorsed by leading cancer centers or health ministries in six countries to date.

IBM then developed an online tool called Cancer Guidelines Navigator to provide African oncology professionals with interactive access to the NCCN Harmonized Guidelines for Sub-Saharan Africa at no charge. Oncologists based in Sub Saharan Africa can input a clinical description for a cancer patient1 — such as tumor type, stage, biomarker status, and prior treatments — into the online tool. The Cancer Guidelines Navigator then points the user to relevant treatment options input from the NCCN Harmonized Guidelines. At this time, the tool includes NCCN Harmonized Guidelines for cervical cancer, prostate cancer, breast cancer, diffuse large B-cell lymphoma, and Kaposi sarcoma.

IBM also helped to transform the ACS ChemoSafe Facility Assessment Tool – from an Excel-based document to an interactive, easy to use mobile application- to scale the program’s goal of improving the safety and quality for chemotherapy handling in cancer centers. This tool, which is accessible at no cost on iOS or Android mobile phones or tablets, allows healthcare workers to review the safety of hazardous drugs at each location where they may be handled in their healthcare facility, including the pharmacy receiving, treatment areas, housekeeping, and waste area. Upon completion of the assessment, the tool provides recommendations to help improve the handling of hazardous drugs at potential points of exposure, based on international and national standards. This information may be used by hospitals to create policies and budgets supporting quality improvement.

"Allied Against Cancer brings together a group of top-notch experts to tackle the growing burden of cancer in Africa, and the American Cancer Society is proud to be a founding member of the alliance," said Gary Reedy, Chief Executive Officer, American Cancer Society.

"With the increasing burden of cancer in this part of the world, we must strive to improve patients’ access to timely and affordable care. Technology and data can help create efficient healthcare systems so that national and regional medical networks can increase support their local communities," said Dr. Solomon Assefa, Vice President, Africa & Emerging Market Solutions and Director, IBM Research – Africa.

"These evidence and expert consensus-based treatment recommendations combine the practical with the aspirational, to elevate the quality of cancer care at a time when the people of Sub-Saharan Africa need it most," said Robert W. Carlson, MD, Chief Executive Officer, NCCN.

"This new alliance will help ensure that lifesaving medications and tools are available where and when they are needed so that health professionals can better diagnose, treat, and care for patients suffering with cancer throughout Sub-Saharan Africa," said CHAI CEO Ira C. Magaziner.

"To address the growing burden of cancer in Africa and worldwide, African oncologists need quick and easy access to current treatment options as well as quality, affordable treatment for their patients. This alliance provides an opportunity to strengthen the ties within the global oncology community in ways that can deliver better outcomes for our patients," said Professor Isaac Adewole, Co-chair of the African Cancer Coalition.

On November 11, 2019 USA News Group – As the global oncology drug market is projected to grow at a rate of 7.6% CAGR to hit $176.5 billion by 2025, there’s a growing interest within the big pharma sector to tap into the power of viruses to fight cancer (Press release, Oncolytics Biotech, NOV 11, 2019, View Source [SID1234550880]). It’s estimated that the therapeutic cancer vaccine market alone will reach more than $15 billion by 2025. Dubbed ‘oncolytic viruses’ these treatments utilize all types of viruses to encourage the patient’s immune system to respond and attack cancer cells with heightened efficacy. It’s been seen that a variety of majors including Amgen Inc. (NASDAQ:AMGN), Merck & Co. (NYSE: MRK), AbbVie Inc. (NYSE:ABBV), and Bristol-Myers Squibb (NYSE:BMY) are looking at a variety of oncolytic virus developers, such as Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC).

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Innovators like development stage Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) are drawing interest from major partners for developing their own immuno-oncology virus. The companuy’s proprietary reovirus, marketed as pelareorep, is currently being studied for potential combination with Opdivo from Bristol-Myers Squibb Company and Keytruda from Merck & Co., Inc.

In 2018, both Opdivo and Keytruda are multi-billion dollar products—Opdivo sales were $6.7 billion, while Keytruda sales were $7.2 billion. Pelareorep is also being studied for potential combinations with Merck/Pfizer’s paclitaxel and Bavencio (which sold $75.5 million in 2018), and Roche’s Tecentriq (which had sales of $766 million in 2018).

Now with the Opdivo and Keytruda developments, it’s worth noting that Bristol-Myers Squibb and Merck are no strangers to the oncolytic virus scene. Both companies have made significant investments in the oncolytics virus sector in recent years.

MAJORS MAKING 9-DIGIT ONCOLYTIC VIRUS INVESTMENTS

In 2015, Amgen Inc. became the first company to win approval for such a treatment, when the FDA approved the therapy T-VEC (or Imlygic) to treat metastatic melanoma that cannot be surgically removed. The approval was based on the results of a multicenter phase 3 clinical trial of patients with metastatic melanoma lesions in the skin and lymph nodes.

Bristol-Myers Squibb followed up this approval, by entering a partnership in 2016 with PsiOxus involving its lead asset Adenovirus, which was in phase 1. The transaction involved a $50 million payment up front, with up to $886 million in milestone payments and royalties at stake. The first milestone payment was earned the following year when it achieved approval for its Clinical Trial Application.

Merck has also been active, including the acquisition of Viralytics for its lead asset Coxsackievirus which was in phase 1b at the time of acquisition, and another immunotherapy partnership with Vyriad (and lab partner Pfizer), involving its lead drug candidate Voyager-V1.

Merck acquired the virus-based cancer drug firm Viralytics for $394 million in 2018, at a premium price of 160% to the average stock price over the previous month. Viralytics’s leading experimental product at the time of acquisition was Cavatak, which uses a proprietary formulation of a common cold virus, and was in the process of being studied in multiple Phase I and Phase II clinical trials.

In 2017, AbbVie Inc. partnered with another Canadian drug developer Turnstone Biologics. The deal gives AbbVie the exclusive right to license up to three of Turnstone Biologics’ immunotherapy treatments for commercial purposes. Terms of the deal, however, are not publicly available.

PELAREOREP’S ONGOING PROGRESS

Pelareorep from Oncolytics Biotech Inc. (ONCY – ONC.TO) selectively infects tumor cells, leading to the creation of inflamed tumors. The body’s ability to target the inflamed tumors is heightened, leading to the creation of tumor reactive T cells. In turn, pelareorep expands existing T cell clones priming the immune system for checkpoint blockade. To date, the drug has synergized with all checkpoint inhibitor combinations tested.

So far, based on the final advice from the FDA following their EOP2 meeting, the company’s been granted Special Protocol Assessment (SPA). It’s been recommended that identification of biomarker should be done before Phase III. Confirmation of a single phase 3 study is required for approval.

Through a partnership with Northwestern Medicine’s Feinberg School of Medicine, and Merck & Co., Oncolytics is studying pelareorep’s potential with Merck’s Keytruda in targeting metastatic pancreatic cancer. The phase 2 study incorporates up to 30 patients.

In another partnership involving Keytruda, Oncolytics is pairing with Merck and Keck Medicine of USC to study a combination efficacy involving multiple myeloma. The phase 2 study involves 22 patients, and will incorporate existing safety data in combination with Keytruda.

For a combination with Opdivo, Oncolytics is also targeting multiple myeloma, by collaborating with Bristol-Myers Squibb and Emory University, in a phase 1 study. The study involves 40 to 50 patients, and so far at the top dose, there has been a 100% response rate.

"Having worked with pelareorep in multiple myeloma and understanding its ability to act as a potentiator of checkpoint blockade, I’m very excited to work with the Oncolytics team on this study," said Dr. Craig Hofmeister, Associate Professor, Department of Hematology and Medical Oncology Emory University School of Medicine. "Pelareorep has proven its ability to create an inflamed phenotype and its potential for upregulation of PD-1 on tumor-infiltrating lymphocytes. My hope is this study leads not only to an effective combination dosing schedule but provides quantitative data describing the expression of PD-1, along with correlative studies that reveal the roles of both immune-mediated and direct cytotoxic myeloma cell killing."

To date, pelareorep has been involved with 1,100 patients treated, of which over 900 were administered intravenously. To date, no maximum tolerated dose (MTD) has been reached.

In terms of manufacturing the product, Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) has established cost-effective contract manufacturing. The final formulation was produced at 100 liter-scale under cGMP—which is more than 50,000 standard doses per production run.

Oncolytics has established a commercial scale manufacturing agreement with SAFC (part of Merck Millipore Sigma). When stored frozen, the liquid formulation is stable for at least five years (with stability testing ongoing).

Pelareorep has been given biosafety level 2 classification, thus requiring no specialized handling requirements. Cost of Goods (COGS) are in line with those of other products made via vaccine manufacturing process.

Oncolytics has 398 patents issued worldwide, including 48 US and 21 Canadian, with over 21 more pending applications worldwide. The reovirus issued patent claims cover compositions of matter comprising reovirus (through 2028 and extendable to 2033), and all pharmaceutical uses of it.

THE ONCOLYTIC VIRUS SCENE AHEAD

Merck & Co. (NYSE:MRK) made a big splash in the oncolytic virus scene when it bought the Australian biotech firm Viralytics for $394 million. The massive price paid signaled that Viralytics was an asset that Merck just had to own.

This was similar to the size of payment that Amgen Inc. (NASDAQ:AMGN) made, when it paid $424 million for Biovex in 2011. Given that Amgen’s T-VEC was the first oncolytic virus to receive FDA approval, it’s realistic to believe that they’re not done solidifying their position in the space. T-VEC is a genetically engineered oncolytic herpes virus, that’s injected into skin tumors, resulting in shrinkage or complete remission of tumors.

AbbVie Inc. (NYSE:ABBV) tipped its hand towards an interest in oncolytics viruses, when it secured an option on three oncolytic viral immunotherapies from Turnstone Biologics. The deal gives AbbVie the chance to add Turnstone’s lead MAGEA3 candidate to its pipeline once data from the two ongoing phase 1/2 trials are available.

While Bristol-Myers Squibb (NYSE:BMY) continues to work with Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) for a combination with Opdivo, the major invested heavily in a partnership with PsiOxus for roughly $900 million. Together, they are developing an oncolytic adenovirus, which has already earned a $15 million milestone payment for PsiOxus.

On November 11, 2019 A quality expert and lead oncology hospitalist from the Dana-Farber Cancer Institute in Boston – the principal teaching affiliate for Harvard Medical School and one of the nation’s highest-ranked cancer hospitals – is the new Chief Medical Officer of University Hospitals Seidman Cancer Center (Press release, University Hospitals, NOV 11, 2019, View Source [SID1234550865]).

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Brett Glotzbecker, MD, brings 15 years of experience at Brigham and Women’s Hospital/Dana-Farber Cancer Institute. As an assistant professor at Harvard Medical School, Dr. Glotzbecker was honored with awards from the Dana-Farber/Harvard Cancer Center for excellence in teaching and quality achievement. She had been the principal investigator on multiple funded projects, most recently to compare outcomes for hematopoietic cell transplant patients and another to improve communication toward a more efficient discharge process.

"The UH Seidman Cancer Center family is so fortunate to have attracted a physician leader of Dr. Glotzbecker’s stature. Her expertise in patient experience, quality and clinical care delivery will help us achieve our stated goal of being the US leader in value based cancer care," said Theodoros N. Teknos, MD, President and Scientific Director of UH Seidman Cancer Center.

Dr. Glotzbecker received her medical degree and a bachelor’s degree in bioengineering from the University of Pennsylvania in Philadelphia. She completed her residency in internal medicine and her clinical/research fellowship in hematology and medical oncology from Beth Israel Deaconess Medical Center in Boston.

As Chief Medical Officer, Dr. Glotzbecker will oversee quality and the patient experience for all disease teams and tumor conferences, providing focused leadership for achieving all key certifications. She will be the senior physician liaison for cancer practitioners throughout the system. Dr. Glotzbecker will work closely with Nursing, Medical Staff and Quality. As a physician of University Hospitals Medical Group and the Department of Medicine Division of Hematology and Oncology, Dr. Glotzbecker also will provide inpatient clinical care or other care, such as consults, tumor boards and call coverage.

On November 11, 2019 DNAtrix, an oncolytic virus immunotherapy company with a proprietary adenovirus platform, reported that updated data from the CAPTIVE / KEYNOTE-192 study of DNX-2401 (tasadenoturev) with pembrolizumab will be presented at the Society for Neuro-Oncology (SNO) Annual Meeting, held from November 22-24, 2019 in Phoenix, Arizona (Press release, DNAtrix, NOV 11, 2019, View Source;keynote-192-study-of-dnx-2401-in-combination-with-pembrolizumab-for-glioblastoma-at-the-2019-sno-annual-meeting-300955205.html [SID1234550881]). Updated safety and efficacy data will be presented from the fully enrolled clinical study evaluating the immunotherapy in patients with recurrent glioblastoma. DNAtrix’s oncolytic virus technology will be highlighted across six additional abstracts selected for presentation.

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"We are pleased that data from a broad range of studies with our oncolytic viruses have been selected for presentations at SNO," said Frank Tufaro, PhD, CEO of DNAtrix. "Our team is committed to developing virus-based therapies to treat devastating diseases like glioblastoma, for which new treatments are desperately needed."

Details of the presentations are as follows:

Oral Presentation: Interim Results of a Phase II Multi-center Study of Oncolytic Adenovirus DNX-2401 with Pembrolizumab for Recurrent Glioblastoma; CAPTIVE Study (KEYNOTE-192)

Presenting Author: Clark Chen, MD, PhD, University of Minnesota

Session Title: Immunology Pre-Clinical and Clinical II (5A)

Date and Time: Sunday, November 24, 8:55 AM – 9:05 AM MST (10:55 AM – 11:05 PM EST)

Abstract Number: ATIM-33

Oral Presentation: Activating the immunity within the tumor using viroimmunotherapy: Delta-24-RGD oncolytic adenovirus armed with the immunopositive regulator GITRL

Presenting Author: Candelaria Gomez-Manzano, MD, MD Anderson Cancer Center

Session Title: Drug Discovery/Drug Resistance and Experimental Therapeutics (2C)

Date and Time: Friday, November 22, 3:15 PM – 3:25 PM MST (5:15 PM – 5:25 PM EST)

Abstract Number: EXTH-27

Oral Presentation: Treatment with Delta-24-RGDOX of subcutaneous tumors results in abscopal effect eradicating intracranial melanomas

Presenting Author: Juan Fueyo, MD, MD Anderson Cancer Center

Session Title: Drug Discovery/Drug Resistance and Experimental Therapeutics (2C)

Date and Time: Friday, November 22, 4:35 PM – 4:40 PM MST (6:35 PM – 6:40 PM EST)

Abstract Number: EXTH-11

E-talk: Stem cell delivery of oncolytic adenovirus DNX-­2401 following surgical resection for the treatment of glioblastoma

Presenter: Sricharan Gopakumar, MD Anderson Cancer Center

Session Title: Drug Resistance/Drug Discovery/Experimental Therapeutics

Date and Time: Friday, November 22, 7:42 PM – 7:46 PM MST (9:42 PM – 9:46 PM EST)

Abstract Number: EXTH-62

E-talk: Oncolytic virus expressing a positive immune checkpoint modulator as a therapeutic approach for DIPG

Presenter: Virginia Laspidea, Clínica Universidad de Navarra

Session Title: Adult Therapeutics/Immunology/Rare Tumors

Date and Time: Saturday, November 23, 5:48 PM – 5:52 PM MST (7:48 PM – 7:52 PM EST)

Abstract Title: IMMU-14

Poster Title: Phase I clinical trial with oncolytic virus DNX-2401 for naive DIPGs

Presenting Author: Marta M. Alonso, PhD, Clínica Universidad de Navarra

Date and Time: Saturday, November 23, 5:00 PM – 7:00 PM MST (7:00 PM – 9:00 PM EST)

Abstract Number: PDCT-18

Poster Title: Delta-24-RGD oncolytic adenovirus mediates anti-tumor effect in localized and disseminated AT/RT murine models

Presenting Author: Marc Garcia-Moure, PhD, Clínica Universidad de Navarra

Date and Time: Saturday, November 23, 5:00 PM – 7:00 PM MST (7:00 PM – 9:00 PM EST)

Abstract Number: PDTM-23

DNX-2401 (Delta-24-RGD, tasadenoturev) and murine DNX-2440 (Delta-24-RGDOX), an oncolytic adenovirus expressing the immune modulator OX40 ligand, are being evaluated in ongoing clinical studies for highly aggressive brain tumors, including recurrent glioblastoma in adults and newly-diagnosed diffuse intrinsic pontine glioma (DIPG) in children.

For more information about ongoing DNAtrix clinical studies, visit the ClinicalTrials.gov website: NCT02798406 (DNX-2401 + pembrolizumab for recurrent glioblastoma), NCT03178032 (DNX-2401 for newly diagnosed pediatric diffuse intrinsic pontine glioma, DIPG), NCT03896568 (DNX-2401 delivered via mesenchymal stem cells for recurrent high-grade glioma), and NCT03714334 (DNX-2440 for recurrent glioblastoma).

About DNX-2401 (Tasadenoturev)
DNX-2401 is an adenovirus engineered specifically to infect, replicate in, and kill cancer cells to elicit an immune response. Clinical studies have demonstrated that DNX-2401 has a positive safety profile and extended survival for patients with recurrent glioblastoma. DNX-2401 has also been granted PRIME and Orphan designation by the EMA, and Fast Track and Orphan designation by the FDA.

On November 11, 2019 Akeso Biopharma ("Akeso") reported that results of phase 1 study of its first-in-class bispecific drug candidate AK104, in patients with advanced solid tumors in 2019 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) ("SITC") (Press release, Akeso Biopharma, NOV 11, 2019, View Source [SID1234550866]). AK104 is a novel, tetrameric bispecific antibody targeting both PD-1 and CTLA-4.

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Dr. Ben Markman, MBBS(Hons) FRACP from Monash Health, Australia gave the oral presentation at the SITC (Free SITC Whitepaper) Single Agent Phase 1 Clinical Trials Session chaired by Dr. Helen Chen from National Cancer Institute and Dr. Naiyer Rizvi of Columbia University Medical Center. "AK104 has shown excellent tolerability so far with encouraging signs of anti-tumor activity. I very much look forward to tracking the further development of this exciting tetrameric bispecific antibody targeting PD1 and CTLA4", commented Dr. Ben Markman.

Updated results from Phase 1a study (NCT03261011):

AK104 showed encouraging anti-tumor activities across a range of tumor types.
– Among 25 PD-1/L1 naïve response-evaluable patients administrated with ≥ 2 mg/kg AK104, ORR: 24% ( DoR ranging from 2+ to 11.1+ months); DCR: 44%.
AK104 had an acceptable safety profile. Early data suggested that AK104 may have improved tolerance compared with the combination of a PD-1 inhibitor and CTLA-4 inhibitor.
– With 55 patients enrolled, most common treatment-related AE includes rash, infusion reaction, nausea, and fatigue.
– ≥ Grade 3 treatment-related AE (TRAE) rate was 11% with only one Grade 4 event reported. Grade 3 immune-related AE (irAE) rate was 3.6%.
AK104 commenced a Phase 1a study in patients with advanced solid tumors in Australia in October 2017, received NMPA IND approval in May 2018, and IND approval from the FDA in April 2019. AK104 is currently in Phase Ib/II clinical trials globally for multiple indications and has exhibited promising clinical safety and efficacy results in monotherapy and combination therapy.

Details of the material used in oral presentation can be found at SITC (Free SITC Whitepaper) website.

About AK104

AK104 is a potential next-generation, first-in-class humanized IgG1 tetrameric bi-specific antibody drug candidate that is based on Akeso’s proprietary "TETRABODY" technology and simultaneously targets two immune checkpoint molecules: PD-1 and CTLA-4. PD-1 and CTLA-4 co-express in tumor infiltrating lymphocytes (TILs), but not in normal peripheral tissues. AK104 is in a tetrameric form, which is designed to bind to PD-1 and CTLA-4 simultaneously to achieve the efficacy of PD-1 and CTLA-4 combination blockade with lowered toxicity.