STAND UP TO CANCER AWARDS $1.1 MILLION IN GRANTS TO RESEARCH TEAMS

On July 29, 2020 Stand Up To Cancer reported five new awards that will cut across institutional and national lines to foster collaborative research and explore new paths to improve cancer treatment (Press release, SU2C, JUL 29, 2020, View Source [SID1234562505]). The projects will receive a combined total of $1.1 million in funding to address some of the most pressing questions associated with colorectal, Ewing sarcoma, pancreatic, lung and pediatric cancers.

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Named for Nobel laureate Phillip A. Sharp, PhD, chairperson of Stand Up To Cancer’s Scientific Advisory Committee, the Phillip A. Sharp Innovation in Collaboration Awards focus on bringing new perspectives together to benefit cancer research. Sharp is an Institute professor at David H. Koch Institute for Integrative Cancer Research at Massachusetts Institute of Technology.

"What sets Stand Up To Cancer apart is its ability to break down historically restrictive silos that cancer researchers have typically worked in," said Sharp. "These grants allow us to further emphasize the importance of collaboration among researchers across different institutions and specialties so that we can bring together the resources and brainpower needed to address some of the biggest challenges we face in cancer research and treatment today."

The Sharp Awards are unique in their collaborative format, but also in the simple and quick selection process. The grants were selected at the annual Stand Up To Cancer Scientific Summit in January 2020 and were based on a 250-word outline of the idea that was reviewed by a board of experts at the summit. Each winning proposal submits a more detailed application before the grant is confirmed. Leaders of each team must be from different existing Stand Up To Cancer research teams. The program, now in its seventh year, encourages the inclusion of early-career investigators.

"The unique nature of the Sharp Awards allows for the extraordinary talent across the SU2C community to come together from different teams and individual grants to tackle some of the toughest new questions facing cancer research," said William G. Nelson, MD, PhD, vice chair of the Stand Up To Cancer Scientific Advisory Committee and director of the Sidney Kimmel Comprehensive Cancer Center Johns Hopkins. "These new grants will help to build upon existing research, while creating the opportunity for researchers to work together on new and innovative projects."

The American Association for Cancer Research (AACR) (Free AACR Whitepaper), Stand Up To Cancer’s scientific partner, will support the administration of these projects receiving funding for the 2020 Sharp Awards, including:

Florencia McAllister, MD, University of Texas MD Anderson Cancer Center, early career investigator on the SU2C-Lustgarten Foundation Pancreatic Cancer Interception Dream Team, and Luis A. Diaz Jr., MD, Memorial Sloan Kettering Cancer Center, leader of the SU2C Colorectal Cancer Dream Team. This team will conduct research on "Genomic and therapeutic implications of selective bacterial and fungal colonization of gastrointestinal malignancies." Total funding: $200,000.
William Freed-Pastor, MD, PhD, Massachusetts Institute of Technology and Dana-Farber Cancer Institute, early career investigator on the SU2C-Lustgarten Foundation Pancreatic Cancer Interception Dream Team, and Phil Greenberg, MD, Fred Hutchinson Cancer Research Center, formerly principal investigator on the SU2C–Cancer Research Institute Cancer Immunology Dream Team, currently serving as SU2C Scientific Reviewer. This team will conduct research on "Utilizing tumor organoids to facilitate the development of effective strategies to target pancreatic cancer with engineered T cells." Total funding: $200,000.
Karin Pelka, PhD, Broad Institute of Massachusetts Institute of Technology and Harvard, SU2C Peggy Prescott Early Career Scientist and Matthew Hellmann, MD, Memorial Sloan Kettering Cancer Center, early career investigator on the SU2C–American Cancer Society Lung Cancer Dream Team and co-leader of the SU2C Catalyst Lung Immuno-Epigenetics Team. This team will conduct research on "Can scRNAseq-derived gene programs predict anti-PD1 response in high TMB CRC and NSCLC patients?" Total funding: $200,000.
Michal Sheffer, PhD, Dana Farber Cancer Institute, post-doctoral Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) fellow, SU2C Natural Killer Cell Resistance Convergence Research Team and David Kirsch, MD, PhD, Duke University, leader of the SU2C Catalyst Sarcoma Research Team. This team will conduct research on "Harnessing NK Cells to Treat Pediatric Cancers." This grant was funded with support from the Emily Whitehead Foundation. Total funding: $250,000.
Poul Sorensen, MD, PhD, University of British Columbia, principal investigator on the SU2C Canada Metastatic Breast Cancer Dream Team and the St. Baldrick’s Foundation – SU2C Pediatric Cancer Dream Team, and Elizabeth Lawlor, MD, PhD, Seattle Children’s Research Institute, principal investigator, Pediatric SU2C Catalyst Epigenetics Research Team, and 2009 SU2C Innovative Research Grant recipient. This team will conduct research on "Enhancing ferroptosis to block Ewing sarcoma metastatic capacity." This grant was funded with support from the Kate McGarrigle Fund and the Steve Golin Prize. Total funding: $250,000.
Special awards this year were funded by the Emily Whitehead Foundation, the Kate McGarrigle Fund, and the Steve Golin Prize.

The Emily Whitehead Foundation is named after the first pediatric patient to receive CAR-T therapy for leukemia. These special awards focus specifically on addressing various therapeutic areas in pediatric cancer research. "We are honored to continue our collaboration with SU2C to fund these researchers focused on furthering pediatric cancer immunotherapy treatments," said Tom Whitehead, co-founder of the Emily Whitehead Foundation. "Collaborative research is essential to developing new, successful treatments. Our hope is that by funding these research grants we will be able to give more kids the chance to survive their cancer and lead happy, healthy lives."

The SU2C Kate McGarrigle Fund is a collaboration of Stand Up To Cancer and singers Rufus Wainwright and Martha Wainwright that raises much-needed funds for sarcoma research and provides music resources to cancer patients and survivors with a passion for music through the Music As Healing program. Kate McGarrigle, Canadian singer, songwriter, mother of Rufus Wainwright and Martha Wainwright, died of sarcoma in 2010.

The Steve Golin Fund accelerates research in Ewing sarcoma, in memory of Steve Golin, the American film producer who died of Ewing sarcoma in 2019. Ewing sarcoma is a rare bone and soft tissue cancer predominantly found in children.

IMV to Present at BTIG’s Virtual Biotechnology Conference

On July 29, 2020 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, reported that company management will present at BTIG’s Virtual Biotechnology Conference on Monday August 10, 2020 at 11 a.m. EDT (Press release, IMV, JUL 29, 2020, View Source [SID1234562504]).

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A live webcast of this presentation will be available under "Events, Webcasts and Presentations" in the investors section of the IMV website and a replay will be available approximately one hour after the presentation. Afterwards, it will be available for approximately 30 days.

GSK delivers Q2 sales of £7.6 billion -2% AER, -3% CER (Pro-forma -10% CER*)

On July 29, 2020 GSK reported Q2 sales of £7.6 billion -2% AER, -3% CER (Pro-forma -10% CER*) (Press release, GlaxoSmithKline, JUL 29, 2020, View Source [SID1234562503])

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Financial and product highlights
Reported Group sales £7.6 billion -2% AER, -3% CER (Pro-forma -10% CER*; -8% CER excluding divestments/brands under review). Pharmaceuticals £4.1 billion -5% AER, -5% CER; Vaccines £1.1 billion -29% AER, -29% CER; Consumer Healthcare £2.4 billion +25% AER, +25% CER (Pro-forma -6% CER)
H1 Reported group sales £16.7 billion 8% AER, 8% CER (Pro-forma flat CER*; +1% CER excluding divestments/brands under review)
Sales decline in Q2 2020 reflects expected disruption from COVID-19, particularly in Vaccines as well as destocking from Q1 2020 in Pharmaceuticals and Consumer Healthcare
Total Respiratory sales £883 million +17% AER, +16% CER. Trelegy sales £194 million +62% AER, +58% CER. Nucala sales £241 million +24% AER, +21% CER
Total HIV sales £1.2 billion, -2% AER, -3% CER. Dolutegravir sales £1.1 billion, -1% AER, -2% CER, two-drug regimen sales £181 million, >100% AER, >100% CER (Dovato sales £68 million, >100% AER, >100% CER, Juluca sales £113 million, +35% AER, +33% CER)
Shingrix sales £323 million, -16% AER%, -19% CER
Total Group operating margin 37.4%. Adjusted Group operating margin 22.9%, reflecting lower sales and growth in investment in R&D
Total EPS 45.5p; >100% AER, >100% CER reflecting profit on disposal of Horlicks and other Consumer Healthcare brands
Adjusted EPS 19.2p -37% AER, -38% CER reflecting lower sales and higher non-controlling interests following creation of the Consumer Healthcare JV in 2019 and a higher tax rate
Q2 net cash flow from operations £2.76 billion. Free cash flow £1.95 billion
19p dividend declared for the quarter
Guidance
Guidance for 2020 Adjusted EPS maintained; outcome is dependent in particular on timing of a recovery in vaccination rates
Pipeline highlights
Continued strengthening of the biopharma pipeline which now contains 35 medicines and 15 vaccines; over 75% of pipeline assets are focused on immunology

Three approvals in Q2: Zejula in ovarian cancer, Rukobia in HIV, Duvroq in anaemia (Japan). Expect further approval decisions for assets in Oncology and Respiratory

HIV

Cabenuva resubmitted in the US as HIV treatment; regulatory decision anticipated Q1 2021

Data showing superiority of long-acting cabotegravir versus Truvada in PrEP presented at IAS

FDA approval of Rukobia as first-in-class treatment for adults with few treatment options available

Oncology

Zejula approved by FDA for first line maintenance treatment in ovarian cancer in all comers regardless of biomarker status

Positive European CHMP opinion for belantamab mafodotin in multiple myeloma; FDA AdCom voted in favour (12-0) of risk-benefit profile with approval decision anticipated in August

Respiratory

Nucala granted priority review by FDA for hypereosinophilic syndrome (HES). Decision expected H1 2021

Vaccines

New positive Phase II data received for RSV vaccine for maternal and older adults. Data to be presented at upcoming scientific congress. Phase III study start in maternal adults planned for H2 2020

Strategic collaboration announced with CureVac on mRNA technology

GSK’s response to COVID-19
Multiple collaborations underway to develop adjuvanted COVID-19 vaccines. Phase I studies initiated by Clover Pharmaceuticals and Medicago
Announced the intention to make 1 billion doses of vaccine adjuvant available in 2021. Agreement reached with UK Government to supply up to 60 million doses of candidate Sanofi-GSK vaccine. Discussions underway with US and EU
Phase II/III study start expected in Q3 for Vir antibody for high-risk outpatients with COVID-19. Phase IIa POC study of otilimab as potential treatment for COVID-19 started

Emma Walmsley, Chief Executive Officer, GSK said:
"The fundamentals of GSK’s business remain strong and we are maintaining good momentum on our strategic priorities. This quarter, we presented promising data and had positive regulatory reviews for new speciality pipeline medicines to treat HIV and Oncology; and made further progress with our Consumer Healthcare integration and Future Ready programmes, both of which will prepare the company for separation.

"We continue to believe that multiple options will be needed to prevent and treat COVID-19 and are working at pace with our partners to develop potential adjuvanted vaccines and therapeutics to fight the virus. At the same time, we have made strategic investments in next-generation vaccine and antibody technologies, most recently through our new collaboration with CureVac.

"As expected, our performance this quarter was disrupted by COVID-19, particularly in our Vaccines business, as visits to healthcare professionals were limited due to lockdown measures. Overall, we are seeing good underlying demand for our major products and are confident this will be reflected in future performance when the impact of COVID measures eases."

Omega Therapeutics Advances Controllable Epigenomic Programming Platform to Deliver a Pipeline of Novel Therapeutics with $85M in Financing

On July 29, 2020 Omega Therapeutics, a company pioneering a new category of genomic medicine through epigenomic programming, reported the completion of an $85 million financing (Press release, Omega Therapeutics, JUL 29, 2020, View Source [SID1234562499]). The funding will support progression to first-in-human clinical trials of the company’s Epigenomic Controllers for programs in oncology, inflammation, autoimmune, metabolic, and rare genetic diseases.

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"We founded Omega with the long-term vision to create a controllable epigenomic programming platform that would identify novel epigenetic targets and therapeutically address them through a new class of genomic medicines," said Noubar Afeyan, Ph.D., Chief Executive Officer of Flagship Pioneering and Co-founder and Chairman of the Board for Omega Therapeutics. "Although human cells all share a common genetic code within their 23 pairs of chromosomes, epigenetic regulation determines identity and function at the tissue and cellular level. Coordinated changes in epigenomic programming drive the cellular variation that controls human biology, in both healthy and diseased states. Omega’s platform enables controllable and tunable epigenomic programming. It will provide patients and physicians with therapeutic alternatives to gene editing and gene therapy while offering the advantages of programmable, nucleic acid sequence-based targeting of medicines, while also avoiding the challenges of small molecule-based epigenetic approaches." Precision Genomic Control delivered through epigenomic programming. Omega’s novel engineered therapeutics, called Epigenomic Controllers, target optimal genomic loci with high specificity to deliver the required potent and durable therapeutic effect to precisely modulate or tune single or multiple genes, up or down, to unleash the human genome’s innate capacity to cure disease without altering native genomic nucleic acid codes.

"We are advancing the frontiers of medicine through epigenomic programming," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "We have engineered novel therapeutics that enable controllable epigenomic programming leading to single and multiple gene modulation. We have therapeutic programs in immunology, oncology, metabolism and other disease areas where our precision genomic modulation approach allows us to go after historically ‘undruggable’ targets," Mr. Karande continued. "Our approach utilizes well-proven aspects of mRNA-based therapeutics as well as drug delivery. We are privileged to continue the Flagship tradition of pioneering innovative genomic medicine-based therapeutic platforms with the potential to generate multiple products, the first of which we plan to have ready for the clinic in 2021."

Omega’s epigenomic programming platform is focused on selectively directing the human genome to treat and cure disease by precisely controlling genomic expression without altering native nucleic acid sequences. Omega has created a proprietary platform and knowledge base that identifies Insulated Genomic Domains (IGDs) and their biological functions in both healthy and diseased states across cell types. IGDs naturally function as the fundamental regulators of the human genome and can be modulated to up-or down-regulate single or multiple genes simultaneously. These scientific and product insights drive the discovery and development of disease-specific genomic modulators called Epigenomic Controllers, which are engineered to precisely tune genomic activity to desired therapeutic levels with high targeting specificity and durability of effect.

"Our Epigenomic Controllers comprise a DNA-binding domain and an epigenetic effector domain delivered as mRNA to modulate gene expression. Besides treating monogenic diseases, our therapeutics can, for example, target and modulate difficult-to-drug oncogenes and growth factors, treat complex multi-genic diseases, and control cellular programming and differentiation," said Thomas McCauley, Ph.D., the company’s Chief Scientific Officer. "A single intervention allows us to modulate single or multiple genes to the desired therapeutically-relevant level with high specificity and a controlled duration of effect through epigenomic programming. This is Precision Genomic Control at its best."

Oncolytics Biotech® to Host Conference Call to Discuss Second Quarter Financial Results and Operational Highlights

On July 29, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that it will host a conference call and webcast on Tuesday, August 4, 2020, at 4:30 pm ET to discuss a corporate update and financial results for the second quarter of 2020 (Press release, Oncolytics Biotech, JUL 29, 2020, https://ir.oncolyticsbiotech.com/news/detail/512/oncolytics-biotech-to-host-conference-call-to-discuss-second-quarter-financial-results-and-operational-highlights [SID1234562497]).

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Conference Call & Webcast

Date: Tuesday, August 4, 2020
Time: 4:30 pm ET
Dial In – Toll-Free: 1-(866)-269-4261
Dial In – International:1-(323)-347-3612
Conference ID:2366778
Webcast: Link

A live webcast of the call will also be available on the Investor Relations page of Oncolytics’ website at www.oncolyticsbiotech.com and will be archived for three months.