On February 23, 2021 Propella Therapeutics Inc. (Propella), a leader in the development of innovative, best-in-class prescription products, and the National Cancer Institute (NCI), part of the National Institutes of Health, reported that have entered into a Cooperative Research and Development Agreement (CRADA) (Press release, Propella Therapeutics, FEB 23, 2021, View Source [SID1234575457]). Under this new partnership, Propella and NCI will conduct a multi-center clinical trial to evaluate abiraterone decanoate, as a new therapy for metastatic prostate cancer.

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Propella holds U.S. Patent 10,792,292, which protects multiple new long-acting, injectable, prodrugs of abiraterone, and includes composition of matter, method of manufacturing, and method of treatment claims. The acetate prodrug of abiraterone, which is given by mouth daily, is a current standard of care for advanced prostate cancer. Abiraterone acetate produces varying blood concentrations of abiraterone metabolites, including high levels that may produce side effects and low levels that may not be effective. Preclinical data indicate that a single injection of Propella’s novel intramuscular (IM) formulation of abiraterone decanoate can deliver more precise drug levels that may prove effective for up to 3 months, potentially providing patients with both greater drug effectiveness and assurance of increased safety.

Propella presented select preclinical findings on Feb. 11, 2021, at the (virtual) annual meeting of The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), Genitourinary Division (GU ASCO (Free ASCO Whitepaper)) that confirmed large and continuous 3-month reductions in testosterone following a single IM injection. The presentation may now be viewed on the Propella website at: View Source

"We’re gratified to have had the opportunity to present compelling preclinical program results at the prestigious GU ASCO (Free ASCO Whitepaper) conference, and to work collaboratively with the scientists at the National Cancer Institute," said Propella President and CEO William Moore, PhD. "The upcoming clinical trial has the potential for abiraterone decanoate to improve the standard of care for patients with advanced prostate cancer."

Under the CRADA, Propella will file and hold the Investigational New Drug application (IND) while NCI will provide clinical research and development expertise along with pharmacokinetic and clinical pharmacology insights and analyses.

According to Dr. William Douglas Figg, Sr., Senior Investigator and Head of the Clinical Pharmacology Program at the NCI, "Propella’s intramuscular formulation of abiraterone, abiraterone decanoate, is an interesting new agent and we look forward to investigating its potential as a therapy choice for men with prostate cancer."

On February 23, 2021 Genmab A/S (Nasdaq: GMAB) reported that it is initiating a share buy-back program to mitigate dilution from warrant exercises and honor our commitments under our Restricted Stock Unit program (Press release, Genmab, FEB 23, 2021, View Source [SID1234575456]). The share buy-back program will be undertaken on the terms set out below and in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation."

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Purpose
The purpose of the share buy-back program is to mitigate dilution caused by warrant exercises and to honor our commitments under our Restricted Stock Unit program.

Time frame
The share buy-back program will start on February 24, 2021 and will be completed no later than June 30, 2021 (unless Genmab terminates or suspends the program).

Terms
Genmab has appointed Danske Bank as lead manager for the share buy-back program. Danske Bank will make its own trading decisions and act independently of and without influence or involvement from Genmab. Under this share buy-back program Genmab may repurchase up to 200,000 shares.

Shares acquired under the program cannot be purchased at a price exceeding the higher of (i) the price of the latest independent transaction on Nasdaq Copenhagen and (ii) the price of the highest independent bid on Nasdaq Copenhagen at the time of the transaction. The total number of shares that may be purchased on a single trading day may not exceed 25% of the average daily trading volume over the preceding 20 trading days on Nasdaq Copenhagen.

As of February 23, 2021, Genmab holds 102,977 treasury shares equal to 0.16% of the share capital.

Genmab is entitled to suspend or stop the program at any time subject to announcement to Nasdaq Copenhagen.

Upon initiation of the program, Genmab will issue a weekly announcement in respect of transactions made under the program.

On February 23, 2021 Genmab A/S (Nasdaq: GMAB) reported the publication of its Annual Report for 2020. Below is a summary of business progress in 2020, financial performance for the year and the financial outlook for 2021 (Press release, Genmab, FEB 23, 2021, View Source [SID1234575455]). The full report is attached as a PDF file and can be found on the investor section of the company’s website, www.genmab.com/investors.

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Conference Call
Genmab will hold a conference call in English to discuss the full year results for 2020 today, February 23, 2021 at 6:00 pm CET, 5:00 pm GMT or noon EST. To join the call dial +1 631 913 1422 (U.S. participants) or +44 3333 000804 (international participants) and provide conference code 82034909.

A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.

On February 23, 2021 Microbiologist Henry Skinner, formerly of Novartis and Tekla Capital, reported it has been announced as the first CEO of the AMR Action Fund, a joint venture aimed at strengthening and accelerating clinical research of new, innovative antibiotics to address the rising issue of antimicrobial resistance (AMR) (Press release, EVERSANA, FEB 23, 2021, View Source [SID1234575454]).

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Through the joint efforts of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the European Investment Bank, and Wellcome Trust, the AMR Action Fund first launched in July 2020 with $1 billion in funding with the goal of bringing four new antibiotics to patients by 2030.

Skinner stated, "I am honored to join the AMR Action Fund and its incredibly important mission. Having worked on this issue from many angles throughout my career, I know how badly novel antibiotics are needed, and I also know how many obstacles currently prevent them from being developed and reaching patients. I am proud and excited to lead the AMR Action Fund in its efforts to tackle the global challenge of AMR. Thank you to everyone involved in developing this critical and groundbreaking initiative, and in particular to the interim CEO of the AMR Action Fund, Martin Bott, for getting us to this point."

The Fund is poised to "take its first steps" in investing in biotech companies focused on developing new antibodies.

At the same time as Skinner was confirmed as CEO, it was announced that the fund had received an additional $140 million in funding from Boehringer Ingelheim Foundation, the European Investment Bank, and Wellcome Trust.

Christoph Boehringer, Chairman of the Boehringer Ingelheim Foundation, commented, "We need innovative solutions to avert the looming health crisis posed by AMR, which threatens to make even common medical procedures potentially deadly. The Boehringer Ingelheim Foundation is committed to fighting the greatest global health threats of our time and we are proud to join this broad alliance of charitable organizations, development banks, and biopharmaceutical companies. We are confident the AMR Action Fund will enable researchers and scientists to bring innovative antibiotics to patients suffering from severe bacterial infections."

The Fund noted that, while additional funding serves as a short-term solution to AMR, longer term policies are necessary to boost the pipeline of new antibiotics.

On February 23, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported publication of an electronic poster at the CAR-TCR Summit Europe 2021 with data from a preclinical study evaluating pelareorep and chimeric antigen receptor (CAR) T cell combination therapy in solid tumors (Press release, Oncolytics Biotech, FEB 23, 2021, View Source [SID1234575453]).

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Newly published results show that loading CAR T cells with pelareorep vastly improved their persistence and efficacy in a murine solid tumor model, in stark contrast to preclinical studies using intratumoral infection with the VSV oncolytic virus that weakened CAR T cells. Efficacy of pelareorep-loaded CAR T cell ("CAR/Pela") therapy was further enhanced by boosting mice 8 days later with a single intravenous dose of pelareorep ("pelareorep boost"), generating highly persistent CAR T cells, inhibition of recurrent tumor growth, and ultimately tumor cures. These synergistic immune effects were specific to pelareorep, as intravenous boosting with VSV did not augment CAR/Pela therapy or prevent the growth of recurrent tumors. Survival data from the preclinical study are shown below:

"These very exciting data demonstrate pelareorep’s ability to overcome major shortcomings of CAR T cells," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "Despite commercial success in hematological cancers, CAR T therapies have limited efficacy against solid tumors due to immunosuppressive tumor microenvironments (TMEs) that promote T cell exhaustion and exclusion. Pelareorep’s ability to reverse immunosuppressive TMEs has been well documented in the clinic, and combining CAR T cells with pelareorep may enable their success against solid cancers. This would be a major advancement, as it would substantially broaden the applicability of CAR T cells to a variety of highly prevalent and difficult-to-treat indications."

Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, added, "While our primary focus is on advancing our lead breast cancer program to a registrational trial, we continue to evaluate additional opportunities to expand pelareorep’s business development and partnership potential. In clinical studies, pelareorep recruited high concentrations of T cells to solid tumors, positioning it to synergistically interact with checkpoint inhibitors. In this newly published study, we show the synergistic benefits of pelareorep can be extended to additional cutting-edge immunotherapeutic agents. Based on these findings, we are specifically exploring a partnership strategy to further the development of pelareorep as an enabling technology for CAR T cells and additional immunotherapies that require immune effector cell infiltration in solid tumors."

The electronic poster titled "Combination Therapy with Oncolytic Viruses and CAR T Cells," was developed in collaboration with researchers from the Mayo Clinic, Duke University, and Oncolytics. It is available on the Posters & Publications page of Oncolytics’ website (LINK).

About CAR T cells and CAR T therapy

The CAR T process begins when blood is drawn from a patient and their T cells are separated so they can be genetically engineered to produce chimeric antigen receptors (CARs). These receptors enable the T cells to recognize and attach to a specific protein or antigen on tumor cells. Once the engineering process is complete, a laboratory can increase the number of CAR T cells into the hundreds of millions. Finally, the CAR T cells will be infused back into the patient where, ideally, the engineered cells further multiply, and recognize and kill cancer cells. Historically, solid tumors have been considered beyond the reach of CAR T therapy due to their tumor microenvironment, which is detrimental to CAR T cell entry and activity, amongst other challenges.1

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.