Team Led by Boundless Bio Scientific Founders Receives $25M Award to Better Understand Extrachromosomal DNA (ecDNA) Through Cancer Grand Challenges

On June 16, 2022 Boundless Bio, a next-generation precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) in oncogene amplified cancers, reported to share the news that a global team of ecDNA experts comprised of several Boundless Bio scientific co-founders and led by Boundless Bio principal founder, Paul Mischel, M.D. has been awarded $25 million in funding by the National Cancer Institute (NCI*) and Cancer Research UK (CRUK) through Cancer Grand Challenges to deepen the understanding of the role of ecDNA in cancer pathogenesis (Press release, Boundless Bio, JUN 16, 2022, View Source [SID1234616050]). Cancer Grand Challenges is a unique global funding initiative founded by CRUK and the NCI, who have set ambitious challenges to assemble global teams to think creatively and make a profound difference in the fight against cancer.

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The global ecDNA research team, also known as "the Cancer Grand Challenges eDyNAmiC team", is led by Dr. Mischel, who has been at the forefront of research into the importance of ecDNA in gene amplified cancers such as EGFR amplified glioblastoma. Dr. Mischel and his team will use the funding to answer key scientific questions to further understand the biological mechanisms of ecDNA generation and function, as well as potential therapeutic strategies to help improve cancer outcomes. The multi-disciplinary research team includes the following scientific experts that are also members of Boundless Bio’s Scientific Advisory Board:

Paul Mischel, M.D., Institute Scholar, ChEM-H; Professor and Vice Chair of Research for the Department of Pathology, Stanford University
Vineet Bafna, Ph.D., Professor of Computer Science & Engineering, University of California San Diego
Howard Chang, M.D., Ph.D., Virginia and D.K. Ludwig Professor of Cancer Genomics and Genetics, Stanford University
Ben Cravatt, Ph.D., Professor and Gilula Chair of Chemical Biology, The Scripps Research Institute
Roel Verhaak, Professor and Associate Director of Computational Biology, The Florine Deschenes Roux Chair for Genomics and Computational Biology, The Jackson Laboratories
"We congratulate Paul and the eDyNAmiC team for receiving the prestigious Cancer Grand Challenges award to progress innovative research in the expanding field of ecDNA," said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. "This award further underscores the importance of ecDNA biology in cancer and our goal to bring the first ecDNA-directed therapeutics (ecDTx) into clinical trials for patients with oncogene amplified cancer. We at Boundless continue to be inspired by Dr. Mischel and the eDyNAmiC scientific team’s commitment to advancing the scientific understanding of ecDNA."

"We are thrilled to receive the NCI and CRUK award, an acknowledgement of the critical role ecDNA play in the biology of cancer," said Dr. Mischel, Professor and Vice Chair of Research for the Department of Pathology, Stanford University. "It is amazing to reflect on how rapidly the ecDNA field has come of age. With this recognition and dedicated funding for ecDNA research, we have the opportunity to further explore the pathogenesis of ecDNA in cancer with the goal of developing innovative new treatments that benefit patients with oncogene amplified cancers driven by ecDNA."

For more information on Cancer Grand Challenges, please visit: www.cancergrandchallenges.org/new-teams-2022

For more information on the eDyNAmiC team, please visit: www.cancergrandchallenges.org/teams/eDyNAmic

*The National Cancer Institute is part of the National Institutes of Health.

About ecDNA

Extrachromosomal DNA ("ecDNA") are circular units of nuclear DNA that are physically distinct from chromosomes and are found within cancer cells. ecDNA encode full length genes, including oncogenes and regulatory regions, are highly transcriptionally active, and lack centromeres. ecDNA replicate and express within cancer cells and, due to their lack of centromeres, can be asymmetrically passed to daughter cells during cell division, leading to focal gene amplification and copy number heterogeneity in cancer. By leveraging the plasticity afforded by ecDNA, cancer cells have the ability to increase or decrease copy number of select oncogenes located on ecDNA to enable survival under selective pressures, including targeted therapy, immunotherapy, chemotherapy, or radiation, thereby making ecDNA one of cancer cells’ primary mechanisms of growth, recurrence, and treatment resistance. ecDNA are not found in healthy cells but are present in many solid tumor cancers. They are a key driver of the most aggressive and difficult-to-treat cancers, specifically those characterized by high copy number amplification of oncogenes.

Termination of a Material Definitive Agreement

On On June 16, 2022, Morphic Holding, Inc. (the "Company") reported that received notice from AbbVie Biotechnology Ltd ("AbbVie") that AbbVie has elected to terminate the Collaboration and Option Agreement (the "Collaboration Agreement") between AbbVie and Morphic Therapeutic, Inc., a wholly owned subsidiary of the Company ("Morphic"), dated October 16, 2018 (Filing, 8-K, Morphic Therapeutic, JUN 16, 2022, View Source [SID1234616130]). AbbVie exercised its right to terminate the Collaboration Agreement for convenience. The termination will be effective as of December 13, 2022, or such earlier date as agreed by the parties.

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Under the terms of the Collaboration Agreement, Morphic granted AbbVie exclusive license options on certain product candidates directed at multiple targets. The termination follows AbbVie’s delivery of notice to the Company that it did not intend to advance any of the selective oral αvβ6-specific integrin inhibitors, which AbbVie had previously licensed pursuant to the terms of the Collaboration Agreement, due to a suspected on-target/ αvβ6-mediated safety signal observed in pre-clinical testing. Effective upon the termination of the Collaboration Agreement, all rights and licenses granted thereunder shall immediately terminate.

Subscription period in Scandion Oncology Rights Issue of up to approximately SEK 93.7 million commences

On June 16, 2022 Scandion Oncology (Scandion or "The Company"), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, reported that the subscription period for the rights issue of shares (the "Rights Issue") announced on June 1, 2022, commences today (Press release, Scandion Oncology, JUN 16, 2022, View Source,c3586144 [SID1234616033]). The Rights Issue is also open for subscriptions to the public.

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Summary of the Rights Issue

For one (1) existing share on the record date of June 13, 2022, shareholders will receive one (1) subscription right. Three (3) subscription rights entitle to subscription of one (1) share.
The subscription price is SEK 8.75 per new share, which, assuming the Rights Issue is fully subscribed, results in the Company receiving issue proceeds of approximately SEK 93.7 million before deduction of transaction costs.
Subscription and guarantee commitments have been received from principal owners and new investors amounting to approximately SEK 75 million, corresponding to approximately 80% of the issue proceeds.
For complete information on the Rights Issue, please see the published prospectus.

Timetable for the Rights Issue

June 16 – June 28, 2022 Trading in subscription rights
June 16 – July 1, 2022 Subscription period
June 16 – until registration with the Danish Business Authority Trading in paid subscription shares (Sw. "BTA")
July 5, 2022 Estimated announcement of outcome in the Rights Issue
Prospectus, terms and conditions

The prospectus, including full terms and conditions, is available together with subscription forms on the Company’s, Hagberg & Aneborn Fondkommission AB´s and Redeye’s respective websites (www.scandiononcology.com, www.hagberganeborn.se, www.redeye.se).

Advisers

Redeye AB acts as financial adviser and Horten Advokatpartnerselskab (as to Danish law) and Advokatfirman Schjødt (as to Swedish law) acts as legal advisers in connection with the Rights Issue. Hagberg & Aneborn Fondkommission AB acts as the issuing agent in the Rights Issue.

The information was provided by the contact person above for publication on June 16, 2022, at 08.30 CET.

RefleXion Holds Cancer Symposium on Tumor Biology for Personalized Radiotherapy

On June 16, 2022 RefleXion Medical, a therapeutic oncology company pioneering the use of biology-guided radiotherapy (BgRT)* for all stages of cancer, reported its first symposium focused on the power of using cancer biology to direct treatment planning and delivery for personalized radiotherapy (Press release, RefleXion Medical, JUN 16, 2022, View Source [SID1234616051]). The symposium is the inaugural event at the company’s newly dedicated Sanjiv "Sam" Gambhir Memorial Learning Center, to be held on Thursday, June 16.

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"We have assembled a group of top-tier radiation oncologists and medical physicists to present their unique approaches to radiotherapy that unleash the power of cancer cell biology to dictate the treatment plan," said Todd Powell, CEO and president at RefleXion Medical. "These novel treatment paradigms dovetail incredibly well with our breakthrough biology-guided radiotherapy and may one day become the new standards of care."

More than 65 cancer care professionals from 30 leading cancer programs are expected to attend the symposium to hear keynote speakers, as well as take part in panel presentations and tour the RefleXion manufacturing facility on its Hayward campus.

The event will commence with a dedication of the Sam Gambhir Memorial Learning Center, named after Sanjiv "Sam" Gambhir, M.D., Ph.D., to honor his pioneering contributions to early cancer detection. Dr. Gambhir was a world-renowned physician-scientist, often referred to as the father of molecular imaging. For decades before his death from cancer in 2020, Dr. Gambhir dedicated his career to advancing technologies to catch tumors in their earliest possible stage. He was an advisor and early supporter of RefleXion’s BgRT.

BgRT is the first and only technology designed to use emissions generated by cancer cells in response to an injected radiotracer to guide the delivery of radiotherapy. RefleXion’s BgRT received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for use in lung tumors because of its potential to detect and then immediately treat moving targets. The company aims to one day scale BgRT to treat all visible cancer sites to create a new treatment option for patients with metastatic disease.

Checkpoint Therapeutics Announces Positive Interim Results from Registration-Enabling Trial of Cosibelimab in Locally Advanced Cutaneous Squamous Cell Carcinoma

On June 16, 2022 Checkpoint Therapeutics, Inc. (Checkpoint) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported positive interim efficacy results from its registration-enabling clinical trial evaluating its anti-PD-L1 antibody, cosibelimab, in patients with locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation (Press release, Checkpoint Therapeutics, JUN 16, 2022, View Source [SID1234616034]). The design of the interim analysis incorporated recent feedback from the U.S. Food and Drug Administration (FDA) and is intended to potentially support the approval of cosibelimab in this indication. As of the March 2022 data cutoff, the objective response rate (ORR) determined by independent central review (ICR) in 31 patients was 54.8% (95% CI: 36.0, 72.7), substantially exceeding a clinically meaningful lower bound of the 95% two-sided confidence interval of 25%.

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Based on these positive results, Checkpoint intends to continue discussions with the FDA on the potential addition of locally advanced cSCC as a second indication in the planned Biologics License Application (BLA) targeted for submission later this year. Checkpoint previously reported positive top-line data from a cohort of 78 patients with metastatic cSCC in its pivotal trial of cosibelimab.

"These exciting positive interim results in this cohort of patients suggest a potential second indication for cosibelimab in locally advanced cSCC, which, when added to the potential labeling in the metastatic cSCC setting, could double the market opportunity at launch for cosibelimab globally. Locally advanced cSCC occurs when tumors become large or have grown deep into underlying tissues, muscles, or nerves, destroying nearby healthy tissue, but have not yet spread metastatically to the lymph nodes or other distant locations of the body," said James Oliviero, President and Chief Executive Officer of Checkpoint.

"We believe the data generated to date continue to show cosibelimab as a differentiated and potentially best-in-class anti-PD-L1 antibody, leveraging a two-fold mechanism of action to deliver robust efficacy with a potentially more favorable safety profile due to its binding to PD-L1 rather than PD-1, an attribute reported in scientific literature as associated with lower rates of severe or worse adverse events as compared to anti-PD-1 therapy," continued Oliviero. "Based on this compelling clinical profile, our planned market-disruptive pricing, and our patent protection through at least 2038, we believe cosibelimab has the opportunity to gain meaningful market share in the $32 billion and growing anti-PD-(L)1 class, while significantly lowering the barrier of high out-of-pocket costs patients endure worldwide to access existing premium-priced cancer therapies."

Cosibelimab was licensed by Checkpoint in 2015 from the Dana-Farber Cancer Institute.

About Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma (cSCC) is the second most common type of skin cancer in the United States, with an estimated annual incidence of approximately 1 million cases according to the Skin Cancer Foundation. While most cases are localized tumors amenable to curative resection, approximately 40,000 cases will become advanced, and an estimated 15,000 people will die from their disease. In addition to being a life-threatening disease, cSCC causes significant functional morbidities and cosmetic deformities based on tumors commonly arising in the head and neck region and invading blood vessels, nerves and vital organs such as the eye or ear.

About Cosibelimab
Cosibelimab (formerly referred to as CK-301) is a potential best-in-class, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 (PD-L1) and blocks the PD-L1 interaction with the programmed death receptor-1 (PD-1) and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained >99% target tumor occupancy to reactivate an antitumor immune response and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity (ADCC) for potential enhanced efficacy in certain tumor types.