Apollo Therapeutics Completes $145 Million Financing Led by Patient Square Capital to Expand and Advance Portfolio-Based Drug Development

On June 17, 2021 Apollo Therapeutics, a portfolio-based biopharmaceutical company rapidly advancing potentially transformative treatments based on breakthrough discoveries, reported that it has completed a $145 million (over £100 million) financing (Press release, Apollo Therapeutics, JUN 17, 2021, View Source [SID1234584153]). The financing was led by Patient Square Capital, which will take a controlling position in the business, with participation from additional investors including Rock Springs Capital, Reimagined Ventures and UCL Technology Fund. Proceeds from the investment will support advancement of Apollo’s robust pipeline into development, expansion of the company’s operations including establishment of a presence in the Boston, MA area and pursuit of new collaborations globally.

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"Five years ago, Apollo’s innovative model was created by three world-leading universities Cambridge, Imperial College London and University College London forming a joint venture with global pharma partners AstraZeneca, GlaxoSmithKline and Johnson & Johnson Innovation to efficiently advance breakthrough discoveries that have the potential to be transformative treatments for patients," said Dr. Richard Mason, CEO of Apollo. "In that time, Apollo has exceeded traditional growth benchmarks – rapidly building a pipeline of over 15 promising programs. There is significant opportunity ahead of us to bring new treatments to market as our lead programs move into clinical development. We will look to build on our existing collaborations, foster new relationships with additional top academics around the world and in-license drug candidates from new partners."

Added Jim Momtazee, Managing Partner of Patient Square and member of Apollo’s Board of Directors, "For the past twenty years, I have pursued a thesis in therapeutics of backing outstanding teams and building multi-product portfolios in important areas of medicine. Patient Square continues to be very enthusiastic about that business model. We are extremely excited to partner with the team at Apollo, as we see tremendous potential in their product portfolio and their novel partnership approach with three of the world’s top academic institutions pursuing some of the most innovative science globally. We look forward to working closely with the Apollo team to broaden their reach globally and to bring a number of potentially life-changing medicines to patients."

Rooted in Collaboration

Apollo was originally established in late 2015 as a unique joint venture between the University of Cambridge, Imperial College London (then subsequently IP Group Plc), University College London, AstraZeneca, GlaxoSmithKline (GSK) and Johnson & Johnson Innovation. Apollo was set-up to bridge the gap from deep academic science to patient benefit in the most capital and time efficient way possible. By fostering relationships with top academic scientists and leveraging insights from strategic partners with late-stage development and commercial expertise, Apollo seeks to develop therapeutics that have transformative potential above the current standard of care. The company evaluates breakthrough scientific discoveries across multiple criteria, including having a compelling and testable biological hypothesis or having a differentiated mechanism or technology compared to other therapeutics in development or on the market. Each of the joint venture founders retains a minority stake in the company post financing.

Efficiency in Development

To advance programs efficiently, Apollo leverages a portfolio-based model with a centralized team of drug development ‘architects’ working alongside asset-level teams of subject matter experts. Together, these teams are able to rigorously evaluate therapeutic programs in an objective, data-driven manner – prioritizing critical experiments to de-risk programs early. The company is able to comprehensively evaluate programs, while committing minimal spend until demonstrating biological validation. This capital efficiency allows Apollo to focus on scaling a robust and potentially transformative pipeline, with over 15 therapeutic programs in development today across oncology, major inflammatory disorders and rare disease.

Building Upon Success

With proceeds from this financing, Apollo plans to advance its lead therapeutic programs into clinical development as well as identify new programs. In addition, the company plans to expand its UK operations in the Cambridge area, and in the United States with a new facility in Boston/Cambridge. Apollo’s growing team will also explore additional collaborative relationships with leading academic researchers around the world.

Established Leadership

Apollo is led by Dr. Richard Mason, who was recently appointed as chief executive officer. Dr. Mason has over 20 years’ experience in the biotech industry, including serving as the head of the Johnson & Johnson Innovation Center in London. Before this, he was CEO of novel anticoagulant antibody company XO1 until the sale of the company. Previously, Dr. Mason was the executive leadership team member responsible for strategy and business development at listed companies BTG and Cambridge Antibody Technology where he led numerous M&A and partnering transactions. He received degrees in medicine from St. Bartholomew’s Hospital Medical College and immunology from University College London and trained in internal medicine in London.

In conjunction with the financing, Jim Momtazee, Managing Partner of Patient Square Capital, will join Apollo’s Board of Directors. Prior to Patient Square, Mr. Momtazee spent over 21 years at KKR, where he helped establish the firm’s health care industry group in 2001 and subsequently was head of the Americas Health Care Investment Team for over 10 years. Mr. Momtazee has spent years on the board of directors of Jazz Pharmaceuticals, HCA, PRA Health Sciences and BridgeBio Pharma, among other companies. Jazz Pharmaceuticals and BridgeBio Pharma are both examples of the multi-product thesis pursued by the Patient Square team, and that accumulated experience will be particularly additive in supporting the growth and expansion of Apollo in the years to come.

Dr. Richard Butt who has been with Apollo since its inception, will serve as the company’s chief scientific officer. Jamie Heath will join the company as chief financial officer and Arjun Krishnan as chief business officer. Dr. Ian Tomlinson who previously chaired Apollo’s investment committee, will join the Board as a non-executive director.

About Patient Square Capital

Patient Square Capital is a dedicated health care investment firm that partners with best-in-class management teams whose products, services and technologies improve health. We utilize our deep industry expertise, our broad network of relationships and a true partnership approach to make investments in companies that will grow and thrive. We believe in the power these companies have to improve patient lives, strengthen communities and create a healthier world. Patient Square is purpose-built by a team of industry-leading executives, differentiated by the depth of our focus in health care, the breadth of our health care investing experience, and the network we can activate to drive differentiated outcomes. Most importantly, patients are squarely at the center of all that we do. For more information, visit www.patientsquarecapital.com.

Merck to Participate in the Guggenheim Biopharma Strategy Series

On June 17, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Dr. Dean Li, executive vice president and president, Merck Research Laboratories, is scheduled to participate in a virtual fireside chat at the Guggenheim Biopharma Strategy Series with Senior Management to discuss Biopharma’s Next Decade: Views from the Top on Global Strategy and Innovation on June 22, 2021, at 9:00 a.m. EDT(Press release, Merck & Co, JUN 17, 2021, View Source [SID1234584095]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at View Source

Entry into a Material Definitive Agreement

On June 14, 2021 Intellia Therapeutics, Inc. ("Intellia") entered into Amendment #3 (the "Amendment") to its License and Collaborative Research Agreement (the "Collaboration Agreement"), dated as of December 18, 2014, with Novartis Institutes for Biomedical Research, Inc. ("Novartis")(Press release, Intellia Therapeutics, JUN 17, 2021, View Source [SID1234584115]). The Amendment amends Novartis’ rights with respect to all the CAR-T Therapeutic Targets (as defined in the Collaboration Agreement) that Novartis selected under the Collaboration Agreement, including (a) making Novartis’ license non-exclusive for such CAR-T Therapeutic Targets, (b) removing Novartis’ diligence and related reporting obligations for such CAR-T Therapeutic Targets, and (c) refining the scope of Novartis’ sublicense rights for such CAR-T Therapeutic Targets. Intellia agreed to pay to Novartis a one-time payment of $10.0 million within 30 days after the effective date of the Amendment.

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The foregoing summary is qualified in its entirety by reference to the Amendment filed as an exhibit to this Form 8-K. The Company has sought confidential treatment for certain portions of the Amendment.

Onconova Therapeutics Announces The Peer-Reviewed Publication Of Preclinical Data Demonstrating The Synergistic Anti-Cancer Activity Of Rigosertib Combined With Immune Checkpoint Blockade

On June 17, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported the publication of a preclinical study in the journal Molecular Cancer (Press release, Onconova, JUN 17, 2021, View Source [SID1234584132]). The study, entitled "Novel induction of CD40 expression by tumor cells with RAS/RAF/PI3K pathway inhibition augments response to checkpoint blockade," showed that rigosertib synergistically enhanced the efficacy of ICB in a murine melanoma model via the induction of immune-mediated cancer cell death.

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"The data from this recent publication demonstrate rigosertib’s potential to address a pressing unmet need, as many patients do not respond to immune checkpoint blockade due to immunosuppressive tumor microenvironments," said Ann Richmond, Ph.D., Ingram Professor of Pharmacology and Medicine at the Vanderbilt University School of Medicine and lead author of the study. "By reversing immunosuppressive tumor microenvironments, rigosertib overcame pro-tumor resistance mechanisms and synergistically enhanced the efficacy of immune checkpoint blockade in a difficult-to-treat murine melanoma model. These compelling findings provide preclinical proof-of-concept for rigosertib-immune checkpoint blockade combination therapy and strongly support its evaluation in clinical trials."

Key data and conclusions from the recent publication include:

Rigosertib treatment enhanced the activation of anti-cancer immune cells and increased the frequency of these cells in the tumor microenvironment (TME).
Rigosertib treatment reduced the frequency of pro-tumor CD206+ M2-like macrophages in the TME.
Rigosertib monotherapy rapidly reduced PI3K signaling with induction of CD40 expression, leading to melanoma cell death and inhibition of tumor growth in vivo due to its ability to promote the tumor infiltration of activated anti-cancer immune cells.
Rigosertib’s ability to remodel the TME enabled it to synergistically combine with ICB and improve tumor growth inhibition and survival in a mouse model of melanoma that did not respond to ICB alone, or a clinically used combination of ICB plus BRAF and MEK inhibitors.
Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, added, "We are very pleased with these recently published results, which will inform the data driven approach guiding our clinical rigosertib investigator-initiated study program. They provide strong mechanistic support for both the ongoing KRAS mutated non-small cell lung cancer trial of rigosertib in combination with a check point inhibitor and a potential trial in patients with advanced melanoma evaluating a rigosertib-checkpoint inhibitor combination that is under active consideration. Looking ahead, we plan to continue leveraging our collaborations with leading institutions such as Vanderbilt University as we pursue opportunities for rigosertib while maintaining our primary focus and resources on our lead ON 123300 multi-kinase inhibitor program."

Foresight Diagnostics to Present a Vision of the New Standard of Lymphoma MRD Detection at the 16th International Conference on Malignant Lymphoma

On June 17, 2021Foresight Diagnostics, the emerging leader in blood-based lymphoma disease monitoring, reported that clinical performance of its minimal residual disease (MRD) detection platform in diffuse large B-cell lymphoma (DLBCL) will be presented at the 16th International Conference on Malignant Lymphoma (ICML) on June 18-22, 2021 (Press release, Foresight Diagnostics, JUN 17, 2021, View Source [SID1234584154]). The oral presentation demonstrates the utility of Foresight Diagnostics’ proprietary PhasED-Seq technology to improve MRD detection rates in DLBCL patients in low-disease burden settings.

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"Foresight’s MRD testing platform can detect relapsing disease 200 days earlier than current methods in DLBCL patients receiving first-line therapy," says David Kurtz, MD, PhD, a Stanford University professor and a co-founder of Foresight Diagnostics who will present the talk at ICML. "We believe that such early detection constitutes the future standard for ctDNA-guided patient monitoring and treatment in the clinic and for drug development applications. We’re proud that our abstract was selected for oral presentation at this year’s ICML meeting and are excited to share this impactful data."

The presentation, titled "Phased variants improve DLBCL minimal residual disease detection at the end of therapy" will be presented during Session 3: Aggressive Lymphomas (Channel 3) on Sunday, June 20 at 17:45-19:15 (CEST).

Circulating tumor DNA (ctDNA) detection has prognostic value in DLBCL and has the potential to change the management of lymphoma in the clinic. But detection is still challenging in low-disease burden states with existing methods, such as MRD detection at the end of therapy.

Foresight’s talk at ICML will introduce Phased Variant Enrichment & Detection Sequencing (PhasED-Seq), Foresight’s proprietary ctDNA technology that leverages a novel class of somatic alteration called "phased variants" (PVs). By identifying and tracking PVs, PhasED-Seq enables ctDNA MRD detection down to parts-per-million levels, providing levels of sensitivity that are significantly better than SNV-based methods. The talk will also demonstrate that PVs are common in B-cell lymphomas and occur in stereotyped locations, enabling an "off-the-shelf" approach to variant monitoring that does not require tumor tissue or patient-specific customization.

"While many patients with diffuse large B-cell lymphoma are cured using standard therapies, there remains a great need to accurately identify those who are not cured and would benefit from new therapeutic strategies," states Foresight Board Member Mark Lee, MD, PhD, a founding executive at GRAIL and most recently SVP and Global Head of Personalized Healthcare at Genentech. "The improved sensitivity for ctDNA-based MRD detection during and after treatment showcases the potential for PhasED-Seq as the new standard for lymphoma MRD applications, such as MRD-adapted clinical trials."

Foresight Diagnostics recently announced a $12.5M Series A financing to accelerate the commercialization of the PhasED-Seq technology and also presented clinical performance data on PhasED-Seq at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Foresight’s first commercially available test offering will be a CLIA-validated B-cell lymphoma MRD assay, and the company is initiating retrospective and prospective clinical studies with multiple partners to evaluate the utility of the assay in patients with a variety of B-cell malignancies.