OncoNano Medicine Raises ~$50 Million in Series B Financing

On June 17, 2021 OncoNano Medicine, Inc. reported the raise of an approximate $50 million Series B financing led by the healthcare investment team at Advantech Capital, a China-based cross border institutional investment fund (Press release, OncoNano Medicine, JUN 17, 2021, View Source [SID1234584156]). Proceeds of the financing will be used, in part, to support the Phase 3 clinical trials in the U.S. and Europe for pegsitacianine, an innovative real-time imaging agent used in intraoperative surgical resection of solid tumors, and accelerate the advancement of the company’s first therapeutic development program, ONM-501, a novel immune-therapeutic formulated with the company’s core delivery technology.

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"We are thrilled to welcome Advantech as an investor in OncoNano and look forward to continuing the momentum we’ve built with our lead development programs that utilize our proprietary pH-activated micelle platform," said Martin Driscoll, CEO at OncoNano Medicine, Inc. "We plan to initiate our pegsitacianine pivotal trial program in the U.S. and Europe and submit an IND for our first therapeutic development program in 2022. The funds from this Series B raise combined with the support of our partners from the Cancer Prevention & Research Institute of Texas (CPRIT) provide the resources to operate our company for several years, advance pegsitacianine further towards commercialization, and progress our novel immuno-oncology compound, ONM-501, through our Phase 1a/1b clinical program. With the inclusion of the new capital, we now have the capability to accelerate our development programs and work to achieve our goal of bringing novel interventions and treatments to cancer patients."

"We are impressed with the potential for OncoNano’s innovative core technology," said Benjamin Qiu, partner at Advantech Capital. "We see great promise in OncoNano and are excited to support the company through its further advancement of pegsitacianine into a pivotal clinical development program and its novel dual-activation STING agonist towards a first in human study to help address the persistent and challenging unmet needs in cancer surgery and treatment."

About Advantech Capital

Advantech Capital is a private equity investment fund, focusing on innovation-driven growth opportunities in China, mainly investing in TMT, pharmaceuticals, and healthcare.

About Cancer Prevention & Research Institute of Texas (CPRIT)

CPRIT has awarded $2.72 billion in grants to Texas research institutions and organizations through its academic research, prevention, and product development research programs. CPRIT has recruited 233 distinguished researchers, supported the establishment, expansion, or relocation of 42 companies to Texas, and generated more than $5.5 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 7.1 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. On November 5, 2019, Texas voters overwhelmingly approved a constitutional amendment providing an additional $3 billion to CPRIT, for a total $6 billion investment in cancer research and prevention efforts across Texas, one of the largest state funded research programs in United States history and the second largest source of funding for cancer research in the world.

Xilio Therapeutics Announces FDA Acceptance of IND Application for XTX101 for the Treatment of Solid Tumors

On June 17, 2021 Xilio Therapeutics, a biotechnology company developing tumor-selective immuno-oncology therapies for patients with cancer, reported that the U.S. Food and Drug Administration has accepted its Investigational New Drug application (IND) to evaluate its checkpoint inhibitor product candidate, XTX101, as a potential treatment for patients with solid tumors (Press release, Xilio Therapeutics, JUN 17, 2021, View Source [SID1234584155]). XTX101 is a tumor-selective anti-CTLA-4 monoclonal antibody designed to improve upon the therapeutic index of existing anti-CTLA-4 therapies by overcoming their historical potency and tolerability limitations.

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"This first IND acceptance for Xilio represents a significant milestone for us as we transition to a clinical-stage organization," said Marty Huber, M.D., chief medical officer of Xilio Therapeutics. "It is well known that checkpoint inhibitors hold significant clinical potential; however, treatment with anti-CTLA-4 therapies has been limited because of challenging autoimmune toxicities. Using our geographically precise solutions (GPS) platform, we have engineered XTX101 with the goal of enhancing the desirable features of an anti-CTLA-4 antibody while limiting the known liabilities. We look forward to beginning Phase 1 development to evaluate the potential that XTX101 may offer as both a monotherapy and combination agent for patients in need."

Leveraging its proprietary GPS platform, Xilio designed XTX101 to be activated in the tumor microenvironment with the potential to result in localized clinical activity without dose-limiting toxicities. In preclinical studies, XTX101 exhibited tumor-selective biological activity and robust tumor growth inhibition, including complete responses in murine cancer models, with favorable tolerability. These data demonstrate enhanced activity and an improved tolerability profile compared to an analog of ipilimumab, a CTLA-4 blocking antibody approved for the treatment of certain solid tumor cancers. XTX101 has also demonstrated enhanced tumor growth inhibition and tolerability when administered in combination with an anti-PD-1 in vivo.

Xilio expects to initiate a Phase 1 clinical trial in the second half of 2021 to evaluate XTX101 as a monotherapy, as well as a combination therapy with KEYTRUDA (pembrolizumab), for the treatment of patients with solid tumors.

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.

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.

CNS Pharmaceuticals Announces Inclusion in the Russell 2000® Index

On June 17, 2021 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported that as part of the annual reconstitution of the Russell stock indexes, CNS Pharmaceuticals has been selected to be added to the Russell 2000 Index effective June 25, 2021, after the close of the U.S. equity markets (Press release, CNS Pharmaceuticals, JUN 17, 2021, View Source;announces-inclusion-in-the-russell-2000-index-301314307.html [SID1234584146]).

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John Climaco, CEO of CNS Pharmaceuticals, commented "We are pleased to meet this noteworthy milestone and be included in the Russell 2000 Index. As our team continues to drive our clinical program forward for the treatment of glioblastoma multiforme (GBM), we believe this inclusion well-positions us to drive market awareness. We are honored to be listed among our industry peers on what is considered to be a widely respected performance benchmark for small-cap companies. We look forward to leveraging the access and positioning this inclusion brings to unlock additional value."

The Russell 2000 Index measures the performance of the small-cap segment of the US equity market. The Russell 2000 Index is a subset of the Russell 3000 Index representing approximately 10% of the total market capitalization of that index. It includes approximately 2,000 of the smallest securities based on a combination of their market cap and current index membership.

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell’s U.S. indexes which are part of FTSE Russell, a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide.

For more information on the Russell Indexes, please visit the FTS Russell website at www.ftserussell.com.