On November 18, 2020 Umoja Biopharma, a biotechnology company pioneering an integrated in vivo immunotherapy platform, reported the completion of its $53 million Series A financing led by MPM Capital and Qiming Venture Partners USA (Press release, Umoja Biopharma, NOV 18, 2020, View Source [SID1234575244]). Umoja was founded by a team of leading scientists and researchers with the vision of creating an entirely new approach to engineered immunotherapies. Umoja’s suite of innovations will re-engineer a patient’s own immune system to attack and destroy both hematologic and solid organ-based tumors with a simplicity and cost that enables widespread implementation.

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"Umoja has already made significant progress on its goal of delivering technologies that will address the limitations of current engineered immunotherapies," said Andy Scharenberg, M.D., co-founder and CEO of Umoja. "Our in vivo-based approach is scalable while also providing control, safety, and highly effective anti-tumor activity; our goal is to improve both access and outcomes."

Umoja’s platform incorporates three core components: the VivoVec delivery platform, RACR/CAR payload architecture, and the TumorTag platform. The VivoVec delivery platform acts in vivo to generate a population of cancer fighting cells, VivoCAR T cells, which can be exquisitely controlled by the RACR/CAR control system using exogenously administered, FDA approved drugs. TumorTag molecules can be used in combination with the VivoCAR T cells to direct cancer-killing T cells to the tumor and the critical supporting cells of the tumor. 2

"This represents an important step forward in delivering on a shared vision to develop transformational therapies for patients who need them, including the most vulnerable population affected by debilitating diseases – children," said Michael Jensen, M.D., co-founder, Umoja Biopharma, vice president, Seattle Children’s Therapeutics and chief therapeutics officer, Seattle Children’s. "We now have the opportunity to combine forces and move at light speed, eclipsing what could have been accomplished singularly or in a normal academic manner."

Umoja Biopharma was founded through an initial seed investment by MPM Capital and DCVC Bio, and its scientific founders from Seattle Children’s Research Institute and Purdue University, based on pioneering work in the laboratory of Philip Low, the Presidential Scholar for Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry. The Series A financing will enable Umoja to advance its platform and therapeutic programs to early clinical development, attract talent and invest in research. "Umoja is comprised of a highly skilled and passionate team that brings together a unique complement of expertise with in vivo gene transfer, drug development and oncology," said Luke Evnin, Ph.D., co-founder and Managing Director of MPM Capital.

"We believe that Umoja’s approach represents the future of cancer treatment." "Umoja is working to create an entirely new approach to engineered immunotherapies that can pave the way for cancer therapies that are more accessible and effective for patients around the world," said John Hamer, Managing Partner, DCVC Bio. "We look forward to continuing to work with the exceptionally skilled Umoja team to support the development of their integrated and scalable VivoVec and TumorTag technology." "We believe that the combination of deep technical experience and integrated technology platform will put Umoja at the forefront of in vivo T cell engineering," said Anna French, Partner at Qiming Venture Partners USA. "Umoja’s universal CAR approach supports multi-antigen targeting which will be required for the development of solid tumor therapeutics."

On November 18, 2020 Cernostics, Inc. the GI Precision Medicine company, reported two newly completed clinical studies confirming the ability of the TissueCypher Barrett’s Esophagus Assay to identify patients at high risk for progression to cancer (Press release, Cernostics, NOV 18, 2020, View Source [SID1234571324]). The two independent peer-reviewed studies, both authored by Prof. Jacques Bergman and Dr. Nicola Frei (University Medical Center, Amsterdam, the Netherlands), have further validated Cernostics’ TissueCypher Barrett’s Esophagus Assay to accurately and objectively predict which patients with Barrett’s esophagus will develop esophageal cancer. These studies confirm the accuracy of the assay in patients with NDBE and LGDBE, and support clinical adoption of the assay to help providers make better-informed clinical decisions. TissueCypher has the potential to improve patient care by identifying patients at high risk for development of esophageal cancer who will benefit from early intervention or increased surveillance, as well as identifying patients at low risk for progression who can avoid unnecessary procedures.

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• Independent Validation of TissueCypher to Predict Future Progression in Non-Dysplastic Barrett’s Esophagus: A Spatial-Temporal Analysis, published in Clinical and Translational Gastroenterology. This blinded independent validation study confirms the ability of TissueCypher to accurately predict incident/future progression to esophageal cancer in patients with NDBE. The study also demonstrated that sampling multiple endoscopic levels across the Barrett’s segment further increases the detection rate for NDBE patients at high-risk for incident progression to esophageal cancer. This study validated findings from previous studies that TissueCypher identifies a high-risk subset of patients with NDBE who progress at a rate that is higher than published estimates for expert pathologist-confirmed LGD. A TissueCypher high-risk score in patients with NDBE may support a management approach similar to the approach for confirmed LGD, which includes endoscopic eradication therapy or increased surveillance to prevent development of cancer. This is a crucial finding as these are the "at-risk" group who may be missed by the current standard of care. This is the fourth study to independently validate the TissueCypher assay, and provides a critical level of evidence to support clinical adoption of the assay to risk stratify patients with non-dysplastic BE.

• Tissue Systems Pathology Test Objectively Risk Stratifies Barrett’s Esophagus Patients with Low-Grade Dysplasia, accepted in American Journal of Gastroenterology This blinded cohort study evaluated the TissueCypher Barrett’s Esophagus Assay in the screening cohort of a randomized controlled trial of SUveillance versus RadioFrequency ablation (SURF) for BE patients with community-based diagnosis of LGD. This is the fifth study to independently validate the risk stratification of TissueCypher, and a key strength is the study design in which the cohort was prospectively enrolled and followed. The results independently validated the ability of TissueCypher to objectively risk-stratify patients with LGD. TissueCypher provided objective risk stratification, whereas there was significant variability between the expert pathologists whose diagnoses were concordant for only 51.7% of cases in this study. In addition to risk stratifying patients with expert pathologist-confirmed LGD, TissueCypher also identified approximately 50% of the progressors that were downstaged to NDBE by expert pathologists. These patients are a high-risk subset who may be missed by the current standard of care, but could be identified early by TissueCypher and undergo management similar to LGD to prevent progression to cancer.

"Key opinion leaders from around the world continue to validate the potential for TissueCypher to improve care for patients with Barrett’s esophagus," commented Cernostics CEO Mike Hoerres. "We appreciate Prof. Jacques Bergman’s continued commitment to evaluating our innovative technology, and we anticipate additional studies from thought-leading institutions in the coming months that further validate the unique ability of TissueCypher to predict progression in patients with BE. Our momentum in growing clinical evidence and adoption bodes well for patients afflicted with this disease state and their physicians."

About Barrett’s Esophagus and TissueCypher

Barrett’s esophagus, which affects more than three million Americans, occurs when chronic exposure to acid from the stomach causes the esophageal cell lining to deteriorate, creating an environment for cancer. Without treatment, BE can lead to esophageal adenocarcinoma, the fastest-rising cancer in the U.S. The current approach to managing BE is surveillance, involving regular endoscopic procedures with biopsies, monitoring for disease progression, and GERD-related drug therapy to control symptoms and prevent injury to the esophagus. Cernostics has developed and commercialized the world’s first precision medicine test that predicts risk of developing esophageal cancer in patients with Barrett’s esophagus. The patent-protected technology platform – TissueCypher Barrett’s Esophagus Assay – uniquely analyzes whole slide digital images with multiplexed fluorescence, providing greater information and accuracy than traditional subjective tissue diagnostics. TissueCypher provides actionable information to gastroenterologists, eliminating the uncertainty related to the management of Barrett’s esophagus patients.

On November 18, 2020 Foundation Medicine reported it has entered into a non-exclusive agreement to license two foundational patent families from TwinStrand Biosciences, a next-generation DNA sequencing technology company based in Seattle (Press release, Foundation Medicine, NOV 18, 2020, View Source [SID1234571357]).

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The patented TwinStrand Duplex Sequencing technology is a biochemistry- and software-based platform that enables researchers and clinicians to detect faint signals of ultra-low frequency DNA mutations often obscured by technical noise.

"Advancing and improving patient care is our highest priority and we’re pleased to work with partners like TwinStrand who share this same goal," said Cindy Perettie, Foundation Medicine’s chief executive officer. "We look forward to expanding this agreement with TwinStrand to explore additional areas for future collaboration."

"We are delighted to partner with Foundation Medicine, a company that shares our patient-centric mission of applying innovative science to advance cancer care globally," said Jesse Salk, MD, PhD, TwinStrand’s chief executive officer. "We are excited to help power Foundation Medicine’s commitment to delivering the highest quality data and genomic insights to physicians and their patients."

On November 18, 2020 QBiotics Group Limited (QBiotics), a life sciences company developing novel anticancer and wound healing pharmaceuticals, reported that the U.S. Food and Drug Administration’s (U.S. FDA) Center for Veterinary Medicine (CVM) has approved its lead veterinary anticancer product, STELFONTA, making it the first FDA approved treatment for all grades of canine non-metastatic mast cell tumours (Press release, QBiotics, NOV 18, 2020, View Source [SID1234571378]). The news follows approvals for STELFONTA in early 2020 by the European Medicines Agency (EMA), the United Kingdoms’s Veterinary Medicines Directorate (VMD), and Swissmedic, with subsequent sales in all major European markets.

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In the United States, STELFONTA (tigilanol tiglate injection) is indicated for the treatment of all non-metastatic cutaneous MCT and non-metastatic subcutaneous MCT, located at or distal to the elbow or the hock in dogs. MCTs are the most frequently diagnosed cancer in dogs, accounting for up to 21% of skin cancer cases[3].

Dr Chad Johannes, Assistant Professor of Oncology at Iowa State University, and consultant to QBiotics commented, "STELFONTA brings a novel therapeutic mechanism and intratumoural delivery route to veterinary medicine. The efficacy and durability of response data in dogs with mast cell tumours are very promising. While surgery will remain the mainstay, I do think STELFONTA will reshape how we approach local mast cell tumour control in many ways."

Dr Victoria Gordon, CEO and Managing Director of QBiotics, said, "FDA approval is a pivotal achievement for both STELFONTA and QBiotics. STELFONTA has the potential to be a category igniter – given it is easy to administer, provides 75% complete tumour resolution after just one injection, and dogs quickly regain pre-treatment quality of life. European sales of STELFONTA have been impressive, and we are excited to be working with Virbac to bring the drug to the US market to help treat the 3 million dogs there that each year are diagnosed with cancer."

Dr Gordon continued, "this approval also provides strong validation of our highly efficient business model, where veterinary product sales provide repeatable revenue for the company, and the strong veterinary data underpins our human drug development programme. Clinical efficacy and safety responses reported in canine patients are also being mirrored in our human patients. In a Phase I/IIa human safety trial, tigilanol tiglate, the active ingredient in STELFONTA, demonstrated antitumour responses in a range of solid tumours. This included complete responses (where the tumour is completely destroyed) in head and neck squamous cell carcinoma and melanoma. Notably, a maximum tolerated dose was not declared for this study. We are currently investigating the drug’s potential as both a monotherapy and an immune checkpoint inhibitor combination therapy through a series of Phase II clinical trials."

Tigilanol tiglate is a small molecule that largely acts through specific protein kinase C (PKC) activation[4], leading to rapid destruction of the tumour mass and the tumour’s blood supply, as well as stimulation of the immune system. Tumour destruction is followed by rapid healing of the site with minimal scarring.

QBiotics and its partner, Virbac, a global animal health company, will first launch STELFONTA to specialist U.S. veterinary oncologists over the coming months, followed by the launch to primary care veterinarians in early 2021.

On November 17, 2020 Hutchison China MediTech Limited ("Chi-Med" or the "Company") (Nasdaq/AIM: HCM) reported that it has entered into a definitive agreement for the sale of US$100 million of shares at a price equivalent to US$30 per American Depositary Share ("ADS") via a private placement to Canada Pension Plan Investment Board ("CPP Investments") (Press release, Hutchison China MediTech, NOV 17, 2020, https://www.chi-med.com/us100-million-equity-investment-by-cpp-investments/ [SID1234571193]).

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Mr. Christian Hogg, Chief Executive Officer of Chi-Med, said, "We are very pleased to welcome CPP Investments as a shareholder. CPP Investments’ focus on building long-term value and its experience in healthcare investing make it an important global strategic partner to Chi-Med. We look forward to building on the partnership as we work, during the next six months, to launch both surufatinib and savolitinib in China, subject to approval, as well as submit our first U.S. NDA on surufatinib."

Mr. Agus Tandiono, Managing Director and Head of Fundamental Equities Asia at CPP Investments, said, "This placement aligns with CPP Investments’ focus on providing strategic, long-term capital to industry leading companies where we can participate in the future success of the business and help create greater value through ongoing partnership. We look forward to supporting Chi-Med’s work on innovation in oncology treatment."

Chi-Med will receive all proceeds from this private placement of the equivalent of 3,333,334 ADSs, which will fund ongoing research and clinical development and support the further growth of its commercialization capabilities both in China and globally.

Description of Share Capital and Securities Regulation
Chi-Med has agreed to issue 16,666,670 ordinary shares, par value US$0.10 each (the "Shares"), pursuant to the private placement. The Shares will, when issued, be credited as fully paid and will rank pari passu in all respects with the existing ordinary shares of Chi-Med. Each ADS represents five Shares.

The securities to be sold in the private placement will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Subject to certain conditions, the Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the Shares sold in the private placement to facilitate future resales by CPP Investments. Any offering of the securities under the resale registration statement will only be made by means of a prospectus. CPP Investments has the right to appoint an observer and a representative director to the board of directors of the Company upon achieving certain ownership thresholds in the future.

This announcement, including any information included or incorporated by reference in this announcement, is for information purposes only and shall not constitute nor form part of, and should not be construed as, an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. No public offering of the securities referred to in this announcement is being made in the United States or elsewhere.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.

Admission to the London Stock Exchange AIM market and Shares Outstanding After Completion
Application will be made for the Shares to be admitted to the AIM market operated by the London Stock Exchange ("Admission"). It is expected that Admission will become effective at 8:00 a.m. GMT on November 26, 2020.

Following admission of the Shares to trading on AIM, the issued share capital of Chi-Med will consist of 727,702,215 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury. The figure of 727,702,215 may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, Chi-Med under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.

For illustrative purposes only, if the 727,702,215 ordinary shares were converted in their entirety, they would be equivalent to 145,540,443 Nasdaq-traded ADSs (each equating to five ordinary shares).