On June 25, 2020 Cernostics, a leader in the development of AI-driven image analysis technologies for precision medicine testing, reported publication of new clinical results demonstrating further validation of how its TissueCypher diagnostic test predicts future disease progression in patients with Barrett’s Esophagus (BE) (Press release, Cernostics, JUN 25, 2020, View Source [SID1234561465]). (Abstract available here. Full article available via journal subscription.) By identifying "at-risk" patients much earlier than traditional methods, TissueCypher provides actionable results that allow physicians to target early therapeutic interventions to prevent cancer.

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TissueCypher is the first and only precision medicine test designed, developed, and commercialized to predict which patients with Barrett’s Esophagus will progress to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC).

In this study, funded by the NIH/NCI, patients with BE who progressed to HGD or EAC after at least one year following endoscopy (n=58) were matched to patients with BE without disease progression after a median of seven years surveillance (n=210). Results demonstrated that patients classified as high-risk by TissueCypher were at 4.7-fold increased risk for HGD/EAC compared to those classified as low-risk (p<0.0001). Furthermore, this study demonstrated that patients with non-dysplastic BE who TissueCypher scored high-risk progressed to HGD or EAC at a rate of more than 5%/year, which is at least a 10-fold increase in reported progression rates for NDBE, based on large population studies.

In an editorial accompanying the published results, Prasad G. Iyer, MD, MSc, at Mayo Clinic in Rochester, Minnesota, describes TissueCypher as the potential "Holy Grail" for Barrett’s Esophagus. "Identification of those at higher risk may allow either intensive endoscopic surveillance (to detect incident dysplasia/EAC) or proactive EET, whereas surveillance intervals could be lengthened in those at low risk. This risk prediction has been referred to as the ‘Holy Grail’ in BE."

"This is the third independent study showing that TissueCypher gives physicians crucial predictive power beyond expert diagnosis, especially in that difficult subset of patients whose true risk may go unnoticed if we rely solely on traditional methods," said lead author Jon M. Davison, MD, Associate Professor of Pathology at University of Pittsburgh in Pittsburgh, Pennsylvania.

TissueCypher’s unique advantages stem from its patented, AI-based digital platform with multi-channel fluorescence imaging that provides physicians with a more in-depth, accurate, and comprehensive view of each patient’s unique pathology.

"The TissueCypher image analysis platform simultaneously and objectively extracts protein expression information from multiple biomarkers, as well as provides a digital expression of tissue architecture and nuclear morphology," says Vani J.A. Konda, MD, Clinical Director, Center for Esophageal Diseases, at Baylor University Medical Center in Dallas, Texas, and a key opinion leader in the use of imaging and novel screening techniques to improve early detection and treatment. "The information physicians receive is meaningful, accurate, and immediately actionable." Dr. Konda has published extensively on the role of biomarkers for improving risk stratification in patients with Barrett’s Esophagus, including an upcoming review paper in the July 2020 issue of Gastroenterology & Endoscopy News.

Cernostics’ innovative technology is unique in today’s market, because tissue structure is preserved while immune, stromal, stem cell and tumor biomarkers are analyzed – all of which is done by evaluation of standard esophageal pinch biopsies readily available from the endoscopy procedure. Biomarker intensity and spatial relationships within the tissue structure are also analyzed and reported, creating an in-depth picture of the patient’s risk from which the physician can create successful patient management protocols.

TissueCypher has been tested and validated in five independent clinical studies at leading centers around the world, including Cleveland Clinic, University of Pennsylvania Medical Center, Geisinger Health, and Academic Medical Center in Amsterdam. Most recent peer-reviewed results are published currently in the June 2020 issue of the American Journal of Gastroenterology.

Using a pinch biopsy specimen routinely collected by the gastroenterologist during an endoscopy procedure, TissueCypher is easily incorporated into a physician’s current practice. The test requires no additional tools or collection devices, as are needed with other currently available diagnostic options.

About Barrett’s Esophagus

Barrett’s Esophagus (BE) affects more than three million Americans, occurring when chronic exposure to stomach acid causes the esophageal cell lining to deteriorate and undergo changes that can create an environment for cancer. Without treatment, Barrett’s can lead to EC, with a poor 5-year survival of less than 20%. Today, Barrett’s is commonly managed by surveillance, involving regular endoscopic procedures with biopsy, monitoring disease progression, and GERD-related drug therapy to control symptoms and prevent esophageal injury.

On June 25, 2020 Poseida Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to utilizing proprietary gene engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure, reported the closing of a Series D financing round, raising $110 million (Press release, Poseida Therapeutics, JUN 25, 2020, View Source [SID1234561464]). The financing was led by funds advised by Fidelity Management Research Company, LLC, with participation by Adage Capital Management and Schonfeld Strategic Advisors. A number of current investors also participated in the financing.

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BofA Securities is acting as sole placement agent for the financing.

"This financing supports the approach we are taking to leverage our broad proprietary gene engineering platform technologies, including the piggyBac DNA Modification System and Cas-CLOVER site-specific gene editing system, for the creation of numerous differentiated cell and gene therapy product candidates," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida.

Poseida’s portfolio includes allogeneic and autologous CAR-T product candidates in both hematological and solid tumor oncology indications, as well as liver-directed gene therapy programs in orphan genetic diseases.

On June 25, 2020 Hoffmann-La Roche reported that Rozlytrek (entrectinib) is the second histology independent drug to be recommended by NICE for use on the Cancer Drugs Fund (CDF), following a green light for Bayer’s Vitrakvi (larotrectinib) earlier this year (Press release, Hoffmann-La Roche, JUN 25, 2020, View Source [SID1234561463]).

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As a histology independent treatment, the drug targets all solid tumours that have a certain genetic mutation (a neurotrophic tyrosine receptor kinase (NTRK) gene fusion), regardless of where the cancer originated in the body.

As NICE notes, this is particularly beneficial to patients with some rare types of cancer where treatment options are currently limited.

Between 600-700 people have solid tumours with NTRK gene fusions. For those aged 12 years and older who have no satisfactory treatment options, treatment with Rozlytrek will be funded via the CDF, once a European marketing authorisation is granted.

The EMA’s human medicines committee recently backed the approval of the drug as monotherapy for adults and paediatric patients 12 years of age and older, with solid tumours expressing an NTRK gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor.

"People across England will be among the first in Europe to benefit from a new generation of medicine that targets tumours based on their genetic make-up, rather than where they are in the body," noted Karen Lightning-Jones, head of Personalised Healthcare and Strategic Partnerships, Roche Products Limited.

"We are proud to have worked in partnership with NHSE, NICE and the Accelerated Access Collaborative, to fast-track access. We look forward to the English Genomic Medicine Service being able to operate at full capacity and help identify those patients who may benefit from entrectinib."

Meindert Boysen, deputy chief executive and director of the centre for health technology evaluation at NICE, said the decision to approve CDF funding for the drug "is another positive step forward for cancer care driven by genomics. Treatments like entrectinib, have the potential to revolutionise how we treat cancers by targeting a genetic mutation that activates tumour growth irrespective of the solid tumour’s location."

On June 25, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported a presentation at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting held from June 22nd-24th, 2020, illustrating a unique approach to creating drugs capable of reaching tumors hiding in organs where existing anticancer drugs cannot accumulate in therapeutic concentrations (Press release, Moleculin, JUN 25, 2020, View Source [SID1234561460]). A poster presentation entitled, "Targeting Cancer Sanctuary Sites: A Novel Approach to the Treatment of Lung Localized Tumors," provided an overview of data demonstrating that uniquely high uptake and retention of Annamycin in the lungs results in consistently high in vivo activity against wide range of lung-localized tumors in mice.

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"We are very encouraged by this data, as we believe it further demonstrates Annamycin’s anti-cancer activity against tumors that evade therapies that may be initially effective in their primary location of origin, but are protected by metastasis to sanctuary organs. In the case of sarcomas treated with the current standard of care, doxorubicin, tumors may be initially responsive in their primary location, but become unresponsive after metastasis to the lungs, which eventually becomes the most likely cause of patients’ death," commented Walter Klemp, Chairman and CEO of Moleculin. "This research also sheds light on why doxorubicin, the current standard of care for many types of cancer, is not effective against lung-localized cancer. Subsequently, we believe that Annamycin’s ability in animal models to effectively accumulate in the lungs without noticeable side effects offers unique therapeutic opportunities that should be explored for the benefit of cancer patients with lung-localized tumors."

Mr. Klemp concluded: "One of the reasons we are so excited about Annamycin’s potential to treat lung-localized tumors is its ability in animal models to accumulate in the lungs and lack of toxic side effects related to the high lung accumulation. This was once again confirmed by the data, as Annamycin accumulated in the lungs at nearly 6 times the level of doxorubicin. Importantly, Annamycin’s ability to accumulate in the lungs also led to high anti-tumor activity, which ranged from the inhibition of tumor progression to complete tumor eradication, resulting in significant improvement of survival in all the models tested. We look forward to exploring Annamycin’s clinical potential to target tumors localized in the lungs, one of the most common sites of cancer metastasis."

The accepted abstract stated, "The high cytotoxic potency of Annamycin against MDR cancer cells is related, in part, to its ability to overcome ABC transporter-mediated efflux and, in contrast to doxorubicin, achieve high intracellular uptake. A greatly increased concentration of Annamycin in the lung, as compared to doxorubicin, leads to high drug efficacy in vivo in lung-localized tumor models. In summary, our studies (1) support the hypothesis of lungs being a sanctuary site for cancer cells and (2) demonstrate that effective targeting of cancers metastatic to the lung is possible by chemical modification of clinically used but currently ineffective drugs, especially in combination with appropriate drug delivery. In more general terms, these studies indicate that the proposed approach can also lead to the identification and elimination of cancer sanctuary sites other than the lungs and creation of more effective anticancer therapies."

On June 25, 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$25.00 per American Depositary Share ("ADS") via a private placement to General Atlantic, a leading global growth equity firm (Press release, Hutchison China MediTech, JUN 25, 2020, https://www.chi-med.com/us100-million-equity-investment-by-general-atlantic/ [SID1234561459]). This fundraise could increase to US$200 million, through a warrant granted with a term of 18 months for a further US$100 million in Chi-Med shares exercisable at a price per share equivalent to US$30.00 per ADS, a 32.5% premium to the 30-day VWAP.

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Chi-Med is delivering on its strategic intention to become a global oncology business. In 2020, there has been significant progress in building an innovative, global, science-focused biopharmaceutical company including three U.S. Food and Drug Administration (FDA) Fast Track Designations for fruquintinib in metastatic colorectal cancer and surufatinib for two forms of advanced neuroendocrine tumors. The submission of a New Drug Application (NDA) for surufatinib in the United States is also planned for later this year.

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

This financing also highlights the strong commitment General Atlantic is making to Chi-Med. General Atlantic has 40 years’ experience in investing in global growth equity companies, with a demonstrated history in the biopharma sector, and has approximately US$34 billion of assets under management. It has a broad portfolio of life science company investments with whom they constructively partner to support further growth.

Mr. Christian Hogg, Chief Executive Officer of Chi-Med, said, "Over the last few months, we have made significant development, regulatory and commercial progress in several oncology programs intended for the global market. We are delighted therefore to welcome General Atlantic to our existing shareholder base and to further strengthen our balance sheet. We are confident that in this phase of material progress for Chi-Med we can deliver innovative cancer therapies to patients internationally."

Mr. David Hodgson, Vice Chairman of General Atlantic, said, "General Atlantic is committed to supporting innovation in the global life sciences industry. Chi-Med has built a deep pipeline of assets powered by its robust research and development engine. We endorse Chi-Med’s strategy to become a leading biopharma innovator and will leverage our global organization in support of Chi-Med’s mission to deliver safe and effective therapeutics to cancer patients in need around the world."

Mr. Lefei Sun, Managing Director and Head of Healthcare for China at General Atlantic, continued, "We believe Chi-Med is a pioneer of the Chinese biotech market in bringing advanced oncology therapies to the world. We are delighted to partner with Chi-Med to help unlock future value."

Chi-Med has agreed to issue the equivalent of 4,000,000 ADSs in a private placement to General Atlantic at a price equivalent to US$25.00 per ADS, resulting in aggregate gross proceeds of US$100 million to Chi-Med. The purchase price represents a 10.4% premium to the 30-day VWAP. The Company has also granted a warrant to General Atlantic to purchase up to an additional equivalent of 3,333,334 ADSs, at an exercise price equivalent to US$30.00 per ADS, and a term of 18 months.

Description of Share Capital and Securities Regulation
Each ADS represents five ordinary shares, par value US$0.10 each (the "Shares"). The new Shares to be issued by Chi-Med including shares issuable upon exercise of the warrant, pursuant to the private placement will, when issued, be credited as fully paid and will rank pari passu in all respects with the existing ordinary shares of Chi-Med.

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 and the Shares issuable upon exercise of the warrant to facilitate future resales by General Atlantic. Any offering of the securities under the resale registration statement will only be made by means of a prospectus. General Atlantic has the right to appoint an observer or 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
The private placement of 20,000,000 Shares (equivalent to 4,000,000 ADSs) to General Atlantic will comprise the issuance of 18,700,000 Shares ("First Tranche Shares") and the issuance of 1,300,000 Shares ("Second Tranche Shares"). Application will be made to the London Stock Exchange for the First Tranche Shares and the Second Tranche Shares to be admitted to the AIM market operated by the London Stock Exchange ("Admission"). It is expected that admission of the First Tranche Shares will become effective at 8:00 a.m. British Summer Time on July 3, 2020 and admission of the Second Tranche Shares will become effective at 8:00 a.m. British Summer Time on July 6, 2020.

Following admission of the First Tranche Shares to trading on AIM, the issued share capital of Chi-Med will consist of 709,274,765 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury. Following admission of the Second Tranche Shares to trading on AIM, the issued share capital of Chi-Med will consist of 710,574,765 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 709,274,765 (following admission of the First Tranche Shares but prior to admission of the Second Tranche Shares) and the figure of 710,574,765 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 710,574,765 ordinary shares were converted in their entirety, they would be equivalent to 142,114,953 Nasdaq-traded ADSs (each equating to five ordinary shares).

In addition, the Company will apply for the block listing of up to 16,666,670 new ordinary shares in accordance with the block listing process under Rule 29 of the AIM Rules for Companies to cover the potential exercise of the warrant. The new ordinary shares subject to the block admission will not be allotted immediately, but rather will be issued and allotted on exercise of the warrant from time to time. The Company will make six-monthly announcements of the utilization of the block listing, in line with its obligations under Rule 29 of the AIM Rules for Companies. The expected effective date of admission of these securities to AIM is on July 6, 2020.

About General Atlantic
General Atlantic is a leading global growth equity firm providing capital and strategic support for growth companies. Established in 1980, General Atlantic combines a collaborative global approach, sector specific expertise, a long-term investment horizon and a deep understanding of growth drivers to partner with great entrepreneurs and management teams to build exceptional businesses worldwide. The firm’s global Life Sciences portfolio includes Adagene, CANbridge, Ginkgo Bioworks, Immunocore, Motif FoodWorks, Ocumension, PathAI, and Royalty Pharma. General Atlantic has more than 150 investment professionals based in New York, Amsterdam, Beijing, Greenwich, Hong Kong, Jakarta, London, Mexico City, Mumbai, Munich, Palo Alto, São Paulo, Shanghai, and Singapore. For more information on General Atlantic, please visit the website: www.generalatlantic.com.