On August 23, 2021 HUTCHMED (China) Limited ("HUTCHMED" or the "Company") (Nasdaq/AIM: HCM) reported the pricing of its global offering (the "Global Offering") of 104,000,000 new ordinary shares (the "Offer Shares") which comprises an international offering (the "International Offering") and a Hong Kong public offering (the "Hong Kong Public Offering") in connection with a primary listing of its ordinary shares (the "Shares") on the Main Board of the Stock Exchange of Hong Kong Limited (the "SEHK") (Press release, Hutchison China MediTech, JUN 23, 2021, View Source [SID1234586913]).

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The final offer price for both the International Offering and the Hong Kong Public Offering (the "Offer Price") has been set at HK$40.10 per Share, which is equivalent to approximately US$25.82 per American depositary share ("ADS") or £3.70 per Share. Each ADS represents five ordinary shares of the Company. The Company has set the Offer Price by taking into consideration, among other factors, the closing price of the ADSs on the Nasdaq Global Select Market ("Nasdaq") and Shares on the AIM market of the London Stock Exchange on June 22, 2021, the latest trading day before pricing. Subject to approval from the SEHK, the Shares are expected to begin trading on the Main Board of the SEHK on June 30, 2021 under the stock code "13".

The gross proceeds to the Company from the Global Offering, before deducting underwriting fees and the offering expenses, are expected to be approximately HK$4.17 billion. In addition, the Company has granted the international underwriters an over-allotment option, exercisable from the date, expected to be on June 30, 2021, on which the Shares are first listed and from which dealings in the Shares are permitted to take place on the Main Board of the SEHK (the "Listing Date") until 30 days after the last day for lodging applications under the Hong Kong Public Offering, to require the Company to issue up to an additional 15,600,000 new Shares at the Offer Price.

The Company will receive all of the net proceeds from the Global Offering and plans to use the net proceeds from the Global Offering primarily to advance its late-stage clinical programs as well as its pipeline of clinical-stage and preclinical drug candidates, further strengthen its commercialization, clinical, regulatory and manufacturing capabilities, fund potential global business development and strategic acquisition opportunities and for general corporate purposes.

Morgan Stanley Asia Limited, Jefferies Hong Kong Limited and China International Capital Corporation Hong Kong Securities Limited are the joint sponsors for the Global Offering.

Information about the Global Offering
Sales of Shares outside of Hong Kong (other than certain Shares which were sold to investors in reliance on Regulation S or another exemption from the registration requirements of the U.S. Securities Act of 1933) initially offered in the United States and sold outside the United States that may be resold from time to time in the United States are being offered pursuant to an automatically effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement relating to and describing the terms of the Global Offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. The final prospectus supplement relating to the Global Offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, an electronic version of the prospectus supplement and the accompanying prospectus relating to these securities, as filed with the SEC, may be obtained for free by mailing the request to: Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attention: Prospectus Department, or E-mail: [email protected]; Jefferies Hong Kong Limited, Email: [email protected]; and China International Capital Corporation Hong Kong Securities Limited, Email: [email protected].

This announcement is not directed to, or intended for distribution or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction.

The 104,000,000 new Shares to be issued by HUTCHMED pursuant to the Global Offering ("New Shares") will, when issued, be credited as fully paid and will rank pari passu in all respects with the existing ordinary shares of HUTCHMED, including the right to receive all dividends and other distributions declared, made or paid in respect of such Shares after the date of issue of the New Shares.

Application will be made to the London Stock Exchange for the 104,000,000 New 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. UK time on June 30, 2021.

Following Admission and prior to any exercise of the over-allotment option, the issued share capital of HUTCHMED will consist of 848,515,660 Shares of US$0.10 each, with each Share carrying one right to vote and with no Shares held in treasury. This figure 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, HUTCHMED under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules. For illustrative purposes only, 848,515,660 Shares would be equivalent to 848,515,660 depositary interests (each equating to one ordinary share) which are traded on AIM or, if the depositary interests were converted in their entirety, equivalent to 169,703,132 ADSs (each equating to five Shares) which are traded on Nasdaq. A further announcement will be made if the over-allotment option is exercised.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018).

On June 23, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that it has obtained manufacturing and marketing approval for the EZH2 inhibitor "Tazverik Tablets 200 mg" (tazemetostat hydrobromide) in Japan with the indication of relapsed or refractory EZH2 gene mutation-positive follicular lymphoma (only when standard treatment is not applicable) (Press release, Eisai, JUN 23, 2021, View Source [SID1234584266]).

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This approval is based on the results of a multicenter, open-label, single-arm clinical phase II trial (Study 206)1 in Japan conducted by Eisai and other studies2 conducted by Epizyme, Inc. (Headquarters: Massachusetts, United States) outside Japan. Study 206 enrolled patients with EZH2 gene mutation-positive, primarily follicular lymphoma, who had relapsed or were refractory. The primary endpoint of this study was objective response rate (ORR), and secondary endpoints included safety. This study achieved the primary endpoint target and exceeded a prespecified tumor response threshold with statistical significance: ORR in patients with EZH2 mutation-positive relapsed or refractory follicular lymphoma (n=17) was 76.5% (90% confidence interval (CI): 53.9-91.5) as measured by independent review. Treatment-emergent adverse events (incidence of 25% or more) observed in this study were dysgeusia (52.9%), nasopharyngitis (35.3%), lymphopenia (29.4%) and blood creatine phosphokinase increased (29.4%). Eisai will conduct a post-marketing special use results survey (all-case surveillance) in all patients who are administered "Tazverik" until a pre-determined number of patients has been reached in accordance with an approval condition imposed by the MHLW.

Created by utilizing Epizyme’s proprietary product platform, "Tazverik" is a first-in-class small molecule inhibitor of the epigenetic enzyme EZH2. It is one of the histone methyltransferases in the epigenetics-related protein group, and is thought to regulate the expression of cancer-related genes and suppress the growth of cancer cells by specifically targeting EZH2, which contributes to the cancer growth process.3 Eisai is responsible for the development and commercialization of this agent in Japan, while Epizyme, Inc. is responsible for all regions outside of Japan. In the United States, "Tazverik" received accelerated approval for the indication of epithelioid sarcoma in January 2020, and follicular lymphoma in June 2020 (Notes to editors 1).

Follicular lymphoma is a low-grade B-cell lymphoma that accounts for 10-20% of non-Hodgkin’s lymphomas. Follicular lymphoma is generally indolent and sensitive to chemotherapy. However, development of a new treatment strategy is required for follicular lymphoma which still remains difficult to cure, as recurrence often occurs repeatedly. 7-27% of follicular lymphomas are reported to have gain-of-function mutations in the EZH2 gene,4,5 and it is estimated that there are approximately 600 to 2,400 patients with follicular lymphoma with EZH2 gene mutations in Japan. A companion diagnostic test for EZH2 gene mutations, "cobas EZH2 Mutation Test" by Roche Diagnostics K.K. (Headquarters: Tokyo) was approved in May 2021.
　

Eisai aims to make continuous efforts to meet the diversified needs of and increase the benefits provided to patients with cancer, their families, and healthcare professionals, by delivering "Tazverik" as a new treatment option for EZH2 gene mutation-positive follicular lymphoma.

On June 23, 2021 Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, reported that its new wholly owned subsidiary, Celsion GmbH, will manage all current and future investigator-sponsored development of ThermoDox, the Company’s proprietary heat-activated liposomal encapsulation of doxorubicin (Press release, Celsion, JUN 23, 2021, View Source [SID1234584283]). Andreas Voss, M.D., a leading oncology researcher, has been named Managing Director of Celsion GmbH and will step down from Celsion’s board of directors later this year to head the subsidiary, which is based in Zug, Switzerland.

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Establishing Celsion GmbH allows Celsion’s management to focus solely on GEN-1, its DNA-mediated IL-12 immunotherapy currently in Phase I/II development for the treatment of advanced ovarian cancer, and PLACCINE, its nucleic acid vaccine platform. In addition to clinical and regulatory advice, Celsion’s ongoing investment in ThermoDox will be limited to providing clinical drug supply and modest financial support.

ThermoDox is currently under investigator-sponsored development for several cancer indications, including:

A Phase I study led by the University Medical Center Utrecht in the Netherlands to determine the safety, tolerability and feasibility of ThermoDox in combination with Magnetic Resonance Guided High Intensity Focused Ultrasound hyperthermia and cyclophosphamide therapy for the local treatment of the primary tumor in metastatic breast cancer.
A Phase I study led by Oxford University in the UK to assess intravenous delivery of ThermoDox in combination with High Intensity Focused Ultrasound in pancreatic cancer.
A clinical project at the National Institutes of Health to evaluate ThermoDox plus the chemotherapy drug mitomycin in bladder cancer.
Commenting on his new role in leading Celsion GmbH, Dr. Voss said, "I am excited to spearhead this effort and to work with investigators around the world who are interested in pursuing further clinical development of ThermoDox. Building upon encouraging preclinical results in several cancer indications, we have been fielding numerous requests from investigators to conduct their own studies. We know that doxorubicin is one of the most active cytotoxic drugs with no known specific resistance mechanism. Furthermore, the ability of ThermoDox to deliver high doses into tumor tissue is proven and its mechanism of action is well understood. Celsion GmbH’s long-term objective is to seek partnerships that will maximize the potential of ThermoDox, ultimately providing value to the parent company."

Michael H. Tardugno, Celsion’s chairman, president and chief executive officer, said, "Despite the bitter disappointment and surprise with our Phase III OPTIMA study of ThermoDox in primary liver cancer, many investigators are undaunted by various anomalies related to that data and see value in the drug’s continued study. We owe patients and the scientific community the opportunity to investigate ThermoDox while removing the financial obligation from our stockholders. Celsion is now solely focused on the significant opportunity we face with GEN-1 and PLACCINE in advanced ovarian cancer and SARS-CoV-2 vaccines, respectively. I am delighted that Celsion GmbH is in the experienced hands of Dr. Voss, who will pursue other collaborations and partnerships with the intent to monetize this asset."

Andreas Voss, M.D. joined Celsion’s board of directors in 2015. Dr. Voss has more than 25 years of research and drug development expertise. He previously served as Vice President of Clinical Affairs for Europe at Caris Life Sciences, a biotechnology company focused on implementing personalized medicine in oncology through its liquid biopsy technology. Prior to joining Caris in 2010, he was responsible for the global clinical development of Avastin and was a member of the Corporate Drug Safety Board at F. Hoffmann-La Roche. Before joining Roche in 2006, he was Medical Director for the Lung Cancer Disease Area at AstraZeneca, and from 2000 to 2003 he was Medical Director for Anti-infectives and Oncology at Bayer GmbH. From 1996 to 2000, Dr. Voss was Head of Medical Research, Oncology at Asta Medica AG. Dr. Voss received his M.D. from the University of Hamburg Medical School and was a postdoctoral fellow at the University of California San Diego.

On June 23, 2021 ImmuneID, Inc., a precision immunology company employing a proprietary platform to identify and therapeutically target antibody interactions that drive immune diseases, reported that it has raised $50 million in Series A financing (Press release, ImmuneID, JUN 23, 2021, View Source [SID1234584298]). This Series A financing brings the total amount raised by ImmuneID since its December 2020 launch to over $70 million. Proceeds from the financing will be used to advance the development of therapeutic candidates to treat autoimmune diseases, severe allergies, cancer and infectious diseases.

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"ImmuneID’s advanced platform leverages technologies such as next-generation sequencing, robotic automation and artificial intelligence to provide insights that can be used to develop precision immunology therapeutics," said Stephen Elledge, Ph.D., ImmuneID co-founder and SAB chair, Lasker Award winner and The Gregor Mendel Professor of Genetics and Medicine at Harvard Medical School. The platform was first featured in Science and additional applications of the platform in multiple disease areas have been published in leading journals such as Science, Cell, PNAS and Nature Communications.

"ImmuneID’s unique and powerful immunological target identification platform unlocks the complexity of human immune responses to guide the development of precision immunology therapeutics in areas where there remains significant unmet patient need," said Longwood Fund’s Christoph Westphal, M.D., Ph.D., ImmuneID co-founder and Executive Chair.

This Series A round was led by new investor Alta Partners and included new investors Alexandria Venture Investments, Redwood Capital Investments, Section 32 and Tekla Capital Management. All existing investors participated in the financing, including Arch Venture Partners, Longwood Fund, Pitango HealthTech, In-Q-Tel, Xfund and others. This Series A financing follows a $22 million seed financing round that was led by founding investor Longwood Fund.

"This financing from an exceptional group of investors positions us to execute on our ambitious plans to develop a new generation of precision immunology therapeutics," said ImmuneID CEO David Donabedian, Ph.D., who brings more than 20 years of experience in biotech company formation and business development to ImmuneID. Dr. Donabedian previously has held various leadership roles at biopharmaceutical companies including AbbVie (NASDAQ: ABBV) and GlaxoSmithKline (NYSE: GSK).

Dan Janney, Managing Partner of Alta Partners, said, "We are excited to lead the Series A financing and join the current syndicate to further support ImmuneID and their promising approach to developing highly targeted therapeutics to treat diseases related to the immune system."

As part of the Series A Financing, Mr. Janney and Dr. Steve Kafka, Managing Partner, Section 32, will join ImmuneID’s board of directors.

About ImmuneID’s Platform and Technology

ImmuneID’s technology platform and the underlying technology is designed to provide insights into human immune response throughout the course of disease progression for the identification of high-quality therapeutic targets. The technology was originally developed in the lab of Stephen Elledge, Ph.D., ImmuneID co-founder and Chair of ImmuneID SAB, Lasker Award winner and The Gregor Mendel Professor of Genetics and Medicine, Harvard Medical School.

On June 23, 2021 Rubius Therapeutics, Inc. (Nasdaq:RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics, reported that the first patient has been dosed in a new Phase 1 arm of the ongoing Phase 1/2 clinical trial of RTX-240 in combination with KEYTRUDA (pembrolizumab)1 for the treatment of patients with relapsed/refractory or locally advanced solid tumors (Press release, Rubius Therapeutics, JUN 23, 2021, View Source [SID1234584708]). To be eligible for the trial, patients must have disease that is relapsed or refractory to an anti-PD-1 or PD-L1 therapy.

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"RTX-240 is designed to activate and expand a patient’s own immune cells to mount a broad and potent anti-tumor response. Combining an immune agonist with a PD-1 checkpoint inhibitor has the potential to prevent the cancer from evading the immune response. The RTX-240 and pembrolizumab combination is anticipated to drive activated T cells and NK cells into the tumor microenvironment with the potential to overcome resistance to PD-1 inhibition," said Christina Coughlin, M.D., Ph.D., chief medical officer at Rubius Therapeutics. "Given the favorable emerging safety profile and promising initial clinical activity reported as part of our initial clinical results from the ongoing Phase 1 monotherapy trial of RTX-240 in advanced solid tumors, we believe that the combination with pembrolizumab has the potential to provide significant benefit to patients with disease that is relapsed or refractory to prior anti-PD-1 or PD-L1 therapy."

"Despite recent advances in cancer immunotherapy, there remains a need for new combination approaches that broaden the benefits of immunotherapy in patients with solid tumors following treatment with checkpoint inhibition," said Omid Hamid, M.D., Chief of Translational Research and Immunotherapy, Director of the Phase 1 Immuno-Oncology Program of The Angeles Clinic and Research Institute, a Cedars-Sinai Affiliate, and RTX-240 investigator. "The exciting initial safety and efficacy data from the ongoing monotherapy Phase 1 clinical trial make RTX-240 a potentially promising candidate for the treatment of cancer, and we are excited to work with Rubius to evaluate RTX-240 in combination with pembrolizumab."

RTX-240 is engineered to express a co-stimulatory molecule, 4-1BB ligand, and a cytokine, IL-15TP, on the cell’s surface, and is designed to broadly stimulate the immune system by activating and expanding both natural killer (NK) cells and T cells to generate a potent anti-tumor response. Pembrolizumab is a humanized monoclonal immunoglobulin G4 antibody (IgG4 mAb) with high specificity of binding to the programmed cell death protein-1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). Based on in vitro data, pembrolizumab has high affinity and potent receptor blocking activity for PD-1. Pembrolizumab is indicated for the treatment of patients across several indications as monotherapy and in combination with numerous therapies.

About the RTX-240 Phase 1/2 Clinical Trial
This is a Phase 1/2 open label, multicenter, multidose, first-in-human dose-escalation and expansion study designed to determine the safety and tolerability, pharmacokinetics, maximum tolerated dose and a recommended Phase 2 dose and dosing regimen of RTX-240. The trial will also assess the pharmacodynamics of RTX-240 measured by changes in T and NK cell number and function relative to baseline and anti-tumor activity. The trial has three separate Phase 1 arms: an ongoing monotherapy dose escalation arm in adults with relapsed/refractory or locally advanced solid tumors, an ongoing monotherapy dose escalation arm in adults with relapsed/refractory acute myeloid leukemia, and a combination therapy dose escalation arm with pembrolizumab in adults with relapsed/refractory or locally advanced solid tumors. The monotherapy arm of the trial in advanced solid tumors includes a Phase 2 expansion in specified tumor types.