On June 30, 2021 Again Life Italia S.r.l. ("ALI"), a pharmaceutical biotechnology company headquartered in Italy, and TannerLAC UK Limited ("TannerLAC"), a subsidiary of Tanner Pharma Group and commercialization leader in Latin America, reported the signing of a business partnership agreement for Latin America (Press release, Tanner Pharma Group, JUN 30, 2021, View Source [SID1234584516]).

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With their global presence, ALI is dedicated to supporting cancer patients undergoing chemo and radiation therapy. Similarly, TannerLAC supports patients and biopharma companies by providing access to medicines in targeted markets.

Carolina Cortez, EVP of TannerLAC, commented, "We are very excited about the opportunity to work with Again Life Italia to improve the quality of life of patients in Latin America who experience side effects from chemo and radiation therapies."

Antonella Sardei, CEO of Again Life Italia, added, "Our partnership with TannerLAC is strategic to promote the products and the philosophy of Again Life Italia in Latin American countries and is in line with the company’s mission in supporting patients, especially those affected by side effects related to anticancer treatments, giving them the respect due to those who suffer."

The objective of the partnership is to leverage TannerLAC’s 18 years of experience to provide ALI’s innovative treatments to markets such as Argentina, Brazil, Chile, Colombia, Ecuador, Mexico and Peru.

On June 30, 2021 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic and therapeutic strategy for treating patients with cancer, reported that it has commenced an underwritten public offering of shares of its common stock (Press release, Celcuity, JUN 30, 2021, View Source [SID1234584501]). As part of the offering, Celcuity expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All of the shares in the offering will be sold by Celcuity . The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Celcuity intends to use the net proceeds from the offering for working capital and general corporate purposes, which may include capital expenditures, research and development expenditures, clinical trial expenditures, expansion of business development activities and other general corporate purposes.

Jefferies and Cowen are acting as joint bookrunning managers for this offering. Canaccord Genuity is acting as the lead manager and Needham & Company is acting as the senior co-manager.

The shares are being offered by Celcuity pursuant to a registration statement on Form S-3 previously filed with and declared effective by the U.S. Securities and Exchange Commission. The offering is being made only by means of a prospectus. A preliminary prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may be obtained, when available, from the following: Jefferies LLC, Attention: Equity Syndicate Prospectus Departments, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, email [email protected], telephone: 833-297-2926.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of, or any solicitation of an offer to buy, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On June 30, 2021 Medsenic, a clinical-stage biopharmaceutical company focused on the discovery and development of novel indications and formulations of arsenic salts for the treatment of severe autoimmune diseases, reported that it has entered into an exclusive licensing agreement with Australian company Phebra for the development of their patented OATO formulation (Oral Arsenic Trioxide) in the treatment of autoimmune diseases (Press release, Phebra, JUN 30, 2021, View Source [SID1234584517]).

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This agreement is a major step in paving the way for the marketing of a second generation of Medsenic’s drug candidates, until now dispensed as an intravenous solution (Arscimed). Phebra’s expertise in drug development, together with Medsenic’s clinically validated scientific discoveries, will confirm further the efficacy of arsenic trioxide observed in a phase 2 study, by switching to the novel and patient administered oral form (OATO).

"We are delighted with this partnership with Phebra, a global reference player renowned for its unique expertise in the development and formulation of critical care medicines and a specific expertise in arsenic-based drugs. This exclusive agreement reflects Medsenic’s commitment to pursue the development of its pipeline of drug candidates targeting autoimmune diseases ; it will allow us to initiate our Phase 3 clinical trial for the treatment of cGvHD and to develop our products in new indications such as systemic sclerosis", said Prof. François Rieger, President and co-founder of Medsenic, who added: "The robust formulation of Arscimed is a real paradigm shift in that it will bring expected comfort to patients with chronic graft-versus-host disease."

"We are impressed by the clinical results obtained by Medsenic with its product Arscimed in the treatment of cGvHD as an intravenous solution. We are confident that the properties of arsenic trioxide observed in various clinical studies have the potential to revolutionize the therapeutic management of autoimmune diseases where there remains a huge unmet medical need. With our novel patented oral formulation, we will contribute to a significant improvement in patient care, avoiding frequent hospital stays, painful injections and potentially less adverse side effects," said Dr Mal Eutick, President of Phebra.

About the ATO :

Arsenic trioxide has the dual property of increasing cellular oxidative stress, to the point where it induces the programmed death of activated cells (enhanced apoptosis) and of modulating their production of proinflammatory cytokines. It thus has a specific long-term immunomodulatory effect on activated cells of the innate immune system, without affecting its normal components, as demonstrated in animal models without autoimmune pathology, and with perfectly controlled side effects. It probably acts at an upstream coordination level of the immune cascade, since a correction of all parameters signaling the autoimmune cascade is observed in various animal models of autoimmunity.

Research programs are being developed to understand the positive effects of arsenic trioxide in human clinical trials. MEDSENIC has provided initial proof of concept in a Phase 2a clinical trial for the treatment of severe systemic lupus erythematosus, followed by positive results in the treatment of cGvHD in Phase 2 (75% success rate in the full analysed population). Medsenic has demonstrated that its arsenic trioxide-based treatment has minimal toxicity and proven efficacy, leading to its wider application in other autoimmune diseases.

On June 30, 2021 HUTCHMED (China) Limited ("HUTCHMED" or the "Company") (Nasdaq/AIM: HCM) reported the listing of its ordinary shares ("Shares") on the Main Board of the Stock Exchange of Hong Kong Limited (the "SEHK") under the stock code "13" and the closing of its previously-announced primary offering of 104,000,000 new ordinary shares on the SEHK (the "Offer Shares"), which comprises an international offering of 91,000,000 Offer Shares ("International Offering") and a Hong Kong public offering of 13,000,000 Offer Shares (the "Hong Kong Public Offering", and together with the International Offering, the "Global Offering") (Press release, Hutchison China MediTech, JUN 30, 2021, View Source [SID1234586914]).

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The gross proceeds to the Company from the Global Offering, before deducting underwriting fees and the offering expenses, were approximately HK$4.17 billion. In addition, the Company has granted the international underwriters an over-allotment option, exercisable from June 30, 2021 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 (defined below).

The Company entered into cornerstone investment agreements with investors affiliated with The Carlyle Group, Canada Pension Plan Investment Board, General Atlantic, HBM Healthcare Investments and CICC Grandeur Fund. Pursuant to such agreements, they subscribed for a total of 63,215,500 Offer Shares, representing approximately 61% of the Offer Shares offered under the Global Offering (assuming the over-allotment option is not exercised).

With effect upon the listing of the Shares on the Main Board of the SEHK, the board of directors of the Company has adopted the Hong Kong Corporate Governance Code (as set out in Appendix 14 to the Rules Governing the Listing of Securities on the SEHK), in replacement of the UK Corporate Governance Code (published by the UK Financial Reporting Council on July 15, 2018). The Company’s updated corporate governance statement of compliance is available on the Company’s website at View Source

As announced on June 23, 2021, the final offer price for both the International Offering and the Hong Kong Public Offering (the "Offer Price") had 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.

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 were 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 and final prospectus supplement relating to and describing the terms of the Global Offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. 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.

Global Offering Use of Proceeds
The net proceeds from the Global Offering to be received by the Company are estimated to be approximately HK$3,950 million (assuming the over-allotment option is not exercised), based on the Offer Price of HK$40.10, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by the Company. The Company currently intends to apply such net proceeds for the following purposes:

approximately HK$1,975 million (or approximately 50% of the net proceeds) to advance the Company’s late-stage clinical programs for savolitinib, surufatinib, fruquintinib, HMPL-689 and HMPL-523 through registration trials and potential NDA submissions;
approximately HK$395 million (or approximately 10% of the net proceeds) to support further proof-of-concept studies and fund continued expansion of the Company’s product portfolio in cancer and immunological diseases through internal research, including the development cost of early-clinical and preclinical-stage pipeline drug candidates;
approximately HK$790 million (or approximately 20% of the net proceeds) to further strengthen the Company’s integrated capabilities across commercialization, clinical and regulatory and manufacturing;
approximately HK$593 million (or approximately 15% of the net proceeds) to fund potential global business development and strategic acquisition opportunities to complement the Company’s internal research and development activities; and
approximately HK$197 million (or approximately 5% of the net proceeds) for working capital, expanding internal capabilities globally and in China, and general corporate purposes.

On June 30, 2021 Cytovation AS, a clinical stage immune-oncology company focused on the development of its first-in-class tumorolytic agent CyPep-1, reported that it has entered into a clinical trial collaboration and supply agreement with MSD to evaluate the safety and efficacy of CyPep-1 in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy (Press release, Cytovation, JUN 30, 2021, View Source;utm_medium=rss&utm_campaign=cytovation-announces-clinical-collaboration-with-msd-to-evaluate-its-first-in-class-tumorolytic-agent-cypep-1-in-combination-with-keytruda [SID1234584502]).

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Cytovation will first expand its ongoing monotherapy Phase I/II "CICILIA" clinical trial, to evaluate safety of CyPep-1 in combination with KEYTRUDA, in a 15-patient cohort. Subsequently, clinical evaluation will proceed into a Phase II trial that will evaluate the efficacy and safety of the combination in up to 90 patients with advanced head and neck squamous cell carcinoma (HNSCC), melanoma, or triple-negative breast cancer (TNBC). Initial results from the safety study are expected early next year with the Phase II trial scheduled to start shortly thereafter.

Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: "Early clinical data for CyPep-1 monotherapy have shown a strong safety profile and encouraging anti-tumor activity that are consistent with our preclinical data, where we have also seen a highly synergistic effect of CyPep-1 with checkpoint inhibitor therapy. We are very pleased to be collaborating with MSD as we explore the potential of this combination in patients."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About CyPep-1

CyPep-1 is a proprietary first-in-class tumorolytic agent engineered to selectively target tumor cell membranes based on their altered molecular composition relative to normal cells. CyPep-1 eliminates cancer cells by forming pores in the plasma membrane, releasing cancer specific antigens to the immune system, promoting an inflammatory microenvironment, and inducing a tumor-specific immune response by in situ vaccination.

Preclinical data suggest this mode of action is highly synergistic with checkpoint inhibitors.