On September 29, 2020 Neuropore Therapies, Inc. reported that it has licensed two mechanistically distinct classes of potent, selective and brain penetrating modulators of mTOR–regulated autophagy to Global Cancer Technology (Press release, Neuropore Therapies, SEP 29, 2020, View Source [SID1234567766]). This portfolio of small molecule autophagy modulators, targeting PI3K and VPS34, was discovered by Neuropore Therapies and characterized using its comprehensive platform of autophagy and lysosomal biogenesis cellular assays. Neuropore Therapies will continue to investigate the utility of autophagy modulators for the treatment of neurodegenerative disorders while Global Cancer Technology will pursue the use of these PI3K and VPS34 inhibitors for the treatment of cancers and other life-threatening diseases.

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Doug Bonhaus, CEO of Neuropore Therapies, commented, "Modulators of autophagy have therapeutic potential in a wide range of diseases including cancers, metabolic and neurodegenerative disorders. While Neuropore Therapies continues to explore the therapeutic potential of autophagy modulators for neurodegenerative disorders, we are very pleased to see the therapeutic potential of these PI3K and VPS34 targeted compounds pursued for additional indications."

On September 29, 2020 ITM Medical Isotopes GmbH, a subsidiary of the biotechnology and radiopharmaceutical group of companies ITM Isotopen Technologien München AG (ITM), Bruce Power, an electricity company, and IsoGen, a joint venture between the two nuclear energy companies Framatome and Kinectrics, reported that Bruce Power and IsoGen have set the first critical milestone for a reliable and consistent irradiation service which will be provided to ITM exclusively for 15 years (Press release, ITM Isotopen Technologien Munchen, SEP 29, 2020, View Source [SID1234567763]). Thereby a dedicated mock-up of the isotope production system was developed for validation, testing and training which will start in fall 2020.

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The medical radioisotope Lutetium-177 (177Lu) will be obtained by irradiating Ytterbium-176 at the Bruce Power Reactors, as contractually stipulated in an exclusive agreement between Bruce Power, IsoGen and ITM Medical Isotopes GmbH. Bruce Power Reactors are uniquely positioned to fulfil the necessary requirements to reach ITM’s high standards validated in a successful feasibility study September last year. The construction of the isotope production system at Bruce Power by IsoGen is currently planned to start in January 2021 once the mock-up has been fully tested. The mock-up is currently in the final phase of engineering, evaluation, and design and will allow validation and training before deploying the isotope production system to Bruce Power’s units.

The intermediate material to be generated at Bruce Power over 15 years will be processed by ITM via its unique manufacturing methodology to the highly pure form of 177Lu, no-carrier-added (n.c.a.) 177Lu (EndolucinBeta), at ITM´s global network of radiopharmaceutical production facilities. N.c.a. 177Lu is supplied by ITM to clinics worldwide and is used as a therapeutic radiopharmaceutical precursor for Targeted Radionuclide Therapy of cancers such as neuroendocrine tumors, prostate cancer, Non-Hodgkin’s lymphoma, bone metastases and several further indications.

Steffen Schuster, CEO of ITM commented: "Seeing the great progress in the development of the isotope production system by Bruce Power and IsoGen, we are confident that this partnership secures another high-quality source of Lutetium-177 for ITM which further increases scalability of our production ensuring a steady supply of n.c.a. Lutetium-177 on a global scale. Our clinical and industry partner’s demand for the radiopharmaceutical precursor no-carrier-added Lutetium-177 is constantly growing and as a company we are dedicated to providing our highly pure radioisotope for Targeted Radionuclide Therapy to cancer patients worldwide."

On September 29, 2020 CStone Pharmaceuticals ("CStone", HKEX: 2616)] and Pfizer Investment Co. Ltd. ("Pfizer Investment") and Pfizer Corporation Hong Kong Limited ("Pfizer Hong Kong") (both of which are subsidiaries of Pfizer Inc. (NYSE: PFE)) reported the formation of a strategic collaboration that encompasses a $200 million equity investment by Pfizer Hong Kong in CStone, collaboration between CStone and Pfizer Investment for the development and commercialization of CStone’s sugemalimab (CS1001, PD-L1 antibody) in mainland China, and a framework between CStone and Pfizer Investment to bring additional oncology assets to the Greater China market (Press release, CStone Pharmaceauticals, SEP 29, 2020, View Source [SID1234567760]).

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This collaboration provides financing to support CStone’s development of sugemalimab, a potential best-in-class PD-L1 antibody that is being developed for high-incidence cancer indications in China, including lung, gastric and esophageal cancers, among others. Pfizer will in-license and exclusively lead commercialization of sugemalimab in China, harnessing its industry-leading capabilities to help doctors and patients across a far wider range of regions gain greater access to this treatment. The collaboration positions CStone and Pfizer to develop and commercialize additional oncology assets for the Greater China market.

"Pfizer’s investment in CStone is a statement of its confidence in the potential of our anti-PD-L1 treatment and recognition of our research and development capabilities," said Frank Jiang, M.D., Ph.D., Chairman and Chief Executive Officer of CStone. "By joining forces with Pfizer and leveraging its commercialization infrastructure, we will ensure that patients across a vastly expanded number of markets in China have quicker access to our highly differentiated PD-L1 treatment. In addition, we have advanced our transformation into a full-fledged biopharmaceutical company by forging a collaboration that will enable us to accelerate development and commercialization of globally innovative therapies for Chinese patients."

"Our company has an extensive and proud history of bringing innovative medicines to patients in China," said Pierre Gaudreault, Acting President of Pfizer Biopharmaceuticals Group China. "This collaboration with CStone builds on that history by helping to develop a potential best-in-class PD-L1 treatment that we can commercialize upon approval. It also fosters our collaboration with a partner that has exceptional clinical development capabilities that can help us meet the clear need for novel oncology treatments in China."

Key Components and Financial Terms of the Collaboration

Pfizer obtains exclusive commercialization rights to sugemalimab in mainland China, while CStone continues to lead clinical development and regulatory strategy for five selected indications.
CStone is entitled to receive up to $280 million in milestone payments for sugemalimab and additional tiered royalties.
CStone retains all development and commercialization rights to sugemalimab outside mainland China.
Pfizer will invest $200 million, consisting of 115,928,803 CStone shares at a price of US$1.725 per share (approximately HK$13.37 per share). As a result of its equity investment, Pfizer will hold a 9.90 percent stake in CStone.
CStone and Pfizer will together select late-stage (post proof-of-concept) oncology assets for co-development in the Greater China market. These assets may come either from Pfizer’s pipeline or through joint in-licensing.
CStone and Pfizer may pursue on a selected basis joint in-licensing arrangements for additional oncology assets for the Greater China market.
The transaction has received the necessary internal approvals of both companies. Closing is not subject to approval by CStone’s shareholders.

Goldman Sachs & Co. LLC is acting as financial advisor to CStone, and Cooley LLP served as legal advisor. Clifford Chance LLP served as Pfizer’s legal advisor.

Investor Presentation Information

CStone will host a live webcast at 11:00am (Hong Kong time) on September 30th, 2020. Please find the access information as below.

All other regions: View Source;tp_key=735ccdf3e4
Mainland China: View Source;tp_key=735ccdf3e4
Password (case sensitive): CStone

About Sugemalimab

Sugemalimab is an investigational anti-PD-L1 monoclonal antibody discovered by CStone. Authorized by a company based in the U.S., Ligand Pharmaceuticals Inc. (NASDAQ: LGND), sugemalimab is developed using the OmniRat transgenic animal platform, which can generate fully human antibodies in one stop. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab mirrors the natural G-type immunoglobulin 4 ("IgG4") human antibody, which may reduce the risk of immunogenicity and toxicities in patients, a potentially unique advantage over similar drugs.

Sugemalimab has completed a Phase I dose-escalation study in China. During Phase 1a and 1b stages of the study, sugemalimab showed antitumor activity in multiple tumor types and was well-tolerated.

Currently, sugemalimab is being investigated in a number of ongoing clinical trials. In addition to a Phase I bridging study in the U.S., the clinical programs in China include one multi-arm Phase Ib study for several tumor types, one Phase II registrational study for lymphoma, and four Phase III registrational studies, respectively, for stage III/IV non-small cell lung cancer, gastric cancer, and esophageal cancer.

On September 29, 2020 Aptorum Group Limited (Nasdaq:APM, Euronext Paris:APM) ("Aptorum Group" or "Aptorum"), a biopharmaceutical company focused on novel technologies including the targeting of infectious diseases, reported the pricing of a public offering of 2,769,231 Aptorum’s Class A ordinary shares (or ordinary share equivalents) and warrants to purchase up to 2,769,231 Class A Ordinary Shares, at a combined public offering price of $3.25 per share and related warrant (Press release, Aptorum, SEP 29, 2020, View Source [SID1234567758]). The warrants have an exercise price of $3.25 per share are exercisable immediately upon issuance and expire on the five year anniversary of the date of issuance.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to Aptorum Group from the offering are expected to be approximately $9.0 million, before deducting the placement agents’ fees and other estimated offering expenses. Aptorum Group intends to use the net proceeds from the offering primarily to conduct further analyses of SACT-1 (a repurposed drug for neuroblastoma & other solid Tumors) and ALS-4 (a small drug molecule candidate for Staphylococcus aureus including MRSA), which are currently on track for IND submission to commence Phase 1b/2a human clinical trials and undergoing final stages of IND enabling studies to initiate Phase 1 human clinical trials respectively, and to accelerate the developments of our pipeline into their respective clinical phases, as well as for expanding businesses, working capital and general corporate purposes.

A registration statement on Form F-1 relating to this offering (file number 333-248743) and an additional registration statement filed pursuant to Rule 462(b) were declared effective by the Securities and Exchange Commission ("SEC") on September 29, 2020. The offering of the Company’s securities was made only by means of a prospectus forming a part of the registration statement. The registration statement on Form F-1 and the final prospectus relating to the Offering are available on the SEC’s website at www.sec.gov. Copies of the final prospectus relating to the offering may be obtained, when available, by contacting H.C. Wainwright & Co. at 430 Park Avenue, New York, New York 10022, by telephone: (212) 356-0500, or by email at [email protected].

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

On September 29, 2020 Greenwich LifeSciences, Inc. (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the closing of its initial public offering of 1,260,870 shares of its common stock at a public offering price of $5.75 per share for gross proceeds of $7,250,002, before deducting offering expenses (Press release, Greenwich LifeSciences, SEP 29, 2020, View Source [SID1234567756]). In addition, the Company has granted the underwriter a 45-day option to purchase up to 189,130 additional shares of common stock at the public offering price, less the underwriting discount, to cover over-allotments, if any. The shares began trading on The Nasdaq Capital Market on September 25, 2020, under the symbol "GLSI."

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Aegis Capital Corp. acted as the sole book running manager.

A registration statement relating to the shares of common stock being sold in this offering was declared effective by the Securities and Exchange Commission (the "SEC") on September 24, 2020. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained on the SEC’s website, www.sec.gov, or by contacting Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th Floor, New York, NY 10019, by email at [email protected], or by telephone at (212) 813-1010.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, 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.

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.