On December 22, 2020 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (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 previously announced underwritten public offering of common stock, resulting in gross proceeds to the Company of $26.4 million (Press release, Greenwich LifeSciences, DEC 22, 2020, View Source [SID1234573204]).. The Company intends to use the net proceeds for completion of all manufacturing and all clinical trial activities to complete an interim analysis and data readout of the GP2 Phase III clinical trial, for the submission of a Biologics Licensing Application to the FDA seeking conditional marketing approval of GP2, for the in-licensing or acquisition and development of additional products, including the coronavirus vaccine program, and for working capital and general corporate purposes.

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The Company has also granted the underwriters a 45-day option to purchase up to an additional 99,000 shares of common stock offered in the public offering to cover over-allotments, if any, at the public offering price, which would increase the total gross proceeds of the offering to approximately $30.4 million, if exercised in full.

Aegis Capital Corp. acted as sole bookrunner for the offering.

This offering was made pursuant to a registration statement on Form S-1 (File No. 333-251366) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and subsequently declared effective on December 17, 2020 and a registration statement on Form S-1 (File No. 333-251438) previously filed with the SEC and immediately declared effective on December 17, 2020. A final prospectus related to the offering was filed and is available on the SEC’s website. Electronic copies of the final prospectus may be obtained 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.

On December 22, 2020 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the publication in Molecular Cancer Research of preclinical results from studies of human and murine versions of DKN-01, a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein (Press release, Leap Therapeutics, DEC 22, 2020, View Source [SID1234573220]). The article, entitled "mDKN-01, a Novel Anti-DKK1 Monoclonal Antibody, Enhances Innate Immune Responses in the Tumor Microenvironment," is available online. The studies characterized a murine version of DKN-01 (mDKN-01) in order to better understand the mechanism of action (MOA) of DKK1 inhibition in two mouse cancer models.

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"In the current studies, we demonstrated that the inhibition of DKK1 with a monoclonal antibody in a syngeneic melanoma model led to tumor growth inhibition (TGI) requiring host NK1.1 cells, but not T or B cells, and provided enhanced efficacy when combined with a PD-1 inhibitor. In a second model, the antibody was a potent inhibitor of breast cancer metastases to lung," said Walter Newman, Ph.D., Senior Research Fellow of Leap. "These results show the innate immune system effects of mDKN-01 and support further exploration as to how DKN-01 results in the activation of NK cells and mitigation of metastatic spread."

DKK1, a secreted modulator of Wnt/Beta-catenin and CKAP4/PI3K/AKT signaling, is overexpressed in many cancers, is associated with worse clinical outcomes, and has been shown to have immunosuppressive effects. To better understand the DKN-01 MOA, Leap engineered a murine framework for the DKN-01 CDR domains and examined the efficacy of mDKN-01 in a mouse model of melanoma. These studies show that targeting DKK1 suppresses tumor growth, reduces intra-tumoral myeloid-derived suppressor cells (MDSC) in the tumor and spleen, activates NK cells, and up-regulates PD-L1 expression on MDSC. Tumor cell signaling analysis in these studies indicates that mDKN-01 is not acting as a Wnt/B-catenin pathway agonist, but is inducing a collection of favorable immune changes in the tumor microenvironment.

In the animal model studied, mDKN-01 and an anti-PD-1 antibody demonstrated additive TGI effects. A clinical trial of DKN-01 plus pembrolizumab, an anti-PD-1 antibody, has recently been completed in esophagogastric cancer patients with promising results in patients whose tumors express high levels of DKK1. Leap has recently initiated a trial of DKN-01 in combination with BeiGene’s tislelizumab, an anti-PD-1 antibody, in DKK1-high second line gastroesophageal junction and gastric cancer (GEJ/GC) patients and in combination with tislelizumab, capecitabine, and oxaliplatin in first-line GEJ/GC patients.

About DKN-01

DKN-01 is a humanized monoclonal antibody that binds to and specifically blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin and CKAP4/PI3K/AKT signaling pathways, frequently implicated in tumorigenesis. The U.S. Food and Drug Administration has granted Orphan Drug Designation for the treatment of gastric and gastroesophageal junction cancer and Fast Track Designation in combination with tislelizumab for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express high DKK1 protein, following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy

On December 22, 2020 SomaLogic, Inc., global leader in proteomic discovery and applications transforming biomedical discovery and clinical diagnostics, reported that it added $81M to its current funding round with investments from a number of additional investors, for a total Series A raise of $214M (Press release, SomaLogic, DEC 22, 2020, View Source [SID1234577552]). The funds raised in this round will facilitate improving, expanding and commercializing SomaLogic’s world-leading proteomic products in both the clinical and life science markets.

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The Series A financing round was led by noted life science investor Casdin Capital, with participation in the first November close from Farallon Capital Management, Foresite Capital, funds and accounts advised by T. Rowe Price Associates, Inc., Blue Water Life Science Advisors, Madryn Asset Management, Fiscus Ventures and Reimagined Ventures (affiliates of Magnetar Capital), Monashee Investment Management, Mossrock Capital, Soleus Capital and others.

In this second close, additional financial investors include Janus Henderson Investors, Redmile Group, Logos Capital, Revelation Partners, Ziff Capital Healthcare Ventures, Boston Millennia Partners and Millennium Management. Strategic investors from a number of premier organizations that span the current and future proteomics market include Novartis, Amgen, Intermountain Ventures and NEC Solution Innovators, Ltd. Cowen was an advisor in this effort.

SomaLogic’s SomaScan Platform technology offers biopharmaceutical and academic researchers unparalleled and reliable coverage of the proteome for revealing new biology, identifying new drug targets, and assessing the effects of current and potential new drug treatments. SomaLogic recently expanded the number of proteins measured by their platform from 5,000 to more than 7,000.

SomaLogic’s growing menu of clinically relevant SomaSignal tests promise a new paradigm of empowering clinicians and individuals to more effectively manage health in real time, with a powerful and first-in-class set of proteomics-based diagnostic tools.

"We are very excited to have these financing partners for the next phase of our strategic growth – a syndicate that unequivocally represents the best of those involved in supporting and growing life sciences tools and leading edge diagnostics companies, and several that represent the growing market for our products as well," said SomaLogic Chief Executive Officer Roy Smythe, M.D. "Proteomics will increasingly transform life sciences research and clinical care in ways previously unimagined and we are now positioned at the very forefront of that endeavor."

"This financing positions SomaLogic to continue to lead in the exploration of the proteome through its powerful technology platform," said Chief Investment Officer and Casdin Founder, Eli Casdin. "We’re excited to partner with the team to build off the decades of trailblazing science and validating partnerships with world-class collaborators to expand access to the technology and to drive value to the clinical and life science ecosystem."

Cowen served as sole placement agent to SomaLogic for the private placement, and Reed Smith LLP served as legal counsel for the transaction.

On December 22, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported the publication of a manuscript on MGD019, an investigational PD-1 × CTLA-4 bispecific DART molecule, in Cell Reports Medicine (Press release, MacroGenics, DEC 22, 2020, View Source [SID1234573205]). MacroGenics’ DART platform allows for the creation of bispecific antibody-based molecules with the ability to bind to two distinct targets in contrast to a single target as supported by traditional monoclonal antibodies.

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The publication, Development and Preliminary Clinical Activity of PD-1-Guided CTLA-4 Blocking Bispecific DART Molecule, highlights key findings from the ongoing Phase 1 trial of MGD019 first-in-human study of patients with advanced solid tumors (NCT03761017) as well as data from mechanistic studies. Findings in mechanistic studies demonstrated that cells co-expressing PD-1 and CTLA-4 are abundant in the tumor microenvironment (TME) compared to normal tissues, supporting PD-1 and CTLA-4 co-blockade in treating solid tumor cancers. This observation suggests that targeting dual PD-1/CTLA-4-expressing cells may also provide an opportunity for increased selectivity of checkpoint blockade in the TME, while relatively reducing effects in normal tissues.

In vitro studies demonstrated that MGD019 may provide complete blockade of PD-1 together with tunable inhibition of CTLA-4, with greatly enhanced blockade of CTLA-4 activity on dual-antigen expressing cells, a potential advantage over PD-1 or CTLA-4 blockade with individual monoclonal antibodies. In addition, MGD019 was well tolerated in non-human primates following repeated intravenous (IV) administrations (four weekly doses) of MGD019 at dose levels of 10, 40 and 100 mg/kg, well exceeding the highest non-severely toxic dose reported for the combination of nivolumab and ipilimumab in this species.

These mechanistic data formed the basis for the on-going, first-in-human study demonstrating clinical activity and correlated pharmacodynamics. At the cutoff date of April 1, 2020, 33 patients representing 21 different advanced solid tumor types were treated, including 13 patients (39.4%) who had previously received checkpoint inhibitor therapy. Objective responses were reported in four patients (including one unconfirmed response) with tumor types typically unresponsive to conventional checkpoint inhibition. MGD019 was generally well-tolerated up to the top predefined dose level of 10 mg/kg, with no dose limiting toxicities (DLTs) observed and a safety profile generally consistent with that of anti-PD-1 monotherapy.

"Treatment with PD-1 and CTLA-4 inhibitors such as nivolumab and ipilimumab has been effective in several cancer indications; however, the combination is associated with significant toxicity," said Paul Moore, Ph.D., MacroGenics’ Vice President of Cell Biology and Immunology and the senior author on the paper. "The pre-clinical and clinical results published today demonstrated that MGD019 can mediate complete blockade of PD-1 with tunable blockade of CTLA-4, which is enhanced on dual-expressing cells, a potential advantage over blockade by combining individual monoclonal antibodies to PD-1 and CTLA-4. The early clinical data from the Phase 1 trial of MGD019 appear to indicate an acceptable safety profile and support further clinical investigation of MGD019 in cancer treatment."

About MGD019

MGD019 is an investigational, bispecific DART molecule that was designed to enable blockade of two immune checkpoint molecules expressed on T cells, PD-1 and CTLA-4. Based upon the establishment of a recommended Phase 2 dose (RP2D) from a dose escalation study, MGD019 is initially being evaluated in a dose expansion study in microsatellite-stable colorectal cancer and non-small cell lung cancer. MacroGenics retains global rights to MGD019.

On December 22, 2020, Gritstone Oncology, Inc. (the "Company") reported that it entered into a Securities Purchase Agreement (the "Purchase Agreement") with certain purchasers identified on the signature pages thereto (the "Purchasers"), pursuant to which the Company has agreed to sell to the Purchasers, in an unregistered offering, shares of common stock, par value $0.0001 per share (the "Common Stock"), and pre-funded warrants to purchase shares of Common Stock for aggregate gross proceeds to the Company of approximately $110.0 million (the "Private Placement") (Filing, 8-K, Gritstone Oncology, DEC 22, 2020, View Source [SID1234573275]). The Private Placement is being conducted in accordance with applicable Nasdaq rules and priced at the "Minimum Price" (as defined in the Nasdaq rules).
The closing of the Private Placement occurred on December 28, 2020 (the "Closing"). Pursuant to the Purchase Agreement, the Company agreed to sell and certain Purchasers agreed to purchase (i) an aggregate of 5,543,351 shares of Common Stock (the "Shares") at a per share purchase price of $3.34, the Nasdaq Official Closing Price of the Company’s Common Stock on December 22, 2020, and (ii) pre-funded warrants to purchase an aggregate of 27,480,719 shares of Common Stock (the "Pre-Funded Warrant" and together with the Shares, the "Securities"). The Pre-Funded Warrants will expire when exercised in full, will have a nominal exercise price of $0.01 per share, and are immediately exercisable upon issuance. The exercise price and number of shares of Common Stock issuable upon the exercise of the Pre-Funded Warrants will be subject to adjustment in the event of any stock dividends and splits, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Pre-Funded Warrants.

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The Company has agreed to file a resale registration statement with the Securities and Exchange Commission as soon as practicable, and in all events within 30 days after the Closing, to register the resale of the Securities issued at the time of the Closing.
Cowen & Company LLC is acting as sole placement agent for the Private Placement.