On December 22, 2020 Skyhawk Therapeutics, Inc. and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported a strategic research collaboration and licensing agreement aimed at the discovery and development of novel small molecules that modulate RNA splicing for the treatment of serious diseases (Press release, Skyhawk Therapeutics, DEC 22, 2020, View Source [SID1234626571]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We believe that splice site modulation holds significant promise for the treatment of diseases which today have limited or no therapeutic options," said Mark Bunnage, D.Phil., Senior Vice President and Site Head, Boston Research at Vertex. "This collaboration brings Skyhawk’s innovative technology together with Vertex’s research and development experience; and fits perfectly with our strategy of investing in new technologies that will help us transform multiple serious diseases."

"We are excited to enter this collaboration with Vertex, a global leader in creating transformative medicines through serial innovation," said Bill Haney, Chief Executive Officer of Skyhawk. "In collaboration with the Vertex team, we look forward to using our SkySTAR platform to discover and develop novel small molecule therapeutics that modulate RNA splicing which have the potential to transform the lives of patients with serious diseases."

Under the collaboration agreement, Vertex will pay Skyhawk $40 million upfront. Skyhawk will grant Vertex options to exclusively license worldwide intellectual property rights to candidates discovered and developed under the collaboration that are directed to program targets. Following Vertex’s exercise of its options, Vertex will be responsible for further development and commercialization. Skyhawk is also eligible to receive up to $2.2 billion in potential milestone payments, as well as potential royalties on future sales.

On December 22, 2020 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company pioneering a new class of oligonucleotide-based therapies called Antibody Oligonucleotide Conjugates (AOCs), reported that Sarah Boyce, President and Chief Executive Officer, reported to present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14th, 2021 at 12:40pm PST (Press release, Avidity Biosciences, DEC 22, 2020, View Source [SID1234573219]). The conference is being held in a virtual format.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation will be available on the Company’s website at www.aviditybiosciences.com in the Investor Resources section. A replay of the presentation will be archived on the Company’s website for 30 days.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.