On December 19, 2019 Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported the pricing of the previously announced underwritten public offering of 10,000,000 shares of its common stock at a price to the public of $2.75 per share (Press release, Exicure, DEC 19, 2019, View Source [SID1234553518]). Exicure has also granted the underwriters a 30-day option to purchase up to an additional 1,500,000 shares of common stock to cover overallotments, if any, at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about December 23, 2019 subject to customary closing conditions.

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Exicure expects to receive gross proceeds of $27.5 million from the sale of common stock in the offering, prior to deducting underwriting discounts and commissions and estimated offering expenses payable by it. Exicure intends to use the net proceeds from the offering to advance AST-008 through a Phase 1b/2 clinical trial; to initiate a second arm in its Phase 1b/2 clinical trial in cutaneous squamous cell carcinoma; to develop an SNA-based therapeutic candidate for the treatment of Friedreich’s ataxia, initiate IND-enabling studies and advance it into Phase 1 clinical trials; to develop a second SNA therapeutic candidate for a neurology condition and initiate IND-enabling studies; and for general corporate purposes.

Guggenheim Securities is acting as sole book-running manager for the offering. Chardan is acting as lead manager for the offering. H.C. Wainwright & Co. and Ladenburg Thalmann are acting as co-managers for the offering.

The securities described above are being offered by Exicure pursuant to a shelf registration statement on Form S-3 (No. 333-230175) that was declared effective by the Securities and Exchange Commission (SEC) on July 24, 2019. A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website located at www.sec.gov. A final prospectus supplement and accompanying prospectus describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained, when available, from: Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-5548, or by email at [email protected].

This press release does 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.

On December 19, 2019 Kinnate Biopharma, Inc., a precision oncology company focused on the discovery and development of novel kinase inhibitors, reported that the company raised $74.5M in an oversubscribed Series B financing (Press release, Kinnate Biopharma, DEC 19, 2019, View Source [SID1234553304]). New investors OrbiMed, Nextech Invest Ltd., and Vida Ventures LLC participated in the round along with existing investors Foresite Capital and Eshelman Ventures.

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"Our Kinnate team has worked efficiently to build a robust, homegrown portfolio of best-in-class and first-in-class drug candidates in less than 21 months from our Series A financing close. This Series B financing positions us well to mature our candidates to clinical Proof-of-Concept"

Kinases play a crucial role in the carcinogenesis and metastases of various types of cancer, and kinase inhibition is a proven approach to addressing cancer resistance. The Kinnate team has been developing a broad portfolio of programs targeting substantial patient populations. Proceeds from the financing will be used to advance several development candidates from Kinnate’s existing programs into the clinic, and to fund new research programs. The funding will also be used to build out the Kinnate team of world-class oncology drug developers in its headquarters in San Diego.

"Our Kinnate team has worked efficiently to build a robust, homegrown portfolio of best-in-class and first-in-class drug candidates in less than 21 months from our Series A financing close. This Series B financing positions us well to mature our candidates to clinical Proof-of-Concept," said Stephen Kaldor, Ph.D., co-founder and CEO of Kinnate.

"We are excited to expand our team here in San Diego with additional top caliber oncology talent on the strength of this funding. Furthermore, we are pleased to have precision oncology luminary Dr. Keith Flaherty, M.D., Director of Clinical Research at the Massachusetts General Hospital Cancer Center, join our Board of Directors," commented Eric Murphy, Ph.D., co-founder and CSO of Kinnate.

In conjunction with the financing, Carl Gordon, Ph.D., CFA, Managing Partner at OrbiMed, Brett Zbar, M.D., Managing Director at Foresite Capital, and Michael Rome, Ph.D., Partner at Foresite Capital, have also joined the company’s board of directors.

"It has been a pleasure to support Kinnate since its 2018 Series A financing. We’re impressed with the team’s progress since then and are privileged to be joined by such a strong set of new Series B investors with particular depth in oncology," said Jim Tananbaum, M.D., founder and managing director of Foresite Capital.

"For two decades, kinase inhibitors have addressed an increasing number of oncology indications. We are pleased to be working with the experienced team at Kinnate to continue this progress," added Dr. Gordon of OrbiMed.

On December 19, 2019 Metabomed, a leading cancer metabolism company reported that it has completed a financing of $12.5 million bringing the total raised to date to $30 million (Press release, Metabomed, DEC 19, 2019, View Source [SID1234553260]). The company announced that it has declared a clinical candidate for its first‐in‐class program targeting the inhibition of the AcetylCoA Short chain Synthase 2 enzyme (ACSS2) in cancers dependent on acetate metabolism.

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The financing round was led by Yonjin Venture, with the participation of all its existing investors: M Ventures, Pfizer Ventures, Pontifex Venture Fund, Boehringer Ingelheim Venture Fund and Arkin Bio Ventures. The proceeds of the round will be used to move Metabomed’s clinical candidate for its ACSS2 program towards IND approval by the end of 2020 and to strengthen its internal pipeline to further develop lead compounds for MetaboMed’s other programs that modulate targets forming synthetic lethal pairs in cancers characterized by metabolic vulnerabilities such as MTAP deficiency, NRF2 addiction and a defective TCA cycle.

Dr. Simone Botti, CEO and co‐founder of Metabomed remarked: "We are proud to add Yonjin Venture to the list of top tier investors in Metabomed and we are glad for the vote of confidence from our current shareholders. We are excited by the progress across all of our programs, but especially by the opportunity to move forward our first‐ in‐class ACSS2 inhibitors closer to the clinic. We hope to be able to show soon that our approach to targeting synthetic lethal metabolic vulnerabilities in cancer will prove itself in the clinic in pathologies like triple negative breast cancer where the current standard of care does not offer effective therapies to many patients"

Prof. David Aviezer, the company’s Chairman of the Board, added "With this financing round, Metabomed is well positioned to rapidly advance towards clinical trials with its lead compound and to further strengthen its promising pipeline".

"We are delighted to be part of Metabomed, a leader in the cancer metabolism space. We look forward to working with the company and its board of directors", commented Daguang Wang PhD, Managing Director, Yonjin Venture."

On December 19, 2019 Oxford Vacmedix UK Limited (OVM), the UK-based biopharma company focusing on the development of cancer vaccines, reported the award of an Innovate UK grant to fund research that capitalises on OVM’s proprietary recombinant overlapping peptide (ROP) technology (Press release, Oxford Vacmedix, DEC 19, 2019, View Source [SID1234553210]). The research will be carried out in collaboration with Imperial College in London and the Ditan hospital in Beijing, the leading infectious disease hospital in China. The project aims to develop a low-cost diagnostic test to detect bacteria resistant to carbapenem antibiotics. This will have advantages in terms of speed, simplicity and cost over DNA sequencing approaches, and will be accessible for low and middle income countries. These prototype assays will be produced at OVM and Imperial College and will be trialled at the Ditan Hospital. Patients in intensive care are at high risk of bacterial infections, a significant proportion of which are resistant to front-line antibiotics.

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The need to monitor and control resistance to antimicrobial therapy has been identified as an urgent global priority by both the WHO and UN. The rise in carbapenem resistance is of particular concern given the importance of this class of antibiotics in the intensive care setting, and its role as a marker for multiple antibiotic drug resistance. The availability of an inexpensive and simple test for carbapenem resistance will enable early identification of affected patients in the community. Once identified, patients can be isolated, appropriate treatment started earlier and clinical control measures put in place.

Spun out from the University of Oxford, OVM is commercialising the research on ROPs developed in the Department of Oncology at the University of Oxford. The principal application of the technology is in the development of a novel type of therapeutic cancer vaccine with potential for increased efficacy, simpler regulatory pathways and lower costs.

This new diagnostic project will run alongside OVM’s main development programmes and will be largely outsourced, allowing the company to focus on the development of its two lead cancer vaccines; OVM-100, an HPV vaccine targeted at cervical cancer; and OVM-200 a new type of vaccine based on survivin that targets solid tumours. Both vaccines address areas of significant unmet medical need and will be tested as single agents and also in combination with other immune-oncology (IO) agents.

Dr Shisong Jiang, CSO and Founder of OVM, said:

"We are very pleased to have this opportunity to work with Imperial College and with the Ditan hospital in Beijing on this important project. This novel application of our recombinant overlapping peptide technology could show real utility in the diagnosis and management of carbapenem resistance and could make a significant difference to the effectiveness of treatment for infectious disease. We very much appreciate the support and funding from Innovate UK for this project"

Professor Xu Xiao-Ning, Chair of Human Immunology at the Imperial College London added:

"This project is an excellent opportunity to widen the applications of the Oxford Vacmedix’s ROP technology and to build on the expertise in immunology and infectious disease at Imperial College. We look forward to a successful collaboration and to developing early diagnosis of carbapenem resistance, to address this real need and benefit a wide population with sometimes limited access to healthcare".

On December 19, 2019 MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company has submitted a Biologics License Application (BLA) for margetuximab, an investigational, Fc-engineered, monoclonal antibody that targets HER2 (Press release, MacroGenics, DEC 19, 2019, View Source [SID1234553174]). The margetuximab BLA is for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy. The submission is based on the safety and efficacy results of the pivotal phase 3 SOPHIA study, which were first presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, with updated data recently presented at the 2019 San Antonio Breast Cancer Symposium.

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"As the Company’s first BLA submission, this is a key milestone for MacroGenics. We are grateful to the patients who participated in this study, as well as their families, and all involved in developing margetuximab," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "With this submission, we look forward to working with the Agency to bring margetuximab to appropriate patients. We believe the positive clinical trial results in SOPHIA demonstrate margetuximab’s potential as a treatment option for patients living with this devastating disease."

About the SOPHIA Study

The SOPHIA study (NCT02492711) is a randomized, open-label Phase 3 clinical trial evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer, who have previously been treated with anti-HER2-targeted therapies. All study patients had previously received trastuzumab and pertuzumab, and approximately 90% had previously received ado-trastuzumab emtansine, or T-DM1.

The study enrolled 536 patients who were randomized 1:1 to receive either margetuximab (n=266) given intravenously at 15 mg/kg every three weeks or trastuzumab (n=270) given intravenously at 6 mg/kg (or 8 mg/kg for loading dose) every three weeks in combination with one of four chemotherapy agents (capecitabine, eribulin, gemcitabine or vinorelbine) given at the standard dose. Intent-to-treat PFS analysis occurred after 265 PFS events, and the first and second interim OS analyses occurred after 158 and 270 OS events, respectively. Final OS analysis is planned after 385 events and is expected to occur in the second half of 2020.

Primary endpoints are sequentially-assessed PFS, determined by centrally-blinded radiological review, and OS. Key secondary endpoints are PFS by investigator assessment and ORR. Tertiary endpoints include ORR by investigator assessment and safety. PFS and ORR were assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Effect of CD16A (FcγRIIIa) 158 genotype on margetuximab activity is a pre-specified exploratory endpoint.

About Margetuximab

Margetuximab is an investigational monoclonal antibody that targets the HER2 oncoprotein. Margetuximab was designed to provide HER2 blockade and has similar HER2 binding and antiproliferative effects as trastuzumab. In addition, the Fc region of margetuximab has been engineered to enhance the engagement of the immune system. Margetuximab is also being evaluated in combination with anti-PD-1 therapy for the potential treatment of patients with HER2-positive gastric or gastroesophageal junction cancer. MacroGenics has initiated the Phase 2/3 MAHOGANY study (NCT04082364). For more information, please visit www.clinicaltrials.gov.