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Compugen Announces Closing of $75 Million Public Offering of Ordinary Shares

On March 17, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported the closing of its previously announced underwritten public offering of 8,333,334 ordinary shares at a price to the public of $9.00 per share (Press release, Compugen, MAR 17, 2020, View Source [SID1234555640]). The gross proceeds to Compugen from the offering were approximately $75 million, before deducting underwriting discounts and commissions and other offering expenses payable by Compugen. In addition, Compugen has granted the underwriters a 30-day option to purchase up to an additional 1,250,000 ordinary shares, at the public offering price less underwriting discounts and commissions, which has not yet been exercised. The offering closed on March 16, 2020.

SVB Leerink and Stifel acted as joint bookrunning managers for the offering. SunTrust Robinson Humphrey acted as lead manager for the offering and Oppenheimer & Co. acted as co-manager for the offering.

The securities described above were offered by Compugen pursuant to a shelf registration statement on Form F-3, including a base prospectus, that was previously filed by Compugen with the Securities and Exchange Commission (the "SEC") and that was declared effective on August 12, 2019. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available for free on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at +1(800) 808-7525, ext. 6218, or by email at [email protected], or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at +1(415) 364-2720 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 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.

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Circle Pharma raises $45 Million in Series B Financing

On March 17, 2020 Circle Pharma, Inc., a macrocycle drug discovery and development company focused on intractable cancer targets, reported that it has raised $45 million in a Series B financing (Press release, Circle Pharma, MAR 17, 2020, View Source [SID1234555639]).

The financing was led by The Column Group, with participation by Nextech Invest. All investors from the prior round – ShangPharma, LifeForce Capital, and the Berkeley Catalyst Fund – joined the financing.

In conjunction with the financing, Peter Svennilson, founder and managing partner of The Column Group, and Thilo Schroeder, Ph.D., partner at Nextech Invest were appointed to the board. John Josey, Ph.D., formerly President and CEO of Peloton Therapeutics, was appointed to the board as Chairman.

Proceeds from the investment will be used to advance Circle’s work to develop inhibitors of Cyclin A and Cyclin E, and to expand the company’s pipeline.

"We are delighted to have these premier life science investors supporting our Series B financing" said David J. Earp, J.D., Ph.D., Circle’s President and CEO. "With this strong backing, we will expand our team, drive our cyclin targeted programs towards the clinic, and apply our macrocycle platform to additional intractable targets."

Circle’s new board appointments:

Peter Svennilson is the founder and managing partner of The Column Group. He was the chairman of Aragon Pharmaceuticals (acquired by Johnson & Johnson) and Seragon Pharmaceuticals (acquired by Roche / Genentech) and was a board director of Gritstone Oncology, NGM Biopharmaceuticals, Immune Design and Constellation Pharmaceuticals. He is currently a board director of ORIC Pharmaceuticals, Ribon Therapeutics and Carmot Therapeutics.

Thilo Schroeder, Ph.D., is a partner at Nextech Invest, a Zurich-based oncology-focused investment firm. He previously served on the board of Peloton Therapeutics (acquired by Merck) and Blueprint Medicines. He is currently a board director at IDEAYA Biosciences, Revolution Medicines, PMV Pharma, Silverback Therapeutics and a board observer at Black Diamond Therapeutics.

John Josey, Ph.D., served as the President, Chief Executive Officer, and member of the Board of Directors at Peloton Therapeutics from 2013 until its acquisition by Merck in 2019. From 2011 to 2013, he was President and Chief Scientific Officer at Peloton, and from 1998 to 2011, Vice President of Discovery Chemistry at Array Pharma.

The continuing members of Circle’s board of directors are Walter H. Moos, Ph.D., CEO of ShangPharma Innovation and Managing Director of Pandect Bioventures, Matthew P. Jacobson, Ph.D., Circle Pharma co-founder, chair of the department of pharmaceutical chemistry at U.C. San Francisco and also co-founder of Global Blood Therapeutics, Relay Therapeutics and Cedilla Therapeutics, and David J. Earp, J.D., Ph.D., President and Chief Executive Officer of Circle Pharma.

Blue Earth Diagnostics Announces Dosing of First Patient in Phase 3 LIGHTHOUSE Clinical Trial of Targeted PET Imaging Agent rhPSMA-7.3 (18F) in Newly Diagnosed Prostate Cancer

On March 17, 2020 Blue Earth Diagnostics, a Bracco company focused on molecular imaging diagnostics, reported that the first patient has been dosed in its Phase 3 LIGHTHOUSE clinical trial of rhPSMA-7.3 (18F), an investigational Prostate Specific Membrane Antigen-targeted radiohybrid PET imaging agent (Press release, Blue Earth Diagnostics, MAR 17, 2020, View Source [SID1234555638]). The LIGHTHOUSE study is a Phase 3, multi-center, single-arm imaging study being conducted in the United States and Europe to evaluate the safety and diagnostic performance of rhPSMA-7.3 (18F) PET imaging in men with newly diagnosed prostate cancer (NCT04186819). The primary objectives of the LIGHTHOUSE study are to assess the sensitivity and specificity of rhPSMA-7.3 (18F) PET for detecting pelvic lymph node metastases compared to surgical pathology on a patient level. The first patient in the LIGHTHOUSE study was dosed in Los Angeles, Calif. at RadNet’s Liberty Pacific Advanced Imaging Center in conjunction with Tower Urology.

"We are excited to initiate this Phase 3 imaging trial of rhPSMA-7.3 (18F), with the hope that it may help address the needs of men with newly diagnosed prostate cancer," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. "LIGHTHOUSE is part of our strategy to expand and advance a world-leading prostate cancer imaging portfolio, alongside our planned Phase 3 clinical trial investigating the use of rhPSMA-7.3 (18F) PET imaging in patients with an elevated Prostate-Specific Antigen (PSA) level after prior therapy. rhPSMA-7.3 (18F) and approved, commercially available Axumin (fluciclovine F 18) have unique and complementary mechanisms of action, and we believe both compounds may ultimately allow physicians and their patients flexibility in selecting the diagnostic agent most appropriate to each specific clinical situation."

"Effective staging of primary prostate cancer − determining its presence and whether it may have metastasized − is critical in assessing a patient’s prognosis and informing individual clinical management strategies," said Gerald L. Andriole, MD, the Robert K. Royce Distinguished Professor and Chief of Urologic Surgery at Washington University School of Medicine. "Up to 25% of prostate cancer patients may have detectable lymph node metastases, which are correlated with a risk for recurrence and associated overall survival. Conventional imaging techniques, such as MRI and CT, are limited in the information they may provide, particularly in high-risk primary prostate cancer, due to low sensitivity and specificity. Pelvic lymph node dissection (PLND), or pelvic lymphadenectomy, is considered the gold standard in assessing pelvic lesions, but its use is limited to the planned surgical area. An ideal staging technique for detecting metastatic disease should not only include the pelvic nodes but also more distant soft tissue and skeletal findings and be both sensitive and specific for identifying prostate cancer metastases. A number of investigational studies have reported promising diagnostic performance using PSMA-targeted PET agents, but none are approved and clinical use is limited to compassionate use and research protocols. The Phase 3 LIGHTHOUSE clinical study is designed to investigate the diagnostic performance of rhPSMA-7.3 (18F) PET imaging as a potential decision-making aid in assessing newly diagnosed disease."

"Prostate cancer is a leading cause of male cancer-related death worldwide, and we anticipate that eventually a large proportion of patients with prostate cancer may be eligible to undergo PSMA PET imaging to help stage their disease and inform subsequent treatment choices," said David Gauden, D.Phil., Chief Scientific Officer of Blue Earth Diagnostics. "Blue Earth Diagnostics acquired an exclusive license to a broad family of theranostic rhPSMA agents in 2018, which includes an exclusive option for therapeutic applications. Since that time, we have worked closely with the Technical University of Munich (TUM) and Scintomics to identify a lead imaging candidate for further development. We selected rhPSMA-7.3 (18F), a single isomer of rhPSMA-7 (18F), as the candidate for our Phase 3 imaging studies. In anticipation of imaging performance, production capacity and quality needs, we selected F18 as the radiolabeling isotope of choice for rhPSMA-7.3 PET imaging. The 110-minute half-life and energy of the F18 radioisotope enable high resolution PET scans; large batch production; consistent, centralized manufacturing; and efficient distribution and broad geographic availability independent of select individual hospitals – all of which are important considerations in facilitating broad availability of this cutting edge technology for prostate cancer patients."

"Results from the early clinical experience by TUM, including with rhPSMA-7.3 (18F) PET, in more than 1,000 prostate cancer patients were included in the Investigational New Drug (IND) submission for the LIGHTHOUSE trial," said Peter Gardiner, MB ChB, MRCP, FFPM, Chief Medical Officer of Blue Earth Diagnostics. "Some of that experience has recently been published online in the Journal of Nuclear Medicine. Retrospective analyses assessed the diagnostic performance, biodistribution and safety of rhPSMA-7 (18F) in primary prostate cancer and in biochemical recurrence after both radical prostatectomy and radiation therapy. Blue Earth Diagnostics is also conducting a Phase 1 clinical study in Finland to assess the safety, biodistribution and dosimetry of rhPSMA-7.3 (18F) in healthy volunteers and patients with prostate cancer."

About the LIGHTHOUSE Phase 3 Clinical Trial for rhPSMA-7.3 (18F)

The LIGHTHOUSE Phase 3 clinical trial is a prospective, Phase 3, multi-center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA-7.3 (18F) Positron Emission Tomography (PET) in men with newly diagnosed prostate cancer. The study will enroll approximately 375 evaluable patients at clinical sites in the United States and Europe. The primary endpoints of the LIGHTHOUSE study are to assess the sensitivity and specificity of rhPSMA-7.3 (18F) PET for detecting pelvic lymph node metastases compared to surgical pathology on a patient level. Secondary endpoints will assess the safety of rhPSMA-7.3 (18F) in patients and determine inter- and intra-reader agreement of rhPSMA-7.3 (18F) scan interpretations by blinded independent readers. Additional information about the Phase 3 LIGHTHOUSE trial is available at www.clinicaltrials.gov (NC04186819).

About rhPSMA

rhPSMA-7.3 (18F) consists of a radiohybrid Prostate-Specific Membrane Antigen (PSMA)-targeted receptor ligand which attaches to and is internalized by prostate cancer cells, and is labeled with the 18F radioisotope for PET imaging. rhPSMA compounds can also be labeled with radioisotopes such as 177Lu and 225Ac for therapeutic use. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA imaging technology from Scintomics in 2018, with an option to therapeutic rights. rhPSMA originated from the Technical University of Munich, Germany, and has been utilized clinically under German legislation at the Department of Nuclear Medicine there for the diagnostic imaging of men with both primary and recurrent prostate cancer. rhPSMA compounds have not received regulatory approval.

NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

This press release is intended to provide information about Blue Earth Diagnostics’ business in the United States and Europe. Please be aware that the approval status and product label for Axumin varies by country worldwide. For EU Axumin product information refer to: View Source;mid=WC0b01ac058001d124.

U.S. INDICATION AND IMPORTANT SAFETY INFORMATION ABOUT AXUMIN
INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Surface Oncology Announces First Patient Dosed in Clinical Trial of Immuno-Oncology Candidate SRF617

On March 17, 2020 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that it has initiated a Phase 1/1b clinical trial of its antibody candidate SRF617, which targets the immunosuppressive protein CD39 (Press release, Surface Oncology, MAR 17, 2020, View Source [SID1234555634]).

"Our comprehensive preclinical data indicate SRF617 is a potent inhibitor of CD39, which may play an important role in tumor growth and spread via the immunosuppressive ‘adenosine axis’," said Robert Ross, M.D., chief medical officer of Surface Oncology. "This study is designed to provide rapid evaluation of SRF617 via multiple arms, including as a monotherapy and in combination with both chemotherapy and other immuno-oncology agents. We believe CD39 presents an important opportunity to develop next-generation treatments for cancer, and we look forward to evaluating our hypotheses in the clinic."

The Phase 1/1b dose escalation study will initially enroll patients with advanced solid tumors, then focus on three combination arms, either with gemcitabine and abraxane, with anti-PD-1, or with AB928, an A2A/A2B small molecule inhibitor (in clinical collaboration with Arcus Biosciences (NYSE: RCUS)). Further planned cohorts will focus on several tumors of high unmet need, including pancreatic cancer, gastric cancer and tumors that have demonstrated resistance to anti-PD-1 therapy. A biopsy expansion cohort has been designed to provide data on changes in tumor tissue CD39 enzymatic activity related to SRF617 treatment. Surface expects to provide an initial clinical update from the dose escalation portion of the study by the end of 2020.

About SRF617
SRF617 is a fully human antibody designed to inhibit the enzymatic activity of CD39, allowing for a dual mechanism of action to promote anti-tumor immunity via reduction of immunosuppressive adenosine in addition to increasing levels of immunostimulatory ATP. In preclinical studies, SRF617 has exhibited strong affinity for and inhibition of CD39, the ability to reduce adenosine and increase ATP levels, and anti-tumor activity both as a single agent and in combination with multiple therapeutic agents.

Kitov Closes $6.0 Million Public Offering

On March 17, 2020 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported the closing of its previously announced public offering of 20,000,000 units at a price to the public of $0.30 per unit, for gross proceeds of $6.0 million, before deducting placement agent fees and other offering expenses payable by Kitov (Press release, Kitov Pharmaceuticals , MAR 17, 2020, View Source [SID1234555633]). Each unit contains one American Depositary Shares ("ADS") (or ADS equivalent) and one warrant to purchase one ADS. Each ADS represents one ordinary share, no par value, of Kitov. The ADSs (or ADS equivalents) and warrants included in the units were purchased together in the offering, but were issued separately and are immediately separable. The warrants have an exercise price of $0.325 per ADS and will be exercisable at any time after the date of issuance and will expire five years from the date of issuance.

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

Kitov intends to use the net proceeds of this offering to fund the development of its oncology drug candidates, acquisition of new assets and for general working capital purposes.

The offering was made under an effective registration statement on Form F-1 (File No. 333-235729) filed with the Securities and Exchange Commission (the "SEC") and declared effective on March 11, 2020. The offering was made only by means of a prospectus forming part of the effective registration statement. The final terms of the offering are disclosed in a final prospectus filed with the SEC and made available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus relating to the offering may also be obtained by contacting H.C. Wainwright & Co., 430 Park Avenue, New York, NY 10022, by telephone at (646) 975-6996 or by email at [email protected].