On October 20, 2020 Replimune Group, Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported a proposed public offering of $125 million of shares of its common stock (Press release, Replimune, OCT 20, 2020, View Source [SID1234568687]). All shares of common stock in the offering will be offered by Replimune. In addition, Replimune intends to grant the underwriters a 30-day option to purchase up to an additional $18.75 million of shares of its common stock from Replimune at the public offering price, less the underwriting discounts and commissions.

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J.P. Morgan Securities LLC and SVB Leerink LLC are acting as joint book-running managers for the proposed offering. The proposed offering is subject to market and other customary closing conditions, and Replimune cannot assure you as to whether or when the proposed offering may be completed.

The proposed offering will be made only by means of a preliminary prospectus supplement and the accompanying prospectus. A copy of the preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering will be filed with the Securities and Exchange Commission (the "SEC") and may be obtained, when available, by visiting EDGAR on the SEC website at www.sec.gov or from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by e-mail at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by e-mail at [email protected]. The final terms of the proposed offering will be disclosed in a final prospectus supplement to be filed with the SEC.

The shares of common stock described above are being offered by Replimune pursuant to its shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Replimune with the SEC on August 11, 2020 and declared effective by the SEC on August 26, 2020. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of securities, in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On October 20, 2020 Replimune Group, Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that it is filing a Current Report on Form 8-K with the Securities and Exchange Commission (SEC), in which it will furnish an updated corporate presentation (Press release, Replimune, OCT 20, 2020, View Source [SID1234568686]). The presentation can be found in the "Investors and Media" section of Replimune’s corporate website under the "Events and Presentations" section (Link to Presentation).

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The presentation includes information relating to the abstracts that are to be presented at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, including updated clinical trial data from the related trials, and other updated information about Replimune. The data from these abstracts appeared briefly and in error on the SITC (Free SITC Whitepaper) website on October 14, 2020, prior to their intended release on November 9, 2020. As a result, the full abstracts were released by Replimune on that date, and are being followed up with data in Replimune’s updated corporate presentation today.

On October 20, 2020 ("Targovax" or the "Company"), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, on 14 October 2020, reported a successfully completed private placement of 10,344,828 new shares in the Company (the "Private Placement") and the potential subsequent offering of up to 1,500,000 new shares at the same subscription price as in the Private Placement of NOK 7.25 per share (the "Subsequent Offering") (Press release, Targovax, OCT 20, 2020, View Source [SID1234568685]).

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The Subsequent Offering has been conditional upon the trading price of the Company’s shares being higher than the subscription price in the Private Placement in a period determined by the board of directors in its sole discretion. In the period since the announcement of the completion of the Private Placement, a number of shares in the Company exceeding the number of shares to be offered in the Subsequent Offering have traded at prices equal to or below the subscription price of NOK 7.25. On that basis, the board of directors has resolved to not proceed with the Subsequent Offering.

On October 20, 2020 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, reported that new data and analyses related to its ongoing Phase 2 trial of onvansertib in metastatic castration-resistant prostate cancer (mCRPC) patients were featured in an electronic poster at the 27th Annual Prostate Cancer Foundation (PCF) Scientific Retreat (Press release, Cardiff Oncology, OCT 20, 2020, View Source [SID1234568684]). The poster includes efficacy data demonstrating success in achieving the primary endpoint of disease control in patients showing initial resistance to Zytiga (abiraterone); safety across three different dose and dosing schedules, as well as the potential clinical benefit for patients with the basal molecular tumor subtype.

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"There is a pressing unmet need for therapies that can address resistance to abiraterone and other androgen receptor signaling inhibitors (ARSi), in mCRPC," said David Einstein, M.D., attending physician at Beth Israel Deaconess Medical Center and principal investigator of the onvansertib Phase 2 trial. "Data presented at the PCF retreat demonstrate the potential of onvansertib to address this need, as we are seeing clinically meaningful rates of disease control, some quite durable, in patients with known mechanisms of ARSi resistance."

Mike Yaffe, M.D., Ph.D., David H. Koch Professor of Science and Professor of Biology and Biological Engineering at MIT, added, "We continue to be excited about the collaboration with Cardiff Oncology and the work we have been conducting to unlock the mechanism of synergy between PLK1 inhibition and abiraterone, which we have previously shown to be independent of AR signaling. We have now identified a specific set of genes related to cell division pathways that can be used to predict which cancer cells will specifically show a synergistic anti-tumor response to treatment with abiraterone in combination with a PLK1 inhibitor. Intriguingly, this set of genes is most correlated with the known molecular basal subtype which suggests that prostate cancer patients with this specific tumor subtype may be more likely to respond to onvansertib-abiraterone combination therapy."

"We are very pleased with the progress and results of the trial to date," said Mark Erlander, Ph.D., chief executive officer of Cardiff Oncology. "In particular, we are encouraged by the identification of a biomarker that could readily select for abiraterone-resistant patients who are most likely to benefit from the addition of onvansertib to their regimen."

Highlights of the PCF Poster Presentation:

Efficacy:
•8 of 26 (31%) evaluable patients achieved the primary endpoint of disease control (defined by a lack of prostate specific antigen progression) after 12 weeks of treatment
•14 of 26 (54%) evaluable patients had stable disease (SD) after 12 weeks of treatment
•8 of 26 (31%) evaluable patients had durable SD (>7 months)
•Of 8 patients harboring AR alterations associated with Zytiga resistance, 3 achieved disease control at 12 weeks, 4 had SD at 12 weeks and 3 had durable SD (>7 months)
Biomarker Analyses:
•Identification of a gene signature (biomarker) associated with onvansertib and abiraterone synergy in prostate cancer cells that is significantly enriched in the basal molecular subtype of prostate cancer patients
Safety:
•The trial’s safety lead-in is complete across Arm A (24 mg/m2 onvansertib), Arm B (18 mg/m2 onvansertib) and Arm C (12 mg/m2 onvansertib)
•Data show that the combination of onvansertib and abiraterone (Zytiga) is safe across three different dosing schedules

The poster presented as part of the 27th Annual PCF Scientific Retreat is available on the "Scientific Presentations" section of the Cardiff Oncology website at View Source

About the Phase 2 Trial of Onvansertib in Metastatic Castration-Resistant Prostate Cancer
This trial is a Phase 2 open-label study of onvansertib in combination with Zytiga (abiraterone) and prednisone, all administered orally, in patients with metastatic castration-resistant prostate cancer showing signs of early progressive disease (demonstrated by two rising prostate-specific antigen values separated by at least one week with no or minimal symptoms) while on Zytiga/prednisone therapy. The primary efficacy endpoint is the proportion of patients achieving disease control after 12 weeks of study treatment, as defined by a lack of prostate specific antigen (PSA), radiographic, or symptomatic progression. The trial is being conducted by Beth Israel Deaconess Medical Center (BIDMC), Dana-Farber Cancer Institute (Dana-Farber), and Massachusetts General Hospital Cancer Center (MGH). David Einstein, MD, Genitourinary Oncology Program at BIDMC, is the principal investigator for the trial. For more information on the trial, please visit View Source

On October 20, 2020 Blue Earth Diagnostics, a Bracco company focused on molecular imaging diagnostics, reported upcoming presentations at the 2020 American Society for Radiation Oncology (ASTRO) Annual Meeting, from October 23 – 28, 2020, to be held in a virtual format (Press release, Blue Earth Diagnostics, OCT 20, 2020, View Source [SID1234568683]).

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Presentations encompass the clinical use of Axumin (fluciclovine F 18) injection positron emission tomography (PET) in recurrent prostate cancer, including a Late-Breaking Abstract Plenary Session presentation by Emory University. Information about an independent investigational study of 18F-fluciclovine PET in brain metastases will also be presented at the meeting. Details of selected oral and poster presentations by Blue Earth Diagnostics collaborators are listed below.

NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Presentations noted by "*" discuss results of investigational studies of an approved product that is not approved by the FDA for the specific use or purpose noted.

HIGHLIGHTED SCIENTIFIC PRESENTATIONS

Monday, October 26, 2020

Axumin (fluciclovine F 18) presentations

Title: LBA 1 Initial Report of a Randomized Trial Comparing Conventional- vs Conventional plus Fluciclovine (18F) PET/CT Imaging-Guided Post-Prostatectomy Radiotherapy for Prostate Cancer

Session Title: PL 01 – Plenary Session

Presenter: Ashesh Jani, MD, FASTRO, Emory University, Atlanta, Ga.

Presentation Time: 1:35 ‒ 1:45 PM ET

Presentation No.: LBA 1

Investigational 18F-fluciclovine presentation

Poster Title: 18F-Fluciclovine PET/CT to Distinguish Radiation Necrosis from Tumor Progression in Brain Metastases Treated with Stereotactic Radiosurgery*

Session Title: PV 05 – Poster Q&A – Session 5

Presenter: Martin C. Tom, MD, Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio

Presentation Time: 4:30 PM ET

Presentation No.: 3587

Wednesday, October 28, 2020

Axumin (fluciclovine F 18) presentations

Poster Title: Advanced Imaging Including the 18-F Fluciclovine PET-CT Is Instrumental In the Salvage Management of Prostate Cancer

Session Title: PV 07 – Poster Q&A – Session 7

Presenter: Max Chiu, MD, Department of Radiation Oncology, University of Nebraska Medical Center, Omaha, Neb.

Presentation Time: 2:00 PM ET

Presentation No.: 4136

Poster Title: The Use of 18F-fluciclovine PET/CT in Prostate Cancer Diagnosis and Therapeutic Decision Making

Session Title: PV 07 – Poster Q&A – Session 7

Presenter: Alexandra Dreyfuss, MD, MS, Department of Radiation Oncology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pa.,

Presentation Time: 2:00 PM ET

Presentation No.: 4056

Blue Earth Diagnostics invites participants at the 2020 ASTRO Annual Meeting to attend the presentations above and to visit Blue Earth Diagnostics’ Commercial Product Showcase for Axumin (fluciclovine F 18) Injection in the Virtual Exhibit Hall. The company also has a Medical Affairs information booth at ASTRO, where attendees can learn about ongoing clinical trials. For full session details and scientific presentation listings, please see the ASTRO2020 online program (View Source).

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.

Full Axumin prescribing information is available at www.axumin.com.

About Axumin (fluciclovine F 18)

Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following prior treatment. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues and is labeled with the radioisotope F 18 for PET imaging. Fluciclovine F 18 was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Axumin was approved by the U.S. Food and Drug Administration in May 2016, following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications including in neuro-oncology.