On February 8, 2021 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported that the first patient has been successfully enrolled and dosed in the randomized, open-label, phase III, multicenter clinical study (NCT04720716) evaluating its IBI310 (anti CTLA-4 monoclonal antibody) in combination with TYVYT (sintilimab injection) for the first-line treatment of patient with advanced hepatocellular carcinoma (HCC) (Press release, Innovent Biologics, FEB 8, 2021, View Source [SID1234574757]).

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In recent years, immune checkpoint inhibitors have brought new hope to HCC patient population with acceptable safety and encouraging efficacy. NCT04720716 is a randomized, open-label, controlled, multicenter phase III study evaluating the efficacy and safety of IBI310 in combination with TYVYT (sintilimab injection) for advanced HCC patients. Primary endpoints include overall survival and objective response rate. The study was led by Professor Fan Jia from Zhongshan Hospital of Fudan University, and Professor Qin Shukui from Affiliated Jinling Hospital, Medical School of Nanjing University. This study involves more than 50 clinical centers.

Dr. Hui Zhou, Vice President and Head of Medical Sciences and Oncology Strategy of Innovent, stated: "CTLA-4 is an important immunosuppressive receptor. IBI310 in combination with TYVYT (sintilimab injection) has shown promising preliminary good safety and anti-tumor activity, suggesting the potential anti-tumor value for this combination. We will evaluate the efficacy of IBI310 combined with TYVYT (sintilimab injection) in this study and we hope to provide more effective treatment to benefit patients and their families."

About IBI310

IBI310 is a recombinant fully-human monoclonal antibody against cytotoxic T lymphocytic associated antigen 4 (CTLA-4). IBI310 can interfere with the binding of CTLA-4 and CD80/CD86 on antigen presenting cells, thereby blocking the inhibitory effect on T cell activation. IBI310 can promote the activation and amplification of T cells, and enhance the anti-tumor ability of the immune system.

CTLA-4 provides a new approach for immunotherapy in many diseases, including tumors. Innovent has announced the preliminary results of the Phase 1 clinical study about anti-CTLA-4 monoclonal antibody (NCT03545971) at the 56th Annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Online Publication, Abstract No. 302489). Phase II/III clinical studies of IBI310 combined with TYVYT (sintilimab injection) for multiple tumors are ongoing.

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection) is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. In December 2018, TYVYT (sintilimab injection) was first approved by the China NMPA for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy. In February 2021, TYVYT (sintilimab injection) was approved by the China NMPA in combination with pemetrexed and platinum chemotherapy as first-line therapy for the treatment of nonsquamous non-small cell lung cancer. TYVYT (sintilimab injection) was included in the National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year.

Currently TYVYT (sintilimab injection) has three supplemental New Drug Applications ("sNDA") under review by the NMPA. In August 2020, the NMPA accepted sNDA for TYVYT (sintilimab injection) in combination with GEMZAR (gemcitabine for injection) and platinum chemotherapy as first-line therapy in squamous NSCLC. In January 2021, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab injection) as first-line therapy in Hepatocellular Carcinoma (HCC) and the sNDA for TYVYT (sintilimab injection) as second-line therapy in squamous NSCLC. Besides, in May 2020, TYVYT (sintilimab injection) monotherapy met the primary endpoint of overall survival in the Phase 2 ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma.

TYVYT (sintilimab injection), is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, block the PD-1 / PD-Ligand 1 (PD-L1) pathway and reactivate T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical studies. Meanwhile, Innovent is conducting clinical research studies on TYVYT (sintilimab injection) worldwide.

On February 8, 2021, Iovance Biotherapeutics, Inc. (the "Company") reported that it entered into an Open Market Sale Agreement (the "Sales Agreement") with Jefferies LLC ("Jefferies") with respect to an "at the market" offering program, under which the Company may, from time to time in its sole discretion, issue and sell through Jefferies, acting as sales agent, up to $350.0 million of shares of the Company’s common stock, par value $0.000041666 per share (the "Common Shares") (Filing, 8-K, Iovance Biotherapeutics, FEB 8, 2021, View Source [SID1234574796]). The issuance and sale, if any, of the Common Shares by the Company under the Sales Agreement will be made pursuant to a prospectus supplement, dated February 8, 2020, to the Company’s registration statement on Form S-3ASR, originally filed with the Securities and Exchange Commission on May 27, 2020, which became effective immediately upon filing.

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Pursuant to the Sales Agreement, Jefferies may sell the Common Shares by any method permitted by law deemed to be an "at the market" offering as defined in Rule 415 of the Securities Act of 1933, as amended (the "Securities Act"). Jefferies will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the Common Shares from time to time, based upon instructions from the Company (including any price or size limits or other customary parameters or conditions the Company may impose).

The Company will pay Jefferies a commission of up to 3.0% of the gross sales proceeds of any Common Shares sold through Jefferies under the Sales Agreement.

The Company is not obligated to make any sales of Common Shares under the Sales Agreement. The offering of Common Shares pursuant to the Sales Agreement will terminate upon the earlier to occur of (i) the issuance and sale, through Jefferies, of all Common Shares subject to the Sales Agreement and (ii) termination of the Sales Agreement in accordance with its terms.

The Sales Agreement contains representations, warranties and covenants that are customary for transactions of this type. In addition, the Company has agreed to indemnify Jefferies against certain liabilities, including liabilities under the Securities Act and the Securities Exchange Act of 1934, as amended.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The legal opinion of DLA Piper LLP (US) as to the legality of the Common Shares is being filed as Exhibit 5.1 to this Current Report on Form 8-K.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation or sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On February, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported presentations on Axumin (fluciclovine F 18) at the upcoming ASCO (Free ASCO Whitepaper) 2021 Genitourinary Cancers Symposium (ASCO GU), from February 11 to 13, 2021, to be held in a virtual format (Press release, Blue Earth Diagnostics, FEB 8, 2021, View Source [SID1234574724]). Details of selected oral poster presentations are listed below.

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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. Axumin is a registered trademark of Blue Earth Diagnostics, Ltd., or its related companies. All other marks are the property of their respective owners.

Highlighted Axumin (Fluciclovine F 18) Scientific Presentations

All ASCO (Free ASCO Whitepaper) GU presentations are available beginning Thursday, February 11, 2021, at 8 a.m. ET.

Track: Prostate Cancer – Advanced

Title: Diagnostic utility of (18)f-fluciclovine positron emission tomography (FACBC) in biochemically recurrent (BCR) prostate cancer (PCa) based on prior primary treatment modality for localized disease and the impact of FACBC findings on treatment selection.

Author(s) Marina N. Sharifi, Petra Lovrec, Jens C. Eickhoff, Aria Kenarsary, David F. Jarrard, John Floberg, Steve Y. Cho, Christos Kyriakopoulos, Hamid Emamekhoo

Session: Poster session

Abstract: 34

Track: Prostate Cancer – Advanced

Title: Use of 18F-fluciclovine PET/CT (FluPET) for prostate cancer (PC): Initial results from a prospective registry at a tertiary academic center.

Author(s): Risa L. Wong, Heather H. Cheng, Sarah K. Holt, Nathan Conrad, Hannah Loesch, Sara Fernandez, Rameen Sahoo, Zoya Bauer, Andrea Toulouse, Petros Grivas, Todd Yezefski, Kenneth J. Russell, Jonathan L. Wright, Michael T. Schweizer, Robert B. Montgomery, Jean H. Lee, Delphine L. Chen, Jing Zeng, Daniel W. Lin, Evan Y. Yu

Session: Poster session

Abstract: 29

Track: Trials in Progress – Advanced Prostate Cancer

Title: 18F-fluciclovine positron emission tomography (PET) in metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone acetate.

Author(s): Pedro C. Barata, Charlotte Manogue, Ellen Jaeger, Malcolm Light, Patrick Cotogno, Elisa M. Ledet, Janeiro Goffin, Jodi L. Layton, Brian E. Lewis, A. O. Sartor

Session: Poster session

Abstract: TPS171

Blue Earth Diagnostics invites participants at the ASCO (Free ASCO Whitepaper) 2021 Genitourinary Cancers Symposium (ASCO GU) to attend the presentations above and to visit Blue Earth Diagnostics’ commercial exhibit in the Virtual Exhibit hall. For full session details and scientific presentation listings, please see the ASCO (Free ASCO Whitepaper) GU online program here.

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.

On February 8, 2021 Seneca Therapeutics, Inc. ("STI"), a clinical-stage biopharmaceutical company dedicated to the development of targeted oncolytic immunotherapeutics based on Seneca Valley Virus (SVV-001), reported the expansion of its R&D pipeline with six new armed gene therapy/oncolytic constructs directed against important cancer targets and indications (Press release, Seneca Therapeutics, FEB 8, 2021, View Source [SID1234574741]). STI also announced an SVV-001 Armed Construct program developing precision medicine constructs expressing patient-specific Neo-antigens. Each of these new gene therapy technologies uses SVV to exclusively target cancer cells with TEM 8 expression. Normal cells lack significant expression of TEM 8 and are therefore not infected by SVV-001, and so the armed transgene will not express in normal cells. Studies in multiple human tumor types indicates TEM 8 expression is an adverse indicator of long-term survival and is associated with cancer metastasis. STI intends to develop each combination as an IV product, taking advantage of the multiple IV dosing program currently underway at the company:

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SVV-012- SVV+ Anti PD-L1 – "Addition of a checkpoint inhibitor is designed to enhance the CD8+ T-cell response against tumors"
SVV-024 – SVV+ Enhanced IL-2 Gene – "This construct is designed to bind IL-2 receptors to activate the immune response in tumors without activating CD25 and thereby avoid toxicities observed with the IL-2 protein"
SVV-037 – SVV+ CXCL-9 – "This construct is designed to express the chemokine CXCL-9 in the tumor microenvironment and promote recruitment of immune cells into treated tumors"
SVV-044 – SVV+ TGF-beta decoy – "This construct is designed to block TGF-beta signaling in tumors and avoid immunosuppression"
SVV- 058 SVV+ Nitroreductase – "This nitroreductase construct is designed to function as a prodrug and convert cytotoxic metabolites selectively in the tumor microenvironment"
SVV- 069 – SVV+ IL-2/IL-15 Fusion Protein – "Vectors delivering IL-2/IL-15 agonists are designed to improve immune cell trafficking and infiltration into tumors and provide both T-cell and NK-cell signals"
Each of these products either has been or is being produced in STI’s SVV platform. Animal studies for each product are anticipated to begin in 2Q21.

The SVV-001 Armed Construct for Neo-antigens program plans to use patient specific neo-antigens to take advantage of the rapid two-week development cycle for SVV-001 Armed Constructs.

"SVV itself has many distinct advantages over other forms of cancer therapy. Chief among these is the exquisite cancer cell specificity of both SVV replication and the expression of a transgene. Together, these make SVV a unique and powerful multi-modal platform," said Dr. Paul Hallenbeck, Ph.D. Founder and President of STI.

On February 8, 2021 Scopus BioPharma Inc. (Nasdaq: SCPS) reported that the underwriters of the company’s follow-on public offering exercised their over-allotment option in full, bringing total proceeds to $10.35 million (Press release, Scopus BioPharma, FEB 8, 2021, View Source [SID1234574758]).

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The exercise of the over-allotment option is expected to close on or about February 10, 2021, subject to customary closing conditions.

Scopus is a biopharmaceutical company developing transformational therapeutics based on groundbreaking scientific and medical discoveries. The company’s lead drug candidate is a novel, targeted immuno-oncology gene therapy for the treatment of multiple cancers.

Scopus intends to use the total proceeds of the follow-on public offering, including the proceeds from the exercise of the over-allotment option, principally for further development of the company’s lead drug candidate, including in combination with checkpoint inhibitors.

The Benchmark Company, LLC acted as Sole Bookrunning Manager and Joseph Gunnar & Co., LLC acted as Co-Manager for the offering.

Greenberg Traurig, LLP is acting as counsel to the company. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is acting as counsel to the underwriters.

An offering statement relating to the shares of common stock was filed with the U.S. Securities and Exchange Commission and became qualified on January 26, 2021. The offering is being made only by means of an offering circular, copies of which may be obtained, when available, by contacting: The Benchmark Company, LLC, Attention: Prospectus Department, 150 E. 58th Street, 17th Floor, New York, NY 10155, by calling (212) 312-6700 or by e-mail at [email protected]; or Joseph Gunnar & Co., LLC, Attention: Prospectus Department, 30 Broad Street, 11th Floor, New York, NY 10004, by calling (212) 440-9600 or by email at [email protected]. The offering circular is also available on the U.S. Securities and Exchange Commission website at www.sec.gov.

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 these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.