On June 22, 2020 Grey Wolf Therapeutics reported that it will present an e-poster and accompanying audio description at AACR (Free AACR Whitepaper) 2020 (Virtual Annual Meeting II) (Press release, Grey Wolf Therapeutics, JUN 22, 2020, View Source [SID1234561270]).

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The company has generated potent oral ERAP1 inhibitors that modify the immunopeptidome in vivo and represent novel immunotherapy agents.

Visit the American Association for Cancer Research (AACR) (Free AACR Whitepaper) website and head to e-poster 5551 for more information. The virtual event will run from June 22 – June 24.

On June 19, 2020 3SBio reported that the anti-HER2 antibody for injection, Inetetamab (commercial name: Cipterbin), which is independently developed by its subsidiary, Sunshine Guojian Pharmaceutical has been formally approved by the National Medical Products Administration of the PRC ("NMPA") (Press release, 3SBio, JUN 19, 2020, View Source [SID1234591388]). The first approved indication of Cipterbin is for the treatment of HER2-positive metastatic breast cancer combining with chemotherapy.

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As a project under the 863 Program of China, the National Major Scientific and Technological Special Project for "Significant New Drugs Development" and the key science and technological project for Shanghai, the approval of the domestically manufactured innovative anti-HER2 monoclonal antibody, Inetetamab, is expected to satisfy the unmet medical need for the clinical treatment of breast cancer patients in China, break the monopoly of imported drugs for anti-HER2 monoclonal antibody and enhance the accessibility of national innovative drugs, thereby benefitting more patients in China.

Rapid development of the anti-HER2 monoclonal antibody market

Breast cancer is the malignancies with the highest incidence rate for female and one of the types of cancers with relatively more treatment options among many other types of cancers. In recent years, the number of new incidents of breast cancer continued to grow. The report published by the National Cancer Centre in 2019 indicated that the number of new patients with breast cancer in China in 2015 was 304,000[1]; among them, 20%-25% of the patients with breast cancer were HER2-positive[2]. As a huge demand for the treatment in relation to clinical practice for HER2- positive breast cancers has not been satisfied, patients still encounter multiple problems such as recurrence and drug resistance.

HER2 target antibody treatment is currently applicable for two indications, which are HER2- positive breast cancers and stomach cancers. Since the first HER2 target monoclonal antibody has been approved for sale in the United States in 1998, the therapy of combining anti-HER2 drugs with chemotherapy drugs and other drugs has been widely adopted in clinical practice. Following the future development of HER2 target treatment in colorectal cancer, lung cancer, cholangiocarcinoma and pancreatic cancer, etc., there remains a huge potential for the market growth of the anti-HER2 drugs including anti-HER2 monoclonal antibody and anti-HER2 small molecule compounds in China.

According to a report from Frost & Sullivan[3], the market for anti-HER2 monoclonal antibody in China grew from approximately 1.4 billion yuan in 2014 to approximately 3.2 billion yuan in 2018, with a compound annual growth rate (CAGR) of 23.9%. As the number of patients with breast cancer increases, the market for anti-HER2 monoclonal antibody drugs will grow rapidly with a CAGR of approximately 23.9% from 2018 to 2023 and the market size is expected to reach approximately 9.4 billion yuan in 2023 and approximately 13.6 billion yuan in 2030.

Inetetamab took the lead in breaking the monopoly of the imported anti-HER2 monoclonal antibody drug

Inetetamab is a "mimetic combination" of an anti-HER2 monoclonal antibody, which is a drug independently developed by Sunshine Guojian for anti-HER2 treatments, leveraging on its own platform technology. It is also a project under the 863 Program, the National Major Scientific and Technological Special Project for "Significant New Drugs Development" and the key science and technological project for Shanghai and was granted with a priority review status. An in vitro research has shown that[4] the Fab region of Inetetamab is consistent with trastuzumab. With the engineered Fc region and optimized production process, it has a stronger ADCC effect, which better achieves the therapeutic goal of the anti-HER2 monoclonal antibody. In addition to directly inhibiting proliferation and growth of tumor cells by blocking the pathway of HER2, the Fab region of Inetetamab can also induce the ADCC effect, recognizing and killing tumor cells through the immune system.

The 2019 American ASCO (Free ASCO Whitepaper) meeting has published a research result of SOPHIA of the antiHER2 monoclonal antibody (Margetuximab). Such monoclonal antibody has a stronger ADCC effect after the reconstruction of the Fc region. The SOPHIA research has shown that such monoclonal antibody can reduce the risk of disease progression by 24% in patients with metastatic breast cancer[5] when compared with the trastuzumab treatment; the stronger ADCC effect after reconstructing monoclonal antibody will be converted to the survival benefit of patients to a certain extent. As the first innovative anti-HER2 monoclonal antibody with engineered Fc region and optimized production process in China, it has a stronger ADCC effect, and Inetetamab is expected to bring clinical benefits to more Chinese HER2-positive cancer patients.

Analysts believe that the approval of Inetetamab will take the lead in breaking the monopoly of imported drugs of the anti-HER2 monoclonal antibody in the domestic market. It is expected that, among the fierce competition between imported anti-HER2 monoclonal antibodies and domestic biosimilars in the future market, Inetetamab, with its advantages of the stronger ADCC effect and stronger bargaining power in pricing of the innovative anti-HER2 monoclonal antibody, etc., will facilitate the market growth of anti-HER2 drugs rapidly, thereby reconstructing the competition landscape for the market of anti-HER2 drugs in China.

Focus on development of antibody drugs and the pipeline of subsequent research and development is worth paying attention to

Sunshine Guojian currently has 4 clinical products under research, and 6 pre-clinical products under research in the anti-tumor area, covering breast cancer, non-Hodgkin lymphoma caner, metastasis colon and rectal cancer, non-small cell lung cancer, gastric cancer and various solid tumors and carried out a multi-target deployment in anti-HER2, CD20, PD1, EGFR, VEGF and other areas. At the same time, Sunshine Guojian is actively deploying the research and development of innovative therapies, including new monoclonal antibodies, bi-specific antibodies, fusion proteins and cell therapeutics to bring multiple treatment options to patients.

Dr. Lou Jing, the Chairman of the Board of Sunshine Guojian, commented, "Cipterbin is the third antibody drug of Sunshine Guojian that is approved to be launched. As a leading innovative biopharmaceutical company in China with three approved antibody therapeutic drugs (including Yisaipu and Xenopax) the company is equipped with a mature system with comprehensive research and development and experience for industrialization and commercialization of antibody drugs, which provides the support and guarantees for maintaining our competitive edge. In the future, the company will continue to strengthen the research and increase the investment in innovative antibody drugs to further consolidate our position as the leader in antibody drugs, realising a stable growth of the company."

As one of the first batch of innovative biopharmaceutical companies focusing on antibody drugs in China, Sunshine Guojian launched Yisaipu in 2005, which is a first-to-market Tumour Necrosis Factor (TNF-α) inhibitor product in the area of rheumatology in China filling the blank of development in antibody drugs of domestic enterprises. Yisaipu is in a leading position in the Chinese market, with a market share of 60.9% in 2019, and has obtained approvals for launch from 15 overseas markets. The Company’s another independently developed anti-CD25 humanized monoclonal antibody, Xenopax , was also launched in 2019, and it has promoted the academic development of the area of transplantation.

About Cipterbin

Cipterbin (Inetetamab) is the first innovative anti-HER2 monoclonal antibody in China with the engineered Fc region, optimized production process and a stronger ADCC effect. Combining with chemotherapy drugs, it has been proved to be capable of delaying the disease progression for and bringing survival benefits to HER2-positive metastatic breast cancer patients

On June 19, 2020 Athenex reported that entered into a $225.0 million senior secured loan agreement (the "Loan Agreement"), with Oaktree Fund Administration, LLC ("Oaktree") as administrative agent, and the lenders party thereto (Filing, 8-K, Athenex, JUN 19, 2020, View Source [SID1234561295]). The first tranche of loans borrowed by us is in an aggregate principal amount of $100.0 million and consists of $89,886,946 of term loans funded on the Closing Date and $10,113,054 of term loans that will be funded ten days after the Closing Date. A portion of the proceeds of the first tranche of loans were used to repay in full our existing senior secured loan with Perceptive Credit Holdings II, LP. The remaining term loan commitments under the Loan Agreement may be borrowed from time to time prior to the date that is either 24 or 36 months after the Closing Date, as applicable, subject to the satisfaction of certain regulatory and commercial milestones.

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The senior secured loans under the Loan Agreement mature on the sixth anniversary from the Closing Date, and bear interest at a fixed annual rate of 11.0%, payable quarterly. We are required to make quarterly interest-only payments until the second anniversary of the Closing Date, after which we are required to make quarterly amortizing payments, with the remaining balance of the principal plus accrued and unpaid interest due at maturity. After the date that is 90 days after the Closing Date, we will be required to pay a commitment fee on any undrawn commitments equal to 0.6% per annum, payable on each subsequent funding date and the commitment termination date. We are also required to pay an exit fee at maturity equal to 2.0% of the aggregate principal amount of the loans funded under the Loan Agreement.

We may voluntarily prepay the Loan Agreement at any time subject to a prepayment premium which up until the second anniversary of the Closing Date is equal to the amount of interest that would have been paid up to, but not including, the second anniversary date (excluding interest amounts already paid), plus 3.0% of the principal amount of the senior secured loans being repaid. Thereafter, the prepayment premium equals 3.0% of the principal amount of the senior secured loans being repaid, and is reduced over time until the fourth anniversary date, after which no prepayment premium is required. We are required to make mandatory prepayments of the senior secured loans with net cash proceeds from certain asset sales or insurance proceeds or condemnation awards, in each case, subject to certain exceptions and reinvestment rights.

Our obligations under the Loan Agreement are guaranteed by us and certain of our existing domestic subsidiaries and subsequently acquired or organized subsidiaries subject to certain exceptions. Our obligations under the Loan Agreement and the related guarantees thereunder are secured, subject to customary permitted liens and other agreed upon exceptions, by (i) a pledge of all of the equity interests of our direct subsidiaries, and (ii) a perfected security interest in all of our tangible and intangible assets.

The Loan Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness, and dividends and other distributions, subject to certain exceptions, including specific exceptions with respect to product commercialization and development activities. In addition, the Loan Agreement contains certain financial covenants, including, among other things, maintenance of minimum liquidity and a minimum revenue test, measured quarterly until the last day of the second consecutive fiscal quarter where the consolidated leverage ratio does not exceed 4.5 to 1, provided that thereafter we cannot allow our consolidated leverage ratio to exceed 4.5 to 1, measured quarterly. Failure of the company to comply with the financial covenants will result in an event of default, subject to certain cure rights of the company.

The Loan Agreement contains events of default which are customary for financings of this type, in certain circumstances subject to customary cure periods. Following an event of default and any cure period, if applicable, Oaktree will have the right upon notice to terminate any undrawn commitments and may accelerate all amounts outstanding under the Loan Agreement, in addition to other remedies available to it as a secured creditor of the company.

In connection with the Loan Agreement, we granted warrants to Oaktree to purchase up to 908,393 shares of our common stock at a purchase price of $12.63 per share (the "Warrant"). The Warrants will expire on June 19, 2027 and may be net exercised at the holder’s election. We also agreed to file a registration statement on Form S-3 to register for resale the shares of common stock issuable upon exercise of the Warrants ("Warrant Shares"). The foregoing summary of the Warrants is not a complete description of the Warrants and is qualified in its entirety by the complete text of the Warrants, the form of which is filed as Exhibit 4.1 to this report.

On June 19, 2020 Bio-Thera Solutions (SHA: 688177), a commercial-stage biopharmaceutical company, reported that the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for BAT1706, a proposed biosimilar to Avastin (bevacizumab) (Press release, BioThera Solutions, JUN 19, 2020, View Source [SID1234561261]). Bio-Thera seeks commercial license for all approved indications of bevacizumab in China, advanced, metastatic or relapsed non-small cells lung cancer and metastatic colorectal cancer.

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"BAT1706 is the company’s second application for marketing approval of a biosimilar in China, following the approval of Qletli (adalimumab injection)," said Dr. Li Shengfeng, founder and CEO of Bio-Thera Solutions. "Lung cancer and colorectal cancer are high-risk cancers and patients need safe, effective, and affordable treatment drugs. BAT1706, developed in accordance with NMPA, FDA and EMA drug regulations, will provide a high-quality, low-cost treatment option for patients worldwide."

BAT1706 is a proposed bevacizumab biosimilar developed by the company. Bevacizumab is a humanized monoclonal antibody that targets vascular endothelial growth factor (VEGF). It can specifically bind to VEGF and block the binding of VEGF to its receptor, thereby reducing neovascularization, inducing the degradation of existing blood vessels, and thereby inhibiting tumor growth. Bevacizumab has been approved in China for two indications, namely advanced, metastatic or recurrent non-small cell lung cancer and metastatic colorectal cancer. The indications approved in the United States and Europe also include certain types of renal cell carcinoma kidney cancer, ovarian cancer and cervical cancer and glioblastoma.

Through a series of preclinical comparison studies, clinical pharmacokinetic comparison studies, and international multi-center phase III clinical comparison studies, Bio-Thera Solutions has obtained data demonstrating that BAT1706 is highly similar to bevacizumab in clinical efficacy and safety.

BAT1706 is Bio-Thera Solutions’ second proposed biosimilar with positive Phase III study results. The company’s first biosimilar product, QLETLI (格乐立), a biosimilar to Humira (adalimumab), has received marketing authorization and is available in China. Bio-Thera Solutions is developing several additional proposed biosimilars, including ustekinumab, secukinumab and golimumab, among others.

About BAT1706

BAT1706 is a monoclonal antibody (mAb) that is in development as a potential biosimilar to Avastin. BAT1706 works by binding the vascular endothelial growth factor (VEGF) protein. In the U.S., Avastin is indicated for the treatment of patients with metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. BAT1706 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not yet been established by regulatory authorities.

On June 19, 2020 IMV Inc. ("IMV" or the "Company") (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of targeted cancer immunotherapies and vaccines against infectious diseases, reported that, in order to replace its prior base shelf prospectus and corresponding shelf registration statement that will expire on July 5, 2020, it has filed a preliminary short form base shelf prospectus (once filed in final form and receipted by the relevant Canadian securities regulatory authorities, the "Shelf Prospectus") with the securities commissions in each of the provinces of Alberta, British Columbia, Manitoba, Newfoundland and Labrador, Nova Scotia, Ontario, Quebec and Saskatchewan in Canada, and a corresponding shelf registration statement on Form F-10 with the U.S. Securities and Exchange Commission (the "SEC") under the U.S./Canada Multijurisdictional Disclosure System (Press release, IMV, JUN 19, 2020, View Source [SID1234561260]).

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The Shelf Prospectus and corresponding shelf registration statement, when made final or effective, will allow IMV to offer up to US$125,000,000 of common shares, preferred shares, subscription receipts, warrants, options or any combination thereof during the 25-month period that the Shelf Prospectus will be effective. The Shelf Prospectus will enable IMV to potentially access new capital if and when needed. The amount and timing of any future offerings will be based on the Company’s financial requirements and market conditions at the time.

The specific terms of any future offering under the Shelf Prospectus will be established at the time of such offering. At the time any of the securities covered by the Shelf Prospectus are offered for sale, a prospectus supplement containing specific information about the terms of such offering will be filed with applicable Canadian securities regulatory authorities and the SEC. The shelf registration statement filed today with the SEC has not yet become effective. No securities may be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This news release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualifications under the securities laws of any such jurisdiction. A copy of the preliminary short form base shelf prospectus can be found on SEDAR at www.sedar.com and a copy of the corresponding shelf registration statement can be found on EDGAR at www.sec.gov or may be obtained upon request to IMV’s Investor Relations Department using the contact information set out below.