On June 19, 2020 AVEO Oncology (Nasdaq: AVEO) reported the closing of its previously announced underwritten public offering of 9,725,000 shares of its common stock, which includes the partial exercise by the underwriters of their option to purchase an additional 1,225,000 shares, at a price to the public of $5.25 per share (Press release, AVEO, JUN 19, 2020, View Source [SID1234561259]). The aggregate gross proceeds to AVEO from the offering were approximately $51.1 million, before deducting underwriting discounts and commissions and offering expenses payable by AVEO.

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The net proceeds of the offering are expected to be used for working capital and general corporate purposes, including funding commercialization activities relating to tivozanib.

SVB Leerink and Stifel acted as joint bookrunning managers for the offering. Baird and H.C. Wainwright & Co. acted as co-lead managers for the offering.

The shares were offered by AVEO pursuant to a shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission ("SEC") on November 30, 2017 and declared effective by the SEC on December 15, 2017.

A final prospectus supplement relating to, and describing the terms of, the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov.

Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6218 or by email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (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, 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 any such state or jurisdiction.

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 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the phase III IPATential150 study met its co-primary endpoint of radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (mCRPC) and whose tumours had PTEN loss (Press release, Hoffmann-La Roche, JUN 19, 2020, View Source [SID1234561240]). In this patient group, ipatasertib in combination with abiraterone and prednisone/prednisolone provided a statistically significant reduction in the risk of disease worsening or death, compared to current standard of care (abiraterone and prednisone/prednisolone) plus placebo. The other co-primary endpoint of rPFS in the overall study population (ITT) was not met. The safety profile for the combination of ipatasertib and abiraterone was consistent with previous analyses and known risks. The results of the IPATential150 study will be presented at an upcoming medical meeting.

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While initial data are encouraging, overall survival benefit and additional secondary endpoints are not yet mature. The trial will continue until the next planned analysis and data will be shared with health authorities.

"Prostate cancer remains a leading cause of death in men worldwide and patients with metastatic castration-resistant prostate cancer can be difficult to treat," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "The early results of the IPATential150 study are encouraging in our ongoing mission to develop new treatment options for people with advanced prostate cancer."

Ipatasertib is an oral, highly specific, investigational medicine designed to target and bind to all three isoforms of AKT (protein kinase B), which blocks the PI3K/AKT signalling pathway – a key driver of cancer cell growth and proliferation in prostate cancer.1,2 The PI3K/AKT pathway has also been implicated in resistance to anti-androgen therapy as androgen receptor (AR) inhibition is associated with an increase in AKT pathway activation.2,3 Functional loss of the tumour suppressor protein PTEN within the tumour, seen in approximately 40-60% of mCRPC patients, results in hyperactivation of the PI3K/AKT pathway and is associated with adverse outcomes such as increased tumour grade and stage, earlier biochemical recurrence after radical prostatectomy, metastasis, prostate-cancer-specific death, and androgen-independent progression.4,5

Roche’s clinical development programme for ipatasertib focuses on tumours that are frequently found to have activation of the PI3K/AKT pathway. In addition to prostate cancer, ipatasertib is being studied in certain types of breast cancer including triple-negative breast cancer (TNBC) and hormone-receptor positive (HR+), HER2- negative breast cancer. Results are anticipated later in 2020.

About the IPATential150 study6
IPATential150 is a double-blind, placebo-controlled, randomised phase III study assessing ipatasertib in combination with abiraterone and prednisone/prednisolone, compared to placebo plus abiraterone and prednisone/prednisolone, in adult male patients with asymptomatic or mildly symptomatic, previously untreated mCRPC.

The co-primary endpoints of the study are investigator-determined rPFS in the overall study population, as well as a subpopulation whose tumours have PTEN loss, as assessed by immunohistochemistry (Ventana assay). PFS in the study is defined as the time from date of randomisation to the first occurrence of disease progression or death from any cause, whichever occurs earlier. Secondary endpoints include overall survival, safety, time to pain progression, time to initiation of cytotoxic chemotherapy and time to function deterioration.

About ipatasertib
Ipatasertib is an oral, highly specific, investigational medicine designed to target and bind to all three isoforms of AKT, which blocks the PI3K/AKT signalling pathway and may prevent cancer cell growth and survival.1,2

Ipatasertib is being studied in tumours that are frequently found to have activation of the PI3K/AKT pathway, including breast and prostate cancers. Clinical studies are ongoing to evaluate the efficacy and safety of ipatasertib and the opportunity it may provide to address significant unmet needs for patients with these diseases.

Ipatasertib was discovered at Genentech in partnership with Array BioPharma Inc. (acquired by Pfizer Inc. on July 30, 2019).

About metastatic castration-resistant prostate cancer (mCRPC)
Prostate cancer is the second most frequent cancer and the fifth leading cause of death in men.7 Metastatic prostate cancer refers to prostate cancer that has spread beyond the prostate to other parts of the body (metastasised).8 Although most men are cured with treatment of localised disease, recurrent or newly diagnosed metastatic disease is associated with significant morbidity and mortality.9,10,11

Primary treatment of advanced prostate cancer is androgen deprivation therapy (ADT); however, up to one-third of patients will progress despite reduction in serum testosterone levels to castrate levels (<50 ng/dL), either through surgical or medical castration.12,13 Castration-resistant prostate cancer (CRPC) is defined by disease progression, as measured by prostate specific antigen (PSA) or radiographic measures, despite adequate suppression of serum testosterone levels.14,15 Despite the current availability of life-extending therapies for mCRPC, the majority of men will die of their disease: the median life expectancy in this population is less than three years.16,17

Prostate cancer growth and survival is driven by abnormal AR signalling. In CRPC, cell growth and proliferation is also commonly driven by activation of the PI3K/AKT signalling pathway.1,2 In particular, functional loss of the tumour suppressor protein PTEN within the tumour, seen in approximately 40-60% of people with mCRPC, results in hyperactivation of the PI3K/AKT pathway.4 PTEN loss is associated with adverse outcomes such as increased tumour grade and stage, earlier biochemical recurrence after radical prostatectomy, metastasis, prostate-cancer-specific death, and androgen-independent progression.5 The PI3K/AKT pathway has also been implicated in resistance to anti-androgen therapy as AR inhibition is associated with an increase in AKT pathway activation, suggesting that the tumour compensates for the loss of one pathway with another.2,3

About Roche in prostate cancer
For more than 50 years, Roche has been developing medicines with the goal of redefining treatment in oncology. Our research and development aim is to provide effective cancer therapies through the discovery and development of novel therapeutics that target the specific molecular pathways associated with cancer. Roche is expanding into additional areas of unmet need, working to find innovative solutions for diseases such as prostate cancer, the most prevalent cancer in men and fifth leading cause of cancer-related male death worldwide.5 Roche is committed to research into genitourinary cancers, including bladder and renal cancers, and to providing life extending treatment options for these patients.

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.

On June 19, 2020 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported the launch of Abiraterone Acetate Tablets USP, 250 mg, a therapeutic equivalent generic version of Zytiga (abiraterone acetate) approved by the U.S. Food and Drug Administration (USFDA) (Press release, Dr Reddy’s, JUN 19, 2020, View Source [SID1234561241]).

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The Zytiga brand and generic market had U.S. sales of approximately $454 million MAT for the most recent twelve months ending in March 2020 according to IQVIA Health*.

Dr. Reddy’s Abiraterone Acetate is available in 250 mg tablets in bottle count sizes of 120.