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CASI Pharmaceuticals Announces Pricing Of $38,000,000 Public Offering Of Common Stock

On July 22, 2020 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported the pricing of an underwritten public offering of 20,000,000 shares of its common stock at a price to the public of $1.90 per share. CASI has granted the underwriters a 30-day option to purchase up to an additional 3,000,000 shares of its common stock (Press release, CASI Pharmaceuticals, JUL 22, 2020, View Source [SID1234562242]). The offering is expected to close on or about July 24, 2020, subject to satisfaction of customary closing conditions. The gross proceeds to CASI from the offering, excluding any exercise by the underwriters of their 30-day option to purchase additional shares, are expected to be approximately $38.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by CASI.

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Oppenheimer & Co. Inc. is acting as the sole bookrunning manager, and Brookline Capital Markets, a division of Arcadia Securities, LLC is acting as co-manager, for the offering.

CASI intends to use the net proceeds of the offering for working capital and general corporate purposes, which include, but are not limited to advancing our product portfolio, acquiring the rights to new product candidates and general and administrative expenses.

The securities described above are being offered by CASI pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed on December 13, 2017 and declared effective by the U.S. Securities and Exchange Commission ("SEC") on December 22, 2017. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may also be obtained from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, by telephone at (212) 667-8055, or by email at [email protected].

Before investing in the offering, you should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that CASI has filed with the SEC that are incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus, which provide more information about CASI and the offering.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

Ascentage Pharma Announces First Patient Dosed in the Phase Ib Study of MDM2-p53 Inhibitor APG-115 as Single Agent and in Combinations for the Treatment of Hematologic Malignancies in China

On July 22, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the Phase Ib study of the company’s novel MDM2-p53 inhibitor candidate APG-115 as a single agent or in combinations for the treatment of Chinese patients with relapsed/refractory acute myeloid leukemia (r/r AML), or relapsed/progressed high/very high risk myelodysplastic syndrome (MDS) has dosed its first patient in China (Press release, Ascentage Pharma, JUL 22, 2020, View Source [SID1234562241]). As the first MDM2-p53 inhibitor entering clinical studies for the treatment of solid tumors in China, this is the first study of APG-115 in patients with hematologic malignancies.

This multicenter Phase Ib clinical study in China is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of APG-115 as a single agent or in combination with azacitidine or cytarabine in patients with hematologic malignancies, including r/r AML and relapsed/progressed high/very high risk MDS.

AML is a clonal proliferative disease of the bone marrow, of which the incidence rate increases with age. AML is the most common type of leukemia in China, with an incidence rate of 1.62-2.32 cases per 100,0001. The standard induction therapy for AML comprises the "7+3" regimen (7 days of cytarabine plus 3 days of anthracycline drugs), but up to 40% of newly diagnosed AML patients do not achieve complete response (CR) during initial induction therapy, which is considered as refractory, or relapse within 6 months after achieving CR2.

MDS is a heterogeneous hematopoietic disease caused by abnormal pluripotent stem cells, and the condition is characterized by poor hematopoietic function, bone marrow failure, reduction in peripheral blood cells, and reduced survival rates. The incidence rate of MDS in China is approximately 5 cases per 100,000. Although hypomethylating agents can produce a high response rate in patients with MDS, many patients eventually develop drug resistance to hypomethylating agents. Patients who have developed the acquired drug resistance commonly face a very poor prognosis. In patients with high-risk MDS, treatment failure with hypomethylating agents is associated with an average survival of less than 6 months3. As a result, both refractory/progressed AML and MDS represent an urgent medical need for more effective therapies.

APG-115 is an orally administered, selective, small-molecule inhibitor of the MDM2-p53 protein-protein interaction (PPI). APG-115 has strong binding affinity to MDM2 and is designed to activate tumor suppression activity of p53 by blocking the MDM2-p53 PPI. APG-115 is the first MDM2-p53 inhibitor entering clinical development in China, with multiple ongoing clinical studies in solid tumors in China and the US. At present, APG-115 is being investigated in a range of hematologic malignancies globally.

"Currently, there remains to be significant unmet medical needs in the treatment of hematologic malignancies, including AML and MDS," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "We have also noticed that drug development targeting the MDM2-p53 pathway has received growing interest. As the first MDM2-p53 inhibitor entering clinical study in China, APG-115 has already demonstrated favorable safety profiles and preliminary efficacy in solid tumors. We will actively explore APG-115’s therapeutic potential in hematologic malignancies, to hopefully provide more options of AML and MDS treatment to patients in China and around the world."

References:

1.Chang R, Wu S, Chen W, et al. Analysis on epidemiological characteristics of leukemia in Gansu Province from 2003 to 2012 [Article in Chinese]. Modern Preventive Med. 2014;41(21):3841-04.

2.Thol F, Schlenk RF, Heuser M, Ganser A. 2015. How I treat refractory and early relapsed acute myeloid leukemia. Blood 126: 319-27

3.Prebet T, Gore SD, Esterni B, Gardin C, Itzykson R, et al. 2011. Outcome of high-risk myelodysplastic syndrome after Azacitidine treatment failure. J Clin Oncol 29: 3322-7

About APG-115

APG-115 is an orally administered, selective, small-molecule inhibitor of the MDM2-p53 PPI. APG-115 has strong binding affinity to MDM2 and is designed to activate p53 tumor suppression activity by blocking the MDM2-p53 PPI. Ascentage Pharma has previously commenced three clinical trials of APG-115 in the US, including a Phase I study as single agent, a Phase Ib/II study in combination with pembrolizumab for treatment of metastatic melanoma and other advanced solid tumors, and a Phase I/II study as a single agent or in combination with chemotherapy for treatment of salivary gland cancer. APG-115 is the first MDM2-p53 inhibitor to enter clinical studies in China. A Phase I study as a single agent, and a Phase Ib study as a single agent or in combination with chemotherapy for treatment of AML (acute myeloid leukemia) or MDS (myelodysplastic syndrome) are ongoing in China.

Olema Oncology Announces $54 Million Series B Financing

On July 22, 2020 Olema Oncology, a biopharmaceutical company developing innovative targeted therapies for women’s cancers, reported the closing of an oversubscribed $54 million Series B financing (Press release, Olema Pharmaceuticals, JUL 22, 2020, View Source [SID1234562240]). Proceeds will be used to advance OP-1250, the Company’s lead program in breast cancer, into Phase 1/2 clinical development and expand ongoing research and development activities.

The financing was co-led by BVF Partners L.P., Logos Capital and Janus Henderson Investors, with participation from new investors Cormorant Asset Management, RA Capital Management, Wellington Management Company, Surveyor Capital (a Citadel company), Venrock Healthcare Capital Partners, and Foresite Capital. Graham Walmsley, M.D., Ph.D., Managing Partner at Logos Capital, has joined Olema’s Board of Directors, which also includes Frank McCormick, Ph.D., FRS, DSc (Hon), Professor, UCSF Helen Diller Family Comprehensive Cancer Center; Andy Rapapport, Partner Emeritus of August Capital; Gorjan Hrustanovic, Ph.D., Principal at BVF Partners, L.P.; and Cyrus Harmon, Ph.D., President and Chief Executive Officer of Olema Oncology.

"We are delighted to have the support of this premier syndicate of investors who share our commitment to developing targeted therapies designed to improve the lives of women living with breast cancer," said Dr. Harmon. "With our deep insight into the biology of breast cancer, including target engagement, receptor binding and intracellular signaling, we have carefully selected OP-1250 as our lead program and are advancing it into human studies. Our goal is to develop more effective medicines to treat estrogen receptor-positive breast cancer."

Olema expects to initiate a Phase 1/2 dose-escalation and expansion clinical trial of OP-1250 in the second half of 2020. The trial will evaluate OP-1250 as a single agent in women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) recurrent, locally advanced or metastatic breast cancer, followed by studies of OP-1250 in combination with other targeted breast cancer therapies.

"We are excited to continue financing the next stage of growth for Olema, and to help build a premier targeted oncology company focused on women’s cancers," said Dr. Hrustanovic. "We were attracted to Olema by its excellent science, robust preclinical data, experienced management team, and potential to make a significant impact on what remains a large unmet need among patients with breast and other hormone-positive cancers. We see a tremendous opportunity for OP-1250 to become a backbone of therapy for patients living with breast and other cancers."

Aurinia Announces Public Offering of Common Shares

On July 22, 2020 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, reported that it has commenced a registered underwritten public offering of its common shares (the "Offering") (Press release, Aurinia Pharmaceuticals, JUL 22, 2020, View Source [SID1234562239]).

Jefferies and SVB Leerink are acting as joint book-running managers for the Offering.

The Company will grant the underwriters an option exercisable, in whole or in part, in the sole discretion of the underwriters, to purchase up to an additional 15% of common shares, for a period of up to 30 days. The Offering is subject to market conditions, and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering.

The Company intends to use the net proceeds of the Offering for pre-commercialization and launch activities, research and development, as well as working capital and general corporate purposes.

The Offering is subject to customary closing conditions, including NASDAQ and TSX approvals. For the purposes of the TSX approval, the Company intends to rely on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as NASDAQ.

The Offering is being made pursuant to a U.S. registration statement on Form F-10, declared effective by the United States Securities and Exchange Commission (the "SEC") on June 19, 2020 (the "Registration Statement"), and the Company’s existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated June 17, 2020. The prospectus supplements relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the "Offering Documents") will be filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States. The Offering Documents will contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the Offering Documents will be available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov, as applicable. Alternatively, copies of the prospectus supplement will be available upon request in the United States by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; 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 1-800-808-7525, ext. 6218, or by email at [email protected]; and in Canada by contacting Jefferies Securities, Inc., attention: Steven Latimer, 161 Bay Street, Suite 2700 Toronto, Ontario M5J 2S1, by telephone at 416-572-2215.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Replimune Appoints Andrea Pirzkall, M.D. as Chief Medical Officer

On July 22, 2020 Replimune Group, Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported the strengthening of its executive team with the appointment of Andrea Pirzkall, M.D. as Replimune’s Chief Medical Officer effective August 31st, 2020 (Press release, Replimune, JUL 22, 2020, View Source [SID1234562237]).

"We are very excited to have Andrea join the Replimune team as we aggressively advance our pipeline," said Philip Astley-Sparke, Chief Executive Officer of Replimune. "Andrea brings a unique profile and skill set in oncology with a track record of success in advancing cancer drugs through all stages of development, including in immuno-oncology, combined with a multi-disciplinary clinical background prior to moving to industry."

Dr. Pirzkall commented, "It is a privilege to be joining Replimune at this very exciting period in the Company’s growth. The data presented for RP1 in Replimune’s lead indications of cutaneous squamous cell carcinoma and anti-PD-1 relapsed/refractory melanoma and emerging data in other solid tumors are very promising. With initial RP2 data expected later this year and with the initiation of clinical development of RP3, it is a transformational time for Replimune and I am very excited to be joining the team. The Replimune team has built a great platform of HSV-based oncolytic immune-gene therapies with a growing pipeline of assets and I look forward to helping advance them to potentially becoming a next corner stone of immuno-oncology treatment regimens."

As Chief Medical Officer, Dr. Pirzkall will lead clinical development of Replimune’s pipeline of next-generation oncolytic immuno-gene therapies for the treatment of cancer. Dr. Pirzkall brings to Replimune over 13 years of biotechnology and pharmaceutical industry experience. Prior to joining Replimune, Dr. Pirzkall served as Executive Director of Clinical Development at BeiGene, Ltd., a publicly traded commercial-stage biotechnology company where she provided strategic oversight of, and worked closely with cross-functional teams in the US, China and Europe, on the development of tislelizumab (anti-PD1) and other pipeline agents, with a focus on thoracic indications, and including several pivotal studies of which an initial two in non-small cell lung cancer achieved positive outcomes earlier this year. She served also as the global clinical development lead on the BeiGene/Celgene joint development committee. Prior to BeiGene, Dr. Pirzkall was a Principal Medical Director at Genentech, a member of the Roche Group. During her 10-year tenure, she held increasing roles of responsibility and, as a Clinical Development Team Leader, worked with multiple cross-functional teams on the development of novel biologic agents (signaling pathway inhibitors, anti-angiogenesis, immunotherapy) in early to late stage development in oncology. Prior to her career in the biotechnology and pharmaceutical industry, Dr. Pirzkall trained in radiation oncology and completed her dissertation at the University Heidelberg and the German Cancer Research Center (dkfz). Following a fellowship in Medical Physics/Radiation Oncology at the University San Francisco (USCF), Andrea held academic positions at UCSF, including Associate Adjunct Professorships in Radiation Oncology, in Radiology, and in Neurosurgery, where she helped pioneer the use of advanced imaging modalities to guide focal therapeutic interventions and to assess responses to standard of care and novel targeted therapies. Dr. Pirzkall holds a Doctor of Medicine from Friedrich-Schiller University Jena, Germany.