On June 30, 2021 Solasia Pharma K.K. (TSE: 4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter "Solasia") reported submission of a New Drug Application (NDA) for its new anti-cancer drug darinaparsin (generic name, development code: SP-02) as a treatment for relapsed or refractory peripheral T-cell lymphoma to the Ministry of Health, Labour and Welfare (MHLW) (Press release, Solasia, JUN 30, 2021, View Source [SID1234584514]). Based on positive results of R&D on darinaparsin, centered primarily on the results of the Asian Multinational Phase 2 Study (study results released in June 2020), Solasia filed an NDA for the drug with the regulatory authority in Japan ahead of anywhere else in the world.

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Solasia expects to obtain regulatory approval in 2022 and to also launch in the same year. If approved and launched, darinaparsin would be the third drug Solasia successfully developed and brought to market since its founding and is expected to contribute to the treatment of PTCL.

Mr. Yoshihiro Arai, President and CEO of Solasia, commented as follows:
"No standard treatment has been established for relapsed or refractory PTCL as of yet. I firmly believe that darinaparsin, with its novel mechanism of action that differs from those of already approved drugs, will contribute to patients and healthcare providers at clinical sites as a new treatment option for relapsed or refractory PTCL. Since founding, Solasia has conducted R&D on five pipeline drugs. Of the five, we have successfully developed and brought to market two drugs, i.e., began providing them to patients, and today, we submitted an NDA for our first anti-cancer drug. Under our mission to provide patients with ‘Better Medicine for a Brighter Tomorrow’, we will continue aiming to contribute to patients’ treatment and enhanced quality of life. "

About darinaparsin (SP-02)
Darinaparsin, an organoarsenic compound with anticancer activity, is a novel mitochondrial-targeted agent being developed for the treatment of various hematologic and solid tumors. The proposed mechanism of action of the drug involves the disruption of mitochondrial function, increased production of reactive oxygen species, and modulation of intracellular signal transduction pathways. Darinaparsin is believed to exert anticancer effect by inducing cell cycle arrest and apoptosis. Darinaparsin has been granted orphan drug designation in the US and EU.
For more information, please visit at View Source

About Asian Multinational Phase 2 Study
The Asian Multinational Phase 2 Study was a multinational, multicenter, single-arm, open-label, non-randomized study to evaluate the efficacy and safety of darinaparsin monotherapy in patients with relapsed or refractory PTCL conducted in Japan, Korea, Taiwan, and Hong Kong. (CT.gov Identifier: NCT02653976).
Solasia plans to present the results of the study at an international academic conference to be held in the near future.

On June 30, 2021 Scopus BioPharma Inc. (Nasdaq: "SCPS"), a clinical-stage biopharmaceutical company developing transformational therapeutics, reported the acquisition of Los Angeles-based Olimmune Inc (Press release, Scopus BioPharma, JUN 30, 2021, View Source [SID1234584530]).

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Olimmune is a developer of groundbreaking oligonucleotide immunotherapies for treatment-resistant and metastatic cancers. Olimmune’s lead drug candidate, OLIM-01, is being developed for genitourinary and head and neck cancers. It is anticipated that INDs for these indications will be submitted by Q1 2023.

Joshua R. Lamstein, Chairman of Scopus BioPharma, stated, "The acquisition of Olimmune dramatically expands our reach in immuno-oncology. Both companies have been pioneering proprietary technologies to address traditionally "undruggable" targets, such as STAT3. This combination positions Scopus as a global leader in bifunctional oligonucleotide cancer therapeutics."

Olimmune was co-founded by Marcin Kortylewski, Ph.D., a leading immuno-oncologist and Professor in the Department of Immuno-Oncology at City of Hope. Dr. Kortylewski and his laboratory were instrumental in the seminal discovery that successful cancer immunotherapy needs to combine both TLR9 immunostimulation and STAT3 inhibition. This strategy underpins CpG-STAT3siRNA, Scopus’ lead drug candidate, which is covered by certain patents licensed from City of Hope. City of Hope is a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases near Los Angeles, California.

Dr. Kortylewski stated, "While it’s necessary to deliver STAT3 inhibitors to the proper cells, STAT3 inhibition, by itself, is not sufficient. You also need to stimulate immune activation. Fortunately, the short CpG sequence also serves as a TLR9 agonist, so you get release of immunosuppression by the STAT3 inhibitor and immune activation through TLR9 activation, both of which are necessary for a robust anti-cancer response."

Dr. Kortylewski added, "City of Hope and Scopus are working closely to initiate a Phase 1 clinical trial evaluating CpG-STAT3siRNA for non-Hodgkin lymphoma. Now, we will work towards expanding our collaboration to other challenging cancer indications, such as head and neck, kidney, or prostate cancers using alternative STAT3 inhibitors."

Alan Horsager, Ph.D., President and Chief Executive Officer of Olimmune, stated, "Scopus BioPharma is the ideal home for Olimmune. The combination of immuno-oncology assets creates a comprehensive portfolio of complementary cell-selective oligonucleotide therapeutics. Moreover, Scopus’ clinical development will provide us with invaluable insights, experience and expertise in bringing our drug candidates into the clinic."

Olimmune has exclusive, worldwide licenses to certain patents from City of Hope to develop and commercialize CpG-STAT3ASO and CpG-STAT3decoy.

Terms of the acquisition have not been disclosed.

On June 30, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA) (the "Company" or "Panbela"), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported that, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 3,333,334 shares of common stock of the Company at a price to the public of $3.00 per share, less underwriting discounts and commissions (Press release, Panbela Therapeutics, JUN 30, 2021, View Source;utm_medium=rss&utm_campaign=panbela-increases-previously-announced-bought-deal-offering-of-common-stock-to-10-million [SID1234584498]). The closing of the public offering is expected to occur on or about July 2, 2021, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company has granted to the underwriter a 30-day option to purchase up to an additional 500,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

The gross proceeds of the offering are expected to be approximately $10.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Panbela and assuming no exercise of the option to purchase additional shares. The Company intends to use the net proceeds of the offering for the continued clinical development of its initial product candidate SBP-101 and for working capital and other general corporate purposes.

The shares of common stock described above are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-255751) filed with the Securities and Exchange Commission ("SEC") and declared effective on May 11, 2021. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus, and the final prospectus supplement and accompanying prospectus, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail at [email protected] or by calling (212) 856-5711.

This announcement is neither an offer to sell, nor a solicitation of an offer to buy, any of these securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such offer, solicitation, or sale is unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus forming a part of the effective registration statement.

On June 30, 2021 Susan G. Komen, the world’s leading breast cancer organization, reported the awarding of 30 new grants to researchers at 18 leading institutions in the U.S. and Canada (Press release, Susan G Komen, JUN 30, 2021, View Source [SID1234584515]). The $14 million in new grants support our mission to end breast cancer through funding two key focus areas: research to better detect and treat stage IV (metastatic) breast cancer and research to eliminate disparities in breast cancer outcomes.

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"We are extremely proud to be able to continue our legacy of leading investments in breast cancer research, especially in light of the challenges all nonprofits faced raising funds during this pandemic year," said Paula Schneider, president and CEO of Susan G. Komen and a breast cancer survivor. "This investment reinforces our commitment to funding innovative science from some of the leading minds in breast cancer research while also developing the next generation of scientists at a time when we have never needed them more."

With our research grant funding overall, we are focused on:

Supporting leaders in the field of breast cancer research
Building the next generation of breast cancer researchers to lead the field
Improving how we detect, prevent and treat metastatic breast cancer, and
Addressing disparities in breast cancer care and outcomes.
Investing in the next generation of breast cancer researchers has long been a priority for Komen. Since 2008, the organization has invested more than $110 million to support 250 early career scientists. This year’s grant slate includes seven Career Catalyst awards focused on utilizing liquid biopsies to improve treatment, detection, and understanding of metastatic breast cancer. These grants will help unlock the potential of liquid biopsy as a simpler, more timely way to monitor cancer progression, monitor the cancer’s response to treatment, and ultimately improve patient outcomes and quality of life.

"Applying the latest molecular biology technology to the major problem of evolving resistance to cancer therapy through innovative use of so-called "liquid biopsies" is an approach poised to alter how we treat, and beat, dangerous breast cancers," said George Sledge, MD, Komen’s Chief Scientific Advisor.

Komen is also committed to increasing the number of researchers focused on breast cancer disparities. Through Komen’s TREND (Training Researchers to Eliminate Disparities) program, grants to the University of Chicago, The Ohio State University and the University of North Carolina at Chapel Hill will continue to support the training and career development of young researchers from diverse backgrounds who are looking to dedicate their careers to understanding and eliminating disparities in breast cancer care and outcomes.

In addition to the emerging leader and training grants, Komen’s new investments include awards to some of the world’s leaders in the field through our Komen Scholars program, including the six new Scholars announced last week. These funds will support research on a range of issues, from:

evaluating treatment response and recurrence risk among high-risk ER+/HER2-negative breast cancer patients,
utilizing big data and artificial intelligence as a tool to advance research discoveries,
leveraging the body’s immune system to attack cancer cells,
understanding how one’s diet and lifestyle may impact recurrence risk, and
working to develop a breast cancer vaccine, among other projects.
This year’s awards also include new funding for:

The Translational Breast Cancer Research Consortium (TBCRC), a collaboration of 19 of the top U.S. academic medical centers administered out of Johns Hopkins University and led by Komen Scholar, Antonio Wolff, M.D., that conducts high-impact clinical trials and translational research projects. This year’s award brings Komen’s total investment in the TBCRC to $15.5 million. The TBCRC has developed 57 breast cancer clinical trials with over 5,500 patients enrolled. About half of TBCRC trials since 2006 have focused on metastatic breast cancer, drug resistance and/or recurrence.
The Carolina Breast Cancer Study (CBCS), led by investigators from the University of North Carolina at Chapel Hill, seeks to understand the complex interactions of ‘biology and access’ that contribute to disparities in breast cancer outcomes. Now in Phase III, the study will collect detailed quality of life and health care access information, along with tumor subtype and treatment information, and will enable researchers to design new interventions that improve survivorship and quality of life among people with breast cancer.
Dr. Jennifer Miller at Yale University to build and pilot a new tool to help improve transparency and representativeness of U.S. breast cancer patients in breast cancer clinical trials.
Komen has now invested about $1.1 billion in research in the nearly 40 years since its founding, the largest collective investment of any breast cancer nonprofit, and second only to the U.S. government.

Visit komen.org for a full list of this year’s research grants.

On June 30, 2021 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported a clinical trial collaboration and supply agreement with Merck (Press release, Alpine Immune Sciences, JUN 30, 2021, View Source [SID1234584500]). This collaboration will evaluate the safety and efficacy of Alpine’s ALPN-202, a first-in-class conditional CD28 costimulator and dual checkpoint inhibitor, in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), the first anti-PD-1 therapy approved in the United States. The clinical trial, NEON-2, began dosing study participants in June 2021.

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"We are extremely pleased to collaborate with Merck, one of the world’s leading immuno-oncology companies," said Stanford Peng, M.D., Ph.D., President and Head of R&D of Alpine. "Our prior preclinical studies demonstrated that the combination of ALPN-202 and a PD-1 inhibitor can be particularly advantageous, and this collaboration will greatly enable our ability to pursue this opportunity in the clinic. This study, in conjunction with NEON-1, ALPN-202’s ongoing first-in-human monotherapy trial, will provide insights across a broad spectrum of cancers and lines of therapy."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. NEON-1 (NCT04186637), a monotherapy study of ALPN-202 in patients with advanced malignancies, and NEON-2 (NCT04920383), a study of ALPN-202 in combination with KEYTRUDA (pembrolizumab) in patients with advanced malignancies, are currently enrolling.