On March 31, 2021 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported the completion of its previously-announced sale of a portfolio of select products to Orifarm Group ("Orifarm") for a total value of up to $670 million USD (Press release, Takeda, MAR 31, 2021, View Source [SID1234577457]). The portfolio includes approximately 130 over-the-counter (OTC) and prescription pharmaceutical products sold in Europe, and two manufacturing sites located in Denmark and Poland. This divestment agreement was first announced in April 2020.

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The divested portfolio includes OTC products and food supplements, plus select products within the Cardiovascular, Anti-inflammatory, Respiratory, and Endocrinology therapeutic areas, primarily sold in Denmark, Norway, Belgium, Poland, Finland, Sweden, the Baltics and Austria. The portfolio generated FY2020 net sales of approximately $240 million USD, driven by sales of cough/cold and vitamin OTC brands, along with prescription products such as Warfarub and Levaxin, and other strong regional brands. The products, while addressing key patient needs in these countries, are outside of the business areas Takeda has chosen as core to its global long-term growth.

As previously announced, Takeda and Orifarm have also entered into manufacturing and supply agreements under which Takeda will continue to manufacture select products on behalf of Orifarm. In addition, approximately 600 employees from the manufacturing sites, sales and marketing professionals and others supporting the divested portfolio and manufacturing sites have transitioned to Orifarm.

Takeda remains focused on executing its long-term growth strategy to optimize our business mix around our key business areas, and simplifying our operations to better serve patients by delivering innovative treatments in these areas.

The Company intends to use the proceeds from the sale to reduce its debt and accelerate deleveraging towards its target of 2x net debt/adjusted EBITDA within Fiscal Years 2021–2023.

Takeda has exceeded its $10 billion non-core asset divestiture target and has announced 12 deals since January 2019 to date for a total aggregate value of up to approximately $12.9 billion.

On March 31, 2021 Kiromic BioPharma (NASDAQ: KRBP), a pre-clinical stage biotechnology company using its proprietary DIAMOND artificial intelligence ("A.I.") platform to improve drug discovery and development with a therapeutic focus on immune-oncology, reported its financial results for the year ended December 31, 2020, and provided an update on its corporate developments (Press release, Kiromic, MAR 31, 2021, View Source [SID1234577456]).

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"Kiromic BioPharma achieved important scientific and operational milestones during the year that we believe have us well positioned for preparing our staff and our facilities for the first in-human dosing in Q3 2021," said Dr. Maurizio Chiriva-Internati, CEO and President of Kiromic BioPharma. "We are thankful to our employees and collaborators who have maintained this high level of execution in the middle of the hard challenges posed by the COVID-19 pandemic."

Our approach and goal is to defeat cancer by developing immunotherapies that rely on improving target discovery and validation. With better targets, we believe our therapies will be more effective than the current array of immunotherapies using older targets.

Corporate and Scientific Highlights

Initial Public Offering Completion – On October 20, 2020, we completed our IPO, raising $15 million of gross proceeds, significantly strengthening the Company’s balance sheet to support the continued development of our promising pipeline of targeted cancer therapies.

Two IND Application Filings – On December 17, 2020 we filed two applications with the U.S. Food and Drug Administration ("FDA"). The first IND was for a Phase 1 clinical trial of intravenously ("IV") administered allogeneic CAR-T for epithelial ovarian carcinoma ("EOC") and malignant pleural mesothelioma ("MPM"). The second IND was for a Phase 1 clinical trial of an intrapleural/intraperitoneal (IP) administered allogeneic CAR-T for EOC and MPM.

Since filing the original INDs in December 2020, the Company has had communications with the FDA, and numerous consults with scientific board and clinical advisors regarding resubmission. In March 2021, we announced that we planned to resubmit the two INDs.

The revised INDs will be for first in-human dosing of our Off-the-Shelf, Allogeneic Gamma-Delta T cell therapy for metastatic and progressive locally advanced solid malignancies.

The revised INDs have protocols which retain approximately 80% of the original INDs.

Longwood University Licensing Agreement – On November 30, 2020, we executed a licensing agreement for chPD1 with Longwood University. This marks a major milestone for Kiromic CAR-T development. With chPD1, we believe our chimeric PD1 CAR-T will be able to overcome the challenging tumor micro-environment (TME) which has plagued other CAR-T programs, while making Kiromic the only CAR-T development program with a built-in capability to meet other CAR-T programs head-on who do not have a bundled chPD1 CAR-T.

GMP Facility Completion – As of September 30, 2020, the key features of the GMP facility have been completed, clearing the path for the production of off-the-shelf Gamma-Delta-T cells, a novel approach to CAR-T cell therapy, which will be evaluated in the upcoming clinical trials.
FY 2020 Financial Highlights

Cash Position: Cash and cash equivalents were $10,150,500 as of December 31, 2020, compared to $1,929,100 as of December 31, 2019. The increase was primarily due to cash inflows of $15,805,600 attributable to financing activities related to the issuance of common stock from the initial public offering, issuance of Series B Preferred Stock and proceeds net of repayments from the Paycheck Protection Program loan. These inflows were offset by outflows of $6,126,600 and $1,457,600 attributable to operating activities and investing activities, respectively.

R&D Expenses: Research and development expenses were $5,052,900 for the year ended December 31, 2020, compared to $1,201,700 for the year ended December 31, 2019. The increase was primarily attributable to augmented headcount, increased square footage to our Houston, TX leased facilities, in-vitro experimentation costs, and intellectual property costs.

G&A Expenses: General and administrative expenses were $14,144,000 for the year ended December 31, 2020, compared to $2,503,700 for the year ended December 31, 2019. This increase was primarily due to increased stock compensation expenses and personnel expenses.

Net Loss: Net loss was $19,200,200 for the year ended December 31, 2020, compared to a net loss of $3,727,900 for the year ended December 31, 2019.

Dr. Chiriva-Internati continued, "Developing live-cell therapies by leveraging artificial intelligence is central to transforming the cost and efficiency of the immune-oncology field and improving the potential for off-the-shelf therapies for cancer patients. We believe our approach will help us design more efficient pre-clinical validation studies and more targeted clinical trials, thereby accelerating our drug candidates’ time to approval and eventually to market. DIAMOND is central to our process in achieving this outcome rapidly and with reduced costs," concluded Dr. Chiriva-Internati.

On March 31, 2021 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, reported that it had closed its Series F Preferred Stock Financing on March 26, 2021 (Press release, Guided Therapeutics, MAR 31, 2021, View Source [SID1234577454]). This oversubscribed sale of 2,114 Series F Preferred Shares resulted in gross proceeds to the Company of $2,114,000, netting approximately $1,980,000 after legal costs, fees and commissions of approximately $134,000 (6.3%). In addition, as board approved non-cash transactions, three of the Company’s officers exchanged and forgave a total of $321,554 in debt owed to them by the Company into 235 Series F Preferred Shares under the same terms as the non-affiliated cash investors.

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The two most important uses of proceeds from the Series F Financing included 1) making the final payment of $750,000 to GPB Holdings, LLC, completed on January 8, 2021, and 2) allocate most of the remainder to completing the U.S. FDA clinical trial for the LuViva Advanced Cervical Scan. The clinical sites currently are reviewing the study protocol that was developed by the Company, which implemented recommendations made by the U.S. FDA. It is expected the trial will begin in the second quarter of 2021. The Company’s primary objective this year is completing the clinical trial of approximately 400 women and filing the results with the FDA.

The Series F Preferred shares are convertible at a fixed price of 25 cents per share, carry a 6% annual dividend and could potentially include an additional dividend of 15% after twelve months if the Company is unable to uplist to a national exchange or complete its FDA study. The dividends can be paid in cash or common shares at the option of the Company. Aspen Capital acted as Financial Advisor to the Company with respect to certain Canadian investments.

"Now that the Series F Financing has closed, netting sufficient funds, we can turn our full attention to completing the FDA study without delay," said Gene Cartwright, Guided Therapeutics CEO, adding, "At the same time, we have made great strides in cleaning up our balance sheet and have significantly reduced our liabilities, thereby setting the stage for a potential uplist to a national exchange, concomitant with the U.S. FDA study and significant progress in China."

On March 31, 2021 Boundless Bio, a next-generation precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) in aggressive cancers, reported plans to present at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, held virtually from April 10-15, 2021 (Press release, Boundless Bio, MAR 31, 2021, View Source [SID1234577453]). The poster presentation will show how ecDNA mediates resistance to targeted therapy via oncogene switching and will highlight the urgent need to develop innovative new therapeutic approaches for gene amplified tumors that are driven by ecDNA.

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Presentation details:

Title: Extrachromosomal DNA (ecDNA)-driven switching of oncogene dependency facilitates resistance to targeted therapy
Session Title: Drug Resistance in Molecular Target Therapeutics
Session Category: PO.ET03.01
Abstract Number: 1089
Date and Time: April 10, 2021, 8:30 a.m. – 11:59 p.m. ET

About ecDNA

Extrachromosomal DNA, or ecDNA, are distinct circular units of DNA lacking centromeres but containing functional genes, including oncogenes, that are separated from tumor cell chromosomes. ecDNA replicate within cancer cells and can be passed to daughter cells asymmetrically during cell division, thereby constituting a primary driver of focal gene amplification and copy number heterogeneity in cancer. By leveraging the plasticity afforded by ecDNA, cancer has the ability to increase or decrease copy number of select oncogenes located on ecDNA to enable survival under selective pressures, including chemotherapy, targeted therapy, immunotherapy, or radiation, making ecDNA one of cancer cells’ primary mechanisms of recurrence and treatment resistance. ecDNA are not found in healthy cells but are present in many solid tumor cancers. They are a key driver of the most aggressive and difficult-to-treat cancers, specifically those characterized by high copy number amplification of oncogenes.

On March 31, 2021 World-renowned cancer research and treatment center City of Hope reported that it has received a $50 million gift from Lennar Foundation, the charitable arm of homebuilder Lennar Corporation (Press release, City of Hope, MAR 31, 2021, View Source [SID1234577452]). This transformational gift of hope is the largest single philanthropic contribution to City of Hope Orange County. It will expedite the health care organization’s bold plans to invest $1 billion to develop and operate a comprehensive cancer campus in Irvine, California, and establish an Orange County network of advanced cancer care and research that will speed groundbreaking treatments directly to a community with growing needs.

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The future 190,000-square-foot Lennar Foundation Cancer Center at City of Hope Orange County will be located on 11 acres at Five Point’s Great Park in the heart of Irvine. It will bring best-in-class cancer care, pioneering research and lifesaving treatments to the county’s 3.2 million residents. Construction is already underway on the comprehensive cancer center, which will open in 2022. In addition, Orange County’s only hospital dedicated exclusively to treating and curing cancer will open at City of Hope Irvine in 2025.

City of Hope’s presence in Orange County offers local access to City of Hope’s National Cancer Institute-designated comprehensive cancer center with world-renowned cancer physicians and researchers who are singularly focused on finding better treatments and cures.

Lennar Foundation Cancer Center at City of Hope Orange County will bring to the region a host of distinguishing services, including:

Local access to more than 1,000 physicians and researchers who are transforming laboratory breakthroughs into targeted treatments that offer the best hope for patients
Access to hundreds of clinical trials that make 21st century treatments available to cancer patients meeting clinical criteria soon after they are developed.
A range of treatment options — from chemotherapy to immunotherapy and more — for combatting even the most aggressive cancers
New ways for preventing and treating cancer in its early stages, including highly targeted genomics and precision medicine breakthroughs
Nationally recognized supportive care programs rooted in more than a century of compassionate caregiving to help patients and their families overcome the psychosocial issues that can accompany a serious illness
As the country emerges from the COVID-19 pandemic, Lennar Foundation’s extraordinary contribution underscores the importance of investing in local health care resources and increasing access to leading-edge care. For Orange County, it is a reminder that cancer does not stop, and that City of Hope’s mission is more important than ever.

Lennar has a long history in Orange County of developing thriving communities, including helping form the vision for a world-class recreation and lifestyle destination. This gift is an extension of this longstanding commitment to improving lives in the regions Lennar helps shape. A portion of the gift to City of Hope is designated to support clinical translational research between City of Hope and the Sylvester Comprehensive Cancer Center of the University of Miami, thus uniting two organizations supported by Lennar’s generosity who share similar goals in developing new treatments and cures for patients with cancer.

City of Hope and Sylvester Comprehensive Cancer Center serve two of the most diverse areas in the United States. Both organizations are committed to conducting high-impact research that addresses the cancer burden in their communities. This gift will enable collaborative, translational science that will drive innovation and catalyze timely and necessary progress towards health equity.

Lennar Foundation’s gift to City of Hope is a generous continuation of Lennar’s longstanding support of the comprehensive cancer center. Jon Jaffe, co-chief executive officer and co-president of Lennar Corporation, is a member of City of Hope’s Construction Industries Alliance Leadership Advisory Council, which raises funds for cancer treatment and research. In recognition of his contributions, Jaffe was awarded City of Hope’s highest honor — The Spirit of Life Award in 2004.

City of Hope Newport Beach, the first phase of City of Hope Orange County’s expansion, opened in early 2020, providing Orange County residents first-time local access to world-renowned physicians backed by the powerful City of Hope network. City of Hope plans to open other clinical network locations across the region.

Supporting quotes

Robert Stone, president and CEO, City of Hope
Helen and Morgan Chu Chief Executive Officer Distinguished Chair

"This is the start — and it is a monumental start — to show the nation that our work in Orange County will catalyze incredible achievements in health care. Visionary donors and volunteers have been foundational to City of Hope’s 108-year history, and we are deeply grateful to the Lennar Foundation for their extraordinary contributions and longstanding support. With this gift, we will achieve the nexus of unsurpassed medical expertise, future-focused communities, groundbreaking technology and innovation, all for the single purpose of saving lives. This partnership supports a system of care delivery that provides state-of-the-art treatments, the latest scientific and medical discoveries, and unprecedented access that will serve as a model across the country."

Stuart Miller, executive chairman, Lennar Corporation

"At Lennar, we are committed to building communities, and we are pleased to support City of Hope to help build the future of cancer care. Together, we are building a state-of-the-art center for advanced cancer care and research that will make a difference in the lives of so many by turning science into practice and hope into reality."

Nicole Petersen Murr, grateful Orange County patient

"City of Hope saved my life. My family and I will be forever grateful to my doctor and care team. Anyone who has heard the words ‘You have cancer’ knows how those words change your life and affect every piece of it. I want everyone who hears those words to have the same compassionate care and access to the latest treatments that I had. Having City of Hope in Orange County changes everything for cancer patients — present and future. I’m so grateful to have this world-renowned care in my own community."

Annette M. Walker, president, City of Hope Orange County

"This generous gift of hope is a historic moment for City of Hope. Thank you to Lennar Foundation, which is united in our vision and understands the urgency of our work, helping us ensure that our promise to Orange County will be fulfilled. We are building a place of hope and healing that will serve residents of Orange County and beyond for generations to come. Every one of us has been touched by cancer and we want all who are impacted by this disease to know we are here for you, your family, friends and neighbors."

Jon Jaffe, co-chief executive officer and co-president, Lennar Corporation

"City of Hope is a leader in the treatment of and race to find a cure for cancer, and it’s gratifying to know that, with this gift, we will make a positive impact by expanding access to care and advancing the research that will treat, prevent and ultimately eliminate cancer — we hope this contribution will encourage other philanthropic leaders to support City of Hope in the fight against cancer."

Kristin J. Bertell, chief philanthropy officer, City of Hope

"This important contribution is a clear demonstration of the power of philanthropy to accelerate positive changes in health care delivery, spur advances in science, research and treatment, and give real hope to patients, families and communities. Lennar Foundation’s generosity continues a long philanthropic legacy that is the cornerstone of our history. There is no doubt that this gift will have a long-lasting impact, and we look forward to engaging the community to make the vision for Orange County and the future of cancer care a reality."

For more information on the progress of City of Hope’s Orange County expansion and its first clinical network location in Newport Beach, please visit CityofHope.org/OC.