On April 8, 2021 City of Hope and CytoImmune Therapeutics Inc. reported that have entered into worldwide exclusive license agreements to several patent applications related to methods to generate large numbers of fully functional natural killer (NK) cells derived from umbilical cord blood and compositions of chimeric receptors (CAR) for targeting NK cells to tumors (Press release, CytoImmune Therapeutics, APR 8, 2021, View Source [SID1234577729]). (Photo: CytoImmune Therapeutics Inc.)

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DUARTE, Calif. & MONROVIA, Calif.–(BUSINESS WIRE)–City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases, and CytoImmune Therapeutics Inc. ("CytoImmune"), a clinical-stage biopharmaceutical company focused on commercializing novel cancer immunotherapy products, announced that they have entered into worldwide exclusive license agreements.

"We are proud of Dr. Caliguiri and Dr. Yu’s discoveries and are pleased to enter into these agreements with CytoImmune."
The agreements include licenses to several patent applications related to methods to generate large numbers of fully functional natural killer (NK) cells derived from umbilical cord blood and compositions of chimeric receptors (CAR) for targeting NK cells to tumors. They include a prostate stem cell antigen (PSCA) CAR to treat pancreatic, gastric, bladder, prostate and some lung cancers, a programmed death-ligand 1 (PD-L1)+ NK cell for use in treating lung cancer, and fms-like tyrosine kinase 3 (FLT3) CAR NK cell therapy for use in treating acute myeloid leukemia.

The licensed technologies are based on discoveries by CytoImmune co-founders Jianhua Yu, Ph.D., professor, City of Hope Department of Hematology & Hematopoietic Cell Transplantation, and Michael A. Caligiuri, M.D., president, City of Hope National Medical Center, who together have over 55 years of experience in NK cell biology and more than 500 original, peer-reviewed publications on NK cells and cancer.

"As an independent institution dedicated to advancing the fight against cancer, City of Hope is committed to finding innovative discoveries and treatments, and NK cell therapies offer great hope for patients," said Robert Stone, president and CEO of City of Hope and the Helen and Morgan Chu Chief Executive Officer Distinguished Chair. "We are proud of Dr. Caliguiri and Dr. Yu’s discoveries and are pleased to enter into these agreements with CytoImmune."

CAR NK therapies are designed to harness the power of NK cells, from healthy donors, that are in turn "engineered" to aggressively treat patients with cancer while minimizing the side effects of treatment. City of Hope, a recognized leader in CAR T cell therapies for solid and blood cancers, has treated more than 600 patients since its CAR T research started in the late 1990s. The institution continues to have one of the most comprehensive CAR T cell GMP facilities and CAR T cell clinical research programs in the world with nearly 50 CAR T cell trials currently taking place at City of Hope or about to open.

"CytoImmune has expanded our productive partnership with City of Hope, a leader in immunotherapy research, and we have solidified our position as leaders in NK cell technology," said Rich Santulli, chairman and CEO of CytoImmune. "Drs. Caligiuri and Yu have worked together for nearly 20 years and have made important and fundamental discoveries in NK cell science. With these agreements, we have gained access to technologies that will generate an abundant supply of our proprietary engineered and enhanced NK cells that can selectively kill both blood and solid tumor cells. We are hopeful that by furthering this research we will ultimately benefit patients who need new treatment options."

"As a scientific founder of CytoImmune, I am pleased to see the company expand its collaboration with City of Hope. NK cell therapy holds great promise for treating both blood and solid tumor cancers. We are excited to see this promising therapy move forward with the goal of helping even more patients battling cancer," said Caligiuri, the Deana and Steve Campbell Physician-in-Chief Distinguished Chair.

Yu and Caligiuri also have many patents between them for many firsts in human NK cell development, survival, activation, in vivo modulation and preclinical models of human NK CAR therapy for cancer. Over 1,000 cancer patients have been treated on protocols designed or co-designed by Caligiuri using cytokine therapies to modulate NK cells.

CytoImmune Therapeutics is translating into the clinic a CAR NK cell platform targeting AML, B cell malignancies and multiple myeloma, as well as pancreatic, gastric, bladder, prostate and lung cancer. Investigational new drug filings are in process or planned for the use of CAR NK cells in these liquid and solid tumors in 2021.

On April 8, 2021 Hutchison China MediTech Limited ("HUTCHMED") (Nasdaq/AIM: HCM) reported that it has entered into a definitive agreement for the issuance of US$100 million of shares at a price equivalent to US$30.5 per American Depositary Share ("ADS") via a private placement to funds affiliated with Baring Private Equity Asia ("BPEA") (Press release, Hutchison China MediTech, APR 8, 2021, View Source [SID1234577727]).

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Mr. Christian Hogg, Chief Executive Officer of HUTCHMED, said, "We expect significant growth of our business this year as we look to accelerate our oncology revenues from ELUNATE, SULANDA and the potential upcoming approval of savolitinib, likely to be a first-in-class selective c-MET inhibitor in China. We are rapidly expanding global development of our ten oncology assets, all of which were discovered in-house at HUTCHMED, and are planning to initiate 8-10 registration and registration-intent studies in 2021. This is the right time to welcome BPEA to our existing shareholder base, a firm with a long history of supporting innovative globally-focused businesses. We look forward to partnering with BPEA in the next stage of our development."

Mr. Jean Eric Salata, Chief Executive Officer and Founding Partner of BPEA, said, "With this strategic investment, BPEA is demonstrating our long-term commitment to HUTCHMED, an emerging biopharma leader in Asia. The healthcare sector in China is a core area of investment focus for BPEA. HUTCHMED is developing and delivering highly differentiated oncology therapies to patients around the world and we look forward to working with the CEO and management team to support the company’s innovation and global growth aspirations."

Founded in 1997, BPEA is one of the largest and most established independent private equity firms in Asia with approximately $23 billion of assets under management. BPEA has a well-established track record investing in the healthcare sector with a diverse portfolio across different verticals, providing strategic capital to and working closely with industry leaders to grow their businesses over the long-term.

HUTCHMED will receive all proceeds from this private placement of the equivalent of 3,278,689 ADSs, which will fund ongoing research and clinical development and support the further growth of its commercialization capabilities both in China and globally.

Description of Share Capital and Securities Regulation

HUTCHMED has agreed to issue 16,393,445 ordinary shares, par value US$0.10 each (the "Shares"), pursuant to the private placement. The Shares will, when issued, be fully paid and will rank pari passu in all respects with the existing ordinary shares of HUTCHMED. Each ADS represents five Shares.

The securities to be sold in the private placement will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Subject to certain conditions, the Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the Shares sold in the private placement to facilitate future resales by BPEA. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

This announcement, including any information included or incorporated by reference in this announcement, is for information purposes only and shall not constitute nor form part of, and should not be construed as, an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. No public offering of the securities referred to in this announcement is being made in the United States or elsewhere.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018).

Admission to the London Stock Exchange AIM market and Shares Outstanding After Completion

Application will be made for the Shares to be admitted to the AIM market operated by the London Stock Exchange ("Admission"). It is expected that Admission will become effective at 8:00 a.m. BST on April 14, 2021.

Following admission of the Shares to trading on AIM, the issued share capital of HUTCHMED will consist of 744,515,660 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury. The figure of 744,515,660 may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, HUTCHMED under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.

For illustrative purposes only, if the 744,515,660 ordinary shares were converted in their entirety, they would be equivalent to 148,903,132 Nasdaq-traded ADSs (each equating to five ordinary shares).

On April 8, 2021 Biogen Inc. (Nasdaq: BIIB) and Bio-Thera Solutions, Ltd. (688177.SH) reported that they entered into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, a Phase 3 clinical stage anti-interleukin-6 (IL-6) receptor monoclonal antibody that is a proposed biosimilar referencing ACTEMRA1 (tocilizumab) (Press release, Biogen, APR 8, 2021, View Source [SID1234577726]).

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ACTEMRA’s primary indication is for moderate to severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis, systemic juvenile idiopathic arthritis, giant cell arteritis and cytokine release syndrome. In 2020 global sales of ACTEMRA were 2.8 billion CHF.2 Biogen will gain exclusive regulatory, manufacturing and commercial rights to BAT1806 in all countries excluding China (including Hong Kong, Macau and Taiwan). Biogen will expand its global biosimilars footprint with the potential approval of BAT1806.

Biosimilars are biologic products that have been demonstrated to be similar in efficacy, safety and immunogenicity to the originator’s approved reference product, with the advantage that they offer cost savings. Biosimilars may lower healthcare system costs broadly, creating headroom for innovation and could enable governments to potentially redirect savings to priorities such as increasing access to transformative therapies.

"We are excited about this new transaction with Bio-Thera Solutions, a leading commercial-stage biopharmaceutical company in China, and how BAT1806 will augment our expanding portfolio of biosimilars assets," said Chirfi Guindo, Head of Global Product Strategy and Commercialization at Biogen. "Biosimilars deliver sustainable value for patients, physicians, healthcare systems and society by expanding access to leading biologic therapies worldwide."

"Bio-Thera Solutions is pleased to work with Biogen, one of the world’s first and leading global biotechnology companies, to commercialize BAT1806, our tocilizumab biosimilar program in all countries outside of China," said Dr. Shengfeng Li, CEO of Bio-Thera Solutions. "This agreement allows Bio-Thera Solutions and Biogen to bring a potentially new biosimilar option to patients."

Under the terms of the agreement, Biogen will make an upfront payment of $30 million to Bio-Thera Solutions, contingent upon Bio-Thera Solutions’ Phase 3 for BAT1806 achieving satisfactory results. Should certain commercial milestones be achieved, Bio-Thera Solutions will be eligible to receive potential milestone payments. Biogen will also pay Bio-Thera Solutions tiered royalties.

Closing of the transaction is contingent upon completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S. The transaction is expected to close in the second quarter of 2021.

On April 8, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing onvansertib to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, pancreatic cancer and castrate-resistant prostate cancer, reported that it will host a key opinion leader (KOL) webinar on onvansertib for the treatment of KRAS-mutated metastatic colorectal cancer on Monday, April 12, 2021 at 11 a.m. Eastern Time (Press release, Cardiff Oncology, APR 8, 2021, View Source [SID1234577725]).

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The webinar will feature presentations by KOLs Daniel H. Ahn, D.O., M.S. (Mayo Clinic Arizona), and Manish R. Sharma, M.D. (START Midwest), who will discuss the current treatment landscape and unmet medical need in KRAS-mutated metastatic colorectal cancer (mCRC), as well as the ongoing Phase 1b/2 clinical trial and observations from the Expanded Access Program evaluating onvansertib in combination with FOLFIRI/Avastin in KRAS-mutated mCRC.
During the webinar, Cardiff Oncology’s CEO, Mark Erlander, Ph.D., will give a corporate update and outlook for the year. Dr. Erlander and Drs. Ahn and Sharma will be available to answer questions following the conclusion of the formal presentations.

About the KOLs
Daniel H. Ahn, D.O, M.S. is a GI Medical Oncologist and Assistant Professor in the Division of Hematology/Medical Oncology at the Mayo Clinic. He conducts clinical and translational research focused on developing anti-cancer agents for patients with gastrointestinal cancers. Dr. Ahn collaborates extensively with various scientists and industry partners to design and execute innovative clinical trials, including many first-in-human studies. He is the Lead for the GI Oncology Translational Research Disease Working Group at Mayo Clinic Arizona. He also serves on the Board of Directors for the Mayo Clinic-supported cancer research consortium Academic and Community Cancer Research United (ACCRU) and is an Alliance for Clinical Trials in Oncology GI Committee member, a National Cancer Institute (NCI)-supported cooperative research group.
Dr. Ahn’s research includes a large focus on the incorporation of agents that target the multiple facets of cancer, including genetic and epigenetic drivers, as well as the feeding microenvironment and the immune milieu. His research has also led to the launch of a number of clinical trials, including recent studies investigating novel agents targeting DNA repair mechanisms, sequencing treatment strategies in colorectal cancer as well as various targeted therapies in advanced colorectal cancer.

Manish R. Sharma, M.D. is the Associate Director of Clinical Research at START Midwest and is a medical oncologist in Grand Rapids, Michigan. He graduated with honors from the University of Michigan Medical School in 2004. He completed his residency in Internal Medicine at the University of California – San Francisco, where he also served as chief resident. He completed a combined fellowship training in Hematology/Oncology and Clinical Pharmacology & Pharmacogenomics at the University of Chicago.
He subsequently spent six years on the faculty as an Assistant Professor of Medicine at the University of Chicago, where he had a Career Development Award from the National Institutes of Health and was very involved in the teaching and mentorship of trainees. Dr. Sharma developed expertise in oncology drug development, gastrointestinal cancers, clinical pharmacology, pharmacogenomics, and pharmacometrics. He is board certified in Medical Oncology and Clinical Pharmacology.
Dr. Sharma joined START Midwest and Cancer & Hematology Centers of Western Michigan in 2018. Throughout his clinical oncology practice, Dr. Sharma has specialized in the treatment of gastrointestinal cancers. His clinical research interests include early phase drug development and clinical pharmacology trials for patients with advanced solid tumors. He has been the principal investigator on more than 25 phase I clinical trials involving immunotherapies, targeted therapies, chemotherapy, antibody-drug conjugates, drug-drug interactions, and food effect. He has co-authored more than 20 peer-reviewed papers related to oncology drug development and has served as a reviewer for many oncology and clinical pharmacology journals.

On April 8, 2021 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported preliminary, unaudited revenue for the first quarter 2021 (Press release, Biofrontera, APR 8, 2021, View Source [SID1234577724]).

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The Company’s preliminary unaudited revenue for the period January 1 to March 31, 2021 amounts to approximately EUR 5.6 million compared to EUR 6.5 million in the same period last year, a decline of 14%.

Preliminary revenues from product sales in the US were around EUR 3.9 million, compared to EUR 4.2 million in Q1 2020, which corresponds to a decline of 6%. In Germany, revenues from product sales amounted to approximately EUR 1.4 million, compared to EUR 1.3 million in Q1 2020, a gain of 7%. In the rest of Europe, the Company generated product sales of around EUR 0.3 million, compared to EUR 0.8 million in the same period last year, a decline of 69%.

While sales in Germany remained relatively stable over the quarter compared to the previous year, revenues in the USA for the months of January and February 2021 were well below those of the previous year due to the pandemic. Starting in the second half of March last year, our sales were significantly impacted by the pandemic, and this is where we already saw a significant upturn this year in the USA compared to last year. In March 2021, our sales in the USA increased by around 46% year-on-year, indicating a significant recovery of the situation in the USA, presumably also due to the high vaccination rates.