GT Biopharma to Present at The Virtual 33rd Annual Roth Conference

On March 10, 2021 GT Biopharma, Inc. (NASDAQ: GTBP) a clinical stage biopharmaceutical company focused on the development and commercialization of disruptive, target-directed Natural Killer (NK) cell engager immunotherapy protein biologic platform technology, TriKE, for the treatment of cancer and infectious diseases, reported that management will present at the Virtual 33rd Annual Roth Conference on Wednesday, March 17th, 2021 at 12:00 p.m. ET (9:00am PT) (Press release, GT Biopharma, MAR 10, 2021, View Source [SID1234576378]).

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A live webcast of the presentation may be accessed by visiting the Investors section of the GT Biopharma website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the presentation.

About GTB-3550 TriKE

GTB-3550 TriKE is a first-in-class immuno-oncology therapeutic being evaluated in patients age 18 and older in a Phase I/II clinical trial (NCT03214666) having CD33+ malignancies (primary induction failure or relapsed AML with failure of one reinduction attempt or high-risk MDS progressed on two lines of therapy). Interim results demonstrated GTB-3550 TriKE reduces bone marrow blast levels in AML and MDS patients, and improved NK cell function and proliferation.

Complix Signs Global Drug Discovery and Development Agreement with I-Mab to Develop Cell Penetrating Alphabodies against Two Intracellular Immuno-oncology Targets

On March 10, 2021 Complix, a biopharmaceutical company developing a pipeline of transformative Alphabody therapeutics reported that it has signed a significant drug discovery deal with I-Mab (Nasdaq: IMAB), an innovation-driven clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel and highly differentiated biologics in the immuno-oncology therapeutic area (Press release, Complix, MAR 10, 2021, View Source;utm_medium=rss&utm_campaign=complix-signs-global-drug-discovery-and-development-agreement-with-i-mab-to-develop-cell-penetrating-alphabodies-against-two-intracellular-immuno-oncology-targets [SID1234576369]).

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Under the terms of the agreement, Complix will use its proprietary Alphabody platform to deliver Cell Penetrating Alphabodies (CPABs) against two immuno-oncology intracellular targets. The resulting CPABs will undergo clinical development that will be jointly managed by both companies.

I-Mab will have an exclusive license to commercialize the CPABs in Greater China, with the rest of the world commercialization rights being equally owned by both companies. In return, Complix is entitled to receive an upfront payment and potential development milestones fees, as well as tiered royalties.

CPABs are a revolutionary class of small proteins engineered to bind to a variety of antigens. Data available show that CPABs have the potential to address a wide range of disease targets, particularly intracellular targets that are difficult for current therapies to reach.

In addition to crossing cellular membranes, Alphabodies have the potential to cross the blood brain barrier to address CNS diseases and to be delivered orally given their ability to cross the gut wall.

Jounce Therapeutics Announces Pricing of $56.25 Million Public Offering of Common Stock

On March 9, 2021 Jounce Therapeutics, Inc. (Nasdaq: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it has priced an underwritten public offering of 5,000,000 shares of common stock at a public offering price of $11.25 per share, which would result in gross proceeds of approximately $56.25 million, before underwriting discounts and commissions (Press release, Jounce Therapeutics, MAR 10, 2021, View Source [SID1234576366]).

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The proceeds of the offering are expected to be used to fund ongoing and planned clinical trials, including the INNATE trial of JTX-8064, to fund research and development to advance Jounce’s pipeline, and for working capital and other general corporate purposes. All shares are being offered by Jounce. Closing of the offering is expected to occur on or about March 12, 2021, subject to customary closing conditions. Jounce has also granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock offered in the public offering on the same terms and conditions.

Cowen and Piper Sandler are acting as joint book-running managers for the offering.

The offering is being made pursuant to a shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on March 8, 2018 and declared effective by the SEC on May 1, 2018. The offering will be made only by means of the prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to, and describing the terms of, the offering has been filed with the SEC and is available on the SEC’s web site at www.sec.gov.

The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering can be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at 833-297-2926; or from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924.

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.

ImmunityBio Begins Trading Today on Nasdaq as Large Cap Biotechnology Company

On March 10, 2021 ImmunityBio, Inc. (NASDAQ: IBRX) reported it has begun trading as a large cap company with approximately 398 million fully diluted shares outstanding following its merger with NantKwest (Press release, ImmunityBio, MAR 10, 2021, View Source [SID1234576365]). The combined company begins trading today on the Global Select Market of the Nasdaq exchange under the IBRX ticker.

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ImmunityBio is a leading late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases. The company’s immunotherapy platform activates both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term "immunological memory."

The company’s broad-based platforms are based on the foundation of four separate modalities: Antibody cytokine fusion proteins, synthetic immunomodulators, second-generation human adenovirus (hAd5) and yeast vaccine technologies, and state-of-the-art, off-the-shelf natural killer cells, including autologous and allogenic cytokine-enhanced memory NK cells.

ImmunityBio has a broad immunotherapy clinical pipeline of over 40 clinical trials in Phase I, II and III development across 19 indications in solid and liquid cancers and infectious diseases. The clinical-stage pipeline and intellectual property portfolio spans 17 first-in-human antibody cytokine fusion proteins, chemo immuno-modulators, vaccine vectors, and cell therapies in 25 Phase II and III clinical trials. Anktiva (ImmunityBio’s lead cytokine infusion protein) is a novel interleukin-15 (IL-15) superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the U.S. Food and Drug Administration (FDA) for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC).

SIR-Spheres® Y-90 Resin Microspheres Obtains Recommendation from NICE and Approval from the FDA

On March 9, 2021 Grand Pharmaceutical and Healthcare Holdings Limited ("GP (HK)" or the "Company", together with its subsidiaries, the "Group", stock code: 00512) reported that the Group’s associate Sirtex Medical Pty Ltd core anti-tumor drug SIR-Spheres Y-90 resin microspheres obtained recommendation from the National Institute for Health and Care Excellence ("NICE") in the treatment of unresectable advanced hepatocellular carcinoma ("HCC") in adults, and obtained an approval from the US Food and Drug Administration ("FDA") to conduct clinical trials on primary liver cancer (Press release, Grand Pharmaceutical, MAR 9, 2021, View Source [SID1234653970]).

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SIR-Spheres Y-90 resin microspheres are used in selective internal radiation therapy for malignant liver tumors. The SIR-Spheres Y-90 resin microspheres are delivered to the vasculature of liver tumor via a worldwide leading interventional technology, and then emit high doses of beta radiation to destroy tumor cells, which are the only radioactive microspheres around the world approved by the FDA.

NICE is an important organization of National Health Service ("NHS") in England, and is one of the recognized premier health technology assessment organizations in the world. More than 75% of the governments and health technology assessment agencies in the world regard NICE’s recommendations as an important decision-making basis for bringing products into their own medical insurance reimbursement. As recommended by NICE, the use of selective internal radiation therapy ("SIRT") using SIR-Spheres Y-90 resin microspheres in England and Wales will be a fully funded and reimbursed option for adult patients with HCC, on the conditions that it is used for patients with Child-Pugh grade A liver impairment when conventional transarterial therapies are inappropriate. This approval opens the potential to treat thousands of patients who would apply to treat with SIR-Spheres Y90 resin microspheres, annually, in the UK. Besides, SIR-Spheres Y-90 resin microspheres obtaining recommendation from NICE is a milestone for its global medical insurance reimbursement access, which is expected to accelerate its access to medical insurance reimbursement in other emerging markets (such as Brazil), further expand its market shares, and help more liver cancer patients worldwide to receive the treatment of SIR-Spheres Y-90 resin microspheres.

In addition, SIR-Spheres Y-90 resin microspheres have been approved by the FDA to conduct clinical trials on primary liver cancer in order to apply for marketing license of primary liver cancer in the United States. The clinical trial is a single arm trial and patients will be recruited in the near future.

The results of clinical studies prove that SIR-Spheres Y-90 resin microspheres can significantly increase tumor response rate, reduce tumor burden and achieve tumor downstaging, so that patients can gain the chances to undergo surgical resection. It can also significantly prolong the progression-free survival, control tumor progression and increase the waiting time for liver transplantation. In the meantime, SIR-Spheres Y-90 resin microspheres bring less side effects and higher quality of life for patients. With its remarkable clinical efficacy, SIR-Spheres Y-90 resin microspheres have been given to over 100,000 people in over 50 countries and regions around the world. It is recommended for treatment of hepatic malignant tumors by many authoritative guidelines, including National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper). It is also covered by medical insurance in places such as the United States and Europe. In addition, it is included in the Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019 edition) and Chinese Guidelines for the Diagnosis and Comprehensive Treatment of Colorectal Cancer Liver Metastasis (2018 edition).

The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented: "Two important developments demonstrate the clinical efficacy and competitive advantages of SIR-Spheres Y-90 resin microspheres, helping more liver cancer patients worldwide receive treatment. The NICE recommendation proves that the treatment of SIR-Spheres Y-90 resin microspheres has positive effects on the quality of life and economic benefits of HCC patients."

"Sticking to patients-centered and innovation-driven, the Group will continue to expand its strategic planning in anti-tumor field and increase its investment in the world-class innovative products in the fields of radiopharmaceuticals and precision interventional therapy. Through cooperating with the three global leading anti-tumor pharmaceutical companies which are invested by the Group, including United Stated based OncoSec, Australia based Sirtex and Telix Pharmaceuticals Limited (ASX: TLX), the Group will continue to introduce world-class innovative products for different cancer indications in response to unmet clinical needs and enrich 3product pipeline and improve supply chain, dedicating itself into building world-leading radiopharmaceuticals platform and Immunotherapy platform integrating diagnostics and treatment. The Group adopts the strategy of ‘global expansion and dual-cycle operation’, forming a new pattern of domestic and international cycles that synergize with each other. The Group makes full use of its domestic industrial advantages and research and development capabilities, to accelerate commercialization processes for innovative products and provide cancer patients with more advanced and diverse treatment options in the world."