On March 28, 2022 ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (hereinafter referred to as "ImmuneOnco") reported that data from 2 different new projects in two posters will be presented at the 2022 annual meeting of American Association for Cancer Research (AACR) (Free AACR Whitepaper) hold in New Orleans from April 8 to 13 (Press release, ImmuneOnco Biopharma, MAR 28, 2022, View Source [SID1234655644]). Two abstracts from ImmuneOnco were selected for poster presentation at the AACR (Free AACR Whitepaper) 2022. These posters will summarize the progress of the company’s early clinical and preclinical pipelines like IMM2902.

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Dr. Wenzhi Tian, founder, chairman and CEO of ImmuneOnco, said: "The data we present at AACR (Free AACR Whitepaper) 2022 will provide insight into the targets related to our 3 pipelines and promising data to support further clinical development. These study data have played a critical role in guiding our clinical development program. We are excited to have the opportunity to share these data with our colleagues in the oncology field.

On March 28, 2022 Nanjing Kati Medical Technology Co., Ltd., a cutting-edge domestic solid tumor CAR-T cell therapy company, reported in early February 2022, the company completed an A+ round of financing totaling more than 70 million yuan (Press release, CART Medical, MAR 28, 2022, View Source [SID1234639848]). This round of financing was jointly completed by Nanjing Chengyi Investment, Qiandao Group, Suzhou Guanya Investment and Haihui Investment. This round of financing will be mainly used to promote IND filing for Kati Medical’s leading product.

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Kati Medical was established in 2017 and is headquartered in the Nanjing Biopharmaceutical Valley, a national-level Jiangbei New Area in Nanjing. It is a key enterprise in the genetic and life health fields and a national high-tech innovation enterprise in Jiangbei New Area. Kati Medical focuses on the development of new CAR-T cell drugs for solid tumors. Focusing on the solid tumor microenvironment, the proprietary technology platform has significant potential. Kati Medicine was founded by Dr. Wang Enxiu, a core member of Carl June’s team at the University of Pennsylvania. The company’s core leadership team comes from the Chinese Academy of Sciences, Tsinghua Union Medical College, Nanjing Medical University, and MD Anderson Cancer Center in the United States. Center and other top institutions have rich experience and high professionalism in oncology, drug research and development, commercial operations, etc. Dr. Wang Enxiu has achieved breakthrough results in CAR-T flexible activation design, and the core patent has been authorized by European, American and Chinese patents. Immune cell CAR-T drugs currently show significant efficacy in the clinical treatment of hematological tumors, but most current CAR-T products have poor efficacy against solid tumors. Dr. Wang pointed out that this is mainly related to the structural design of CAR. Solid tumors have a more complex microenvironment than hematological tumors. Without technological innovation, it is difficult to apply the structural design of traditional CAR to bring clinical efficacy. Cati Medical has identified this need and pain point, concentrated its efforts, designed the CAR-T architecture for the solid tumor microenvironment, and independently developed a new DAP-CAR-T solid tumor CAR-T technology platform. The DAP-CAR-T technology platform based on flexible activation can effectively improve the adaptability of CAR-T cells to the tumor microenvironment, reduce clinical side effects and have good durability. Kati Medical relies on its own technology platform to develop a series of new candidate R&D drugs with independent intellectual property rights. It has 5 R&D pipelines including KT030, KT032, KT095, KT081, and KT051. Among them, KT032 treats pancreatic cancer, ovarian cancer, and mesothelial cancer. Cancer and other solid tumors are designated as indications, and it is the leading research and development pipeline of Kati Medicine. KT032 is a solid tumor CAR-T product targeting Mesothelin. Early IIT data show that among 8 patients with mesothelin-positive solid tumors (one of which was pancreatic tumor and the rest were ovarian cancer), the best curative effect after treatment was PR (4/7), SD (3/7), and the overall response rate ( ORR) was 57.5%, the disease control rate (DCR) was 100%, the median progression-free survival was 7 months, and the longest progression-free survival was 17 months; the median survival was 11.625 months, and the longest survival The term is 17 months. Kati Medical is currently carrying out in-depth cooperation with top domestic hospitals. The number of patients enrolled in the trial continues to increase, forming a trial progress rate of one case recovery, one case preparation, and one case blood collection, and continues to collect trial data. Dr. Wang Enxiu, founder of Kati Medical, said: "Our vision is to be the most innovative cell drug company in China. Currently, Kati Medical has built a third-generation signaling platform for the "activation end" of CAR, which can realize target replacement at any time. , thereby expanding different indications. In the future, we will use our own innovative platform to open a richer product pipeline and achieve more diversified product transformation." Wang Yuan, partner of Nanjing Chengyi Investment, said: "Kati Medical The founder of Penn made a significant contribution to the collaboration between Penn and Novartis to promote the launch of the world’s first CAR-T drug. He has more than ten years of experience and accumulation in the field of CAR-T technology and is a trustworthy partner. In addition, , we attach great importance to Kati Medical’s own technology platform, based on which Kati Medical can establish a rich product pipeline for different solid tumors." Jiang Yu, investment director of Qiandao Investment Fund, said: "There are many fields in the field of gene and cell therapy. Opportunities for layout, CAR-T has shown good clinical efficacy in the treatment of hematological tumors, but there is still room for breakthrough in solid tumors. We recognize the accumulation and experience of Kati Medical and founder Dr. Wang Enxiu in the CAR-T field, and are optimistic about it The layout and prospects of the company’s product pipeline." About Chengyi Investment Chengyi Investment was founded in 2015, based in Nanjing and radiating to the Yangtze River Delta region. Focus on equity investment and value-added services in early and growth stages, with a core focus on biomedicine and technological innovation. At present, the scale of Chengyi Investment Management Fund is nearly 2 billion yuan. In the field of biomedicine, we have invested in a number of outstanding companies that represent the future development direction, including Zhonghui Biotech, Bioxin Biotech, and Kewang Pharmaceuticals. In addition to capital assistance, Chengyi Investment also provides all-round and multi-level help and support to each invested enterprise to promote enterprise innovation and growth, so that they can eventually develop into industry leaders and beneficially promote industrial change and social progress. About Gandao Group Gandao Group was founded in 2011. Adhering to the concept of "technology empowers finance, financial services industry, and industry serves the motherland", it is deeply involved in China’s economic development and industrial upgrading, and is committed to becoming a comprehensive holding company that leads innovation with technology and serves the real economy. group. Qandao focuses on multiple asset management and investment businesses such as equity investment, industrial investment, and special opportunity investment. The group owns Qandao Investment Fund Management Co., Ltd., which focuses on medicine and medical technology, advanced manufacturing, and new energy, as well as a subsidiary of a state-owned enterprise under mixed ownership reform— —China Emerging Asset Management Co., Ltd. and many other member companies. Qandao’s pharmaceutical and medical investment focuses on innovative drugs including biomedicine, in vitro diagnostics, innovative medical devices, medical services and technology. About Suzhou Crown Asia Investment Suzhou Guanfengyu Venture Capital Center (Limited Partnership) is a private equity investment fund managed by Crown Asia Investment. Crown Asia Investment is established by professionals with senior professional background, work experience and independent judgment. , has rich investment experience and resource accumulation in the fields of biomedicine and equipment, semiconductors and new energy. Guided by industrial development needs, based on hard-core technology investment, and relying on rich industrial resources, the company continuously discovers and cultivates outstanding innovative enterprises with growth potential, creates long-term value for investors, and supports the growth of innovative enterprises. Protect and protect. About Haihui Investment

Haihui Investment was established in 2007 and is headquartered in Guangzhou. It is the first venture capital fund in Guangzhou to obtain national registration and management. It is a venture capital institution (VC) that has long been focused on start-up companies. It has worked with Jiete Biotech, Hongya CNC, Boyun New Materials, Gaolan Shares, Lushan New Materials, etc. have dozens of successful IPO exit cases as early investors. The cumulative assets of its managed funds are tens of billions. It is the national technology-based small and medium-sized enterprise guidance fund recognized management agency, and has been continuously It has received key support from the National Venture Capital Guidance Fund Project for more than ten years.

On March 28, 2022 Immorna Biotherapeutics, Inc. (Immorna), a rapidly-expanding biotechnology company developing both self-replicating and conventional mRNA-based therapeutics and vaccines, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for JCXH-211, a novel self-replicating mRNA encoding human interleukin (IL)-12 protein (Press release, Immorna, MAR 28, 2022, View Source [SID1234619633]).

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This IND clearance allows Immorna to initiate a Phase 1, multi-center, open-label, First-in-Human (FIH) dose escalation and expansion study of JCXH-211 in patients with malignant solid tumors, administered via intratumoral injection. The goal of the study is to establish a recommended dosing regimen, and assess the safety, tolerability and preliminary efficacy of JCXH-211 in cancer patients.

JCXH-211 is the first-in-class lipid nanoparticle (LNP) encapsulated self-replicating mRNA, using Immorna’s proprietary technology, encoding the human IL-12 protein. The strong anti-viral innate response triggered by RNA replicon together with the potent anti-cancer immunity stimulated by IL-12 conferred JCXH-211 superior tumor-eradicating potency in multiple preclinical animal and patient-derived xenograft (PDX) models, which was better than similar investigational drug employing conventional (non-replicating) mRNA. JCXH-211 was manufactured by Immorna’s robust CMC process and showed very favorable safety profiles in comprehensive GLP toxicology studies.

IL-12 is a naturally occurring cytokine that plays a key role in the body’s immune response against cancer. Despite consistently showing potent antitumor activity in preclinical studies, the efficacy of IL-12 treatment at tolerable doses in humans failed to provide clinical benefit. One key challenge for IL-12 treatment is the delivery method. IL-12 given through bolus injection was unstable and had a short half-life, and frequent intravenous administration of recombinant human IL-12 protein was challenging due to unacceptable toxicities. Alternate localized delivery systems, such as intratumoral injection, could potentially help to overcome this hurdle by directly targeting the tumor microenvironment whilst limiting systemic exposure and thereby minimizing adverse effects.

"IL-12 is crucially important in providing the immune antitumor response," said NgocDiep Le, M.D., Ph.D., Global Chief Medical Officer of Immorna. "Immorna is excited to have received FDA clearance to initiate this FIH study of JCXH-211, the first-in-class LNP-encapsulated self-replicating mRNA encoding human IL-12 protein, in patients with malignant solid tumors. We look forward to working with the investigators and patients to bring this potential novel therapy to patients who are in dire need of new and effective treatments."

"Our RNA encodes innovation. With this IND clearance, we are thrilled that Immorna is now transitioning into a clinical-stage biotech," said Zihao Wang, Ph.D., Co-Founder and Chief Executive Officer of Immorna. "Since its founding, Immorna has established robust processes that can efficiently and consistently produce high quality and potent cell-replicating as well as conventional mRNA. Immorna has also developed an arsenal of mRNA delivery vehicles, including thermal-stable ones. This IND clearance of JCXH-211 marks Immorna’s first Oncology investigational drug to be tested in humans and, more importantly, FDA’s acceptance of our mRNA platform technology. We expect to bring more potentially life-saving drugs and vaccines to the clinic in the near future."

On March 28, 2022, Allarity Therapeutics reported that it entered into an amended and restated license agreement with LiPlasome Pharma and Chosa regarding the development and commercialization of LiPlaCis as a cancer treatment drug (Filing, 8-K, Allarity Therapeutics, MAR 28, 2022, View Source [SID1234611644]). The Amended License Agreement assigned, amended and restated the original license agreement dated February 15, 2016, as subsequently amended and restated as of January 27, 2021, by and between us and LiPlasome (the "Original Agreement"). Under the Original Agreement, we were granted an exclusive license to develop and commercialize LiPlaCis as a cancer treatment drug. Pursuant to the Exclusive License Agreement dated as of June 26, 2020 (the "2020 Sublicense Agreement") with Smerud Medical Research International AS, a company organized under the laws of Norway ("Smerud"), we sub-licensed our exclusive rights to LiPlaCis and 2X-111 (a Phase 2-stage cancer drug that is a targeted, liposomal formulation of chemotherapeutic doxorubicin), to Smerud. Under the Amended License Agreement, the parties agreed to replace Allarity Europe with Chosa, an affiliate of Smerud, as exclusive licensee to further advance clinical development and commercialization of LiPlaCis.

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Under the Amended License Agreement, Chosa replaced Allarity Europe as the exclusive licensee to the LiPlaCis technology. In addition, we also granted Chosa an exclusive, royalty-free, transferable and sublicensable license for (i) our DRP Companion Diagnostics that are specific for Cisplatin or LiPlaCis (a liposomal formulation of Cisplatin) for the research and development of LiPlaCis products, and (ii) the use of any and all know-how and intellectual property rights owned by us for Chosa’s use of our DRP Companion Diagnostics that are specific for Cisplatin or LiPlaCis (a liposomal formulation of Cisplatin) for the development and commercialization of LiPlaCis products, as contemplated in the Amended License Agreement.

Development Milestone Payments

Pursuant to the Amended License Agreement, we are entitled to receive certain milestone payments from Chosa relating to the development and commercialization of LiPlaCis upon the occurrence of the following events, which milestone payments are to be shared with LiPlasome: (i) upon the regulatory approval of a product in the United States, (ii) upon the regulatory approval of a product in any country in Europe, including on a centralized filing basis by the EMA, (iii) upon the first achievement on a cumulative basis of net sales of a product in the United States, and (iv) upon the first achievement on a cumulative basis of net sales of a product in any country in Europe. Each milestone payment is payable one time only, regardless of the number of times the corresponding milestone event is achieved by a product and regardless of the number of products to achieve such milestone event. If all milestones are achieved, then we would be entitled to receive up to $3.5 million in milestone payments under the Amended License Agreement ("Milestone Payments").

As a result of the Amended License Agreement, we no longer have any rights to use or commercialize LiPlaCis and are only entitled to receive the Milestone Payments upon the achievement of the respective milestones.

LiPlaCis Support Agreement with Smerud, Chosa and LiPlasome

On March 28, 2022, concurrent with the entry into the Amended License Agreement, we entered into the LiPlaCis Support Agreement with Allarity Europe, Smerud, Chosa and LiPlasome (the "Support Agreement"). Pursuant to the terms of the Support Agreement, we agreed (i) to pay to LiPlasome a certain percentage of the Commercialization Proceeds (as defined under the Original Agreement) we received from Smerud by way of debt cancellation relating to prior work on LiPlaCis by Smerud, which obligation was to be satisfied by the payment of 2,273,020 Danish Kroner to LiPlasome upon execution of the Support Agreement, (ii) to equally share the milestone payments under the terms of the License Agreement, pursuant to which it was contemplated that upon the achievement of all the milestones, our pro rata share of the Milestone Payments would be up to $3.5 million, (iii) to amend and restate the Original License Agreement, and (iv) to terminate the 2020 Sublicense Agreement as contemplated by the parties pursuant to the terms of the Support Agreement.

The foregoing summary of the terms of the Amended License Agreement and the Support Agreement do not purport to be complete. Copies of the Amended License Agreement and the Support Agreement (both in redacted form subject to a confidential treatment request submitted to the Securities and Exchange Commission (the "SEC")) will be filed as Exhibits to the Company’s Form 10-K to be filed for the fiscal year ended December 31, 2021.

Item 1.02 Termination of Material Definitive Agreement.

The information contained in Item 1.01 of this Current Report on Form 8-K in connection with the Amended License Agreement and the Support Agreement are incorporated herein by reference.

Notwithstanding the provisions of Section 8.1 of the 2020 Sublicense Agreement regarding the rights relating to the ownership of certain intellectual property (and the defined terms therein) which was agreed to survive without limitation, pursuant to the terms of the Support Agreement and in connection with the termination of our exclusive licensee rights to LiPlaCis under the Amended License Agreement, on March 28, 2022, Smerud and Allarity Europe agreed to terminate the 2020 Sublicense Agreement. However, notwithstanding the termination of the 2020 Sublicense Agreement, we are currently engaged in discussions with Smerud in connection with the further development of 2X-111.

The foregoing description of the 2020 Sublicense Agreement does not purport to be complete and is qualified in its entirety by the full text of the 2020 Sublicense Agreement, a copy of which was filed as Exhibit 10.2 to our Registration Statement on Form S-4 with the SEC on August 20, 2021.

On March 28, 2022 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Filing, 6-K, Novo Nordisk, MAR 28, 2022, View Source [SID1234611403]). This programme is part of the overall share repurchase programme of up to DKK 22 billion to be executed during a 12-month period beginning 2 February 2022.

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Under the programme initiated 2 February 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 2 February 2022 to 2 May 2022.

Since the announcement 21 March 2022, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 35,798,396 B shares of DKK 0.20 as treasury shares, corresponding to 1.5% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 22 billion during a 12- month period beginning 2 February 2022. As of 25 March 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 4,012,228 B shares at an average share price of DKK 686.97 per B share equal to a transaction value of DKK 2,756,290,966.