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Phase I clinical trial of IMM2902 completed the first patient enrollment and dosing in the United States

On June 20, 2022 ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco" and the company) reported that, on June 20, local time, an FDA-registered Phase I clinical trial of the first globally novel bi-specific antibody-receptor fusion protein targeting human CD47xHER2（IMM2902) completed the first patient in (FPI) (Press release, ImmuneOnco Biopharma, JUN 20, 2022, View Source [SID1234655662]). The first subject has been enrolled and dosed in the United States, and the infusion went well without any complications.

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IMM2902 is a CD47xHER2 bispecific fusion protein in the most cutting-edge of global research field for solid tumors. It was previously approved by the U.S. Food and Drug Administration (FDA) for clinical trials on August 21, 2021. It is the third CD47-based new drug projects in the clinical research stage of the company. On February 15, 2022, IMM2902 completed the first subject enrollment and dosing in China, and the clinical trial is progressing well. On June 16, the invention patent of the IMM2902 was authorized by the US Patent Office. The completion of the first patient enrollment and dosing of IMM2902 in the United States is another major milestone for the company!

Founder, Chairman and CEO of ImmuneOnco Dr. Tian, Wenzhi, said: "We are very pleased that our IMM2902 program has completed the first patient enrollment and dosing in clinical studies in the United States. IMM2902 is a bispecific molecule targeting CD47 and HER2 developed based on our mAb-Trap technology platform. The high affinity to HER2 enables the drug to bind to tumor cells preferentially without binding to human erythrocytes and avoiding the "antigen sink effect", thus greatly enhancing the specific synergistic effect against tumors. Although Her2-related ADC drugs have excellent clinical performance, the unavoidable serious toxic and side effects (such as the incidence of interstitial pneumonia as high as 9% and the fatality rate as high as 2.6%) also bring greater risks to patients. We believe that, on the premise of ensuring similar efficacy, IMM2902 will greatly improve clinical safety. We truly believe that IMM2902 has great value for further clinical development."

Novo Nordisk A/S – Share repurchase programme

On June 20, 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") (Press release, Novo Nordisk, JUN 20, 2022, View Source [SID1234616121]). This programme is part of the overall share repurchase programme of up to DKK 24 billion to be executed during a 12-month period beginning 2 February 2022.

Under the programme initiated 3 May 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 4 May 2022 to 2 August 2022.

Since the announcement 13 June 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 14,731,381 B shares of DKK 0.20 as treasury shares, corresponding to 0.6% of the share capital. The total amount of A and B shares in the company is 2,280,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 24 billion during a 12- month period beginning 2 February 2022. As of 17 June 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 12,991,818 B shares at an average share price of DKK 757.73 per B share equal to a transaction value of DKK 9,844,234,990

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 49,300 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, and YouTube.

Issuance and repurchase of C-shares to establish an at-the-market program

On June 20, 2022 The Board of Directors of Calliditas Therapeutics AB (publ) reported to carry out a new issue of 5,908,018 C-shares and to subsequently immediately repurchase the 5,908,018 newly issued C-shares which are subsequently intended to be converted into ordinary shares in accordance with the company’s articles of association and held as treasury shares (Press release, Calliditas Therapeutics, JUN 20, 2022, View Source [SID1234616111]). The purpose of the issue and repurchase is to secure future potential delivery of shares under the company’s at-the-market program which is intended to be launched by the company during the second quarter 2022.

The Board’s resolution was made on the basis of the authorization granted by the Annual General Meeting on May 19, 2022.

Aktieinvest FK AB will subscribe for all issued C-shares at a subscription price of SEK 0.04 per share. The 5,908,018 issued C-shares will be repurchased by Calliditas Therapeutics AB (publ) for SEK 0.04 per share. The new share issue will hence increase the share capital by SEK 236,321.

The purpose of the issue, repurchase and subsequent conversion is to ensure timely future potential delivery of shares in the form of American Depositary Shares under of the company’s at-the-market program, according to communication and description at the AGM. Potential future use of an ATM program will be evaluated by the Board taking into account capital requirements, dilution and other potential sources of financing and the company has no obligations to utilize the program.

Acepodia Announces FDA Clearance of IND Application for ACE1831, an Anti-CD20 Armed Allogeneic gamma delta T-cell Therapy Candidate to Treat Patients with non-Hodgkin’s Lymphoma

On June 20, 2022 Acepodia, a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) platform technology to address gaps in cancer care, reported that it has received clearance of its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate a Phase 1, first-in-human, multi-center clinical study of its ACE1831 in patients with non-Hodgkin’s lymphoma (Press release, Acepodia, JUN 20, 2022, prnewswire.com/news-releases/acepodia-announces-fda-clearance-of-ind-application-for-ace1831-an-anti-cd20-armed-allogeneic-gamma-delta-t-cell-therapy-candidate-to-treat-patients-with-non-hodgkins-lymphoma-301570711.html [SID1234616110]).

"The FDA clearance of our IND application for ACE1831 is a significant milestone for Acepodia as we move into the clinic with a first antibody armed allogeneic gamma delta T cell product candidate through our unique ACC platform. Based on ACE1831’s encouraging preclinical data, we believe that our antibody armed gamma delta T cell therapy has the potential to provide additional treatment options for patients with NHL," said Sonny Hsiao, Ph.D., chief executive officer of Acepodia. "The ACC approach allows us to circumvent the limitations of current T cell engager therapies. Meanwhile, we can also significantly reduce manufacturing costs and has the potential to generate a cost-effective cancer treatment for patients. We look forward to advancing ACE1831 into its first clinical trial," said the chief executive officer.

About Gamma-Delta (γδ) T Cells
Acepodia’s gamma delta T cell program harnesses the unique properties of gamma delta T cells to develop a new class of allogeneic cell therapies for the treatment of cancer. Gamma delta T cells have characteristics of both the innate and adaptive immune systems that make them an ideal chassis for the development of cell therapies. This cell type can recognize and attack cancerous cells as well as coordinate a broad antitumor immune response by recruiting other immune factors and cells to the site of disease. Gamma delta T cells have also been shown to preferentially traffic to distinct tissues and could be ideally suited for more targeted treatment of certain types of cancers.

Innovent and Lilly Jointly Announce the Approval of TYVYT® (sintilimab injection) by China NMPA in Combination with Chemotherapy as First-Line Treatment for Esophageal Squamous Cell Carcinoma

On June 20, 2022 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, autoimmune, metabolic, ophthalmology and other major diseases, and Eli Lilly and Company ("Lilly",NYSE: LLY) reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for TYVYT (sintilimab injection) in combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) (Press release, Innovent Biologics, JUN 20, 2022, View Source [SID1234616109]).

This is the fifth NMPA-approved indication of TYVYT. In China, TYVYT was approved for: the treatment of relapsed or refractory classical Hodgkin’s lymphoma in December 2018; the first-line treatment of non-squamous non-small cell lung cancer (NSCLC) in February 2021; and the first-line treatment of squamous NSCLC as well as the first-line treatment of hepatocellular carcinoma in June 2021.

The new approval was based on the interim analysis of ORIENT-15, a global randomized, double-blind, multi-center Phase 3 clinical trial – which evaluated sintilimab in combination with chemotherapy compared to placebo in combination with chemotherapy as first-line therapy for ESCC. Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), sintilimab in combination with chemotherapy demonstrated a statistically significant improvement in the primary endpoint of overall survival (OS) compared to placebo in combination with chemotherapy regardless of PD-L1 expression status, meeting the pre-defined superior efficacy criteria. Safety profile was consistent with that observed in previously reported studies of sintilimab without new or unexpected safety signals. The results of ORIENT-15 were published in British Medical Journal on April 19, 2022[1].

Prof. Shen Lin, Principal Investigator of ORIENT-15 Study, Peking University Cancer Hospital and Institute, stated," Esophageal cancer is one of the most common cancers in China ranking fifth in cancer prevalence and the fourth in mortality cases, with squamous cell carcinoma as most predominant histologic type[2]. In the past, median OS was approximately 10 months for chemotherapy as the first-line standard of care[3]. The results of ORIENT-15 demonstrated that sintilimab plus chemotherapy as the first-line treatment for ESCC significantly improved overall survival (OS) and progression-free survival (PFS) compared to placebo plus chemotherapy, with median OS of 16.7 months（vs. 12.5 months, HR=0.63） and median PFS of 7.2 months（vs. 5.7months,HR=0.56） for sintilimab plus chemotherapy. In addition, the results showed the general applicability of sintilimab with two different chemotherapy regimens[1]. The approval of sintilimab in combination with chemotherapy as a first-line treatment for ESCC is exciting news and will provide an effective and affordable treatment option for patients living with ESCC in China."

Dr. Yongjun Liu, President of Innovent, stated," TYVYT (sintilimab injection) is the only innovative PD-1 inhibitor with positive Phase 3 studies results as a first-line treatment for five major types of cancer, including the squamous/non-squamous non-small cell lung cancer, liver cancer, gastric cancer and now esophageal cancer. We are encouraged by the results of the ORIENT-15 study, a global multi-center phase 3 trial demonstrating sintilimab as a high quality treatment option with great clinical value for people living with esophageal cancer. Innovent is committed to our mission of developing high-quality biopharmaceuticals that are affordable and contribute to the ‘Healthy China 2030’ Plan for cancer prevention and treatment."

Dr. Hui Zhou, Senior Vice President of Innovent, stated, "There is a huge unmet clinical need for the first-line treatment of advanced or metastatic ESCC. The results of ORIENT-15 demonstrated that sintilimab can bring significant clinical benefit to the treatment of ESCC. Today, the NMPA of China approval marks another important milestone for sintilimab, and we believe the positive study results will soon translate into superior clinical benefits for ESCC patients. We believe the approval of this new indication will further strengthen the leadership position of TYVYT (sintilimab injection) and bring hopes to more Chinese cancer patients in broader market."

Mr. Julio Gay-Ger, President and General Manager of Lilly China, stated, "From Hodgkin’s lymphoma, lung cancer, liver cancer, and now to esophageal squamous cell carcinoma (ESCC), we are excited to see another indication of TYVYT (sintilimab injection) approved in China in a short of time, bringing new options to Chinese esophageal cancer patients. With our commitment to oncology, Lilly strives to bring high-quality and affordable innovative drugs to Chinese cancer patients through both independent R&D and local partnerships. TYVYT (sintilimab injection) sets a great example for our partnership with Innovent, and the new approval will further benefit more Chinese cancer patients."

Dr. Li Wang, Senior Vice President of Lilly China and Head of Lilly China Drug Development and Medical Affairs Center, stated, "The approval of TYVYT (sintilimab injection) for the first-line indication of esophageal squamous cell carcinoma (ESCC) demonstrated the clinical value of combined immunotherapy in this field. The number of new cases and deaths of esophageal cancer in China accounts for more than half of the world’s total[2]. The ORIENT-15 study, starting from the Chinese ESCC population while having a global perspective, achieved promising results of benefiting the entire population, bringing new options and new hope for the treatment of ESCC patients[1]."

About the ORIENT-15 Study

ORIENT-15 is a global randomized, double-blind, multicenter Phase 3 clinical study evaluating sintilimab in combination with chemotherapy (cisplatin plus paclitaxel or 5-fluorouracil [5-FU]), compared to placebo in combination with chemotherapy, for the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ClinicalTrials.gov, NCT03748134). At the time of interim analysis, a total of 659 eligible patients (of the planned 676 estimated participants) were enrolled and randomly assigned into the experimental group or control group in a 1:1 ratio. The primary endpoints were overall survival (OS) in all randomized patients and OS in PD-L1 positive (defined as CPS ≥10) patients[1].

Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), sintilimab in combination with chemotherapy demonstrated a statistically significant improvement in the primary endpoint of overall survival (OS) compared to placebo in combination with chemotherapy, regardless of PD-L1 expression status, meeting the pre-defined superior efficacy criteria. Safety analyses revealed no new safety signals. The results of ORIENT-15 were published in British Medical Journal on April 19, 2022[1].

About Esophageal Squamous Cell Carcinoma (ESCC)

Esophageal cancer (EC) is one of the most common malignant tumors worldwide that begins in the inner layer (mucosa) of the esophagus, which connects the throat to the stomach. Based on GLOBOCAN 2020 estimates, approximately 600,000 new cases of esophageal cancer are diagnosed and approximately 540,000 deaths result from the disease worldwide each year[4]. Esophageal cancer is the seventh most commonly diagnosed cancer and the sixth leading cause of death from cancer worldwide[4]. More than half of new and fatal cases of esophageal cancer in the world occur in China[2]. In China, it is estimated there were approximately 320,000 new cases of esophageal cancer diagnosed and approximately 300,000 deaths resulting from the disease in 2020[2]. Esophageal cancer is the fifth most commonly diagnosed cancer and the fourth leading cause of death from cancer in China, where it has a five-year survival rate of only 30%[2].

The two main types of esophageal cancer are squamous cell carcinoma (SCC) and adenocarcinoma. In China, SCC is the predominant histologic type, accounting for more than 90% of all esophageal cancer[5]. In the past, first-line standard systemic therapy was chemotherapy based on platinum drugs for unresectable locally advanced, recurrent or metastatic ESCC, which calls for more effective first-line treatment options. Several PD-1 inhibitors have been approved as first-line treatment in combination with chemotherapy[6],[7] .

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibodyjointly developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells[8]. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for four indications, and recently approved for one additional indication including:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy;
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of non-squamous non-small cell lung cancer lacking EGFR or ALK driver mutations;
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer;
In combination with BYVASDA (bevacizumab biosimilar injection) for the first-line treatment of unresectable or advanced hepatocellular carcinoma;
In combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil for the first-line treatment of esophageal squamous cell carcinoma.
Additionally, Innovent currently has two regulatory submissions under review in the China’s NMPA for sintilimab:

In combination with chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;
In combination with bevacizumab biosimilar and chemotherapy for EGFR-mutated non-squamous NSCLC following EGFR-TKI treatment.
Additionally, two clinical studies of sintilimab have met their primary endpoints:

Phase 2 study as second-line treatment of esophageal squamous cell carcinoma;
Phase 3 study as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy.