On March 21, 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, MAR 21, 2022, View Source [SID1234610595]). 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.

With the transactions stated above, Novo Nordisk owns a total of 35,310,319 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 18 March 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 3,524,151 B shares at an average share price of DKK 679.99 per B share equal to a transaction value of DKK 2,396,381,074.

On March 21, 2022 RNAGene Inc., a South Korean biotech which specializes in the development of mRNA (messenger ribonucleic acid)-based therapeutics, reported that it has signed a Collaborative Research Agreement with PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next-generation antibody therapeutics (Press release, RNAGene, MAR 21, 2022, View Source [SID1234610504]).

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Under the agreement, both companies will collaborate to develop next-generation mRNA-based antibody therapeutics by utilizing the proprietary mRNA platform from RNAGENE.

Unlike the existing antibody treatments, in which antibodies are artificially produced from external cell lines, mRNA-based therapies involve administration of mRNA in patients so that patients’ own cells can produce the encoded therapeutic antibody.

"The Company entered this agreement because this partnership gives us an extraordinary opportunity to expand our development strategy and discover new possibilities in the mRNA therapeutic area," said Dr. Jin-San Yoo, CEO of PharmAbcine. "Through this collaboration, both parties will explore new potentials between the two platforms and develop a new therapeutic approach to help patients with unmet medical needs."

"One of the key strengths of mRNA therapy is that it is simple and cost-effective because there is no need to produce antibodies externally in a facility," said Dr. Woo Gil Lee, CEO of RNAGENE. "We are delighted to have PharmAbcine, one of the leading antibody-based therapeutic companies, as a partner for this collaborative research, and we are confident that our advanced mRNA technology platform will help create alternative therapeutic options in oncology field."

On March 21, 2022 Compugen Ltd. (Nasdaq: CGEN), ("Compugen," the "Company"), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that it will give a presentation today on exploring the immune-tumor microenvironment (TME) using high resolution single-cell spatial transcriptomics at the Keystone Symposium: Cancer Immunotherapy: Decoding the Cancer Immunity Interactome, March 20-24 at Whistler, British Columbia, Canada (Press release, Compugen, MAR 21, 2022, View Source [SID1234610502]).

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"Compugen’s predictive computational platform is the cornerstone of our drug discovery and development capabilities. The biology of the TME is complex, and an in-depth understanding is required to develop novel cancer immunotherapies," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "At the Keystone Symposium, we will share how we are successfully employing high resolution single cell spatial mapping of immune cells to decipher this complexity. Leveraging our long-term expertise in computational immuno-oncology biology we have used a cutting-edge technology to provide an unprecedented view into the composition and spatial localization of individual cells in the TME. Initial findings further suggest the presence of the DNAM-1 pathway including PVRIG, an immune checkpoint discovered by Compugen, at the sites of T cell priming, including the tertiary lymphoid structures. This is exciting as it confirms what we have seen previously and further supports the rationale to block PVRIG to address immunotherapy resistance in both inflamed and less inflamed tumors. Our ability to study cancer at the spatially resolved single-cell level is expanding our understanding of the complex interactions in the TME and opens the door to new therapeutic approaches."

Compugen’s cloud-based computational platform integrates proprietary omics data, such as proteomics and spatial single-cell transcriptomics with public domain genomics and clinical metadata towards a machine learning based discovery of novel immuno-oncology specific targets, biomarkers, and mechanism of action. The computational-driven hypotheses are then rapidly tested and validated by an internal wet-lab experimental group. The validated information is integrated back into the discovery cycle, providing an additional layer of proprietary data which is being utilized to further optimize the computational predictive models. This tight in-house integration of computational prediction with experimental validation is one of Compugen’s strengths and has proved to be essential in its immuno-oncology discoveries, clinical-stage programs, and pipeline progression.

Presentation & poster details
Meeting title: Cancer Immunotherapy: Decoding the Cancer Immunity Interactome
Session title: Imaging Cancer Immunity
Presentation & poster title: Exploring the immune-tumor microenvironment using high resolution single-cell spatial transcriptomics
Lead author: Roy Granit
Oral presentation date: Monday, March 21, 2022
Poster date: Tuesday, March 22, 2022
Poster number: Poster #2041

The presentation is available on the publication section of Compugen’s website www.cgen.com.

On March 21, 2022 GT Biopharma, Inc. ("the Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary tri-specific natural killer (NK) cell engager, TriKE protein biologic technology platform, reported, preclinical data to be presented at the hybrid 48th European Society for Blood and Marrow Transplantation Annual Meeting (EBMT) (Press release, GT Biopharma, MAR 21, 2022, View Source [SID1234610501]). The poster presentation titled, "Tri-specific Killer Engager (TriKE) against B7-H3 enhances NK cell mediated killing of multiple myeloma," is presented by Aimee Merino, MD, PhD, Assistant Professor of Medicine, Division of Hematology, Oncology and Transplantation at the University of Minnesota. GTB-5550 (B7-H3 TriKE) is the Company’s tri-specific killer engager (TriKE) with camelid single-chain Fv fragments against B7-H3 (CD276) and CD16 linked by IL-15 to enhance NK cell killing of myeloma. GTB-5550 is part of GT Biopharma’s portfolio of lead TriKE product candidates being investigated as a mono- and combination therapy against multiple myeloma.

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Dr. Gregory Berk, President of R&D and Chief Medical Officer noted, "Testing GTB-5550 across several multiple myeloma cell-lines has yielded preclinical evidence suggesting further investigation of this TriKE in the clinic. We continue to push the boundaries of the natural killing power of NK cells enhanced by the Company’s TriKE protein therapeutics across multiple types of liquid, solid and refractory cancer types. Additionally, this study further validates the potential of the Company’s TriKE assets both as a mono- and combination therapy, with NK cells and anti-cancer agents."

Poster Title: "Tri-specific Killer Engager (TriKE) against B7-H3 Enhances NK Cell Mediated Killing of Multiple Myeloma"

Background – Natural Killer (NK) cell-based therapies hold great promise in treating multiple myeloma. One method to enhance NK cell specificity against myeloma is antibody dependent cellular cytotoxicity through a CD16 receptor. B7-H3 (CD276) was targeted as its expression in myeloma is associated with decreased progression free survival, it exhibits low expression on healthy tissue, and it is expressed on myeloid derived suppressor cells (MDSC), which promote myeloma growth.

Study design and analysis – The study compared the ability of peripheral blood NK cells with or without GTB-5550 to kill myeloma cells in live imaging IncuCyte Zoom assays with escalating doses of TriKE. Maximal killing occurred with 3 nM concentration. Testing was performed across four different myeloma cell lines (H929, MM1S, RPMI-8226, U266). In the study, the efficacy of GTB-5550 was also tested in combination with the proteasome inhibitor bortezomib (10 nM) and the immunomodulatory drug lenalidomide (5 mM). Cytotoxicity curves were compared by repeated measures ANOVA and performed in triplicate.

Results – NK cell mediated killing increased statistically significantly across all multiple myeloma cell lines tested. Combination therapy with GTB-5550 and anti-cancer agent showed enhanced killing as compared to NK cells or TriKE alone.

Statistically significant increase in NK cell mediated killing across all lines when 3nM B7-H3-TriKE was added. Against U266 and MM1S, B7-H3-TriKE significantly enhanced killing at effector:target (E:T) ratios of 2:1 and 4:1. RPMI-8226 showed relatively high resistance to NK cell cytotoxicity but B7-H3-TriKE enhanced killing at E:T of 4:1. H929 cells were more potently killed in the presence of B7-H3-TriKE at E:T of 2:1 but there was no difference in killing at E:T 4:1 likely due to high natural cytotoxicity in both groups.

Combination therapy with GTB-5550, NK cells, and lenalidomide showed synergistic killing of H929 cells after 48 hours of live cell imaging (p=0.047) but combination with bortezomib did not further enhance killing as compared to NK cells and TriKE alone. Both lenalidomide and bortezomib showed a trend toward improved killing against MM1S when given with NK cells and B7-H3 TriKE but it did not reach statistical significance. Combination therapy with B7-H3-TriKE, NK cells, and lenalidomide or bortezomib showed synergistic killing of RPMI-8226 cells after 48 hours of live cell imaging (p<0.001 and 0.015 respectively). Bortezomib combined with GTB-5550 and NK cells enhanced killing in U266 cells (p=0.037).

Conclusion – B7-H3-TriKE significantly enhances NK cell mediated killing of myeloma cells, even in the relatively low B7-H3-expressing H929 line. Our data also shows it can reverse MDSC-induced myeloma growth.
The EBMT poster presentation details are as follows:

EBMT Poster Presentation Details

Title: A Tri-specific Killer Engager (TriKE) against B7-H3 enhances NK cell mediated killing of multiple myeloma
Abstract Number: AS-EBMT-2022-00508
Session: New Drugs- and Cell-Based Immune Therapies
Presentation Type: Poster
Session Date and Time: March 19, 2022 9:50 AM (CET)
Location: Prague Congress Center, Czech Republic
Poster Board Number: P153

Multiple Myeloma (Kahler’s disease) – is a cancer of the plasma cell. Normal plasma cells are a type of white blood cell that helps make up your immune system. They are located within the bone marrow – the spongy interior of bones that produces blood cells. When your body is fighting an infection, plasma cells produce antibodies (proteins) which attack viruses and bacteria. If a plasma cell becomes cancerous, it multiplies rapidly. This is multiple myeloma. Malignant plasma cells may crowd out normal blood-forming cells within the bone marrow, reducing the production of healthy blood cells. Additionally, rather than producing infection-fighting antibodies, the cancer cells begin to produce an abnormal antibody called a monoclonal protein (m protein) or paraproteins. In the urine, they are called Bence Jones proteins. These proteins do not fight against infection. For more information about multiple myeloma please click here.

On March 21, 2022 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported new Signatera data from the prospective, multi-center CIRCULATE-Japan trial, reported by Dr. Eiji Oki of Kyushu University in an oral presentation at the Society of Surgical Oncology (SSO) 2022 International Conference on Surgical Cancer Care (Press release, Natera, MAR 21, 2022, View Source [SID1234610500]).

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CIRCULATE-Japan is the largest molecular residual disease (MRD)-guided clinical trial with more than 3,300 stage I-IV colorectal cancer (CRC) patients enrolled to date. This interim analysis at SSO, similar to the one previously presented at the 2022 ASCO (Free ASCO Whitepaper) GI symposium, analyzed 6-month and 12-month outcomes from 1,040 patients and showed that Signatera MRD-positive patients benefited significantly from adjuvant chemotherapy (ACT), while Signatera MRD-negative patients did not benefit from ACT.

Latest findings exclusive to SSO 2022 demonstrate 75% (45/60) detection of recurrence in stage II-III patients with a single blood draw at 4 weeks post surgery. The previous analysis from ASCO (Free ASCO Whitepaper) GI, which showed a single time point sensitivity of 68% (46/68), did not exclude non-cancer or treatment-related deaths. Prior studies have shown that serial monitoring further increases the detection rate of recurrence up to 88-93%.1,2

"Learnings from our study consistently suggest that stratifying post-surgical treatment decisions using Signatera can identify patients likely to benefit from adjuvant chemotherapy across stages," said the study’s Principal Investigator, Dr. Takayuki Yoshino, of the National Cancer Center Hospital East, Kashiwa, Chiba, Japan. "We look forward to continuing to expand the study."

The presentation at SSO also indicates increasing interest in and adoption of Signatera among cancer surgeons, who are finding utility in personalized monitoring and MRD assessment to inform surgical decisions. Signatera has been shown in several studies3,4 to be predictive of treatment response in the neoadjuvant setting (before surgery) as well as the adjuvant setting (after surgery), across multiple cancer types.

In addition to presenting the latest CIRCULATE-Japan study data, Natera also announced the activation of the CIRCULATE-US trial, a national, prospective, multi-center, randomized clinical trial to investigate MRD-guided treatment strategies for patients with early-stage CRC. The study, which is being conducted in partnership with NRG Oncology and funded by the National Cancer Institute (NCI), was recently granted an investigational device exemption (IDE) from the FDA after a thorough review of Natera’s clinical and analytical validation data.

"Natera is dedicated to continuing to drive improvement in MRD test sensitivity and improving CRC patient outcomes by executing definitive, practice-changing prospective studies," said Dr. Adham Jurdi, medical director of oncology at Natera. "We’re delighted to be at the forefront of MRD and colorectal cancer research and excited to see these landmark studies, like CIRCULATE-US, progress."

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes Signatera’s accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and assess how much cancer is left in the body, to identify recurrence earlier and to help optimize treatment decisions.