On April 14, 2021 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) reported that the publication of the Full Year 2020 financial results, which had been scheduled for April 20th, 2021, will be postponed until April 30th, 2021 (Press release, Vivoryon Therapeutics, APR 14, 2021, View Source [SID1234578010]). The postponement is due to unexpected delays in the finalization of Vivoryon’s financial statements related to its transition into a Dutch N.V. corporation. The Company’s Board of Directors made the decision to move the reporting date to ensure completeness of the filing and in compliance with the laws of the Netherlands.

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On April 14, 2021 TILT Biotherapeutics, a clinical-stage biotechnology company developing cancer immunotherapeutics, reported a clinical trial collaboration agreement with MSD, a premier research-intensive biopharmaceutical company, to evaluate TILT’s adenoviral cancer immunotherapy TILT-123, a dual cytokine armed oncolytic adenovirus, in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, in a Phase I dose escalation trial in platinum resistant or refractory ovarian cancer (Press release, TILT Biotherapeutics, APR 14, 2021, View Source [SID1234577994]).

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The trial will include 15 to 30 patients and will be led by Dr. Matt Block at Mayo Clinic (Minnesota, USA). During the first month of the trial, patients will receive TILT-123 monotherapy, and thereafter consecutive treatments of TILT-123 in conjunction with pembrolizumab. The trial’s objective is to evaluate the safety and efficacy of TILT-123 in combination with pembrolizumab and is designed to also deliver insights about the mechanism of action of TILT-123 in humans.

A Phase I trial with TILT-123 conducted in Europe showed no serious adverse events when used as a monotherapy or in combination with tumour infiltrating lymphocytes (TILs) at the first dose level (1) and has now progressed to the second dose level.

TILT Biotherapeutics’ CEO, Akseli Hemminki, a biotech entrepreneur and cancer clinician who has personally treated almost 300 patients with ten different oncolytic viruses, said, "There is a pressing need for a therapy to address platinum refractory ovarian cancer. The heart of our approach revolves around the use of oncolytic adenoviruses armed with cytokines to boost the patient’s immune response towards the tumor, enabling it to find and destroy cancer cells. We are delighted to be working with MSD to progress our lead candidate, TILT-123, towards the clinic in combination with its breakthrough immunotherapy KEYTRUDA."

(1) View Source

On April 13, 2021 Bridge Biotherapeutics reported that the company’s former vice president, Lee Kwang-hee, the company established a new bio company named, Boostimmune, (Press release, Boostimmune, APR 13, 2021, View Source [SID1234634467]). It is a determination to develop an immuno-anticancer agent that will be effective against various cancers with MDSC inhibitor technology introduced by the University of Tokyo.

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Former Vice President Lee left Bridge Bio early this year and established BoostImmune in February. The company is located in Pangyo, Seongnam-si, Gyeonggi-do, and a total of three people, including CEO Lee Kwang-hee, are working. CEO Lee said, "We established the company for the purpose of developing a protein-based immuno-oncology drug, not a synthetic drug."

Tadatsugu Taniguchi, professor emeritus at the University of Tokyo, is the co-founder. Professor Tada is a scholar who first discovered ‘interleukin 2’ and ‘interferon beta’, regular customers of immunology research, and has published 300 papers related to immunology alone. There are multiple pipeline tasks, including MDSC inhibitors introduced by the University of Tokyo.

CEO Lee explained, "There are various mechanisms that prevent immune cells from working properly, and one of them is MDSC (Myeloid derived suppressor cell)." Representative Lee pursued a master’s degree in molecular biology at Seoul National University and a doctoral course at Washington University School of Medicine in the United States, and accumulated research and development experience at the US National Institutes of Health (NIH), Genentech, and Sanofi.

While working at Bridge Bio, he has experience in clinical application (IND) to the U.S. Food and Drug Administration (FDA) for three drugs: ulcerative colitis treatment (BBT401), idiopathic pulmonary fibrosis treatment (BBT877), and non-small cell lung cancer treatment (BBT176). .

BoostImmune’s role model is Genentech. Genentech is a first-generation protein drug company. Herceptin (breast cancer treatment), Rituxan (autoimmune disease treatment), and Avastin (metastatic colorectal cancer treatment), which are blockbuster biopharmaceuticals developed by Genentech, achieved sales of $6 billion (6.75 trillion won), $6.5 billion, and $7.1 billion, respectively, in 2019. . In 2009, Roche acquired Genentech for $47 billion (approximately 52 trillion won) and took the copyright.

On April 13, 2021 NKMax, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, reported the expansion of its clinical trial and supply agreement with Merck KGaA, Darmstadt, Germany to conduct a Phase I/IIa open-label, single-center trial evaluating the safety and anti-tumor activity of SNK01 (autologous natural killer cells) in combination with either gemcitabine/carboplatin or gemcitabine/carboplatin plus cetuximab (ERBITUX)* in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has progressed after prior tyrosine kinase inhibitor (TKI) therapy (Press release, NKGEN Biotech, APR 13, 2021, View Source [SID1234578708]). Preliminary in vitro data from an NKMax study suggested that EGFR-TKI resistant NSCLC cells highly express EGFR and are more efficiently killed by SNK01 in the presence of cetuximab through antibody-dependent cellular cytotoxicity (ADCC). Dr. Jae-Cheol Lee, M.D., Ph.D. from the Department of Oncology and Lung Cancer Center at Asan Medical Center, Seoul, Korea will be acting as principal investigator. This study was approved by Korea’s regulatory agency, MFDS, earlier this year as well as by the Asan Hospital IRB. The first patient will soon be enrolled.

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"We are pleased to continue studying SNK01 in combination with well-known cancer therapies," said Sangwoo Park, Chief Executive Officer of NKMax. "Our strategy is to first take our autologous, non-genetically modified NK cell therapy into the clinic for cancer, followed by our allogeneic program later in 2021."

Under the terms of this agreement, NKMax will be the study sponsor, and Merck KGaA, Darmstadt, Germany will supply cetuximab for a Phase I/IIa clinical trial in NSCLC patients for weekly dosing with 250 mg/m2 cetuximab administered by intravenous injection. The trial will include patients whose disease has progressed after prior TKI therapy for EGFR, ALK or ROS1 alterations at least once will be enrolled to receive SNK01, chemotherapy, and cetuximab. The primary objective of the trial is to assess the safety and drug tolerance of SNK01 administered in combination with cytotoxic chemotherapy or cytotoxic chemotherapy plus cetuximab. The secondary objective of the trial will be to obtain efficacy assessments on the combination treatments. Both parties will have access to the clinical trial data.

NKMax has developed its own proprietary NK cell expansion and activation technology platform which allows it to produce unprecedented commercial amounts of autologous and allogenic NK cells from numerous donors which have near total expression of activating receptors like CD16, NKG2D, NKp30, and NKp46. In addition, its unique technology raises the cytotoxicity of the expanded NK cells with little loss during cryopreservation.

* ERBITUX is not approved for any use in metastatic non-small cell lung cancer anywhere in the world.

On April 13, 2021 Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, reported that a paper published in the peer-reviewed Journal for ImmunoTherapy of Cancer (JITC), the highest ranked fully open access immunology journal, provides further clinical evidence that using belapectin, a potent galectin-3 inhibitor, in combination with pembrolizumab (KEYTRUDA), a PD-1 inhibitor, significantly enhances tumor response to immunotherapy in patients with advanced metastatic melanoma (MM) and head and neck squamous cell carcinoma (HNSCC) (Press release, Galectin Therapeutics, APR 13, 2021, View Source [SID1234578044]).

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The paper, titled "Enhancing Clinical and Immunological Effects of anti-PD-1 with Belapectin, a Galectin-3 Inhibitor" (doi:10.1136/jitc-2021-002371) describes results from an ongoing Phase 1 clinical study, a collaboration between Galectin Therapeutics and Providence Cancer Institute in Portland, Oregon.

Following the recent publication of positive preclinical results that showed the inhibition of galectin-3 in combination with an agonist anti-OX40 monoclonal antibody reprograms the tumor microenvironment to favor anti-tumor activity, the current study tests the clinical hypothesis that galectin-3 blockade with belapectin in combination with pembrolizumab enhances tumor response for patients with advanced MM or HNSCC.

In the study, as previously disclosed, an objective response was observed in 50% of MM (7/14) and 33% of HNSCC (2/6) patients. This compares favorably to published response rates on pembrolizumab alone. The authors noted that the combination was associated with fewer immune-mediated adverse events than anticipated with pembrolizumab alone. In addition, the analysis of patients’ tumor tissue revealed reduced monocytic myeloid-derived suppressor cells and increased effector memory T-cell activation in responders compared with non-responders. Also, an increased baseline expression of galectin-3 positive tumor cells correlated with clinical response.

"Immunotherapy is a significant breakthrough in the treatment of many cancers, but tumor-induced immune suppression contributes to treatment resistance. Galectin-3 is an important driver of this tumor-induced immunosuppression, and this clinical study constitutes proof-of-concept that the addition of belapectin, a galectin-3 inhibitor, to a PD-1 inhibitor can benefit cancer patients," said Dr. Brendan Curti, M.D., Earle A. Chiles Research Institute, a division of Providence, and the first author of the paper.

"The analysis of patients’ tumor tissues is consistent with previously published pre-clinical data with belapectin and confirms the ability of belapectin to modulate the tumor microenvironment to favor anti-tumor activity. The possibility to improve the tolerance and safety of immunotherapy is also very exciting," commented Pol F. Boudes, M.D., Chief Medical Officer of Galectin Therapeutics. "These proof-of-concept clinical data provide a strong rationale to initiate a randomized placebo-controlled phase 2 clinical trial to evaluate the efficacy and safety of belapectin in combination with a PD-1 inhibitor compared to a PD-1 inhibitor alone in this cancer patient population. We look forward to continuing our work with Providence Cancer Institute, and we anticipate the upcoming release of additional data from the expansion cohort in this study."

About Belapectin (GR-MD-02)

Belapectin (GR-MD-02) is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. A Phase 2 study showed belapectin may prevent the development of esophageal varices in NASH cirrhosis; these results provide the basis for the conduct of the NAVIGATE trial. The NAVIGATE trial (NAVIGATEnash.com), entitled "A Seamless Adaptive Phase 2b/3, Double-Blind, Randomized, Placebo-controlled Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis" began enrolling patients in June 2020 and is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3 also has a significant role in cancer, and the Company is supporting a Phase 1 study in combined immunotherapy of belapectin and KEYTRUDA in treatment of advanced melanoma and in head and neck cancer.