On December 20, 2021 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that mOS of 25.0 months for treatment with ONCOS-102 in combination with Standard of Care (SoC) chemotherapy in malignant pleural mesothelioma (MPM) in the subgroup of patients receiving therapy in the first-line setting (Press release, Targovax, DEC 20, 2021, View Source [SID1234597439]).

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The study is an open-label, exploratory phase 1/2 trial adding ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first and later line MPM to assess safety, immune activation and clinical efficacy compared with SoC alone. A total of 31 patients were enrolled in the trial, with 20 patients in the treatment group receiving ONCOS-102 plus SoC chemotherapy, and 11 patients in the control group receiving SoC only. The 30-month follow-up has now been completed.

At the 30-month follow-up, mOS was 25.0 months for the subgroup of randomized, first-line ONCOS-102-treated patients (n=8). This is a clear improvement over the mOS of 13.5 months observed in the first-line SoC-only control group (n=6). Previous phase 3 clinical trials in MPM have reported mOS in the range of 12-16 months for patients receiving the same SoC chemotherapy treatment in the first-line setting1. The combination of Opdivo/Yervoy double checkpoint inhibition was recently approved as a first-line treatment option for MPM based on a phase 3 trial showing 18.1 months mOS2.

Objective response rate (ORR), progression free survival (PFS) and mOS have been previously reported, and remain unchanged. The 30-month follow-up analysis completes the mOS data set for all subgroups in the trial.

Immune activation was assessed in tumor biopsies pre- and post-ONCOS-102 treatment (Day 0 and Day 36). The tumor tissue analyses revealed powerful and consistent ONCOS-102-induced remodeling of the tumor microenvironment with increased T-cell infiltration and a shift towards pro-inflammatory immune cells, far beyond what was observed for the SoC-only control group. This immune activation is associated with tumor responses and is most pronounced in patients with better survival outcomes, indicating that the immune activating capacity of ONCOS-102 is driving the clinical benefit for patients.

Dr. Magnus Jäderberg, Chief Medical Officer of Targovax, commented: "This excellent survival outcome suggests a great promise for ONCOS-102 to benefit mesothelioma patients. The results complement the class-leading ORR and immune activation ONCOS-102 has demonstrated in anti-PD1 resistant melanoma by showing that ONCOS-102 can be used in combination with both chemotherapy and anti-PD1 checkpoint inhibition. Importantly, we have confirmed that ONCOS-102 is active and effective in highly different types of solid tumors in both early and late lines of therapy. Based on the encouraging patient outcomes and deep mechanistic analysis from the phase 1/2 program, we are currently designing and preparing for the next phase in ONCOS-102 clinical development."

On December 20, 2021 IMMUNOPRECISE ANTIBODIES LTD. ("IPA" or the "Company") (NASDAQ: IPA) (TSX VENTURE: IPA) and ChemPartner Biologics Co. Ltd. ("ChemPartner") reported their global antibody manufacturing collaboration under which ChemPartner will manufacture and supply to IPA’s specifications IPA’s proprietary PolyTope TATX-03 Therapy, a rationally designed four monoclonal antibody cocktail developed for use in human clinical trial for the potential prevention and treatment of infection with current and future variants of SARS-CoV-2 (Press release, ImmunoPrecise Antibodies, DEC 20, 2021, View Source [SID1234597438]). The goal of this collaboration is to secure the ability to quickly develop and manufacture in parallel the individual cocktail antibodies in IPA’s PolyTope TATX-03 up to large scale required for use in clinical development and using ChemPartner’s state-of-the-art manufacturing facilities, with the potential for additional capacity to manufacture ‘plug-and-play’ antibodies addressing novel variants of concern in the event this is desired.

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"In light of the recent events as it pertains to concerns about vaccines and therapeutic antibodies losing efficacy against novel variants of concern, we believe that, if the preclinical data that we have to date is confirmed through human clinical studies, IPA is in a strong position to potentially address a worldwide need for alternative SARS-CoV-2 therapies using our Polytope cocktail. Our relationship with ChemPartner is one further step in that direction. Based on the work we have done to date with ChemPartner, and the positive interactions between our two teams, we believe that ChemPartner has the experience and global capabilities to meet our currently anticipated manufacturing needs for PolyTope TATX-03 cocktail," stated Dr. Jennifer Bath, President and Chief Executive Officer at IPA.

"We are impressed by the innovative approaches of ImmunoPrecise Antibodies and excited to help advance their TATX-03 PolyTope antibody cocktail program against SARS-CoV-2," said Livia Legg, Chief Commercial Officer at ChemPartner. "ChemPartner Biologics is strategically positioned to join forces in the battle against Covid-19 disease by utilizing our extensive capabilities and expertise in developing, scaling and manufacturing of complex biologics."

On December 20, 2021 Avecho Biotechnology Limited (ASX:AVE) has reported it has entered into a licensing and supply agreement with Medterra Pharma – one of the most successful CBD companies in the United States – to develop and commercialise Avecho’s soft-gel CBD capsule for the treatment of arthritis (Press release, Phosphagenics, DEC 20, 2021, View Source [SID1234597431]).

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Arthritis represents a promising opportunity for development, with the osteoarthritis therapeutics market projected to reach US$11 billion by 2025. Medterra scientists have already demonstrated the therapeutic potential of CBD for arthritis in preclinical models, and a six-week human study using the soft-gel for pain reduction in patients with osteoarthritis of the knee is scheduled for early next year.

This partnership is a strategic move for our Company. We know that our product has wide-ranging potential for a number of indications, and our ambition is to secure FDA approval for our proprietary CBD soft-gel product. By working in partnership with a reputable, well-resourced partner, this allows us to pursue regulatory approval in the US in parallel to our current efforts to register our product for sleep indications with the TGA in Australia.

On December 20, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported it has entered into an agreement with Gilead Sciences, Inc. (Headquarters: Foster City, California, "Gilead") for the commercialization and distribution of filgotinib (generic name, product name: Jyseleca ), an oral, JAK1 preferential inhibitor for indications of rheumatoid arthritis (RA), ulcerative colitis, and Crohn’s disease in Asia (South Korea, Taiwan, Hong Kong and Singapore) (Press release, Eisai, DEC 20, 2021, View Source [SID1234597411]). In December 2019, Eisai signed a partnership agreement with Gilead Sciences K.K. (Headquarters: Tokyo), a Japanese subsidiary of Gilead, for the distribution and co-promotion of filgotinib in Japan.

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Under the terms of the new agreement, Eisai will obtain an exclusive marketing right for filgotinib in South Korea, Taiwan, Hong Kong and Singapore from Gilead. Gilead has received approval for the treatment of RA in Taiwan and has applied for approval of filgotinib for the treatment of RA in South Korea. Following approvals, Eisai will take over the manufacturing and marketing licenses for filgotinib from Gilead in South Korea and Taiwan. In Hong Kong and Singapore, Eisai will apply for approval for filgotinib. With this agreement, Eisai will pay Gilead a contractual up-front payment, as well as regulatory milestones and sales milestones.

Filgotinib is a once-daily, oral, JAK1 preferential inhibitor. In Japan, filgotinib has been approved for the treatment of rheumatoid arthritis (including prevention of structural joint damage) in patients who have had an inadequate response to conventional therapies. In April 2021, Gilead Sciences K.K. applied for an additional indication of filgotinib as a treatment for patients with moderate to severe active ulcerative colitis.

Eisai will leverage its strong business foundation throughout Asia, provide new treatment options for patients with rheumatoid arthritis and inflammatory bowel disease, and contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients their families, and healthcare providers.

1. About filgotinib

Filgotinib is a once-daily, oral, JAK1 preferential inhibitor. In Japan, filgotinib has been approved for the treatment of RA (including prevention of structural joint damage) in patients who have had an inadequate response to conventional therapies. In April 2021, Gilead Sciences K.K. applied for an additional indication of filgotinib as a treatment for patients with moderate to severe active ulcerative colitis.

In addition, filgotinib has been approved in the European Union and Great Britain for the treatment of adults with moderate to severe active rheumatoid arthritis who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib has also been approved in the European Union for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. Applications have been submitted to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with moderately to severely active ulcerative colitis and are currently under review.

2. About the market for biological products South Korea, Taiwan, Hong Kong and Singapore

The market of biological products in 2020 in South Korea, Taiwan, Hong Kong and Singapore is approximately US $ 400 million, accounting for approximately more than 80% of the total market for biological products in Asia (Hong Kong, India, Indonesia, South Korea, Malaysia, Philippines, Singapore, Taiwan, Thailand and Vietnam).1 Many of biological products are adapted in the treatments for rheumatoid arthritis and inflammatory bowel disease.

1 Copyright © 2021 IQVIA. Internal analysis based on IQVIA Analytics Link 2020. Unauthorized reproduction prohibited.

On December 19, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported dosing in Australia of the first subject in the Phase I PROBE Trial, a first-in-human study of ATG-101 in patients with metastatic/advanced solid tumors and B-cell non-Hodgkin’s lymphoma (B-NHL) (Press release, Antengene, DEC 19, 2021, View Source [SID1234597415]). The primary objective of the study is to evaluate the safety and tolerability of ATG-101 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ATG-101; the secondary objective is to evaluate preliminary anti-tumor activity of ATG-101.

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ATG-101 is a novel bispecific antibody that was designed to block the binding of immunosuppressive PD-1/PD-L1 and conditionally induce 4-1BB stimulation, thus activating anti-tumor immune effectors, while delivering enhanced anti-tumor activity, with an improved safety profile. ATG-101 demonstrated significant anti-tumor activity in animal models of resistant tumors as well as those that progressed on anti-PD-1/L1 treatment. Furthermore, no liver toxicity was observed in GLP toxicology studies in cynomolgus monkeys with doses up to 100 mg/kg.

"ATG-101 has been specifically designed to combine the proven activity of PD-1 inhibition with the immune stimulating activity of 4-1BB. Our intent is to further enhance the role of immune-oncological drugs, by turning "cold" tumors "hot" and thereby improve outcomes for patients who do not respond to anti-PD-1/PD-L1 monotherapies, or regain control of disease that has become resistant or refractory to these drugs. This has become a growing and increasingly important medical need." said Dr. Kevin Lynch, Chief Medical Officer of Antengene. "PROBE is Antengene’s first global trial of an in-house developed, novel drug. The program is now enrolling patients in Australia, thereafter expanding to the U.S. where the IND has been cleared by the FDA. Dosing of the first subject is an important milestone, highlighting our cross-regional Discovery and Clinical execution capabilities. We are very grateful to the patients, investigators and study site staff for their dedication and support for this program and hope we will be able to make an important difference in cancer with ATG-101."

"As many patients with malignancies are resistant or refractory to current therapies, including chemotherapy, targeted therapy and monoclonal antibodies, there remains a need for novel treatments for this patient population," said Dr. Charlotte Lemech, Medical Director of Scientia Clinical Research in Sydney, Australia.

Dr. Lemech continued, "Accumulating evidence suggests that bispecific antibodies will fill an important role as one of these novel strategies. We are excited to be leading this clinical trial, the first to administer ATG-101 – a novel PD-L1/4-1BB bispecific antibody – bringing together a group of highly experienced Australian investigators to collaborate with Antengene. The design of ATG-101 incorporates a high affinity for PD-L1 and conditional activation of 4-1BB, which potentially reduces the risk of 4-1BB related liver toxicity. We are looking forward to assessing whether this bispecific antibody can provide enhanced efficacy with a better safety profile and a new option for these patients."

About the PROBE Trial
The PROBE trial is a first-in-human Phase I trial of ATG-101 in patients with metastatic/advanced solid tumors and mature B-cell non-Hodgkin lymphomas (B-NHL). The study will be conducted in the Dose Escalation Phase and Dose Expansion Phase, with the primary objective to evaluate the safety and tolerability of ATG-101 and to determine the MTD) and/or RP2D) of ATG-101, and the secondary objective to evaluate preliminary anti-tumor activity of ATG-101. The study will also evaluate a range of pharmacology, immunology and biomarker measurements.

About ATG-101
ATG-101 is a novel PD-L1/4-1BB bi-specific antibody being developed for the treatment of multiple kinds of cancer. ATG-101 was designed to activate anti-tumor immune effectors, by forming a cell-antibody-cell trimer to simultaneously block the binding of PD-L1/PD-1 and induce 4-1BB stimulation, with limited hepatoxicity. ATG-101 activates exhausted cells in vitro, signaling a potential in reversing T-cell dysfunction and exhaustion (on PD-1 cross-linking). In PD-L1 over-expressing cancer cells, ATG-101 demonstrated significant anti-tumor activity in animal tumors that progressed on anti-PD-1/L1 treatment and a favorable safety profile in GLP toxicology studies. Data from these studies, as well as unique computational semi-mechanistic pharmacology modeling work, was recently presented at the Society of Immunology and Cancer (SITC 2021).