Aulos Bioscience to Present Initial Safety Data From First-in-Human Phase 1/2 Clinical Trial of IL-2 Therapeutic AU-007 at 37th Society for Immunotherapy of Cancer (SITC) Annual Meeting

On October 11, 2022 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported that initial safety data from patients who received monotherapy treatment in the Phase 1/2 trial of AU-007 will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting (Press release, Aulos Bioscience, OCT 11, 2022, View Source [SID1234621875]). AU-007 is a monoclonal antibody computationally designed by Biolojic Design that is highly selective for the CD25-binding portion of interleukin-2 (IL-2). The SITC (Free SITC Whitepaper) meeting is being held virtually and in Boston, Massachusetts, from November 8-12, 2022.

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"As the first computationally designed human monoclonal antibody ever to enter a clinical trial, AU-007 offers a novel approach for treating solid tumor cancers by redirecting IL-2, tipping the balance toward immune activation and away from immune suppression and vascular leak," said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. "As we continue to enroll patients in the AU-007 Phase 1/2 study in Australia, we look forward to presenting initial safety results at the SITC (Free SITC Whitepaper) Annual Meeting."

Poster Title: Initial results from dose escalation of a phase 1/2 first-in-human, open label study of AU-007, a monoclonal antibody that binds to IL-2 and prevents its binding to CD25, in patients with solid tumors
Abstract: 775
Date and Time: Thursday, November 10, 2022, 9:00 a.m.-9:00 p.m. EST
Presenter: Jim Vasselli, M.D., Chief Medical Officer, Aulos Bioscience

The poster will be presented in the Poster Hall, Hall C at the Boston Convention and Exhibition Center. It will also be available as an ePoster on display on the SITC (Free SITC Whitepaper) 2022 virtual meeting platform.

About AU-007
AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by T effector cells, from binding to trimeric receptors on T regulatory cells while still allowing IL-2 to bind and expand T effector and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to trimeric receptors on vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

Aulos is evaluating AU-007 in an open label, first-in-human Phase 1/2 clinical trial designed to assess the safety, tolerability, immunogenicity and clinical activity of AU-007 in patients with unresectable locally advanced or metastatic cancer. To learn more about the clinical trial program, visit ClinicalTrials.gov (NCT05267626).

Reminder: Invitation to Roche’s 3rd Quarter Sales 2022 Webinar

On October 11, 2022 Roche reported that it will publish its Sales Results for the 3rd Quarter of 2022 prior to the opening of the Swiss Stock Exchange on Tuesday, 18 October 2022 (Press release, Hoffmann-La Roche, OCT 11, 2022, View Source [SID1234621874]).

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BerGenBio Announces Initiation of Phase 1b/2a Trial Evaluating Bemcentinib in 1st line Non-Small Cell Lung Cancer Patients Harboring STK11 Mutations

On October 11, 2022 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported the initiation of a Phase 1b/2a trial evaluating bemcentinib in combination with the current standard of care, checkpoint inhibitor pembrolizumab and doublet chemotherapy, for the treatment of 1st line (1L) Non-Small Cell Lung Cancer (NSCLC) patients harboring STK11 mutations (STK11m) (Press release, BerGenBio, OCT 11, 2022, View Source [SID1234621873]).

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"Real-world data continues to reinforce that the presence of STK11m currently result in particularly poor outcomes for NSCLC patients," said Martin Olin, Chief Executive Officer of BerGenBio. "We believe that bemcentinib’s proficiency in blocking AXL overexpression may result in the reversal of an immunosuppressive tumor microenvironment leading to activation of immune response, restoration of sensitivity to immune checkpoint therapy and potentiation of chemotherapy effects in this large, underserved patient population."

Bemcentinib, is a potent, first-in-class highly selective inhibitor of the receptor tyrosine kinase AXL, which is overexpressed in response to cellular stress, inflammation, hypoxia and chemotherapy. STK11 mutations are detected in approximately 20% of non-squamous NSCLC patients and are known to create a more immunosuppressive tumor microenvironment limiting the response to checkpoint inhibition. Preclinical data have demonstrated that by selectively blocking AXL activation, bemcentinib restores sensitivity to immune checkpoint inhibitor therapy, enhances chemotherapy, while also, pertinently, driving the expansion of CD8+ T cells in STK11m models. Early clinical data also point to the activity of bemcentinib in NSCLC patients, including those harboring STK11m.

The global, open-label Phase 1b/2a trial is designed to determine the safety, tolerability and efficacy of bemcentinib with standard of care in untreated advanced/metastatic non-squamous NSCLC patients with STK11 mutations and no actionable mutations. The Phase 1b portion of the study will evaluate the safety and feasibility of bemcentinib in combination with pembrolizumab and doublet chemotherapy in 1L advanced/metastatic non-squamous NSCLC patients, regardless of STK11 status. The Phase 2a expansion part will assess the efficacy of bemcentinib in the same treatment combination in 1L advanced/metastatic non-squamous NSCLC patients with STK11 mutations. The first patient is expected to begin treatment in the fourth quarter of 2022.

Harbour BioMed Enters into Agreement with CSPC Pharmaceutical Group Limited for Batoclimab (HBM9161) in Greater China

On October 10, 2022 Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunology, reported that it has entered into an agreement with CSPC NBP Pharmaceuticals Co., Ltd. (NBP Pharma), a wholly-owned subsidiary of CSPC Pharmaceutical Group Limited (CSPC), to transfer the exclusive rights to develop, manufacture and commercialize batoclimab (HBM9161) in Greater China (including mainland China, Hong Kong, Macau and Taiwan) to NBP Pharma (Press release, Harbour BioMed, OCT 10, 2022, View Source [SID1234621944]). According to the agreement, Harbour BioMed will potentially receive a total of over RMB 1 billion, including an upfront payment of RMB 150 million and other potential milestone payments. In addition, the Company will receive tiered royalties based on annual net sales of batoclimab in Greater China.

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Batoclimab is the first novel fully human anti-FcRn monoclonal antibody being developed in Greater China. It blocks FcRn-IgG interactions, accelerating the degradation of autoantibodies and leads to the treatment of pathogenic IgG-mediated autoimmune diseases. As the clinically most advanced FcRn inhibitor being developed in Greater China, batoclimab has the potential to be a breakthrough treatment for a wide spectrum of autoimmune diseases in Greater China. Batoclimab is currently undergoing a number of clinical studies in Greater China including myasthenia gravis (MG), immune thrombocytopenia (ITP), neuromyelitis optical spectrum disorder (NMOSD), Thyroid Eye Disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP) and pemphigus vulgaris (PV).

Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed, said: " Over the past few years, we are delighted to see the excellent clinical efficacy of batoclimab, and are also looking forward to the commercialization of this product. CSPC has a leading position in the commercialization of innovative drug products in China, and we are delighted to enter into this cooperation with CSPC to optimize market potential and advance clinical development, so as to further maximize the value of batoclimab in Greater China. In the future, Harbour BioMed will continue to implement the Company’s strategy, optimize resources, cultivate its innovative R&D capabilities, and leverage the value of its core platforms to develop more differentiated therapies for patients around the world."

"We are pleased to have reached this agreement with Harbour BioMed," said Cuilong Zhang, CEO of CSPC. "Batoclimab is a promising innovative drug, and we hope to accelerate its clinical development, manufacturing, registration and commercialization in China, so as to benefit the patients in China better and earlier

Novo Nordisk A/S – Share repurchase programme

On October 10, 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, OCT 10, 2022, View Source [SID1234621902]). 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.

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Under the programme initiated 3 August 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 4 August 2022 to 31 October 2022.

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 21,836,688 B shares of DKK 0.20 as treasury shares, corresponding to 1.0% 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 7 October 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 20,125,909 B shares at an average share price of DKK 768.99 per B share equal to a transaction value of DKK 15,476,594,378.