Global Roundup: Sigrid Therapeutics Forges Manufacturing Agreement with Japan's AGC

Global Roundup_Compressed

Sweden’s Sigrid Therapeutics forged a manufacturing agreement with Japanese company AGC Si-Tech for SiPore15, Sigrid’s lead asset designed to reduce blood sugar in diabetes patients. SiPore15 is a tasteless and odorless white powder taken with water that has been shown to reduce the uptake of carbohydrates and fats in the gut. Sigrid is developing the asset for people at risk of developing type 2 diabetes, pre-diabetics, and newly diagnosed type 2 diabetics.

Under terms of the agreement, AGC will bolster the manufacture of SiPore15. Sigrid and AGC have had ongoing discussions about partnering on the manufacture of SiPore15 for the past few years, the company said. Chief Executive Officer Sana Alajmovic said the agreement will allow Sigrid to scale up manufacturing for ongoing clinical studies and potential commercialization in the United States.

In addition to the deal with AGC, Alajmovic has been named one of the Female Leaders of the Future and also won the Life Science category of the Nova 111 list.

Elsewhere around the globe:

Pilloxa – Also based in Sweden, digital health company Pilloxa launched a cloud-hosted solution for pharmaceutical companies and medical research teams that will allow them to engage with patients and also learn from them. Pilloxa’s platform allows the customer to become the innovator themselves and accelerate patient-centric learnings. Through the platform, the customer chooses the modules that they would like to include in their own patient-facing mobile app program, including medication support, adherence dashboards, and even interactive learning material on the medication and treatment journey.

SOTIO – Czech Republic-based presented positive biomarker data from a Phase II study with dendritic cell vaccine DCVAC/OvCa at the American Society for Clinical Oncology meeting. DCVAC/OvCa is being developed as a first line treatment in adults with ovarian cancer. The data demonstrate signs of efficacy and safety of DCVAC/OvCa combined with chemotherapy in patients with newly diagnosed epithelial ovarian carcinoma and provide strong rationale for potential study in larger clinical trials. Treatment with DCVAC/OvCa was shown to be safe and well tolerated and also, the data showed that treatment significantly improved progression free survival (PFS) in optimally debulked EOC patients, with a demonstrable trend towards improved overall survival.

Iksuda Therapeutics – Antibody drug conjugate-focused Iksuda, based in the United Kingdom, completed a $47 million financing round. The funding will support the advancement of Iksuda’s lead ADC assets and expansion of its payload and conjugation platform technologies. Iksuda’s lead pre-clinical candidate, IKS03, is a best-in-class CD19-targeted ADC candidate for B-cell cancers. The investment will enable progression of IKS03 to first-in-human Phase I clinical trials. It will also be used to accelerate the company’s earlier-stage programs, including IKS04 and IKS012 to IND filing. The financing round was co-led by Mirae Asset Capital and its subsidiaries, Celltrion and Premier Partners.

Avacta Group – U.K.-based Avacta Group announced the MHRA has confirmed registration of Avacta’s AffiDX SARS-CoV-2 antigen lateral flow test, which will allow the company to place the product on the market in the U.K. The clinical data for Avacta’s AffiDX SARS-CoV-2 antigen lateral flow test demonstrated 100% sensitivity for identifying infectious individuals.

ERS Genomics – Ireland-based ERS Genomics Limited announced a non-exclusive license agreement granting genOway past and future access to ERS Genomics’ CRISPR/Cas9 patent portfolio. Financial details of the agreement were not disclosed. genOway said the deal will broaden its CRISPR IP portfolio and widen its rodent model offering.

Sphere Fluidics – U.K.-based Sphere Fluidics and Norway’s ClexBio launched of the biocompatible CYTRIX Microfluidic Hydrogel Kit, which combines ClexBio’s novel CYTRIX Hydrogel with Sphere Fluidics’ specially designed Pico-Gen double aqueous biochip. The kit will allow for the plug-and-play generation of defined, reproducible and tailorable hydrogel microstructures for 3D cell culture, organoids, single-cell analysis, and many other applications, the companies said in a joint statement.

CyGenica – India’s CyGenica raised $1.4 million in seed funding. The financing will be used to accelerate validation of CyGenica’s proprietary technology which enables safe, targeted and affordable intercellular drug delivery. CyGenica’s technology addresses the problem of delivering large-molecule therapeutics into living cells without damaging them or triggering an adverse immune response. The seed funding round was led by SOSV and supported by Voyager Health-Tech Fund, as well as other investors.

Byondis B.V. – Netherlands-based Byondis announced its breast cancer drug hit the mark in a Phase III study. The late-stage TULIP study demonstrated the efficacy of the company’s antibody-drug conjugate (ADC) [vic-] trastuzumab duocarmazine (SYD985) compared to physician's choice treatment in patients with pretreated HER2-positive unresectable locally advanced or metastatic breast cancer (MBC). The study met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement over physician’s choice. The study also demonstrated preliminary supportive overall survival (OS) results, Byondis said. Detailed results from the TULIP study will be published at a future scientific conference. Byondis will complete the biological license application (BLA) and intends to submit it before the end of 2021. Byondis is planning to explore partnerships with pharma and biopharma companies in order to commercialize SYD985.

Drogsan Pharmaceuticals – Turkey-based Drogsan forged a licensing deal with Rockwell Medical for the rights to commercialize Triferic AVNU (ferric pyrophosphate citrate injection) in Turkey. Drogsan will be the exclusive development and commercialization partner for Triferic in Turkey. The agreement allows for Drogsan to negotiate further geographic expansion into the surrounding region. In consideration for the license, Rockwell Medical will receive an upfront fee and will be eligible for milestone payments based on reimbursement price approval.

ProBioGen AG – Germany-based ProBioGen struck a deal with City of Hope that grants the company rights to the company’s cell line AGE1.CR.pIX to support the manufacturing of City of Hope's COVID-19 vaccine candidate. ProBioGen's vaccine development platform is expected to be ideally suited for the production of large quantities of City of Hope's synthetic MVA-based COVID-19 vaccine. It will enable City of Hope and/or its commercial partners to manufacture the vaccine at scale for late stage clinical development and eventually, the market to address the urgent needs of the ongoing pandemic. The vaccine is currently being tested in a Phase I clinical trial.

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