by Jakub Jarolím, Business Intelligence Department
SOTIO Biotech
30/12/2021
by Jakub Jarolím, Business Intelligence Department
Market
Stocks around the world fell and oil prices plunged, after evidence of a new coronavirus variant in South Africa prompted another round of travel restrictions and reignited concerns about the economic toll imposed by the pandemic. Nasdaq Biotech Index lost 4% during November.
Antibody-Drug Conjugates
A unique ADC, which delivers a high dose of a cancer-killing drug to tumor cells through a targeted antibody, has been found in a global phase 3 clinical study to nearly double the survival time of patients with refractory metastatic triple-negative breast cancer.
The study of the ADC drug sacituzumabgovitecan (SG), reported superior outcomes compared to single-agent chemotherapy, the standard for treating metastatic triple-negative breast cancer.
Interleukin-15 and Interleukin-2
SOTIO Biotech announced new data from the ongoing Phase 1/1b AURELIO-03 study of SOT101, an IL-15 superagonist, as a monotherapy and in combination with pembrolizumab in patients with advanced/metastatic solid tumors.In a combination of SOT101 with pembrolizumab in the AURELIO-03 study, the majority of the 13 patients with advanced/metastatic solid tumors had clinical benefit, including in checkpoint inhibitor (CPI) refractory patients.
Cell Therapies
Affimed’s recent string of positive data for AFM13 continued with an impressive early efficacy report for the bispecific Innate Cell Engager in Hodgkin lymphoma patients, but investors still want to learn more about the treatment’s durability.
Affimed reported that AFM13, a bispecific NK cell engager targeting CD30 on tumor cells and CD16A on NK cells, conjugated to allogeneic NK cells, led to a 100% ORR with five complete responses (42%) among the first 12 patients treated at the recommended Phase 2 dose in an open-label Phase 1/2 study.
Other Innovative Treatment Areas
Oncorus offered initial safety, tolerability and immune activation and clinical response data from its ongoing Phase 1 trial with ONCR-177 at SITC. In the fully enrolled and completed surface-lesion, dose-escalation part of the study, single-agent ONCR-177, an oncolytic herpes simplex virus for intratumoral injection, proved well-tolerated with no dose-limiting toxicities.
As of the Nov. 8, 2021, cutoff date, three of eight evaluable patients at the recommended phase II dose of 4x108 PFU in 4 mL with cutaneous melanoma, squamous cell carcinoma of the head and neck, and mucosal melanoma, showed clinical benefit after two doses of the compound, which will also be tried in combination with Merck’s anti-PD-1 Keytruda.
Oncology Transactions
SOTIO Biotech announced an exclusive, target-specific license and option agreement with LegoChem Biosciences. SOTIO will obtain rights to deploy LegoChem’s ADC technology for up to five therapeutic programs targeting distinct tumor-associated antigens. The deal enables SOTIO to combine its proprietary antibodies with LegoChem’s ADC technology platform in order to deliver novel therapeutics for the treatment of solid tumors and includes LegoChem’s proprietary conjugation technology ConjuAll and potent linker-payload platform including multiple different payloads.
LegoChem is eligible to receive upfront and potential milestone payments worth up to $1027.5 million, payable based on certain developments and regulatory achievements, plus royalties on net sales. The deal includes upfront and near-term milestones worth up to $29.5 million, subject to exercise of the options and achievement of success-based milestones. SOTIO will be responsiblefor R&D, manufacturing, andcommercializationof the ADC products, while LCB will support and work closely with SOTIO for the research activities and the manufacturing of components that are specifically related to its proprietary ConjuAll and the linker-payload technologies.
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