Biomica | October 13, 2020
Biomica, an emerging biopharmaceutical company developing innovative microbiome-based therapeutics, and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), announced today the advancement to large-scale production of BMC128, its Live Bacterial Product (LBP) candidate consortium. The microbes, which will be produced in large-scale are expected to support Biomica's first-in-man proof-of-concept clinical trials for its immuno-oncology program, anticipated to begin in 2021. BMC128 is advancing to the GMP production stage following the successful completion of the initial R&D stage of drug product development and manufacturing, conducted by Biose Industrie (Aurillac, France). Biomica's immuno-oncology program is focused on its leading 4-strain candidate consortium BMC128. Biomica recently announced positive results in the program, demonstrating the efficacy of BMC128 in potentiating the response to immune-checkpoint inhibitors (ICI) in preclinical studies. In these studies, BMC128 was administered to mice bearing cancer tumors prior to and during ICI therapy, and the results showed that treatment with BMC128 significantly improved anti-tumor activity. Biose Industrie is a drug-GMP certified manufacturer of bacteria-based APIs and clinical and commercial products. As previously announced earlier this year, Biomica engaged Biose for the scale-up development and GMP production of a clinical batch of its drug candidates.
Sesen Bio | December 02, 2020
Sesen Bio, a late-stage clinical organization creating focused on combination protein therapeutics for the therapy of patients with cancer, and Hikma Pharmaceuticals, a worldwide pharmaceutical organization and driving permitting partner in the Middle East and North Africa ("MENA") area spend significant time in the turn of events and commercialization of an expansive scope of great medicines, today declared that the organizations have gone into exclusive licensing agreement for the registration and commercialization of Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC") and different sorts of cancer in MENA. Vicineum, a privately managed combination protein, is Sesen Bio's lead product competitor presently in the subsequent phase of a Phase 3 enrollment preliminary for the treatment of high-hazard, BCG-unresponsive NMIBC. In December 2019, the Company started the BLA submission for Vicineum to the FDA under Rolling Review.
Under the details of the understanding, Sesen Bio granted Hikma a exclusive license to register and commercialize Vicineum in all of the 19 MENA markets in a course of action foreseen to convey equivalent worth offer to the two players. Monetary terms of the arrangement are secret and incorporate a forthright installment to Sesen Bio, deals related achievement installments, and eminences on net deals in the locale for the term of the understanding. Sesen Bio holds full turn of events and commercialization rights for Vicineum for the treatment of NMIBC in the US and the remainder of the world barring Greater China and MENA.
Achiko AG | January 15, 2022
Achiko AG is pleased to report that new optimizations during recent calibration testing of its affordable, non-invasive Covid-19 saliva-based rapid test AptameX™ correctly differentiated 100% of test samples up until a comparable reverse transcription polymerase chain reaction cycle threshold value of 33, indicating the system’s ability to deliver a > 97% sensitive and > 97% specific rapid test at a wider range of viral loads than most other rapid tests.
“The data we’re reporting today shows that our technology allows for more sensitive and affordable tests compared to antigen-based tests. These high-fidelity calibration testing results suggest not only that AptameX has potential as a very compelling alternative to rapid antigenic tests, but also may be used as an accurate alternative in many mass market applications to slow and expensive RT-PCR technology. This is particularly important in Lower to Middle Income Countries where vaccination rates are lower and the leading testing technologies are impractically expensive for the vast majority of people.”
Achiko CEO Steven Goh
New data announced for the first time show that, after the recent improvements, AptameX achieved 100% sensitivity and specificity in a controlled experiment in 58 human Covid-19 samples. These gains both confirm AptameX’s ability to perform at low viral loads.
The experiment was conducted in Indonesia using samples that were confirmed positive or negative for SARS-CoV-2. AptameX delivered a sensitivity of 100% across a range of CT values below 25 and CT values within the 25-33 range, which is important as the sensitivity of other rapid tests typically drops dramatically in the 25-33 CT value range. The results are consistent and extend earlier work in Spain and other testing in Indonesia. Achiko is looking forward to replicating the study internationally as it moves to complete its CE Mark.
These results compare favorably to other testing technologies. Because of its accuracy, RT-PCR technology has become the gold standard for detecting Covid-19 infection. However, RT-PCR is often not the most practical for large-scale testing because it requires specialized equipment, is relatively slow and expensive. Using RT-PCR technology, scientists have established a benchmark for detecting Covid-19 infection: a healthy person is considered Covid-19 negative if their RT-PCR CT value is greater than 33. If, however, the CT value is below 33, the person is Covid-19 positive. Most rapid tests may tout a high sensitivity result where the CT values are under 25. However, according to Euro surveillance, more recent work on Omicron indicates the mean value for Covid-19 infection is around 28, hence the frequent reports of lower sensitivity in the majority of antigenic rapid test kits. Therefore, the AptameX result is important as it presents a viable alternative to other testing.
"The improved sensitivity and specificity results announced by Achiko following completion of calibration testing on its SARS-CoV2 rapid test kit is a significant milestone,” stated AptameX inventor Dr. Michael Edel. "AptameX has the capability to meet the increasing global need for frequent mass testing that is fast, low-cost and non-invasive.”
Furthermore, the AptameX test has completed and tested its first few hundred thousand kits in production and is now moving to produce one million kits a month. From there, the format is highly amenable to large-scale manufacturing and offers a considerable production cost advantage. Late last year the Company optimized the first-generation test kit using a simpler supply and manufacturing chain in Taiwan and Indonesia, that can easily be replicated to other geographies. In a matter of months and subject to financing, production capacity can rapidly be scaled to hundreds of millions of kits per month. The Company is looking to finance scale production primarily through trade finance.
Production of the second-generation rapid test kits is underway and will ramp up further this quarter. Shipments of AptameX kits within Indonesia have been completed to meet prior sales orders as the Company expects to be able to provide 3-4 tests per months for 5% of Indonesia’s 270 million population by mid-year. Additionally, a CE Mark registration is expected in early 2022, allowing the Company to respond to inquiries and move towards commercialization in Europe, the Middle East and Asia and elsewhere.
“It’s evident that as we move to the endemic phase of Covid-19, regular vaccinations and mass testing will become a part of our daily lives,” added Goh. “We are enormously pleased with the great results we are able to share today. They confirm the competitive positioning of the platform and the role we can play in getting us all back to a ‘normal’ life.”
ABOUT ACHIKO AG
Achiko AG is developing disruptive diagnostic solutions that puts people first. The company’s lead product is a rapid, reliable Covid-19 test with a companion app offering a user-friendly digital health passport. The test and companion app were launched in Indonesia in mid-2021 and an application for CE Mark approval in Europe will be submitted in 2022.