Keytruda Benefits Reported at AACR for Advanced Small Cell Lung Cancer

GEN | April 08, 2019

The anti-PD-1 monoclonal antibody immunotherapy pembrolizumab (Keytruda) is FDA approved to treat multiple types of cancer including melanoma, classical Hodgkin lymphoma, advanced cervical cancer, and more. Encouraging data presented at last week’s AACR meeting, showing antitumor activity with durable responses, may boost the chances of Merck & Co’s drug receiving FDA approval to treat previously treated, advanced small cell lung cancer (SCLC.) “Up to 70% of patients with SCLC have advanced disease at diagnosis,” said Hyun Cheol Chung, MD, PhD, professor at Yonsei Cancer Center, Yonsei University College of Medicine in Seoul, Republic of Korea. “Current treatment guidelines specify a variety of first- and second-line treatment options; however, for patients who require third-line therapy, there are no specific recommendations and prognosis is very poor.”

Spotlight

Anaxomics has developed a novel method of analysis for microarray data based on the generation and subsequent comparison of 2D fingerprints for each sample. Microarray results are incorporated into a protein interaction network and embedded with all sorts of biological and medical data.Multidimensional scaling is use to reduce the multidimensional network into a 2D map, generating a specific projection “fingerprint”.  A repertory of cell-type specific 2D fingerprints based on previous experiments stored in GEO database has been generated.

Spotlight

Anaxomics has developed a novel method of analysis for microarray data based on the generation and subsequent comparison of 2D fingerprints for each sample. Microarray results are incorporated into a protein interaction network and embedded with all sorts of biological and medical data.Multidimensional scaling is use to reduce the multidimensional network into a 2D map, generating a specific projection “fingerprint”.  A repertory of cell-type specific 2D fingerprints based on previous experiments stored in GEO database has been generated.

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MEDICAL

GT Biopharma Announces FDA Data - GTB-3550, for Treatment of High-risk Myelodysplastic Syndromes

GT Biopharma | December 23, 2020

GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology organization focused in on innovative treatments dependent on the Company's restrictive NK cell engager (TriKE™) innovation stage is satisfied to report the introduction of extra interval information results for the Company's lead therapeutic competitor, GTB-3550, for the treatment of high-risk myelodysplastic syndromes (HR-MDS). Erica Warlick, M.D, Principal Investigator for the GTB-3550 clinical trial, introduced extra clinical data results with the treatment with HR-MDS persistent #7 of its TriKE™ GTB-3550 during the Q&A meeting following her introduction at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma commented, "Our clinical data demonstrates that our proprietary TriKE™ (CD16/IL15/CD33), safely activated and harnessed the patient's native NK cell's cancer killing ability in a target-directed fashion without side effects. Which is not the case with highly expensive and intrusive supplemental NK cell therapies. We look forward to progressing to the next level."

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CELL AND GENE THERAPY

Bone Therapeutics and Link Health sign a non-binding term sheet for the global rights of ALLOB

Bone Therapeutics | November 29, 2021

BONE THERAPEUTICS the cell therapy company addressing unmet medical needs in orthopedics and other diseases, and Link Health Pharma Co., Ltd announce the signing of a non-binding term sheet for the global rights for ALLOB, Bone Therapeutics’ allogeneic bone cell therapy. Subject to the fulfillment of customary condition precedents, Bone Therapeutics and Link Health aim to complete the final agreement and to fully execute it by the end of 2021. This new partnership is separate and independent from the existing license agreement signed on October 5, 2020, for the rights to develop, manufacture and commercialize ALLOB in China for Pregene, and in Hong Kong, Macau, Singapore, Taiwan, Thailand and South Korea for Link Health. Bone Therapeutics will continue to work closely in partnership with Link Health and Pregene on all development activities. Link Health will be responsible for all future development, including the ongoing ALLOB TF2 Phase IIb trial and costs related to development, process development (scale up) and manufacturing of ALLOB. The deal will have no immediate direct cash impact, other than support of all development costs, since no upfront payment is foreseen, however, Bone Therapeutics will receive commercial milestone payments of up to €60 million in total and tiered royalties on net sales of up to 25%. “The existing collaboration between Bone Therapeutics, Link Health and Pregene for the development of ALLOB in Asia has progressed swiftly and fully in line with the anticipated schedule. Bone Therapeutics expanding its collaboration with Link Health will allow for the development and potential availability of ALLOB globally for the benefit of patients with high orthopedic unmet medical needs. This deal now enables Bone Therapeutics to concentrate resources and focus more fully on its iMSC platform. We are now utilizing our extensive cell therapy expertise to develop cell and gene therapy products that have strong anti-inflammatory and immunomodulatory properties, for the treatment of acute life-threatening diseases.” Miguel Forte, MD, PhD, Chief Executive Officer of Bone Therapeutics “Link Health has now broadened its therapeutic portfolio to address orthopedic unmet medical needs, aiming to be a global leader in this area. We have already several assets in clinical trial and next generation drug-material combo will also part of our efforts. For ALLOB, we believe that the evidence that Bone Therapeutics has already generated supports its potential clinical value for patients in various indications including spinal fusion and difficult fractures.” said Yan Song, PhD, Chief Executive Officer of Link Health. “Our extended collaboration with Bone Therapeutics will further support the global development of ALLOB. This will enable us to progress in delivering novel disease modifying solution for unmet medical needs for orthopedic patients worldwide.” ALLOB is currently being evaluated in a randomized, double-blind, placebo-controlled Phase IIb study in patients with high-risk tibial fractures. This study will assess and compare against placebo, in association with standard of care stabilization surgery, the potential for ALLOB to accelerate fracture healing after 3-months follow-up and prevent late-stage complications. ALLOB will be applied by a single percutaneous injection 24-96 hours post-definitive reduction surgery in patients with fresh tibial fractures at risk of delayed or non-union. About ALLOB ALLOB is Bone Therapeutics’ off-the-shelf allogeneic cell therapy platform consisting of human allogeneic bone-forming cells derived from cultured bone marrow mesenchymal stromal cells (MSC) from healthy adult donors. To address critical factors for the development and commercialization of cell therapy products, Bone Therapeutics has established a proprietary, optimized production process that improves consistency, scalability, cost effectiveness and ease of use of ALLOB. This optimized production process significantly increases the production yield, generating thousands of doses per bone marrow donation. Additionally, the final ALLOB product is cryopreserved, enabling easy shipment and the capability to be stored at the point of care for easy clinical use. The process will therefore substantially improve product quality, reduce overall production costs, simplify supply chain logistics, increase patient accessibility and facilitate global commercialization. The Company has implemented the optimized production process to produce clinical batches for the ongoing Phase IIb clinical trial in patients with difficult-to-heal tibial fractures. About Link Health Pharma Co., Ltd Link Health is a leading Chinese pharmaceutical company based in Guangzhou, Southern China. Link Health has a well-established team with solid track records in Licensing and local development of innovative medicinal products in China and Asia-Pacific. By its fully controlled subsidiary BioBone BV, Link Health has created a pipeline including 8 assets for global development in orthopedics and pain management. Link Health has its own research laboratories and core technology to lead drug-materials combo research and lead in the disease modifying novel therapy for orthopedic complicated diseases. Link Health has full team to execute registration, clinical development, business and marketing in China, in several Asian territories and in Netherlands in the Europe. About Bone Therapeutics Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a diversified portfolio of cell therapies at different stages ranging from pre-clinical programs in immunomodulation to mid stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation. Bone Therapeutics’ core technology is based on its cutting-edge allogeneic cell and gene therapy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in the hospital. Currently in pre-clinical development, BT-20, the most recent product candidate from this technology, targets inflammatory conditions, while the leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics’ scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company has initiated patient recruitment for the Phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental. Bone Therapeutics’ cell therapy products are manufactured to the highest GMP portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium.

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INDUSTRIAL IMPACT

Achiko AG Reports Breakthrough Calibration Results for its AptameX™ Covid-19 Rapid Test Technology

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.

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