Palm Beach, FL – January 19, 2023 – FinancialNewsMedia.com News Commentary – Gamma Delta T Cell Therapy represents one of the most promising T Cell therapies in clinical development. The introduction of T cell-based immunotherapy has greatly revolutionized the paradigm of cancer treatment. The progress in clinical research and innovation has led to the identification of small subsets of T cells classified as gamma delta T cells. Gamma delta T cells are the minor subsets of T cells that constitutes only about 1% to 5% of T cell population. Their unique biology and conferred advantages over conventional T cells have enabled the researchers to utilize these novel cells as a promising candidate for adoptive immunotherapy. Since its identification, scientists have harnessed the potential of gamma delta T cells in the management of several cancers. A report from ResearchAndMarkets projects that the global gamma delta T-cell therapy market is expected to surpass US$ 4 Million by 2028. The report said: “The gamma delta T cell therapy represents one of the most promising T cell therapies in clinical development which can be suggested by the rapid research and development activities among the pharmaceutical companies. The major companies in the market are presenting promising preclinical and clinical data of gamma delta T cell therapies… The encouraging data from a clinical trial suggest the promising future of gamma delta T cell therapy in the management of cancer.” Active companies in the markets this week include: TC Biopharm (Holdings) PLC (NASDAQ: TCBP), Cardiff Oncology, Inc. (NASDAQ: CRDF), Celyad Oncology SA (NASDAQ: CYAD), Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL), AstraZeneca PLC (NASDAQ: AZN).
ResearchAndMarkets continued: “Apart from cancer, researchers are also expanding the role of gamma delta T cell therapy in the management of other diseases such as HIV, COVID-19, and other viral infections… Furthermore, several preclinical studies also indicate an innate involvement of gamma delta T cells in viral infections. The coming years will witness the translation of these investigations into clinical trials, which will further propel the growth of market. US is currently dominating the global initiatives in the development of gamma delta T cell therapy driven by a large number of ongoing clinical trials, presence of key players in the region, and increasing initiatives from various stakeholders in the industry. Apart from this, US FDA is also granting orphan drug designation to gamma T cell therapies which provides several financial and non-financial incentives to boost the drug development process.”
TC Biopharm (Holdings) PLC (NASDAQ: TCBP) BREAKING NEWS: TC BioPharm Announces Strategic Collaboration to Advance Gamma Delta T Cells in Oncology – TC Biopharm (Holdings) PLC (“TC Biopharm” or the “Company”) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer treatment, this week announces a strategic collaboration with The University of Texas MD Anderson Cancer Center to expand the knowledge base of how gamma-delta T cells work in oncology settings.
The collaboration brings together MD Anderson’s clinical trial infrastructure and the translational research expertise of its immunotherapy platform with the clinical data of TC BioPharm’s targeted gamma-delta T cell oncology pipeline. Under the terms of the three-year agreement, the research teams will work together on both preclinical and clinical studies to evaluate the potential for gamma-delta T cell therapies and to better understand the behaviors of these cells in patients. The collaborators will form a six-person steering committee to drive the development of both the data set and subsequent assays for each study.
The comprehensive immunoprofiling capabilities of MD Anderson’s immunotherapy platform will enable correlative studies on clinical samples to uncover detailed insights on the behavior of gamma-delta T cells and corresponding responses in patients. The platform is co-led by Padmanee Sharma, M.D., Ph.D., professor of Genitourinary Medical Oncology and Immunology, and James Allison , Ph.D., regental chair of Immunology.
Formulating a better picture of what is occurring in patients during gamma delta T cell therapies is expected to allow TC Biopharm to better design future studies as well as form a view towards future targeted cancer studies in other blood cancers and solid tumors potentially.
“We are enthusiastic about working with MD Anderson to further our knowledge of gamma delta T cells in order to help TC Biopharm develop future trials and treatments using our platform therapy OmnImmune,” said Bryan Kobel , CEO of TC BioPharm. “This collaboration reinforces our mutual commitment to accelerating the discovery and development of cell therapies, and it highlights TC Biopharm’s expertise in the gamma delta T cell space.” CONTINUED… Read this full press release and more news for TC Biopharm at: https://www.financialnewsmedia.com/news-tcbp/
TC Biopharm also recently announced the dosing of its first three patients within its Phase 2b clinical trial of OmnImmune®, an allogeneic unmodified cell therapy focused on treating Acute Myeloid Leukemia (AML). Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow — the spongy tissue inside bones where blood cells are made.
The initial 5 patients in the trial are deemed a “safety cohort”, spaced two weeks apart with safety review by an oversight board to confirm no drug related toxicity issues, subsequent to 5 patients being dosed the study will advance to open enrollment. This safety cohort is in line with TCBP’s step-wise clinical trial advancement, moving from donor matching in the Phase 1b to a universal donor model with no HLA matching of donor to patient.
“The launch of our Phase 2B trial is a key milestone in the development of our lead therapeutic, OmnImmune®, for patients with AML and for TC BioPharm’s emerging pipeline of ‘off-the-shelf’ gamma-delta T cell therapies,” said Bryan Kobel, CEO of TC BioPharm. “This study design includes a 5 patient safety cohort prior to open enrollment, we expect to complete the safety cohort before the end of 2022. The next step in the study is a 19 patient interim review, which will allow TCBP to review dosing and increase dosing to a higher level should our team deem it necessary for efficacy, or we can elect to maintain our current dosing level of 7×10^7 or 700 million cells per dose. We look forward to moving ahead with our Phase 2b trial with a target for open enrollment in January 2023, as well as our efforts to expand our clinical efforts in the US in the first half of 2023.” CONTINUED… Read this full press release and more news for TC Biopharm at: https://ir.tcbiopharm.com/news/press-releases/detail/40/tc-biopharm-begins-dosing-phase-2b-clinical-study
Other recent developments in the markets of note include
Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, recently announced financial results and recent highlights for the third quarter ended September 30, 2022.
“We recently announced Phase 1b/2 data that demonstrate onvansertib’s ability to generate durable responses in KRAS-mutated mCRC patients, with various underlying mutations, when combined with standard-of-care FOLFIRI/bevacizumab. In addition, we observed an increase in objective response rate and progression-free survival in the bevacizumab-naïve subgroup of patients, providing key learnings to maximize ovansertib’s therapeutic and commercial potential,” said Mark Erlander, PhD, chief executive officer of Cardiff Oncology. “In the fourth quarter we plan to activate ONSEMBLE, a randomized Phase 2 trial in our lead KRAS/NRAS-mutated mCRC program. This trial is designed to corroborate the robust signal of efficacy provided by the Phase 1b/2 results and position onvansertib for a possible accelerated approval opportunity by demonstrating its contribution over standard-of-care alone.”
Celyad Oncology SA (NASDAQ: CYAD), a biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, recently provided an update on its financial results and recent business developments for the fiscal quarter ended September 30, 2022.
“This past quarter has been a pivotal moment for the Company as we focus on a new Celyad 2.0 strategy as we seek to monetize our valuable IP estate and leverage our dynamic shRNA technology for our R&D programs. We’ve bolstered our cash runway with an asset purchase agreement for our manufacturing business unit and we believe we are well-positioned to unleash the power of our IP estate and potentially redefine the cell therapy space,” said Michel Lussier, interim Chief Executive Officer of the Company.
Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) recently announced that REZLIDHIA(olutasidenib) has been added by the National Comprehensive Cancer Network® (NCCN®) to the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for acute myeloid leukemia (AML). REZLIDHIA (olutasidenib) is now included as a recommended targeted therapy for adult patients with relapsed/refractory (R/R) AML with isocitrate dehydrogenase-1 (IDH1) mutation.
“We are pleased that REZLIDHIA was quickly added to the NCCN Guidelines® for AML, receiving important recognition as an appropriate treatment option for adult R/R AML patients with an IDH1 mutation,” said Raul Rodriguez, president and CEO of Rigel. “Inclusion in the NCCN Guidelines for AML reinforces the strength of the data, which supports the safety and efficacy of REZLIDHIA.” In December 2022, the U.S. Food and Drug Administration (FDA) approved REZLIDHIA capsules for the treatment of adult patients with R/R AML with a susceptible IDH1 mutation as detected by an FDA-approved test. REZLIDHIA is an oral, small molecule, inhibitor of mutated IDH1 designed to bind to and inhibit mIDH1 to reduce 2-hydroxyglutarate levels and restore normal cellular differentiation of myeloid cells.
AstraZeneca PLC (NASDAQ: AZN) recently said that detailed results from the SERENA-2 Phase II trial showed AstraZeneca’s next-generation oral selective estrogen receptor degrader (ngSERD) camizestrant demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) at both 75mg and 150mg dose levels versus FASLODEX® (fulvestrant) 500mg in post-menopausal patients with estrogen receptor (ER)-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy. Results will be presented today in an oral presentation at the 2022 San Antonio Breast Cancer Symposium (SABCS).
Mafalda Oliveira, MD, PhD, Vall d’Hebron Hospital and Vall d‘Hebron Institute of Oncology in Barcelona, Spain, and lead investigator for the SERENA-2 Phase II trial, said: “These data reflect an important step toward a potential new treatment option for patients with advanced ER-positive disease. Based on the SERENA-2 results, camizestrant was well tolerated at both doses and significantly improved patient outcomes, nearly doubling median progression-free survival in this setting compared with the current SERD standard of care.”
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