This collaboration does sound interesting.
There is benefit for both companies in making the collaboration work.
Here is a recent announcement:
FDA Grants Orphan Drug Designation to NeoImmuneTech's NT-I7 for the Treatment of Acute Radiation Syndrome
20 Nov, 2023, 06:19
https://www.prnewswire.com/news-releases/fda-grants-orphan-drug-designation-to-neoimmunetechs-nt-i7-for-the-treatment-of-acute-radiation-syndrome-301993403.html?tc=eml_cleartime&utm_source=PRN&utm_medium=Press+release&utm_campaign=FDAODD&utm_term=ARS
FDA Grants Orphan DrugDesignation to NeoImmuneTech's NT-I7 for the Treatment of Acute RadiationSyndrome
NEWS PROVIDED BY
The FDA's Orphan DrugDesignation is aimed at advancing treatments for rare diseases, including AcuteRadiation Syndrome (ARS), which currently has limited treatment options.
NeoImmuneTech's NT-I7 hasshown potential in nonclinical studies to address the immunosuppressive effectsof ARS.
ROCKVILLE, Md, Nov. 20, 2023 /PRNewswire/ --
NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), a clinical-stageT cell-focused biopharmaceutical company, today announced that the U.S. Food andDrug Administration (FDA) has granted Orphan Drug Designation (ODD) for theirinvestigational drug NT-I7 (efineptakin alfa) (rhIL-7-hyFc) for the treatmentof Acute Radiation Syndrome (ARS).
ARS is an illness that occurs following a high dose of radiationexposure, leading to severe damage to the bone marrow and the immune system.Currently, there are no treatments available that effectively promote T cellrecovery after such exposure. NT-I7, a novel long-acting human interleukin-7 (IL-7), is expected to addressthis unmet medical need, with the potential to rapidly recover and improve theimmune response. In the clinical setting, NT-I7 has demonstrated impressiveresults by effectively and consistently boosting T cell counts, all whilemaintaining a remarkable level of safety and tolerance.
The FDA's ODD for NT-I7 reflects progress in the company's efforts. Acontract research organization (CRO) under contract to National Institute ofAllergy and Infectious Diseases (NIAID), part of the National Institutes ofHealth (NIH), is conducting a study that employs well-developed NIAID ARSrodent models to investigate NT-I7's efficacy as a potential treatment for theserious health implications of ARS. NIAID is supporting this research throughproduct development funding to the CRO.
Dr. Se Hwan Yang, Ph.D., President and Chief Executive Officer ofNeoImmuneTech, Inc., said: "Obtaining the Orphan Drug Designation from theFDA is an important acknowledgment of the immense potential that NT-I7 holds inproviding a beacon of hope for the treatment of ARS."
ODD is a status assigned to a medicine intended for use against a raredisease or condition that affects fewer than 200,000 people in the UnitedStates. The designation provides incentives to advance the development oftreatments for rare diseases, including protection from competition once thedrug is on the market, tax credits for clinical research costs, and exemptionfrom prescription drug user fees.
About Acute Radiation Syndrome (ARS)
Acute Radiation Syndrome (ARS) is an acute illness caused by irradiationof the entire body by a high dose of penetrating radiation in a very shortperiod of time (typically a matter of minutes or less). Examples of people whosuffered from ARS are individuals exposed during the Hiroshima and Nagasaki atomicbombings, and the firefighters that responded after the Chernobyl Nuclear PowerPlant incident in 1986.[1]
About NT-I7 (efineptakin alfa) (rhIL-7-hyFc)
NT-I7 (efineptakin alfa) (rhIL-7-hyFc) is the only clinical-stagelong-acting human IL-7 and is being developed in oncologic and immunologicindications, where T cell amplification and increased functionality may provideclinical benefit. IL-7 is a fundamental cytokine for naïve and memory T celldevelopment and sustaining immune response to chronic antigens (as in cancer)or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PDand safety profiles, making it an ideal combination partner. NT-I7 is beingstudied in multiple clinical trials in solid tumors and as a vaccine adjuvant.Studies are being planned for testing in hematologic malignancies, additionalsolid tumors and other immunology-focused indications.
About NeoImmuneTech, Inc. (NIT)
NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceuticalcompany dedicated to expanding the horizon of immuno-oncology and enhancingimmunity to infectious diseases. NIT is led by the scientific founder andinventor of NT-I7 (efineptakin alfa) and has a strong executive team with richindustry experience. NIT is expanding rapidly in personnel and operations, aswell as partnering with industry and academic leaders to investigate NT-I7 asmonotherapy and in combination with various immunotherapeutics. For moreinformation, please visit .
Forward-looking Statements
The statements contained herein may contain certain forward-lookingstatements relating to NeoImmuneTech, Inc. (the "Company") that arebased on its beliefs and expectations about the future. These forward-lookingstatements are based on a number of assumptions about the future, some of whichare beyond the Company's control and are not a guarantee of future performanceor developments. Such forward-looking statements are subject to certain risksand uncertainties that could cause actual results to differ materially fromthose contemplated by the relevant forward-looking statements. The Company doesnot undertake any obligation to update any forward-looking statements to reflectevents that occur or circumstances that arise after the date of thesedocuments. Accordingly, you should not place reliance on any forward-lookinginformation or statements contained herein.
Some of the data contained in these documents were obtained from variousexternal sources, and the Company has not independently verified such data.Accordingly, the Company makes no representations as to the accuracy orcompleteness of the data, and such data involves risks and uncertainties and issubject to change based on various factors.
Investors:
+82 31 709 5858
[1]
SOURCE The NeoImmuneTech, Inc
(20min delay)
