PLANTATION, Florida and HOUSTON, Texas, Oct. 7, 2024 /PRNewswire/ -- GBI Biomanufacturing [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=2537838533&u=https%3A%2F%2Fwww.gbibio.com%2F&a=GBI+Biomanufacturing], a leading Contract Development and Manufacturing Organization (CDMO), and Allterum Therapeutics [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=3458545142&u=https%3A%2F%2Fallterum.com%2F&a=Allterum+Therapeutics], a Fannin-Founded Company [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=2818386439&u=https%3A%2F%2Fwww.fannininnovation.com%2F&a=Fannin-Founded+Company], are pleased to announce a manufacturing partnership to advance Allterum's lead candidate 4A10 [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=1424213342&u=https%3A%2F%2Fallterum.com%2Fscience%2F&a=4A10] into clinic. 4A10 [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=1424213342&u=https%3A%2F%2Fallterum.com%2Fscience%2F&a=4A10] is a monoclonal antibody (mAb) targeting CD127, a receptor expressed by a broad variety of cancers.
https://mma.prnewswire.com/media/2523494/GBI_Biomanufacturing.jpg [https://mma.prnewswire.com/media/2523494/GBI_Biomanufacturing.jpg]
With this collaboration, GBI [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=2709128768&u=https%3A%2F%2Fwww.gbibio.com%2F&a=GBI] will leverage their extensive expertise [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=927257238&u=https%3A%2F%2Fwww.gbibio.com%2Ftech-transfer-focus-on-the-details%2F&a=expertise] in manufacturing complex biologics [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=150769899&u=https%3A%2F%2Fwww.gbibio.com%2Fapplications%2F&a=complex+biologics] to ensure the high-quality production of 4A10 [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=1424213342&u=https%3A%2F%2Fallterum.com%2Fscience%2F&a=4A10] for Phase 1/2a clinical trials. Allterum's [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=1220361859&u=https%3A%2F%2Fallterum.com%2F&a=Allterum%27s] initial trial will focus on patients who have acute lymphoblastic leukemia (ALL), with subsequent expansion to trials in patients with other CD127-expressing hematological malignancies, including lymphomas and acute myeloid leukemia.
"We are honored to be chosen by Allterum [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=240675421&u=https%3A%2F%2Fallterum.com%2F&a=Allterum] as their trusted partner on this important project," said Karl Pinto [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=2478096251&u=https%3A%2F%2Fwww.linkedin.com%2Fin%2Fkarl-pinto-7397022%3Flipi%3Durn%253Ali%253Apage%253Ad_flagship3_profile_view_base_contact_details%253BcZNGDt98R9qBWVH6lBwcbA%253D%253D&a=Karl+Pinto], Chairman and CEO of GBI [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=2067608827&u=https%3A%2F%2Fwww.gbibio.com%2Fboard-of-directors%2F&a=GBI]. "Our team is dedicated to providing the highest quality development and manufacturing services for drug substance and drug product [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=2043379036&u=https%3A%2F%2Fwww.gbibio.com%2Fcgmp-clinical-commercial-manufacturing%2F&a=manufacturing+services+for+drug+substance+and+drug+product], ensuring the success of this promising treatment. This collaboration is a testament of our commitment to advancing the field of oncology and making a meaningful difference in the lives of patients."
Atul Varadhachary [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=4174141753&u=https%3A%2F%2Fnam12.safelinks.protection.outlook.com%2F%3Furl%3Dhttps%253A%252F%252Fwww.linkedin.com%252Fin%252Fvaradhachary%252F%26data%3D05%257C02%257CYAlicea-Hidrovo%2540gbibio.com%257C45789d7b215e40de50ff08dcd8112e5b%257C4fca6b8be17743f39b7116b00b026913%257C0%257C0%257C638622816426179670%257CUnknown%257CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%253D%257C0%257C%257C%257C%26sdata%3D%252FJO4Vpz%252B%252BiwIdOSZy4jhVlG91ktB74ycYwbGnNgnkJk%253D%26reserved%3D0&a=Atul+Varadhachary], Allterum's [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=1584275925&u=https%3A%2F%2Fallterum.com%2Fteam%2F&a=Allterum%27s] CEO and Managing Partner at Fannin [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=3279496962&u=https%3A%2F%2Fwww.fannininnovation.com%2F&a=Fannin] added, "4A10 [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=1424213342&u=https%3A%2F%2Fallterum.com%2Fscience%2F&a=4A10] has demonstrated robust preclinical activity across multiple cancers and we are excited about advancing it into clinic. We selected GBI [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=2709128768&u=https%3A%2F%2Fwww.gbibio.com%2F&a=GBI] as our manufacturing partner based on their years of experience with complex biologics, and we look forward to working together to ensure our program's success."
Allterum's 4A10 [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=887205103&u=https%3A%2F%2Fallterum.com%2Fscience%2F&a=Allterum%27s+4A10] development program is supported by grant funding from the Cancer Prevention and Research Institute of Texas (CPRIT) [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=2531887313&u=https%3A%2F%2Fcprit.texas.gov%2F&a=Cancer+Prevention+and+Research+Institute+of+Texas+(CPRIT)], the National Cancer Institute (NCI) [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=533466778&u=https%3A%2F%2Fwww.cancer.gov%2F&a=National+Cancer+Institute+(NCI)] and additionally has been supported through the NCI Experimental Therapeutics Program (NExT) [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=1926969382&u=https%3A%2F%2Fnext.cancer.gov%2F&a=NCI+Experimental+Therapeutics+Program+(NExT)]. The antibody, invented at the NCI by senior investigator Scott Durum, PhD [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=3971894989&u=https%3A%2F%2Fccr.cancer.gov%2Fstaff-directory%2Fscott-k-durum&a=Scott+Durum%2C+PhD] and his collaborators, is licensed exclusively to Allterum [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=240675421&u=https%3A%2F%2Fallterum.com%2F&a=Allterum]. Allterum has received Orphan Drug and Rare Pediatric Disease designations for ALL from the FDA, which will provide facilitated access to the FDA and potentially qualify 4A10 [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=1424213342&u=https%3A%2F%2Fallterum.com%2Fscience%2F&a=4A10] for a Pediatric Priority Review Voucher.
Successful completion of Allterum's [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=617162253&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4270518-1%26h%3D763698771%26u%3Dhttps%253A%252F%252Fallterum.com%252F%26a%3Dhttps%253A%252F%252Fallterum.com%252F&a=Allterum%27s] Phase 1/2a clinical trials [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=1085753680&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4270518-1%26h%3D2992103586%26u%3Dhttps%253A%252F%252Fwww.gbibio.com%252Fregulatory-cmc-support%252F%26a%3Dclinical%2Btrials&a=clinical+trials] will mark a significant milestone in developing this promising anti-cancer drug, addressing major unmet medical needs.
To learn more about GBI, click the link below:
https://www.gbibio.com/ [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=3023980185&u=https%3A%2F%2Fwww.gbibio.com%2F&a=https%3A%2F%2Fwww.gbibio.com%2F]
To learn more about Allterum Therapeutics, click the link below:
https://allterum.com/ [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=763698771&u=https%3A%2F%2Fallterum.com%2F&a=https%3A%2F%2Fallterum.com%2F]
To learn more about Fannin Partners, click the link below:
https://www.fannininnovation.com/ [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=591844510&u=https%3A%2F%2Fwww.fannininnovation.com%2F&a=https%3A%2F%2Fwww.fannininnovation.com%2F]
Media Contact: info@GbiBio.com [mailto:info@GbiBio.com]
https://mma.prnewswire.com/media/2523058/ALLTERUM_01.jpg [https://mma.prnewswire.com/media/2523058/ALLTERUM_01.jpg]
Logo - https://mma.prnewswire.com/media/2523494/GBI_Biomanufacturing.jpg [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=1568276412&u=https%3A%2F%2Fmma.prnewswire.com%2Fmedia%2F2523494%2FGBI_Biomanufacturing.jpg&a=https%3A%2F%2Fmma.prnewswire.com%2Fmedia%2F2523494%2FGBI_Biomanufacturing.jpg]
Logo - https://mma.prnewswire.com/media/2523058/ALLTERUM_01.jpg [https://c212.net/c/link/?t=0&l=en&o=4270518-1&h=400279396&u=https%3A%2F%2Fmma.prnewswire.com%2Fmedia%2F2523058%2FALLTERUM_01.jpg&a=https%3A%2F%2Fmma.prnewswire.com%2Fmedia%2F2523058%2FALLTERUM_01.jpg]
View original content:https://www.prnewswire.co.uk/news-releases/gbi-biomanufacturing-and-allterum-therapeutics-announce-strategic-collaboration-to-manufacture-therapeutic-antibody-for-clinical-trials-302268128.html [https://www.prnewswire.co.uk/news-releases/gbi-biomanufacturing-and-allterum-therapeutics-announce-strategic-collaboration-to-manufacture-therapeutic-antibody-for-clinical-trials-302268128.html]
Photo: https://mma.prnewswire.com/media/2523494/GBI_Biomanufacturing.jpghttps://mma.prnewswire.com/media/2523058/ALLTERUM_01.jpg GBI Biomanufacturing
