Randomized, Double-blind, Placebo-controlled, 28-Day Daily-dose Crossover Study of the Safety and Tolerability of SB-121 (Lactobacillus Reuteri With Sephadex® and Maltose) in Subjects, Ages 15 to 45 Years, Diagnosed With Autistic Disorder

SB-121 is being developed for use in the treatment of autistic disorder (AD).
This study is a multiple-dose, randomized, double-blind, placebo-controlled, cross-over single-site Phase I study.
The primary objective is to evaluate the safety and tolerability of multiple doses of SB-121 in subjects ages 15 to 45 years with AD.
Additionally, multiple measures of AD, as well as mechanistic biomarkers, will be assessed in order to inform later stage trials.

Start Date02 Aug 2021

Sponsor / Collaborator

Scioto Biosciences, Inc.Startup

100 Clinical Results associated with SB-121

100 Translational Medicine associated with SB-121

100 Patents (Medical) associated with SB-121

Literatures (Medical) associated with SB-121

30 Mar 2023·Scientific reports

Results of a phase Ib study of SB-121, an investigational probiotic formulation, a randomized controlled trial in participants with autism spectrum disorder.

Article

Author: Will, Meredith ; Barber, Lillian ; West, Korbin H J ; Smith, Elizabeth G ; Ahuja, Sanjeev ; Heiman, Mark ; Pedapati, Ernest V ; Lamy, Martine ; Hughes, Phoevos ; Schmitt, Lauren M ; Trebley, Joe ; Erickson, Craig A ; Meyer, Kevin ; Horn, Paul S

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by core impairments in social communication as well as restricted, repetitive patterns of behavior and/or interests. Individuals with ASD, which includes about 2% of the US population, have challenges with activities of daily living and suffer from comorbid medical and mental health concerns. There are no drugs indicated for the core impairments of ASD. As such, there is a significant need for the development of new medication strategies for individuals with ASD. This first-in-human placebo-controlled, double-blind, crossover study investigated the safety (primary objective) and efficacy of oral SB-121, a combination of L. reuteri, Sephadex® (dextran microparticles), and maltose administered once daily for 28 days in 15 autistic participants. SB-121 was safe and well tolerated. SB-121-associated directional improvements in adaptive behavior measured by Vineland-3 and social preference as measured with eye tracking were noted. These results provide support for further clinical evaluation of SB-121 as a treatment in autistic patients. To evaluate the safety and tolerability of multiple doses of SB-121 in subjects with autism spectrum disorder. Single-center, randomized, placebo-controlled, double-blind, crossover trial. 15 patients with autism spectrum disorder were randomized and analyzed. Daily dosing of SB-121 or placebo for 28 days, followed by approximately a 14 day washout, then 28 days of dosing with other treatment. Incidence and severity of adverse events, presence of Limosilactobacillus reuteri and Sephadex® in stool, and incidence of bacteremia with positive L. reuteri identification. Additional outcomes include changes from baseline on cognitive and behavior tests as well as biomarker levels. Adverse event rates were similar between SB-121 and placebo, with most reported as mild. There were no severe or serious adverse events. No participants had features of suspected bacteremia or notable changes in vital signs, safety laboratory, or ECG parameters from baseline. There was a statistically significant increase from baseline in the Vineland-3 Adaptive Behavior Composite score (p = 0.03) during SB-121 treatment. There was a trend for increased social/geometric viewing ratio following SB-121 treatment compared to placebo. SB-121 was safe and well tolerated. SB-121-associated directional improvements in adaptive behavior measured by Vineland-3 and social preference as measured with eye tracking were noted.Trial registration: clinicaltrials.gov Identifier: NCT04944901.

01 Jul 2012·Wei sheng yan jiu = Journal of hygiene research

[Rapid determination of 19 elements in human urine by inductively coupled plasma-mass spectrometry with dynamic reaction cell].

Article

Author: Liao, Qinqin ; Wang, Jun ; Liu, Huijian ; Xu, Jian ; Tan, Hongxing ; Liu, Xiaoli

OBJECTIVEA simple method is proposed for determination of Be, Rb, Sr, Cd, Pb, Cs, Tl, V, Cr, Mn, Ni, Co, Cu,Zn, Sn, Sb, Te, As and Se in urine by using inductively coupled plasma mass spectrometry with dynamic reaction cell.METHODSPrior to analysis, samples were diluted (1: 20) in a solution of nitric acid (3%, V/V). The DRC mode was applied to determine the content of V51, Cr52, Mn55, Ni58, Co59, Cu63, Zn64 Sn120, Sb121, Te130, As75 and Se80. For the other elements, the instrument was operated in standard mode.RESULTSThe method detection limits were 2.7ng/L for Be9, 2.0ng/L for V51, 2.7ng/L for Cr52, 1.5ng/L for Mn55, 3.9ng/L for Ni58, 0.8ng/L for Co59, 5.8ng/L for Cu63, 35.3ng/L for Zn64, 32.4ng/L for As75, 21.1ng/L for Se80,1.4ng/L for Rb85, 4.2ng/ L for Sr88, 1.1 ng/L for Cd 9.1 ng/L for Sn120, 1.1ng/L for Sb121, 8.6ng/L for Te130, 0.1 ng/L for Cs133, 0.2ng/L for Tl205 and 1.0 ng/L for Pb208. The precisions of the method were in the range of 0.3% - 2.6%.CONCLUSIONThe proposed method was rapid, accurate and can be used for measurement with simple pre-treatment, less sample and lower cost. The method was also suitable for massive samples in screening and monitoring.

14 May 2006·The Journal of Chemical PhysicsQ2 · CHEMISTRY

The quadrupole moment of the Sb nucleus from molecular microwave data and calculated relativistic electric-field gradients

Q2 · CHEMISTRY

Article

Author: Cooke, Stephen A. ; Sadlej, Andrzej J. ; Demovic, Lukas ; Kello, Vladimir

The recently determined accurate values of the nuclear quadrupole coupling constant of the Sb nucleus in SbN, SbP, SbF, and SbCl and the calculated electric-field gradients at Sb in these molecules are used to obtain the nuclear quadrupole moment of Sb121 and Sb123. The calculation of the electric-field gradient has been carried out by using the infinite-order two-component relativistic method in the scalar approximation. The accompanying change of picture of the electric-field gradient operator has been accounted for by employing the shifted nucleus model of nuclear quadrupoles. The electron correlation effects are calculated at the level of the coupled cluster approximation. The present calculations give the “molecular” value of the nuclear quadrupole moment of Sb121 equal to −556±24mb which is considerably different from the old “recommended” value of −360±40mb and also differs from the recent “solid-state” result (−669±15mb). The validation of the present data is comprehensively discussed.

News (Medical) associated with SB-121

23 Oct 2023

·www.sciencedaily.com

Probiotics delivered in biofilm state protect the intestines and brain in NEC model

Researchers have been working on a novel solution to prevent NEC. They have developed a novel probiotic system that harnesses the durability of biofilms to improve the administration of probiotics to patients. Their latest study describes the use of a biofilm formulation of Limosilactobacillus reuteri (Lr) to prevent NEC in a piglet model. Necrotizing enterocolitis (NEC) is a debilitating and deadly condition that affects infants who were born preterm. In NEC cases, intestinal tissues become inflamed, and in severe cases there is ischemia and death of the involved intestines. Treatment for NEC often involves surgery to remove the dying tissue. "Even after decades of research, little has changed in terms of prognosis for infants who develop NEC," says Gail Besner, MD, pediatric surgeon and principal investigator in the Center for Perinatal Research at Nationwide Children's. "Anywhere from 30 to 50% of infants with NEC will die from it. And even those who survive face lifelong challenges including short-gut syndrome and neurodevelopmental delays." ]Dr. Besner and her collaborators Michael Bailey, PhD, and Steven Goodman, PhD, both principal investigators in the Center for Microbial Pathogenesis at Nationwide Children's, have been working on a novel solution to prevent NEC. They have developed a novel probiotic system that harnesses the durability of biofilms to improve the administration of probiotics to patients. It has been licensed to Scioto Biosciences. Their latest study, published in Nature Scientific Reports, describes the use of a biofilm formulation of Limosilactobacillus reuteri (Lr) to prevent NEC in a piglet model. "Our previous studies have shown that the biofilm probiotic works in mouse and rat models," says Dr. Besner. "But there are many examples where researchers find something that works in rodents, but it fails to translate to humans. We wanted to show that this approach to preventing NEC would work in an animal model that was more similar to humans." Dr. Besner and her team therefore adapted the very challenging piglet model of NEC into her laboratory for this study. Notably, preterm piglets and preterm humans are very similar in terms of size and intestinal anatomy. Care that would normally be given to a preterm infant, including medications and fluids, nasogastric (NG) tube feedings, and round-the-clock monitoring, are all included in the model. The data from the piglet model validated findings in rodent models. Findings demonstrate the superiority of Lr in its biofilm state compared to planktonic (free-living) Lr in preventing the morbidity and mortality associated with NEC. Importantly, Lr in its biofilm state not only protects the intestines from NEC, but protects the brain as well, a finding of great potential importance for survivors of NEC. "The piglet is an excellent model to help prepare for studies in neonates. The data from this study help us understand the safety and efficacy pro this novel formulation. This will be helpful as we work with the FDA to plan for future human studies," says Joe Trebley, PhD, founder and chief executive officer of Scioto Biosciences. A similar probiotic formulation developed by the team, SB-121, has been tested in a clinical trial in adults with autism spectrum disorder (ASD). The association between the brain and the gut symptoms in autism has been well-established in the literature, with more than half of people with autism also experiencing abdominal problems. The study, which primarily evaluated the safety of SB-121, also found that some participants showed treatment-driven improvements in their ASD test outcomes. The promising results of that phase 1b trial were published earlier this year in Nature Scientific Reports. "Taken together, the current piglet study, the previous rodent studies, and the recent SB-121 clinical trial provide a solid foundation for pursuing a clinical trial in neonates at risk of developing NEC," says Dr. Besner. "We are excited to continue pursuing this research with the hope that someday, infants born preterm will have more options to protect them from NEC." This research was funded through a $2.3M SBIR grant from the National Institute of General Medical Sciences at the National Institutes of Health. Drs. Besner, Bailey and Goodman are all scientific founders of Scioto Biosciences.

Phase 1Clinical Result

03 Apr 2023

·www.biospace.com

Scioto Biosciences Announces Publication of Phase 1b Study in Autism

"Results of a phase Ib study of SB-121, an investigational probiotic formulation, a randomized controlled trial in participants with autism spectrum disorder" FISHERS, Ind.--(BUSINESS WIRE)-- Scioto Biosciences Inc., (the “Company” or “Scioto Biosciences”) a clinical stage company developing innovative therapies to transform the delivery of microbiome therapeutics, today announced the publication of results from a Phase 1b study of their lead product SB-121 in patients with Autistic Spectrum Disorder (ASD). The publication, Results of a phase Ib study of SB-121, an investigational probiotic formulation, a randomized controlled trial in participants with autism spectrum disorder, was published in the journal Scientific Reports. Scientific Reports, a part of Nature Publishing, is an open access journal requiring a rigorous peer-review process prior to publication. According to its website, Scientific Reports is the 5th most cited journal in the world with more than 696,000 citations in 2021. The top-line results of the study were announced last summer. The first-in-human study was double-blind, placebo controlled, 28-day crossover study of the safety and tolerability of SB-121. SB-121 is a novel formulation of Lactobacillus reuteri (Lr) and was given to patients 15 to 45 years of age diagnosed with ASD. Lr is a species of bacteria that is often found in breastmilk. With the results now published, the study demonstrated that SB-121 was safe and well-tolerated. The study also showed treatment-associated improvements in the Vineland-3 adaptive behavior assessment, measures of eye tracking and increases in peripheral oxytocin. Oxytocin is a natural hormone that, among many functions, encourages bonding and social interaction. The study was performed by Dr. Craig Erickson MD at the Cincinnati Children’s Hospital. Dr. Erickson is the corresponding author on the paper. Additional authors include Lauren Schmitt PhD, Elizabeth Smith PhD, Ernest Pedapati MD MS, Paul Horn PhD, Meredith Will PhD, Martine Lamy MD PhD, and Lillian Barber from Cincinnati Children’s Hospital and Joe Trebley PhD, Kevin Meyer, Mark Heiman PhD, Korbin West PhD, Phoevos Hughes JD, and Sanjeev Ahuja MD from Scioto Biosciences. “We are very pleased to have this study accepted for publication. It is an exciting result that certainly warrants further investigation in a larger Phase II study. We look forward to continuing to help move this forward in the clinic so that we can eventually get it to the patients that so desperately need it,” said Dr. Erickson. “Scioto is incredibly grateful for the team at Cincinnati Children’s Hospital. We are proud to have published this important work alongside them. The peer-review process is such a critical part of science. It is incredibly gratifying to have this study published in such a well-cited journal,” explained Joe Trebley, PhD, CEO of the Company. Trebley also said that hope to begin a Phase II study in the 2nd half of this year. According to the Center for Disease Control (CDC) about 1 in 44 children have been identified with ASD, and prevalence in adults continues to grow creating the bulk of the economic burden of the disorder. Estimates of economic costs in the US only are in the 100’s of billions of dollars. About Scioto Biosciences Based in Fishers, IN, Scioto Biosciences is a clinical stage company developing innovative therapies devoted to having a transformative impact on the delivery of live bacterial therapeutics (LBTs). Scioto Biosciences was founded in 2017 as a partnership between Indiana business accelerator, Monon Bioventures (MBV) and The Research Institute at Nationwide Children's Hospital (RINCH), with whom the company has a worldwide exclusive licensing agreement. The Company’s Activated Bacterial Therapeutic Platform has the potential to enhance efficacy wherever LBTs are used such as neurological disorders, gastrointestinal health, and others. For more information, visit

Phase 1License out/inPhase 2Clinical ResultMicrobial therapy

27 May 2022

·www.biospace.com

Clinical Catch-Up: 3's the Charm for Pfizer-BioNTech Vaccine in Kids & More

As Memorial Day officially kicks off the summer season, there are plenty of clinical trial highlights. Here’s a look. COVID-19-Related Pfizer released toplined data from its Phase II/III trial of the Pfizer-BioNTech COVID-19 vaccine in children ages six months to five years. The data support the use of a three-dose regimen. Ocugen reported the FDA had lifted a second clinical hold on its studies of Covaxin, a COVID-19 vaccine. The hold was placed on a Phase II/III trial over concerns about the company’s developmental partner Bharat Biotech International Limited’s manufacturing facility. Edesa Biotech announced it had initiated enrollment for a second cohort of patients for the Phase III portion of a Phase II/III trial of EB05 for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS). The drug is a monoclonal antibody. Codagenix dosed the first patient in a Phase I trial of CoviLiv as a booster in healthy adults after previous vaccination with approved COVID-19 vaccines. CoviLiv is an intranasal, live-attenuated virus vaccine. Moleculin Biotech initiated dosing in its Phase Ia trial of WP1122. The drug is a metabolism/glycosylation inhibitor being developed to treat COVID-19. Non-COVID-19-Related Armata Pharmaceuticals reported that it had dosed the first patient in its Phase Ib/IIa trial of AP-SA02 for adults with bacteremia from Staphylococcus aureus infections. In June 2020, the company was awarded $15 million from the U.S. Department of Defense through the Medical Technology Enterprise Consortium (MTEC) managed by the Naval Medical Research Center with funding from the Defense Health Agency and Joint Warfighter Medical Research Program, to evaluate AP-SA02 as an adjunct to best available antibiotic treatment. Alnylam Pharmaceuticals reported 18-month results from a Phase III Helios-A trial of vutrisiran in transthyretin-mediated hereditary (hATTR) amyloidosis. Vutrisiran targets and silences the mRNA linked to the production of TTR proteins. The company also announced new positive results from the Phase III ILLUMINATE-C trial of lumasiran for advanced primary hyperoxaluria type 1 (PH1). The new results were a six-month primary analysis period of the ILLUMINATE-C trial of lumasiran. Lumasiran, marketed as Oxlumo and indicated for primary hyperoxaluria type 1, is an RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1), the gene encoding glycolate oxidase (GO). The company previously reported that lumasiran caused substantial reductions in plasma oxalate (POx) at six months. Regeneron Pharmaceuticals reported positive data from its Phase III trial of Evkeeza for homozygous familial hypercholesterolemia (HoFH). Evekeeza (evinacumab) is a fully human monoclonal antibody against ANGPTL3. Seres Therapeutics reported positive data from the Phase III ECOSPOR trial of SER-109 for the prevention of recurrent C. difficile infection. SER-109 is an oral microbiome therapeutic containing Firmicutes spores, typically found in healthy microbiomes. Vera Therapeutics announced new data from its Phase II trial of atacicept for systemic lupus erythematosus. Atacicept is a recombinant fusion protein. Day One Biopharmaceuticals dosed the first patients in sub-study 2 of FIRELIGHT-1, a Phase Ib/II trial of tovorafenib in combination with pimasertib in adolescent and adult patients with recurrent, progressive, or refractory solid tumors with MAPK pathway aberrations. The drug is an oral, brain-penetrant, highly selective type II pan-RAF kinase inhibitor. Pimasertib is an oral, highly selective small-molecule inhibitor of mitogen-activated protein kinases 1 and 2 (MEK-1/-2). Albireo presented analysis of its pivotal PEDFIC 1 and PEDFIC 2 studies of Bylavy for progressive familial intrahepatic cholestasis (PFIC). Bylvay is a potent, non-systemic once daily ileal bile acid transport inhibitor approved in the U.S. for pruritus in patients three months of age and older in all types of PFIC. Anokion announced positive results from the Phase I ACeD trial of KAN-101 for celiac disease. KAN-101 is designed to induce tolerance to gliadin, a core component of gluten. Vectorious Medical Technologies announced the results of Vector-HF I, a first-in-man study of its V-LAP wireless system for left atrial pressure management of heart failure. The V-LAP system in an implanted heart sensor. Janssen, a Johnson & Johnson company, published findings from the Phase III COMPASS long-term open-label extension study of Xarelto (rivaroxaban) and Xarelto in combination with acetylsalicylic acid (aspirin). The studies supported the role of dual pathway inhibition with Xarelto and aspirin in patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD). The company also presented data from the Phase II Galaxi 1 trial of Tremfya (guselkumab) in moderately to severely active Crohn’s disease. The data demonstrated that patients who were intolerant of or had poor responses to conventional therapies achieved highly clinical biomarker response levels of 47.5% to 66.7%. Seagen announced positive topline results from the pivotal Phase II MOUNTAINEER trial of Tukysa (tucatinib) in combination with trastuzumab in patients with previously treated HER2-positive metastatic colorectal cancer. Tukysa is an oral TKI inhibitor. Stealth Biotherapeutics announced new data from the Phase II Reclaim-2 trial of elamipretide in geographic atrophy secondary to dry age-related macular degeneration. Elamipretide is designed to ameliorate mitochondrial-based diseases of the eye. Ascendis Pharma announced that results from Visen Pharmaceuticals’ Phase III trial of TransCon hGH in children with growth hormone deficiency in China demonstrated results consistent with Ascendis’ Phase III trial. The drug is already approved in U.S. and EU for pediatric GHD. Recce Pharmaceuticals announced that in cohort five of a Phase I trial, R327 demonstrated a good safety and tolerability pro 10 healthy male subjects. The drug, RECCE 327 is an IV and topical therapy being developed for serious and potentially life-threatening infections from Gram-positive and Gram-negative bacteria. Pfizer presented detailed results from two pivotal studies that make up the Elevate UC Phase III program of etrasimod for moderately-to-severely active ulcerative colitis (UC). The drug is a once-daily, oral, selective sphingosine 1-phosphate (S1P) receptor modulator. Both studies hit all primary and key secondary endpoints. SpringWorks Therapeutics announced positive topline results from the DeFi Phase III trial of nirogacestat in adults with progressing desmoid tumors. The drug is an oral gamma-secretase inhibitor. Eli Lilly shared results from its Phase III Lucent-2 trial of mirikizumab for ulcerative colitis. Patients who responded to the drug at 12 weeks achieved and maintained statistically superior and clinically meaningful improvements at one year compared to placebo across all primary endpoints of clinical remission and all key secondary endpoints. Mirikizumab is a humanized IgG4 monoclonal antibody that binds to the p19 subunit of interleukin 23. Imugene and City of Hope dosed the first patient in a Phase I trial of CF33-hNIS (Vaxinia) for metastatic or advanced tumors. The drug is a genetically altered oncolytic virus programmed to infiltrate cancer cells and cause them to burst. Alpine Immune reported the FDA had removed a partial clinical hold on its NEON-2 trial of davoceticept with Merck’s anti-PD-1 checkpoint inhibitor Keytruda (pembrolizumab) in adults with advanced malignancies. Davoceticept is a first-in-class conditional CD28 costimulator and dual checkpoint inhibitor. Luxa Biotechnology announced the first patient was transplanted with RPESC-RPE-4W for dry age-related macular degeneration in its Phase I/IIa trial. The therapy is a cell product derived from the retinal pigment epithelium stem cell (RPESC) that is present in the adult human retina. Aerie Pharmaceuticals dosed the first participant in the Phase III Comet-2 study of AR-15512 ophthalmic solution for dry eye disease. AR-15512 is a first-in-class TRPM8 agonist. Cingulate completed enrollment in its formulation study of CTx-2103 for the management of anxiety-related disorders. Results from the trial are expected in July 2022. CTx-2103 contains the active pharmaceutical ingredient buspirone hydrochloride, a non-benzodiazepine medication. Pharmazz announced positive topline data from its Phase III trial of sovateltide for acute ischemic stroke. The data at 90 days demonstrated mRS (median score reduction) had a significantly greater number of patients with an improvement of 2 or more points on mRS. It produced a statistically significant and clinically meaningful improvement in neurological outcomes in patients 90 days post-treatment. Endeavor BioMedicines dosed the first patient in an open-label Phase II trial of ENV-101 (taladegib) in patients with advanced solid tumors harboring Patched-1 loss of function mutations. ENV-101 is a Hedgehog signaling inhibitor. Oncotelic Therapeutics reported the FDA had approved its launch of a Phase II trial of OT-101 with Merck’s checkpoint inhibitor Keytruda in metastatic plural mesothelioma. OT-101 is a TGF-beta inhibitor. Crinetics Pharmaceuticals announced positive results from the multiple-ascending dose (MAD) portion of a Phase I trial of CRN04894 for Cushing’s disease. The drug is a first-in-class, oral, nonpeptide adrenocorticotropic hormone (ACTH) antagonist. CytomX Therapeutics dosed the first patient in a Phase I trial of CX-904. The drug is a conditionally activated T-cell-engaging bispecific designed to target EGFR on cancer cells and the CD3 receptor on T-cells within the tumor microenvironment. SciSparc received Ethics Committee approval in Germany and Israel to run a Phase IIb trial of SCI-110 in patients with Tourette syndrome. The drug is based on cannabinoid pharmaceuticals. SELLAS Life Sciences Group announced topline data from its Phase I/II trial of galinpepimut-S for WT1(+) r/r platinum-resistant advanced metastatic ovarian cancer. The drug is a Wilms Tumor-1 (WT1)-targeting peptide immunotherapeutic. It is being evaluated with Merck’s anti-PD-1 drug Keytruda. Laekna Therapeutics dosed the first patients in a Phase Ib/III trial of afuresertib in combination with fulvestrant in HR+/HER2- breast cancer patients who failed after one or two lines of CDK4/6 inhibitors, endocrine, or chemotherapy treatments. Afuresertib in an AKT kinase inhibitor. Cynata Therapeutics received the green light from the FDA for a Phase II trial of CYP-001 in acute graft versus host disease. The drug is based on its stem cell platform technology, Cymerus. Yingli Pharma US dosed the first patient in its Phase I study of YL-13027. The drug is a potent and selective TGF beta receptor 1 inhibitor being developed for advanced solid tumors. Scioto Biosciences announced topline results from a Phase Ib trial of SB-121 in patients with an autism spectrum disorder. The drug is based on a novel microbiome delivery platform, Activated Bacterial Therapeutics (ABT), which delivers best-in-class, live therapeutic bacteria to the gut. The therapeutic was well tolerated. Biomind Labs received approval in Argentina to run a third Phase II trial of BMND08 for depression and anxiety in Alzheimer’s disease patients. The drug is a 5-Methoxy-N,N-dimethyltryptamine. Q32 Bio dosed the first patient in its Phase I trial of ADX-097 for complement disorders. The drug is a first-in-class fusion protein that inhibits complement activation. InnoCare Pharma received approval in China to run a Phase II trial of tafasitamab with lenalidomide for r/r diffuse large B-cell lymphoma patients not eligible for autologous stem cell transplantation. Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. Genentech, a Roche company, announced new data from its glofitamab for r/r diffuse large B-cell lymphoma. The drug is a CD20XCD3 T-cell engaging bispecific antibody. After treatment, 34.9% achieved a complete response, with half achieving an overall response. Adicet Bio announced positive preliminary data from its r/r B-cell NHL therapeutic ADI-001. The drug is a form of CAR T-cell therapy. Of six patients that could be evaluated, 67% had an OR or a CR. Bristol Myers Squib reported positive Phase II data from its study of Breyanzi (lisocabtagene maraleucel) for r/r large B-cell lymphoma after first-line therapy who were not deemed candidates for high-dose chemotherapy or hematopoietic stem cell transplant. Breyanzi is a form of CAR-T therapy. AstraZeneca announced the first patients had been dosed in the IRIS Phase III trial of Saphnelo (anifrolumab) in lupus nephritis. The drug has been approved for adults with moderate to severe systemic lupus erythematosus who are receiving standard care. Purple Biotech announced positive interim safety and efficacy data from the Phase I trial of NT219 in adults with advanced solid tumors. The drug is a first-in-class small molecule, a director inhibitor of Insulin Receptor Substrates ½ and STAT3.

VaccineAntibodyFirst in ClassCell TherapySmall molecular drug

100 Deals associated with SB-121

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Autistic Disorder	Phase 1	United States	Genome & Co.	-
Clostridium difficile infection	Discovery	United States	Scioto Biosciences, Inc.Startup	05 Nov 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04944901 (CTgov)	Phase 1	Autistic Disorder	15	SB-121 (SB-121)	twnfmdphzw(zwogmpmzcn) = zzkoyfvzot sjuovmfapv (yqiuhoqrdr, zoyzplzdar - zaadsuripb) View more	-	25 Mar 2024
				Placebo (Placebo)	twnfmdphzw(zwogmpmzcn) = zikwhkajrc sjuovmfapv (yqiuhoqrdr, uxtojoduwo - czscdgnmez) View more
NCT04944901 (Corporate Publications) Manual	Phase 1	Autism Spectrum Disorder First line	-	SB-121	(psfsxebsjq) = bgngyrolwj jpbbaruvlp (fbpyvkhgsb )	Positive	26 May 2022
				Placebo	-

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