Semzuvolimab

Sarah Silbiger/Getty Images The U.S. Food and Drug Administration had a busy week leading up to the Labor Day holiday. Here’s a look at the agency’s recent activities. Sept 1 Immusoft’s IND for a Phase I trial of ISP-001, being developed to treat mucopolysaccharidosis type I, was granted the FDA’s green light. It is the first-ever engineered B cell therapy to enter the clinic, the company reported. eCential Robotics received FDA 501(k) clearance for its 3D imaging, navigation and robotics guidance system. Aston Sci. obtained FDA approval to initiate a Phase II trial of AST-301, a therapeutic cancer vaccine, in patients with triple-negative breast cancer. BioCryst Pharmaceuticals received Orphan Drug Designation for BCX9250, which is being developed to treat fibrodysplasia ossificans progressiva (FOP). Intellia Therapeutics was granted Orphan Drug Designation for its in vivo CRISPR/Cas9 genome editing candidate NTLA-2002 for hereditary angioedema (HAE). Revelle Aesthetics received extended FDA clearance for its precision cellulite release device Aveli. It is now indicated for long-term reduction in the appearance of cellulite in the buttocks and thigh areas of adult women. GenBody America announced the FDA had amended its EUA for the GenBody COVID-19 Ag kit, which was updated to include prefilled individual reagent tubes for each device. Aug 31 Longeveron received Fast Track Designation for Lomecel-B for Hypoplastic Left Heart Syndrome (HLHS). Sanofi reported the FDA-approved Xenpozyme (olipudase alfa-rpcp) for adult and pediatric patients with acid sphingomyelinase deficiency (ASMD), also called Niemann-Pick disease. The company also received Priority Review for its BLA for efanesoctocog alfa for the treatment of hemophilia A. The PDUFA date is February 28, 2023. United BioPharma received the go-ahead for a Phase II trial. The IND was submitted by NIAID to evaluate the antiviral activity of UB-421 in combination with optimized background ART in HIV-1 patients with multi-drug resistance. UB-421 is an anti-CD4 antibody. Scilex Holding Company, a subsidiary of Sorrento Therapeutics, received Fast Track Designation for SP-103, a drug and device product candidate to treat acute and chronic pain. The drug is being developed to be a non-opioid triple-strength, non-aqueous lidocaine topical system for treatment of acute LBD. Maze Therapeutics’ MZE001 received Orphan Drug Designation from the FDA for Pompe disease. The drug is an oral glycogen synthase (GYS1) inhibitor. Pfizer and BioNTech’s bivalent and Omicron BA.4/BA.5 COVID-19 vaccines for COVID-19 were granted Emergency Use Authorization for people 12 years and older as a single booster dose. Moderna reported the FDA granted EUA for its bivalent COVID-19 vaccine for people 18 years and older as a single booster. Aquestive Therapeutics reported the FDA granted tentative approval for Libervant (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity. Baxter International announced the FDA granted 510(k) clearance for its new Novum IQ syringe infusion pump with Dose IQ Safety Software. Aug. 29 Neuronetics received 510(k) clearance for its D-Tect MT Accessory, which helps doctors by visually reporting the magnitude of finger movements during motor threshold (MT) mapping for treatment of major depressive disorder. Serpex Medical received 510(k) clearance for its Recon Steerable Sheath, a steerable endobronchial tool to enable physicians to access difficult-to-reach areas of the lung. TRACON Pharmaceuticals received the go-ahead for a Phase I/II trial of YH001 in combination with envafolimab and doxorubicin for sarcoma patients, including treatment-naïve patients. It will evaluate patients with the combination of YH001 and envafolimab in patients with the rare sarcoma subtypes of alveolar soft part sarcoma and chondrosarcoma. It will also evaluate YH001, envafolimab and doxorubicin in the more prevalent subtypes of leiomyosarcoma and dedifferentiated liposarcoma. YH001 is an IgG1 antibody against CTLA-4. BrainsWay received 510(k) clearance from the FDA for its Deep TMS H7 Coil for use in treating adults with major depressive disorder and depression including those with comorbid anxiety symptoms (anxious depression). Deep TMS is Deep Transcranial Magnetic Stimulation.

TAIPEI, Aug. 31, 2022 /PRNewswire/ -- United BioPharma (UBP) announced today that the U.S. Food and Drug Administration (FDA) has approved a phase 2 clinical trial IND submitted by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) of NIH. The purpose of this study is to assess the safety and antiviral activity of UB-421 in combination with optimized background ART in HIV-1 infected patients with multi-drug resistance (MDR). The study protocol is entitled: "A Single arm Open Label Phase 2 trial of anti-CD4 Antibody UB-421 in Combination with Optimized Background Antiretroviral Therapy in Patients with Multi-Drug Resistant HIV-1 Infection." In this trial sponsored by the NIAID/NIH, UBP will be responsible for supplying the investigational drug, UB-421. UBP has been collaborating with NIAID since 2015 to study the unique characteristic properties of UB-421 for treatment of HIV. The potent efficacy of UB-421 against HIV clinical isolates resistant to HIV broadly neutralizing antibodies, entry inhibitors, and other antiretroviral drugs is well documented. "We are excited for the NIAID to recognize the effectiveness of UB-421 through extensive collaborative studies, and to sponsor a phase 2 clinical trial in multi-drug resistant HIV patients." said Dr. Shugene Lynn, the CEO and President of UBP. The treatment of HIV-1 infection with antiretroviral therapy (ART) has significantly decreased HIV-1-related mortality and transformed HIV-1 infection into a treatable chronic disease. Successive generations of ART agents have shown improved efficacy and tolerability while minimizing drug-related toxicities. However, the ability of HIV-1 to develop resistance to multiple classes of antiretroviral (ARV) drugs continues to present challenges to the treatment of some ARV treatment-experienced patients. Multi-drug resistant (MDR) HIV-1 has been associated with a higher risk of disease progression and death. Therefore, new agents and drug classes are necessary to keep up with ongoing viral mutations in an attempt to achieve sustained suppression of HIV-1 plasma viremia and prolong the life of persons with MDR HIV infection, as well as to prevent viral replication and transmission of such MDR strains. Drugs with novel mechanism of action, such as UB-421, are of particular interest because empirical resistance is unlikely. About UB-421 UB-421 is an Fc-aglycosylated, non-T cell depleting and CD4-specific humanized IgG1 derived from the parent murine B4, which binds to discontinuous, conformational epitopes on the HIV-receptor complex, including CD4 (domain 1), and competitively blocks HIV entry. Both the murine and humanized mAbs bind to CD4+ T cells with approximately 50-100-fold higher affinity than HIV-gp120. UB-421 has been shown to inhibit viral entry with remarkable viral load reduction potency in Phase 1 and Phase 2a clinical studies involving treatment-naïve HIV-infected patients. In the Phase 2 study with ART-stabilized HIV-infected patients, UB-421 monotherapy maintains viral suppression for up to 16 weeks without viral rebound in the absence of ART. UB-421 is currently in the stage of phase 2 and phase 3 clinical trials for ART substitution, treatment of multi-drug resistant HIV as well as proof-of-concept study of HIV functional cure. About United BioPharma United BioPharma (UBP) is a late clinical stage biopharmaceutical company that is dedicated to the development of novel monoclonal antibodies (mAbs) for infectious diseases, cancer and immune disorders. UBP is headquartered in Taiwan, with subsidiary companies in China, and liaison offices in the U.S. The company has a passionate global team, developing therapeutic mAbs and delivering affordable treatments to bring a better quality of life to patients. For more information, please visit the website at: SOURCE United BioPharma Inc.