A First in Human, Phase 1/2a, Multicentre, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of PBP1510 in Patients With Advanced/Metastatic Pancreatic Cancer

The first in human clinical study is planned as an open-label, dose-escalation, and dose-expansion, multicentre, two-part, Phase 1/2a study of PBP1510 administered to patients with advanced/metastatic pancreatic cancer. The study will be conducted in two parts, Part 1 as a PBP1510 single agent dose-escalation, and PBP1510 dose-escalation in combination with gemcitabine, and Part 2 as PBP1510 dose-expansion at the RP2D in combination with gemcitabine.

Start Date05 Jun 2023

Sponsor / Collaborator

Prestige BioPharma Ltd.

NCT05108259 / RecruitingPhase 1

A Phase 1, Double-blind, Randomized, Three-arm, Parallel Group Study to Compare the Pharmacokinetics and Safety of a Single Subcutaneous Dose of PBP1502, EU-Humira®, and US-Humira® in Healthy Male and Female Subjects.

The main purpose of the study is to demonstrate pharmacokinetic (PK) equivalence of PBP1502 to the European (EU) and American (US) Humira reference products, following a single subcutaneous (SC) dose of 40 mg in healthy volunteers.

Start Date30 Mar 2022

Sponsor / Collaborator

Prestige BioPharma Ltd.

EUCTR2021-000682-32-ES / Unknown statusPhase 1/2

A First in human, Phase 1/2a, Multicentre, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of PBP1510 in Patients with Advanced/Metastatic Pancreatic Cancer

Start Date16 Feb 2022

Sponsor / Collaborator

Prestige BioPharma Ltd.

100 Clinical Results associated with Prestige BioPharma Ltd.

0 Patents (Medical) associated with Prestige BioPharma Ltd.

Literatures (Medical) associated with Prestige BioPharma Ltd.

05 Apr 2024·Cancer Research

Abstract CT083: A first-in-human phase 1/2a study of a novel anti-PAUF monoclonal antibody PBP1510 in patients with advanced/metastatic pancreatic cancer

Author: Pradhan, Sumita ; Park, Yun-Yong ; Loh, Wei Qi ; Batlle, Jaime Feliu ; Kim, Jamie ; King, Daniel A. ; Mandakhalikar, Kedar Diwakar

AbstractBackground Pancreatic Adenocarcinoma Up-regulated Factor (PAUF) is a protein overexpressed in pancreatic cancer but not in non-cancerous tissues and plays an important role in carcinogenesis and metastasis. PBP1510 is a first-in-class, anti-PAUF humanized immunoglobulin G1 monoclonal antibody developed for treatment of pancreatic cancer. PBP1510 demonstrated promising pancreatic cancer growth inhibition efficacies in in vivo patient-derived xenograft studies and is being evaluated in humans for the first time in the ongoing PAUF-I study.Methods PAUF-I (NCT05141149) is an open-label, multi-center, Phase 1/2a study in advanced/metastatic pancreatic cancer patients. Eligible patients must have a tumor that has progressed on standard chemotherapy, with at least 1 measurable lesion per RECIST v1.1 criteria, an ECOG performance status score of 0 or 1, a life expectancy of ≥ 3 months, and adequate baseline organ function to enroll. PBP1510 is administered as a 90-minute intravenous infusion in 28-day cycles and tumor assessments are performed every 8 weeks from the first dose.Phase 1 uses a 3 + 3 dose-escalation design to assess the safety, tolerability, pharmacokinetics (PK), and immunogenicity of ascending doses of PBP1510 as a single agent or in combination with gemcitabine (Table 1). The observation period for dose-limiting toxicities (DLT) is 28 days. ORR and pre- and post-treatment PAUF levels in tumor tissue will be explored in the analyses. A recommended phase 2 dose (RP2D) will be selected based on PK, safety, and efficacy data from Phase 1. Phase 2a is the dose expansion phase which aims to evaluate the safety, tolerability, PK, immunogenicity, and efficacy of PBP1510 administered at RP2D in combination with gemcitabine.As of January 2024, 6 patients have been enrolled. The 1M cohort (1 mg/kg) was completed without any report of DLT. Dose escalation is in progress and DLT evaluation is ongoing for the 2nd and 3rd patients in the 2M cohort.TABLE 1: NAND Dose escalation and cohorts (Phase 1) Monotherapy Combination Cohort PBP1510 Dose (mg/kg) Gemcitabine Dose (mg/m2) Cohort PBP1510 Dose (mg/kg) Gemcitabine Dose (mg/m2) 1M 1 - 1C 1 1000 2M 3 - 2C 3 1000 3M 6 - 3C 6 1000 4M 10 - 4C 10 1000 5M 15 - 5C 15 1000Citation Format: Jaime Feliu Batlle, Daniel A. King, Jamie Kim, Sumita Pradhan, Yun-Yong Park, Kedar Diwakar Mandakhalikar, Wei Qi Loh. A first-in-human phase 1/2a study of a novel anti-PAUF monoclonal antibody PBP1510 in patients with advanced/metastatic pancreatic cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(7_Suppl):Abstract nr CT083.

01 Jun 2022·Journal of Clinical Oncology

First-in-class monoclonal antibody (mAb) PBP1510 targeting pancreatic adenocarcinoma upregulated factor (PAUF) for pancreatic cancer (PC) treatment: Preclinical perspectives.

Author: Mandakhalikar, Kedar Diwakar ; Kim, Jamie ; Feyaerts, Peggy ; Jeong, Seong-Yun ; Koh, Sang Seok ; Pradhan, Sumita ; Jaison, Litha ; Karuna, Ratna ; Park, Jin ; Moshinsky, Deborah ; Kim, Yeon Jeong

e16274 Background: PAUF has been shown to induce PC cell proliferation, angiogenesis and evasion of immune surveillance, thereby promoting tumour progression and metastasis. PBP1510, a novel humanized IgG1 mAb developed by Prestige Biopharma Limited, Singapore, binds to and neutralizes PAUF with high specificity and affinity. With no available targeted therapies against PAUF, the first in its class, PBP1510, has been granted Orphan Drug Designation by EMA, US FDA and Korea MFDS. Methods: To assess inhibition of migration and invasion of PC in vitro, PC cell lines (CFPAC-1 and BxPC-3) with high expression levels of PAUF, and primary PC cells extracted from patients were treated with PBP1510 or human IgG (negative control). Suitability of cynomolgus monkey as animal model for pharmacokinetic (PK) and toxicity studies was verified by comparing binding affinities of PBP1510 to human and monkey PAUF. PK characteristics and immunogenicity of PBP1510 (up to 20 mg/kg), were examined in single dose studies in 6 monkeys. A 4-week repeated dose toxicity study was also conducted in 32 monkeys with PBP1510 (up to 40 mg/kg). An in vitro tissue cross-reactivity study was also conducted in a full panel of normal human tissues, to assess potential toxicity in humans. Results: PBP1510 suppressed the proliferation of the PC cell lines compared to negative control. The migration and invasion of PBP1510 treated PC cell lines as well as the primary tumour cells from patients was significantly reduced compared to the respective control groups in vitro. Similarity in binding affinity of PBP1510 to human PAUF and monkey PAUF, and amino acid sequence homology between human and monkey PAUF, suggest that monkey is an appropriate animal species for toxicity and PK studies of PBP1510. In monkey studies, a dose-proportional increase in systemic exposure was observed at low and high doses. PBP1510 at doses up to 40 mg/kg was well tolerated by study animals and no notable local or systemic toxicity was observed. Low immunogenic profile of PBP1510 was indicated by an absence of anti-PBP1510 antibodies till up to 57 days (8 doses and 28-day recovery period). These data are used to simulate human PK profile and to derive the starting dose and maximum escalated dose for the upcoming Phase 1 clinical studies. Cross-reactivity results did not reveal non-specific binding of PBP1510 in the human tissues except in the cytoplasm of acinar and duct epithelium in the salivary gland which is not expected to be of major toxicologic significance. Conclusions: The efficacy and safety data presented here, along with the data from in vivo mouse studies demonstrating superior anti-tumour activity of PBP1510 treatment, support further clinical development of PBP1510 as a novel anti-cancer agent to treat PAUF-positive PC. The pivotal step of advancing PBP1510 into initial human studies is now in progress.

01 May 2022·JAMA OncologyQ1 · MEDICINE

A Multicenter Phase 3 Randomized Clinical Trial

Q1 · MEDICINE

Article

Author: Shamrai, Volodymyr ; Soo Hoo, Hwoei Fen ; Nikolaevich, Lipatov O. ; Kaewkangsadan, Viriya ; Deforce, Filip ; Dzagnidze, Giorgi ; Jaison, Litha ; Georgievich, M. A. ; Bonamy, Ghislain M. C. ; Pradhan, Sumita ; Derde, Marie-Paule ; Cox, David G. ; Villanueva, Cristian ; Kim, Jamie ; Hii, Jocelyn ; Petrelli, Fausto ; Kaufman, Leonard ; Feyaerts, Peggy ; Pivot, Xavier

ImportanceThe drug HD201 is a biosimilar candidate for breast cancer treatment as the reference trastuzumab.ObjectiveTo compare the efficacy of HD201 with referent trastuzumab.Design, Setting, and ParticipantsThis randomized clinical trial (TROIKA) included 502 women with ERBB2-positive early breast cancer treated with either HD201 or referent trastuzumab. It was conducted across 70 centers in 12 countries, including Western and Eastern Europe and Asian countries. Randomization was stratified by tumor hormone receptor status, clinical stage, and geographic region of recruitment. This analysis was conducted on February 12, 2021, after the completion of the adjuvant phase at a median of 31 months (IQR, 28-33 months) of follow-up.InterventionsPatients with ERBB2-positive early breast cancer were randomly assigned to receive HD201 or referent trastuzumab in the neoadjuvant setting for 8 cycles, concurrently with 4 cycles of docetaxel, which was followed by 4 cycles of epirubicin and cyclophosphamide. Patients then underwent surgery, which was followed by treatment with 10 cycles of adjuvant HD201 or referent trastuzumab.Main Outcome and MeasuresThe primary end point was the total pathological complete response (tpCR) assessed after neoadjuvant treatment. Equivalence was concluded if the 95% CI of the absolute difference in tpCR between arms in the per-protocol set was within the margin of more or less than 15%. Other objectives included the breast pathological complete response, overall response, event-free and overall survival, safety, pharmacokinetics, and immunogenicity.ResultsA total of 502 female patients (mean [range] age, 53 [26-82] years) were randomized to receive either HD201 or referent trastuzumab, and 474 (94.2%) were eligible for inclusion in the per-protocol set. The baseline characteristics were well balanced between the 2 arms; 195 tumors (38.8%) were hormone receptor-negative , and 213 patients (42.4%) had clinical stage III disease. The tpCR rates were 45% and 48.7% for HD201 and referent trastuzumab, respectively. The difference between the 2 groups was not significant at -3.8% (95% CI, -12.8% to 5.4%) and fell within the predefined equivalence margins. The ratio of the tpCR rates between the 2 arms was 0.92 (95% CI, 0.76 to 1.12). A total of 433 patients (86.1%) presented with 2232 treatment-emergent adverse events of special interest for trastuzumab during the entire treatment period, with 220 (88.0%) and 213 (84.5%) patients in the HD201 and referent trastuzumab groups, respectively.Conclusions and RelevanceThe results of this randomized clinical trial found that HD201 demonstrated equivalence to referent trastuzumab in terms of efficacy for the end point of tpCR, with a similar safety profile.Trial RegistrationClinicalTrials.gov Identifier: NCT03013504.

News (Medical) associated with Prestige BioPharma Ltd.

01 Aug 2024

·www.prnewswire.com

Prestige Biopharma's Herceptin Biosimilar Tuznue® Receives Positive CHMP Opinion from the EMA

Following approval by the European Commission, Prestige Biopharma's Herceptin biosimilar Tuznue® would become the first biosimilar from a Singaporean company to be authorized in the European Union. SINGAPORE, Aug. 1, 2024 /PRNewswire/ -- Prestige Biopharma, a pioneer in biopharmaceuticals, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for Tuznue®, a Herceptin (trastuzumab) biosimilar. This milestone positions Prestige Biopharma to become the first Singaporean firm to commercialize its biosimilar in the European Union. The CHMP's positive opinion is based on clinical evidence from Phase 1 and Phase 3 clinical studies that tested the biosimilarity of Tuznue® to Herceptin®. The Phase 1 clinical PK study in healthy volunteers demonstrated PK equivalence, as well as similarity in safety and immunogenicity. Finally, the global Phase 3 confirmatory efficacy and similarity study met its primary endpoint and demonstrated similarity in efficacy, PK, safety, and immunogenicity in HER2-positive patients with early breast cancer. This favourable decision is a crucial step toward final approval from the European Commission (EC). Once approved, Tuznue® will be commercialized across Europe. Prestige Biopharma has already established licensing agreements with major pharmaceutical partners for global marketing and sales. These agreements are set to generate immediate milestone payments and provide early revenue for the company. Negotiations are also underway to ensure a strong market entry for Tuznue® in Europe. "Receiving a positive CHMP opinion for Tuznue® marks a major milestone for Prestige Biopharma, significantly advancing our revenue generation strategy and accelerating future pipeline approvals," said Lisa Park, the CEO of Prestige Biopharma. "This recognition solidifies our position as a leading biosimilar developer. We are committed to leveraging this achievement to enhance our market presence and drive continued success." About TUZNUE® (HD201, Herceptin biosimilar) Tuznue® is a biosimilar of Herceptin® (trastuzumab), developed to offer a more cost-effective therapeutic alternative for patients. It maintains comparable efficacy and safety profiles to the original branded medication. Tuznue® is indicated for the treatment of patients with HER2-positive metastatic breast cancer (MBC), HER2-positive early breast cancer (EBC), and HER2-positive metastatic gastric cancer (MGC). About Prestige Biopharma: Established in 2015 in Singapore and listed in the Korea Exchange in 2021 (KOSPI: 950210), Prestige Biopharma Limited is a biopharmaceutical company with a diversified portfolio, including biosimilars (HD204 Avastin biosimilar in filing stage, PBP1502 Humira biosimilar in clinical stage) and new antibody drugs. Among its many pipelines, a first-in-class antibody drug and key biosimilars referencing blockbuster drugs are ongoing clinical development. Notably, the first-in-class, PAUF-based antibody drug, Ulenistamab, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) in Korea, as well as Fast Track Designation by the U.S. FDA. A global Phase 1/2a clinical trial is currently underway in the United States, Europe, and Asia, with the aim of bringing this innovative therapy to the clinic. Contacts Prestige Biopharma Group Donghee Im [email protected] Logo -

Clinical ResultOrphan DrugLicense out/inPhase 3Fast Track

01 Jul 2024

·www.prnewswire.com

Oncolytic Viruses: Unlocking a New Era in Cancer Immunotherapy | DelveInsight

The potential of oncolytic viruses as a novel approach to cancer treatment is exciting and offers a targeted approach that holds promise for overcoming treatment resistance and achieving durable responses in a range of malignancies. LAS VEGAS, July 1, 2024 /PRNewswire/ -- Oncolytic viruses are either RNA or DNA viruses. RNA viruses such as reoviruses, paramyxoviruses, and picornaviruses, which encode only a few genes, often undergo rapid proliferation and lysis of tumor cells. On the other hand, oncolytic DNA viruses such as herpes viruses, adenoviruses, or poxviruses allow for the insertion of multiple foreign genes but are slower in replication and amplification. Among the selected cancers, bladder cancer accounted for the maximum cases as compared to other selected indications in 2023 among the 7MM. As per the DelveInsight assessment, in 2023, the total incident cases of melanoma, non-melanoma skin cancer, pancreatic cancer, renal cell carcinoma, prostate cancer, brain cancer, bladder cancer, and ovarian cancer combined in the United States were 1.1 million. Currently, only two oncolytic virus therapies are approved, namely, IMLYGIC (Talimogene laherparepvec/T-VEC; Amgen) and DELYTACT (teserpaturev/G47∆; Daiichi Sankyo). Learn more about the FDA-approved oncolytic viruses @ Oncolytic Viruses Cancer Treatment IMLYGIC (T-VEC), developed by Amgen, became the first oncolytic virus to receive approval from the FDA in 2015. It is indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with recurrent melanoma following initial surgery. Subsequently, in December 2015, the European Commission (EC) also approved for its use in treating adults with unresectable melanoma that has regionally or distantly metastasized (Stage IIIB, IIIC, and IVM1a), excluding bone, brain, lung, or other visceral diseases. This genetically modified herpes simplex virus type 1 is engineered to replicate within tumors and express an immune-stimulating protein known as granulocyte-macrophage colony-stimulating factor (GM-CSF). DELYTACT (G47Δ) is a modified form of herpes simplex virus type 1 (HSV-1) with three mutations, designed to selectively replicate within cancer cells. In 2021, it received provisional approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for hospital-based commercialization, specifically for treating malignant glioma patients over 7 years. This approval followed a Phase II trial demonstrating improved one-year survival rates among patients with recurrent glioblastoma, previously treated with radiotherapy and temozolomide chemotherapy. DELYTACT marks the world's first oncolytic virus therapy for brain cancer and only the third globally available oncolytic virus treatment. To learn more about oncolytic viruses cancer treatment options, visit @ Oncolytic Virus Cancer Therapy The field of oncolytic virus therapy is still developing. Further research is needed to determine their long-term efficacy and potential challenges. Still, early results seem encouraging, suggesting that oncolytic viruses may become a powerful tool for the treatment of patients with cancer. Presently, oncolytic virus therapy is only approved for melanoma and malignant glioma (in Japan). However, the pipeline suggests its emergence as a potential treatment for various cancers, including ovarian cancer, non-small cell lung cancer, breast cancer, renal cell carcinoma, and others. The pipeline for oncolytic viruses is robust, with major pharmaceutical companies such as Replimune (RP1), Genelux (Olvi-Vec), Candel Therapeutics (CAN-2409), Imugene (CF33-HNIS), EpicentRx (AdAPT-001), and others actively engaged in research to enhance cancer treatment options. Discover which therapies are expected to grab major oncolytic virus therapy market share @ Oncolytic Virus Therapy Market Report Olvi-Vec is a proprietary oncolytic vaccinia virus engineered to enhance safety, tumor selectivity, and therapeutic potential. Originally a non-human pathogen used in the smallpox vaccine, the vaccinia virus induces immunogenic cell death and activates the immune system for long-term cancer immunotherapy. According to Genelux's recent corporate presentation, topline results for the Phase III OnPrime/GOG-3076 study are expected in the second half of 2025. In November 2023, Genelux announced that the US FDA granted Fast Track Designation for Olvi-Vec (olvimulogene nanivacirepvec) in treating patients with platinum-resistant/refractory ovarian cancer. The drug is currently in Phase III clinical development, with the study anticipated to be completed by 2026. RP1 is Replimune's leading product candidate, developed from a proprietary new strain of herpes simplex virus. It has been genetically modified and enhanced with a fusogenic protein (GALV-GP R-) and GM-CSF to enhance tumor-killing potency, improve the immunogenicity of tumor cell death, and stimulate a systemic anti-tumor immune response. In April 2024, Replimune presented interim results from ARTACUS, a Phase I/II clinical trial testing RP1 monotherapy for skin cancers in patients who have undergone solid organ or hematopoietic cell transplants. Currently, RP1 is in the Phase II IGNYTE study, a multi-cohort clinical trial combining RP1 with OPDIVO. AdAPT-001 is an experimental immunotherapy featuring a TGF-β receptor-immunoglobulin Fc fusion trap. It is designed to neutralize isoforms 1 and 3 of the profibrotic, proangiogenic, prohypoxic, and immunosuppressive cytokine, TGF-β, and make resistant tumors more responsive to checkpoint blockade. In the ongoing Phase I/II BETA PRIME trial, AdAPT-001 is being administered alone and in combination with checkpoint inhibitors to patients with treatment-resistant tumors. Notably, AdAPT-001 combined with checkpoint inhibitors has shown improved toxicity and adverse event profiles compared to the typical results seen with checkpoint inhibitors alone. Discover more about oncolytic viruses in development @ Oncolytic Viruses Cancer Therapy Clinical Trials The anticipated launch of these emerging therapies are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the oncolytic virus cancer therapy market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for oncolytic virus therapy is expected to grow with a significant CAGR by 2034. As per DelveInsight, the United States accounts for the largest oncolytic virus market size accounting for more than 70% of the total market, in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan. Among all the emerging oncolytic virus therapies, RP1 is the most promising therapy accounting for ~40% of the oncolytic virus market in the coming decade due to its high efficacy. DelveInsight's latest published market report titled as Oncolytic Virus Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the oncolytic virus country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The oncolytic virus market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Incident Cases of Selected Cancer Types Target Patient Pool of Oncolytic Virus Cancer Therapy by Cancer Types Total Treated Cases by Line of Therapies The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM oncolytic virus market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this oncolytic virus market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the oncolytic virus market. Also, stay abreast of the mitigating factors to improve your market position in the oncolytic virus therapeutic space. Related Reports Oncolytic Virus Competitive Landscape Oncolytic Virus Competitive Landscape – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key oncolytic virus companies, including Genelux Corporation, Candel Therapeutics, CG Oncology, DNAtrix, SillaJen Biotherapeutics, Oncolytics Biotech, Wuhan Binhui Biotechnology, Oryx GmbH, Jiangsu Sinorda Biomedicine Co., Ltd, Virogin Biotech, Replimune, Viralytics, Oncolys Biopharma, Istari Oncology, Immvira Pharma, Seneca Therapeutics, Treovir, LLC, Targovax, Lokon Pharma, ORCA Therapeutics, Beijing SyngenTech, ViruCure, Tasly Pharmaceuticals, Turnstone Biologics, BioInvent, Transgene, Elicera Therapeutics, Orgenesis, Virttu Biologics, Imugene, Astellas Pharma, Wuhan Binhui Biotechnology Co., Ltd., Mustang Bio, Virogin Biotech, Vaxiion Therapeutics, ImmVirX, Memgen, Replimune, Immvira Pharma, ViroCure, GeneMedicine, PsiOxus Therapeutics, VCN Biosciences, Candel therapeutics, Sorrento Therapeutics, Imugene Limited, Calidi Biotherapeutics, Replimune, TILT Biotherapeutics, Guangzhou Virotech Pharmaceutical, DNAtrix, Oncorus, BioEclipse Therapeutics, among others. Oncology Drugs Market Oncology Drugs Market Insight, Competitive Landscape, and Market Forecast – 2030 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key oncology drugs companies, including GlaxoSmithKline, Eli Lilly & Company, F. Hoffmann-La Roche Ltd, AbbVie Inc., Amgen Inc, Sanofi, Merck & Co., Inc, Novartis AG, Pfizer Inc, AstraZeneca, Bristol Myers Squibb., Gilead Sciences, Inc., Janssen Global Services, LLC, BAYER AG., Celldex Therapeutics Inc., Alaunos Therapeutics, Inc., Astellas Pharma Inc., Genentech, Inc., Sandoz International GmbH, BeiGene, among others. Melanoma Market Melanoma Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key melanoma companies including IO Biotech, Merck Sharp & Dohme, Eisai, Regeneron Pharmaceuticals, Iovance Biotherapeutics, Highlight Therapeutics, Linnaeus Therapeutics, Spring Bank Pharmaceuticals, Taiga Biotechnologies, Inc., Aivita Biomedical, Inc., Genentech, Inc., Dana-Farber Cancer Institute, BioMed Valley Discoveries, Inc, Amgen, Checkmate Pharmaceuticals, Astellas Pharma Inc, Galectin Therapeutics Inc., Eucure (Beijing) Biopharma Co., Ltd, Mologen AG, Ultimovacs ASA, Seagen Inc., MedImmune LLC, OnKure, Inc., Syntrix Biosystems, Inc., Anaveon AG, iOx Therapeutics, Portage Biotech, ModernaTX, Inc., Nektar Therapeutics, BioNTech SE, Sapience Therapeutics, HUYABIO International, LLC., Provectus Biopharmaceuticals, Inc., Cantargia AB, Turnstone Biologics, Corp., Aura Biosciences, F-star Therapeutics, Inc., Day One Biopharmaceuticals, Inc., Kinnate Biopharma, Xencor, Inc., HiFiBiO Therapeutics, among others. Pancreatic Cancer Market Pancreatic Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key pancreatic cancer companies including FibroGen, OSE Immunotherapeutics, Lokon Pharma, Oncotelic Inc., Tesaro, Inc., Helix BioPharma Corporation, Theradex, Tvardi Therapeutics, Incorporated, AIM ImmunoTech Inc., BioNTech SE, Prestige Biopharma Limited, HCW Biologics, Cantex Pharmaceuticals, XBiotech, Inc., Lumicell, Inc., CARsgen Therapeutics Co., Ltd., Panbela Therapeutics, Inc. , among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

Phase 2Phase 3Clinical ResultImmunotherapyFast Track

14 Aug 2023

·www.fiercebiotech.com

FDA urges public to throw away pregnancy, UTI tests from unauthorized California lab

The FDA said Universal Meditech has stopped all commercial operations—but its tests have also been sold online under the brand names Prestige Biotech, HealthyWiser, Home Health US and AC&C Distribution. The FDA is urging the public to throw away any pregnancy or ovulation tests manufactured by Universal Meditech, Inc.—a final step to remove the troubled company’s products from the market following previous diagnostic recalls and the shutdown of its California production facilities after they were found to be operating without permits. Per the FDA’s notice, its reviewers have been unable to confirm whether the company’s tests are safe, effective or accurate. Meanwhile, Universal Meditech’s locations in the greater Fresno area have seen lab equipment and biological materials seized and destroyed by county health inspectors, according to reports from the local ABC affiliate station KFSN-TV. The federal agency said Universal Meditech has stopped all commercial operations. However, its tests have also been sold online directly to consumers, potentially under the brand names of four different distributors: Prestige Biotech, HealthyWiser, Home Health US and AC&C Distribution. They include home pregnancy and ovulation tests, as well as test strips to help diagnose urinary tract infections and detect the presence of alcohol in expressed breast milk. “Immediately stop using and destroy these recalled tests by placing them in the trash,” the FDA said in its notice. “While UMI initiated a recall to remove undistributed tests from their distributors, UMI did not initiate a recall for tests that were already distributed to consumers.” The company previously recalled its COVID-19 antigen tests in January, including 56,300 Skippack Medical Lab kits that were shipped without clearance from the FDA. The same test had been the focus of a recall launched by SML Distribution in early 2022 for the same reason, spanning more than 209,000 units. According to KFSN-TV, local officials found “unauthorized biological agents, samples of bodily fluid, infectious diseases, COVID and pregnancy tests and nearly 1,000 mice” at the lab facility in Reedley, California. In addition, a report from the Fresno Bee said that the location’s refrigerators included “coronavirus and other exotic contagions, such as malaria, Hepatitis B and C, chlamydia, human herpes and rubella, among others, used in the production of various test kits.” The company also previously operated a warehouse laboratory in southwest Fresno, which caught fire in August 2020. An inspection afterward found Universal Meditech did not have a hazmat business plan and was storing ethanol on site.

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Pipeline Snapshot as of 22 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Trastuzumab Biosimilar (Prestige BioPharma) ( HER2 )	HER2 Positive Breast Cancer More	Approved
Bevacizumab biosimilar(Hanwha Biologics) ( VEGF-A )	Recurrent Lung Non-Squamous Non-Small Cell Carcinoma More	Phase 3
Ulenistamab ( ZG16B )	Pancreatic Cancer More	Phase 2 Clinical
Adalimumab biosimilar(Prestige BioPharma Ltd.) ( TNF-α )	Arthritis More	Phase 1
Natalizumab Biosimilar (Prestige BioPharma) ( CD49d )	Crohn Disease More	Preclinical

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