- |||||||||| Journal: Antibodies to watch in 2024. (Pubmed Central) - Jan 9, 2024
In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi))...These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa)...Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.
- |||||||||| Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei, Onbrez (indacaterol) / Novartis
Journal: The effect of lung emptying before the inhalation of aerosol drugs on drug deposition in the respiratory system. (Pubmed Central) - Jul 5, 2023 The workflow proposed in this study demonstrates that the combination of MVDA tools and H NMR technology is highly appealing to the research of the biomanufacturing process, and applies well to provide guidance in future work on consistency evaluation and biochemical marker monitoring of the production of other biologics. For drugs with negative correlation of lung dose with flow rate (all the studied drugs except the above two) lung emptying caused increased (Foster
- |||||||||| Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei
Trial completion date, Trial primary completion date: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma (clinicaltrials.gov) - May 22, 2023 P2, N=42, Recruiting, Active, not recruiting --> Suspended Trial completion date: Feb 2024 --> May 2025 | Trial primary completion date: Feb 2024 --> May 2025
- |||||||||| pritumumab (CLNH 11) / Nascent Biotech
Phase 1 study of pritumumab in brain cancer. (On Demand | Hall A; Poster Bd # 410) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1086; P1 A phase 2 study is being planned as single agent and in combination with checkpoint inhibitors in both recurrent gliomas and upfront with chemoradiation in newly diagnosed gliomas. Clinical trial information: NCT04396717.
- |||||||||| PLX038 / ProLynx, firtecan pegol (PEG-SN38) / Belrose, Rubraca (rucaparib) / Pharma& Schweiz
Enrollment closed, Enrollment change: PLX038 (PEGylated SN38) and Rucaparib in Solid Tumors and Small Cell Cancers (clinicaltrials.gov) - Dec 20, 2022 P1/2, N=10, Active, not recruiting, This meta-analysis confirms the superiority of combination therapy over monotherapy in rheumatoid arthritis, in accordance to the usual guidelines. Recruiting --> Active, not recruiting | N=65 --> 10
- |||||||||| firtecan pegol (PEG-SN38) / Belrose
Journal: Pulmonary delivery of liposomes co-loaded with SN38 prodrug and curcumin for the treatment of lung cancer. (Pubmed Central) - Oct 15, 2022 SN38 was linked to cell-penetrating peptide (CPP) TAT via a polyethylene glycol (PEG) linker to form the SN38 prodrug (TAT-PEG-SN38)...The combination induced significant tumor inhibition in a BALB/c mouse lung cancer model. These results indicated that our SN38 prodrug and curcumin co-delivery system was a promising candidate for lung cancer treatment.
- |||||||||| Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei
New P2 trial: Pharmacokinetics, pharmacodynamics, safety and tolerability of glycopyrronium (bromide) in children (6 to less than 12 years) with asthma. Farmacocinética, farmacodinámica, seguridad y tolerabilidad de bromuro de glicopirronio en niños con asma (de 6 a menos de 12 años de edad). (EUDRACT) - Jun 24, 2022 P2, N=42, Ongoing,
- |||||||||| PLX038 / ProLynx, firtecan pegol (PEG-SN38) / Belrose, Rubraca (rucaparib) / Pharma& Schweiz
Enrollment open, Enrollment change: PLX038 (PEGylated SN38) and Rucaparib in Solid Tumors and Small Cell Cancers (clinicaltrials.gov) - May 4, 2022 P1/2, N=65, Recruiting, These data support further clinical development of BR105, especially as a therapeutic agent to enhance efficacy when used in combination with tumor-targeting antibodies or antibodies that target other immune checkpoints. Suspended --> Recruiting | N=10 --> 65
- |||||||||| HS016 (adalimumab biosimilar) / Zhejiang Hisun
Journal: Physicochemical and functional characterization of HS016, a biosimilar of adalimumab (Humira). (Pubmed Central) - Apr 26, 2022 However, no differences in antigen binding activity, Fc receptor affinity, antibody-dependent cell-mediated cytotoxicity or complemented-dependent cytotoxicity were found. The primary and higher order structures, physicochemical properties, and biological activity of HS016 and adalimumab were similar.
- |||||||||| firtecan pegol (PEG-SN38) / Belrose
Trial termination, Metastases: PEG-SN38: A Phase 2 Study of EZN-2208 in Patients With Metastatic Breast Cancer (clinicaltrials.gov) - Feb 14, 2022 P2, N=160, Terminated, These findings suggest that HS016 is an alternative economical treatment for Chinese AS patients producing a rapid amelioration of symptoms, aiding them to recover their lifestyle satisfaction. Active, not recruiting --> Terminated; Program suspended and divested
- |||||||||| firtecan pegol (PEG-SN38) / Belrose
Enrollment change, Trial termination: Study of EZN-2208 Pediatric Patients With Solid Tumors (clinicaltrials.gov) - Feb 14, 2022 P1/2, N=32, Terminated, Active, not recruiting --> Terminated; Program suspended and divested N=24 --> 32 | Active, not recruiting --> Terminated; Program suspended and divested
- |||||||||| irinotecan / Generic mfg.
Journal: A Nanotherapeutic Strategy to Overcome Chemoresistance to Irinotecan/7-Ethyl-10-Hydroxy-Camptothecin in Colorectal Cancer. (Pubmed Central) - Jan 27, 2022 As the first nano-formulation of Ko143 and the first systemic co-delivery vehicle of SN38/CPT-11 and a BCRP inhibitor, BI@PEG-SN38 provides a new strategy for clinical development of SN38 and numerous "chemosensitizers", and exhibits promising applicability in precision cancer medicine. Panels of cancer cell lines established here provides a useful platform for BCRP- and cancer-related research and technology development.
- |||||||||| PLX038 / ProLynx, firtecan pegol (PEG-SN38) / Belrose, Rubraca (rucaparib) / Pharma& Schweiz
Enrollment change, Trial suspension: PLX038 (PEGylated SN38) and Rucaparib in Solid Tumors and Small Cell Cancers (clinicaltrials.gov) - Sep 29, 2021 P1/2, N=10, Suspended, Panels of cancer cell lines established here provides a useful platform for BCRP- and cancer-related research and technology development. N=65 --> 10 | Recruiting --> Suspended
- |||||||||| pritumumab (CLNH 11) / Nascent Biotech
Review, Journal, IO biomarker: Unconventional immunotherapy with an unconventional target. (Pubmed Central) - Sep 22, 2021 A clinical trial assessing higher doses of pritumumab as a therapeutic for brain cancer is expected to begin this year. Overall, these data together suggest pritumumab is suitable for further development as an anti-tumor therapeutic.
- |||||||||| hyzetimibe (HS-25) / Zhejiang Hisun
PK/PD data, Journal: Pharmacokinetic Study of Oral C-Radiolabeled Hyzetimibe, A New Cholesterol Absorption Inhibitor. (Pubmed Central) - Jun 16, 2021 The changed hydroxyl group in the hyzetimibe structure made it easier for that drug, compared with ezetimibe, to combine with glucuronic acid and subsequently increased the urinary excretion of hyzetimibe vs. ezetimibe. These differences highlight the need to investigate in more detail the different pharmacokinetic impacts on the efficacy and safety of hyzetimibe and ezetimibe.
- |||||||||| Onbrez (indacaterol) / Novartis
Clinical, Journal: Numerical simulation of the effect of inhalation parameters, gender, age and disease severity on the lung deposition of dry powder aerosol drugs emitted by Turbuhaler®, Breezhaler® and Genuair® in COPD patients. (Pubmed Central) - May 27, 2021 Mean values and distributions of the deposited lung doses proved to be both drug and device specific, yielding 24.2 (±7.8), 22.6 (±3.6), 34.2 (±4.8) and 23.9 (±5.4) % values for Symbicort®, Onbrez®, Seebri® and Bretaris®, respectively...A more powerful inhalation significantly increases the lung dose for the drug emitted by Turbuhaler®, while long breath-hold is likely to yield significantly higher deposition for drugs emitted by Breezhaler® and Genuair®. Lung doses of two different drugs dispensed in the same inhaler can be significantly different.
- |||||||||| firtecan pegol (PEG-SN38) / Zhejiang Hisun, Belrose
Journal: EZN-2208 treatment suppresses chronic lymphocytic leukaemia by interfering with environmental protection and increases response to fludarabine. (Pubmed Central) - Apr 27, 2021 Here, we tested the hypothesis that a pharmacological compound previously shown to inhibit HIF-1α may act as a chemosensitizer by interrupting protective microenvironmental interactions and exposing CLL cells to fludarabine-induced cytotoxicity. We found that the camptothecin-11 analogue EZN-2208 sensitizes CLL cells to fludarabine-induced apoptosis in cytoprotective in vitro cultures; in vivo EZN-2208 improves fludarabine responses, especially in early phases of leukaemia expansion, and exerts significant anti-leukaemia activity, thus suggesting that this or similar compounds may be considered as effective CLL therapeutic approaches.
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