Samsung Biologics to help Enzolytics advance clinical development of mAbs
BioPharma Reporter
OCTOBER 11, 2021
Samsung Biologics and Enzolytics have entered into a strategic CDMO partnership agreement targeting monoclonal antibody production.
Antibody Clinical Development Production 
Astellas and Sutro partner to develop immunostimulatory ADCs
Pharmaceutical Technology
JUNE 28, 2022
Astellas Pharma and Sutro Biopharma have entered a global, strategic partnership and licencing agreement to discover and develop new immunostimulatory antibody-drug conjugates (iADCs). An iADC merges an antibody with a small molecule compound that elicits immunogenic cell death, and an immune-activating molecule.
Development 
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Gilead partners with MacroGenics for bispecific antibody development
Pharmaceutical Technology
OCTOBER 18, 2022
Gilead Sciences has entered an exclusive option and partnership agreement with MacroGenics for developing bispecific antibodies. Under the deal, the companies will leverage MacroGenics’ DART platform to develop MGD024 as well as two further bispecific research programmes.
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Syncromune and Eucure enter antibody licence deal
Pharmaceutical Technology
OCTOBER 19, 2022
Syncromune and Biocytogen Pharmaceuticals’ wholly owned subsidiary Eucure Biopharma have entered an exclusive global licence agreement for OX40 antibody YH002 and two other active ingredients. . Eucure will oversee the production and delivery of the drug, while Syncromune will handle the clinical development and marketing.
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China’s NMPA accepts IND for SinoMab BioScience’s SM17 to treat asthma
Pharmaceutical Technology
MAY 22, 2023
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma.
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Upstream Bio raises funds to advance clinical development of UPB-101
Pharmaceutical Technology
JUNE 9, 2023
It is also preparing for a swift transition to Phase III development. A new recombinant fully human immunoglobulin G1 monoclonal antibody, UPB-101, is now being evaluated in a Phase 1b trial to treat asthma. It targets the human thymic stromal lymphopoietin receptor to inhibit signalling.
AbbVie begins trials of COVID-19 antibody therapy
pharmaphorum
DECEMBER 16, 2020
AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.
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Rilzabrutinib Sets a New Benchmark in Immune Thrombocytopenia Trials
XTalks
DECEMBER 10, 2024
Rilzabrutinib joins a wave of innovative ITP therapies , including thrombopoietin-receptor agonists like eltrombopag and romiplostim, which boost platelet production. By inhibiting this protein, the drug disrupts pathways that contribute to platelet destruction and insufficient production.
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FibroGen and Fortis sign exclusive licence deal for mCRPC drug candidate
Pharmaceutical Technology
MAY 9, 2023
FibroGen has signed an exclusive licence agreement with Fortis Therapeutics for the FOR46 antibody-drug conjugate (ADC) that targets a new epitope on CD46, a protein-coding gene. FOR46 is a natural fit with our research and development capabilities and expertise.
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Ono Pharmaceutical enters research deal with Monash University
Pharmaceutical Technology
JANUARY 16, 2023
Ono Pharmaceutical and Monash University have entered an option and research collaboration for the discovery and development of antibodies that target G protein-coupled receptors (GPCRs). We look forward to working with Ono Pharmaceutical to accelerate treatments across a variety of diseases.”.
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Pyxis Oncology signs agreement to buy Apexigen
Pharmaceutical Technology
MAY 25, 2023
Apexigen discovers and develops a new generation of antibody therapeutics to treat cancer, along with new immuno-oncology products to harness the immune system to combat and eradicate cancer.
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Immuno-oncology market set to grow in billions, but access concerns remain
Pharmaceutical Technology
MAY 26, 2023
GlobalData separates immuno-oncology treatments into six broad classes, which include bispecific antibodies, cancer vaccines, and cell therapies. There are currently over 700 immuno-oncology products in Phase I-III of development in the eight major markets, said Chalk. PD1, BCMA and PDL1 follow as the most common targets.
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EC approves AstraZeneca-Sanofi’s Beyfortus for preventing RSV in infants
Pharmaceutical Technology
NOVEMBER 7, 2022
The latest approval in the EU is based on findings from Beyfortus's clinical development programme, including the Phase III MELODY, Phase II/III MEDLEY and Phase IIb clinical trials. Beyfortus is a long-acting antibody. compared with placebo through day 151.
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Manufacturing challenges set back development progress of cell therapies in oncology
Pharmaceutical Technology
NOVEMBER 21, 2022
ITIL-168 is an autologous TIL therapy, meaning that patients need to undergo apheresis and wait for the product to be manufactured and reinfused. Only 29% of patients successfully received the CAR-T product within 12 months, and 31.9%
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AbbVie and HotSpot sign partnership for autoimmune disease therapy
Pharmaceutical Technology
DECEMBER 7, 2022
On AbbVie exercising its licencing option, the company will be responsible for carrying out all clinical development, production and marketing works of the IRF5 inhibitor programme in the future. HotSpot focuses on discovering and developing small-molecule allosteric therapies for cancer and autoimmune ailments.
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ASP-2138 by Xencor for Metastatic Adenocarcinoma of The Pancreas: Likelihood of Approval
Pharmaceutical Technology
FEBRUARY 25, 2023
ASP-2138 is under clinical development by Xencor and currently in Phase I for Metastatic Adenocarcinoma of The Pancreas. The therapeutic candidate is a bispecific antibody targeting CD3 and claudin 18.2 The drug candidate is being developed based on XmAb technology. It is administered through intravenous drip route.
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ASP-2138 by Xencor for Gastric Cancer: Likelihood of Approval
Pharmaceutical Technology
FEBRUARY 25, 2023
ASP-2138 is under clinical development by Xencor and currently in Phase I for Gastric Cancer. The therapeutic candidate is a bispecific antibody targeting CD3 and claudin 18.2 The drug candidate is being developed based on XmAb technology. It is administered through intravenous drip route.
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ASP-2138 by Xencor for Adenocarcinoma Of The Gastroesophageal Junction: Likelihood of Approval
Pharmaceutical Technology
FEBRUARY 25, 2023
ASP-2138 is under clinical development by Xencor and currently in Phase I for Adenocarcinoma Of The Gastroesophageal Junction. The therapeutic candidate is a bispecific antibody targeting CD3 and claudin 18.2 The drug candidate is being developed based on XmAb technology. It is administered through intravenous drip route.
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Regeneron and CytomX partner to develop bispecific cancer therapies
Pharmaceutical Technology
NOVEMBER 18, 2022
Under the deal, the companies will work together on the discovery activities for identifying and validating the conditionally active bispecific antibodies. This collaboration will use Regeneron’s Veloci-Bi bispecific antibody development platform and CytomX's Probody therapeutic platform.
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Numab raises $110m to develop cancer bispecific antibodies
pharmaphorum
MAY 20, 2021
Switzerland’s Numab has raised 100 million Swiss francs – around $110 million – in Series C financing to develop bispecific antibodies for cancer and inflammation, with Novo Noldings and HBM Partners co-leading the investor syndicate. The post Numab raises $110m to develop cancer bispecific antibodies appeared first on.
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STRO-002 by Sutro Biopharma for Refractory Acute Myeloid Leukemia: Likelihood of Approval
Pharmaceutical Technology
FEBRUARY 19, 2023
STRO-002 is under clinical development by Sutro Biopharma and currently in Phase I for Refractory Acute Myeloid Leukemia. It is a monoclonal antibody conjugate that acts by targeting f olate receptor alpha (FolR alpha). Sutro Biopharma owns a manufacturing facility in San Carlos, California.
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Gemini enters business combination deal with Disc Medicine
Pharmaceutical Technology
AUGUST 11, 2022
They include various patient clinical trials for Disc’s programmes, bitopertin and DISC-0974, which are currently in the clinical development stage. A GlyT1 glycine transporter inhibitor, bitopertin showed effects on heme biosynthesis in clinical trials. In-licensed from AbbVie in 2019, DISC-0974 is a monoclonal antibody.
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Astellas pumps $90m into Sutro immuno-oncology alliance
pharmaphorum
JUNE 28, 2022
billion partnership with US biotech Sutro Biopharma for a series of antibody-drug conjugates for cancer, focusing on applications in patients who don’t respond to current immunotherapies. The biotech has the option to share costs and profits for developing and commercialising the three product candidates in the US.
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Izokibep by Acelyrin for Panuveitis: Likelihood of Approval
Pharmaceutical Technology
JUNE 5, 2023
Izokibep is under clinical development by Acelyrin and currently in Phase II for Panuveitis. It is developed based on affibody technology. Affibody molecules are antibody mimetics with superior characteristics surpassing monoclonal antibodies and antibody fragments. ABY-035 is a IL-17A blocking molecule.
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Inhaled mAb therapy against COVID-19 in the works: ‘The product is not dependent on cold chain distribution and storage’
BioPharma Reporter
JUNE 25, 2021
Augmenta Bioworks and TFF Pharmaceuticals Inc have selected their first lead monoclonal antibody (mAb) for clinical development against COVID-19 as part of their collaborative alliance.
Sanofi signs deal to buy Provention Bio for $2.9bn
Pharmaceutical Technology
MARCH 13, 2023
This further drives the company’s strategic shift toward products with a differentiated profile. The CD3-directed antibody Tzield received approval last year in the US as the first and only therapy developed for delaying the onset of Stage 3 T1D in adults and paediatric patients aged eight years and above with Stage 2 T1D.
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Evaxion and ExpreS²ion partner to develop new CMV vaccine
Pharmaceutical Technology
DECEMBER 6, 2022
In the partnership’s discovery phase, RAVEN, an artificial intelligence (AI) platform of Evaxion will be leveraged for designing a next-generation vaccine candidate that induces cellular as well as humoral/antibody responses. Using ExpreS 2 ion’s ExpreS2 platform, the company will manufacture the antigen constructs obtained from RAVEN.
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RZ-358 by Rezolute for Hyperinsulinemia: Likelihood of Approval
Pharmaceutical Technology
JUNE 10, 2023
RZ-358 is under clinical development by Rezolute and currently in Phase II for Hyperinsulinemia. RZ-358 overview RZ-358 (XOMA-358) is under development for the treatment of hyperinsulinemic hypoglycemia post gastric bypass surgery, and hypoglycemia associated with congenital hyperinsulinism.
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RZ-358 by Rezolute for Hyperinsulinemia: Likelihood of Approval
Pharmaceutical Technology
JUNE 10, 2023
RZ-358 is under clinical development by Rezolute and currently in Phase II for Hyperinsulinemia. RZ-358 overview RZ-358 (XOMA-358) is under development for the treatment of hyperinsulinemic hypoglycemia post gastric bypass surgery, and hypoglycemia associated with congenital hyperinsulinism.
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Genmab’s Silver Anniversary: Reflecting on 25 Years of Breakthroughs in Antibody Therapeutics
XTalks
MAY 9, 2024
Genmab, a trailblazer in the field of antibody therapeutics, celebrates this milestone by reflecting on its impressive journey from a small-scale startup to a global leader in cancer treatment and beyond. Since then, innovative science has been at Genmab’s core, as we harness the power of human antibodies to improve the lives of patients.
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Amivantamab by Johnson & Johnson for Colorectal Cancer: Likelihood of Approval
Pharmaceutical Technology
FEBRUARY 24, 2023
Amivantamab is under clinical development by Johnson & Johnson and currently in Phase I for Colorectal Cancer. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It is formulated as solution and concentrate for solution for intravenous infusion.
Kid EDV by ImmunityBio for Pediatric Diffuse Intrinsic Pontine Glioma: Likelihood of Approval
Pharmaceutical Technology
JUNE 5, 2023
Kid EDV is under clinical development by ImmunityBio and currently in Phase I for Pediatric Diffuse Intrinsic Pontine Glioma. Kid EDV overview Kid EDV is under development for the treatment of recurrent or refractory solid or CNS tumors including diffuse intrinsic pontine gliomas of children. It is administered intravenously.
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Gilead pledges $1.76bn to MacroGenics for bispecific cancer antibody
pharmaphorum
OCTOBER 18, 2022
Gilead Sciences has made yet another rush into the oncology category, licensing a bispecific antibody from MacroGenics in development as a treatment for CD123-positive blood cancers, including acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS). Along with the signing fee, there is another $1.7
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AbbVie Snatches Up Antibody from Harbour BioMed to Fight COVID-19 and Related Mutations
The Pharma Data
DECEMBER 14, 2020
Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. The product is designed for the prevention and treatment of COVID-19, along with related coronaviruses. before expanding it into Europe.
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Pfizer acquires ADC pioneer Seagen for $43bn
Pharmaceutical Technology
MARCH 23, 2023
Seagen specialises in developing antibody-drug conjugates (ADCs) which will complement Pfizer’s oncology portfolio. Seagen will maintain its operations in the Seattle area and will leverage Pfizer’s protein-engineering capabilities to develop next-generation biologics.
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MCLA-129 by Merus for Esophageal Squamous Cell Carcinoma (ESCC): Likelihood of Approval
Pharmaceutical Technology
FEBRUARY 28, 2023
MCLA-129 is under clinical development by Merus and currently in Phase II for Esophageal Squamous Cell Carcinoma (ESCC). The therapeutic candidate is a bi-specific monoclonal antibody that acts by targeting epidermal growth factor receptor (EGFR) and hepatocyte growth factor receptor (MET).
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Novavax Announces COVID-19 Vaccine Clinical Development Progress
The Pharma Data
NOVEMBER 30, 2020
Therefore, the Company has been working closely with the FDA to complete trial-initiation gating activities related to its commercial-scale production at FUJIFILM Diosynth Biotechnologies in Research Triangle Park, North Carolina. Novavax will use vaccine material produced at commercial scale for this trial. Novavax was awarded $1.6
Novo Nordisk’s Alhemo Wins FDA Nod as First Daily Subcutaneous Injection for Hemophilia with Inhibitors
XTalks
JANUARY 6, 2025
However, some patients develop inhibitors antibodies that neutralize the efficacy of replacement therapies. Alhemo works by inhibiting TFPI, which enhances factor Xa (FXa) production during the initiation phase of coagulation. This, in turn, leads to improved thrombin generation a crucial protein involved in blood clotting.
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Rituximab biosimilar by Dr. Reddy’s Laboratories for Rheumatoid Arthritis: Likelihood of Approval
Pharmaceutical Technology
MARCH 2, 2023
Rituximab biosimilar is under clinical development by Dr. Reddy’s Laboratories and currently in Phase III for Rheumatoid Arthritis. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
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Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen
The Pharma Data
DECEMBER 29, 2020
As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis). The results passed the futility analysis (p<0.3
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Sanofi preps trials of second COVID-19 shot, as Russia approves another
pharmaphorum
OCTOBER 16, 2020
Sanofi will shortly start human trials of a second coronavirus vaccine, developed with US biotech Translate Bio, after reporting that it stimulated antibodies against SARS-CoV-2 in preclinical testing. Antibody levels were lower in older recipients, however.
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Sibeprenlimab Reduces Proteinuria in Phase III IgA Nephropathy Trial
XTalks
OCTOBER 23, 2024
Sibeprenlimab, which has a Breakthrough Therapy designation, is a monoclonal antibody that blocks APRIL ( A PR oliferation- I nducing L igand), a critical step in the immune cascade contributing to IgAN. IgAN, also known as Berger’s disease, occurs when IgA antibodies build up in the kidneys, leading to inflammation.
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New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19
The Pharma Data
DECEMBER 17, 2020
NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.
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Pharmaceutical Technology
FEBRUARY 20, 2023
ABN-401 is under clinical development by Abion and currently in Phase II for Solid Tumor. It conducts research activities to develop biopharmaceutical drugs and companion diagnostic systems for the treatment of incurable diseases. The company offers preclinical phase products such as ABN101, ABN301, ABN302, ABN401, and others.
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