Disc wins orphan drug tag for rare blood cancer
Pharmaceutical Technology
FEBRUARY 12, 2024
The humanised monoclonal antibody DISC-3405 is under investigation in a Phase I clinical trial, with data expected this year.
tag Antibody Related Topics 
Can gene therapies for haemophilia defend their high price tags?
Pharmaceutical Technology
NOVEMBER 9, 2022
million price tag. Both factor VIII prophylactics and Roche’s bispecific antibody Hemlibra that are used for haemophilia A patients are expensive, and so a gene therapy could save money, says Dr. David Rind, chief medical officer (CMO) of ICER. The post Can gene therapies for haemophilia defend their high price tags?
Gene Therapy 
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FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag
pharmaphorum
JANUARY 5, 2022
The FDA thinks an antibody-drug conjugate (ADC) developed by AbbVie could set new standards in treatment for certain patients with lung cancer, awarding the drug breakthrough status. The post FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag appeared first on.
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FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag
pharmaphorum
DECEMBER 23, 2021
Daiichi Sankyo has been granted breakthrough status by the FDA for patritumab deruxtecan, a HER3-targeted antibody-drug conjugate (ADC) in clinical trials for lung cancer. The post FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag appeared first on.
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Enhertu gets breakthrough tag in HER2-low breast cancer
pharmaphorum
APRIL 27, 2022
The coveted status has been awarded to the HER2-targeting antibody-drug conjugate (ADC) on the back of the DESTINY-Breast04 trial results, unveiled in February, which involved patients with HER2-low, unresectable and/or metastatic breast cancer previously treated with one to two prior lines of chemotherapy. .”
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Sponsored content: Why choose Bethyl antibodies for your R&D
Drug Discovery World
JANUARY 10, 2023
For over 50 years, Bethyl Laboratories (now a Fortis Life Sciences brand) has been dedicated to improving lives by supporting scientific discovery through qualified antibody products and custom services. All of our antibodies are highly validated using six pillars of validation, meaning that our antibodies do what we say they’ll do.
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Gilead tags Merck for first-line triple negative breast cancer trial
pharmaphorum
OCTOBER 29, 2021
Gilead’s Trop-2 targeting antibody-drug conjugate Trodelvy (sacituzumab govitecan) will be paired with Merck’s PD-1 inhibitor Keytruda (pembrolizumab) in a new phase 3 trial in previously-untreated subjects with locally advanced or metastatic TNBC. While its headline revenue of $7.4
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Patent wars: what’s behind Amgen’s possible win over Sanofi at the US Supreme Court
Pharmaceutical Technology
FEBRUARY 22, 2023
The patent battle between Amgen and Sanofi over their cholesterol-lowering antibodies has divided big pharma in the past months. Both drugs are monoclonal antibodies that inhibit the protein PCSK9. Both drugs come with a high price tag. To an extent, the challenge here lies in the nature of antibodies, says Contreras.
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Roche’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease
The Pharma Data
OCTOBER 9, 2021
Roche (SIX RO, ROG; OTCQX RHHBY) now posted that gantenerumab, ananti-amyloid beta antibody developed for subcutaneous administration, has been granted Improvement Rectifier Designation by theU.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer’s fever ( Notice).
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J&J gets first approval for multiple myeloma bispecific Tecvayli
pharmaphorum
AUGUST 25, 2022
Johnson & Johnson has its first worldwide regulatory approval – in the EU – for Tecvayli, one of two much-anticipated bispecific antibodies the drugmaker has developed for patients with multiple myeloma. Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.
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A broad range of unmet needs remains in the immuno-oncology space
Pharmaceutical Technology
MAY 2, 2023
IO agents include the classes of immune checkpoint modulators, cell therapies, bispecific antibodies, oncolytic viruses, therapeutic vaccines, and cytokines. Marketed bispecific antibodies are largely bispecific T-cell engagers (BiTEs), which work by directing T-cells to antigen-expressing tumour cells.
Grand Rounds January 12, 2024: Design and Implementation of a Weighted Lottery to Equitably Allocate Scarce Covid-19 Resources (Erin K. McCreary, PharmD, BCIDP)
Rethinking Clinical Trials
JANUARY 17, 2024
The first monoclonal antibody (mABs) treatment for treatment of COVID-19 was approved in November 2020. UPMC built upon the success of the Remdesivir lottery and in December 2020, UPMC began infusing monoclonal antibodies across 45 UPMC locations. We know there is a digital gap in disadvantaged patients and elderly patients.
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CHMP backs J&J’s myeloma bispecific Tecvayli, ahead of US decision
pharmaphorum
JULY 25, 2022
Tecvayli (teclistamab) is an off-the-shelf bispecific antibody targeting both BCMA and CD3 which is also under review at the FDA and if approved will slot into J&J’s myeloma therapy portfolio alongside Darzalex (daratumumab) – an antibody directed at CD38 – and BCMA-targeted CAR-T therapy Carvykti (ciltacabtagene autoleucel).
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With rivals threatening, Argenx scores key myasthenia gravis win
pharmaphorum
MARCH 23, 2022
Argenx only recently scored FDA approval for its intravenous anti-neonatal FC receptor (FcRn) antibody Vyvgart for generalised myasthenia gravis (gMG), but is already looking to defend its franchise with a new subcutaneous version of the drug. After 29 days’ treatment IgG levels were reduced by 66.4% in the IV arm.
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Clover Biopharmaceuticals Announces Publication of Phase 1 Clinical Trial Data for its Adjuvanted COVID-19 Vaccine Candidates in The Lancet
The Pharma Data
JANUARY 31, 2021
Both vaccines induced high levels of neutralizing antibodies comparable to or exceeding levels in human convalescent sera as well as a strong Th1-biased cell-mediated immunity. Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate.
Leading innovators in peptide nano-particle conjugates for the pharmaceutical industry
Pharmaceutical Technology
MAY 15, 2023
Adeno-associated virus vectors, alcohol dehydrogenase compositions, and antibody serum stabilisers are some of the accelerating innovation areas, where adoption has been steadily increasing. Among maturing innovation areas are anti-influenza antibody compositions and anti-interleukin-1, which are now well established in the industry.
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Clover Biopharmaceuticals Announces Positive Phase 1 Data for its Adjuvanted S-Trimer COVID-19 Vaccine Candidates
The Pharma Data
DECEMBER 3, 2020
S-Trimer adjuvanted with GSK’s pandemic adjuvant system induced neutralizing antibody titers (seroconversion) in 100% of participants at the selected 9 µg S-Trimer dose in both adult and elderly groups, with geometric mean titers (GMT) greater than 1:1,800. About Trimer-Tag © Technology. About COVID-19 S-Trimer Vaccine.
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Almirall and IRB Barcelona team up to tackle skin disease
pharmaphorum
JANUARY 18, 2022
The hope is that they will harness and re-programme natural cellular mechanisms to selectively remove the disease driving proteins from human tissues, working by boosting interactions – gluing – between therapeutically relevant proteins and the machinery used by cells to naturally tag and destroy proteins.
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ASH: Argenx cues up a second use for efgartigimod
pharmaphorum
DECEMBER 12, 2022
Vyvgart is already approved to treat generalised myasthenia gravis, getting a green light for that indication from the FDA a year ago, and launched with a $225,000 per annum price tag in competition with rival gMG drugs like AstraZeneca/Alexion’s C5 inhibitor Soliris (eculizumab).
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NICE says yes to Novartis’ multiple sclerosis therapy Kesimpta
pharmaphorum
APRIL 20, 2021
The cost-effectiveness agency has said that anti-CD20 antibody Kesimpta (ofatumumab) can be prescribed via the NHS in England and Wales as a treatment for adults with RMS with active disease, as either a first-line therapy or after alternative drugs have been tried.
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Sarepta’s Elevidys Reaches Finish Line as First Gene Therapy Approved for Duchenne Muscular Dystrophy
XTalks
JUNE 28, 2023
million price tag of Elevidys, a one-time gene therapy. It has taken Sarepta six years to develop Elevidys with several roadblocks in its journey, including two clinical holds due to safety concerns. It has taken Sarepta six years to develop Elevidys with several roadblocks in its journey, including two clinical holds due to safety concerns.
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Roche’s Early Alzheimer’s Blood Test Gets FDA Breakthrough Device Designation
XTalks
APRIL 18, 2024
Previously, Roche secured an FDA breakthrough tag for another one of its Alzheimer’s blood tests that detects levels of pTau-181 and ApoE4 (apolipoprotein e4). However, the guidance doesn’t say whether it could serve as a study’s primary endpoint on its own.
After a slow start for expensive CAR-T therapies, drug developers revisit oral therapies for blood cancer
pharmaphorum
DECEMBER 23, 2022
There’s been huge progress in treatments for blood cancer in recent years – but drawbacks of expensive CAR-T cell and injected antibody therapies have led drug developers to look at novel oral therapies as patient-friendly alternatives. Oral therapy data presented at ASH. CellCentric, a U.K-based
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Clover and Dynavax Announce Planned Global Phase 2/3 Efficacy Trial of Adjuvanted COVID-19 Vaccine Candidate
The Pharma Data
JANUARY 31, 2021
In its Phase 1 clinical trial, Clover’s protein-based COVID-19 S-Trimer vaccine candidates in combination with adjuvants from either Dynavax or GlaxoSmithKline plc (GSK, London Stock Exchange: GSK) both performed well and induced high levels of neutralizing antibodies while demonstrating favorable safety and tolerability profiles.
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FDA Trims Broad Label for Biogen’s Alzheimer’s Drug Amidst Harsh Criticism
XTalks
JULY 12, 2021
The FDA’s rationale for granting the approval was based on the function of the drug as an amyloid beta targeting antibody. On the other hand, Biogen is being aggressively questioned over its tacking on of such a hefty price tag for the drug.
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Cocktail of modified antibodies provides strong effect against SARS-CoV-2
The Pharma Data
APRIL 22, 2023
Cocktail of modified antibodies provides strong effect against SARS-CoV-2 Is it possible to improve the antibodies that the body produces to fight SARS-CoV2? In a study led by researchers from Lund University in Sweden, this was investigated by redesigning antibodies and combining them against the virus.
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Meet the Researcher: Andreas Bader, Triumvira Immunologics
Drug Discovery World
JUNE 14, 2023
We have now our lead product in a Phase I/II study, which is a HER-2 directed tag T cell product for patients with HER-2 positive solid tumours. I started as a cancer biologist and worked with small molecules and antibodies. I’ve been with a company for more than five years now. This is not how I started out.
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Amtagvi (Lifileucel) Scores Landmark Win as First FDA-Approved T-Cell Therapy for a Solid Tumor
XTalks
FEBRUARY 27, 2024
Addressing the high price tag, Iovance’s commercial chief Jim Ziegler said, “Payers have expressed their appreciation for the value proposition for Amtagvi.” Vogt said Iovance set Amtagvi’s price based on its value as the first drug approved in the post-PD-1 melanoma setting, and the company’s analysis of relevant benchmarks.
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Biogen’s Aducanumab Becomes First Drug Approved for Alzheimer’s in Nearly 20 Years Despite Controversy
XTalks
JUNE 9, 2021
Aducanumab is a human IgG1 monoclonal antibody that binds to aggregated forms of amyloid beta to help reduce its buildup. Aducanumab Controversy and Price Tag. Biogen developed aducanumab in partnership with Japanese pharmaceutical company Eisai. Evidence for aducanumab’s efficacy has been highly contested.
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New to ELRIG Drug Discovery 2022: Tech Theatre supported by DDW
Drug Discovery World
OCTOBER 3, 2022
She also works on her own research following her PhD in the digitisation of scientific research, smart labs and the lab of the future, and semantic tagging of scientific data, which she has continued as part of the Physical Sciences Data Infrastructure (PSDI) Project. Fellowship Programme.
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What to expect from PEGS Europe 2023: Day 2
Drug Discovery World
NOVEMBER 9, 2023
Ahead of protein and antibody engineering conference PEGS Europe 2024 in Lisbon, DDW’s Megan Thomas looks at what to expect from each track of the annual biologics technology meeting. Kielczewska will present: ‘Discovery of antibody-based therapeutics to challenging targets: Platform considerations’.
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Company Spotlight: Cue Biopharma Innovates in the Immunotherapy Space with its Immuno-STAT Platform
XTalks
AUGUST 17, 2020
Monoclonal antibodies : these are antibodies that are designed to bind to specific targets on cells. The design of the immune biologic puts these elements together on an antibody scaffold. With the Neo-STAT platform, “it’s like making a separate antibody molecule for each one of those. Immune system modulators (i.e.
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Conjugation and Labeling of Molecules: A Burgeoning Approach in Therapeutics Development and Molecular Imaging
Roots Analysis
SEPTEMBER 13, 2023
Conjugation is the process of formation of a single, stable hybrid, wherein one of the entities is a molecule, such as protein, antibody, peptide and small molecule. Bioconjugation is a subset of conjugation where one of the entity is a biomolecule, such as protein or an antibody.
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Roche’s quantitative COVID-19 antibody test; Janssen buys a gene therapy asset; Zimmer Acquires A&E Medical; Glaucoma research study: Merck chooses TriNKET cancer immunotherapy program; Ovid fails Angelman phase 3 study
Delveinsight
DECEMBER 3, 2020
Roche receives FDA authorization for the quantitative COVID-19 antibody test. Roche has got an authorization from the FDA for a more accurate COVID-19 blood test capable of measuring the levels of specific antibodies, which target the cell-unlocking spike protein of coronavirus. Merck chooses TriNKET cancer immunotherapy program.
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What to expect from PEGS Europe 2023: Day 3
Drug Discovery World
NOVEMBER 13, 2023
Ahead of protein and antibody engineering conference PEGS Europe 2024 in Lisbon, DDW’s Megan Thomas looks at what to expect from each track of the annual biologics technology meeting. Hiroki Shirai, PhD, Coordinator, RIKEN Center for Computational Science, on: ‘Applying deep learning anomaly detection to antibody structures’.
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Roctavian okay sets up another gene therapy test for Europe
pharmaphorum
AUGUST 26, 2022
The US biotech claimed conditional marketing approval from the European Commission for Roctavian (valoctocogene roxaparvovec) as a treatment for adults with severe haemophilia A, who don’t have a history of developing the antibodies that inhibit the activity of blood-clotting protein Factor VIII. million spread over five years.
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CHMP backs J&J’s myeloma CAR-T therapy Carvykti
pharmaphorum
MARCH 27, 2022
The KarMMa trial of Abecma involved a similar patient group – treated with at least three lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody such as J&J’s Darzalex (daratumumab) – with an overall response rate of 72% and 28% complete responses.
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This week in drug discovery (24-28 October)
Drug Discovery World
OCTOBER 28, 2022
Click’ chemistry used to tag proteins made by cancer cells . Experimental monoclonal antibodies block EBV infection . A panel of investigational monoclonal antibodies (mAbs) targeting different sites of the Epstein-Barr virus (EBV) have been shown to block infection when tested in human cells in a laboratory setting. . .
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Cytiva supports Clover Biopharmaceuticals to scale up the output of its vaccine candidate
The Pharma Data
NOVEMBER 15, 2020
Peng Liang , Founder and Chief Scientific Officer of Clover and inventor of the Trimer-Tag© technology, says, “A successful vaccine that can truly modulate the course of the COVID-19 pandemic must have four essential characteristics: safety, efficacy, scalability of manufacturing, and speed. .”
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Leveraging flow cytometry in drug discovery
Drug Discovery World
OCTOBER 21, 2022
The main principle involves a well-defined light source such as that produced by lasers that excites fluorescent tags bound to the cells or particles present in a sample. Best antibody development practices are summarised in Fig. Figure 1: Best practices followed by reliable, best in class antibody developers.
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AAIC 2021: Six Ways the Approval of Aducanumab Will Change Alzheimer’s Clinical Trials
XTalks
AUGUST 23, 2021
But studies investigating both classes of drugs in combination must also consider the potential that the tau-targeting agent might only receive approval to be prescribed alongside an anti-amyloid antibody like aducanumab. With a $56,000 price tag for a year’s worth of treatment, Aduhelm is far from the most expensive drug on the market.
TG Therapeutics challenges Roche with FDA filing for CLL drug
pharmaphorum
DECEMBER 2, 2020
The New York-based firm has requested approval for the combination of its anti-CD20 antibody ublituximab and umralisib, an oral drug that inhibits PI3K-delta and CK-1 epsilon. US biotech TG Therapeutics has begun a rolling filing with the FDA for its combination therapy for chronic lymphocytic leukaemia, in a challenge to Roche.
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Unveiling Potential: Exploring Alpha Emitter Radiopharmaceuticals
XTalks
JANUARY 19, 2024
To specifically target cancer cells, alpha-emitting radionuclides are often attached to molecules that have a high affinity for cancer cells, such as antibodies or peptides (ligands). Due to their short range, alpha particles can destroy cancer cells while minimizing damage to surrounding healthy tissue.
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Merck KGaA raises full-year forecast; Perlmutter’s new gig tackles ‘undruggable targets’
The Pharma Data
MAY 5, 2021
India approves Roche/Regeneron antibody cocktail to treat COVID-19 ( Reuters ). Adagio offers first peek at Covid-19 antibody data, with preventative numbers that may rival mRNA vaccines ( Endpoints ). FDA approves 100th monoclonal antibody product ( Nature Reviews Drug Discovery ).
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