Pharmaceutical Technology

SEPTEMBER 16, 2022

The US Food and Drug Administration (FDA) has granted fast track designation to Jasper Therapeutics’ antibody, JSP191, for the treatment of severe combined immunodeficiency (SCID) patients who undergo allogeneic hematopoietic stem cell transplant. . The antibody was also analysed in a total of more than 110 healthy subjects and patients. .

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Pharmaceutical Technology

MARCH 28, 2023

On March 27, OncoVerity announced the acquisition of worldwide licensing rights of the anti-CD70 monoclonal antibody cusatuzumab from the biotech argenx. Alongside this, the company closed a $30 million Series A, which came from both argenx and the venture of UCHealth and the University License Equity Holdings.

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Pharmaceutical Technology

APRIL 6, 2023

The designation, under the regulator’s Innovative Licensing and Access Pathway (ILAP), will fast-track a potential route to market for AD04 by providing collaborative opportunities with UK institutes like the National Institute for Health and Care Excellence (NICE).

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FDA Approval Licensing Licensing Antibody 264

Pharmaceutical Technology

JULY 29, 2022

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease.

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Trials Clinical Trials Clinical Trials Licensing 264

Pharmaceutical Technology

MARCH 23, 2023

The regulator granted approval for Zynyz’s Biologics License Application (BLA) under accelerated approval based on the duration of response (DOR) and tumour response rate. Zynyz (retifanlimab-dlwr) is a humanised monoclonal antibody targeting programmed death receptor-1 (PD-1).

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FDA Approval Licensing Licensing Antibody 245

Pharmaceutical Technology

AUGUST 25, 2022

The treatment is indicated for patients with no history of Factor VIII inhibitors and any detectable antibodies to adeno-associated virus serotype 5 (AAV5). The approval is based on comprehensive data from the clinical development programme of Roctavian, including two-year findings from the international Phase III GENEr8-1 clinical trial.

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Pharmaceutical Technology

AUGUST 8, 2022

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. Enhertu-treated subjects had a median overall survival (OS) of 23.4 months compared with 16.8

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FDA Approval HR Clinical Trials Clinical Trials 264

pharmaphorum

AUGUST 25, 2020

The first patients have been dosed in a trial of two AstraZeneca antibodies, collectively known as AZD7442, that are being developed to both treat and prevent coronavirus infections. The phase 1 trial – funded by the US government – will take place in the UK and will test the safety of AZD7442 and its pharmacokinetic profile.

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Antibody Trials Trial Funding Licensing 84

pharmaphorum

SEPTEMBER 27, 2022

While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. The biotech said earlier it planned to seek FDA approval to start clinical trials towards the end of 2022.

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pharmaphorum

JANUARY 27, 2021

AstraZeneca is playing catch up with Eli Lilly and Regeneron with its antibody therapy for COVID-19, but aims to narrow the gap with the help of decentralised clinical trial specialist Care Access Research. One of those trials – BLAZE-2 – was also run using Care Access’ mobile capabilities.

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XTalks

MAY 2, 2022

This year, the monoclonal antibody lecanemab is approaching final stages of investigation as a treatment for targeting the A? The Phase IIb clinical trial focused on the long-term clinical outcomes and safety for patients with MCI and amyloid pathology (early AD). The main pathological markers of AD are beta-amyloid (A?)

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Clinical Trials Clinical Trials Antibody Trials 98

pharmaphorum

JUNE 24, 2021

Armed with a positive mid-stage trial readout in lung cancer, Arcus Biosciences will expand a phase 3 programme for domvanalimab, its anti-TIGIT antibody. Zimberelimab “showed activity similar to that of marketed anti-PD-1 antibodies studied in this setting,” said Arcus’ chief medical officer Bill Grossman.

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Antibody Trials Licensing Licensing 84

Pharmaceutical Technology

APRIL 5, 2023

It is a first-in-class monoclonal anti-human complement factor C5a antibody. The regulator granted the EUA based on data obtained from the multicentre Phase III PANAMO trial, which was conducted in Covid-19 patients who are invasively mechanically ventilated in intensive care units.

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Licensing Licensing Antibody Regulation 246

pharmaphorum

JUNE 17, 2021

Biogen has four other Alzheimer’s candidates in its clinical pipeline behind recently-approved Aduhelm, but one of them – anti-tau antibody gosuranemab – has just been canned. The drug also proved ineffective in an earlier trial in patients with progressive supranuclear palsy (PSP), another neurodegenerative disorder.

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Antibody Protein Licensing Licensing 98

pharmaphorum

JANUARY 12, 2021

ImmunityBio has licensed technology underpinning a COVID-19 vaccine that could be administered orally rather than by injection from UK biotech iosBio. ImmunityBio’s vaccine design drives both antibody and T-cells to the spike (S) protein and nucleocapsid (N) protein.

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Pharmaceutical Technology

DECEMBER 19, 2022

With the latest development, Sanofi will licence a NK cell engager programme that acts on B7H3 from the antibody-based NK cell engager therapeutics (ANKET) platform of Innate. Initially, the companies signed a research collaboration and licensing agreement in 2016 to develop and assess up to two bispecific NK cell engagers.

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Fierce Pharma

JANUARY 9, 2024

The FDA has sent a complete response letter to Astellas, rejecting zolbetuximab because of unresolved deficiencies identified in a pre-license inspection of a third-party manufacturing facility. But the Japanese company will have to clear up manufacturing issues first.

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Manufacturing Antibody Licensing Licensing 118

pharmaphorum

APRIL 9, 2021

The issues are holding up discussions between the agency and company about labeling and post-marketing requirements for teplizumab, and are concentrated around the pharmacokinetics data for the antibody, and whether it is comparable to the drug that its original developer Eli Lilly entered into clinical trials.

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Pharmaceutical Technology

OCTOBER 25, 2022

TSHA-102 is the first gene therapy in the clinical development stage for Rett syndrome currently while TSHA-120 is being analysed in a Phase I/II clinical trial for treating GAN. Astellas will also receive specific rights linked to any possible change of Taysha’s control.

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Gene Therapy Gene Development Genetics 264

Pharmaceutical Technology

MAY 12, 2023

On 8 May 2023, China-based Bliss Biopharmaceutical (BlissBio) announced a clinical trial collaboration with Eisai to develop BB-1701, an antibody-drug conjugate (ADC) for multiple cancer types. Eisai signed a licensing agreement with BlissBio in 2018 for the Chinese companies’ exclusive right to use eribulin as their ADC payload.

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Clinical Trials Clinical Trials Licensing Licensing 162

XTalks

JANUARY 29, 2021

Data from Eli Lilly and Company’s (NYSE: LLY) Phase III clinical trial evaluating its monoclonal antibody drugs bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) show that combining the two significantly reduced the risk of COVID-19 hospitalizations and death by 70 percent. percent) compared with 36 events (7.0

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Antibody Clinical Trials Clinical Trials Trials 96

pharmaphorum

NOVEMBER 28, 2021

An investigator-led trial of Jazz Pharma’s cannabis extract-based drug Sativex in glioblastoma – an aggressive form of brain cancer – will get underway in the UK next year. The post Trial of Jazz’ cannabis drug in glioblastoma will start next year appeared first on.

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Trials Drugs Clinical Trials Clinical Trials 136

pharmaphorum

OCTOBER 31, 2022

Actinium Pharma is on course to submit its targeted radiotherapy for acute myeloid leukaemia (AML) patients needing a bone marrow transplant in the US, buoyed by top-line data from a pivotal trial. The post Actinium eyes filing as conditioning drug for AML aces trial appeared first on.

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Trials Gene Therapy Drugs Antibody 124

Pharmaceutical Technology

JANUARY 23, 2023

Furthermore, similar to GSK’s strategy with Benlysta, AstraZeneca initiated the Phase III TULIP subcutaneous (SC) trial in SLE using subcutaneous delivery of Saphnelo in June 2021. However, the 2021 approval of AstraZeneca’s Saphnelo in the US will mean increasing competition for Benlysta in the coming years.

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pharmaphorum

SEPTEMBER 2, 2020

The drug, JTX-1811, is a monoclonal antibody designed to selectively deplete immunosuppressive tumour-infiltrating T regulatory (TITR) cells. . When JTX-1811 binds to CCR8, it targets TITR cells for depletion by an enhanced antibody-dependent cellular cytotoxicity mechanism. . In 2016 Celgene signed a $2.6 In 2016 Celgene signed a $2.6

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Licensing Licensing Antibody Immune Response 71

Pharmaceutical Technology

JULY 7, 2022

The US Food and Drug Administration (FDA) has granted priority review to Roche’s Biologics License Application (BLA) of Lunsumio (mosunetuzumab) to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL). The submission is based on positive data from the pivotal Phase I/II GO29781 clinical trial of Lunsumio.

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Clinical Trials Clinical Trials Trials Licensing 162

pharmaphorum

JANUARY 25, 2021

GlaxoSmithKline has suffered another research setback after it axed a phase 2 trial of an anti-LAG3 drug in patients with ulcerative colitis, following a major disappointment with a key lung cancer drug last week. Immutep said a collaboration with GSK remains in place and GSK2831781 continues to be under exclusive license with GSK.

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Drug Trials Trials Drugs Licensing 103

pharmaphorum

FEBRUARY 11, 2021

Shares in Swiss biotech AC Immune have risen sharply after it said a vaccine in development for Alzheimer’s disease (AD) hit the mark in a phase 1/2 trial. . The vaccine stimulated antibodies against the protein in all 32 patients with early-stage AD in the study at levels that AC Immune thinks should have a therapeutic effect.

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Antibody Protein Vaccine Vaccination 128

pharmaphorum

FEBRUARY 21, 2022

In contrast, up to 55% of all patients with breast cancer have tumours with a HER2-low score, as defined in the DESTINY-Breast04 trial, and approval in this group could unlock $3 billion in additional sales for Enhertu, according to analysts at Credit Suisse. billion upfront to license rights to Enhertu in a deal that could be worth up to $6.9

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Trials Sales Hormones Drugs 132

Pharmaceutical Technology

OCTOBER 31, 2022

Simultaneously, Genmab has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for the investigational subcutaneous IgG1-bispecific antibody to treat R/R large B-cell lymphoma (LBCL) patients.

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XTalks

DECEMBER 13, 2024

The DREAMM-7 Phase III trial has spotlighted the potential of Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) to improve survival outcomes for relapsed or refractory multiple myeloma. DREAMM-7, an international, open-label trial, enrolled 494 participants with at least one prior multiple myeloma therapy.

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Pharmaceutical Technology

AUGUST 11, 2022

The proceeds from the business combination will be utilised to advance the pipeline of Disc to clinical trials and offer funding into 2025. They include various patient clinical trials for Disc’s programmes, bitopertin and DISC-0974, which are currently in the clinical development stage.

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Medicine Clinical Trials Clinical Trials Licensing 147

pharmaphorum

JUNE 16, 2022

The litany of failed trials of amyloid-targeting drugs for Alzheimer’s disease has added another verse, as Roche concedes that its crenezumab candidate was unable to slow cognitive decline in patients with an inherited form of the disease.

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Trials Clinical Trials Clinical Trials Licensing 111

pharmaphorum

FEBRUARY 9, 2021

An international trial led by US experts is to begin testing AstraZeneca’s long-acting antibody combination therapy to treat COVID-19. The combination known as AZD7442 is to be added to the phase 3 adaptive trial called ACTIV-3, where investigators add new sub-studies of investigational new agents.

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pharmaphorum

DECEMBER 2, 2021

Novartis has licensed a potential drug for Parkinson’s from Belgium’s UCB that it thinks could be the first oral, disease-modifying drug for the disease – if it can avoid the fate of earlier drugs in the class. The track record of drugs targeting alpha-synuclein isn’t that good however.

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Antibody Licensing Licensing Gene Therapy 111

Pharmaceutical Technology

JANUARY 19, 2023

The expanded manufacturing and marketing approval was based on the data obtained from the Phase II trial, conducted in Australia and the US; a separate Phase II trial held in South Africa; and the UK-sponsored COV-BOOST trial. It has been developed using the company’s recombinant nanoparticle technology.

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pharmaphorum

JUNE 16, 2022

MorphoSys seemingly inexorable shift into an oncology pure-play has continued with an out-licensing deal for two programmes in the kidney disease and immunology categories to China’s HIBio.

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