Clinical Research Informer

Immunocore’s Kimmtrak Gets FDA Approval as First Treatment for Rare Eye Cancer and First T Cell Receptor Therapeutic

XTalks

JANUARY 28, 2022

Up to 50 percent of patients will develop metastatic disease, mainly spreading to the liver, making treatment difficult and limited. As such, unresectable or metastatic uveal melanoma usually has a poor prognosis and until the approval of Kimmtrak, there was no approved treatment. The median treatment time is about 23 weeks (or 5.3

FDA Approval

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Enhertu gets breakthrough tag in HER2-low breast cancer

pharmaphorum

APRIL 27, 2022

AstraZeneca and Daiichi Sankyo have claimed a fifth breakthrough designation from the FDA for Enhertu, shortly after showing the drug extended survival in patients with HER2-low metastatic breast cancer. The post Enhertu gets breakthrough tag in HER2-low breast cancer appeared first on.

Sales

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A broad range of unmet needs remains in the immuno-oncology space

Pharmaceutical Technology

MAY 2, 2023

While initially only approved for metastatic disease, ICIs have now moved into earlier disease settings, reducing the risk of disease progression and relapse. IO therapies come with a hefty price tag, with ICI therapies in the US typically exceeding $100,000, while cell therapies can exceed $400,000.

Genetic Engineering

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Immunocore gets EU nod for TCR cancer therapy Kimmtrak

pharmaphorum

APRIL 5, 2022

Kimmtrak (tebentafusp) has been cleared to for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM), mirroring its label in the US. The European population is meanwhile estimated at several thousand patients, across all stages, according to registry data.

Protein

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Bristol Myers Squibb pays $475 million for exclusive rights to Dragonfly Therapeutics' IL-12 immunotherapy programme

The Pharma Data

AUGUST 18, 2020

Since July, the company has been running the therapy through Phase 1/2 studies to evaluate its efficacy in generating anti-tumour responses in locally advanced or metastatic solid tumours when used as a monotherapy and in combination with PD-1 inhibitors. .

Protein

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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

Trials

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FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag

pharmaphorum

DECEMBER 23, 2021

The designation – which is awarded to therapies that could represent a significant improvement over standard of care in either efficacy, safety, or both – has been awarded on the strength of phase 1 results in patients with metastatic or locally advanced EGFR-mutated non-small cell lung cancer (NSCLC).

Drugs

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Amtagvi (Lifileucel) Scores Landmark Win as First FDA-Approved T-Cell Therapy for a Solid Tumor

XTalks

FEBRUARY 27, 2024

Amtagvi is approved for the treatment of unresectable or metastatic melanoma following prior treatment with a PD-1 inhibitor and a BRAF inhibitor if the tumor harbors a BRAF V600 mutation. TILs are immune cells that attack and penetrate tumors. Approximately 95 clinical trials evaluating TIL therapies have been registered globally.

FDA Approval

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Clover biopharmaceuticals raises $230 M; BrainStorm after ALS; BARDA grants $5.65 M LightDeck for SARS-CoV-2 antigen test; Libtayo for first-line advanced NSCLC subset

Delveinsight

FEBRUARY 23, 2021

The company plans to use the capital to expand its pipeline of protein-based vaccines and biologic cancer therapies utilizing its innovative and proprietary Trimer-Tag technology platform. The company develops transformative biologics including vaccines and therapeutics for the world’s most debilitating diseases.

In-Vitro

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Grand Rounds March 17, 2023: Remote Symptom Monitoring with Electronic Patient-Reported Outcomes (ePROs) in Oncology (Ethan Basch, MD, MSc)

Rethinking Clinical Trials

MARCH 21, 2023

At each practice up to 50 patients with metastatic cancer, receiving systemic therapy, not on a therapeutic trial, were randomized to an intervention arm with digital monitoring or a control arm with usual care. Symptom monitoring enables control of chemotherapy side effects, enabling more intensive and longer duration of cancer treatment.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Company Spotlight: Cue Biopharma Innovates in the Immunotherapy Space with its Immuno-STAT Platform

XTalks

AUGUST 17, 2020

CUE-101 is in the clinic right now, being tested in patients with HPV-driven, recurrent metastatic head and neck cancer in a Phase I dose-escalation and expansion study. IL-2 is not only a validated T cell target, but is also an approved drug for metastatic melanoma and renal cell carcinoma. 101, 102, 103).

Protein

Protein Engineer Immune Response In-Vivo

Unveiling Potential: Exploring Alpha Emitter Radiopharmaceuticals

XTalks

JANUARY 19, 2024

The discussion centered on the evolving potential of alpha particle therapy for treating advanced and metastatic tumors. The approval was a major step forward in the treatment of metastatic castration-resistant prostate cancer, explained Dr. Guarnaschelli in the webinar.

DNA

DNA Radiology FDA Approval Development

How data is crucial to the relaunch of the Cancer Moonshot

pharmaphorum

OCTOBER 4, 2022

The Biobank was launched in 2020, with an initial aim of enrolling at least 1,000 patients with locally advanced or metastatic solid tumours and haematologic malignancies undergoing standard of care therapy. Building a bank. The entire process takes place in the physician’s office, alongside a clinician.

Biobanking

Biobanking Clinical Trials Clinical Trials Trials

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

MAY 4, 2021

up 28%, primarily driven by continued strong demand in the metastatic and non-metastatic castration-resistant prostate cancer indications, as well as the metastatic castration-sensitive prostate cancer indication, which was approved in the U.S. in December 2019; and. View source version on businesswire.com : [link].

Vaccination

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Clinical Research Informer

Immunocore’s Kimmtrak Gets FDA Approval as First Treatment for Rare Eye Cancer and First T Cell Receptor Therapeutic

Enhertu gets breakthrough tag in HER2-low breast cancer

Trending Sources

A broad range of unmet needs remains in the immuno-oncology space

Immunocore gets EU nod for TCR cancer therapy Kimmtrak

Bristol Myers Squibb pays $475 million for exclusive rights to Dragonfly Therapeutics' IL-12 immunotherapy programme

Gilead tags Merck for first-line triple negative breast cancer trial

FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag

Amtagvi (Lifileucel) Scores Landmark Win as First FDA-Approved T-Cell Therapy for a Solid Tumor

Clover biopharmaceuticals raises $230 M; BrainStorm after ALS; BARDA grants $5.65 M LightDeck for SARS-CoV-2 antigen test; Libtayo for first-line advanced NSCLC subset

Grand Rounds March 17, 2023: Remote Symptom Monitoring with Electronic Patient-Reported Outcomes (ePROs) in Oncology (Ethan Basch, MD, MSc)

Company Spotlight: Cue Biopharma Innovates in the Immunotherapy Space with its Immuno-STAT Platform

Unveiling Potential: Exploring Alpha Emitter Radiopharmaceuticals

How data is crucial to the relaunch of the Cancer Moonshot

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

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