Pfizer puts up $1bn to buy into Arvinas breast cancer programme

Pharma Phorum

Pfizer has pledged a whopping $1 billion upfront for rights to an Arvinas drug for breast cancer from its protein degrader platform, which harnesses cells’ natural protein-denaturing machinery to remove rogue proteins associated with disease.

Cullgen Announces “Featured Article” Publication of First in Class TRK Protein Degraders in Journal of Medicinal Chemistry

The Pharma Data

TRK fusion proteins have been found across a wide range of human malignancies, including lung cancer, colorectal cancer, and soft tissue sarcoma. In addition, acquired drug resistance has been reported in patients after treatment with approved TRK protein inhibitors. 16, 2020 09:20 UTC.

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Ribometrix and Genentech Partner in Potential $1 Billion+ RNA Deal

The Pharma Data

Targeting RNA is believed to be a way to develop therapeutics for so-called undruggable proteins. This is because many proteins do not have small-molecule binding sites. So therapeutics that focus on RNA are designed to stop the DNA from coding for disease-causing proteins.

RNA 52

New FDA Guidances for August 2020 and Upcoming Advisory Committee Meetings

CATO Research

Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry: Draft Guidance for Industry – Draft Guidance.

FDA Advisory Committee Recommends Use of Investigational Drug Maribavir (TAK-620) to Treat Post-Transplant Recipients with Cytomegalovirus (CMV) Infection and Disease Refractory to Treatment With or Without Resistance

The Pharma Data

Maribavir, an orally bioavailable anti-CMV compound, is the only antiviral agent presently in Phase 3 development for the treatment of adult post-transplant patients with CMV in SOT or HSCT.

Selva Therapeutics Announces First Dosing in Phase 1 Clinical Study of SLV213, a Potential Oral Treatment for COVID-19

The Pharma Data

As an orally bioavailable small molecule with broad antiviral activity, SLV213 could be a valuable treatment to meet today’s urgent need to fight COVID-19 as well other life-threatening infectious diseases, such as Chagas disease, Ebola virus disease, and Nipah virus infection.”.

New FDA Gudiances for August 2020 and Upcoming Advisory Committee Meetings

CATO Research

Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry: Draft Guidance for Industry – Draft Guidance. By Dieanira Erudaitius, PhD, RAC, Regulatory Scientist, Regulatory Affairs at CATO SMS. Special Interest Guidances/Information. Date Posted.

Lilly’s lebrikizumab significantly improved skin clearance and itch in people with moderate-to-severe atopic dermatitis in two Phase 3 trials

The Pharma Data

Lebrikizumab is a novel monoclonal antibody (mAb) that binds soluble IL-13 with high affinity, has high bioavailability, a long half-life and blocks IL-13 signaling. In people with AD, the IL-13 protein—a central pathogenic mediator in the disease—is overexpressed, driving multiple aspects of AD pathophysiology by promoting T-helper type 2 (Th2) cell inflammation and resulting in skin barrier dysfunction, itch, infection and hard, thickened areas of skin.

Merck, Eisai in renal cancer market; G1 Therapeutics on Cosela’s approval; Takeda’s Maribavir; Astellas/Seagen Padcev

Delveinsight

Padcev is a first-in-class antibody-drug conjugate (ADC) directed against Nectin-4, a protein. The therapy is the first therapy of its kind to target the Nectin-4 protein. Maribavir is an orally bioavailable anti-CMV compound.

Innovative Companies Diving into The Neuro Market Ahead of 2021

The Pharma Data

Artificial intelligence holds immense promise to catalyze the development of the next generation of highly selective, orally bioavailable molecules, with reduced side effects, for the most impactful drug targets,” Feinberg said at the time of the launch.

Novartis’s Spartalizumab Combo Stubles; Union Therapeutics Doses In COVID-19 Trial; Yumanity To Merge With Proteostasis

Delveinsight

The drug is directly delivered to lungs via inhalation to achieve high local exposures, and address the concerns of low oral bioavailability linked to niclosamide. . Both the companies have candidates that address the misfolded proteins at the root of disease.

Ikena bags $120M; Terns raises $87M for NASH; Ribometrix Genentech Collaboration; Hologic acquires Biotheranostics

Delveinsight

It also slates to commence a Phase Ib trial of its second candidate, TERN-201, a vascular adhesion protein (VAP-1) inhibitor, with top-line data anticipated in the first half of 2022. Ikena secures USD 120 Million to advance a growing pipeline of cancer drugs.

RNA 52

Alzprotect Strengthens Its Intellectual Property Portfolio for Its First-in-Class Clinical Stage Drug Ezeprogind

The Pharma Data

EZEPROGIND, which is kicking off phase 2a trials, is a bioavailable neurotrophic inducer. Unlike most products developed by the competition, EZEPROGIND targets all causes of neurodegeneration and is not only aiming at markers such as Abeta protein or Tau protein. The pharmacological targets are Abeta protein, Tau protein and neuroinflammation. 23, 2020 10:33 UTC.

Systemic Lupus Erythematosus Treatment Market: How the Leading Companies are Countering the Rising Prevalence?

Delveinsight

Baricitinib, also known as LY3009104 or INCB028050 , is a novel orally bioavailable inhibitor of the tyrosine-protein kinase JAK1 or JAK2.

Sales 52

A Complex Chromosomal Abberation Called Adrenoleukodystrophy

Delveinsight

Adrenoleukodystrophy (ALD/ X-ALD) is a rare, X-linked disorder secondary to a mutation in the ABCD1 gene, which encodes for a peroxisomal membrane protein, resulting in an excessive accumulation of very-long-chain fatty acids (VLCFAs) in the brain and adrenal glands.

Sosei Heptares’ COVID-19 Program Identifies Potent Broad Spectrum Anti-Viral Small Molecules for Further Development

The Pharma Data

Program focused on inhibitors of SARS-CoV-2 main protease, a highly conserved protein essential for viral replication. These compounds have demonstrated high potency in inhibiting the activity of the M pro protease as well as promising oral bioavailability and blood plasma levels in animal studies. Structure-based design approach has identified potent compounds for further development as oral treatments for SARS-CoV-2 infection and related human coronaviruses.