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JNJ Begins Phase 3 COVID-19 Vaccine Trial, Another Headstone In Alzheimer's Graveyard, PFE On Watch

biotech sept24 lt

Today's Daily Dose brings you news about AC Immune's disappointing results in Alzheimer's trial, Actinium Pharma's progress in the Acute Myeloid Leukemia study, Johnson & Johnson initiating phase III trial of its COVID-19 vaccine candidate, and Pfizer's regulatory catalyst.

Read on…

1. AC Immune's TAURIEL Joins the List of Failed AD Trials

Shares of AC Immune SA (ACIU) plunged over 40% on Wednesday, following disappointing top-line results in a phase II trial of investigational drug Semorinemab in early (prodromal to mild) Alzheimer's disease, dubbed TAURIEL.

Semorinemab, the company's anti-Tau antibody is being co-developed in collaboration with Roche's Genetech.

In the TAURIEL study, Semorinemab did not meet its primary efficacy endpoint of reducing the decline on Clinical Dementia Rating-Sum of Boxes (CDR-SB) compared to placebo. Two secondary endpoints, Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13) and Alzheimer's Disease Cooperative Study Group - Activities of Daily Living Inventory (ADCS-ADL) were also not met.

Another phase II study of Semorinemab in a different patient population, i.e., moderate Alzheimer's disease, known as LAURIET, is ongoing.

ACIU closed Wednesday's trading at $4.80, down 44.9%.

2. Actinium Pharma's AML Trial Chugs Along

Actinium Pharmaceuticals Inc. (ATNM) has successfully completed the first dosing cohort in its phase I study of Actimab-A and Venetoclax combination therapy in patients with Relapsed or Refractory ("R/R") Acute Myeloid Leukemia. The results from the proof of concept study are expected in 2021.

A pivotal phase III trial of Iomab-B in patients with relapsed or refractory acute myeloid leukemia, of ages 55 and above, dubbed SIERRA, is underway, with results expected by this year-end.

ATNM closed Wednesday's trading at $8.91, down 9.36%.

3. Cytokinetics Moves 2nd Cardiac Myosin Inhibitor into Clinical Trial

Cytokinetics Inc. (CYTK) has initiated a phase I placebo-controlled, single ascending dose clinical study of CK-271 in healthy adults.

CK-271 is the second cardiac myosin inhibitor, discovered by company scientists, in development for the potential treatment of hypertrophic cardiomyopathy. The company's first cardiac myosin inhibitor, CK-274, is currently in phase II testing.

The phase I study of CK-271 will include three cohorts, with 8 healthy adults per cohort - randomized to CK-271 or placebo. The primary objective of this clinical study is to assess the safety and tolerability of CK-271 and the secondary objective is to evaluate the pharmacokinetic profile of CK-271 following single oral ascending doses.

CYTK closed Wednesday's trading at $21.07, up 2.38%.

4. Johnson & Johnson's COVID-19 Vaccine Candidate on Track

Johnson & Johnson (JNJ) has commenced its large-scale, pivotal, multi-country phase III trial for its COVID-19 vaccine candidate, JNJ-78436735, dubbed ENSEMBLE.

The initiation of the ENSEMBLE trial follows positive interim results from the company's phase 1/2a clinical study.

The ENSEMBLE will enroll up to 60,000 volunteers across three continents and will study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.

The Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) are collaborating with the company in initiating the ENSEMBLE study.

Johnson & Johnson has agreed in principle to collaborate with the United Kingdom of Great Britain and Northern Ireland on a separate phase III clinical trial in multiple countries to explore a two-dose regimen of JNJ-78436735.

The company expects to deliver the JNJ-78436735 vaccine for emergency use authorization in early 2021.

JNJ closed Wednesday's trading at $144.44, up 0.16%.

5. Pfizer Seeks Expanded FDA Approval for XALKORI

Pfizer Inc.'s (PFE) supplemental New Drug Application for XALKORI for the treatment of ALK-positive pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma has been accepted for priority review by the FDA, with a decision expected in January 2021.

Anaplastic large cell lymphoma is a rare type of non-Hodgkin lymphoma, divided into ALK-positive or ALK-negative disease. If approved, XALKORI would be the first biomarker-driven therapy for pediatric ALK-positive Anaplastic Large Cell Lymphoma, noted Pfizer.

XALKORI is already approved for the treatment of patients with metastatic Non-small-cell lung carcinoma whose tumors are ALK-positive or ROS1-positive. The drug brought in annual sales of $530 million for Pfizer in 2019 compared to $524 million in 2018.

PFE closed Wednesday's trading at $36.00, down 0.69%.

6. Stocks That Moved On No News

ASLAN Pharmaceuticals Limited (ASLN) closed Wednesday's trading at $1.92, up 16.36%.

American Well Corporation (AMWL) closed Wednesday's trading at $28.50, up 15.38%.

Forte Biosciences Inc. (FBRX) closed Wednesday's trading at $46.52, up 8.19%.

Retractable Technologies Inc. (RVP) closed Wednesday's trading at $6.34, down 20.65%.

Vaccinex Inc. (VCNX) closed Wednesday's trading at $1.86, down 19.83%.

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