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

(RTTNews) - 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%.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


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