Asana BioSciences to Present Correlation Between Microbiome Changes and Clinical Efficacy With JAK/SYK Inhibitor ASN002 in the Late-Breaking News Session at the American Academy of Dermatology (AAD) Annual Congress

First demonstration of changes in Staphylococcus aureus in lesional
skin, correlating with clinical efficacy

LAWRENCEVILLE, N.J.–(BUSINESS WIRE)–Asana BioSciences, a clinical stage biopharmaceutical company, announced
that it will present ASN002 data demonstrating changes in skin
microbiome and correlation with clinical efficacy in patients with
moderate-to-severe atopic dermatitis. These data will be presented in a
late-breaking news session at the AAD Annual Congress in Washington,
D.C. to be held March 1-5, 2019. The details of the presentation are as
follows:

Abstract: 11189 – Staphylococcus dysbiosis correlates of success of
treatment of atopic dermatitis with the JAK/SYK inhibitor ASN002

Date/Time/Location: Saturday, March 02 9:00 AM — 11:00 AM;
Room 101

Session: F055 Late-Breaking Research: Basic
Science/Cutaneous Oncology/Pathology

Authors/Investigators: Avidan U. Neumann,
Matthias Reiger, Madhumita Bhattacharyya, Amedeo de Tomassi, Thomas
Nussbaumer, L. Denis, N. Rao, D. Zammit, Claudia Traidl-Hoffmann

Atopic dermatitis (AD) is a severe inflammatory skin disease.
Dysregulation of Th2 and Th22 cytokine pathways is implicated in the
pathogenesis of atopic dermatitis. The inhibition of JAK and SYK
pathways diminishes cytokine production and signaling including those
mediated by Th2 and Th22 cytokines. In a recent Phase 1b/2a study,
ASN002, a novel oral JAK/SYK inhibitor, demonstrated significant
decreases in EASI scores over 4 weeks of treatment and was well
tolerated. ASN002 has recently been granted Fast Track designation by
the U.S. FDA and is the first oral drug to demonstrate improvement in
atopic dermatitis lesional skin phenotype correlating with clinical
efficacy.

In AD patients, Staphylococcus aureus (S. aureus)-dominated skin
microbiome dysbiosis has also been implicated in manifestation of
disease severity. However, the impact of inhibition of the JAK-STAT
pathway on AD-associated microbiome dysbiosis is unknown. An analysis of
the microbiome from the skin biopsies of patients in this study showed
higher S. aureus frequency in lesional skin was the major cause
for microbiome dysbiosis and was associated with higher EASI scores at
baseline. ASN002 not only improved clinical scores but also reduced S.
aureus
frequency in lesions and predicted sustained responses after
the cessation of treatment with ASN002. This is the first report
demonstrating that a JAK/SYK inhibitor can influence the skin microbiome
with corresponding improvements in EASI scores.

Professor Claudia Traidl-Hoffmann, a dermatologist and Director of the
Institute of Environmental Medicine (IEM), UNIKA-T, Helmholtz Zentrum
Munich and Technical University Munich, Augsburg, Germany, stated, “This
study opens new avenues in both atopic eczema treatment and personalized
medicine on the basis of skin microbiome analysis. This study may pave
the way to further unravel the role of S. aureus in aggravation
of the disease but also in endotyping of different subforms of atopic
eczema.”

About Asana BioSciences, LLC

Asana BioSciences is a clinical stage biopharmaceutical company based
near Princeton, NJ. Asana is focused on discovery and development of
novel targeted investigational medicines in immunology/inflammation and
oncology. Multiple assets from Asana’s portfolio besides ASN002 are in
clinical development.

Asana’s lead asset for immunology/dermatology indications – ASN002, a
novel dual inhibitor of JAK and SYK kinases – is in Phase 2b development
in moderate-to-severe atopic dermatitis patients (RADIANT study –
NCT03654755). ASN002 is also being evaluated in patients with severe
chronic hand eczema in a separate Phase 2b study (NCT03728504).

Asana’s second immunology/dermatology asset ASN008 is a novel, topical Na+-channel
blocker with high functional selectivity for itch and pain sensing
neurons. It is being developed for the treatment of chronic itch
conditions and pain with rapid onset and long duration of action after a
single application. ASN008 is currently being evaluated for the
treatment of pruritus associated with atopic dermatitis in a
First-in-Human clinical trial.

Asana also has several oncology assets. ASN007 is in Phase 1 clinical
development. It is a potent inhibitor of the
extracellular-signal-regulated kinases ERK1 and ERK2, which are key
players in the RAS/RAF/MEK/ERK (MAPK) signaling pathway. ASN007 is being
evaluated in patients with advanced solid tumors, including BRAF- and
KRAS-mutant cancers (NCT03415126).

ASN003 is a selective inhibitor of BRAF and PI3 kinases. Dual targeting
of RAF and PI3K pathways has the potential to overcome and/or delay
acquired resistance to selective RAF inhibitors in patients with
BRAFV600 mutated metastatic melanoma, metastatic colorectal and advanced
non-small cell lung cancer (NCT02961283).

ASN004 is an Antibody Drug Conjugate (ADC) that targets the 5T4
oncofetal antigen, which is expressed in a wide range of malignant
tumors but has very limited expression in normal tissues. ASN004
demonstrates robust and durable antitumor activity after single
administration in multiple human tumor xenograft models. A
First-in-Human Phase 1 trial is currently planned for initiation in 2019.

www.asanabiosciences.com

Contacts

Roger Smith
Asana BioSciences
Ph: 908-698-0839
Roger.smith@asanabio.com

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