IRX Therapeutics’ Board of Directors Announces New Senior Management Appointments of Mark Leuchtenberger and Monil Shah

NEW YORK–(BUSINESS WIRE)– IRX Therapeutics, Inc. (IRX) announced today that the Company’s Board of
Directors has appointed Mark Leuchtenberger, as President, Chief
Executive Officer and Director, and Monil Shah as Chief Operating
Officer. Mr. Leuchtenberger and Dr. Shah are two biotechnology industry
veterans who bring extensive experience in corporate and operational
leadership and oncology drug development to IRX. IRX also announced that
John W. Hadden II, a founder of IRX and its prior CEO, will continue as
a Director.

“Today’s appointment of Mark Leuchtenberger and Monil Shah begins the
next chapter in IRX’s development and affirms the Board’s commitment to
delivering operating excellence to its partners and stakeholders,” said
John W. Hadden II. “Mark is a highly experienced executive, ideally
suited to lead IRX through its next stage of development, with a passion
for advancing new therapies that address unmet patient needs. Monil has
deep experience in oncology and immuno-oncology drug development that
provides an excellent foundation from which to lead IRX’s operations.”

“On behalf of IRX stakeholders, I want to thank John for his leadership
in building IRX Therapeutics and his role in recruiting Mark and Monil.
We look forward to your continued involvement in advancing IRX,” said
David Deming, Chairman of the Board, IRX Therapeutics.“I am excited to
welcome Mark and Monil to IRX in their respective senior leadership
capacities. Mark is a seasoned executive with private and public company
experience, who has demonstrated a unique ability to build value
advancing novel therapies. Monil has a proven track record of delivering
outstanding operating results that will benefit IRX going forward.”

“I am very excited to join the team at IRX Therapeutics at this
important inflection point in the company’s evolution,” said Mark
Leuchtenberger. “The positive Phase 2a results for IRX-2, including
encouraging 5-year survival data in squamous cell carcinoma of the head
and neck, provide a strong basis for the growth of IRX Therapeutics in
the area of immuno-oncology. I look forward to building on the
extraordinary results that have been achieved to date so that we can
make a difference in the lives of cancer patients.”

“IRX Therapeutics has a tremendous opportunity to advance the
development of cancer immunotherapy based on data suggesting IRX-2 may
be reversing immune suppression in the cancer tumor microenvironment,”
said Monil Shah. “We believe this mechanism for immunomodulation may be
synergistic with checkpoint inhibitors, and this is an exciting clinical
opportunity that we intend to explore further. I look forward to working
with Mark and the rest of the management team to build an organization
that can help transform the treatment of cancer.”

Mark Leuchtenberger has over 20 years of experience as a senior
executive in the biopharmaceutical industry where he has led companies
through private financings and initial public offerings, taken products
from IND through to commercialization and achieved M&A exits. Mr.
Leuchtenberger was President and Chief Executive Officer and a member of
the board of directors at Chiasma (NASDAQ: CHMA), Acusphere, Inc.
(OTCMKTS: ACUS) and Rib-X Pharmaceuticals, Inc. (now Melinta
Therapeutics, Inc.). Mr. Leuchtenberger served as President and Chief
Executive Officer of Targanta Therapeutics Corporation, where he led the
company’s initial public offering in 2007 and its acquisition by The
Medicines Company in 2009. Mr. Leuchtenberger served as the President
and Chief Executive Officer of cancer vaccine company, Therion Biologics
Corporation. Prior to Therion, Mr. Leuchtenberger was a senior officer
at Biogen Inc., where he led the late-stage development of Avonex and
its launch in the United States and subsequently managed North American
and international commercial operations as well as business development.
He is a director and past chairman of the Massachusetts Biotechnology
Council Board of Directors, and is a past trustee for Beth Israel
Deaconess Medical Center and Chairman of the Advisory Committee for the
MassDevelopment Emerging Technology Fund. He is a co-founder of Albor
Biologics, Inc. and Alvos Therapeutics, Inc. He served as non-executive
Chairman of the Board of Directors of Xenetic Biosciences, Inc.
(OTCMKTS: XBIO), a biopharmaceutical company developing next generation
biologic drugs and novel oncology therapeutics, from May 2014 to April
2015. Mr. Leuchtenberger received his M.B.A. from the Yale School of
Management and his B.A. from Wake Forest University.

Monil Shah has over 17 years of pharmaceutical and biotechnology
industry experience in Oncology drug development, including Clinical
Research and Development and Medical Affairs. Dr. Shah has led and built
senior level teams and also conducted business development activities,
including joint collaborations and evaluation of in-licensing
opportunities. Most recently, Dr. Shah was the Medical Affairs Lead for
Immuno-Oncology at Bristol Myers Squibb. Dr. Shah helped start a biotech
company as the Head of Clinical Operations and Development at Ventrus
Biosciences. Prior to Ventrus, Dr. Shah led the solid tumor development
programs and was eventually offered the opportunity to lead the clinical
portfolio and strategic planning function at Celgene Corporation. He led
the Oncology Development and Operations activities at Fibrogen and
Novacea. Dr. Shah began his career at Novartis in the Oncology Early
Development Group leading clinical trials and then continued to grow his
skills in the Medical Sciences Group at Amgen. Dr. Shah received his
B.S. and PharmD degrees from Rutgers, The State University of New Jersey
and his M.B.A. from Florida Institute of Technology.

About IRX-2

IRX-2 is a primary cell-derived biologic. Data collected to date suggest
that IRX-2 reduces the immune suppression that is often seen in the
cancer tumor microenvironment. This immunomodulatory activity appears to
occur through the restoration of immune function and activation of a
coordinated immune response against the tumor. IRX-2 is a proprietary
therapeutic containing numerous active cytokine components, which
restores and activates multiple immune cell types, including T cells,
dendritic cells, and natural killer cells, that are able to recognize
and destroy tumors. Currently, IRX-2 is being studied in an on-going
Phase 2b clinical trial in patients with newly diagnosed Stage II, III,
and IVA squamous cell carcinoma of the head and neck (SCCHN) (INSPIRE)
(clinicaltrials.gov NCT02609386) and in pre-operative early stage breast
cancer (ESBC) (clinicaltrials.gov NCT02950259).

IRX-2 Phase 2a Results

Data collected in a Phase 2a trial of patients with squamous cell
carcinoma of the head and neck (SCCHN) demonstrated that neoadjuvant
IRX-2 stimulated lymphocyte infiltration (LI) into the tumors, and
greater LI was associated with longer survival. The overall 5-year
survival rate was 65% (17/26), and in patients with a large change in LI
after treatment, there was a greater than 80% probability of survival at
5 years (LIavg vs. survival, p<0.05).¹ Of the 27 patients
evaluable for safety, 85.2% experienced at least one treatment-emergent
adverse event (TEAE), the most common (>10%) study drug-related TEAEs
included nausea, injection site pain, headache, and dizziness. There
were no drug-related deaths reported.²

¹ Increased lymphocyte infiltration in patients with head and
neck cancer treated with the IRX-2 immunotherapy regimen. Berinstein NL,
Wolf GT, Naylor PH, et al. Cancer Immunol Immunother.
2012;61(6):771-782

² Novel neoadjuvant immunotherapy regimen safety and survival
in head and neck squamous cell cancer. Wolf GT, Fee WE, Dolan RW, et al.
Head and Neck. 2011; 33:1666-74.

About IRX Therapeutics

IRX Therapeutics is a clinical-stage company developing novel
immunotherapies focused on reducing the immune suppression that is seen
in the cancer tumor micro-environment, restoring immune function, and
activating a coordinated immune response against the tumor. The lead
candidate, IRX-2, is a proprietary therapeutic containing numerous
active cytokine components. Data collected to date indicates that IRX-2
acts to restore and activate multiple immune cell types, including T
cells, dendritic cells, and natural killer cells, to recognize and
destroy tumors. For more information about the Company and its clinical
programs, please visit www.IRXTherapeutics.com.

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