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Startup Impact Biomedicines Raises $22M to Bring Fedratinib to Myelofibrosis Patients

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Today, Impact Biomedicines ("Impact") announced its launch to pioneer
the development of life-changing treatments for patients with
myeloproliferative neoplasms and other cancers. The Company's pipeline
is centered around fedratinib, a potent and highly selective oral small
molecule JAK2 kinase inhibitor that is being developed initially for the
treatment of myelofibrosis (MF) and polycythemia vera (PV). In
conjunction with this launch, Impact is pleased to share that the U.S.
Food and Drug Administration (FDA) has removed the clinical hold placed
on fedratinib and that the company has received $22.5 million from
Medicxi through a Series A financing.

Impact was formed in 2016 after acquisition of Sanofi's full rights for
the global development and commercialization of fedratinib. The majority
equity holders in Impact include the co-founders and Medicxi, with
Sanofi retaining a minority stake.

In 2013, the development of fedratinib was discontinued by Sanofi after
the FDA issued a clinical hold subsequent to reports of a few potential
cases of Wernicke's encephalopathy (WE), an acute neurological condition
usually indicative of a vitamin B deficiency, in patients participating
in fedratinib clinical trials. Following a Type A meeting and review of
additional data, the FDA concluded that Impact provided the necessary
documentation to support lifting the clinical hold – opening the path
for Impact's continued development of fedratinib.

The clinical package for fedratinib includes data from a total of 18
studies completed in 877 subjects. In JAKARTA-1, a completed
international Phase 3 pivotal trial for the treatment of myelofibrosis,
fedratinib met its primary and secondary endpoints by reducing spleen
size in 47% of patients by ≥35% at 24 weeks (p<0.0001) and improving
symptom score in 36% of patients by ≥50% at 24 weeks (p< 0.0001).
Comparable responses were seen in patients with normal or low platelet
counts and thrombocytopenia was similar between placebo and the target
dose of 400mg. In JAKARTA-2, a follow-on study in patients who were
unresponsive to all other available therapies, including patients who
were either Jakafi® (ruxolitinib) resistant or intolerant, fedratinib
showed similar activity. In that study, 55% of patients who had failed
or were intolerant to ruxolitinib experienced a spleen size reduction of
≥35% with fedratinib. Notably, responses were noted in 63% of patients
intolerant to ruxolitinib and 61% of patients who had lost ruxolitinib
response. Currently, ruxolitinib is the only drug approved by the FDA to
treat patients with MF and PV. The most common adverse events for
fedratinib were hematological (anemia) and gastrointestinal (nausea,
diarrhea and vomiting). The results of these trials have been published
in leading peer-reviewed journals.

"The decision to discontinue the development of fedratinib in 2013 was
heartbreaking for the patients who were experiencing positive responses
while in clinical trials. There are very limited therapeutic options for
these patients and fedratinib was active in most patients when nothing
else had worked. Because of the very high unmet medical need in MF, the
Impact team completed a thorough review of the available data, including
careful due diligence into the potential cases of WE and I am glad to
report that as a result of this effort, the FDA has lifted the clinical
hold," said John Hood, Ph.D., Chief Executive Officer of Impact. "In
addition to MF, Impact intends to pursue multiple clinical indications
for fedratinib to realize its potential as a best-in-class JAK2 kinase
inhibitor."

To support the Company's drug development and manufacturing efforts and
the build out of the management team, Impact closed a $22 million Series
A financing with Medicxi.

"We've made it a point to double down and invest more in maturing life
science companies who are delivering innovation where it's needed most.
In line with our ‘asset-centric' approach, we believe Impact is doing
just that by reviving fedratinib with a thoughtful development approach
and due diligence," said Kevin Johnson, Impact board member and
Co-Founder of Medixci. "We are confident that the dedicated team at
Impact has the vision and skill to create a sustainable long-term
business around fedratinib."

The development of fedratinib is being led by a highly skilled and
devoted team, including members of the original TargeGen team, where
fedratinib was first developed prior to its acquisition by Sanofi.

Dr. Hood serves as Chief Executive Officer of Impact Biomedicines. Prior
to founding Impact, he was co-founder and Chief Scientific Officer of
Samumed, a pharmaceutical platform company focused on advancing
regenerative medicine and oncology applications. Prior to that, Dr. Hood
was Director of Research and co-inventor of fedratinib at TargeGen,
Inc., (subsequently acquired by Sanofi SA), where he led a team
identifying small molecule kinase inhibitors for the treatment of eye
diseases and cancer. He is an inventor on 100+ patents and author on 50+
scientific articles. Dr. Hood obtained a Ph.D. in medical physiology and
B.S. in biochemistry from Texas A&M University.

Dr. Catriona Jamieson serves as Interim Chief Medical Officer of Impact
Biomedicines, and co-founder. Concurrently, Dr. Jamieson is a Professor
of Medicine and Chief of Regenerative Medicine, Deputy Director of the
Sanford Stem Cell Clinical Center, Co-leader of the Hematologic
Malignancies Program, and Director of Stem Cell Research at the Moores
UC San Diego Cancer Center. She specializes in myeloproliferative
neoplasms and leukemia, and was the principal investigator on several
fedratinib trials. Dr. Jamieson obtained an M.D., a Ph.D. in
microbiology and a B.S. in Genetics from the University of British
Columbia prior to completing fellowships in hematology and bone marrow
transplantation at Stanford University and being recruited to UC San
Diego.

About Myeloproliferative Neoplasms
Myeloproliferative
Neoplasms (MPN) are a closely-related group of blood cancers in which
the body, specifically the bone marrow, makes too many red blood cells,
platelets, or certain white blood cells. There are three types of blood
cancers that comprise MPNs: Myelofibrosis, Polycythemia Vera and
Essential Thrombocythemia. MPNs are characterized by the mutations of
JAK2, MPL or CALR.

About Impact Biomedicines
Impact Biomedicines is pioneering
the development of life changing treatments for patients with complex
cancers. The Company's pipeline is centered around fedratinib, a potent
and highly selective oral small molecule JAK2 kinase inhibitor that is
being developed initially for the treatment of myelofibrosis and
polycythemia vera.

About Medicxi
Medicxi was established by the former Index
Ventures life sciences team. Medicxi manages the legacy life science
portfolio of Index Ventures as well as the newly launched Medicxi 1
(MV1) and Medicxi Growth 1 (MG1) funds, which focus on investing in
early-stage and late-stage life sciences opportunities, respectively.

GSK, Johnson & Johnson, and Novartis, three of the world's largest
pharmaceutical companies back Medicxi along with Verily, an Alphabet
company. These companies, whilst participating in the SABs of the funds,
do not receive any preferential rights to the portfolio companies.

Please see https://www.medicxiventures.com/
for more information.

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