Philogen Announces R&D Program Update
Philogen
Announces R&D
Program Update
Fibromun shows
activity in pretreated
glioma and sarcoma patients;
OncoFAP targets tumor lesions in cancer
patients; a new
product partnered with AbbVie entered clinical studies
Siena (Italy), 2
July, 2021 – (Globe Newswire) – Philogen
S.p.A. (BIT:PHIL), a clinical-stage biotechnology company focused
on the development of innovative medicines based on tumor targeting
antibodies and small molecule ligands, is pleased to provide an
update on three R&D programs: Fibromun, OncoFAP and ABBV-022. A
full pipeline update will be made to the market on 28 September,
2021, in the Company’s Half Year results announcement.
Prof. Dr. Dario Neri, Co-Founder, Chief
Executive Officer and Chief Scientific Officer of
Philogen S.p.A.,
said: “We are extremely pleased to see that our technology
has been delivering exciting product candidates of diverse nature,
both by our partners such as AbbVie and under our ownership, across
a variety of clinical trials. The early signs of activity support
our ambition to bring innovative treatment options to patients with
serious unmet medical need.”
Fibromun
Fibromun (L19TNF), wholly-owned by Philogen, is
a fully-human immunomodulatory product consisting of the L19
antibody and TNF (a strong pro-inflammatory cytokine). Recombinant
TNF has so far been approved only for certain loco-regional
clinical applications.
- Promising
interim survival benefits have been demonstrated in the European
Phase I/II trial, investigating Fibromun as a monotherapy for the
treatment of IDH wildtype WHO Grade III-IV High-Grade Glioma at
first recurrence/relapse. Data on progression free survival at six
months are being finalized, while the overall survival data will be
consolidated by the end of 2021, with expected publication in a
peer-reviewed scientific journal in 2022.
- In the European
Phase I/II trial, in which Fibromun is combined with lomustine for
the treatment of Glioblastoma at first recurrence/relapse, a
partial response has been observed already in the first patient
treated in the study. The historical overall response rate for this
patient population is 4.3% (Wick et al., J Clin Oncol 2010,
28,1168)
- A Parallel
Scientific Advice (PSA) with the European Medicines Agency and the
US Food and Drug Administration has been completed in June 2021.
The development plan for the treatment of glioblastoma and the
proposed strategy for marketing authorization have been discussed
and agreed with competent authorities. Philogen will follow the
recommendations that were provided during the PSA.
- In the European
Phase II trial, in which Fibromun is combined with dacarbazine for
the treatment of pretreated advanced/metastatic Soft Tissue Sarcoma
(3rd line), the second patient treated in the study enjoyed a
partial response. The historical overall response rate for this
patient population is 4.0% (Garcia-del-Muro et al., J Clin Oncol
2011, 29,2528). After the run-in part of the trial, the trial
progresses to a randomized part.
- Fibromun is
investigated in six clinical trials, of which five have a pivotal
potential. In Soft Tissue Sarcoma, the European Phase III trial in
1st line and the Phase II trial in 3rd line are expected to read
out by the end of 2023.
OncoFAP
OncoFAP is a small molecule radiotracer,
wholly-owned by Philogen, with ultra-high affinity for Fibroblast
Activation Protein (FAP). The product is suitable for the
non-invasive detection of a variety of metastatic solid tumors, as
FAP is overexpressed in more than 90% of epithelial cancers (e.g.,
malignant breast, colorectal, ovarian, lung, skin, prostate, and
pancreatic cancers, as well as in some soft tissue and bone
sarcomas)
- Clinicians from
the Department of Nuclear Medicine at the University Hospital of
Münster have employed a OncoFAP-based radionuclide conjugate
(OncoFAP-68Ga) in clinical scanning of patients with various
FAP-positive cancer types and have shown excellent tumor uptake in
both primary and metastatic lesions with low uptake in healthy
organs (including kidneys) after intravenous injection.
- These clinical
results also support the investigation of OncoFAP-177Lu for
Radionuclide Ligand Therapy (RLT).
- Philogen is
currently planning international, exploratory, clinical trials to
investigate OncoFAP in a variety of cancer indications. The results
from these studies will provide the basis for a pivotal clinical
program in selected cancer types.
ABBV-022
ABBV-022, a product out-licensed by Philogen to
AbbVie, consists of an IL-22 payload fused to a targeting antibody.
The cytokine, selectively delivered to the epithelial surface of
damaged gut mucosa, promotes survival of intestinal stem cells,
improves goblet cell function and epithelial barrier, thereby
reducing inflammation.
- ABBV-022 has started a Phase I
clinical trial for the treatment of Ulcerative Colitis. The
original collaboration between Philogen and AbbVie began in
2014.
About
Philogen
Philogen is a Swiss-Italian clinical-stage
biotechnology company listed on the Italian Stock Exchange. It is
engaged in the discovery and development of novel pharmaceutical
and biopharmaceutical products. Philogen’s strategy is to deliver
bioactive agents, for example cytokines or drugs, to the site of
disease using antibodies and other ligands that specifically and
efficiently target stromal antigens. This technology has generated
a strong proprietary pipeline of clinical-stage products and
preclinical compounds in an array of disease indications. Philogen
is headquartered in Siena, Italy, and has research activities at
its subsidiary company Philochem near Zurich, Switzerland. Philogen
has signed agreements with several major pharmaceutical companies.
For more information, please visit www.philogen.com.
Forward-Looking
Statements
The forward-looking statements contained in this
press release may be identified by words such as “aims,”
“anticipates,” “believes,” “could,” “estimates,” “expects,”
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“potential,” “seeks,” “will” and variations of these words or
similar expressions that are intended to identify forward-looking
statements, although not all forward-looking statements contain
these words. Forward-looking statements in this press release
include, but are not limited to, statements regarding anticipated
advancement of preclinical development efforts and initiation and
progression of clinical trials; anticipated enrollment in and
progression of Philogen’s clinical trials; the availability of data
from clinical trials and preclinical studies; anticipated
regulatory filings; the therapeutic potential of Philogen’s product
candidates; Philogen’s ability to achieve planned milestones.
Philogen may not actually achieve the plans, intentions or
expectations disclosed in these forward-looking statements, and you
should not place undue reliance on these forward-looking
statements. Actual results or events could differ materially from
the plans, intentions and expectations disclosed in these
forward-looking statements as a result of various factors,
including: risks to site initiation, clinical trial commencement,
patient enrollment and follow-up, as well as to Philogen’s and its
partners’ abilities to meet other anticipated deadlines and
milestones, also due to the ongoing COVID-19 pandemic;
uncertainties inherent in the initiation and completion of
preclinical studies and clinical trials and clinical development of
Philogen’s product candidates by Philogen or its partners; the risk
that Philogen may not realize the intended benefits of its
technology; availability and timing of results from preclinical
studies and clinical trials; whether the outcomes of preclinical
studies will be predictive of clinical trial results; whether
initial or interim results from a clinical trial will be predictive
of the final results of the trial or the results of future trials;
the risk that trials and studies may be delayed and may not have
satisfactory outcomes; potential adverse effects arising from the
testing or use of Philogen’s product candidates; risks related to
Philogen’s ability to maintain existing collaborations and realize
the benefits thereof; expectations for regulatory approvals to
conduct trials or to market products; other factors which could
cause our actual result to differ from those contained in the
forward-looking statements, as also described in greater detail in
the Risk Factors section in the prospectus drafted by Philogen and
approved by Consob on February 17, 2021. Any forward-looking
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date hereof, and Philogen expressly disclaims any obligation to
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a result of any new information, future events, changed
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Philogen
contacts
Dr. Christian Lizak (Business Development), Dr.
Emanuele Puca (Investor Relations)
+41 (0) 43 544 88 00
christian.lizak@philogen.com,
emanuele.puca@philogen.com
Consilium Strategic
Communications contacts
Mary-Jane Elliott, Davide Salvi
Philogen@consilium-comms.com
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