– Companies to Leverage Lead Product Candidate
from IGM’s Proprietary IgM Antibody Platform with ZYNLONTA® for
Novel Combination Therapy in Relapsed/Refractory B Cell NHL –
– Phase 1 Trial Expected to be Initiated in
1Q23 –
IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage
biotechnology company focused on creating and developing IgM
antibodies, and ADC Therapeutics SA (NYSE: ADCT) today announced
that they have entered into a clinical trial collaboration and
supply agreement to evaluate the combination of imvotamab, IGM’s
novel IgM CD20 x CD3 T cell engaging bispecific antibody, and
ZYNLONTA® (loncastuximab tesirine-lpyl), ADC Therapeutics’
CD19-directed antibody drug conjugate (ADC), for the treatment of
patients with relapsed/refractory (R/R) B cell non-Hodgkin’s
lymphoma (NHL).
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“Patients with B cell non-Hodgkin’s lymphoma are in need of
efficacious and well-tolerated treatments,” said Chris Takimoto,
M.D., Ph.D., F.A.C.P., Chief Medical Officer of IGM Biosciences.
“We are excited to enter this collaboration with ADC Therapeutics
that aims to provide a novel combination regimen targeting both
CD19- and CD20-expressing cells for patients with
relapsed/refractory B cell non-Hodgkin’s lymphoma. We look forward
to working with the team at ADC Therapeutics and initiating
clinical testing in the first quarter of 2023.”
In data previously reported at the 2021 American Society of
Hematology (ASH) Annual Meeting, imvotamab showed a 50% complete
response (CR) rate at the likely optimal 100 mg dose (n=10). Of the
28 patients treated in the titration dosing cohorts at that time,
cytokine release syndrome was seen in <20% of patients.
“We are pleased to collaborate with IGM Biosciences to explore
ZYNLONTA in combination with imvotamab,” said Joseph Camardo, M.D.,
Chief Medical Officer of ADC Therapeutics. “This collaboration
extends ADC Therapeutics’ commitment to maximizing the potential of
our CD19-directed ADC for patients with significant unmet medical
needs, both as a single agent and in novel combinations with other
anti-cancer agents. The safety profile of imvotamab and the
activity observed so far in phase 1 are highly promising for future
development.”
Under the terms of the agreement, IGM will be responsible for
conducting clinical testing to evaluate the safety and efficacy of
imvotamab in combination with ZYNLONTA® for the treatment of
patients with R/R NHL. ADC Therapeutics will provide clinical
expertise on ZYNLONTA® as well as drug supply to support the trial.
IGM expects to initiate the trial in the first quarter of 2023. The
clinical collaboration is based on compelling mechanistic rationale
and preclinical data showing strong activity of this approach.
About IGM Biosciences, Inc.
IGM Biosciences is a clinical-stage biotechnology company
committed to developing and delivering a new class of medicines to
treat patients with cancer, infectious diseases and autoimmune and
inflammatory diseases. The Company’s pipeline of clinical and
preclinical assets is based on the IgM antibody, which has 10
binding sites compared to conventional IgG antibodies with only 2
binding sites. The Company also has an exclusive worldwide
collaboration agreement with Sanofi to create, develop,
manufacture, and commercialize IgM antibody agonists against
oncology and immunology and inflammation targets. For more
information, please visit www.igmbio.com.
About Imvotamab (IGM-2323)
Imvotamab is a novel IgM-based CD20 x CD3 bispecific antibody T
cell engager (TCE) with the therapeutic potential to be a backbone
treatment in hematology. Preclinical research demonstrates that
imvotamab may have advantages over IgG bispecific antibodies
including greater binding power to CD20 expressing cancer cells
especially when CD20 expression has been reduced due to prior
treatment with anti-CD20 antibodies. It has also been shown to have
good target cell killing efficacy combined with a lower cytokine
release profile associated with the T cell directed cellular
cytotoxicity (TDCC) mechanism. Data generated from Phase 1 clinical
trials provide evidence that imvotamab exhibits a favorable safety
and tolerability profile with promising activity in refractory or
relapsed NHL patients. Imvotamab is currently being studied in two
Phase 2 trials to assess the safety and efficacy of two doses 100
mg and 300 mg, in patients with diffuse large B cell lymphoma
(DLBCL) and follicular lymphoma (FL).
About ZYNLONTA® (loncastuximab tesirine-lpyl)
ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once
bound to a CD19-expressing cell, ZYNLONTA is internalized by the
cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload.
The potent payload binds to DNA minor groove with little
distortion, remaining less visible to DNA repair mechanisms. This
ultimately results in cell cycle arrest and tumor cell death.
The U.S. Food and Drug Administration (FDA) has approved
ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult
patients with relapsed or refractory (r/r) large B-cell lymphoma
after two or more lines of systemic therapy, including DLBCL not
otherwise specified, DLBCL arising from low-grade lymphoma and also
high-grade B-cell lymphoma. The trial included a broad spectrum of
heavily pre-treated patients (median three prior lines of therapy)
with difficult-to-treat disease, including patients who did not
respond to first-line therapy, patients refractory to all prior
lines of therapy, patients with double/triple hit genetics and
patients who had stem cell transplant and CAR-T therapy prior to
their treatment with ZYNLONTA. This indication is approved by the
FDA under accelerated approval based on overall response rate and
continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial.
ZYNLONTA is also being evaluated as a therapeutic option in
combination studies in other B-cell malignancies and earlier lines
of therapy.
About ADC Therapeutics
ADC Therapeutics (NYSE: ADCT) is a commercial-stage
biotechnology company improving the lives of those affected by
cancer with its next-generation, targeted antibody drug conjugates
(ADCs). The Company is advancing its proprietary PBD-based ADC
technology to transform the treatment paradigm for patients with
hematologic malignancies and solid tumors.
ADC Therapeutics’ CD19-directed ADC ZYNLONTA (loncastuximab
tesirine-lpyl) is approved by the FDA for the treatment of relapsed
or refractory diffuse large b-cell lymphoma after two or more lines
of systemic therapy. ZYNLONTA is also in development in combination
with other agents. Cami (camidanlumab tesirine) is being evaluated
in a pivotal Phase 2 trial for relapsed or refractory Hodgkin
lymphoma and in a Phase 1b clinical trial for various advanced
solid tumors. In addition to ZYNLONTA and Cami, ADC Therapeutics
has multiple ADCs in ongoing clinical and preclinical
development.
ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and
has operations in London, the San Francisco Bay Area and New
Jersey. For more information, please visit
https://adctherapeutics.com/ and follow the Company on Twitter and
LinkedIn.
ZYNLONTA® is a registered trademark of ADC Therapeutics SA.
IGM Biosciences Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements,
including statements relating to IGM’s plans, expectations and
forecasts and to future events. Such forward-looking statements
include, but are not limited to: the potential of, and expectations
regarding, IGM’s technology platform and its IgM antibodies and
product candidates, including IGM-2323; expectations regarding the
agreement with ADC Therapeutics; IGM’s plans and expectations
regarding its clinical development efforts and activities;
statements regarding the clinical development of IGM-2323,
including the timing of initiation of a Phase 1 trial in
combination with Zynlonta ; and statements by IGM’s Chief Medical
Officer. Such statements are subject to numerous important factors,
risks and uncertainties that may cause actual events or results to
differ materially, including but not limited to : potential delays
and disruption resulting from the COVID-19 pandemic and
governmental responses to the pandemic, including any future
impacts to IGM’s operations, the manufacture of its product
candidates, the progression of its clinical trials, enrollment in
its current and future clinical trials and progression of its
collaborations and related efforts; the risk of the occurrence of
any event, change or other circumstance that could give rise to the
termination of collaborations with third parties, including the
agreement with Sanofi; IGM’s early stages of clinical drug
development; risks related to the use of engineered IgM antibodies,
which is a novel and unproven therapeutic approach; IGM’s ability
to demonstrate the safety and efficacy of its product candidates;
IGM’s ability to successfully and timely advance its product
candidates through preclinical studies and clinical trials; IGM’s
ability to enroll patients in its clinical trials; the potential
for the results of clinical trials to differ from preclinical,
preliminary, initial or expected results; the risk of significant
adverse events, toxicities or other undesirable side effects; IGM’s
ability to successfully manufacture and supply its product
candidates for clinical trials; the potential impact of continuing
or worsening supply chain constraints; the risk that all necessary
regulatory approvals cannot be obtained; the potential market for
IGM’s product candidates, and the progress and success of
alternative therapeutics currently available or in development;
IGM’s ability to obtain additional capital to finance its
operations, if needed; uncertainties related to the projections of
the size of patient populations suffering from the diseases IGM is
targeting; IGM’s ability to obtain, maintain and protect its
intellectual property rights; developments relating to IGM’s
competitors and its industry, including competing product
candidates and therapies; general economic and market conditions;
and other risks and uncertainties, including those more fully
described in IGM’s filings with the Securities and Exchange
Commission (SEC) including IGM’s most recent Quarterly Report on
Form 10-Q filed with the SEC on August 8, 2022 and in IGM’s future
reports to be filed with the SEC. Any forward-looking statements
contained in this press release speak only as of the date hereof,
and IGM specifically disclaims any obligation to update any
forward-looking statement, except as required by law.
ADC Therapeutics Forward-Looking Statements
This press release contains statements that constitute
forward-looking statements. All statements other than statements of
historical facts contained in this press release, including
statements regarding our future results of operations and financial
position, cash runway, business and commercial strategy, market
opportunities, products and product candidates, research pipeline,
ongoing and planned preclinical studies and clinical trials,
regulatory submissions and approvals, projected revenues and
expenses and the timing of revenues and expenses, timing and
likelihood of success, as well as plans and objectives of
management for future operations, are forward-looking statements.
Forward-looking statements are based on our management’s beliefs
and assumptions and on information currently available to our
management. Such statements are subject to risks and uncertainties,
and actual results may differ materially from those expressed or
implied in the forward-looking statements due to various factors,
including those described in our filings with the U.S. Securities
and Exchange Commission. No assurance can be given that such future
results will be achieved. Such forward-looking statements contained
in this document speak only as of the date of this press release.
We expressly disclaim any obligation or undertaking to update these
forward-looking statements contained in this press release to
reflect any change in our expectations or any change in events,
conditions, or circumstances on which such statements are based
unless required to do so by applicable law. No representations or
warranties (expressed or implied) are made about the accuracy of
any such forward-looking statements.
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IGM Biosciences Contact: Argot Partners David Pitts
212-600-1902 igmbio@argotpartners.com ADC Therapeutics Investors
Contacts: Eugenia Litz ADC Therapeutics
Eugenia.Litz@adctherapeutics.com +44 7879 627205 Amanda Loshbaugh
ADC Therapeutics Amanda.Loshbaugh@adctherapeutics.com +1
917-288-7023 ADC Therapeutics Media Contact: Mary Ann Ondish
ADC Therapeutics maryann.ondish@adctherapeutics.com +1
914-552-4625
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