Full Press Release Details
and ADC Therapeutics Announce Clinical Collaboration Agreement to Evaluate Imvotamab (IGM-2323) in Combination with ZYNLONTA in
Patients with Relapsed or Refractory B Cell Non-Hodgkin's Lymphoma
to Leverage Lead Product Candidate from IGM's Proprietary IgM Antibody Platform with ZYNLONTA for Novel Combination Therapy
in Relapsed/Refractory B Cell NHL -
1 Trial Expected to be Initiated in 1Q23 -
VIEW, Calif. and LAUSANNE, Switzerland, November 2, 2022 - 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).
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
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%
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."
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.
IGM Biosciences, Inc.
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.
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).
ZYNLONTA (loncastuximab tesirine-lpyl)
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.
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.
is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.
(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.
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
Therapeutics is based in Lausanne (Biop le), 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.
Biosciences Cautionary Note Regarding Forward-Looking Statements
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
Forward-Looking Statements
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
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can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the