Seattle Genetics Announces Initiation of Phase 1 Clinical Trials for Two Novel Antibody-Based Drug Candidates
June 18 2020 - 8:00AM
Business Wire
- Effector Function Enhanced Anti-TIGIT
Antibody -
- Antibody-Drug Conjugate Targeting Integrin
Beta-6 -
- Both Drug Candidates to be Evaluated in
Multiple Tumor Types -
Seattle Genetics, Inc. (Nasdaq:SGEN) today announced dosing of
the first patient in a phase 1 clinical trial evaluating
investigational agent SEA-TGT, also known as SGN-TGT, an anti-TIGIT
antibody for patients with solid tumors and lymphomas. TIGIT
(T-cell immune receptor with Ig and ITIM domains) is an inhibitory
immune receptor that is emerging as a clinically relevant
immuno-oncology target. SEA-TGT is a nonfucosylated human IgG1
antibody that uses the Company’s proprietary Sugar Engineered
Antibody (SEA) technology. The Company also announced the dosing of
the first patient in a phase 1 clinical trial evaluating
investigational agent SGN-B6A, an antibody-drug conjugate (ADC)
targeting integrin beta-6, which is overexpressed in numerous solid
tumors and has been demonstrated to be a negative prognostic
indicator across a diverse range of cancers.
Preclinical data indicate that SEA-TGT has enhanced effector
function enabled by the Company’s SEA technology. These data
indicate that SEA-TGT may have best-in-class potential through
enhanced depletion of TIGIT-positive regulatory T-cells (Tregs),
distinct immune changes including amplified naïve and memory T-cell
responses, and induction of innate immune cell activation. Curative
anti-tumor activity in preclinical models was observed as a single
agent and in combination with a PD-1 checkpoint inhibitor. These
data support potential for improved monotherapy and combinatorial
clinical activity as compared to a non-enhanced TIGIT antibody.
SGN-B6A is an ADC targeting integrin beta-6 to deliver the
clinically validated payload monomethyl auristatin E (MMAE). In
preclinical research, this ADC has demonstrated in vivo activity in
models spanning a range of antigen expression levels and tumor
types.
“We believe that anti-TIGIT antibodies may have an important
therapeutic role in the evolving immuno-oncology landscape,” said
Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics.
“SEA-TGT utilizes our novel SEA technology, which in preclinical
research has demonstrated enhanced effector function that
potentially differentiates it from other TIGIT antibodies in the
clinic. The initiation of clinical trials for both SEA-TGT and the
ADC, SGN-B6A, underscore our commitment to advancing novel drug
candidates from our pipeline into clinical testing.”
SEA-TGT Phase 1 Trial
The phase 1 trial of SEA-TGT will evaluate the safety and
anti-tumor activity of SEA-TGT as a single agent as well as in
combination with the anti-PD-1 antibody, pembrolizumab. The phase 1
trial will evaluate SEA-TGT in advanced solid tumors and lymphomas,
including non-small cell lung cancer, gastric carcinoma, Hodgkin
and selected non-Hodgkin lymphomas. The study is currently open in
multiple sites in the United States and is expected to enroll
approximately 111 participants. More information about the study of
SEA-TGT is available at clinicaltrials.gov.
SGN-B6A Phase 1 Trial
SGN-B6A is an ADC targeting integrin beta-6 to deliver the
clinically validated payload MMAE. The phase 1 trial will evaluate
SGN-B6A in solid tumors, including non-small cell lung cancer, head
and neck squamous cell cancer, breast, esophageal, ovarian,
bladder, cervical and gastric cancers. The study is currently open
in multiple sites in the United States and is expected to enroll
approximately 235 participants. More information about the study of
SGN-B6A is available at clinicaltrials.gov.
About Seattle Genetics
Seattle Genetics, Inc. is a global biotechnology company that
discovers, develops and commercializes transformative cancer
medicines to make a meaningful difference in people’s lives.
ADCETRIS® (brentuximab vedotin) and PADCEV™ (enfortumab
vedotin-ejfv) use the Company’s industry-leading antibody-drug
conjugate (ADC) technology. ADCETRIS is approved in certain
CD30-expressing lymphomas, and PADCEV is approved in certain
metastatic urothelial cancers. TUKYSA™ (tucatinib), a small
molecule tyrosine kinase inhibitor, is approved in certain
HER2-positive metastatic breast cancers. The company is
headquartered in the Seattle, Washington area, with locations in
California, Switzerland and the European Union. For more
information on our robust pipeline, visit www.seattlegenetics.com
and follow @SeattleGenetics on Twitter.
Forward Looking Statements
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to therapeutic
potential of SEA-TGT and SGN-B6A, their possible safety, efficacy,
and therapeutic uses and anticipated development activities
including the enrollment of patients in the Company’s phase 1
studies, future clinical trials and intended regulatory actions.
Actual results or developments may differ materially from those
projected or implied in these forward-looking statements. Factors
that may cause such a difference include the difficulty and
uncertainty of pharmaceutical product development, the risk of
adverse events or safety signals, the inability to show sufficient
activity in clinical trials and the possibility of adverse
regulatory actions as product candidates are evaluated in clinical
trials even after promising results in preclinical research. More
information about the risks and uncertainties faced by Seattle
Genetics is contained under the caption “Risk Factors” included in
the Company’s Quarterly Report on Form 10-Q for the quarter ended
March 31, 2020 filed with the Securities and Exchange Commission.
Seattle Genetics disclaims any intention or obligation to update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise, except as required by
law.
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version on businesswire.com: https://www.businesswire.com/news/home/20200618005283/en/
Media: Monique Greer (425) 527-4641 mgreer@seagen.com
Investors: Peggy Pinkston (425) 527-4160
ppinkston@seagen.com
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