EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), HER3 antagonists(Receptor tyrosine-protein kinase erbB-3 antagonists)

Therapeutic Areas

NeoplasmsRespiratory Diseases

Active Indication

Non-Small Cell Lung CancerSquamous Cell Carcinoma of Head and Neck

Inactive Indication

Neoplasm Metastasis

Originator Organization

Symphogen A/S

Active Organization

Symphogen A/SUniversity of Wisconsin School of Medicine & Public Health

Inactive Organization-

License Organization-

Drug Highest PhasePreclinical

First Approval Date-

Regulation-

Structure/Sequence

Sequence Code 134197L

Sequence Code 144960H

Sequence Code 144961L

Sequence Code 145014H

Sequence Code 145020L

Sequence Code 4691217H

Sequence Code 4691223L

Sequence Code 4691288H

Sequence Code 4691293L

Sequence Code 4691299H

Sequence Code 4691302L

Sequence Code 1116885929H

Clinical Trials associated with Sym-013

NCT02906670

/ TerminatedPhase 1/2

An Open-label, Multicenter, Phase 1a/2a Trial Investigating the Safety, Tolerability and Antitumor Activity of Multiple Doses of Sym013, a mAb Mixture Targeting EGFR, HER2 and HER3, in Patients With Advanced Epithelial Malignancies

This is the first study to test Sym013 (Pan-HER) in humans. The primary purpose of this study is to see if Sym013 is safe and effective for patients with advanced epithelial malignancies without available therapeutic options.

Start Date01 Nov 2016

Sponsor / Collaborator

Symphogen A/S

100 Clinical Results associated with Sym-013

100 Translational Medicine associated with Sym-013

100 Patents (Medical) associated with Sym-013

Literatures (Medical) associated with Sym-013

01 Jun 2022·Investigational new drugsQ3 · MEDICINE

First-in-human trial exploring safety, antitumor activity, and pharmacokinetics of Sym013, a recombinant pan-HER antibody mixture, in advanced epithelial malignancies

Q3 · MEDICINE

Article

Author: Patnaik, Amita ; Whisenant, Jennifer G ; Ding, Cliff ; Pedersen, Mikkel W ; Horak, Ivan D ; Skartved, Niels Jørgen Ø ; Hansen, Ulla Holm ; Lantto, Johan ; Wood, Debra L ; Berlin, Jordan ; Nadler, Paul I ; Tolcher, Anthony W

PURPOSE:

Sym013 contains six humanized monoclonal antibodies that bind to non-overlapping epitopes on three human epidermal growth factor receptors (HER1-3). Preclinical studies suggested Sym013 strongly suppresses growth of multiple epithelial tumors. This is a first-in-human study exploring safety and efficacy of Sym013 in patients with advanced epithelial malignancies.

METHODS:

Dose escalation used single-patient cohorts until the stopping rule was met, followed by 3 + 3 design. Dose levels planned were: 1, 2, 4, 6, 9, 12, 15, and 18 mg/kg. Treatment cycles were 28 days with imaging every eight weeks. Serum samples were collected at multiple time points for assessment of pharmacokinetics and development of anti-drug antibodies.

RESULTS:

Thirty-two patients were enrolled with multiple solid tumors, most common being colorectal cancer (CRC; 10/32, 31%). Due to mucositis, rash, and diarrhea at 4 mg/kg once-weekly, dosing was changed to biweekly (Q2W). Mandatory prophylaxis was added due to Grade 3 infusion-related reaction and oral mucositis at 9 mg/kg Q2W. The 15 mg/kg Q2W cohort was enrolling when the study was terminated for business reasons. Most common adverse events were skin (81%) and gastrointestinal (75%) disorders, including dermatitis/rash, stomatitis, and diarrhea. One patient with CRC achieved a partial response; 12 patients with varied malignancies had stable disease.

CONCLUSION:

During the conduct of the study, management of frequent infusion-related reactions, skin toxicities, and mucosal disorders, which are indicative of HER inhibition, necessitated multiple protocol amendments. The investigators, in concert with the Sponsor, agreed that achieving a tolerated regimen with acceptable target saturation was unlikely.

TRIAL REGISTRY:

www.

CLINICALTRIALS:

gov ; NCT02906670 (September 20, 2016).

01 May 1997·Molecular & general genetics : MGG

Sequential functioning of Sym-13 and Sym-31, two genes affecting symbiosome development in root nodules of pea (Pisum sativum L.)

Article

Author: V. E. Tsyganov ; V. K. Lebsky ; I. A. Tikhonovich ; Al. Y. Borisov ; S. M. Rozov ; E. V. Morzhina

Two Fix- mutants of pea (Pisum sativum L.) which are unable to fix molecular nitrogen, E135f (sym-13) and Sprint-2Fix- (sym-31), were crossed to create the doubly homozygous recessive line, named RBT (sym-13, sym-31). The ultrastructural organization of nodules of the RBT line was compared with that of each of the two parental mutant lines and with the original wild-type genotypes of the cultivars Sparkle and Sprint-2. It was shown that the RBT line is similar to the mutant line Sprint-2Fix- in having abnormal symbiosome composition and bacteroids with relatively undifferentiated morphology. Because the phenotypic manifestation of the sym-31 mutant allele suppresses the phenotypic manifestation of the sym-13 mutant allele, it is concluded that the function of the gene Sym-31 (which is mutated in the Sprint-2Fix- line) is necessary at an earlier stage of symbiosome development than the gene Sym-13 (which is mutant in the E135f line).

100 Deals associated with Sym-013

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasm Metastasis	Phase 2	United States	Symphogen A/S	01 Nov 2016
Non-Small Cell Lung Cancer	Preclinical	United States	University of Wisconsin School of Medicine & Public Health	01 Oct 2014
Non-Small Cell Lung Cancer	Preclinical	Denmark	Symphogen A/S	01 Oct 2014
Squamous Cell Carcinoma of Head and Neck	Preclinical	United States	University of Wisconsin School of Medicine & Public Health	01 Oct 2014
Squamous Cell Carcinoma of Head and Neck	Preclinical	Denmark	Symphogen A/S	01 Oct 2014

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