SLS
Category: History
Updated: 11 months ago
Contributors
Created byZero Insider Purchases
Attachments
Events
EMA Orphan Drug Designation
Peripheral T-cell Lymphomas
SLS009FDA Rare Pediatric Disease Designation
Pediatric Acute Myeloid Leukemia
SLS009EMA Orphan Drug Designation
Acute Myeloid Leukemia
SLS009FDA Rare Pediatric Disease Designation
Pediatric Acute Lymphoblastic Leukemia
SLS009IDMC Continuation of Phase 3
No Safety or Futility Concerns
GPSEnrollment Completion & Initial Positive
Data Phase 2a in r/r AML
100% Overall Response Rate
GPSPhase 2 Update
100% Overall Response Rate & All Patients Alive
SLS009IDMC Continuation of Phase 3
Patients living far longer than expected
GPSPhase 2A
First CR Patient Continues on Study &
Remains Leukemia-Free 9 Months Since Enrollment
SLS009Steering Committee
Update on Phase 3 REGAL Study
GPSExecutive Leadership Reorganization &
Prioritization of Commercialization PartnershipsFDA Fast Track Designation
Relapsed/Refractory Acute Myeloid Leukemia
SLS009Publication of Preclinical Data on its
Highly Selective CDK9 Inhibitor in Oncotarget
SLS009Phase 2A Study Update
First Enrolled Patient Achieved Complete Remission
SLS009Phase 1 combo with Opdivo
Primary Endpoint of Safety and Efficacy Met,
a Three-fold or 208.3% Increase in Survival Time
GPSFDA Orphan Drug Designation
Peripheral T-cell Lymphomas
SLS009Phase 2A Clinical Trial
First Patients Enrolled in 60 mg Dose Cohort
SLS009IDMC Continuation of Phase 3
IDMC Expressed Satisfaction with
Speed of Enrollment and High Study Integrity
GPSPhase 3 Update
Reaches Target Enrollment ex-China in REGAL Trial
GPSFDA Type C Meeting Feedback
Feedback indicates Company’s CMC plans
are in alignment with FDA’s requirements and
expectations towards a BLA
GPSPresent Positive Data from Phase 1/2 Trial of (GPS) in
Combination with Keytruda at the International
Gynecologic Cancer Society 2023 Annual Global Meeting
GPSFDA Fast Track
Relapsed/Refractory Peripheral T-cell Lymphomas
SLS009Positive Initial Topline Phase 2a Data in AML
Anti-leukemic Effects Observed in All Patients No
Significant Safety Issues Observed
SLS009Provides Update on Phase 3 REGAL Clinical Trial
GPSFirst Patient Dosed in Phase Ib/II Trial in Relapsed/Refractory Peripheral T-cell Lymphomas
SLS009Orphan Drug Designation - Acute Myeloid Leukemia
SLS009Oral Presentation of SLS009 Phase 1 Data
for Acute Myeloid Leukemia Patients
at 2024 ESH Conference
SLS009Phase 1
Announces Positive Topline Data in Lymphoma Cohort
Supporting Advancement to Phase 2 Clinical
Study; Primary and Secondary Endpoints Met
SLS009IDMC Recommends Galinpepimut-S REGAL Trial
to Continue Without any Modifications
GPSFDA Rare Pediatric Disease Designation
Pediatric Acute Myeloid Leukemia
GPSSELLAS Life Sciences to Present at the 66th
American Society of Hematology (ASH)
Annual Meeting & Exposition 2024
SLS009ER Release
"We are extremely grateful to the patients and
their families, principal investigators and study
teams, SELLAS employees, and all of those
who have contributed to our Phase 3 REGAL
study of galinpepimut-S (GPS). We are excited
to be on the cusp of potentially adding a
novel immunotherapy to physicians’ arsenals in
their mission to prolong patients’ lives. We are
looking forward to the significant milestones
on the horizon, with interim analysis from
our Phase 3 REGAL
study of GPS in AML ..."SELLAS Announces Positive Data from Preclinical
Studies Indicating ASXL1 Mutations as Predictor
of Response to SLS009 in Solid Cancers
SLS009SELLAS Life Sciences Triggers Interim Analysis in
Phase 3 REGAL Trial of GPS in Acute Myeloid Leukemia
GPSSELLAS to Host Corporate Update Call
on January 8, 2025, at 9:00 am ET
Featuring CEO and Dr. Yair Levy, Director of
Hematologic Malignancies at the
Baylor University Medical Center
Member of Regal Steering CommitteeApproval of “tambiciclib” as Recommended
International Nonproprietary Name for SLS009
SLS009Applied for Non-Dilutive Grant Funding to Expand
SLS009 Development Into Frontline Setting in AML
SLS009Fox News Issues "Fox News Flash"
Biotech CEO predicts 'revolutionary' steps
toward curing cancer on horizon thanks to AICEO Appears on Fox News
"I think it's going to be a revolutionary
decade in medicine and in clinical
research," he said Thursday on "Fox & Friends."CEO Appears on Fox Business
The Big Money Show discussing the impact
of #AICancerVaccines & how we’re
advancing targeted immunotherapies
for the treatment of cancer.SELLAS Announces Positive Data from
Phase 2a Trial of SLS009 in
Combination with Zanubrutinib in DLBCL
Median Overall Survival Not Reached Yet
67% of Patients Still Alive
SLS009SELLAS Life Sciences Announces Positive
Outcome of Interim Analysis for its
Pivotal Phase 3 REGAL Trial of GPS in Acute Myeloid LeukemiaSELLAS Announces Positive Overall
Survival in Cohort 3 from
the Ongoing Phase 2 Trial of SLS009 in r/r AML
SLS009SELLAS Life Sciences Reports
Full Year 2024 Financial Results
and Provides Corporate UpdateSELLAS Life Sciences Group Announces
$25 Million Registered Direct Offering
Priced At-the-Market Under Nasdaq RulesSellas Life Sciences
Updated Corporate Presentation
April 2025SELLAS to Present at the
2025 American Society of
Clinical Oncology (ASCO)
Annual Meeting
SLS009ASCO Presentation
In vitro efficacy of CDK9
inhibitor tambiciclib(SLS009)
in ASXL1 mutated colorectal
cancer cell lines.Annual Report 10-K
ReleasedAnnual Shareholder MeetingSELLAS Unveils Breakthrough
Preclinical Data Highlighting
Efficacy of SLS009 in TP53
Mutated AML at the 2025
AACR Conference
SLS009SELLAS Life Sciences to be
Added to Russell 3000®
and Russell 2000® IndexesSELLAS Life Sciences Expands
Scientific Advisory Board with
Addition of Two World-Renowned
Hematology and Oncology ExpertsSELLAS Presents Preclinical Efficacy
of SLS009 in ASXL1 Mutated
Colorectal Cancer at 2025
ASCO Annual Meeting
SLS009Periods
Data from the Phase 2a Trial of SLS009 in Relapsed/Refractory
AML After Venetoclax Failure to be Presented at the Upcoming
American Society of Hematology (ASH) Annual Meeting in December
SLS009National Cancer Institute
Pivot Program Update Due
SLS009Full Topline Phase 2 Data in Acute
Myeloid Leukemia and FDA Regulatory
Review Expected in 1H 2025
Trial Continues with Full Data and FDA
Regulatory Path Feedback Expected in 1H 2025
SLS009
Comments