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Sellas Life Sciences files to sell 818,900 shares of common stock for holders  16:33
05/29/20
05/29
16:33
05/29/20
16:33
SLS

Sellas Life Sciences

$3.43 /

-0.05 (-1.44%)

 
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SLS Sellas Life Sciences
$3.43 /

-0.05 (-1.44%)

SLS Sellas Life Sciences
$3.43 /

-0.05 (-1.44%)

11/15/19 Maxim
Sellas Life Sciences upgraded to Buy from Hold at Maxim
SLS Sellas Life Sciences
$3.43 /

-0.05 (-1.44%)

Over a week ago
Hot Stocks
Sellas Life Sciences forms IDMC for Phase 3 REGAL trial » 08:36
05/18/20
05/18
08:36
05/18/20
08:36
SLS

Sellas Life Sciences

$2.86 /

+ (+0.00%)

SELLAS Life Sciences…

SELLAS Life Sciences Group announced the formation of the Independent Data Monitoring Committee for its pivotal Phase 3 REGAL clinical trial of galinpepimut-S in patients with acute myeloid leukemia who have achieved complete remission after second-line anti-leukemic therapy. The DMC is comprised of an independent group of medical, scientific and biostatistics experts and is responsible for reviewing and evaluating patient safety and efficacy data for the Company's Phase 3 REGAL clinical trial. The DMC will review study data at regular intervals in order to ensure the safety of all patients enrolled in the study. The Committee will also monitor the quality and overall conduct and ensure the validity, scientific and clinical merits of the study, including each site's compliance with the requirements specified in the study protocol. The DMC is charged with assessing such actions in light of an acceptable benefit/risk profile for GPS and will also make applicable recommendations regarding the clinical trial to SELLAS. The Data Monitoring Committee currently consists of four members: Moshe Talpaz, M.D., Associate Director of Translational Research and Associate Chief of the Division of Hematology/Oncology at the University of Michigan Comprehensive Cancer Center and Chair of the REGAL Data Monitoring Committee. Thomas Fleming, Ph.D., Professor and former department chair of the University of Washington Department of Biostatistics, Member of the Fred Hutchinson Cancer Research Center, former Director of the Statistical Center for HIV/AIDS Prevention Trial Network, NIAID, Special Government Employee for the FDA, and for more than 25 years, a regular member of several FDA Advisory Committees. Miguel-Angel Perales, M.D., Chief, Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center. Stephane de Botton, M.D., Head of the Hematology Department at the Gustave Roussy Cancer Campus in Paris, France. The Company previously reported initial data from the Phase 2a study of GPS in AML patients in CR2 at a median follow-up of 19.3 months, showing median overall survival in vaccine-treated patients of 16.3 months vs. 5.4 months in a patient cohort contemporaneously treated with best standard therapy. The final analysis, at a median follow-up of 30.8 months, showed a median OS of 21 months in the GPS-treated patient cohort. A second previous Phase 2 study of GPS in AML patients who achieved first complete remission also met its primary endpoint with an OS rate at 3 years from first vaccination of 47%. The REGAL study is an ongoing 1:1 randomized, open-label study comparing GPS monotherapy in the maintenance setting to investigators' choice best available treatment in AML patients who have achieved hematologic complete remission, with or without thrombocytopenia, after second-line antileukemic therapy and who are deemed ineligible for or unable to undergo allogeneic stem-cell transplantation. The primary endpoint is OS from the time of study entry. Secondary endpoints include leukemia-free survival, antigen-specific T-cell immune response dynamics, measurable residual disease by multigene array, and assessments of AML clonal evolution and inflammasome molecular signatures in the tumor microenvironment in bone marrow biopsy samples. The Company anticipates interim analysis for safety and futility in the fourth quarter of 2021.

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SLS Sellas Life Sciences
$2.86 /

+ (+0.00%)

SLS Sellas Life Sciences
$2.86 /

+ (+0.00%)

11/15/19 Maxim
Sellas Life Sciences upgraded to Buy from Hold at Maxim
SLS Sellas Life Sciences
$2.86 /

+ (+0.00%)

Over a month ago
Hot Stocks
Sellas Life Sciences CEO says will continue to report data in 2020 into 2021 » 08:49
04/28/20
04/28
08:49
04/28/20
08:49
SLS

Sellas Life Sciences

$2.00 /

+0.08 (+4.17%)

SELLAS Life Sciences…

SELLAS Life Sciences Group announced that it has released its annual letter to shareholders. In the shareholder letter Angelos Stergiou, MD, ScD h.c., SELLAS' President & CEO, addresses the Company's product development, anticipated clinical milestones, and operational plans for 2020. Excerpted here are two key passages: "As I write this letter, we are in unprecedented times and all of us at SELLAS wish you and your families to remain safe and healthy. Although we are now all living through this COVID-19 pandemic, I hope to convey a theme of growth and transformation at SELLAS as we are further advancing our clinical programs and remain diligent in our business development and licensing efforts. We greatly appreciate your dedication and support of our company over the years and we are confident that 2020 will demonstrate that your loyalty was well-placed. SELLAS remains clear in its mission and vision to develop and deliver complex and innovative treatments for patients battling cancer. Against the backdrop of the current pandemic, we are doing our best to manage those elements of our business that we believe we can control - progressing our assets, generating clinical and immunobiological data, executing on clinical development and progressing with business development opportunities. As of this writing, the three ongoing clinical trials for our lead clinical candidate, galinpepimut-S, have not been materially impacted. And our business development efforts seeking a licensee for our Phase 3 ready nelipepimut-S are also continuing. As such, we plan to continue to report data from our programs as it becomes available throughout the remainder of 2020 and into 2021."

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SLS Sellas Life Sciences
$2.00 /

+0.08 (+4.17%)

11/15/19 Maxim
Sellas Life Sciences upgraded to Buy from Hold at Maxim
Hot Stocks
Sellas Life Sciences appoints steering committee for ongoing Phase 3 REGAL trial » 08:44
04/16/20
04/16
08:44
04/16/20
08:44
SLS

Sellas Life Sciences

$1.68 /

-0.06 (-3.45%)

SELLAS Life Sciences…

SELLAS Life Sciences Group announced the formation of the Steering Committee for its Phase 3 REGAL clinical trial of galinpepimut-S in patients with acute myeloid leukemia who have achieved complete remission after second-line anti-leukemic therapy. The Steering Committee will provide scientific oversight and guidance of the practical aspects of the ongoing REGAL study. The Steering Committee will also review the results of the trial as they become available, analyze current clinical practices to identify AML patients most likely to benefit from entry to the study, design and implement the most efficient continued approaches to conducting the study and make recommendations regarding the monitoring of the clinical study in consultation with the independent data monitoring committee. The Steering Committee currently consists of three members: Dr. Hagop Kantarjian, MD, Professor and Chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center, and Principal Investigator at MD Anderson for the multi-center Phase 3 REGAL study and Chair of the REGAL Steering Committee. Dr. Javier Pinilla-Ibarz, MD, PhD, Director of Immunotherapy for Malignant Hematology at the H. Lee Moffitt Cancer Center and member of the SELLAS Scientific Advisory Board. Dr. Moshe Yair Levy, MD, Director of Hematologic Malignancies at the Texas Oncology - Baylor Charles A. Sammons Cancer Center. The Company previously reported initial data from the Phase 2a study of galinpepimut-S in AML patients in CR2 at a median follow-up of 19.3 months, showing median overall survival in vaccine-treated patients of 16.3 months vs. 5.4 months in a patient cohort contemporaneously treated with best standard therapy. The final analysis, at a median follow-up of 30.8 months, showed a median OS of 21 months in the GPS-treated patient cohort. A second previous Phase 2 study of galinpepimut-S in AML patients who achieved first complete remission also met its primary endpoint with an OS rate at 3 years from first vaccination of 47%. The REGAL study is an ongoing 1:1 randomized, open-label study comparing GPS monotherapy in the maintenance setting to investigators' choice best available treatment in AML patients who have achieved hematologic complete remission, with or without thrombocytopenia, after second-line antileukemic therapy and who are deemed ineligible for or unable to undergo allogeneic stem-cell transplantation. The primary endpoint is OS from the time of study entry. Secondary endpoints include leukemia-free survival, antigen-specific T-cell immune response dynamics, measurable residual disease by multigene array, and assessments of AML clonal evolution and inflammasome molecular signatures in the tumor microenvironment in bone marrow biopsy samples. The Company anticipates interim analysis for safety and futility in the fourth quarter of 2021.

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SLS Sellas Life Sciences
$1.68 /

-0.06 (-3.45%)

11/15/19 Maxim
Sellas Life Sciences upgraded to Buy from Hold at Maxim
Hot Stocks
Sellas announces antigen-specific immune response data for Nelipepimut-S » 08:33
03/18/20
03/18
08:33
03/18/20
08:33
SLS

Sellas Life Sciences

$1.80 /

-0.03 (-1.64%)

SELLAS Life Sciences…

SELLAS Life Sciences announced preliminary antigen-specific immune response data from a Phase 2 randomized investigator-sponsored trial of nelipepimut-S in combination with granulocyte-macrophage colony-stimulating factor in women with ductal carcinoma in situ of the breast who are HLA-A2+ or A3+ positive, express HER2 at IHC 1+, 2+, or 3+ levels, and are pre- or post-menopausal. The study enrolled 13 patients, with nine patients receiving NPS plus GM-CSF and four patients receiving GM-CSF only. The relative frequency of NPS-specific CD8 cytotoxic T-lymphocytes as a percentage was twice as large in the NPS-treated patients. The NPS-CLT% was measured in the peripheral blood by a sensitive and specific assay using dextramer staining followed by flow cytometry, both at baseline and at 30 days after surgery. The mean difference in NPS-CTL% increase between the active and control groups was +0.10% vs +0.05%. The relative magnitude of change in NPS-CTL% mean values in NPS-treated patients over time was an 11-fold increase, from 0.01% at baseline to 0.11% after surgery, indicating a continued antigen-specific T-cell response post-NPS vaccination. NPS was generally well-tolerated in the study with no drug-related unexpected serious adverse reactions. The overall adverse event profile was consistent with previous safety data. The final data is being further analyzed by the National Institute of Health, MD Anderson Cancer Center and the study principal investigator, Dr. Elizabeth Mittendorf, MD, PhD of the Dana-Farber/Brigham and Women's Cancer Center, and will be presented at an upcoming medical conference.

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SLS Sellas Life Sciences
$1.80 /

-0.03 (-1.64%)

11/15/19 Maxim
Sellas Life Sciences upgraded to Buy from Hold at Maxim
04/08/19
Sellas Life Sciences initiated with a Buy at Alliance Global Partners
03/25/19
Sellas Life Sciences downgraded to Hold from Buy at Maxim
03/22/19 Maxim
Sellas Life Sciences downgraded to Hold from Buy at Maxim
Earnings
Sellas Life Sciences reports FY19 EPS ($10.92), two est. ($9.70) » 08:37
03/13/20
03/13
08:37
03/13/20
08:37
SLS

Sellas Life Sciences

$1.90 /

-0.22 (-10.38%)

"Our clinical and…

"Our clinical and corporate progress in 2019 has laid the foundation for a busy and exciting 2020. We are progressing our clinical development program for galinpepimut-S, including our Phase 3 REGAL study in acute myeloid leukemia, our Phase 1/2 basket study in combination with pembrolizumab, and our Phase 1 trial in combination with nivolumab in malignant pleural mesothelioma. The positive follow-up data of the Phase 2a AML CR2 study announced last month further support our Phase 3 REGAL study design," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "Additionally, we have received and incorporated feedback from the U.S. Food and Drug Administration on the design and plan for a Phase 3 registration-enabling study of nelipepimut-S in patients with triple negative breast cancer. Coupled with the Phase 2b data for NPS in combination with pembrolizumab in TNBC patients that were recently published in Clinical Cancer Research, this supports our business development efforts to pursue out-licensing opportunities for NPS' clinical development."

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SLS Sellas Life Sciences
$1.90 /

-0.22 (-10.38%)

11/15/19 Maxim
Sellas Life Sciences upgraded to Buy from Hold at Maxim
04/08/19
Sellas Life Sciences initiated with a Buy at Alliance Global Partners
03/25/19
Sellas Life Sciences downgraded to Hold from Buy at Maxim
03/22/19 Maxim
Sellas Life Sciences downgraded to Hold from Buy at Maxim
Over a quarter ago
Hot Stocks
Sellas Life Sciences announces follow-up Phase 1/2 data for GPS in AML » 08:40
02/26/20
02/26
08:40
02/26/20
08:40
SLS

Sellas Life Sciences

$2.09 /

-0.15 (-6.70%)

SELLAS Life Sciences…

SELLAS Life Sciences Group announced final follow-up data for its Phase 1/2 study of GPS in patients with acute myeloid leukemia in second complete remission. The final data show a median overall survival of 21.0 months, at a median follow-up of 30.8 months, in patients receiving GPS therapy compared to 5.4 months in the AML CR2 patients treated with best standard care, a statistically significant difference. Final analysis also showed that GPS therapy continued to be well-tolerated throughout the study. The Company previously reported initial data from the Phase 1/2 study of GPS in AML patients in CR2 at a median follow-up of 19.3 months, showing median OS in GPS-treated patients of 16.3 months vs. 5.4 months in a patient cohort contemporaneously treated with best standard therapy. The final analysis, at a median follow-up of 30.8 months, now shows a median OS of 21 months in the GPS-treated patient cohort. SELLAS is currently enrolling patients in the ongoing Phase 3 REGAL study, a 1:1 randomized, open-label study comparing GPS monotherapy in the maintenance setting to investigators' choice best available treatment in AML patients who have achieved hematologic complete remission, with or without thrombocytopenia, after second-line antileukemic therapy and who are deemed ineligible for or unable to undergo allogeneic stem-cell transplantation. The primary endpoint is the OS from the time of study entry. Secondary endpoints include leukemia-free survival, antigen-specific T-cell immune response dynamics, measurable residual disease by multigene array, and assessments of AML clonal evolution and inflammasome molecular signatures in the tumor microenvironment in bone marrow biopsy samples. SELLAS expects an interim analysis for safety and futility in the fourth quarter of 2021.

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SLS Sellas Life Sciences
$2.09 /

-0.15 (-6.70%)

11/15/19 Maxim
Sellas Life Sciences upgraded to Buy from Hold at Maxim
04/08/19
Sellas Life Sciences initiated with a Buy at Alliance Global Partners
03/25/19
Sellas Life Sciences downgraded to Hold from Buy at Maxim
03/22/19 Maxim
Sellas Life Sciences downgraded to Hold from Buy at Maxim
Hot Stocks
Sellas Life Sciences announces feedback from Type C review with FDA » 08:32
02/14/20
02/14
08:32
02/14/20
08:32
SLS

Sellas Life Sciences

$2.80 /

-0.03 (-1.06%)

SELLAS Life Sciences…

SELLAS Life Sciences Group announced feedback from a Type C review with the U.S. Food and Drug Administration regarding its clinical development program for nelipepimut-S in patients with triple negative breast cancer. Based on written feedback from the FDA and on the totality of clinical, safety and translational NPS data presented to date, the Company has finalized the design and plan for a Phase 3 registration-enabling study of NPS in combination with trastuzumab for the treatment of patients with TNBC in the adjuvant setting after standard treatment. If successful, this study may be considered as the basis for a Biologics License Application submission to the FDA. The planned Phase 3 study will be a 1:1 randomized, blinded two-arm study to evaluate the efficacy and safety of the NPS vaccine in combination with trastuzumab vs. GM-CSF alone as maintenance treatment in the adjuvant setting following standard-of-care therapy in patients with TNBC, defined as hormone receptor-negative, HER2 1+/2+ tumors, at high risk of recurrence. The FDA indicated in its feedback that there is adequate safety information to support the use of NPS in combination with trastuzumab. SELLAS previously reported the final efficacy and safety results from a Phase 2b study of NPS in combination with trastuzumab in TNBC patients. The disease-free survival rate at 24 months was 92.6% for the combination arm vs. 70.2% for the trastuzumab alone arm, a clinically meaningful and statistically significant improvement in favor of the combination therapy. This was associated with a statistically significant reduction of 71.9% in the frequency of clinically detected recurrences also in favor of the combination arm. Immune response analysis showed that non-recurrent TNBC patients mounted both vigorous NPS-specific clonal CD8+ cytotoxic T-lymphocyte expansion and enhanced in vivo post-antigen challenge cutaneous delayed type hypersensitivity. Most treatment-emergent adverse events were mild or moderate and consisted of manageable local injection site reactions, skin induration, pruritus, and fatigue.

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SLS Sellas Life Sciences
$2.80 /

-0.03 (-1.06%)

11/15/19 Maxim
Sellas Life Sciences upgraded to Buy from Hold at Maxim
04/08/19
Sellas Life Sciences initiated with a Buy at Alliance Global Partners
03/25/19
Sellas Life Sciences downgraded to Hold from Buy at Maxim
03/22/19 Maxim
Sellas Life Sciences downgraded to Hold from Buy at Maxim
Hot Stocks
Sellas Life Sciences announces 2020 clinical milestones » 09:02
01/13/20
01/13
09:02
01/13/20
09:02
SLS

Sellas Life Sciences

$3.66 /

+0.1 (+2.81%)

Expected 2020 Clinical…

Expected 2020 Clinical Milestones First patient dosed in the Phase 3 registration-enabling study of GPS in AML patients in February 2020. First patient dosed in the Phase 1 open-label study of GPS with nivolumab in MPM patients in January 2020. Interim analysis of the Phase 1/2 basket study of GPS with pembrolizumab in multiple tumor types in the second half of 2020. Guidance from the FDA on the regulatory and development pathway for NPS in TNBC patients in the first quarter of 2020. Initial data from Phase 2 trial of NPS in DCIS in the first quarter of 2020.

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SLS Sellas Life Sciences
$3.66 /

+0.1 (+2.81%)

11/15/19 Maxim
Sellas Life Sciences upgraded to Buy from Hold at Maxim
04/08/19
Sellas Life Sciences initiated with a Buy at Alliance Global Partners
03/25/19
Sellas Life Sciences downgraded to Hold from Buy at Maxim
03/22/19 Maxim
Sellas Life Sciences downgraded to Hold from Buy at Maxim
Hot Stocks
Sellas Life Sciences starts Phase 3 REGAL study of Galinpepimut-S » 08:33
01/08/20
01/08
08:33
01/08/20
08:33
SLS

Sellas Life Sciences

$4.01 /

+0.11 (+2.82%)

SELLAS Life Sciences…

SELLAS Life Sciences Group announced that it has started patient screening for its pivotal Phase 3 REGAL clinical trial of its lead clinical candidate, galinpepimut-S, in patients with acute myeloid leukemia who have achieved complete remission after second-line anti-leukemic therapy. The study is expected to enroll approximately 116 patients across approximately 50 clinical sites in the U.S. and Europe. GPS was previously granted Fast Track designation and orphan drug designation in AML by the U.S. Food and Drug Administration and orphan drug designation by the European Medicines Agency. The REGAL study is a 1:1 randomized, open-label study comparing GPS monotherapy in the maintenance setting to investigators' choice best available treatment in AML patients who have achieved hematologic complete remission, with or without thrombocytopenia, after second-line antileukemic therapy and who are deemed ineligible for or unable to undergo allogeneic stem-cell transplantation. The primary endpoint is the overall survival from the time of study entry. Secondary endpoints include leukemia-free survival, antigen-specific T-cell immune response dynamics, measurable residual disease by multigene array, and assessments of AML clonal evolution and inflammasome molecular signatures in the tumor microenvironment in bone marrow biopsy samples. The Company anticipates interim analysis for safety and futility in the fourth quarter of 2021. In a previous Phase 2a study in AML patients in the CR2 setting, GPS demonstrated a clinically meaningful and statistically significant median OS of 16.3 months in AML CR2 patients vs. 5.4 months in contemporaneously assessed unvaccinated patients. Treatment-related adverse events were primarily comprised of Grade 1 or 2 local injection site reactions and one Grade 3 adverse event. A second previous Phase 2 study of GPS in AML patients who achieved first complete remission also met its primary endpoint with an OS rate at 3 years from first vaccination of 47%.

ShowHide Related Items >><<
SLS Sellas Life Sciences
$4.01 /

+0.11 (+2.82%)

11/15/19 Maxim
Sellas Life Sciences upgraded to Buy from Hold at Maxim
04/08/19
Sellas Life Sciences initiated with a Buy at Alliance Global Partners
03/25/19
Sellas Life Sciences downgraded to Hold from Buy at Maxim
03/22/19 Maxim
Sellas Life Sciences downgraded to Hold from Buy at Maxim

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