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SELLAS Life Sciences Group, Inc. (SLS)

NasdaqCM - NasdaqCM Real Time Price. Currency in USD
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6.87-0.20 (-2.83%)
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  • j
    james
    The Chairman of the Leukemia Dept at the University of Texas MD Anderson Cancer Center - “Given these results, (21 months of Survival vs 5 with Best available treatment) it is particularly exciting to be involved in the ongoing pivotal Phase 3 REGAL study of GPS in AML patients in CR2 said Hagop M. Kan.tarjian, MD, REGALs principal investigator. We are working to rapidly enroll patients who meet entry criteria for this study and believe these compelling results will enhance the visibility of this novel therapy and encourage broader participation in the pivotal Phase 3 trial."
  • R
    Real Immuno Investor 10
    Dr Mittendorf/ Peoples Glsi Trial Docs “Trastuzumab increased the sensitivity of the tumor cells to CTL-mediated lysis after stimulation with either nelipepimut-S or GP2, even in patients with low levels of HER2 expression. Interestingly, they also found peripheral blood lymphocytes lyse trastuzumab-treated breast cancer cells more efficiently after nelipepimut-S vaccination. We are currently investigating the possibility of a synergistic immunologic effect when nelipepimut-S is given in combination with trastuzumab in a phase II trial in HER2 over-expressing (3+ by IHC; NCT02297698).’
    The website https://clinicaltrials.gov/ct2/show/NCT02297698 says ‘Estimation primary completion date is December 2021’
    I see now that during the SABC Symposium 2021 (7-10 Dec 2021), there is a Spotlight Session https://www.sabcs.org/Program/Daily-Schedule/Day-3
    Poster Session 4 Hall 1 (from 5.00 to 6.30 PM)
    Where Mittendorf will attend to discuss ‘Spotlight Poster Discussion 10 - Novel Immunotherapy Approaches’
    Bullish
  • J
    Joe
    I added $10k worth yesterday at bottom, hoping for some gifts before the end of the year
    Bullish
  • R
    Real Immuno Investor 10
    Great News For 3DMed - China’s FDA Approves its Checkpoint Agent Today, China's NMPA approved envafolimab, a
    fusion protein of a humanized anti-PD-L1 single domain antibody and human IgG1 Fc formulated for subcutaneous injection, for the treatment of patients with previously treated MSI-H/dMMR advanced cancer. This landmark approval
    represents the first approval of a subcutaneously administered PD(L)1 antibody by a major health authority globally! Thanks to all patients and
    investigators who have participated in envafolimab
    clinical trials, the study team at 3D Medicines, and our partners, this approval is the best
    Thanksgiving gift one can hope for!!!
    Bullish
  • G
    Gabriele
    In 2020 the following article was published by Mittendorf, Peoples et Al.
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7188712/
    In the discussion they argue
    ‘Previous preclinical work by Mittendorf et al. demonstrated that HER2 receptors on the tumor cell surface can be saturated by treatment with trastuzumab, promoting internalization in a time and dose-dependent manner. Trastuzumab increased the sensitivity of the tumor cells to CTL-mediated lysis after stimulation with either nelipepimut-S or GP2, even in patients with low levels of HER2 expression. Interestingly, they also found peripheral blood lymphocytes lyse trastuzumab-treated breast cancer cells more efficiently after nelipepimut-S vaccination. We are currently investigating the possibility of a synergistic immunologic effect when nelipepimut-S is given in combination with trastuzumab in a phase II trial in HER2 over-expressing (3+ by IHC; NCT02297698).’
    The website https://clinicaltrials.gov/ct2/show/NCT02297698 says ‘Estimation primary completion date is December 2021’
    I see now that during the SABC Symposium 2021 (7-10 Dec 2021), there is a Spotlight Session https://www.sabcs.org/Program/Daily-Schedule/Day-3
    Poster Session 4 Hall 1 (from 5.00 to 6.30 PM)
    Where Mittendorf will attend to discuss ‘Spotlight Poster Discussion 10 - Novel Immunotherapy Approaches’

    Let’s stay vigilant on this, guys!
  • R
    Real Immuno Investor 10
    Nps better than Glsi’s drug worth $500M - Nps Results Imminent. “ Interestingly, they also found peripheral blood lymphocytes lyse trastuzumab-treated breast cancer cells more efficiently after nelipepimut-S vaccination. ”
    Bullish
  • C
    Cured
    Up from 15 to 55 institutional funds invested in SLS this Year, have been buying all the cheap shares getting sold, accumulating ahead of the REGAL Phase 3 FDA review in 7 months time, Enrollment at MD Anderson began Feb 2020, covid shutdown March, there were a goodly number of patients in Queue at launch who all now are almost 2 years into a trial where Os averages only 5.5 months. Much of the trial data is clearly significant at this point. Mayo Clinic opened enrollment in July with the UCLA Medical center, among many sites in Germany FR GR.
    In August Dr. levy Gps symposium discussed his thoughts on GPs results potential to be better than the existing therapies, In Phase 2, 90% of Gps P2 patients exhibited IR, with correlated survival benefit, he said no new agents have benefitted patients in overall survival since REGAL began. Essentially confirming GPS is working.

    I am optimistic, a clear significant advantage to gps vaccinated patients offers more than enough advantage in overall life spans. Idmc will be reviewing for Efficacy PRIOR to the Interim as well, a halt on compassionate use makes sense. Gps only benefits building patients with a supercharged immunity to kill WT1 expressed cancer cells with no safety or Qol negatives.
    Bullish
  • d
    david
    Normal movement in bio before skyrocket. Penny flippers and day traders, shorts soon gone for good. So many catlysts comiing in next months. Funny to see shorts screaming for lives here. Buy and hold based on data and facts always best.
  • J
    Jerome
    You have got to love the human condition. The stock drops on a general meltdown in the small biotech space and all the fearmongers come out of the woodwork. There is a delay in the REGAL study, that is the only thing that has changed since July when the stock was at $10. We have updates coming. And yes, although we will need to raise cash, we have an ATM in place (which I hope the firm won't use too much), we have 3D licensing payouts and we have the NPS licensing deal to be announced (at some point soon, who knows exactly when). In the meantime, we will have two important updates on GPS in combo with Opdivo and Keytruda for meso and ovarian cancer. Am I disappointed with the price action? Obviously yes as I loaded up and cannot reasonably add more at these low prices. But I am happy for those who can. Would I sell now? Not a single share. Can it go to $5? Sure it can. It can also fly to $15 or more in a hearbeat. I mean, a market cap of $100M at this point, whether we go to $80M or $120M is nothing in the grand scheme of things. Still here for the potential of GPS. And for now, not one study indicates anything else but success. Obviously, still some execution risk and it is certainly not in the bag before FDA says so, but I do like the firm's prospect. The CEO is young and certainly his communication with the markets could be better. But he is also executing and I am glad he (in conjunction with the board) did not go for a dozen indications. Pushing for AML CR2 first was smart and hopefully by late 2022, we will get results that will unequivocal from REGAL. I will hold until those results come out.
  • c
    cancercure
    Those of you impatient on the litigation close date: it executed on nov19 but most legal have 72hr recension and hence the notification on Monday. Same with every other news pending in here. just matter of time. imminent!
  • L
    Lars
    European Journal of Cancer
    Published:November 22, 2021

    Therapeutic vaccines for breast cancer: Has the time finally come?

    significant clinical benefit was seen in patients expressing HLA-A24 (hazard ratio, HR = 0.41; p = 0.05) and in the TNBC subgroup (i.e. HR, DFS, 0.25; 95% CI: 0.08–0.81; p = 0.01) [[59],[60]]. Based on the present data, Nelipepimut-S will be further evaluated in a phase III trial in combination with trastuzumab for the treatment of patients with TNBC in the adjuvant setting, after standard treatment [[60],[61]].
  • C
    Cured
    Final data from the Moffit Center AML P2 study shows a median OS of 21.0 months, at a median follow-up of 30.8 months, in patients receiving GPS therapy versus 5.4 months OS for those AML CR2 patients being treated with best standard care, a statistically significant difference (p-value < 0.02) for the patients treated with GPS. In both studies, serial active immunization with GPS showed a well-tolerated safety profile. In addition, GPS elicited immune responses in patients, including CD4+ and CD8+ T cell responses.

    Based on the above data and following review by the FDA, a pivotal Phase 3 clinical trial, the REGAL study, for AML patients in CR2 was commenced in January 2020. 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 (CR2/CR2p), 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 (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 study is expected to enroll approximately 116 patients across approximately 50 clinical sites in the United States and Europe.
    Bullish
  • C
    Cured
    more tough news for AML patients
    FDA halts phase 1b Kura Oncology trial in acute myeloid leukemia following patient death
    by Kyle LaHucik | Nov 24, 2021 9:55am FDA Building 2
    The cause of death in Kura Oncology's early-stage cancer trial, differentiation syndrome, is seen in some treatments for acute myeloid leukemia (AML) and was included in the black box warning of an AML drug approved by the FDA in 2018. (FDA)
    The FDA sidelined an early-stage cancer trial from $Kura Oncology after a patient died due to a serious adverse event related to the oral treatment's mechanism of action.

    The partial clinical hold means no additional patients in the acute myeloid leukemia trial will be enrolled until the FDA gives the green light. The regulator's information request is "not complicated," and the hold should be "relatively short," Kura's management said in a conference call Wednesday morning.

    Kura's stock was down 22% to $12.95 a share as of 9:30 a.m. ET.
    Bullish
  • C
    Cured
    Halt for Efficacy Likely if Gps continues to do what it has done in every single other trial: Imo
    In addition to the planned interim analysisunder the SAP, the final charter for the Independent Data Monitoring Committee for the REGAL study provides for enrollment-based safety, futility, and efficacy analyses prior to the planned interim analysis.
  • G
    Gabriele
    SABC Symposium 2021 (7-10 Dec 2021): Spotlight Session https://www.sabcs.org/Program/Daily-Schedule/Day-3

    Poster Session 4 Hall 1 (from 5.00 to 6.30 PM)

    Prof. Mittendorf will attend and discuss ‘Spotlight Poster Discussion 10 - Novel Immunotherapy Approaches’

    The website https://clinicaltrials.gov/ct2/show/NCT02297698 [Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-risk HER2+ Breast Cancer Patients (HER3+)] indicates ‘Estimation primary completion date is December 2021’ - Prof Peoples and Mittendorf work specifically on the trial (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7188712/)

    so, lets stay vigilant and monitor this!
  • C
    CS1001
    just bought 50k shares went through the dman dark pool
  • d
    david
    Will drug gps increasing lives for cancer patients by 300% patients living 21 months vs not treated gps dying at 5months when not treated with gps will this big story going forward?
  • d
    david
    Shorting and open and end of day each day to keep excitement down and shorts still down 150% this year. Desparate tactics because they know same institutions know. Shorts covering and institutions loading up 500% year. 12 institutions owned last year. Now 55. 54 of those institutions long, 1 short. That is conviction. Vangaurd now owns 1.4million of 15million shares. Why ????
  • R
    Real Immuno Investor 10
    GPS and GPS+ are innovative therapeutics and, with growing need for new treatments, GPS’ potential use as a monotherapy as well as in combination with our Envafolimab, an innovative subcutaneous PD-L1 antibody which we have just filed for marketing approval in China, could create significant value for both 3DMed and SELLAS. This partnership highly reflects the vision of 3DMed to help patients with cancer to live longer and better. We believe that the addition of the GPS and GPS+ assets to our clinical portfolio is an important synergistic and strategic step for 3DMed as this partnership will expand our company’s therapeutic area expertise and improve our competitiveness.”

    Under the financial terms of the agreement:

    SELLAS could potentially receive up to $202 million in license and milestone payments during the course of the collaboration, not including future royalties.

    SELLAS will receive payment of an upfront license fee of $7.5 million payable this quarter and is eligible to receive potential near-term milestones totaling up to an additional $8.0 million.

    SELLAS is entitled to receive royalties on Chinese sales on a tiered basis, dependent on sales levels, ranging from the high single to low double-digit percentage.

    3DMed will be responsible for the costs of all development and regulatory activity for Greater China.
    Torreya acted as a financial advisor to SELLAS.
    Bullish
  • D
    Dangremaus
    I'm going to buy more on Friday when I get my bonus. I truly believe this won't stay here too much longer. We had a 1 day delay in the Galena filing. We'll most likely get news before the end of the year on NPS.
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