|Over a week ago|
Biotech Alert: Searches spiking for these stocks today » 11:0011/1611/16/22
OPNT, MOR, STOK, STSA, PDSB, INVVY, RHHBY
These names in the…
Biotech Alert: Searches spiking for these stocks today » 11:1411/1511/15/22
MOR, OPNT, PDSB, STSA, RHHBY, INVVY, XNCR
These names in the…
PDS Biotechnology price target raised to $16 from $15 at Chardan » 16:3011/1411/14/22
Chardan analyst Geulah…
Chardan analyst Geulah Livshits raised the firm's price target on PDS Biotechnology to $16 from $15 and keeps a Buy rating on the shares post the Q3 results.
Fly Intel: Pre-market Movers » 09:1411/1411/14/22
OPNT, LLY, BIIB, TSN, TSEM, MNDY, PDSB, MGIC, PNT, OTLY, GRCL, ROIV, PTN, INVVY, RHHBY
Check out this morning's…
PDS Biotechnology reports Q3 EPS (26c), consensus (28c) » 07:3911/1411/14/22
PDS Biotech's cash…
PDS Biotech's cash balance as of September 30, 2022 was approximately $71.6 M. "Q3 has been monumental for PDS Biotech, and we continue to make strides towards commercialization of our lead candidate, PDS0101," stated CEO Frank Bedu-Addo. "We've remained focused on progressing our four Phase 2 clinical programs, most recently, announcing data from our IMMUNOCERV trial in locally, advanced cervical cancer. 100% of patients had a clinical response with tumor shrinkage of over 60% at the midpoint evaluation, and 89% of patients had a complete response with no evidence of disease at day 170, when treated with a combination of PDS0101 and chemotherapy...And, with VERSATILE-002 in which PDS0101 is combined with KEYTRUDA, we are preparing for a registrational trial after our successful end-of-Phase 2 meeting with the FDA. To date, we have presented PDS0101 Phase 2 efficacy data in over 60 patients and safety data in over 100 patients." CFO Matthew Hill stated, "...This August, we increased our cash position by entering into a loan agreement with Horizon Technology Finance Corporation, where we received an initial tranche of $25M in term loans. This financing provides PDS Biotech with the financial resources and runway needed to prepare for a registrational trial for our lead candidate, PDS0101, and to advance our preclinical pipeline."
PDS Biotechnology announces updated clinical data from IMMUNOCERV trial » 07:2811/1411/14/22
PDS Biotechnology announced that updated clinical data from the ongoing IMMUNOCERV Phase 2 clinical trial was presented during a poster session on November 11 at the 37th Annual Meeting for the Society for Immunotherapy of Cancer. These data expand upon results detailed in the abstract submitted to SITC 2022 that was released to the public on November 7. The enhanced data was presented in the poster titled, "IMMUNOCERV, an Ongoing Phase II Trial Combining PDS0101, an HPV-Specific T Cell Immunotherapy, with Chemotherapy and Radiation for Treatment of Locally Advanced Cervical Cancers," which highlights key findings from The University of Texas MD Anderson Cancer Center-led IMMUNOCERV Phase 2 clinical trial. The study is investigating PDS0101 in combination with standard-of-care chemoradiotherapy. New data from the study presented at SITC 2022 include:9 of the 17 patients have now completed a day 170 post-treatment Positron Emission Tomography, Computed Tomography scan to assess the status of their cancer; 100% of patients treated with the combination of PDS0101 and CRT had a clinical response with tumor shrinkage greater than60% at mid-point evaluation by MRI; 89% of patients treated with the combination of PDS0101 and CRT demonstrated a complete response on day 170 by PET CT. One patient who received 3 of the 5 scheduled doses of PDS0101 showed signs of residual disease; 1-year disease-free survival and 1-year overall survival of 89% (8/9) in patients treated with the combination of PDS0101 and CRT. In addition, a second poster titled "Immune Correlates Associated with Clinical Benefit in Patients with Checkpoint Refractory HPV-Associated Malignancies Treated with Triple Combination Immunotherapy," reported data from the Phase 2 triple combination trial. The study is investigating PDS0101 in combination with two investigational immune-modulating agents: M9241, a tumor-targeting IL-12, and bintrafusp alfa, a bifunctional checkpoint inhibitor. Highlights included: A more than two-fold increase in HPV16-specific T cells in the blood of 79% of the evaluated patients; Increases on day 15 in several monitored immune correlates, such as granzyme B and interferon-gamma, were associated with a clinical response; Immune responses were associated with increases in natural killer cells, soluble granzyme B, IFN-gamma, tumor necrosis factor-alpha; These immunogenicity findings highlight the potential role of the combination in altering immune suppressive forces.
PDS Biotechnology announces presentation on preliminary PDS0101 data » 08:2911/0711/07/22
PDS Biotechnology announced upcoming poster presentations of clinical data from two Phase 2 clinical trials of PDS0101 at the 37th Annual Meeting for the Society for Immunotherapy of Cancer, SITC 2022, being held November 8-12, 2022 in Boston. The first abstract accepted for presentation, titled, "IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation for treatment of locally advanced cervical cancers," highlights data from IMMUNOCERV Phase 2 clinical trial. The study is investigating PDS0101 in combination with standard-of-care chemoradiotherapy for the potential treatment of cervical cancer in patients with large tumors over 5cm in size and/or cancer that has spread to the lymph nodes. Highlights from the study being presented at SITC 2022 include: 17 patients have been enrolled in the trial; 8 of the 17 patients had completed a Day 170 post-treatment Positron Emission Tomography, Computed Tomography scan to assess the status of the cancer; 87.5% of patients treated with the combination of PDS0101 and CRT demonstrated a complete response on Day 170 by PET CT. One patient who received 3 of the 5 scheduled doses of PDS0101 showed signs of residual disease; In comparison, 74.1% of locally advanced patients who received CRT alone and were monitored at The University of Texas MD Anderson Cancer Center on a prospective protocol independent of IMMUNOCERV had a CR on PET CT at Day 170; The 1-year overall survival is 100% in patients treated with the combination of PDS0101 and CRT; The observed 1-year disease-free survival rate for IMMUNOCERV patients is 87.5%; Patients treated with the combination of PDS0101 and CRT had a 71% increase in multi-cytokine-inducing killer T cells within the tumors from baseline to end of treatment. This increase in activated T cells was not seen in patients receiving standard-of-care CRT. Toxicity of PDS0101 was limited to low-grade local injection site reactions. The second abstract, titled "Immune Correlates Associated with Clinical Benefit in Patients with Checkpoint Refractory HPV-Associated Malignancies Treated with Triple Combination Immunotherapy," reports data from the Phase 2 triple combination trial. The study is investigating PDS0101 in combination with two investigational immune-modulating agents: M9241, a tumor-targeting IL-12, and bintrafusp alfa, a bifunctional checkpoint inhibitor.
|Over a month ago|
PDS Biotechnology initiated with Buy, $10 target at B. Riley » 07:4511/0111/01/22
B. Riley analyst Kalpit…
B. Riley analyst Kalpit Patel initiated coverage of PDS Biotechnology with a Buy rating and $10 price target. The company's lead asset, PDS0101, is a lipid nanoparticle-based cancer vaccine that utilizes HPV16 antigens to trigger an immune response against HPV16-positive tumors, Patel tells investors in a research note. While the programs are in the early stages of development, PDS's initial data point toward PDS0101 producing a synergistic anti-tumor response in both doublet and triplet combinations, says the analyst.
PDS Biotechnology initiated with a Buy at B. Riley » 04:5211/0111/01/22
B. Riley initiated…
B. Riley initiated coverage of PDS Biotechnology with a Buy rating and $10 price target.
PDS Biotechnology provides highlights from Head, Neck Cancer KOL rountable » 08:2210/2710/27/22
PDS Biotechnology provided highlights from its Head and Neck Cancer Key Opinion Leader, KOL, Roundtable. "We are very honored to have had the opportunity to conduct a KOL Roundtable featuring such an accomplished panel of experts in head and neck cancer research and treatment," said Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. "As we advance the development of PDS0101 in multiple Phase 2 clinical trials targeting HPV-positive cancers, including recurrent and/or metastatic head and neck cancer, we are continually reminded of the need for improved treatment options for this devastating disease. On behalf of PDS Biotech, I would like to personally thank Drs. Gross, Price, and Weiss for discussing these important opportunities and where HPV-targeted immunotherapies, such as PDS0101, may help to improve the lives of head and neck cancer patients."