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PDS Biotech (PDSB) Completes Enrollment for HPV Cancer Study
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PDS Biotech (PDSB - Free Report) stock rose almost 5% as the company completed enrollment in the immune checkpoint inhibitor naïve group of its VERSATILE-002 phase II study on pipeline candidate PDS0101 for treating adults with HPV16-positive unresectable recurrent or metastatic head and neck squamous cell carcinoma (“HNSCC”).
The mid-stage study, VERSATILE-002, is an open-label study being conducted across multiple centers. The study aims to evaluate the efficacy and safety of its lead candidate PDS0101, which is administered in combination with Keytruda (pembrolizumab). Keytruda is Merck’s (MRK - Free Report) anti-PD-1 therapy that helps immune cells kill cancer cells in different cancer indications.
The study aims to examine two patient groups. The first group comprises those who have not previously received an immune checkpoint inhibitor (ICI), referred to as the ICI naïve cohort. The second group includes those who have failed prior treatments, including ICI therapy, referred to as ICI refractory group.
Shares of PDS Biotech have fallen 44% year to date compared with the industry’s 7.8% decline.
Image Source: Zacks Investment Research
In December 2022, the company completed enrollment in the ICI refractory group. PDS0101, in combination with Keytruda, has been granted Fast Track designation in June 2022. The Fast Track designation is designed to expedite the review of drug candidates that could potentially treat serious or life-threatening conditions.
The company plans to initiate phase III study (VERSATILE-003) by the end of this year.
PDS0101 is also being evaluated in triple combination with M9241 (now PDS0301) and bintrafusp alfa for HPV-16 patients with HNSCC. The study is being led by National Cancer Institute.
The company is advancing its development candidates PDS0102, PDS0103 and PDS0104, targeting different cancer indications.
In the past 60 days, the Zacks Consensus Estimate for Allogene Therapeutics’ 2023 and 2024 loss per share has narrowed from $2.50 to $2.32 and $2.48 to $2.21, respectively. Shares of ALLO have declined 3.4% in the year-to-date period.
Allogene’s earnings beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 5.08%.
In the past 60 days, the Zacks Consensus Estimate for Halozyme Therapeutics’ 2024 earnings have increased from $3.75 per share to $3.76. Shares of HALO have plunged 41.5% in the year-to-date period.
Halozyme Therapeutics’ earnings beat estimates in three of the last four quarters and missed the mark once, the average surprise being 12.09%.
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PDS Biotech (PDSB) Completes Enrollment for HPV Cancer Study
PDS Biotech (PDSB - Free Report) stock rose almost 5% as the company completed enrollment in the immune checkpoint inhibitor naïve group of its VERSATILE-002 phase II study on pipeline candidate PDS0101 for treating adults with HPV16-positive unresectable recurrent or metastatic head and neck squamous cell carcinoma (“HNSCC”).
The mid-stage study, VERSATILE-002, is an open-label study being conducted across multiple centers. The study aims to evaluate the efficacy and safety of its lead candidate PDS0101, which is administered in combination with Keytruda (pembrolizumab). Keytruda is Merck’s (MRK - Free Report) anti-PD-1 therapy that helps immune cells kill cancer cells in different cancer indications.
The study aims to examine two patient groups. The first group comprises those who have not previously received an immune checkpoint inhibitor (ICI), referred to as the ICI naïve cohort. The second group includes those who have failed prior treatments, including ICI therapy, referred to as ICI refractory group.
Shares of PDS Biotech have fallen 44% year to date compared with the industry’s 7.8% decline.
Image Source: Zacks Investment Research
In December 2022, the company completed enrollment in the ICI refractory group. PDS0101, in combination with Keytruda, has been granted Fast Track designation in June 2022. The Fast Track designation is designed to expedite the review of drug candidates that could potentially treat serious or life-threatening conditions.
The company plans to initiate phase III study (VERSATILE-003) by the end of this year.
PDS0101 is also being evaluated in triple combination with M9241 (now PDS0301) and bintrafusp alfa for HPV-16 patients with HNSCC. The study is being led by National Cancer Institute.
The company is advancing its development candidates PDS0102, PDS0103 and PDS0104, targeting different cancer indications.
PDS Biotechnology Corporation Price and Consensus
PDS Biotechnology Corporation price-consensus-chart | PDS Biotechnology Corporation Quote
Zacks Rank and Stocks to Consider
Currently, PDS Biotech carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the same sector are Allogene Therapeutics (ALLO - Free Report) and Halozyme Therapeutics (HALO - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, the Zacks Consensus Estimate for Allogene Therapeutics’ 2023 and 2024 loss per share has narrowed from $2.50 to $2.32 and $2.48 to $2.21, respectively. Shares of ALLO have declined 3.4% in the year-to-date period.
Allogene’s earnings beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 5.08%.
In the past 60 days, the Zacks Consensus Estimate for Halozyme Therapeutics’ 2024 earnings have increased from $3.75 per share to $3.76. Shares of HALO have plunged 41.5% in the year-to-date period.
Halozyme Therapeutics’ earnings beat estimates in three of the last four quarters and missed the mark once, the average surprise being 12.09%.