Replimune Group REPL announced that it has submitted a biologics license application (BLA) to the FDA for its lead pipeline candidate, RP1, in combination with Bristol Myers’ BMY blockbuster immuno-oncology drug Opdivo (nivolumab) to treat adult patients with anti-PD1 failed advanced melanoma. The regulatory filing has been made under the FDA’s Accelerated Approval pathway. In response to the encouraging news, the stock rose 19.4% in the after-market hours on Thursday. The stock is also rising today during the pre-market hours.
RP1 is based on a proprietary strain of herpes simplex virus, engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response.
REPL’s RP1 BLA Submission Supported by Robust Study Data
Replimune’s BLA submission for RPI, in combination with Bristol Myers’ Opdivo, for the advanced melanoma indication is supported by positive top-line results from the primary analysis of the IGNYTE study. The study evaluated the combo drug in adult patients who experienced confirmed disease progression while being treated with at least eight weeks of prior anti-PD1 therapy.
Results showed that the overall response rate (ORR) was 33.6% by modified RECIST 1.1 criteria, the primary endpoint as defined in the protocol. ORR was 32.9% by RECIST 1.1 criteria, an additional analysis requested by the FDA. Responses from the baseline were highly durable, with all responses lasting more than six months and the median duration of response exceeding 35 months.
The combination continues to be well-tolerated, with mainly grade 1-2 constitutional-type side effects. Year to date, shares of Replimune have gained 31.1% against the industry’s 9.7% decline.
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FDA Grants Breakthrough Therapy Tag to RP1/Opdivo Combo
In the same press release, Replimune announced that the FDA has also granted the Breakthrough Therapy designation to RP1 in combination with Bristol Myers’ Opdivo for treating adult patients with advanced melanoma who have previously received an anti-PD1-containing regimen. This has also likely contributed to the stock price gain.
The FDA’s Breakthrough Therapy designation is a process that speeds up the development and review of drugs for serious or life-threatening conditions. This designation is granted when early clinical evidence suggests the drug may significantly improve over existing treatments on an important clinical measure. Drugs with this designation receive more intensive guidance and organizational support from senior FDA managers.
This designation by the FDA is also supported by positive safety and clinical activity observed in the anti-PD1 failed melanoma cohort of the IGNYTE clinical study.
REPL’s Key Pipeline Programs
Replimune is currently enrolling patients in its confirmatory phase III IGNYTE-3 study of RP1 in combination with Bristol Myers’ Opdivo for advanced melanoma patients who have progressed on anti-PD1 and anti-CTLA-4 therapy, or who are not eligible for anti-CTLA-4 treatment.
Apart from the melanoma indication, the company is studying the combo therapy in a separate cohort of the IGNYTE study for several non-melanoma skin cancer indications. The company is also evaluating RP1 as a monotherapy in solid organ transplant recipients with skin cancers. RPI, in combination with the skin cancer drug Libtayo, is also being evaluated for the treatment of cutaneous squamous cell carcinoma.
Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone, intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The company currently has three RPx product candidates in its portfolio, namely RP1, RP2 and RP3.
RP2 is being evaluated for the treatment of uveal melanoma and hepatocellular carcinoma (HCC). Replimune expects to initiate the registration-directed clinical study on RP2, combined with Opdivo, for metastatic uveal melanoma in patients who are immune checkpoints inhibitor-naïve in the first quarter of 2025. A mid-stage study evaluating RP2 in anti-PD1/PD-L1 progressed HCC of RP2, combined with atezolizumab and bevacizumab, is also expected to begin soon. The successful development of its candidates should be a significant boost for this clinical-stage biotechnology company.
Please note that BMY’s Opdivo is approved, both as a monotherapy and in combination with Yervoy, to treat a plethora of cancer indications in many countries, including the United States and the EU.
Replimune Group, Inc. Price and Consensus
Replimune Group, Inc. Price and Consensus
Replimune Group, Inc. price-consensus-chart | Replimune Group, Inc. Quote
REPL’s Zacks Rank & Stocks to Consider
Replimune currently carries a Zacks Rank #3 (Hold).
Some better-ranked pharma stocks are Allogene Therapeutics ALLO and Pfizer PFE, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, Allogene Therapeutics’ estimates for loss per share have narrowed from $1.40 to $1.35 for 2024, and that for 2025 has narrowed from $1.46 to $1.34. ALLO shares have lost 34.3% year to date.
Allogene Therapeutics’ earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 9.42%.
Over the past 60 days, Pfizer’s earnings estimates have risen from $2.62 to $2.91 per share for 2024, while that for 2025 has increased from $2.85 to $2.92. PFE shares have lost 12.7% year to date.
Pfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.
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