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Iovance (IOVA) Doses First Patient in TIL Cancer Therapy Study
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Iovance Biotherapeutics (IOVA - Free Report) recently announced that the first patient had been dosed in phase I/II IOV-GM1-201 study, evaluating the company’s genetically modified, tumor-infiltrating lymphocyte (TIL) therapy, IOV-4001 in patients with previously-treated metastatic non-small cell lung cancer (NSCLC) or advanced melanoma.
The first patient in the study has also completed the safety observation period.
IOV-4001 leverages the gene-editing TALEN technology licensed by Iovance from Cellectis (CLLS - Free Report) to inactivate the gene coding for PD-1 protein, an important barrier that prevents T-cells from attacking cancer.
Iovance entered a research collaboration and exclusive worldwide licensing agreement with Cellectis in January 2020, allowing the former to use the latter’s Talen technology to develop TIL products to create potent cancer therapies.
In March, the FDA allowed an investigational new drug application (“IND”) to proceed with the clinical study of IOV-4001 for treating NSCLC and stage III or IV metastatic melanoma,
Post the IND approval, Iovance initiated the IOV-GM1-201 study in the first quarter of 2022 and recently dosed the first patient.
In cohort 1 of the study, Iovance intends to enroll patients with advanced melanoma who have progressed following anti-PD-1/PD-L1 blocking antibody therapy and patients with BRAF mutations after BRAF/MEK inhibitor therapy.
While in the second cohort of the study, the company will enroll patients with NSCLC who have received not more than three prior lines of therapy, with or without oncogene-driven mutations.
Presently, the company is actively enrolling adult patients in both cohorts of the study.
Shares of Iovance have declined 54.7% in the year-to-date period, compared to the industry’s fall of 27%.
Image Source: Zacks Investment Research
Without any marketed products in its portfolio, Iovance is highly dependent on its pipeline candidates’ successful development and potential commercialization. All of Iovance’s pipeline candidates target oncology indications, which have tremendous potential.
The lead candidate in Iovance’s pipeline is lifileucel, which is being developed as a monotherapy for treating metastatic melanoma and metastatic cervical cancer in two mid-stage studies. The company started a rolling submission of the biologics license application (BLA), seeking approval for lifileucel in August 2022 for melanoma. The company is also developing combination therapies of lifileucel for other oncology indications.
Acadia’s loss per share estimates for 2022 have narrowed from $1.30 to $1.29 in the past 30 days. The loss per share for 2023 has narrowed from 67 cents to 60 cents in the same time frame.
Earnings of Acadia beat estimates in two of the trailing four quarters while missing the same in the remaining two occasions. The average negative earnings surprise for STSA is 6.83%.
Aridis Pharmaceuticals' loss estimates for 2022 have remained steady at 23 cents over the past 30 days. The loss estimates for 2023 also remained steady at 53 cents per share in the same time frame.
ARDS surpassed earnings in three of the trailing four quarters, missing the same in one. The average negative earnings surprise for Aridis is 238.54%.
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Iovance (IOVA) Doses First Patient in TIL Cancer Therapy Study
Iovance Biotherapeutics (IOVA - Free Report) recently announced that the first patient had been dosed in phase I/II IOV-GM1-201 study, evaluating the company’s genetically modified, tumor-infiltrating lymphocyte (TIL) therapy, IOV-4001 in patients with previously-treated metastatic non-small cell lung cancer (NSCLC) or advanced melanoma.
The first patient in the study has also completed the safety observation period.
IOV-4001 leverages the gene-editing TALEN technology licensed by Iovance from Cellectis (CLLS - Free Report) to inactivate the gene coding for PD-1 protein, an important barrier that prevents T-cells from attacking cancer.
Iovance entered a research collaboration and exclusive worldwide licensing agreement with Cellectis in January 2020, allowing the former to use the latter’s Talen technology to develop TIL products to create potent cancer therapies.
In March, the FDA allowed an investigational new drug application (“IND”) to proceed with the clinical study of IOV-4001 for treating NSCLC and stage III or IV metastatic melanoma,
Post the IND approval, Iovance initiated the IOV-GM1-201 study in the first quarter of 2022 and recently dosed the first patient.
In cohort 1 of the study, Iovance intends to enroll patients with advanced melanoma who have progressed following anti-PD-1/PD-L1 blocking antibody therapy and patients with BRAF mutations after BRAF/MEK inhibitor therapy.
While in the second cohort of the study, the company will enroll patients with NSCLC who have received not more than three prior lines of therapy, with or without oncogene-driven mutations.
Presently, the company is actively enrolling adult patients in both cohorts of the study.
Shares of Iovance have declined 54.7% in the year-to-date period, compared to the industry’s fall of 27%.
Image Source: Zacks Investment Research
Without any marketed products in its portfolio, Iovance is highly dependent on its pipeline candidates’ successful development and potential commercialization. All of Iovance’s pipeline candidates target oncology indications, which have tremendous potential.
The lead candidate in Iovance’s pipeline is lifileucel, which is being developed as a monotherapy for treating metastatic melanoma and metastatic cervical cancer in two mid-stage studies. The company started a rolling submission of the biologics license application (BLA), seeking approval for lifileucel in August 2022 for melanoma. The company is also developing combination therapies of lifileucel for other oncology indications.
Iovance Biotherapeutics, Inc. Price
Iovance Biotherapeutics, Inc. price | Iovance Biotherapeutics, Inc. Quote
Zacks Rank and Stocks to Consider
Iovance currently holds a Zacks Rank #4 (Sell).
Some better-ranked stocks in the same sector include Acadia Pharmaceuticals (ACAD - Free Report) and Aridis Pharmaceuticals (ARDS - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Acadia’s loss per share estimates for 2022 have narrowed from $1.30 to $1.29 in the past 30 days. The loss per share for 2023 has narrowed from 67 cents to 60 cents in the same time frame.
Earnings of Acadia beat estimates in two of the trailing four quarters while missing the same in the remaining two occasions. The average negative earnings surprise for STSA is 6.83%.
Aridis Pharmaceuticals' loss estimates for 2022 have remained steady at 23 cents over the past 30 days. The loss estimates for 2023 also remained steady at 53 cents per share in the same time frame.
ARDS surpassed earnings in three of the trailing four quarters, missing the same in one. The average negative earnings surprise for Aridis is 238.54%.