Celsion advances Phase II advanced ovarian cancer trial

Celsion Corporation (NASDAQ:CLSN) announced that it has randomized the first two patients in the Phase II portion of its OVATION 2 study. The company expects the enrollment to be completed by the third quarter of 2021. It is likely that the trial will involve up to 118 patients. The study is an open label trial and will allow the company to provide updates on a regular basis.

The OVATION 2 Study is an open-label, 1-to-1 randomized trial. It is 80% powered to show the equivalent of a 33% improvement in progression-free survival, which is the primary endpoint of the trial when the treatment arm is compared with the control arm. The trial evaluates GEN-1 with standard-of-care neoadjuvant chemotherapy in patients with newly diagnosed with Stage III/IV ovarian cancer.

The OVATION 2 study will use NACT, which is deigned to shrink the cancer to facilitate optimal surgical removal after three cycles of chemotherapy. The patients will undergo interval debulking surgery after NACT. Further, they will be given three adjuvant cycles of chemotherapy and up to nine additional weekly GEN-1 treatments. The main aim of this regimen is to improve overall survival by delaying progression.

GEN-1 has been designed using TheraPlas, which is a proprietary delivery system platform of Celsion. The delivery platform incorporates synthetic non-viral nanoparticles. It is an interleukin-12 (IL-12) DNA plasmid vector and is connected to a non-viral nanoparticle delivery system, facilitating cell transfection and consequent constant and localized secretion of the IL-12 protein.

In March 2020, the company had reported that the European Medicines Agency Committee for Orphan Medicinal Products had recommended orphan medicinal product designation for GEN-1 for treating ovarian cancer. Dr. Nicolas Borys, Celsion's Chief Medical Officer said,

"The results suggested that GEN-1 nearly doubled progression-free survival (PFS) in these patients. These findings are not statistically significant, however, due to the small number of patients, but nonetheless are encouraging and supportive of our current Phase II study."

GEN-1 works by using IL-12 protein, which is one of the most active cytokines for the induction of potent anti-cancer immunity. It acts through introducing T-lymphocyte and natural killer cell proliferation. The data collected from Phase I trial of GEN-1 given as monotherapy or a combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer showed positive safety profile. The company has competed a Phase 1b trial as well with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer.

Celsion is a fully integrated pharma company and mainly focuses on developing cancer treatments such as immunotherapies, RNA- or DNA-based therapies or directed chemotherapies. Its lead program is ThermoDox is a proprietary heat-activated liposomal encapsulation of doxorubicin. The program is currently in Phase III development for treating primary liver cancer. Its another lead program is GEN-1, which is a DNA-based immunotherapy for the localized treatment of late stage ovarian cancer. The company also has two platform technologies for developing novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies.

Zentalis Pharmaceuticals Inc. (ZNTL) announced entering into a clinical collaboration with Eli Lilly and Company (LLY). Under this new deal, Zentalis will assess the combination of ZN-c5 with Verzenio in patients with ER+/HER2- advanced breast cancer. The former product belongs to Zentalis and is an oral selective estrogen receptor degrader (SERD) product candidate, while the latter is an CDK4 and 6 inhibitor and is owned by Eli Lilly.

The newly inked deal is a non-exclusive collaboration. Under the terms, Zentalis will have the responsibility for carrying out the study by providing all required doses of abemaciclib. The company will retain full ownership of ZN-c5. Dr. Anthony Sun of Zentalis said,

"Among its approved indications, abemaciclib is prescribed in combination with hormonal therapy, including fulvestrant, the only FDA-approved SERD, to treat patients with ER+/HER2- advanced or metastatic breast cancer following endocrine therapy."

He added that ZN-c5 aims to overcome the shortcomings of current hormonal therapies.

ZN-c5, is an oral, small molecule selective estrogen receptor degrader. It is currently being evaluated for treating ER+/HER2- advanced or metastatic breast cancer and is a part of a Phase 1/2 clinical trial of ZN-c5 in patients with ER+/HER2- advanced or metastatic breast cancer. Through a clinical collaboration with Pfizer (NYSE:PFE), it is undergoing evaluation as a monotherapy and in combination with Palbociclib.

Verzenio is an inhibitor of cyclin-dependent kinases CDK4 and 6 and is activated by attaching to D-cyclins. It is approved by the FDA and is indicated for treating HR+/HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor for postmenopausal women as initial endocrine-based therapy. It may also be used in combination with other therapies.

Zentalis is a clinical-stage biopharmaceutical company. It is mainly invested in developing small molecule therapeutics targeting fundamental biological pathways of cancers. The company has robust developmental pipeline with product candidates such as ZN-c5, ZN-c4 and ZN-c3.

Aerie Pharmaceuticals (AERI) reported positive data from its Phase 2 clinical trial of AR-1105. The trial evaluated two formulations of the drug candidate in patients with macular edema associated with retinal vein occlusion. The trial did not report any new safety signals.

The Phase 2 clinical trial consisted of 49 patients spread across 19 sites in the United States, completing the study. The trial was conducted in two stages. The initial safety stage involved five participants who were given CF-1, delivering a 340g dose of dexamethasone in a single intravitreal injection. The second stage had 44 patients, randomized 1:1 to be administered either CF-1 or CF-2.

The primary endpoint of the trial was to assess two formulations of AR-1105 with different steroid release profiles. Vicente Anido, Jr. of Aerie said,

"We are very pleased with the AR-1105 clinical trial results, our first successful clinical trial from our retina program. The profiles of the different cohorts demonstrate the flexibility of our PRINT sustained release technology platform in enhancing the management and durability of treatment effects."

The company added that it does not plan to start any new clinical trial for the drug candidate until the second half of 2021.

AR-1105 is a bio-erodible implant, aiming to provide sustained release of steroid dexamethasone over a six-month period. It is administered through intravitreal injection. It is a subject of various clinical trials for different indications.

Aerie is an ophthalmic pharmaceutical company and aims to develop therapies for ocular surface diseases, retinal diseases, and open-angle glaucoma. Its flagship product Rhopressa is an FDA-approved treatment for reducing increased intraocular pressure in open-angle glaucoma or ocular hypertension patients. Its another product Rocklatan is the first and only fixed-dose combination of Rhopressa and the widely-prescribed PGA (prostaglandin analog) latanoprost and aims to decrease elevated IOP in patients with open-angle glaucoma or ocular hypertension.

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Celsion Trial Progress, And Other News: The Good, Bad And Ugly Of Biopharma - Seeking Alpha