On April 20, 2017 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies and cancer vaccines, reported that the first patient has been dosed in a Phase 1/2 clinical trial of its anti-PD-1 antibody, AGEN2034.

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The open-label, dose-escalation portion of the trial is designed to evaluate the safety and pharmacological activity of AGEN2034 in patients with advanced solid tumors. Part 2 of the trial is planned to evaluate the recommended dose of AGEN2034 in patients with second line cervical cancer. Preliminary safety and efficacy data are expected to be available within the next 9-12 months.

"The entry of our PD-1 antagonist into the clinic is key to our strategy to pursue combination therapies," said Garo H. Armen, Ph.D. Chairman and CEO of Agenus. "PD-1 is a clinically validated target, and to combine it with our CTLA-4 directed antibody is the backbone of Agenus’ combination strategy. We also intend to pursue combinations of PD-1 and CTLA-4 antibodies with our novel portfolio of other checkpoint antibodies as well as our neoantigen cancer vaccines."

AGEN2034 is an antagonist antibody targeting programmed death 1, or PD-1. PD-1 is an inhibitory receptor expressed on activated T cells. When this receptor interacts with PD-L1 or PD-L2 molecules expressed on cancer cells, the T cells’ ability to kill cancer cells is neutralized. Therefore, blocking PD-1 with AGEN2034 may allow T cells to recognize and kill tumor cells.

"Immune checkpoint antibodies targeting PD-1/PD-L1 and CTLA-4 have become the mainstay of I-O combinations," said Jean-Marie Cuillerot, M.D., Chief Medical Officer of Agenus. "Co-targeting the PD-1/PD-L1 axis in combination with CTLA-4 has shown a near doubling of clinical efficacy in certain indications. We believe our strategy in pursuing virally-induced cancers presents a rapid path to BLA for our PD-1 and CTLA-4 antagonists. In addition, combination approaches involving our vaccines offer a unique opportunity for differentiation in patients who are unresponsive to checkpoint directed monotherapies."

Additional information about the trial can be found here.

AGEN2034 was originally developed under a Collaborative Research and Development Agreement between Ludwig Cancer Research, 4-Antibody AG and Recepta Biopharma S.A.

On April 20, 2017 Nektar Therapeutics (Nasdaq: NKTR) reported that it will host an analyst and investor event with clinical investigators on Saturday, June 3, 2017 at 6:00 pm CDT in Chicago, IL during the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting. The event will include a presentation and discussion of updated clinical data for the company’s CD122-biased agonist, NKTR-214.

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Data from two studies of NKTR-214 will be reviewed at the event, including the Phase 1 dose-escalation study of NKTR-214 in combination with nivolumab in patients with melanoma, renal cell carcinoma and non-small cell lung cancer (PIVOT-02); and the Phase 1 study of monotherapy NKTR-214 in patients with advanced solid tumors (EXCEL).

Presenters will include Dr. Adi Diab, Assistant Professor, Melanoma Medical Oncology at the University of Texas MD Anderson Cancer Center, Dr. Nizar Tannir, Professor, Genitourinary Medical Oncology at the University of Texas MD Anderson Cancer Center and Dr. Michael Hurwitz, Assistant Professor of Medicine (Medical Oncology) at Yale Cancer Center.

NKTR-214 is an investigational immuno-stimulatory therapy designed to expand specific cancer-fighting CD8+ effector T cells and natural killer (NK) cells directly in the tumor micro-environment and increase expression of PD-1 on these immune cells. NKTR-214 targets CD122 specific receptors found on the surface of these cancer-fighting immune cells in order to stimulate their proliferation. In preclinical studies, treatment with NKTR-214 resulted in a rapid expansion of these cells and mobilization into the tumor micro-environment.1,2 NKTR-214 has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines.

Investors and analysts are invited to listen to a live audio webcast of the presentation at View Source The event will also be available for replay for two weeks on the company’s website, www.nektar.com.

For those interested in attending this event in person, please contact [email protected]. Please RSVP in advance as seating is limited.

On April 20, 2017 Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported that the Markey Cancer Center at the University of Kentucky has enrolled the first patient into a new phase 1 study of CA4P in combination with everolimus for the treatment of neuroendocrine tumors (Press release, Mateon Therapeutics, APR 20, 2017, View Source [SID1234518638]).

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"The combination of CA4P and everolimus has the potential to decrease the ability of tumor cells to recover between CA4P treatment cycles," stated Lowell B. Anthony, M.D., Professor of Medicine and Chief, Division of Medical Oncology, Markey Cancer Center, University of Kentucky. "This is the first trial testing this hypothesis in neuroendocrine tumors – with CA4P disrupting the existing tumor blood supply and everolimus preventing a new tumor blood supply from re-forming. Our findings from this trial should lead to a larger clinical study once we have identified the optimal dose and schedule for the combination of these two agents."

Study MCC-2016-088 is designed to demonstrate whether the addition of CA4P to everolimus may improve tumor control without additional toxicity. Everolimus has been approved by the U.S. Food and Drug Administration for the treatment of advanced pancreatic neuroendocrine tumors and progressive gastrointestinal neuroendocrine tumors, among other indications, and is marketed by Novartis under the tradename AFINITOR. Mateon has previously demonstrated initial evidence of efficacy for CA4P in patients with neuroendocrine tumors when CA4P was provided as a single agent.

Study MCC-2016-088 is being sponsored, funded, and conducted by the Markey Cancer Center, with Mateon providing the investigational drug. The study is designed as a single center, open label, phase 1 clinical trial for patients with grade 1-3 gastroenteropancreatic neuroendocrine tumors. In the first part of the study, up to 15 patients will be treated with everolimus in combination with two different dosing regimens of CA4P to establish appropriate CA4P dosing levels and evaluate the safety of the drug combination. The second part of the study is designed to enroll 15 additional patients for assessment of additional safety and efficacy data. Patients enrolled in MCC-2016-088 will be treated with CA4P and everolimus for 12 weeks.

For further information about the clinical trial, please visit www.clinicaltrials.gov, Study NCT03014297.

Mateon has received orphan drug designation for CA4P for the treatment of neuroendocrine tumors from both the U.S. Food and Drug Administration and from the European Medicines Agency.

On April 20, 2017 Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, reported an update on its OVATION Study, a Phase Ib dose escalating clinical trial combining GEN-1, the Company’s DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced (stage III/IV) ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery (Press release, Celsion, APR 20, 2017, View Source [SID1234518637]). GEN-1 is an IL-12 DNA plasmid vector formulated as a nanoparticle in a non-viral delivery system to cause the sustained local production and secretion of the Interleukin-12 (IL-12) protein loco-regionally to the tumor site.

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The Company announced that an abstract for the OVATION Study has been accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2017 Annual Meeting, which will take place from June 2-6 at McCormick Place in Chicago, IL.

The abstract, entitled "Phase 1 study of the safety and activity of formulated IL-12 plasmid administered intraperitoneally in combination with neoadjuvant chemotherapy in patients with newly diagnosed advanced stage ovarian cancer," will be presented in a poster presentation session on Saturday, June 3rd from 1:15 PM to 4:45 PM by Dr. Premal H. Thaker, Associate Professor, Obstetrics and Gynecology Division of Gynecologic Oncology, Washington University in St. Louis School of Medicine.
The presentation will summarize clinical findings and translational data from all available patients treated in the trial. The translational data will provide further insight into GEN-1’s mechanism of action through the evaluation of dose-related changes in the tumor and peritoneal immune cell population, as well as through the peritoneal cytokine levels.

Celsion has previously reported highly encouraging interim data from the first twelve patients who have completed treatment in the OVATION Study. GEN-1 plus standard chemotherapy produced excellent results, with no dose limiting toxicities and promising dose dependent efficacy signals which appear to correlate well with successful surgical outcomes as summarized below:
Of the twelve patients treated, one patient demonstrated a complete response, eight (8) patients demonstrated a partial response and three (3) patients demonstrated stable disease, as measured by RECIST criteria. This translates to a 100% disease control rate ("DCR") and a 75% objective response rate ("ORR").
Eleven patients had successful resections of their tumors, with six (6) patients (55%) having an R0 resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed, and four (4) patients (36%) having a R1 resection, indicating microscopic residual tumor.
One patient demonstrated a pathological complete response (pCR). pCRs are typically seen in less than 7% of patients receiving neoadjuvant chemotherapy followed by surgical resection, and have been associated with a median overall survival (OS) of 72 months, which is more than three years longer than those who do not experience a pCR.

All patients experienced a dramatic decrease in their CA-125 protein levels as of their most recent study visit. CA-125 is used to monitor certain cancers during and after treatment. CA-125 is present in greater concentrations in ovarian cancer cells than in other cells.

"We have now completed enrollment of our OVATION Study in newly diagnosed ovarian cancer patients, one goal of which is to determine GEN-1’s activity in combination with standard chemotherapy. The previously reported remarkable, unexpected surgical outcomes among all patients completing the prescribed eight weekly treatments reinforce our confidence in the promise of GEN-1’s ability to work safely and effectively in advanced ovarian cancer," said Michael H. Tardugno, Celsion’s chairman, president and CEO. "We are looking forward to Dr. Thaker’s report of comprehensive findings at the upcoming ASCO (Free ASCO Whitepaper) meeting and to learning more about the utility of our gene-based immunotherapy approach as this important study matures."

OVATION Study Design
The Phase Ib trial will evaluate weekly intraperitoneal dosing of GEN-1 in combination with neoadjuvant chemotherapy, the standard of care for patients newly diagnosed with ovarian cancer. Concurrently with neoadjuvant chemotherapy, enrolled patients will receive escalating weekly doses of GEN-1, from levels beginning at 36mg/m², to 47mg/m², 61mg/m² and 79mg/m² weekly for 8 treatments in total, with interval debulking surgery to follow. The regimen will primarily be evaluated for its safety and tolerability.

About GEN-1 Immunotherapy
GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company has previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy in patients with peritoneally metastasized ovarian cancer, and recently completed a Phase Ib trial of GEN-1 in combination with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer.