On December 13, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, reported that investigators shared new positive data from the company’s ongoing DeCidE1 (DPX-Survivac with low dose CyclophosphamIDe and Epacadostat) clinical trial at the 2018 ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress (Press release, IMV, DEC 13, 2018, View Source [SID1234534100]). The phase 1b/2 study is evaluating the safety and efficacy of the combination of IMV’s lead candidate DPX-Survivac, low dose cyclophosphamide, and 100 mg or 300mg of Incyte’s IDO1 enzyme inhibitor epacadostat in patients with advanced recurrent ovarian cancer.

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In a poster presentation, Oliver Dorigo, M.D., Ph.D., Associate Professor of Obstetrics and Gynecology (Oncology), Stanford University Medical Center, who served as the trial’s lead investigator and author on the poster, shared topline safety results from 53 enrolled patients and efficacy data from the 32 participants evaluable for immune-related and clinical responses, as well as blood sample and tumor biopsy analyses.

Key findings include:

Evidence of a clinical marker based on Baseline Tumor Burden (BTB), a measure of tumor size predictive of patient response to DPX-Survivac

37.5% (12/32) of evaluable study subjects began treatment with a non-bulky disease defined as BTB < 5 cm.

73% (8/11) of tumor regressions and 80% of clinical responses (4/5) observed in subset of patients with BTB < 5 cm.

Responders showing prolonged duration of clinical benefits reaching up to more than two years, surpassing the progression-free interval from their previous chemotherapy treatment

Robust systemic survivin-specific T cell responses and evidence of survivin-specific T cells tumor infiltration correlated with clinical benefits

100% of durable clinical responses correlated with T cell infiltration

Epacadostat triggered inhibition of the conversion of tryptophan into kynurenine that was dose dependent

Cohort demographics were balanced and the combination yielded a tolerable safety profile

"This data set provided meaningful information on how the potential benefits of DPX-Survivac may best be translated to patients, including the connection between tumor regressions and T cell infiltration in the tumor microenvironment," said Frederic Ors, Chief Executive Officer at IMV. "We believe that DPX-Survivac is the first targeted T cell therapy to induce significant tumor regressions in challenging tumors such as those seen in ovarian cancer. We remain committed to developing DPX-Survivac for patients with significant unmet medical needs, and look forward to our upcoming discussions with regulatory authorities in the USA, Canada and Europe."

Updated Clinical Response and Safety Data for DeCidE1

At the time of data cut-off, 53 patients were enrolled in the phase 1b clinical trial, including 14 from the 100mg epacadostat dosing cohort and 39 from 300mg epacadostat cohort. Based on 300 mg cohort results, IMV and Incyte agreed to stop dosing patients with epacadostat before completion of the study. Patients who completed at least one CT scan, as required per the trial protocol, were evaluable for response analysis.

71% of patients were evaluable for responses in the 100mg cohort and 56% in the 300mg dose cohort. At time of data cut-off, 8 participants remained on treatment and were being evaluated for clinical responses.

(1) Partial Response (PR) is defined as ≥30% decrease in sum of target lesions
(2) Stable Disease (SD) is defined as  30% decrease and ≤ 20% increase in sum of target tumor lesions
(3) Disease Control Rate (DCR) refers to the total number of patients achieving complete response, partial response, and stable disease.

"Recurrent ovarian cancer treatment remains a significant unmet need and represents a challenge for immunotherapy," said Gabriela Nicola Rosu, M.D., Chief Medical Officer at IMV Inc. "What we have showed here is that the dynamic interaction between the survivin specific T cells induced by DPX-Survivac and the tumor size and its growth kinetics can be a determinant of clinical responses. We

believe that this information is significant for the future development of DPX-Survivac and may indicate a pathway to more efficacious immunotherapeutic treatments for patients."

Poster Session Details

Session Title: Poster Display Session
Location: Foyer, Geneva Palexpo
Poster ID: 87P; Abstract ID 262
Abstract Title: "New clinical data from the DeCidE1 trial: Results on DPX-Survivac, low dose cyclophosphamide (CPA), and epacadostat (INCB024360) in subjects with advanced recurrent epithelial ovarian cancer"
Date: December 14 – 15, 2018
Time: 12:30 p.m. – 13:00 p.m. (local time)
Presenter: Dr. Oliver Dorigo, DeCidE1 Clinical Investigator and Lead Author
Investor Call Information

IMV will host a webcast and conference call on Thursday, December 13 at 8:30 a.m. ET to provide an overview of its ESMO (Free ESMO Whitepaper)-IO presentation.

Dial-in: (844) 461-9932 (U.S. and Canada) or (636) 812-6632 (International)

Conference ID#: 6192578

A live audio webcast and presentation will be available via this link, or by pasting this URL in an internet browser: View Source

About the DeCidE1 Phase 1b/2 Trial

The phase 1b/2 trial is an open label, uncontrolled, safety and efficacy study for individuals with advanced, platinum-sensitive and resistant ovarian cancer. The phase 1b portion has two dosing cohorts:

100mg of epacadostat twice daily (BID), with DPX-Survivac and low dose cyclophosphamide, and

300mg of epacadostat BID in combination with DPX-Survivac and low dose cyclophosphamide.

The primary endpoints are to determine:

The safety profile of the combination regimen,

Induction of systemic survivin specific T cells in the blood, and

Induction of T cell infiltration into tumors.

Secondary endpoints include objective response rate (ORR) using modified RECIST v1.1 criteria; duration of response based on modified RECIST criteria; time to progression (TTP); and overall survival (OS.)

IMV conducted the phase 1b/2 study in collaboration with Incyte Corporation. IMV recently announced that, based on the 300 mg cohort results, IMV and Incyte have agreed to stop dosing patients in this trial with epacadostat. IMV is continuing the phase 2 portion of the trial as a monotherapy study evaluating DPX-Survivac in the advanced and recurrent ovarian cancer subpopulation with BTB < 5 cm.

IMV intends to report updated results from the phase 1b when data from at least 16 evaluable participants in the second dosing cohort are available. Investigators plan to submit final results for publication in a peer-reviewed journal.

About Ovarian Cancer

According to the American Cancer Society (ACS), ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. Often diagnosed in its advanced stages, about 21,290 women received a new diagnosis of ovarian cancer in 2015; approximately 14,180 women would die from the disease, according to ACS estimates.

Ovarian cancer has a significant impact globally as well. The World Cancer Research Fund reports that ovarian cancer is the seventh most common cancer in women worldwide (18 most common cancer overall), with 239,000 new cases diagnosed in 2012.

On Decembber 13, 2018 Incyte Corporation (Nasdaq:INCY) reported that it will present at the following investor conferences during the month of January (Press release, Incyte, DEC 13, 2018, View Source [SID1234532052]):

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Goldman Sachs 11th Annual Healthcare CEOs Unscripted: A View from the Top Conference on Thursday, January 3, 2019 at 11:00 am (EST) in New York; and
J. P. Morgan 37th Annual Healthcare Conference on Monday, January 7, 2019 at 1:30 pm (PST) in San Francisco
The presentations will be webcast live and can be accessed at www.incyte.com in the Investors section under "Events and Presentations." Investors interested in listening to the live webcast should log on before the start time in order to download any software required.

On December 13, 2018 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that the European Union’s (EU) European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending an additional indication to include rucaparib as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy (Press release, Clovis Oncology, DEC 13, 2018, View Source [SID1234532054]). EC approval is anticipated in the first quarter of 2019.

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Once approved, Rubraca’s indication will expand beyond its initial Marketing Authorization in Europe granted in May 2018 for adult patients with platinum-sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

The CHMP’s positive opinion for this additional indication was based on data from the phase 3 ARIEL3 clinical trial, which found that rucaparib significantly improved progression-free survival in all ovarian cancer patient populations studied.i

"The CHMP recommendation represents an important step forward for women with recurrent ovarian cancer, for whom additional treatment options are needed. The ARIEL3 trial demonstrated rucaparib to be effective across all patient types, regardless of their BRCA mutation status, and is the only PARP-inhibitor trial in which independent radiological review reported a median progression-free survival of more than one year across the entire population studied," said Professor Jonathan Ledermann, MD, Professor of Medical Oncology, UCL Cancer Institute and UCL Hospitals, London, global Principal Investigator for non-US sites in the ARIEL3 study. "The meaningful efficacy data and tolerable safety profile offers women diagnosed with relapsed ovarian cancer a new therapy option."

Ovarian cancer is the sixth deadliest cancer amongst women in Europe, where more than 65,000 women are diagnosed annually.ii Ovarian cancer is challenging to treat, and most women will relapse after surgery and chemotherapy. The 80 to 85 percent of women diagnosed in the later stages of the disease (III and IV) have particularly poor outcomes.iii

"We are pleased that the CHMP recognizes the clinical relevance of rucaparib in the maintenance treatment setting for European women with relapsed platinum-sensitive ovarian cancer," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "This brings us a step closer to delivering on our commitment to ensure that women who may benefit from treatment with rucaparib have the opportunity to do so. We seek to make ovarian cancer an actively managed disease, rather than one that is treated and then wait for recurrence. Rucaparib’s clinical benefit in the maintenance treatment setting is supported by the pivotal ARIEL3 study, which showed that Rubraca provided benefit in all ovarian cancer patient populations studied."

About the ARIEL3 Pivotal Study

ARIEL3 is a double-blind, placebo-controlled trial of rucaparib that enrolled 564 women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer. The primary efficacy analysis evaluated three prospectively defined molecular sub-groups in a step-down manner: 1) BRCA mutant (BRCAmut+); 2) HRD positive (HRD+) inclusive of BRCA mutant; and finally, 3) the intent-to-treat population, or all patients treated in ARIEL3. The study achieved its primary endpoint of improved PFS by investigator review in each of three populations.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian, metastatic castration-resistant prostate, and bladder cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

In October 2018, Rubraca was granted Breakthrough Therapy Designation by the FDA as monotherapy treatment of adult patients with BRCA1/2-mutated mCRPC who have received at least one prior androgen receptor (AR)-directed therapy and taxane-based chemotherapy.

Clovis holds worldwide rights for Rubraca. Rubraca is an unlicensed medical product outside of the U.S. and Europe.

Rucaparib EU Authorized Use

Rucaparib is indicated for adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Click here to access the current Summary of Product Characteristics. Healthcare professionals should report any suspected adverse reactions via their national reporting systems.

Rucaparib U.S. FDA Approved Indications and Important Safety Information

Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Rubraca is indicated as monotherapy for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Select Important Safety Information

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur uncommonly in patients treated with Rubraca and are potentially fatal adverse reactions. In approximately 1100 treated patients, MDS/AML occurred in 12 patients (1.1%), including those in long term follow-up. Of these, 5 occurred during treatment or during the 28-day safety follow-up (0.5%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 28 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents.

Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1).

Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose (see Dosage and Administration (2.2) in full Prescribing Information) and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

Based on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca.

Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%), and neutropenia (20%).

Most common laboratory abnormalities in ARIEL3 (≥ 25%; Grade 1-4) were increase in creatinine (98%), decrease in hemoglobin (88%), increase in cholesterol (84%), increase in alanine aminotransferase (ALT) (73%), increase in aspartate aminotransferase (AST) (61%), decrease in platelets (44%), decrease in leukocytes (44%), decrease in neutrophils (38%), increase in alkaline phosphatase (37%), and decrease in lymphocytes (29%).

Most common adverse reactions in Study 10 and ARIEL2 (≥ 20%; Grade 1-4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%), and thrombocytopenia (21%).

Most common laboratory abnormalities in Study 10 and ARIEL2 (≥ 35%; Grade 1-4) were increase in creatinine (92%), increase in alanine aminotransferase (ALT) (74%), increase in aspartate aminotransferase (AST) (73%), decrease in hemoglobin (67%), decrease in lymphocytes (45%), increase in cholesterol (40%), decrease in platelets (39%), and decrease in absolute neutrophil count (35%).

Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the last dose.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch. You may also report side effects to Clovis Oncology, Inc. at 1-844-258-7662.

On December 12, 2018 Checkmate Pharmaceuticals Inc., a clinical stage biopharmaceutical company focused upon activation of innate immunity to treat advanced cancer, reported that it has appointed Barry Labinger as President and CEO. Arthur M. Krieg, MD, Checkmate’s founder and current President and CEO, will assume the newly-created role of Chief Scientific Officer (Press release, Checkmate Pharmaceuticals, DEC 12, 2018, View Source [SID1234532035]). Both Mr. Labinger and Dr. Krieg will serve on Checkmate’s Board of Directors.

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Checkmate also announced the completion of a $22 million financing led by a new investor, Decheng Capital. The financing also included participation from existing investors, Sofinnova, venBio, and F-Prime.

"Checkmate’s encouraging early clinical data provide a strong foundation for its further growth as a leading cancer immunotherapy company with broad potential. Barry’s deep experience in oncology drug development and commercialization, along with this additional funding, will support Checkmate’s further progress," commented Mike Powell, Chairman of the Board of Checkmate, and General Partner, Sofinnova Ventures. "Art has successfully led the company to this critical stage in its growth, including this planned leadership transition. We are delighted to have Barry as CEO and Art as CSO. We are confident that they will successfully guide Checkmate to its next stage of evolution," continued Dr. Powell.

Mr. Barry Labinger brings to Checkmate nearly three decades of pharmaceutical and biotech industry experience, most recently serving as President, CEO, and Director of Biothera Pharmaceuticals, a clinical stage cancer immunotherapy company focused on innate immune activation. Prior to Biothera, he was Executive Vice President and President, Biosciences Division, at Emergent BioSolutions Inc., where he led the development and commercialization of oncology, immunology, and hematology products and product candidates. He previously held leadership roles at Human Genome Sciences, 3M Pharmaceuticals, and Immunex.

"I firmly believe in the importance of innate immune activation to enhance the benefits of other cancer immunotherapeutics," said Mr. Labinger. "CMP-001 has demonstrated best-in-class potential, and I’m excited to join Art, the Checkmate team, and our Board to maximize the potential of CMP-001 to improve outcomes for cancer patients."

"My initial goal in founding Checkmate was to determine if intratumoral TLR9 activation could induce tumor regression in anti-PD-1 refractory advanced cancer patients," Dr. Krieg commented. "Now that we have achieved that goal, I am delighted to turn over Checkmate’s leadership to Barry, so that I can focus my own efforts on the further scientific development of our platform. I believe that our complementary experience and our shared vision will enable us to accelerate and maximize Checkmate’s further development."

Proceeds from the financing will support ongoing clinical development of Checkmate’s lead product CMP-001 in advanced melanoma and non-small cell lung cancer (NSCLC) refractory to prior anti-PD-1 therapy, along with expansion into additional solid tumor types.

On December 12, 2018 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class AXL kinase inhibitors to treat multiple cancer indications, reported that the Company will be presenting key results from its Phase II clinical programme with selective AXL inhibitor bemcentinib at the DNB’s 9th Annual Nordic Healthcare Conference in Oslo, Norway, today at 10:15-10:40 CET (Press release, BerGenBio, DEC 12, 2018, View Source [SID1234532017]).

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The slides are available for download at the Company’s website: www.bergenbio.com/investors/presentations/

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We have made significant progress during 2018 establishing clinical proof of concept for the remarkable utility of bemcentinib in cancers with high unmet clinical need and large market potential. We have shown that our once-a-day, oral selective AXL inhibitor is well tolerated as a monotherapy and in combination with immune-, targeted and chemotherapies. What is more, consistently we have seen that efficacy scales with AXL biomarker expression leading to superior response rates in AXL biomarker positive relapsed/refractory AML and MDS as a monotherapy as well as non-small cell lung cancer where we are combining with the immunotherapy blockbuster Keytruda. We have met all our operational milestones this year and are looking forward to starting a randomised phase II programme towards the end of H1 2019 based on key results obtained this year".