On August 6, 2019 Replimune Group, Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that Philip Astley-Sparke, Executive Chairman and Director of Replimune, will present and host one-on-one meetings at the 2019 Wedbush PacGrow Healthcare Conference being held in New York City (Press release, Replimune, AUG 6, 2019, View Source [SID1234538170]). The Company is scheduled to present on Wednesday, August 13, 2019 at 1:55 PM ET.

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On August 6, 2019 Leap Therapeutics, Inc. (NASDAQ:LPTX) reported that its anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with Merck’s anti-PD-1 antibody, KeytrudaÒ (pembrolizumab), demonstrated higher survival and objective response outcomes in patients with advanced gastroesophageal junction and gastric cancer (GEJ/GC) whose tumors expressed high levels of DKK1 (DKK1-high) (Press release, Leap Therapeutics, AUG 6, 2019, View Source [SID1234538168]). DKN-01 plus Keytruda therapy achieved over 22 weeks median progression-free survival (PFS) and nearly 32 weeks median overall survival (OS) with a 50% overall response rate (ORR) and 80% disease control rate (DCR) in patients with DKK1-high GEJ/GC who had not received prior anti-PD-1/PD-L1 therapy. Leap will host a DKN-01 Clinical Perspectives and Program Update for the investment community through a live conference call and webcast with two clinical investigators today at 8:30 AM US Eastern Time.

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"Gastric and gastroesophageal junction cancers represent a major global cancer burden with significant unmet needs, particularly in patients with advanced disease. Outside of rare microsatellite instable tumors and EBV-associated cancers the response rates to immune checkpoint inhibitors are low and median progression free survival remains short, in the range of 6-8 weeks. Oncologists and patients are eager for new therapeutic combinations and biomarkers to help predict patients most likely to benefit from a given treatment," stated Samuel J. Klempner, MD, Assistant Professor, Massachusetts General Hospital Cancer Center and Harvard Medical School.

"The responses and early survival data seen in DKK1-high patients treated with DKN-01 plus pembrolizumab are highly encouraging," commented Dr. Klempner. "This study builds on previously reported positive monotherapy and paclitaxel combination data and importantly suggests that elevated DKK-1 expression is a potential predictive biomarker. DKN-01 warrants further study in gastroesophageal cancers in combination with immune checkpoint inhibitors and with chemotherapy."

Key Findings from KEYNOTE-731 DKN-01 plus Keytruda Combination

The esophagogastric cancer clinical trial is a multipart study of DKN-01 as a monotherapy and in combination with paclitaxel or pembrolizumab. Sixty-three patients were treated with DKN-01 plus Keytruda combination therapy across all arms and dose groups of the study. Fifty-three patients had not received prior PD-1/PD-L1 therapy, and ten patients were refractory to PD-1/PD-L1 therapy. All of the patients enrolled had tumors that were microsatellite stable or unknown. Patients in the study were heavily pretreated having had received one to five prior lines of therapy, with nearly 64% having received a prior taxane regimen, 37% having received prior ramucirumab, and 24% having received prior trastuzumab. The combination therapy was well tolerated with no new safety signals.

The combination of DKN-01 and Keytruda in GEJ/GC patients demonstrated improved outcomes in patients whose tumors are DKK1-high and who were PD-1/PD-L1 naïve. DKK1-high patients experienced

over 22 weeks median PFS and nearly 32 weeks OS, with a 50% ORR and 80% DCR in ten evaluable patients. DKK1-low patients experienced nearly 6 weeks median PFS and over 17 weeks OS, with a 20% DCR in fifteen evaluable patients.

PD-L1 Combined Positive Scores (CPS) did not predict efficacy on the combination of DKN-01 plus Keytruda. In multi-variate analysis, DKK1-high status correlated with longer PFS independent of PD-L1 CPS scores. One-third of patients in the study were DKK1-high.

Among the six GEJ/GC patients who were refractory to PD-1/PD-L1 therapy, three DKK1-high patients had a best response of stable disease, whereas the three patients with DKK1-low tumors had progressive disease.

DKN-01 Clinical Perspectives Conference Call and Webcast

Samuel J. Klempner, MD, Assistant Professor, Massachusetts General Hospital Cancer Center and Harvard Medical School, will describe his experience with treating esophagogastric cancer patients in the DKN-01 study. In addition, Rebecca C. Arend, MD, Assistant Professor and Associate Scientist, Gynecologic Oncology Clinic, UAB Comprehensive Cancer Center Experimental Therapeutics Program, will discuss her experience with endometrial cancer and carcinosarcoma patients treated with DKN-01.

To access the conference call, please dial (866) 589-0108 (US/Canada Toll-Free) or (409) 231-2048 (international) and refer to conference ID 3571417. The presentation will also be webcast live and will be available under "Events & Presentations" in the Investor section of Leap’s website, View Source A replay of the webcast will be available on Leap’s website shortly after the event and will be available for a limited time.

On August 5, 2019 Omeros Corporation (NASDAQ: OMER) reported that the company will issue its second quarter 2019 financial results for the period ended June 30, 2019, on Thursday, August 8, 2019, after the market closes (Press release, Omeros, AUG 5, 2019, View Source [SID1234538208]). Omeros management will host a conference call and webcast that day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

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Conference Call Details

To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 1697797. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 1697797.

To access the live and subsequently archived webcast of the conference call, go to Omeros’ website at www.omeros.com and select "Events" under the Investors section of the website. Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

On August 5, 2019 Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company developing innovative targeted medicines and artificial intelligence to find, fight and follow cancer, reported that it has completed enrollment five months ahead of schedule in the Company’s Phase 3 CONDOR study evaluating the diagnostic performance and clinical impact of PyLTM (18F-DCFPyL) in men with biochemical recurrence of prostate cancer (Press release, Progenics Pharmaceuticals, AUG 5, 2019, View Source [SID1234538165]). PyL is the Company’s PSMA-targeted small molecule PET/CT imaging agent designed to visualize prostate cancer.

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The Company also reported that it recently met with the U.S. Food and Drug Administration (FDA) to discuss the regulatory path for PyL. Based on those discussions, the Company believes that positive data from the CONDOR study and the previously reported OSPREY study could serve as the basis for a regulatory submission. Progenics intends to submit a New Drug Application (NDA) with the FDA for PyL following the Phase 3 CONDOR study, assuming positive results.

"We have made significant progress with our PyL program in recent months on both the clinical and regulatory fronts, demonstrating our ability to execute complex, multi-center studies under ambitious timelines," said Vivien Wong, Ph.D., Executive Vice President, R&D, of Progenics. "The accelerated enrollment completion in our Phase 3 CONDOR study underscores the clinical interest in our PSMA-targeted imaging agent and the need for better diagnostic options for patients with biochemical recurrent prostate cancer."

Dr. Wong continued, "We believe that PyL has the potential to alter physician treatment plans and improve patient outcomes through the detection of small nodal and metastatic lesions that are missed by currently available conventional imaging modalities. Currently, over 1,000 men with prostate cancer have been imaged with PyL in the clinical setting. We look forward to rapidly advancing this program toward NDA submission and commercialization following positive CONDOR data. We are grateful to the patients and their caregivers who participated in the trial, and to the investigators and their study staff for their extraordinary efforts in executing this study ahead of schedule."

The Phase 3 CONDOR study is a multi-center, open label study that dosed 208 patients with biochemical recurrence of prostate cancer at 14 sites in the United States and Canada. The primary endpoint is based on positive predictive value and will assess the correct localization rate (CLR), defined as a percentage of subjects with a one-to-one correspondence between localization of at least one lesion identified by PyL and the composite truth standard. Secondary measures include the percentage of subjects with a change in intended prostate cancer treatment plans due to PyL PET/CT imaging.

About PyL for PET Imaging of Prostate Cancer

PyL (also known as 18F-DCFPyL) is a fluorinated PSMA-targeted Positron Emission Topography ("PET") imaging agent that enables visualization of both bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. Progenics initiated patient dosing of the Phase 3 study evaluating the diagnostic performance and clinical impact of PyL in November 2018. The last patient visit is expected in September and top-line data is expected by year end.

PyL and 1095

The multicenter, randomized, open-label, controlled Phase 2 clinical study is evaluating the efficacy and safety of I-131-1095 in combination with enzalutamide compared to enzalutamide alone in patients with mCRPC who are PSMA-avid, chemotherapy naïve, and progressed on abiraterone. PSMA-avidity is determined utilizing PyL imaging which enrich for patients who are most likely to respond to 1095 therapy, highlighting the synergistic potential of our PSMA-targeted pipeline to better diagnose and treat prostate cancer. Based on the early data from this open-label study and dialogue with the FDA, we plan to evaluate initiating a pivotal trial of 1095 in 2020.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in nine men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 174,650 new cases of prostate cancer will be diagnosed and about 31,620 men will die of the disease. Approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.

On August 5, 2019 ChemoCentryx, Inc., (Nasdaq:CCXI), reported financial results for the second quarter ended June 30, 2019 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, AUG 5, 2019, View Source [SID1234538164]).

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"Strong momentum is with us as we move closer to our goal of releasing topline data from no fewer than five clinical trials over the next 18 months," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "First and foremost, we look forward to announcing topline results from the pivotal ADVOCATE Phase III trial of avacopan in ANCA-associated vasculitis in the fourth quarter of this year. The ADVOCATE trial is based on a wealth of data from well controlled pharmacological and clinical studies, including the successful multi-center, placebo controlled CLEAR and CLASSIC Phase II clinical trials. That foundation provides the basis for optimism that avacopan will provide much needed relief for ANCA patients."

"Recently we reached another milestone by completing patient enrollment in our LUMINA 1 trial of our second drug candidate, CCX140, in patients with primary FSGS, and we expect to release topline data in the first half of the coming year."

"Rounding out the pipeline readout roster through the coming year, our clinical trials of avacopan in C3 glomerulopathy and hidradenitis suppurativa, along with our LUMINA 2 trial of CCX140 in patients with nephrotic proteinuria primary FSGS, are also enrolling well. We expect to release top line data from these three clinical trials during the course of 2020."

"We continue to execute on our 2019 goals, fortified by our strong financial position. In short, we have the people, the assets, and the experience to deliver real value to investors and patients alike, as I believe this important time in our history will now begin to reveal."

Recent Highlights

Remained on track for Q4 topline data from the ADVOCATE global Phase III trial of avacopan in 331 patients with ANCA-associated Vasculitis.

Completed patient screening in the Company’s LUMINA 1 Phase II randomized clinical trial of CCX140, an inhibitor of the chemokine receptor known as CCR2, in patients with sub-nephrotic primary Focal Segmental Glomerulosclerosis (FSGS), another rare kidney disease. The last patient is expected to be randomized in mid-August and top line data anticipated in the first half of 2020. The single-arm, open label LUMINA 2 study continues to enroll, evaluating CCX140 in patients with the rarer and more severe nephrotic proteinuria primary FSGS.

ACCOLADE Phase II clinical trial of avacopan in patients with the rare kidney disease C3 Glomerulopathy (C3G, a devastating and expensive kidney disease with no approved effective treatment), reached fifty percent in overall enrollment and nearly 100% in the first stratum of patients with high levels of activated complement in the blood.

Acceleration in site activation and patient enrollment in the Company’s AURORA Phase IIb clinical trial of avacopan for the treatment of the chronic disabling skin disease Hidradenitis Suppurativa (HS), with over 50% sites now activated and approximately 25% patients enrolled to date.

First Quarter 2019 Financial Results

Revenue was $7.2 million for the second quarter of 2019, compared to $15.0 million for the same period in 2018. Revenue is recognized based on the proportionate amount of costs incurred as a percentage of total budgeted costs to fulfill the performance obligations under the Company’s avacopan and CCX140 commercialization agreements with Vifor Pharma. The decrease from 2018 to 2019 was primarily due to a higher proportion of avacopan related costs relative to budgeted costs incurred in 2018.

Research and development expenses were $17.6 million for the second quarter of 2019, compared to $17.8 million for the same period in 2018. Expenses decreased in 2019 for the avacopan ADVOCATE Phase III pivotal trial as the study was fully enrolled in 2018, while Phase II clinical expenses increased primarily due to patient enrollment of the avacopan AURORA Phase II clinical trial in patients with HS and the two CCX140 LUMINA Phase II clinical trials in patients with FSGS.

General and administrative expenses were $5.6 million for the second quarter of 2019, compared to $4.7 million for the same period in 2018. The increase from 2018 to 2019 was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, and higher professional fees.

Net loss for the second quarter of 2019 was $15.2 million, compared to $6.9 million for the same period in 2018.

Total shares outstanding at June 30, 2019 were approximately 58.2 million shares.

Cash, cash equivalents and investments totaled $223.1 million at June 30, 2019. The Company expects to utilize cash and investments in the range of $70.0 million to $80.0 million in 2019.

Conference Call and Webcast

The Company will host a conference call and webcast today, August 5, 2019 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial (877) 303-8028 (Domestic) or (760) 536-5167 (International). The conference ID number is 7548439. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.