On August 14, 2018 AVEO Oncology (Nasdaq: AVEO) reported that the China National Drug Administration (CNDA) has accepted CANbridge Life Sciences’ Investigational New Drug (IND) Application for a Phase Ib/III clinical trial of CAN017 (AV-203), AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate, in esophageal squamous cell cancer (ESCC) (Press release, AVEO, AUG 14, 2018, View Source [SID1234528891]).

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Under the terms of a March 2016 agreement, the acceptance of this IND triggers a $2 million milestone payment to AVEO from CANbridge Life Sciences. CANbridge licensed worldwide rights, excluding the United States, Canada, and Mexico, to AV-203 from AVEO and AVEO is eligible to receive up to $40 million in potential additional development and regulatory milestone payments and up to $90 million in potential commercial milestone payments, assuming the successful achievement of specified development, regulatory and commercialization objectives.

"CANbridge continues to make progress in advancing CAN017, and we look forward to the initiation of a Phase Ib/extension clinical trial in ESCC, a large unmet medical need globally with a particularly acute need in Asia," said Michael Bailey, president and chief executive officer of AVEO. "Together with ficlatuzumab, our partnered oncology programs allow us to retain meaningful rights to a promising pipeline and advance it at little or no cost to AVEO, allowing us to focus resources on our tivozanib strategy, including U.S. registration for kidney cancer as well as combinations with immunotherapy."

AVEO previously completed a Phase 1, open-label, dose-escalation study of AV-203 (CAN017) in patients with advanced solid tumors. In this study, AV-203 was found to be generally safe and well-tolerated, with an early signal of activity consistent with preclinical data showing the potential for heregulin or neuregulin, the only known ligand for ErbB3, to serve as a biomarker predictive of AV-203 anti-tumor activity.

AVEO will pay percentage of the milestone payment to Biogen Idec International GmbH as a sublicensing fee.

On August 14, 2018 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or "the Company"), reported that it will conduct a conference call on Wednesday, August 15, 2018 at 9:00 AM ET to provide an update on the Pivotal Phase 3 SIERRA Trial (Study of Iomab-B in Elderly Relapsed/Refractory AML) of Iomab-B (Press release, Actinium Pharmaceuticals, AUG 14, 2018, View Source [SID1234528958]). Actinium recently announced that the SIERRA trial had reached twenty-five percent patient enrollment and that the independent Data Monitoring Committee (DMC) would conduct a formal analysis, which has now occurred. Post this event, members of Actinium’s management team are hosting this call to provide an update on the SIERRA trial.

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Conference Call Details

Date: Wednesday, August 15, 2018
Time: 9:00 AM ET
Registration Link: View Source
Toll-Free Dial-in: (855) 427-0225
Dial-in: (718) 865-8336
Conference ID: 4831

"Based on the DMC’s unanimous recommendation, we are pleased that the ongoing SIERRA trial will continue as planned," said Dr. Mark Berger, Chief Medical Officer of Actinium. "This is an important milestone for Iomab-B since it is the first formal safety evaluation of the trial. We note that no Iomab-B safety concerns were raised. With new insights from the data available from the trial thus far as well as feedback from the trial sites, we will make certain protocol revisions to further expand salvage regimens in the control arm. We’ll also be making it easier for patients on the Conventional Care arm who have disease progression to access Iomab-B treatment. In addition, we will be simplifying certain data collection requirements. These improvements coupled with our deeper understanding of referral patterns and other outreach efforts, are anticipated to enable the recently strengthened SIERRA clinical team to complete the trial as quickly as possible with the goal of bringing Iomab-B to a patient population with a significant unmet need."

Sandesh Seth, Actinium’s Chairman and CEO added, "Iomab-B is a very compelling drug candidate that has been studied in over 500 patients in multiple hematologic malignancies including AML, myelodysplastic syndrome, lymphoma and multiple myeloma and is intended to facilitate a potentially curative bone marrow transplant. Iomab-B was developed by the Fred Hutchinson Cancer Research Center in collaboration with the National Cancer Institute and has been studied extensively by leading bone marrow transplant physicians. We are incredibly proud of the pedigree of Iomab-B and motivated by its potential to address unmet medical needs as a targeted conditioning agent in multiple hematologic diseases. We believe that Iomab-B via the SIERRA trial can be the linchpin for developing the leading franchise in targeted conditioning with an emphasis on improving bone marrow transplant access and outcomes."

About Iomab-B

Iomab-B, Actinium’s lead targeted conditioning product candidate, is currently being studied in a 150-patient, multicenter pivotal Phase 3 clinical trial in patients with relapsed or refractory acute myeloid leukemia who are age 55 and above. This pivotal Phase 3 study is called the SIERRA Trial (Study of Iomab-B in Elderly Relapsed/Refractory AML). Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant which is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B targets cells that express CD45, an antigen widely expressed in the hematopoietic system on all leukemic and lymphomic (white blood cells), bone marrow cells and cancer stem cells with the monoclonal antibody, BC8 or apamistamab, labeled with the radioisotope, iodine-131. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B will avoid the side effects that conventional treatments such as chemotherapy and radiation has on most healthy tissues while effectively killing the patient’s cancer and marrow cells potentially enabling more bone marrow transplants with better outcomes through targeted conditioning. In a Phase 2 clinical study in 68 patients with advanced AML or high-risk myelodysplastic syndrome (MDS) age 50 and older, who typically would not be transplant candidates, were able to receive a transplant after being conditioned with Iomab-B and the study resulted in significantly improved transplant success and survival. Iomab-B was developed at the Fred Hutchinson Cancer Research Center where it has been studied in almost 500 patients in a number of Phase 1 and Phase 2 clinical trials across a variety of blood cancer indications with promising results. The studies included patients with acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). Iomab-B has been granted Orphan Drug Designation for relapsed or refractory AML in patients 55 and above by the U.S. Food and Drug Administration and the European Medicines Agency.

On August 14, 2018 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, reported financial results for the second quarter ended June 30, 2018 and provided an overview of the Company’s recent developments (Press release, UroGen Pharma, AUG 14, 2018, View Source;p=RssLanding&cat=news&id=2363555 [SID1234529234]).

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"There aren’t many opportunities in this industry to be first, but with UGN-101 (formerly referred to as MitoGel), we have the potential to have the first drug ever approved for low-grade upper tract urothelial cancer (LG UTUC). We believe that we will be one step closer to this major milestone in the field of uro-oncology with the planned rolling submission of a New Drug Application (NDA) for UGN-101 in the fourth quarter of this year," said Ron Bentsur, Chief Executive Officer of UroGen. "In the past six months, we have focused on full execution of UGN-101, from clinical development, to regulatory process, to preparing for potential commercialization. We are leveraging the momentum and learnings from our UGN-101 program to initiate our Phase 2b trial for UGN-102 (formerly referred to as VesiGel) which has the potential to treat a significantly larger population, patients diagnosed with low-grade non-muscle invasive bladder cancer (LG NMIBC). As we continue to advance our pipeline, we believe this is just the beginning of what’s possible for UroGen and our RTGel platform."

Recent Highlights and Upcoming Milestones

UGN-101 Regulatory and Clinical Development:
Announced positive findings from an interim analysis of the ongoing pivotal Phase 3 OLYMPUS clinical trial of UGN-101, an investigational mitomycin formulation for the non-surgical treatment of LG UTUC in May 2018.
Interim analysis showed a complete response (CR) rate of 59 percent (20 out of the interim analysis intent to treat population of 34 patients) who were evaluated for primary disease evaluation (PDE, or the primary endpoint).
15 percent (five of 34 patients) achieved a partial response.
At the time of the interim analysis presentation, of the 20 patients who achieved a CR, 13 patients had reached three-month follow-up, and all remained in CR. Four of these 13 patients had reached six-month follow-up and one of the 13 patients had reached nine-month follow-up, and all remained in CR.
Top-line results from the OLYMPUS trial are expected in 2H 2018.
UroGen intends to initiate a rolling NDA submission for UGN-101 for the treatment of LG UTUC in Q4 2018 with a targeted completion by the end of Q1 2019.
Potential approval and commercial launch could potentially occur in 2019. The Company previously received Fast Track and Orphan Drug Designations for UGN-101.
If approved, UGN-101 would be the first approved therapy for LG UTUC.

UGN-102 (VesiGel) Clinical Development:
Successful Investigational New Drug (IND) application for UGN-102 for the treatment of LG NMIBC in Q2 2018.
Initiated Phase 2b single-arm, open-label, multi-center trial designed to assess the efficacy and safety of UGN-102 as a potential first-line chemoablation agent in the treatment of patients with LG NMIBC at risk for recurrence.
There are currently no drugs approved by the FDA as first-line treatment for NMIBC, and only three drugs have been approved by the FDA, all as adjuvant treatments, following TURBT (transurethral resection of bladder tumor).
In 2012, the annual incidence of urothelial bladder cancer was 80,000 in the United States with a prevalence of 700,0001. NMIBC accounts for approximately 80% of all new cases of bladder cancer diagnosed in the United States each year, with the majority of patients experiencing life-long, repetitive surgical treatment for cancer recurrence.

Advancing the Potential of the RTGel Platform:
UGN-201 (Vesimune): The Company continues to advance research for its novel imiquimod formulation for bladder instillation as a single agent and in combination with immune checkpoint inhibitors for the treatment of high-grade urothelial cancer. Pre-clinical models have demonstrated antitumor effects of UGN-201 as a single agent as well as in combination with novel immunomodulatory molecules via intravesical instillation in urothelial cancer. A clinical trial of UGN-201 remains on track for 1H 2019.
BotuGel: Enrollment of patients by Allergan in the Phase 2 trial of RTGel in combination with BOTOX2 for the treatment of overactive bladder is ongoing. This clinical trial, if successful, has the potential to demonstrate the broad applicability of the RTGel platform beyond uro-oncology. Phase 2 data is expected in 2019.

Corporate Developments Supporting Commercialization Efforts:
The addition of Peter P. Pfreundschuh as Chief Financial Officer aligns with the company’s strategy as it prepares for continued growth and potential commercialization in 2019. Mr. Pfreundschuh brings over 25 years of leadership experience in the biotechnology and medical device sectors overseeing finance, business development and commercial operations.
The Company strengthened its Board of Directors with the appointment of Shawn Tomasello, a renowned industry expert with a track record of commercializing revolutionary, multi-billion dollar products in oncology. Most recently, she served as Chief Commercial Officer of Kite Pharma (subsequently Kite, a Gilead Company), where she led the commercialization of Yescarta3 (axicabtagene ciloleucel), the first approved chimeric antigen receptor (CAR) T therapy for the treatment of adult patients with relapsed or refractory non-Hodgkin lymphoma. Previously, Ms. Tomasello served as Chief Commercial Officer at Pharmacyclics, Inc.
Second Quarter 2018 Financial Results

As of June 30, 2018, cash and cash equivalents totaled $119.1 million.
Research and development expenses for the six months ended June 30, 2018 were $15.9 million, including non-cash share-based compensation expense of $5.3 million. Research and development expenses for the three months ended June 30, 2018 were $8.3 million, including non-cash share-based compensation expense of $2.8 million.
General and administrative expenses for the six months ended June 30, 2018 were $16.3 million, including non-cash share-based compensation expense of $7.0 million. General and administrative expenses for the three months ended June 30, 2018 were $10.2 million, including non-cash share-based compensation expense of $4.9 million.
The Company reported a net loss of $31.4 million, or basic and diluted net loss per ordinary share of $2.02, for the six months ended June 30, 2018. The Company reported a net loss of $18.0 million, or basic and diluted net loss per ordinary share of $1.14, for the three months ended June 30, 2018.
Conference Call & Webcast Information

Members of UroGen’s management team will host a live conference call and webcast today at 8:30 a.m. Eastern Time to review the Company’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (888) 771-4371 (U.S.) or (847) 585-4405 (International) to listen to the live conference call. The conference ID number for the live call will be 47260983. An archive of the webcast will be available for two weeks on the Company’s website.

On August 14, 2018 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported financial and clinical updates for the second quarter ended June 30, 2018 (Press release, Heat Biologics, AUG 14, 2018, View Source [SID1234528875]).

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Jeff Wolf, Heat’s CEO, commented, "Earlier this year we reported positive interim results from our Phase 2 trial investigating HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), in patients with advanced non-small cell lung cancer (NSCLC). Since then, we have continued to execute on our clinical plan and remain on track to report additional interim Phase 2 data in the fourth quarter of 2018 and to complete trial enrollment in Q2 2019."

"In addition to our Phase 2 HS-110 program, we look forward to filing our Investigational New Drug (IND) application to initiate a Phase 1 clinical trial for our ComPACT trial in the fourth quarter of 2018. Our ComPACT therapy combines T-cell activators and co-stimulators within a single treatment, simplifying combination immunotherapy while providing superior immune activation and reduced treatment costs."

"Finally, we look forward to filing our second Investigational New Drug (IND) application to initiate a Phase 1 clinical trial for PTX-35, a novel co-stimulatory monoclonal antibody, in the first quarter of 2019. Each of our therapies is designed to enhance the response rate for patients least likely to respond to checkpoint inhibitors through a combination treatment that enhances the immune defense mechanisms."

"Importantly, we completed a capital raise of $20.7 million in the second quarter of 2018. In addition, we have subsequently generated an additional $4.8 million through the exercise of warrants. These funds, combined with the additional $6.9 million in CPRIT grant funds for PTX-35, which we expect to receive in the third quarter of this year, should provide us sufficient capital to advance our clinical programs and achieve a number of major milestones through the end of 2019."

Second Quarter 2018 Corporate Highlights

On April 18, 2018, Heat Biologics released guidance regarding major upcoming milestones through Q3, 2019.
On May 7, 2018, Heat Biologics announced the closing of $20.7 million public offering.
Second Quarter 2018 Financial Results

Recognized $1.1 million of grant revenue for qualified expenditures under the CPRIT grant.
Research and development expenses increased approximately 59.1% to $3.5 million for the quarter ended June 30, 2018 compared to $2.2 million for the quarter ended June 30, 2017. The $1.3 million increase is due in part to PTX expenses, as the Company began pre-clinical development of PTX-35 and PTX-15 against TNFRSF25 for testing in patients.
General and administrative expense decreased approximately 12.5% to $1.4 million for the quarter ended June 30, 2018 compared to $1.6 million for the quarter ended June 30, 2017. The $0.2 million decrease is primarily attributable to the acquisition costs of the Pelican subsidiary during the three months ended June 30, 2017.
Net loss attributable to Heat Biologics was approximately $4.1 million, or ($0.27) per basic and diluted share for the quarter ended June 30, 2018 compared to a net loss of approximately $3.2 million, or ($0.91) per basic and diluted share for the quarter ended June 30, 2017.
As of June 30, 2018, the Company had approximately $24.7 million in cash and cash equivalents.

On August 14, 2018 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended June 30, 2018 (Press release, Cel-Sci, AUG 14, 2018, View Source [SID1234528892]). The Company also reported key clinical and corporate developments achieved during the quarter.

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Clinical and Corporate Developments included:

CEL-SCI’s Phase 3 head and neck cancer study continued to follow all 928 patients. Enrollment was completed in September of 2016. Based on published survival data, we believe top line results may be available as soon as early 2019. All that remains to be done in this pivotal Phase 3 study, the largest in the world in head and neck cancer, is to continue to track patient survival until it can be determined if the primary endpoint has been met. The primary endpoint of the study, a 10% improvement in overall survival of the Multikine treatment regimen plus Standard of Care (SOC) vs. SOC alone, will be determined after a total of 298 deaths have occurred in the two main comparator arms of the study and have been recorded in the study database.
The US Patent and Trademark Office allowed two new patents to CEL-SCI for the Company’s LEAPS platform technology. Titled "Method for Inducing an Immune Response and Formulations Thereof" and " Method for Inducing an Immune Response against avian, swine, Spanish, H1N1, H5N9 influenza viruses and formulations", these patents relate to methods for diagnosing, preventing, and treating disease by generating or modulating the immune response through the use of specific peptides.
CEL-SCI won the arbitration against the clinical research organization (CRO) that ran the Phase 3 head and neck cancer study from 2011-2013. The arbitrator ruled that the CRO materially breached its contract with CEL-SCI. The arbitrator’s decision has vindicated CEL-SCI. Many investment funds and analysts did not like the legal risk of this arbitration and now that the arbitration has been resolved in CEL-SCI’s favor, this should no longer be an impediment to investors and should result in renewed investment interest in CEL-SCI. With the arbitration completed, CEL-SCI moves forward with a clean slate.
"We are proud of having run the largest head and neck cancer Phase 3 study in the world, in an indication that has not seen a new drug approved by the FDA in over 60 years. This has not been easy for many reasons, including the fact that our approach to immunotherapy involves treating the patient when they first get diagnosed instead of using immunotherapy as a last ditch option for survival. Our approach meant a longer clinical trial period, with nearly one thousand patients enrolled. Despite the many challenges of this study, we believe the potential to bring a new immunotherapy to help save the lives of newly diagnosed cancer patients has been worth it," said CEL-SCI’s Chief Executive Officer, Geert Kersten. "As we look forward to a readout of the endpoint data which may happen in early 2019, we also continue to develop our LEAPS technology platform with the support of the U.S. National Institutes of Health. Should our Phase 3 results lead to marketing approval in head and neck cancer, we will also have the opportunity to purse clinical development and marketing approval of our immunotherapy in other cancer indications."

During the nine months ended June 30, 2018, the Company’s cash remained constant. Cash used in operations of approximately $9.1 million was offset by approximately $9.1 million in cash provided by financing activities. Sources of financing during the nine months included approximately $7.0 million in proceeds from the issuance of common stock and warrants and $2.1 million in proceeds from the exercise of warrants.

CEL-SCI reported an operating loss of ($4,070,363) for the quarter ended June 30, 2018 versus an operating loss of ($4,758,719) for the quarter ended June 30, 2017. The operating loss was ($13,187,538) for the nine months ended June 30, 2018 versus an operating loss of ($17,603,283) for the nine months ended June 30, 2017.