On February 9, 2017 Immunomedics, Inc. (NASDAQ:IMMU) ("Immunomedics" or "the Company") reported financial results for the second quarter ended December 31, 2016 (Filing, Q2, Immunomedics, 2017, FEB 9, 2017, View Source [SID1234517688]). The Company also highlighted recent key developments and planned activities for its clinical pipeline.

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Second Quarter Fiscal 2017 Results

Total revenues for the second quarter of fiscal 2017, which ended on December 31, 2016, were $0.4 million, compared to $0.7 million for the same quarter last fiscal year, a decrease of $0.3 million, or approximately 43%. The decrease was due primarily to a $0.3 million decrease in LeukoScan product sales, primarily from a delay in obtaining regulatory approval for new LeukoScan inventory.

Total costs and expenses for the quarter ended December 31, 2016 were $15.7 million, compared to $16.4 million for the same quarter in fiscal 2016, a decrease of $0.7 million or approximately 4%. This decrease was due primarily to $1.5 million reduction in research and development expenses resulting from a $4.6 million reduction in expenses related to the Phase 3 PANCRIT-1 clinical trial, which was terminated during the third quarter of fiscal 2016, and a $0.6 million reduction in manufacturing material purchases compared to the same period in the prior year. These reductions were partially offset by a $3.7 million increase in product development expense related to manufacturing of the antibody drug-conjugate sacituzumab govitecan (IMMU-132). The decrease in research and development expenses was also partially offset by a $1.1 million increase in general and administrative expenses, due primarily to a $0.5 million increase in legal fees and a $0.9 million increase in professional fees associated with the proxy contest commenced by venBio Select Advisor LLC ("venBio"), partially offset by a reduction in employee related costs.

The Company recognized a $7.2 million non-cash expense during the three-month period ended December 31, 2016 reflecting the corresponding increase in the fair value of the warrant liability at December 31, 2016 resulting from the increase of the common stock price from the issuance date of October 11, 2016. Interest expense related to the 4.75% Convertible Senior Notes due 2020 was $1.4 million for both quarters ended December 31, 2016, and December 31, 2015, including amortization of $0.2 million debt issuance costs in each quarter.

There was no income tax benefit for the quarter ended December 31, 2016, compared to $3.2 million income tax benefit for the same quarter in fiscal 2016, which is related to the sale of a portion of our New Jersey State tax net operating losses (NOL) and research and development (R&D) tax credits.

Net loss attributable to stockholders was $24.4 million, or $0.23 per basic and diluted share, for the second quarter of fiscal year 2017, compared to net loss attributable to stockholders of $13.7 million, or $0.15 per basic and diluted share, for the same quarter in fiscal 2016, an increase of $10.7 million, or approximately 78%. The increase was due primarily to the increase in the fair value of the warrant liability of $7.2 million, the receipt of proceeds from the non-recurring $3.2 million NOL and R&D tax credit sale in 2015, and the $1.1 million increase in general and administrative expenses primarily attributable to the proxy contest commenced by venBio, partially offset by a $1.5 million decrease in research and development expenses.

First Half Fiscal 2017 Results

Total revenues for the first half of fiscal 2017 were $1.1 million, compared to $1.4 million for the same period last fiscal year, a decrease of $0.3 million, or approximately 21%. The decrease was due primarily to $0.3 million decrease in LeukoScan product sales, primarily from a delay in obtaining regulatory approval for new LeukoScan inventory.

Total costs and expenses for the six-month period ended December 31, 2016 were $31.4 million, compared to $31.2 million for the same period in fiscal 2016, an increase of $0.2 million or approximately 0.6%. Research and development expenses increased $0.1 million over the prior year due primarily to a $8.4 million increase in product development expense from manufacturing the antibody drug-conjugate sacituzumab govitecan (IMMU-132), which was partially offset by a $7.7 million decrease in expenses related to the early termination of the Phase 3 PANCRIT-1 clinical trial. General and administrative expenses increased $0.1 million compared to the previous year, reflecting an $0.8 million increase in legal fees and a $0.9 million increase in professional fees associated with the proxy contest commenced by venBio, offset by approximately $1.5 million in adjustments for deferred unearned executive bonuses compared to the same period in the prior year.

The Company recognized a $7.2 million non-cash expense during the six-month period ended December 31, 2016 reflecting the corresponding increase in the fair value of the warrant liability at December 31, 2016 resulting from the increase of the common stock price from the issuance date of October 11, 2016. Interest expense related to the 4.75% Convertible Senior Notes due 2020 was $2.7 million for both periods ended December 31, 2016 and December 31, 2015, including amortization of $0.4 million debt issuance costs in each quarter.

There was no income tax benefit for the six-month period ended December 31, 2016, compared to $3.2 million income tax benefit for the same period in fiscal 2016, which is related to the sale of a portion of our New Jersey State tax NOL’s or R&D tax credits.

Net loss attributable to stockholders was $40.7 million, or $0.41 per basic and diluted share, for this period, compared to net loss attributable to stockholders of $29.1 million, or $0.31 per basic and diluted share, for the same period last fiscal year, an increase of $11.6 million, or approximately 40%. The increase was due primarily to the increase in the fair value of the warrant liability of $7.2 million and the receipt of proceeds from the non-recurring $3.2 million NOL and R&D tax credit sale in fiscal 2016.

Cash, cash equivalents, and marketable securities were $46.6 million as of December 31, 2016.

Michael R. Garone, Vice President Finance and Chief Financial Officer, said, "We continue to make significant progress in our efforts to initiate a Phase 3 trial and file a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of IMMU-132 in patients with metastatic triple-negative breast cancer (TNBC) in mid-2017. As always, we are committed to taking all actions to realize the full potential of our pipeline, including a robust strategic process, and delivering on the significant promise it holds for cancer patients."

Additionally, during the quarter Immunomedics achieved and planned for critical milestones, including:

Sacituzumab Govitecan (IMMU-132)

Updated Phase 2 clinical results in patients with metastatic TNBC were presented at the 2016 San Antonio Breast Cancer Symposium

The Company achieved its target enrollment of 100 assessable TNBC patients with at least two prior therapies required for a BLA submission to the FDA, which is on track for mid-2017

As part of the preparation for the BLA filing, the Company has retained an outside consultant to conduct an independent audit of commercial manufacturing facilities, processes, and other relevant Chemistry, Manufacturing, and Controls matters

New data in metastatic TNBC, urothelial cancer (UC) , non-small-cell lung cancer (NSCLC) and small-cell lung cancer (SCLC) were presented at the Company’s Investor R&D Day in January 2017

Results in patients with metastatic UC will be updated at the 2017 Genitourinary Cancers Symposium in Orlando, Florida

On February 9, 2017 Boehringer Ingelheim reported the initiation of a Phase II trial of afatinib* (Giotrif) in combination with pembrolizumab (Keytruda) for patients with locally advanced or metastatic squamous cell carcinoma (SqCC) of the lung (Press release, Boehringer Ingelheim, FEB 9, 2017, View Source [SID1234517687]).

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Benjamin Levy, MD, Clinical Director, Sidney Kimmel Cancer Center, Johns Hopkins Medicine at Sibley Memorial Hospital Washington DC, USA said, "Given the complexity of tumours and their ability to evade immune destruction, combination approaches rooted in both clinical and scientific rationale are desperately needed. Bringing together two drugs, afatinib and pembrolizumab, which have each demonstrated meaningful activity and survival advantages in advanced stage squamous cell lung cancer patients, is an attractive strategy that needs to be further investigated as a treatment combination. The potential synergy in these agents will hopefully advance care and therapeutic options for this group of patients."

Afatinib is approved in the EU (Giotrif), US (Gilotrif) and other markets in patients with advanced SqCC of the lung whose disease has progressed on or after (EU label) / after (US label) treatment with platinum-based chemotherapy.

Pembrolizumab is approved in the US, EU, Japan and other markets for the treatment of previously-untreated patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression (tumour proportion score (TPS) >50%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations. Pembrolizumab is also indicated for the treatment of previously-treated patients with metastatic NSCLC whose tumours express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy.

The trial is being conducted in collaboration with a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada) and the combination of afatinib and pembrolizumab studied in this trial is currently not an approved treatment regimen in the studied indication.


Dr Victoria Zazulina
Dr Victoria Zazulina, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim said, "We are excited to collaborate with MSD and launch this trial, allowing us to gain further insights into the opportunities around treatment of squamous cell carcinoma of the lung. Around the world, patients with this type of cancer are already benefitting from anti-PD-1 therapies and afatinib, the only oral tyrosine kinase inhibitor (TKI) used in this indication. It is intriguing to combine both approaches in an attempt to improve the outcomes for patients with squamous lung cancer and equip physicians with new options."

The Phase II trial will include approximately 60 patients who have progressed or relapsed on or after prior platinum-based chemotherapy, and who have not previously received therapy with an anti-PD-1 therapy, a PD-L1/L2 antibody, or other checkpoint inhibitor or anti-EGFR targeted therapy. The trial aims to measure the decrease in tumour size (primary endpoint; objective response rate) and will confirm the dose of afatinib in combination with the standard dose of pembrolizumab, as well as the tolerability of this new regimen. In addition, it will evaluate anti-tumour activity in terms of disease control, duration of response, progression-free survival (PFS) and overall survival (OS).

SqCC of the lung is the second largest sub-type of NSCLC and represents approximately 20-30% of NSCLC cases.1,2 Patients with advanced SqCC of the lung typically have a poor prognosis and the median overall survival after diagnosis is around one year.3,4

Afatinib is also approved in over 70 countries for the first-line treatment of EGFR mutation-positive NSCLC and continues to be more broadly studied beyond the approved indications.

Notes to editors

Intended audiences
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

About Afatinib
Afatinib* is approved in the EU (Giotrif), US (Gilotrif) and other markets in patients with advanced SqCC of the lung whose disease has progressed on or after (EU-label) / after (US label) treatment with platinum-based chemotherapy.

Approval of afatinib in this indication is based on results of the LUX-Lung 8 study, which showed a significantly improved OS and PFS compared to Tarceva (erlotinib) in patients with SqCC of the lung.5
LUX-Lung 8 is part of the LUX-Lung programme – the largest collection of clinical trials of any EGFR TKI, with over 3,760 patients across eight studies conducted across the world.
Afatinib is also approved in over 70 countries for the first-line treatment of EGFR mutation-positive NSCLC.

Approval of afatinib in this indication was based on the primary endpoint of PFS from the LUX-Lung 3 clinical trial where afatinib significantly delayed tumour growth when compared to standard chemotherapy. 6
In addition, afatinib is the first treatment to have shown an OS benefit for patients with specific types of EGFR mutation-positive NSCLC compared to chemotherapy.7 A significant OS benefit was demonstrated independently in the LUX-Lung 3 and 6 trials for patients with the most common EGFR mutation (del19) compared to chemotherapy.7
Most recently in the LUX-Lung 7 trial, a reduction in the risk of death was observed for patients treated with afatinib versus Iressa (gefitinib), in the first-line treatment of patients with EGFR mutation-positive advanced NSCLC, without reaching significance.8
View Source

On February 9, 2017 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, reported top-line results from a randomized Phase 2 clinical trial of TRC105 in recurrent glioblastoma (GBM) funded and conducted by the Clinical Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI) (Press release, Tracon Pharmaceuticals, FEB 9, 2017, View Source [SID1234517685]).

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In the trial, TRC105 combined with Avastin (bevacizumab) was compared to single agent Avastin in a total of 101 patients with recurrent GBM following chemoradiation. The trial was designed to detect a three-month improvement in progression free survival (PFS), the primary endpoint, from the expected value of 3.45 months with single agent Avastin. Top-line data indicate that the combination of TRC105 and Avastin did not improve median PFS versus single agent Avastin in recurrent GBM patients, although the combination was associated with a non-significant increase in overall survival. Detailed data and the associated correlative analyses are expected to be presented at an oncology conference later this year.

"Glioblastoma is a very challenging indication for drug development," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We are grateful to the National Cancer Institute for sponsoring the trial and to the patients and providers who participated, and look forward to the detailed survival analysis from this trial, as well as data from multiple company-sponsored trials of TRC105 in other indications later this year."

About TRC105 and other Endoglin Antibodies

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in one Phase 3 and multiple Phase 2 clinical trials sponsored by TRACON or the National Cancer Institute for the treatment of solid tumor types in combination with VEGF inhibitors. The ophthalmic formulation of TRC105, DE-122, is currently in a Phase 1/2 trial for patients with wet AMD. TRC205, a second generation antibody to endoglin, is undergoing preclinical testing in models of fibrosis. For more information about the clinical trials, please visit TRACON’s website at View Source

On February 9, 2017 AVEO Oncology (NASDAQ:AVEO) reported clinical and regulatory updates for its lead drug candidate, tivozanib, an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) (Press release, AVEO, FEB 9, 2017, View Source [SID1234517674]).

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The Company announced today that its pivotal, Phase 3 TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC), is enrolling substantially ahead of schedule. The Company now expects TIVO-3 to complete enrollment in June 2017, ahead of its prior guidance of August 2017. Because the study is event driven the Company is not revising the anticipated time to topline data at this time, which is currently expected in the first quarter of 2018. TIVO-3 is expected to undergo a pre-planned futility analysis around midyear. The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of RCC, is designed to support first and third line indications for tivozanib in the U.S.

The Company also announced today that the Phase 1/2 AVEO-sponsored TiNivo trial evaluating tivozanib in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, Opdivo (nivolumab), in advanced RCC, is scheduled to open sites for enrollment in early March, with dosing of the first patient expected in the same timeframe. The company received approval by the French National Agency for Medicines and Health Products Safety (ANSM) to initiate the study and is currently labelling the nivolumab supply provided by Bristol-Myers Squibb for use in the trial. The study, which will be led by the Institut Gustave Roussy in Paris, is under the direction of Professor Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee. The Phase 1 trial will evaluate the safety of tivozanib in combination with nivolumab at escalating doses of tivozanib and, assuming favorable results, is expected to be followed by an expansion Phase 2 cohort at the established combination dose.

AVEO also announced today that its European licensee for tivozanib, EUSA Pharma, a specialty pharmaceutical company with a focus on oncology and oncology supportive care, has received the Day 180 List of Outstanding Issues (LOI) from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The Day 180 LOI signifies that the Marketing Authorization Application is not approvable at the present time, and outlines outstanding deficiencies, which are then required to be satisfactorily addressed in an oral explanation and/or in writing prior to a final application decision. EUSA has informed AVEO that it expects to submit written responses to the Day 180 LOI in April 2017, and the EMA has tentatively scheduled EUSA to provide an oral explanation to the CHMP at its May 2017 meeting.

"We continue to execute on the TIVO-3 and TiNivo studies in our effort to complete our U.S. pivotal clinical strategy, as well as support EUSA Pharma in its response to European regulators," said Michael Bailey, president and chief executive officer of AVEO. "The rapid pace of enrollment in our TIVO-3 study is a testament to the broad level of support and enthusiasm for tivozanib among investigators. Fundamental to this drug candidate’s unique profile would be its potential to be safely combined with PD-1 immunotherapies, and we look forward to initial results from the Opdivo combination TiNivo study in RCC in the first half of 2017."

About Tivozanib

Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers.

About the TIVO-3 Trial

The Phase 3 TIVO-3 trial is a pivotal, randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC). The trial is expected to enroll approximately 322 patients with recurrent RCC who have failed at least two prior regimens, including VEGFR-TKI therapy (other than sorafenib). Eligible patients may also have received checkpoint inhibitor therapy in earlier lines of treatment. Patients will be randomized 1:1 to receive either tivozanib or sorafenib, with no crossover between arms. The primary endpoint of the study is progression free survival. Secondary endpoints include overall survival, overall response rate, and safety and tolerability. The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of RCC, is designed to support a first and third line indication for tivozanib in the U.S.

On Thursday 9, 2017 The Merck Foundation (Foundation), reported the selection of the six program sites and National Program Office forming the Alliance to Advance Patient-Centered Cancer Care (the Alliance) (Press release, Merck & Co, FEB 9, 2017, View Source [SID1234517673]). With $15 million in funding from the Foundation over five years, the Alliance aims to increase timely access to patient-centered cancer care for vulnerable and underserved populations in the United States.

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The following organizations have been selected based on a variety of criteria, including the technical merit of their proposed programs, their organizational capabilities and experience, relationships with community partners, and ability to promote sustainable improvements in the delivery of cancer care.

Grady Health System in Atlanta, Ga.;
The Johns Hopkins University in Baltimore, Md.;
Massachusetts General Hospital in Boston, Mass.;
Northwestern University in Chicago, Ill.;
Ohio State University in Columbus, Ohio; and
The University of Arizona in Tucson, Ariz.

The University of Michigan School of Nursing, in Ann Arbor, Mich., will serve as the Alliance’s National Program Office.

"With 1.7 million Americans newly diagnosed with cancer each year, there is a great need to improve the quality and delivery of patient-centered care to help address the significant challenges of those facing this diagnosis," said Julie L. Gerberding, chief patient officer, Merck and chief executive officer, Merck Foundation. "These superb program sites and the National Program Office should accelerate identification and uptake of innovations that benefit patients, improve health communications, and enhance the overall coordination of care."

Through an independent cross-site evaluation, the Foundation will evaluate the impact of the Alliance and its programs. The evaluation findings and lessons learned will be disseminated to promote best practices in patient-centered cancer care.

About The Merck Foundation

The Merck Foundation is a U.S.-based, private charitable foundation. Established in 1957 by Merck, a global health care leader, the Foundation is funded entirely by the company and is Merck’s chief source of funding support to qualified non-profit charitable organizations. Since its inception, the Merck Foundation has contributed more than $870 million to support important initiatives that address societal needs and are consistent with Merck’s overall mission to help the world be well. For more information, visit www.merckgiving.com.