On May 15, 2017 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported financial results for the first quarter 2017 and a re-evaluation of its financing and development strategies for ICT-107, its patient-specific, dendritic cell-based immunotherapy for patients with newly diagnosed glioblastoma (Press release, ImmunoCellular Therapeutics, MAY 15, 2017, View Source [SID1234519149]). Despite having made meaningful progress in executing the ongoing phase 3 registration trial of ICT-107, it has become clear that ImmunoCellular’s ability to access sufficient additional financial resources needed to complete the trial and continue its ongoing operations are limited. As of March 31, 2017 , the Company had $5.3 million in cash.

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Accordingly, ImmunoCellular’s board of directors has undertaken a strategic review to determine the feasibility of continuing to execute this trial independently or completing development through a partnership or acquisition of the asset. Given its limited financing options, ImmunoCellular is considering restructuring its business if a partner or acquirer for ICT-107 is not identified in the near term, but in any event, not later than 30 days. While this review is in progress, ImmunoCellular also intends to evaluate strategies to refocus and reallocate its available resources on its promising Stem-to-T-Cell research programs.

In light of the uncertainties surrounding these strategic pursuits, the Company is deferring a business update conference call in conjunction with reporting first quarter 2017 financial results until a later date.

First Quarter 2017 Financial Results

For the quarter ended March 31, 2017, ImmunoCellular incurred a net loss of $5.8 million, or $1.64 per basic and diluted share, compared to a net loss of $5.6 million, or $2.47 per basic and diluted share, for the quarter ended March 31, 2016.

For each of the quarters ended March 31, 2017 and March 31, 2016, the Company incurred approximately $4.7 million of research and development expenses. During the quarter ended March 31, 2017, the Company incurred expenses related to the Phase 3 trial of ICT-107 as the Company increased the number of sites participating in the trial and as treated more patients. During the quarter ended March 31, 2016, the Company incurred significant initial expenses to the North American and European cooperative groups for their support for ICT-107. During the most recent quarter, the Company also incurred expenses related to its Stem-to-T-cell immunotherapies.

The Company also reported that cash used in operations in the first quarter of 2017 was $6.1 million compared to $5.4 million in the prior year quarter. The increase primarily reflects a reduction in accounts payable and accrued expenses as of March 31, 2017. As of March 31, 2017, the Company had $5.3 million in cash and 3.5 million shares of common stock outstanding.

On May 15, 2017 Novocure (NASDAQ:NVCR) reported that United States Food and Drug Administration (FDA) has designated it’s Tumor Treating Fields (TTFields) delivery system as a Humanitarian Use Device (HUD) for the treatment of pleural mesothelioma (Press release, NovoCure, MAY 15, 2017, View Source [SID1234519135]).

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HUD designation covers devices that treat rare, orphan diseases or conditions. The HUD designation is the first step in obtaining a Humanitarian Device Exemption (HDE) for the treatment of pleural mesothelioma with TTFields. Novocure enrolled the last patient in its STELLAR trial, a phase 2 pilot trial in pleural mesothelioma, in March 2017 and, with final data collection in 2018, is evaluating its options to file an HDE application with the STELLAR data. An approved HDE would allow Novocure to market TTFields in combination with standard of care chemotherapy as a treatment for pleural mesothelioma in the United States.

"Due to the clinical and pathological course of mesothelioma, standard treatment methods rarely lead to a complete cure and new effective treatments are desperately needed. Our interim data from the STELLAR trial give us hope that TTFields used in combination with standard of care chemotherapies may increase survival for patients with mesothelioma without significantly increasing side effects," said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. "We are pleased that the FDA has recognized orphan status for mesothelioma and acknowledges the urgent demand for new treatment options."

Novocure’s ongoing STELLAR trial includes 80 patients with unresectable, previously untreated malignant pleural mesothelioma. STELLAR’s primary endpoint is overall survival and secondary endpoints are progression free survival, response rate, and treatment-emergent toxicity. Interim results presented in December 2016 at the International Association for the Study of Lung Cancer (IASLC) 17thWorld Conference on Lung Cancer suggest improvements in progression free survival and one-year survival rates when TTFields is added to standard chemotherapy. Forty-two STELLAR patients who received treatment with TTFields plus pemetrexed and cisplatin or carboplatin experienced a 12-month survival rate of 79.7 percent and median progression free survival of 7.3 months. Median survival had not been reached at the time of presentation due to limited follow-up time, with an average follow-up time of 11.5 months. No device-related serious adverse events were reported.

"We believe that treatment with TTFIelds affects fundamental aspects of cell division and may have broad applicability across a variety of solid tumors," said Asaf Danziger, Chief Executive Officer of Novocure. "We are pleased to receive HUD designation as it is a major step towards a second regulatory approval for TTFields in the United States."

Treatment with TTFields is not approved for the treatment of mesothelioma by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields therapy for mesothelioma has not been established.

On May 15, 2017 Zymeworks Inc. ("Zymeworks") (NYSE: ZYME; TSX: ZYME) a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics, initially focused on the treatment of cancer, reported financial results for the first quarter ended March 31, 2017 (Press release, Zymeworks, MAY 15, 2017, View Source [SID1234519134]).

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"During the first quarter, among other highlights, we received top-line data from the dose escalation stage of our on-going Phase 1 clinical trial of our lead product candidate, ZW25," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "ZW25 has demonstrated preliminary anti-tumor activity across multiple cancer types in HER2 expressing patients who have progressed after several lines of treatment with HER2-targeted therapies."
First Quarter Highlights:
Preliminary data for ZW25 phase 1 clinical trial received
Orphan drug designation for ZW25 in gastric cancer received
Second research milestone with collaborator Eli Lilly announced
Two industry veterans added to Board of Directors
State-of-the-art lab facility opened

On May 3, 2017, subsequent to the first quarter, Zymeworks completed its initial public offering and sold 4,500,000 common shares at a price of $13.00 per share. In addition, Zymeworks has granted the underwriters an option, exercisable within 30 days of the date of its final prospectus relating to the IPO, to purchase up to an additional 675,000 common shares.

First Quarter Ended March 31, 2017 Financial Results
All amounts are in U.S. dollars. Zymeworks’ unaudited condensed consolidated financial statements are prepared in accordance with accounting principals generally accepted in the United States ("U.S. GAAP").

Revenues for the first quarter ended March 31, 2017 were $0.2 million compared to $0.3 million for the same period of 2016. The decrease in collaboration revenue of $0.1 million is due to a $0.3 million decrease in research support payments from Merck, which was partially offset by the increase in research support payments of $0.2 million from Daiichi.

Research and development expenditures for the first quarter ended March 31, 2017 were $9.1 million, compared to $7.9 million for the same period in 2016. The increase of $1.2 million, was primarily due to increased activities associated with our therapeutic platforms and early-stage research and discovery programs, recorded in other research activities.

General and administrative expenses in the first quarter ended March 31, 2017 were $6.3 million compared to $2.1 million for the same period in 2016. General and administrative expenses increased by $4.2 million, compared to the same period in 2016, primarily due to an increase in professional fees and compensation costs. The compensation cost increase was the result of higher share-based compensation expenses due to reclassification under U.S. GAAP of certain awards from equity to liability for accounting purposes as well as certain new hires. The increase in professional fees over the same period in 2016 was associated with consulting services as well as legal, intellectual property, assurance and taxation services.

Net loss for the three months ended March 31, 2017 was $15.9 million. Zymeworks expects that over the next several years, research and development expenditures will increase in connection with the ongoing development of product candidates and other clinical, preclinical and regulatory activities.

As of March 31, 2017, Zymeworks had $26.8 million in cash and cash equivalents and short-term investments, as well as $1.9 million in SR&ED and IRAP receivables. On May 3, 2017, subsequent to the first quarter, Zymeworks completed its initial public offering for a total of $58.5 million in aggregate gross proceeds.

On May 15, 2017 The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) reported that it has achieved the recruitment goal with the inclusion of currently 540 patients for the pivotal IMPALA study in metastatic colorectal cancer "mCRC" (Press release, Mologen, MAY 15, 2017, View Source [SID1234519133]). The aim of this study is to show that a switch maintenance therapy with the immunotherapeutic agent lefitolimod can lead to a prolongation of overall survival in patients with mCRC. With the finalization of recruitment, the company reached the next important milestone in the clinical study program of its lead product lefitolimod.
"We are pleased that the enrollment for IMPALA has been completed and that treatment with lefitolimod is so far well tolerated", said Dr. Matthias Baumann, Chief Medical Officer of MOLOGEN AG. "This is an important milestone for us as the pivotal IMPALA study is by far the largest study for us to date. We look forward to the study results in this high medical need indication, which will be available, once sufficient survival data have been collected. This is currently expected in 2019, which of course depends on the actual overall survival rates.

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Approximately 540 patients from more than 120 centers in eight European countries, including the five most important European pharmaceutical markets, participate in the study. The study will be evaluated once a certain number of deaths (events) have occurred, which is currently estimated to be reached around two years after completion of patient enrollment. MOLOGEN is continuously and closely monitoring the events and the corresponding timeline for the results.

Colorectal cancer
Colorectal cancer is one of the most common cancers worldwide with 1,361,000 cases in 2012. In the same year it accounted for approximately 694,000 deaths worldwide. In the US 134,000 cases have occurred in 2012, and 55,000 people have died from this disease.
About IMPALA
IMPALA (Immunomodulatory MGN1703 in Patients with Advanced Colorectal Carcinoma with tumor reduction during induction treatment) is a pivotal, randomized, international, multicenter, open-label phase III trial. The study aims to prove that a switch maintenance therapy with an active immunotherapy with lefitolimod leads to an increased overall survival of patients who have achieved a response during their first line treatment of metastatic colorectal cancer. The primary endpoint is overall survival and secondary study endpoints include progression-free survival, safety and tolerability, as well as Quality of Life (QoL).

The study is conducted in collaboration with three renowned national study groups: Arbeitsgemeinschaft Internistische Onkologie (AIO) in Germany, Grupo Españiol de Tratamiento de Tumores Digestivos (TTD) in Spain and Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR) in France. The steering committee consists of internationally recognized medical experts including Prof. David Cunningham, MD, Department of Medicine and Director of Clinical Research, Royal Marsden Hospital, London, UK, as coordinating investigator

On May 15, 2017 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of disease-driving genes, reported that the first patient has been dosed in the Phase 1 clinical trial of SY-1365, its first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, in patients with advanced solid tumors, including transcriptionally dependent cancers such as triple negative breast, small cell lung and ovarian cancers (Press release, Syros Pharmaceuticals, MAY 15, 2017, View Source [SID1234519132]).

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"SY-1365 represents a promising new approach for treating a number of aggressive cancers that have eluded treatment with other targeted approaches," said Anthony W. Tolcher, M.D., Director of Clinical Research at South Texas Accelerated Research Therapeutics (START), and a clinical investigator in the trial. "Certain cancers are particularly dependent on high expression of transcription factors for their growth and survival, and SY-1365 has shown substantial anti-tumor activity in preclinical models of these cancers. We’re pleased to have enrolled the first patient in this clinical trial and look forward to further investigating SY-1365 for patients with these difficult-to-treat solid tumors."

SY-1365 has shown significant anti-proliferative and pro-apoptotic activity in multiple preclinical models of difficult-to-treat solid tumors, including triple negative breast, small cell lung and ovarian cancers. SY-1365 has induced anti-tumor activity in both cell line-derived xenograft and patient-derived xenograft models of triple negative breast cancer, including complete regressions at a twice weekly dosing regimen consistent with the initial regimen being used in the Phase 1 clinical trial. In preclinical models, SY-1365 has also been shown to preferentially kill cancer cells over non-cancerous cells and can lower the expression of oncogenic transcription factors, including MYC.

"Patients with triple negative breast, small cell lung and ovarian cancers, as well as other transcriptionally dependent cancers, are in dire need of better treatment options," said David A. Roth, M.D., Chief Medical Officer of Syros. "Based on the strong preclinical data, we believe SY-1365 could provide a meaningful benefit for patients with these cancers. We have designed our Phase 1 trial to efficiently assess early proof of mechanism during the dose escalation phase and early anti-tumor activity by focusing the expansion phase of the trial on a set of transcriptionally dependent tumors that are most sensitive to CDK7 inhibition and for which early anti-tumor activity may be observed."

The Phase 1 trial is a multi-center, open-label trial that is expected to enroll approximately 70 patients with advanced solid tumors, including expansion cohorts focused on transcriptionally dependent cancers. The primary objective of the trial is to assess the safety and tolerability of escalating doses of SY-1365, with the goal of establishing a maximum tolerated dose and a recommended Phase 2 dose and regimen. The dose-escalation phase will be open to solid tumor patients for whom standard curative or palliative measures do not exist or are no longer effective. Following the dose-escalation phase, expansion cohorts are planned to further evaluate the safety and anti-tumor activity of SY-1365 in patients with triple negative breast, small cell lung and ovarian cancers, to confirm a recommended Phase 2 dose and regimen, and to enroll patients with tumors of any histology in a cohort focused on analyzing biopsied tumor tissue. Syros plans to expand future clinical development of SY-1365 into acute leukemias based on the data generated in this trial. Additional details about the trial can be found using the identifier NCT03134638 at www.clinicaltrials.gov.