On December 7, 2017 Northwest Biotherapeutics (OTCQB: NWBO) (NWBio), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that it has completed a $12 million financing to fund operations (Press release, Northwest Biotherapeutics, DEC 7, 2017, View Source [SID1234522446]). The majority of the financing is being provided by new investors.

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The financing is in the form of Series A Convertible Preferred Stock and Warrants. The Preferred Stock will be convertible into common stock, but only when common stock is available or after 6 months following issuance. The Warrants will be exercisable for common stock, but only when common stock is available. The shares are registered, but are subject to restrictions under which they may not be conveyed or traded until a shareholder vote takes place, pursuant to which the number of authorized shares is increased. The shares are also subject to a voting agreement, under which the investors have agreed to vote in support of such increase in authorized shares.

The investors are purchasing the Series A Preferred Stock at a price of $1.70 per share, and each such preferred share will be convertible into 10 common shares valued at $0.17 cents per share. The investors are also receiving Warrants for a number of common shares equal to the number of conversion shares, with an exercise price of $0.22 per share and an exercise period of two years.

As reported in the Company’s recent 10-Q filing, the Company has been in discussions with investors for this financing during the last couple of months. During this period, while the price of the Company’s common stock hovered mostly at $0.16- $0.17 per share, the terms were set at $0.17 per share of common stock and $0.22 exercise price for the warrants. As also previously reported, some of the investors provided advance funding prior to completion of the financing and its documentation.

Linda Powers, the Company’s CEO, commented, "We are pleased to see a growing number of new investors becoming interested in our DCVax technology and its encouraging potential, and providing the majority of the largest financing we have done this year. We are also grateful for our long-term, patient and loyal shareholder base, and their participation in this financing as well. It is gratifying to have both ongoing and expanded support as we move forward with our ongoing Phase 3 trial (in which we are continuing to ship doses, treat patients and collect data) and other programs we have been preparing."

On December 7, 2017 Radius Health, Inc. (Nasdaq:RDUS) reported an update on data from the Phase 1 005 clinical study of elacestrant (RAD1901), an oral selective estrogen receptor degrader (SERD), in patients with estrogen receptor positive (ER+) breast cancer (Press release, Radius, DEC 7, 2017, View Source [SID1234522447]). The data were presented at a Spotlight Presentation (Abstract 1410) during the 2017 San Antonio Breast Cancer Symposium (SABCS). Elacestrant recently received Fast Track designation from the U.S. Food and Drug Administration.

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There are 40 patients that have been treated at the 400 mg dose in the elacestrant Phase I dose escalation and expansion cohorts. All study participants are heavily pretreated ER+, HER2-negative, advanced breast cancer patients that have received a median of three prior lines of systemic therapy and have evaluable advanced or metastatic disease. Of the enrolled patients, 22 patients met the RECIST measurable disease criteria at baseline and there were 6 confirmed partial responses in this group. Elacestrant was well-tolerated with the most common adverse events being low grade nausea, dyspepsia and vomiting.

"It is quite encouraging to see the clinical activity with elacestrant in the heavily pretreated advanced patient population, and further therapeutic development is warranted for patients with hormone receptor positive breast cancer", commented Dr. Aditya Bardia, Director of Precision Medicine and attending physician at Center for Breast Cancer, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA.

Radius plans to initiate a Phase 2 clinical study of elacestrant monotherapy, a potentially pivotal study, for women with advanced or metastatic ER+/HER2- breast cancer early in 2018.

"Patients cycle through and generally do not repeat treatment regimens, limiting treatment options as their disease advances. We are pleased about the potential to offer patients who have progressed or relapsed during their current standard of care with a new treatment option," said Gary Hattersley, PhD, Chief Scientific Officer. "Radius is committed to developing and to providing breast cancer patients with the next generation of hormonal treatment options, as a single agent and in combination, across all lines of therapy."

An update on data from the elacestrant FES PET 106 Phase I clinical study in the EU was presented yesterday and demonstrated that elacestrant reduces 18F-FES uptake in patients with advanced ER+ breast cancer who progressed on prior endocrine therapy. The reduction in FES uptake supports elacestrant dose selection for further clinical development and was similar in patients harboring mutant or wildtype ESR-1. Three preclinical poster presentations further highlighting and demonstrating elacestrant activity, as a single agent and in combination with other targeted therapies, will be presented tomorrow morning at SABCS.

Following a strategic review, Radius has decided to discontinue further evaluation of elacestrant for vasomotor symptoms and will focus instead on the continued clinical development of the compound as a potential treatment option in breast cancer.

WEBCAST/CONFERENCE CALL

In conjunction with today’s elacestrant Spotlight presentation at SABCS, Radius will host a conference call and live webcast at 8:00 p.m. CT today to discuss the results of the Phase I program as of the cutoff date of October 30, 2017 and provide a company update.

The live webcast titled "Oncology Program Update from San Antonio Breast Cancer Symposium — 2017" will be available at View Source or by visiting the Investors section of Radius’ website at View Source

Conference call information:

Domestic Dial-in Number: (866) 323-7965
International Dial-in Number: (346) 406-0961
Conference ID: 9089206

A replay of the webcast will be available on the company’s website, www.radiuspharm.com in the Investor section under Events and Presentations for 7 days following the live webcast.

About Elacestrant (RAD1901)
Elacestrant is a selective estrogen receptor degrader (SERD), which is being evaluated for potential use as a once daily oral treatment for hormone-receptor positive breast cancer. Elacestrant is currently being investigated for potential use in women with advanced estrogen receptor positive, HER2 negative, breast cancer, the most common form of the disease. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer.

Additional information on the clinical trial program of elacestrant (RAD1901) is available on www.clinicaltrials.gov.

On December 7, 2017 ERYTECH Pharma (Euronext Paris: ERYP) (Nasdaq: ERYP) ("ERYTECH"), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported topline results from its Phase 2b clinical study evaluating eryaspase (GRASPA) for the treatment of acute myeloid leukemia (AML) (Press release, ERYtech Pharma, DEC 7, 2017, View Source [SID1234522449]).

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The open-label, randomized, multi-center clinical study, evaluated eryaspase in newly diagnosed AML patients over the age of 65 and unfit for intensive chemotherapy. The study enrolled a total of 123 patients at 30 European sites. The median age of the patients was 78 years. Patients were randomized two-to-one to receive eryaspase in combination with low-dose cytarabine (LDAC) versus LDAC alone. The primary endpoint in this proof-of concept study was overall survival (OS). The key secondary endpoints included progression free survival, overall response and toxicity. The study was performed in collaboration with Orphan Europe (Recordati Group), ERYTECH’s partner for the anticipated commercialization of GRASPA for the treatment of ALL and AML in Europe.

The study did not meet its primary endpoint of overall survival (OS). The OS Hazard Ratio (HR) was 1.06 (95% CI; 0.70, 1.61). When adjusting for minor imbalances in the main prognostic factors at baseline (age, karyotype and FAB status), the OS HR was 0.98 (95% CI; 0.64, 1.50). The median number of months on treatment was less then 2 months in both treatment arms. The toxicity profile was acceptable and consistent with previously reported data for eryaspase.

"These data reflect the complexity of this disease, particularly in the older age group." commented Iman El-Hariry, MD, PhD, Chief Medical Officer of ERYTECH. "While we are disappointed with the outcome, we are reassured with the safety profile of eryaspase in these very frail and elderly patients."

Gil Beyen, Chairman and CEO of ERYTECH, added, "Although clearly disappointing, these results do not change our commitment to the development of the eryaspase product candidate. Eryaspase has shown positive safety and efficacy results in the treatment of pancreatic cancer and acute lymphoblastic leukemia and we remain committed to bringing this treatment option to patients in these and potential other indications."

ERYTECH will hold a conference call and webcast on Monday, December 11th at 10:00 am EST to discuss the results of this study. The full dataset will be discussed at a scientific congress in 2018.

Investors and analysts wishing to participate can access the call via the following teleconferencing numbers:

USA: +1 833 8186807 United-Kingdom: +080 00323836
Switzerland: +080 0561782 Germany: +080 01815287
France: +080 5081485 Belgium: +080 073308
Sweden: +020 798505 Finland : +080 0412874
Netherlands: +080 00200089

Password: 6983889

The webcast can be followed live online via the following link:

Webcast Link: View Source

An archive of the webcast will be available for 90 days on the "Webcast" section of the Company’s investor relations site at www.erytech.com.

Additionally, a replay of the call will be available for 7 days. To listen to the replay, please dial:

USA: +1 404 537 3406
Participant Password: 6983889

About acute myeloid leukemia (AML)

AML is a form of acute leukemia or blood cancer that results from the improper maturation of myeloid stem cells leading to the production of myeloblasts. The increasing numbers of abnormal blasts crowd out healthy cells in bone marrow (resulting in infection, anemia, and bleeding) and can spread to other parts of body. With about 40,000 new patients per year in Europe and the United States, AML is the most common type of acute leukemia. Affecting mainly the adult and senior patient population, the median age of patients diagnosed with AML is approximately 67 years, and AML represents one of the highest mortality rates among all type of cancers and an important unmet medical need.

On December 7, 2017 AVEO Oncology (NASDAQ:AVEO) reported clinical updates for two of its oncology programs: FOTIVDA (tivozanib), the Company’s potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors, and ficlatuzumab, the Company’s humanized IgG1 antibody that binds to the hepatocyte growth factor (HGF) ligand with high affinity and specificity to inhibit the biological activities of the HGF/c-Met pathway (Press release, AVEO, DEC 7, 2017, View Source;p=RssLanding&cat=news&id=2321570 [SID1234522414]).

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"We continue to build strong momentum in our oncology programs, including progress with our lead program, tivozanib, and the advancement of our other oncology programs, including ficlatuzumab and AV-203," said Michael Bailey, president and chief executive officer of AVEO. "With approval of tivozanib and commercial sales underway in Europe, we are squarely focused on the next two pillars of our tivozanib strategy: the potential for U.S. registration and additional immunotherapy combination studies. As these strategies unfold, 2018 is expected to be another transformative year, with anticipated top-line results in the TIVO-3 study of tivozanib in third line advanced renal cell carcinoma (RCC), as well as development of our earlier-stage programs, including the TiNivo study of tivozanib in combination with Opdivo, and the initiation of two ficlatuzumab investigator-sponsored studies."

Tivozanib Updates

Enrollment Complete in Phase 2 Portion of Phase 1/2 TiNivo Trial in Advanced RCC. AVEO announced today that enrollment of 21 patients is now complete, with one patient remaining in screening, in the Phase 2 portion of the TiNivo study, a Phase 1/2 multicenter trial of tivozanib in combination with Bristol-Myers Squibb’s OPDIVO (nivolumab), an immune checkpoint, or PD-1, inhibitor, for the treatment of advanced RCC. In the Phase 1 dose escalation portion of the trial, tivozanib was administered in two escalating dose cohorts, 1.0 and 1.5 mg daily, in combination with nivolumab at 240 mg every 2 weeks (n=6).

Phase 1 data from the study, which were presented at the 16th International Kidney Cancer Symposium, demonstrated that the combination of Opdivo and tivozanib was well tolerated up to the full dose and schedule of single agent tivozanib (1.5 mg daily), with no dose limiting toxicities. The most common adverse events (any grade) were hypertension, asthenia and decreased appetite. No grade 4 adverse events were reported. Two grade 3 events were reported beyond cycle 1 (stomatitis and increased ALT), which did not lead to study discontinuation and were managed concurrently. Best response at the time of presentation included a 67% (4/6) partial response (PR) rate and a 100% disease control rate (4 confirmed PR + 2 stable disease, 1 of which was unconfirmed). Additional results from the Phase 1 portion of the trial and initial results from the Phase 2 portion are expected to be presented at scientific meetings in the first half of 2018, including at the 2018 Genitourinary Cancers Symposium taking place February 8-10, 2018, and co-sponsored by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).
Ficlatuzumab Updates

Phase 2 Study of Ficlatuzumab in Combination with Cetuximab in HNSCC Initiated. The Company announced today the initiation of an investigator-sponsored randomized, multicenter Phase 2 trial of ficlatuzumab and cetuximab (ERBITUX), an EGFR-targeted antibody, in patients with cetuximab-resistant, metastatic head and neck squamous cell carcinoma (HNSCC). AVEO is partnered with Biodesix, Inc. on the developments of ficlatuzumab. The study will seek to confirm findings from a Phase 1 study where the addition of ficlatuzumab to cetuximab resulted in a disease control rate of 67%, and prolonged progression free and overall survival compared to historical controls, in addition to being well tolerated. This Phase 2 multi-center study, which is being conducted under the direction of Julie E. Bauman, MD, MPH, Professor of Medicine, Chief, Division of Hematology/Oncology, Associate Director of Translational Research, University of Arizona Cancer Center, is expected to enroll approximately 60 patients randomized to receive either ficlatuzumab alone or ficlatuzumab and cetuximab.
Phase 1b Study of Ficlatuzumab in Combination with Gemcitabine and Nab-paclitaxel in Pancreatic Cancer Initiated. The Company announced today the initiation of an investigator-sponsored Phase 1b study to test the safety and tolerability of ficlatuzumab when combined with Nab-paclitaxel and Gemcitabine in previously untreated metastatic pancreatic ductal cancer (PDAC). The goal of the study, which is based on preclinical findings demonstrating a synergistic effect of these drugs in a preclinical model of PDAC, is designed to determine maximum tolerated dose of ficlatuzumab when combined with gemcitabine and nab-paclitaxel. Secondary outcome measures include response rate and progression free survival. The study, which is being conducted under the direction of Kimberly Perez, M.D. at the Dana-Farber Cancer Institute, is expected to enroll approximately 30 patients.
About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma in the European Union plus Norway and Iceland. 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 Ficlatuzumab

Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) inhibitory antibody that binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. AVEO and Biodesix, Inc. currently divide all worldwide development costs for ficlatuzumab and are seeking a commercialization partner. Ficlatuzumab is currently being evaluated in investigator-sponsored trials in squamous cell carcinoma

On December 7, 2017 Generex Biotechnology Corporation (OTCQB:GNBT) (View Source) (www.generex.com) reported that its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com), has entered into a License and Research Agreement with Shenzhen BioScien Pharmaceuticals Co. Ltd. www.BioScien.cn to develop and commercialize the Antigen Express AE37 immunotherapeutic vaccine for prostate cancer in the People’s Republic of China (including Taiwan, Hong Kong, and Macau) (Press release, Generex, DEC 7, 2017, View Source [SID1234522511]).

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"We are pleased to be able to include this in our innovative pipeline of novel therapeutics."
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A previously completed Phase I study of the vaccine conducted by Antigen Express in patients with prostate cancer demonstrated robust, long-term, and specific activation of cancer-fighting T cells in immunized patients.

Shenzhen BioScien will pay Generex a non-refundable, up-front license fee of $700,000 USD. Under the Agreement, Shenzhen BioScien will also make milestone payments to Generex of $1,000,000 USD each upon completion of the Phase II and Phase III clinical studies of the vaccine as well as a milestone payment of $2,000,000 USD upon regulatory approval of the vaccine in the territory. Generex will also receive a 10% royalty on net sales of the product.

Under the Agreement, Shenzhen BioScien has responsibility for paying for and conducting the clinical trials, securing Chinese regulatory approvals, and the manufacturing, marketing, distribution, and sale of the product. The clinical trials will be designed and conducted so as to meet the regulatory requirements of the U.S. Food and Drug Administration and the European Medicines Agency and Antigen Express will have free access to all data for support of global regulatory filings and further development and commercialization initiatives outside the licensed territories.

The AE37 vaccine is designed using a proprietary technology platform that ensures a more robust and long-lasting immune response than would be possible otherwise. In addition to the Phase I prostate study, the clinical activity of AE37 has been demonstrated in a controlled, randomized Phase II study in 300 breast cancer patients. Based on encouraging efficacy data from that study, the Company has entered into an agreement with Merck (d.b.a. as Merck Sharp & Dohme outside the United States and Canada) to evaluate Antigen’s AE37 cancer vaccine in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA (pembrolizumab), in patients with metastatic triple-negative breast cancer.

"We are delighted that Shenzhen BioScien will continue development of AE37 for prostate cancer," said Joe Moscato, President & Chief Executive Officer of Generex. "AE37 is the lead compound being developed using our Antigen Express technology platform. The clinical studies conducted to date establish the wide applicability of AE37 and its underlying Ii-Key technology. This license, together with the Merck collaboration, highlights the value of the core assets of Generex as we reinvigorate those assets in the wake of our recently completed reorganization."

"The AE37 cancer vaccine has shown impressive results in clinical trials," said Dr. Yinke Yang, Chief Executive Officer of Shenzhen BioScien. "We are pleased to be able to include this in our innovative pipeline of novel therapeutics."