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Advaxis Submits Investigational New Drug Application for Phase 1/2 Study of ADXS-HPV and MedImmune’s MEDI4736 for the Treatment of HPV-Associated Cervical and Head & Neck Cancer

On November 12, 2014 Advaxis reported that the Company has submitted an Investigational New Drug application (IND) to the United States Food and Drug Administration (FDA) to conduct a Phase 1/2 study of ADXS-HPV (ADXS11-001) alone or in combination with MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, for the treatment of advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer (Press release Advaxis, NOV 12, 2014, View Source [SID:1234500957]).

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This follows the press release issued in July 2014 announcing the clinical trial collaboration between Advaxis and MedImmune, the global biologics research and development arm of AstraZeneca.

ADXS-HPV is Advaxis’s lead Lm-LLO immunotherapy designed for the treatment of HPV-associated cancers. Preclinical evidence suggests that the combination of ADXS-HPV with a checkpoint inhibitor, such as MEDI4736, can enhance overall anti-tumour response.

Pending FDA’s acceptance of the IND submission, the proposed Phase 1/2 protocol is designed to evaluate the safety and efficacy of ADXS-HPV as monotherapy and in combination with MEDI4736. Specifically, the Phase 1 part of the trial is expected to establish a recommended dose regimen of ADXS-HPV with MEDI4736, and the Phase 2 portion will assess the safety and efficacy of the combination. The study is planned to begin in early 2015.

"The filing of our ADXS-HPV + MEDI4736 IND for HPV associated cervical and head and neck cancers is another significant advance in Advaxis’s clinical strategy as it adds to our rapidly growing pipeline and positions Advaxis as a clear leader in the immunotherapy-checkpoint inhibitor combination therapy market," commented Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. "Additionally, the filing of this IND and the recently announced filing of the ADXS-PSA + KEYTRUDA (pembrolizumab) IND demonstrate Advaxis’s ability to rapidly transition partnering agreements to clinical programs. Since announcing our agreements with MedImmune and Merck in July and August, respectively, we have worked diligently with both companies’ research teams to develop IND filings involving each company’s checkpoint inhibitor that, upon acceptance by FDA, should enable us to initiate two Phase 1/2 trials in early 2015."

Within 30 calendar days of the IND filing, FDA will notify Advaxis of any questions it has or protocol revisions it requests which may delay this timing. Advaxis plans to work with the FDA review team to address any questions or requests that arise within this 30-day window.

Blueprint Medicines Secures $50 Million in Series C Financing

On November 12, 2014 Blueprint Medicines reported the completion of a $50 million Series C financing (Press release Blueprint Medicines, NOV 12, 2014, View Source [SID:1234500956]). Proceeds from the financing will be used to advance Blueprint Medicines’ two lead product candidates through clinical trials in 2015 and fund the continued development of Blueprint Medicines’ kinase discovery platform and pipeline.

"The proceeds from this financing provide us with the financial strength to initiate clinical trials for our FGFR4 and KIT Exon 17 inhibitors in 2015 with the goal of establishing proof of concept rapidly and ultimately improving the lives of patients," said Jeffrey Albers, chief executive officer of Blueprint Medicines. "We are incredibly pleased to welcome such highly respected public investors to our shareholder base. Their investment provides strong endorsement for the quality of the platform, pipeline and team we’ve built at Blueprint Medicines over the past three years."

Blueprint Medicines’ Series C financing was led by Partner Fund Management and included additional new investors, Wellington Management Company, RA Capital, Tavistock Life Sciences, Perceptive Advisors, Sabby Capital, Cowen Investments and Redmile Group. The Company’s existing shareholders – Biotechnology Value Fund, Casdin Capital, Fidelity Biosciences, Nextech Invest and Third Rock Ventures – also participated in the financing.
"Blueprint Medicines’ proprietary kinase platform, which combines a first-of-its-kind chemical library and a novel genomics-based target discovery engine, holds significant value creation potential," said Alex Virgilio, Ph.D. of Partner Fund Management. "The team has achieved impressive results to date by rapidly discovering and advancing two first-in-class product candidates toward clinical development. We believe the team can sustainably replicate this success based on the strength of the platform in producing exquisitely selective inhibitors to novel genomically defined kinase targets."

Blueprint Medicines expects to initiate clinical trials in 2015 with its two lead product candidates:
 BLU-285 is the first known selective inhibitor of KIT Exon 17 mutants. The Company intends to initiate two clinical studies, including one for the underserved systemic mastocytosis patient population and another for genomically defined subsets of patients with gastrointestinal stromal tumors (GIST).
 BLU-554 is the first known selective FGFR4 inhibitor. Blueprint Medicines anticipates initiating a clinical study for patients suffering from hepatocellular carcinoma with aberrant FGFR4 pathway activation.

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8-K – Current report

On November 11, 2014 Threshold Pharmaceuticals reported that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for TH-302, an investigational anticancer drug, for the treatment of previously untreated patients with metastatic or locally advanced unresectable soft tissue sarcoma (STS) (Filing 8-K , Threshold Pharmaceuticals, NOV 12, 2014, View Source [SID:1234500955]).

The FDA established the Fast Track designation process to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. An important feature of Fast Track is that the FDA may consider a “rolling review” of completed sections of the New Drug Application (NDA) before the complete application is submitted.

“We are pleased that FDA has granted Fast Track status for TH-302 for the treatment of previously untreated patients with metastatic or locally advanced unresectable soft tissue sarcoma,” said Barry Selick, Ph.D., Chief Executive Officer of Threshold. “Our ongoing Phase 3 trial of TH-302 in these patients is being conducted under a Special Protocol Assessment with the FDA. If successful, the Fast Track designation may provide an added benefit of facilitating the NDA review process. Currently, we anticipate the primary analysis of overall survival of the Phase 3 trial to be conducted in the first quarter of 2016.”

About the Phase 3 Trial

Threshold is conducting this international, randomized pivotal Phase 3 clinical trial in partnership with the Sarcoma Alliance for Research through Collaboration (SARC) and under a Special Protocol Assessment (SPA) agreement with the U.S. FDA. The trial is designed to investigate the efficacy and safety of TH-302 in combination with doxorubicin, compared with doxorubicin alone, in previously untreated patients with metastatic or locally advanced unresectable STS. The primary endpoint of the trial is overall survival. Secondary endpoints include progression-free survival, overall response rate, pharmacokinetics and safety. Patients were randomized to either doxorubicin alone or to receive TH-302 300 mg/m2 administered intravenously on Days 1 and 8 with doxorubicin 75 mg/m2 on Day 1 of each 21-day cycle. After six cycles, patients with stable and/or responding disease could receive maintenance monotherapy with TH-302 according to the same dosing schedule, 300 mg/m2 Days 1 and 8 of each 21-day cycle. The trial enrolled a total of 640 patients across 81 study sites in Europe, Israel, North America and the Russian Federation.

Patrys to Initiate Clinical Trial with Onyx Pharmaceuticals

On November 11, 2013 Patrys reported that it is initiating an investigator-sponsored trial (IST) evaluating the effectiveness of Patrys’ lead anti-cancer drug PAT-SM6 in combination with carfilzomib, in patients with relapsed and refractory multiple myeloma (MM) (Press release Patrys, NOV 11, 2014, View Source [SID:1234500543]). The trial will be headed by Professor Dr. Hermann Einsele, Director of the Department of Medicine II, University of Würzburg, Germany, and is being funded by Onyx Pharmaceuticals, Inc., an Amgen subsidiary.
Both clinical and preclinical studies of PAT-SM6 conducted to date have shown evidence of activity in patients with relapsed and refractory MM. One of the notable features of PAT-SM6, being demonstrated in the currently-ongoing Phase I/IIa clinical trial, is the lack of serious side-effects in treated patients. This feature of PAT-SM6 may allow it to be safely administered in combination with carfilzomib and may have the potential to improve current treatments for MM. Carfilzomib is a proteasome inhibitor owned by Onyx, and is marketed in the United States (U.S.) under the brand name Kyprolis (carfilzomib) for Injection. Onyx will provide carfilzomib study drug for the trial.

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10-Q – Quarterly report [Sections 13 or 15(d)]

Dendreon has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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