On July 1, 2015 Exelixis reported yesterday Exelixis’ partner Genentech, a member of the Roche Group, informed Exelixis that, in order to accommodate its review of a supplemental data submission, the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for its review of Genentech’s New Drug Application (NDA) for cobimetinib by the standard extension period of three months, from August 11, 2015 to November 11, 2015 (Press release, Exelixis, JUL 1, 2015, View Source;p=RssLanding&cat=news&id=2064058 [SID:1234506017]).

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FDA extended its review after Genentech submitted, at FDA request, additional data from coBRIM, the phase 3 registrational trial of cobimetinib and vemurafenib in patients with BRAF V600 mutation-positive advanced melanoma.

Exelixis discovered cobimetinib, a selective inhibitor of MEK, internally and advanced the compound to investigational new drug (IND) status. In late 2006, Exelixis entered into a collaboration agreement with Genentech, under which Exelixis received initial upfront and milestone payments in connection with signing the agreement and submitting the IND. Exelixis was responsible for development of cobimetinib through the determination of the maximum tolerated dose in phase 1, at which point Genentech exercised its option to further develop the compound.

In November 2013, Exelixis exercised its option to co-promote cobimetinib, if approved, in the United States. Exelixis is entitled to an initial equal share of U.S. profits and losses, which will decrease as sales increase, and will share equally in the U.S. marketing and commercialization costs. Exelixis is eligible to receive royalties on any sales of the product outside the United States.

About the Cobimetinib and Vemurafenib Combination

Cobimetinib is a selective inhibitor that blocks the activity of MEK, a protein kinase that is part of a key pathway (the RAS-RAF-MEK-ERK pathway) that promotes cell division and survival. This pathway is frequently activated in human cancers including melanoma, where mutation of one of its components (BRAF) causes abnormal activation in about 50% of tumors. Tumors with BRAF mutations may develop resistance and subsequently progress after treatment with a BRAF inhibitor. In preclinical melanoma models, co-treatment with a BRAF inhibitor and a MEK inhibitor may delay the emergence of resistant tumors. In addition to the combination with vemurafenib in melanoma, cobimetinib is also being investigated in combination with several investigational medicines, including an immunotherapy, in several tumor types, including non-small cell lung cancer, colorectal cancer, triple-negative breast cancer and melanoma.

On June 30, 2015 Telesta Therapeutics Inc. (TSX: TST) (PNK: BNHLF) reported that it has submitted electronically, through its U.S. agent, a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for MCNA1 (Press release, Telesta Therapeutics, JUN 30, 2015, View Source [SID:1234507864]). MCNA is Telesta’s novel biologic immunotherapeutic for the treatment of high-risk non-muscle invasive bladder cancer patients who have failed first-line BCG therapy.

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Telesta also announced today that they have received from the FDA a waiver exempting Telesta from the payment of the $US2.3 million BLA application fee.

The FDA has a 60-day filing review period to determine whether Telesta’s BLA submission for MCNA is complete and acceptable for filing, whether MCNA will be designated for priority review or standard review and whether an advisory committee meeting will be scheduled. Their decisions on these items will be communicated to Telesta in the FDA’s official filing communication known as the "Day-74 letter". Telesta will communicate the FDA’s filing decisions upon receipt.

Telesta’s BLA submission has been made following extensive and ongoing dialogue with the US FDA, including a formal pre-BLA meeting in November, 2014 and a Type C facility meeting in February, 2015. As part of this process, Telesta has incorporated the FDA’s recommendations into the current submission and the Company has also been working with top tier regulatory consultants to ensure that their BLA submission meets all current regulatory requirements.

Concurrently with this BLA submission, Telesta confirmed the completion of a number of upgrades and improvements to Telesta’s manufacturing facility and operating procedures, undertaken following recommendations received from the FDA at the Type C facility meeting held in February. As previously announced, these improvements were implemented by Telesta to ensure that their manufacturing facility is well positioned for the FDA pre-approval inspection that will take place as part of the FDA’s formal review process.

"The BLA submission for MCNA marks an major step towards our ultimate goal of providing bladder cancer patients and the medical professionals in the urology community, with a therapeutic alternative to radical cystectomy," said Dr. Michael Berendt, CEO & Chief Scientist of Telesta Therapeutics. "There is an urgent and unmet medical need to develop new therapies for bladder cancer patients who have not seen new therapies approved for almost 20 years. I am incredibly proud of Telesta’s dedicated and talented employees, many of whom have been working for more than a decade to advance this important therapeutic agent, for their hard work and professionalism that has permitted us to achieve this key corporate milestone."

Current practice guidelines for the treatment of high-risk non-muscle invasive bladder cancer patients who are refractory to or have relapsed from first line BCG therapy call for radical cystectomy (surgical removal of the bladder and adjacent organs). MCNA was developed to provide a much-needed therapeutic option for these patients. This BLA submission is the first step towards the potential regulatory approval and commercialization of MCNA, which could become the first approved therapeutic alternative for these high-risk bladder cancer patients since 1998. The approval of MCNA in the U.S. could occur as early as Q1/2016 should the FDA designate the MCNA BLA submission for priority review.

About MCNA

Telesta’s MCNA is a biologic therapy derived from the cell wall fractionation of a non-pathogenic bacteria. Its activity is believed to be through a dual mechanism of immune stimulation and direct anti-cancer effects. MCNA was developed to be delivered as a sterile suspension for intravesical administration by urologists and urology nurses, following the same dosing paradigm as first-line BCG therapy, with the advantage that it can be prepared, handled and disposed of easily and safely. The efficacy, duration of responses and safety data from MCNA’s pivotal Phase 3 trial were recently published in the Journal of Urology2. Telesta continues to prosecute novel composition of matter, methods of use and manufacturing patents in most regions of the world and recently announced the granting of the key composition of matter patent in the United States providing intellectual property coverage of MCNA to 2031.

A recent commercial assessment, conducted by Medical Marketing Economics ("MME"), a global leader in the development of value-based strategies and market research, employed rigorous qualitative and quantitative primary market research with payers (managed care organizations/decision makers both from the private and public sector) and over 100 urologists (community urologists and key opinion leaders), to define market size, pricing strategy and market access context as well as reimbursement potential for MCNA. This study confirmed a commercial U.S. market opportunity of more than $400 million and clearly established that the target product profile of MCNA represents an extremely interesting therapeutic option for practicing urologists.

About Telesta Therapeutics Inc.

Telesta Therapeutics Inc. is a late stage therapeutics company with near term commercial potential focused on the manufacturing, marketing and licensing/acquisition of proprietary and innovative therapies for the global health market. The Company’s primary goal is to develop and commercialize products that advance human health and increase shareholder value. For more information, please visit www.telestatherapeutics.com

On June 30, 2015 Medigene AG (MDG1, Frankfurt, Prime Standard) completed the capital increase reported on 12 June 2015 for the funding of its cancer immunotherapy programmes, achieving gross proceeds of approximately EUR 46.4 million by placing the maximum number of 5,594,178 new offered shares to existing shareholders and selected new institutional investors for the subscription and placement price of EUR 8.30 (Press release, MediGene, JUN 30, 2015, View Source [SID:1234506543]). Gross proceeds from the placement exceeded the Company’s targeted EUR 40 million raise by over 15%. The rump placement was oversubscribed. A US-based specialist institutional investor participated as the cornerstone investor in the transaction and as a new investor in Medigene AG.

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Dr Frank Mathias, Chief Executive Officer of Medigene AG: "With this capital measure which was successfully completed despite a difficult European market environment we are now well-positioned to further advance our cancer immunotherapy programmes into decisive new stages of development. We plan to deliver final clinical data from the current phase I/II trial with our DC vaccines, initiate up to three clinical trials with our TCR programme and develop up to 10 TCR lead candidates thereby extending and accelerating the clinical development of our T cell based therapies. We feel encouraged by having gained new and leading international biotech investors for our goals and are highly motivated to make our promising cancer therapies usable for patients."

By issuing 5,594,178 new shares from authorised capital, the share capital of Medigene AG increases by EUR 5,594,178.00 from EUR 14,051,815.00 to EUR 19,645,993.00. The gross proceeds generated from the issuing of new shares amounts to EUR 46,431,677. The new shares are scheduled to be admitted to trading from 6 July up to 13 August with ISIN DE000A161NA3, securities identification number WKN A161NA and stock exchange symbol MDGJ. From 14 August 2015 on, the new shares will have the same ISIN, securities identification number (WKN) and stock exchange symbol as the existing Medigene shares (ISIN: DE000A1X3W00, WKN: A1X 3W0, MDG1).

Baader Bank AG acted as sole global coordinator and sole bookrunner. Trout Capital LLC acted as the US selling agent.

About Medigene’s Immunotherapies: Medigene is working on three complementary immunotherapy strategies for the treatment of different forms and stages of cancer with focus on T-cells which play a central role in the immune system. The Company is developing new generation antigen-tailored dendritic cell vaccines (DCs), T-cell receptor-based adoptive T-cell therapies and T-cell-specific monoclonal antibodies (TABs).

The DC vaccines are currently being evaluated in a company-sponsored clinical trial in acute myeloid leukaemia (AML). Further studies utilizing Medigene’s DC vaccine technologies include two ongoing clinical investigator-initiated trials (IITs), a clinical phase II trial (prostate cancer) at Oslo University Hospital and a clinical phase I/II trial (AML) at the Ludwig-Maximilians University Hospital Großhadern, Munich, as well as a compassionate use programme[1] including patients with diverse malignancies.

For the TCR platform, the activities are focused on the preparation of the first clinical trial with TCR product candidates and on the further development of a GMP compliant production process. In addition, novel TCRs with specificities for promising tumour-associated antigens will be isolated and further characterised. Medigene plans to participate in an academic Phase I trial for the treatment of haematological malignancies which is projected to commence in the first half of 2016, subject to grant funding.

On June 30, 2015 Aeterna Zentaris reported that it has reached its goal of recruiting 500 patients for its pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) clinical study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer (Press release, AEterna Zentaris, JUN 30, 2015, View Source;q=675 [SID:1234506531]). The trial is being conducted in over 120 sites in North America, Europe and Israel. The primary efficacy endpoint is improvement in overall survival.

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Following its first pre specified interim analysis last April, a Data and Safety Monitoring Board recommended that the ZoptEC Phase 3 study continue as planned. A second interim analysis is expected during Q4, 2015 at approximately 192 events, with the final analysis planned at an anticipated 384 events. The trial is expected to be completed by the end of 2016.

David A. Dodd, Chairman and CEO of Aeterna Zentaris, commented, "We are very excited to have completed patient recruitment for our ZoptEC Phase 3 trial in endometrial cancer earlier than expected, and I would like to thank everyone involved in this project for their steadfast commitment. We believe zoptarelin doxorubicin has the potential to become the first FDA approved medical therapy for advanced, recurrent endometrial cancer. This could result in its rapid adoption as a novel core therapy for patient treatment and management, and therefore, could represent a significant market opportunity for the Company. Moving forward, we are continuing to develop our commercialization plans regarding zoptarelin doxorubicin in this indication, including establishing additional partnerships in territories that we do not intend to pursue ourselves. Furthermore, contingent on the success of the ZoptEC program, we have additional areas of interest for further therapeutic development, including ovarian, prostate and triple negative breast cancer. Our commitment is to provide therapies to patients and their physicians that can potentially improve and extend the quality of lives."

About the ZoptEC Phase 3 trial

The ZoptEC Phase 3 trial is an open-label, randomized-controlled study, comparing the efficacy and safety of zoptarelin doxorubicin, a hybrid molecule composed of a synthetic peptide carrier and a well known chemotherapy agent, doxorubicin, to doxorubicin alone. It is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration ("FDA"). Patients are centrally randomized in a 1:1 ratio and receive either zoptarelin doxorubicin (267 mg/m2) or doxorubicin (60 mg/m2) intravenously, every 3 weeks and for up to 9 cycles. Response will be evaluated every 3 cycles during treatment, thereafter, every 12 weeks until progression. All patients will be followed for survival as the primary efficacy endpoint ("EP"). Secondary EPs include progression free survival, objective response-rate, and clinical benefit rate.

For more information on this trial, please consult (ClinicalTrials.gov Identifier: NCT01767155; EudraCT No: 2012-005546-38; ZoptEC: Zoptarelin doxorubicin in endometrial cancer).

About Zoptarelin Doxorubicin

Zoptarelin doxorubicin represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. Zoptarelin doxorubicin is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically to LHRH-receptor expressing tumors, which could result in a more targeted treatment with less damage to healthy tissue. The Company is currently conducting a ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 trial in women with advanced, recurrent or metastatic endometrial cancer, while zoptarelin doxorubicin is also in an investigator initiated Phase 2 trial in prostate cancer. Aeterna Zentaris owns the worldwide rights to this compound except in China (including Hong Kong and Macau) where rights have been out-licensed to Sinopharm A-Think Pharmaceuticals, a subsidiary of Sinopharm, the largest medical and healthcare group in China and on Fortune’s Global 500 list. On April 16, 2015, the Company announced the filing of a patent application intended to strengthen the exclusivity of zoptarelin doxorubicin through a unique, significantly lower cost in the manufacturing process.

About Endometrial Cancer

Endometrial cancer is the most common gynecologic malignancy in developed countries and develops when abnormal cells amass to form a tumor in the lining of the uterus. It largely affects women over the age of 50 with a higher prevalence in Caucasians and a higher mortality rate among African Americans. According to the American Cancer Society, there will be approximately 55,000 new cases of endometrial cancer in the U.S. alone in 2015, with about 20% of recurring disease.