On December 18, 2019 FerGene, a new gene therapy company launched by Ferring Pharmaceuticals and Blackstone Life Sciences in November, reported the appointment of David Meek as President and Chief Executive Officer, effective January 14, 2020 (Press release, FerGene, DEC 18, 2019, View Source [SID1234552477]).

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Mr. Meek has 30 years of industry experience. Most recently, he has served as CEO of Ipsen, a leading global biopharmaceutical company focused on innovation and specialty care and dedicated to improving lives through the discovery of new medicines in oncology, neuroscience and rare diseases.

"I’m honored to lead FerGene in this exciting role and spearhead the effort to develop and commercialize this critical and innovative therapy and advance its clinical development. We will build a committed, patient-centric team and with the support from Ferring and Blackstone Life Sciences, I am confident we can efficiently and effectively bring this life changing therapy to patients in need," said Mr. Meek.

Jean Duvall, Co-Chair of FerGene and Executive Committee member of Ferring Pharmaceuticals, said, "We are extremely confident in David and his ability to lead and build FerGene as it seeks to bring a promising therapy to market for bladder cancer patients and improve the standard of care. With an impressive track record of corporate leadership experience, David is poised to excel in this role."

Paris Panayiotopoulos, Co-Chair of FerGene and Blackstone Life Sciences Managing Director, said, "We are thrilled to welcome David as FerGene’s new CEO. David’s proven track record of growing businesses across both Biotech and Pharma, as well as his deep knowledge of the US Oncology market, make him the ideal fit to lead FerGene. David’s experience will be instrumental as we advance a breakthrough investigational gene therapy that offers the potential to meaningfully improve the standard of care for a patient population which has seen little innovation over the past twenty years."

FerGene was launched in November 2019 with a focus on US commercialization of nadofaragene firadenovec (rAd-IFN/Syn3), an investigational novel gene therapy in late stage development for patients with high-grade, Bacillus Calmette-Guérin (BCG) unresponsive, non-muscle invasive bladder cancer (NMIBC).

FerGene also recently announced Phase 3 study results of nadofaragene firadenovec, which FerGene reports met its primary endpoint with more than half of patients with high-grade, BCG unresponsive non-muscle invasive bladder cancer (cis ± ta/t1) achieving a complete response at three months.

While at Ipsen, Mr. Meek has led a growth strategy of financial results and pipeline advancement. He has also transformed Ipsen into a global biopharma growth leader with initiatives to transform external innovation, Ipsen’s R&D operations and build out the company’s footprint in countries like the U.S. and China. In addition to his time as CEO of Ipsen, Mr. Meek’s prior leadership roles have included serving as Executive Vice President & President of Oncology at Baxalta from 2014 – 2016, following its spin-off from Baxter. He was also Chief Commercial Officer of Endocyte from 2012 – 2014. Prior to that, Mr. Meek served in various executive leadership roles at Novartis Pharma and Novartis Oncology after beginning his career at Johnson & Johnson and Janssen from 1989 – 2004.

About nadofaragene firadenovec

Nadofaragene firadenovec (rAd-IFN/Syn3) is an investigational gene therapy being developed as a treatment for patients with high-grade, BCG unresponsive, NMIBC. It is an adenovirus vector-based gene therapy containing the gene interferon alfa-2b, administered by catheter into the bladder every three months. The vector enters the cells of the bladder wall, where, it breaks down, releasing the active gene to do its work. The internal gene/DNA machinery of the cells ‘picks up’ the gene and translates its DNA sequence, resulting in the cells secreting high quantities of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This novel gene therapy approach thereby turns the patient’s own bladder wall cells into multiple interferon microfactories, enhancing the body’s natural defenses against the cancer.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

NMIBC is an early form of bladder cancer which is present in the superficial layer of the bladder and has not invaded deeper into the bladder or spread to other parts of the body.1 It is estimated that there will be 80,000 new cases of bladder cancer in the U.S. in 2019; more than 70% of these cases present as NMIBC.2,,3 In patients with high-grade NMIBC, intravesical BCG is the recommended treatment; however, between 30% and 50% cases with high-grade disease will recur.4 The outcome for BCG unresponsive patients is poor, with total cystectomy (complete removal of the bladder) often being the next treatment option.5

On December 18, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tucatinib, in combination with trastuzumab and capecitabine, for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have been treated with trastuzumab, pertuzumab, and T-DM1 (Press release, Seattle Genetics, DEC 18, 2019, View Source [SID1234552476]). The positive topline results of the pivotal HER2CLIMB clinical trial were announced in October 2019, and additional data were presented at the 2019 San Antonio Breast Cancer Symposium (SABCS) on December 11, 2019 and were simultaneously published in the New England Journal of Medicine (NEJM). Tucatinib is an oral, small molecule tyrosine kinase inhibitor (TKI) that is highly selective for HER2.

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The FDA’s Breakthrough Therapy process is intended to expedite the development and review of promising drug candidates intended for serious or life-threatening conditions. Designation is based upon preliminary clinical evidence of the potential for substantial improvement over existing therapies on one or more clinically significant endpoints.

"The addition of tucatinib to the commonly used combination of trastuzumab and capecitabine demonstrated superior activity compared to trastuzumab and capecitabine alone in patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including those with and without brain metastases," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "The decision by the FDA to grant Breakthrough Therapy designation to tucatinib recognizes the urgent need for new medicines that can impact the lives of those with HER2-positive metastatic breast cancer. We intend to submit a New Drug Application to the FDA and an MAA to the EMA by the first quarter 2020, with the goal of making tucatinib available to patients in this setting as soon as possible."

This Breakthrough Therapy designation was based on data from the pivotal HER2CLIMB clinical trial, which compared tucatinib in combination with trastuzumab and capecitabine to trastuzumab and capecitabine alone in patients with locally advanced unresectable or metastatic HER2-positive breast cancer. Patients had previously received trastuzumab, pertuzumab and ado-trastuzumab emtansine (T-DM1). Patients had received a median of four prior lines of therapy overall and three in the metastatic setting. Forty-seven percent of the patients enrolled in the trial had brain metastases at the time of enrollment.

Data presented at SABCS and published in NEJM include the primary endpoint of progression-free survival (PFS) as assessed by blinded independent central review (BICR) in the first 480 patients enrolled in the trial. The primary endpoint of PFS showed that the addition of tucatinib was superior to trastuzumab and capecitabine alone, with a 46 percent reduction in the risk of disease progression or death (hazard ratio (HR)=0.54 (95% Confidence Interval (CI): 0.42, 0.71); p<0.00001). The trial met the two key secondary endpoints at interim analysis. The tucatinib arm demonstrated an improvement in overall survival, with a 34 percent reduction in the risk of death (HR=0.66 [95% CI: 0.50, 0.88]; p=0.0048), compared to the control arm. For patients with brain metastases at baseline, the tucatinib arm also demonstrated superior PFS, with a 52 percent reduction in the risk of disease progression or death, compared to the control arm (HR=0.48 [95% CI: 0.34, 0.69]; p<0.00001).

Tucatinib in combination with trastuzumab and capecitabine was generally well tolerated. The most common adverse events occurring in more than 20 percent of patients in the tucatinib arm vs. the control arm included diarrhea, palmar-plantar erythrodysaesthesia syndrome (PPE), nausea, fatigue, and vomiting. Discontinuation of tucatinib and placebo due to adverse events was 5.7 percent in the tucatinib arm and 3.0 percent in the control arm. Greater than or equal to Grade 3 diarrhea was seen in 12.9 percent of the patients in the tucatinib arm vs. 8.6 percent in the control arm. Antidiarrheal prophylaxis was not required per protocol. Antidiarrheals were used in less than half of all cycles where diarrhea was reported. In both treatment arms, when used, the duration of antidiarrheal treatment was short (median of 3 days/cycle). Greater than or equal to Grade 3 aspartate aminotransferase (AST) was seen in 4.5 percent of the patients in the tucatinib arm vs. 0.5 percent in the control arm, and alanine aminotransferase (ALT) elevation in 5.4 percent vs. 0.5 percent, respectively. Discontinuations due to liver transaminase elevations were infrequent in both arms (ALT: 1.0 vs. 0.5 percent; AST: 0.7 vs. 0.5 percent).

About HER2-Positive Breast Cancer

Patients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the aggressive spread of cancer cells. An estimated 271,270 new cases of invasive breast cancer will be diagnosed in the U.S. in 2019.1 Between 15 and 20 percent of breast cancer cases worldwide are HER2-positive.2 Historically, HER2-positive breast cancer tends to be more aggressive and more likely to recur than HER2-negative breast cancer.2, 3, 4 In patients with metastatic breast cancer, the most common site of first metastasis is in bone, followed by lung, brain, and liver.5, 6 Up to 50 percent of metastatic HER2-positive breast cancer patients develop brain metastases over time.2, 7 Despite recent treatment advances, there is still a significant need for new therapies that can impact metastatic disease, especially brain metastases. There are currently no approved therapies demonstrating progression-free survival or overall survival benefit for the treatment of patients with HER2-positive metastatic breast cancer after progression on T-DM1.8, 9, 10

About HER2CLIMB

HER2CLIMB is a multinational randomized (2:1), double-blind, placebo-controlled, active comparator, pivotal clinical trial comparing tucatinib in combination with trastuzumab and capecitabine compared with trastuzumab and capecitabine alone in patients with locally advanced unresectable or metastatic HER2-positive breast cancer who were previously treated with trastuzumab, pertuzumab and T-DM1. The primary endpoint of the trial was PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by blinded independent central review (BICR) in the first 480 patients enrolled in the trial. HER2CLIMB enrolled a total of 612 patients to support the analyses of key secondary endpoints, including overall survival, PFS per BICR in patients with brain metastases at baseline and confirmed objective response rate. Safety data were evaluated throughout the study.

About Tucatinib

Tucatinib is an investigational, orally bioavailable, potent tyrosine kinase inhibitor that is highly selective for HER2 without significant inhibition of EGFR. Inhibition of EGFR has been associated with significant toxicities, including skin rash and diarrhea. Tucatinib has shown activity as a single agent and in combination with both chemotherapy and other HER2 targeted agents such as trastuzumab.1,2 Studies of tucatinib in these combinations have shown activity both systemically and in brain metastases. HER2 is a growth factor receptor that is overexpressed in multiple cancers, including breast, colorectal and gastric cancers. HER2 mediates cell growth, differentiation and survival. Tucatinib has been granted orphan drug designation by the FDA for the treatment of breast cancer patients with brain metastases.

In addition to HER2CLIMB, tucatinib is being evaluated in a randomized, double-blind, placebo-controlled, multi-center phase 3 trial of tucatinib in combination with T-DM1 compared to T-DM1 alone, in patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including those with brain metastases, who have had prior treatment with a taxane and trastuzumab. The primary endpoint is progression-free survival per RECIST criteria. Secondary endpoints include overall survival, objective response rate and duration of response. The trial is being conducted in North America and is expected to enroll approximately 460 patients. More information about the phase 3 trial, including enrolling centers, is available at www.clinicaltrials.gov.

Tucatinib is also being evaluated in a multi-center, open-label, single-arm phase 2 clinical trial known as MOUNTAINEER, which is evaluating tucatinib in combination with trastuzumab in patients with HER2-positive, RAS wildtype metastatic or unresectable colorectal cancer. The primary endpoint of the trial is objective response rate by RECIST criteria. Progression-free survival, duration of response, overall survival and safety and tolerability of the combination regimen are secondary objectives. Results for 26 patients were evaluated in an analysis and presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress. Enrollment is ongoing. More information about the MOUNTAINEER trial, including enrolling centers, is available at www.clinicaltrials.gov.

On December 18, 2019 BioInvent International AB ("BioInvent" or the "Company") (OMXS: BINV) reported that it has entered into a clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ., USA, to evaluate the combination of BioInvent’s BI-1206, one of its proprietary anti-FcγRllB antibodies and MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in a Phase l/lla clinical trial for patients with solid tumors (Press release, BioInvent, DEC 18, 2019, View Source [SID1234552475]).

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Martin Welschof, CEO of BioInvent, said, "We are very pleased to have concluded this agreement with Merck, which helps us to expand BI-1206 clinical development to solid tumors in combination with one of the most powerful and successful immune-oncology drugs. This will enable us to build on recent preclinical data which demonstrates BI-1206’s ability to address an important mechanism of resistance to PD-1 inhibition."

The Phase l/lla clinical trial will evaluate the drug combination in patients with advanced solid tumors, who have been previously treated with anti-PD-1 or anti-PD-L1 antibodies, and is a multicenter, dose-finding, consecutive-cohort, open-label trial. BI-1206 is currently being investigated in non-Hodgkin lymphoma and chronic lymphocytic leukemia.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

On December 18, 2019 Varian (NYSE: VAR) reported its first quarter fiscal year 2020 earnings release date (Press release, Varian Medical Systems, DEC 18, 2019, View Source [SID1234552473]).

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The Company will report results for the first quarter of fiscal year 2020 after market close on Wednesday, January 29, 2020. The news release will be followed by a teleconference available to all interested at 1:30 p.m. Pacific Time. To access the teleconference call and replay:

Teleconference: Access from within the U.S. by dialing 1-877-869-3847, and from outside the U.S. by dialing 1-201-689-8261.

Replay: Access from within the U.S. by dialing 1-877-660-6853 and from outside the U.S. by dialing 1-201-612-7415 and enter conference ID 13697535. The teleconference replay will be available until 5:00 p.m. Pacific Time, Friday, January 31, 2020.

Webcast: To access the live webcast and replay, visit the company website at: www.varian.com/investors and click on the link for First Quarter Earnings Results.

For automatic e-mail alerts regarding Varian news and events, investors can subscribe on the company website: View Source

On December 18, 2019 Vaccitech Ltd reported that its strategic collaboration with the Ludwig Institute for Cancer Research (Ludwig), Vaccitech Oncology Limited (VOLT), has entered into a clinical partnership with Cancer Research UK to develop VOLT’s VTP-600 immunotherapy as a treatment option for patients with non-small cell lung cancer (NSCLC) (Press release, Vaccitech, DEC 18, 2019, View Source [SID1234552472]).

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VTP-600 is a cancer immunotherapy comprised of Vaccitech’s proprietary heterologous prime-boost T cell induction platform; ChAdOx1 and Modified Vaccinia Ankara (MVA). The two viral vectors are engineered to express the tumour-associated antigens MAGE-A3 and NY-ESO-1, previously discovered and clinically validated by Ludwig. MAGE-A3 and NY-ESO-1 are aberrantly expressed by tumour cells and elicit strong immune responses. The VTP-600 therapeutic vaccine is administered intramuscularly and designed to stimulate the immune system to produce sustained cytotoxic CD8+ T cells specific for cancers that highly express the antigens, which include NSCLC. To maximise therapeutic benefit, VTP-600 can be administered selectively to patients whose tumours express MAGE-A3 alone, and those which also express NY-ESO-1. This novel design may help boost an optimal, highly specific, anti-tumour immune response to destroy cancer cells.

Cancer Research UK’s Centre for Drug Development (CDD) will sponsor and manage a Phase I/IIa clinical trial of VTP-600 in combination with current standard of care and first-line treatment (chemotherapy and anti-PD-1) in approximately 80 patients with NSCLC. The trial is anticipated to begin in Q4 2020 across multiple clinical sites in the UK. VOLT holds an option to licence the results of the trial in order to undertake further clinical development and commercialisation of VTP-600.

Vaccitech’s CEO, Bill Enright, said: "We are delighted to enter into a clinical development partnership with two of the world’s most prestigious cancer research institutions. We believe that this partnership is an important validation of our prime boost platform’s utility in oncology as well as infectious disease."

Jonathan Skipper, Executive Vice President for Technology Development, Ludwig Institute for Cancer Research, commented, "Previous clinical trials of experimental cancer vaccines targeting MAGE and NY-ESO antigens have demonstrated that these antigens are highly specific to cancer and capable of eliciting strong immune responses. We believe that Vaccitech’s highly effective T cell induction platform should provide a potent immunotherapeutic that, in combination with checkpoint blockade, is capable of inducing sustained levels of cancer antigen-specific CD8+ T cells and the desired therapeutic effect in patients."

Dr Nigel Blackburn, Cancer Research UK’s director of drug development, said: "This partnership with VOLT is an important step to help accelerate this promising immunotherapy and could help more people survive lung cancer, which remains very hard to treat. This novel approach using a modified adenovirus to prime the immune system and alert it to the presence of cancer cells could offer a completely new way to treat the disease."