1stOncology™: Cancer Intelligence Service – Page 14328 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

TX05 Press Release

On September 28, 2017 Tanvex BioPharma, Inc. reported its plans for an international Phase 3 trial of its biosimilar drug candidate, TX05, its investigational trastuzumab biosimilar (a proposed biosimilar to Herceptin) in patients with early stage breast cancer (Press release, Tanvex BioPharma, SEP 28, 2017, View Source [SID1234524596]). In accordance with advice from the US Food and Drug Administration, the global Phase 3 trial, "A randomized, double-blind, parallel group, Phase III trial to compare the efficacy, safety and immunogenicity of TX05 with Herceptin in subjects with HER2 positive early breast cancer", has been designed to compare the therapeutic equivalence of biosimilar candidate TX05 to Herceptin in HER2-positive, early-stage breast cancer patients based on the pathological complete response rate following neoadjuvant therapy. Approximately 800 patients are anticipated to be enrolled from about 209 study centers in 19 countries. The primary efficacy endpoint, pCR, will be assessed through specimens obtained during surgery and analyzed by a central review of local histopathology reports. Equivalence will be considered to be demonstrated if the 95% confidence interval of the risk ratio of the pCR rates (TX05/Herceptin) is within a predefined interval agreed between Tanvex and FDA.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Worldwide, nearly 2 million women are diagnosed with breast cancer each year, making it the second most common cancer in the world. Approximately 20% to 30% of primary breast cancers are HER2-positive.

"This represents another major milestone for our company. TX05 will be our second biosimilar product to enter Phase 3 trials and reinforces our commitment to expand access to affordable, high quality products to patients with serious illness," said Allen Chao, PhD, CEO of Tanvex.

US sales of Herceptin were US$2.7 billion in 2016.

Why would Novartis buy a $2.6B radiotherapy maker? Its neuroendocrine franchise, analyst says

Megamerger deal speculation has swirled around Novartis as the Swiss drugmaker eyes its operations—particularly Alcon—for cash-generating sales or spinoffs (Press release, FiercePharma, SEP 28, 2017, View Source;utm_medium=rss [SID1234520701]). But all along, CEO Joe Jimenez has been pledging bolt-on deals instead, and the latest buzz says he has one on tap.

That would be Advanced Accelerator Applications, a maker of radioactive tracers used in diagnostic scans, Bloomberg reports. But the target’s real attraction might be its pipeline. Its lead candidate is an actual cancer therapeutic in a field Novartis already knows: neuroendocrine tumors (NETs).

The in-development med, Lutathera, is at the regulatory filing stage, and it would come with two marketed NET diagnostic agents, NetSpot and Somakit. It’s a radiotherapy based on the rare earth metal leutetium, which is now used primarily as a catalyst for cracking hydrocarbons in oil refineries, according to the Royal Society of Chemistry.

"We believe a Novartis acquisition of AAAP for Lutathera in neuroendocrine tumors would be highly synergistic with [its] existing franchise, including Sandostatin and Afinitor, making a potential deal very logical," Canaccord Genuity analyst John Newman said in a Thursday morning note to investors.

With its $16 billion deal for GlaxoSmithKline’s oncology assets in 2015, Novartis beefed up its cancer portfolio, and the recent approval of its CAR-T drug Kymriah gave it another boost. It moved into the CDK 4/6 cancer therapy market with Kisqali earlier this year, and it’s also been racking up new indications for Afinitor, including nods in gastrointestinal and lung NETs last February.

RELATED: New Novartis CEO Narasimhan will face plenty of obstacles despite CAR-T triumph

Right now, AAA’s products are marketed mostly in Europe, with NetSpot its only U.S.-approved agent. Presumably, Novartis would use its expertise at advancing products through the FDA to bring AAA’s meds to the U.S., all while reaping sales in AAA’s established markets. The Big Pharma is adept at winning initial approvals in small patient populations and then expanding into follow-up indications that add significantly to sales prospects.

AAA, which went public in 2015, saw its American depositary receipts surge on the M&A reports, hitting a valuation of $2.6 billion on Thursday morning, Bloomberg says.

Whether Novartis moves forward with a deal remains to be seen; the company has been actively scouting for deals for some time, and various potential buys have been buzzed about over the past couple of years. One of those was Amneal, a generics maker said to be a Novartis target late last year; it’s now reportedly in the sights of Impax Laboratories, the generics maker that recently brought in Actavis/Allergan vet Paul Bisaro as CEO.

But AAA does look like the sort of deal that Big Pharmas have been shopping lately: companies with current revenue streams and late-stage pipeline meds. And if Newman is correct, AAA’s top med could be a boost for Novartis sales for years. "We see very long-duration revenues for Lutathera due to the extremely high barrier for generics, limited supply of leutetium and very high efficacy benefit over current therapies," he wrote.

Just what Novartis plans to do going forward is up in the air, however; Jimenez recently announced his departure, planning to hand the reins to current R&D chief Vas Narasimhan in February.

Cancer, gene therapy biotechs raise $303M in IPO bonanza

Three biotech companies focusing on cancer and eye diseases have collectively raised more than $300 million (Press release, FierceBiotech, SEP 28, 2017, View Source;utm_medium=rss [SID1234520700]).

Kinase inhibitor biotech Deciphera Pharmaceuticals raised $128 million, at the high-end of the range, with British cancer oncology NuCana, which is working on second-generation chemotherapies for resistant tumors, raising $100 million, and within the range.

Fellow British biotech Nightstar Therapeutics, a gene therapy player working on rare retinal diseases, also got off a $75 million IPO, within the midpoint of the range.

After a lackluster biotech IPO market in 2016 and a slow start to this year, public offerings for life sciences have started to take off in the second half.

Deciphera has a pipeline of oral drug candidates that include three clinical-stage and two research-stage programs. Its lead drug candidate, DCC-2618, is designed to stop mutant or amplified KIT and PDGFRα kinases that drive cancers such as gastrointestinal stromal tumors, or GIST.

It’s currently in phase 1, and at this year’s ASCO (Free ASCO Whitepaper) Deciphera posted data showing that in GIST patients shown to harbor a broad range of KIT and PDGFRα mutations, it saw a disease control rate of 85% at eight weeks in 27 patients, 78% at 12 weeks in 23 patients and 60% at 24 weeks in 15 patients.

The biotech is also working on small molecule drug candidates, DCC-3014 and rebastinib, as immuno-oncology kinase, or immunokinase, switch control inhibitors targeting colony stimulating factor receptor 1, or CSF1R, and the TIE2 kinase, respectively.

Back in June, Deciphera raised $52 million in a series C, building on the $75 million it raised in 2015 during its series B round. Its largest stakeholder had been Brightstar Associates, which owned nearly 68% of the company.

At the time of its B round, its pipeline was led by altiratinib, which acts on the MET/TIE2/VEGFR2 pathways, but that asset no longer appears in the company’s R&D pipeline and seems to have been canned.

Edinburgh, U.K.-based NuCana, meanwhile, had been seeking a top $115 million IPO, but got a little less at $100 million.

The cash boost should still be enough to help fund late-phase trials of NuCana’s reformulated cancer candidates, including a version of Eli Lilly’s Gemzar it hopes will supplant the veteran chemotherapy in some indications.

The biotech has built its pipeline upon the same phosphoramidate chemistry approach that underpins Gilead’s hepatitis C blockbuster Sovaldi.

NuCana has used the approach to add a phosphate group protected by groupings of aryl, ester and amino acids to existing drugs. In doing so, NuCana thinks it has created drugs free from the membrane transport, activation and breakdown issues that render cancers resistant to the products they are based on.

The company was down to the last $16 million of its $57 million series B by the end of June, meaning this IPO was a key financial driver for its future, as it eyes later stage tests across a broad range of tumors.

And finally Nightstar, which had filed for an $86 million IPO and managed $75 million, will equip the biotech to complete a phase 3 trial of its choroideremia gene therapy and advance two other eye disease candidates through early-stage clinical studies.

London-based Nightstar, also known as NightstaRx, is set to move the choroideremia asset into phase 3 in the first half of next year. The therapy, NSR-REP1, is advancing into the 140-patient trial on the strength of data on 32 subjects treated in investigator-sponsored studies. Those trials found 90% of patients either maintained or improved their visual acuity in the year after receiving the gene therapy.

The biotech was originally spun out of the University of Oxford in 2014, starting life with a £12 million raise from Syncona.

It pulled in a further £5 million when it named former Johnson & Johnson VP David Fellows as CEO early in 2015, with a $35 million series B round following later that year. And Nightstar broadened its investor base and raised a further $45 million in a series C round just a few months ago.

ZIOPHARM Oncology Appoints David Mauney, M.D., as Executive Vice President and Chief Business Officer

On September 28, 2017 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focusing on new immunotherapies, reported the appointment of David Mauney, M.D., as Executive Vice President and Chief Business Officer effective from September 28, 2017 (Press release, Ziopharm, SEP 28, 2017, View Source [SID1234520697]). ZIOPHARM also reports the details of an inducement award granted to Dr. Mauney, approved by the Compensation Committee of the Company’s Board of Directors in connection with his employment.

Dr. Mauney joins ZIOPHARM from Harvest Capital Strategies, LLC, where he served as a Managing Director. With twenty years of experience in the raising, management and disposition of almost $900 million in life science venture capital, Dr. Mauney will lead ZIOPHARM’s corporate development and investor strategy functions, reporting directly to Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM.

"David brings to our executive leadership team a wealth of entrepreneurial experience, keen insights and multiple relationships that will leverage existing and future capital markets and corporate partnership opportunities, all of which will support our core portfolio of immunotherapy platforms," said Dr. Cooper. "I look forward to working with David at this important stage of growth for the Company, as we continue to advance the development of our innovative gene expression, control, and cell technologies."

Prior to Harvest Capital Strategies LLC, Dr. Mauney co-founded and served as a Managing Director of De Novo Ventures, a health care investment firm founded in 2000. Dr. Mauney was also the Lead Partner of Health Care Investments for Asset Management Company, and he was the first employee and Director of Business Development for Fox Hollow Technologies, which later went public and was ultimately sold to EV3. Dr. Mauney holds an M.D. from the Dartmouth School of Medicine and a B.A. in psychology from Duke University.

ZIOPHARM also announces that David Connolly recently joined the Company as Vice President of Corporate Communications and Investor Relations.

Mr. Connolly brings more than 15 years’ experience in corporate communications, public relations and investor relations experience to ZIOPHARM. Prior to joining ZIOPHARM, he served as Senior Vice President at JPA Health Communications and before that, LaVoieHealthScience, both communications agencies where he was the strategic lead for integrated communications, public relations and advocacy programs for public and private biopharmaceutical and medical device companies. Mr. Connolly holds a B.A. from the College of the Holy Cross.

Inducement Award Granted to David Mauney, M.D.

ZIOPHARM announces that as an inducement material to Dr. Mauney entering into employment with the Company, the Compensation Committee of ZIOPHARM’s Board of Directors granted an inducement award to Dr. Mauney in accordance with NASDAQ Listing Rule 5635(c)(4). The inducement award consists of a stock option to purchase up to 500,000 shares of the Company’s common stock, with a per share exercise price equal to $6.19, the closing price of the Company’s common stock on the grant date of September 28, 2017, the date of Dr. Mauney’s first day of employment with ZIOPHARM, and a ten-year term. The stock option was granted outside of, but subject to the terms generally consistent with, the Company’s 2012 Equity Incentive Plan, as amended, and will vest with respect to one-third of the shares subject to the stock option award on the first anniversary of the grant date and with respect to remaining two-thirds in two annual installments on each of the second and third anniversaries of the grant date, subject to Dr. Mauney’s continuous service with the Company through each applicable vesting date and may be eligible for potential vesting acceleration under certain circumstances pursuant to the terms of Dr. Mauney’s stock option award agreement.

TESARO Expands Our Way Forward Program for the Ovarian Cancer Community and Partners With Olympic Gymnast Shannon Miller

On September 28, 2017 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported the availability of a number of new support resources and services that address unmet educational needs for women living with ovarian cancer (Press release, TESARO, SEP 28, 2017, View Source [SID1234520693]). The new resources are part of the expansion of the Our Way Forward platform — a program launched earlier this year, which features the results of a national survey that uncovered gaps in communication amongst patients and physicians. The expanded website includes numerous resources and tools for ovarian cancer patients and their loved ones, as well as a series of local ovarian cancer educational programs, including a special storytelling event with "The Moth" this fall. World-champion gymnast and gold medalist, Shannon Miller, will join TESARO to complement the Our Way Forward program and educate and empower the ovarian cancer community, sharing her experience as an ovarian cancer survivor.

"As the Our Way Forward survey indicated, we as a community still have a long way to go to meet the needs of women with ovarian cancer. As a company, we measure our success by the number of patients and their loved ones that we impact in a positive manner," Mary Lynne Hedley, Ph.D., President and Chief Operating Officer. "By offering expanded educational content that emerged from perspectives and experiences of patients, survivors and caregivers like Shannon, we are committed to addressing the physical and emotional challenges that ovarian cancer brings to women."

The Our Way Forward website expansion used the findings uncovered in the Our Way Forward survey to develop informed resources and provide a call-to-action for patients, their loved ones and physicians to rethink how they talk about advanced, recurrent ovarian cancer. The Our Way Forward survey was conducted online in the U.S. by Harris Poll on behalf of TESARO, Inc. between April 2017 and May 2017, among 254 women living with ovarian cancer and 232 physicians who treat ovarian cancer patients. The updated website includes tailored content that addresses the emotional support needs of the caregiver, self-care and empowerment tips for women at any point during their personal ovarian cancer experience, first-person perspectives from women living with ovarian cancer and video content from "The Moth" storytelling event.

"As an ovarian cancer survivor, I am well aware of the anxiety and fear that goes along with an initial diagnosis, as well as the fear of recurrence even after treatment. It’s something that is always there. That’s why I am thrilled to join TESARO to be a part of a program that directly addresses the unique challenges of women after an ovarian cancer diagnosis and those currently living with ovarian cancer," said Mrs. Miller. "With Our Way Forward, TESARO has demonstrated their commitment to women like me — and their families and caregivers — who are faced with the possibility of cancer returning. As new medicines become available to treat women living with recurrent ovarian cancer, programs to support women from an emotional and psycho-social standpoint remain equally critical."

Upcoming resources will include new content created by Mrs. Miller, as she shares her personal ovarian cancer story, including the risks one still faces with an ovarian cancer diagnosis and treatment.

The Our Way Forward survey revealed that around half (53 percent) of patients polled felt that ovarian cancer had a severe or very severe impact on their lives. For patients who are currently in treatment or who have been treated, about half (49 percent) admitted that they find not being sure of the path forward after diagnosis to be very or extremely challenging. According to the survey, more than two in five patients who are either currently in treatment, or who have been treated, find not knowing what to expect during treatment (46 percent) or after treatment (47 percent) to be very or extremely challenging.

Approximately 85 percent of women with advanced ovarian cancer will experience recurrent disease after treatment. Despite high response rates to chemotherapy, its effectiveness diminishes over time. Many women have been told to "watch and wait" — along with the healthcare professionals, monitoring the cancer for recurrence. Until recently, before maintenance treatments were available, after a response to platinum-based chemotherapy, women had limited treatment options that would delay progression of the disease. These treatments have been shown to extend patients’ time in remission and increase progression-free survival rates.

About the Our Way Forward Survey
The Our Way Forward survey was conducted online in the U.S. by Harris Poll on behalf of TESARO, Inc. between April 13 and May 2, 2017, among 254 women 18+ years of age living in the U.S. who have been diagnosed with ovarian cancer. Survey respondents were selected from individuals who had agreed to participate in surveys through the Harris Poll and their partners, or were recruited to participate by patient advocacy organizations, NOCC and OCRFA. Results are representative of only those surveyed. A parallel survey was conducted between April 17 and May 5, 2017, among 232 physicians who treat ovarian cancer patients in the U.S., consisting of 201 medical oncologists and 31 gynecologic oncologists. Survey respondents were selected from physicians who had agreed to participate in surveys through the Harris Poll and their partners. More information about the campaign, full survey methods and survey findings, including important resources to enhance conversations about ovarian cancer, are available on the Our Way Forward website at www.ourwayforward-oc.com and via NOCC at ovarian.org and OCRFA at ocrfa.org.

About Ovarian Cancer

Approximately 22,000 women in the United States are diagnosed with ovarian cancer each year, many of whom will be diagnosed with advanced disease; while more than 65,000 women are diagnosed annually in Europe. In 2017 alone, 14,000 women will die of ovarian cancer, as it is the fifth leading cause of cancer death among women. Despite high-response rates to platinum-based chemotherapy in the second-line advanced treatment setting, approximately 85 percent of patients will experience recurrence within two years.