Oncologie Closes an $80M Series B Financing

Oncologie Closes an $80M Series B Financing

BOSTON, MA, Biopharmaceutical company has closed an $80M Series B financing.

Click here for more funding data on Oncologie
To export Oncologie funding data to PDF and Excel, click here
Oncologie, an innovative biopharmaceutical company using proprietary biomarkers to drive clinical development of next-generation oncology therapeutics, announced today that it has closed an $80M Series B financing. Existing investors, led by Nan Fung Life Sciences and Pivotal BioVentures China, are joined by a syndicate of new investors including Panacea Venture Healthcare and Korea Investment Partners.The funding will be used to advance Oncologie’s three clinical stage programs, as well as its proprietary biomarker platform and in-licensing activities. Oncologie will initiate key clinical trials in the coming months, including a global proof of concept gastric cancer study with its lead compound, bavituximab, in combination with pembrolizumab (Keytruda). Bavituximab is an investigational immune-modulatory monoclonal antibody that targets phosphatidylserine (PS), a phospholipid that inhibits the ability of immune cells to recognize and fight tumors. Oncologie’s other programs include a TLR9 activator, lefitolimod, and a unique VEGF-targeting antibody, varisacumab. Oncologie’s biomarker platform is designed to better inform patient selection across the portfolio by matching patients lacking a genetic “driver” mutation with the right medicine and allowing for selection of patients for treatment based on the microenvironmental defects of their tumor. The Company will also continue to leverage its platform to identify best-in-class assets for licensing and development.

“Expectations for precision medicine are increasing worldwide. By matching the right drug to the right patient, Oncologie’s innovative biomarker platform is designed to build value by narrowing patient populations, accelerating development timelines and reducing failure,” said Laura E. Benjamin, PhD, Founder, President, and CEO. “This funding allows us to accelerate the development of our pipeline and platform, and grow our portfolio through partnering or acquisition.”

“Over the past year, Oncologie has assembled an outstanding team of experienced professionals and a robust pipeline around a truly innovative biomarker platform,” said Peter Bisgaard, Managing Director for NanFung Life Sciences and Managing Partner of Pivotal BioVenture Partners. “I am particularly excited by Oncologie’s biomarker strategy and approach, which leverages cutting-edge science to optimize patient selection in the challenging arena of the tumor microenvironment. This team has ambitious and strategic growth plan for building a leading oncology therapeutics company around this platform and around a pipeline of next-generation immunotherapies. ”

About Oncologie, Inc.

ONCOLOGIE is an oncology therapeutics company committed to delivering better outcomes for cancer patients through an improved understanding of which patients will benefit from each drug in the pipeline. The current pipeline is focused on mid-stage clinical programs that modify the immune system to enhance efficacy of current standards of care and emerging immunotherapy agents. Headquartered in Boston, Massachusetts and Shanghai, China, Oncologie is working with global partners to acquire and develop innovative drugs for cancer patients around the world. For more information on Oncologie, Inc., please visit WWW.ONCOLOGIE.INTERNATIONAL.

Source: Oncologie Closes an $80M Series B Financing

Ivenix Infusion System Designed to Reduce Medication Errors is FDA Cleared

Ivenix Infusion System Designed to Reduce Medication Errors is FDA Cleared

Infusion pumps have been known to be a vector for a variety of medical mistakes, primarily adverse drug events. This has become such an issue that a few years ago the FDA began its Infusion Pump Improvement Initiative. One of the results of this program was the establishment of new requirements, aimed at reducing errors, for the manufacture of infusion pumps. Ivenix, a company based outside of Boston, just received FDA clearance for its Ivenix Infusion System that was envisioned, designed, and manufactured with the new requirements in mind.

The product is a large-volume infusion pump that features proprietary adaptive flow control technology that measures the fluid moving through the pump and adjusts its action in real time. This helps to eliminate the chance of free flow and nearly guarantees that the proper amount of fluids is administered throughout treatment.

Operating the pump was designed to be reminiscent of how one uses a smartphone, which helps to make things intuitive, reduces setup time, and minimizes errors and alarms. Ivenix believes that the benefits the pump delivers should lead to savings associated with reduced error rates.

Additional features of the Ivenix Infusion System include a wide range of administration sets and a management suite that lets clinicians remotely monitor infusions and be notified of any problems.

“For years, I’ve studied smart infusion pump safety and efficiency,” said Karen Giuliano, PhD, RN, FAAN, Associate Professor and Executive Director of Healthcare Innovation at Northeastern University Bouvé College of Health Sciences, in a press release. “My research has focused on revealing the serious usability challenges, which exist in the most commonly used IV smart pumps. Data suggest that the Ivenix Infusion System can enable clinicians to more quickly administer IV medications with significantly fewer errors compared with today’s leading pumps. Nurses, and the healthcare industry as a whole, have been waiting for an innovative solution like this.”

Flashback: The Ivenix Infusion System for Enhanced Delivery: Interview with Stuart Randle, President and CEO of Ivenix

Product page: Ivenix Infusion System

Via: Ivenix TrendMD v2.4.6

Source: Ivenix Infusion System Designed to Reduce Medication Errors is FDA Cleared

BlackThorn Therapeutics Lands $76M Series B Financing.

BlackThorn Therapeutics Lands $76M Series B Financing.

SAN FRANCISCO, CA, BlackThorn Therapeutics today announced the close of its $76 million Series B financing.

Click here for more funding data on BlackThorn Therapeutics
To export BlackThorn Therapeutics funding data to PDF and Excel, click here
BlackThorn Therapeutics, a clinical-stage, neurobehavioral health company pioneering next-generation artificial intelligence (AI) technologies to advance targeted therapeutics, today announced the close of its $76 million Series B financing. New investors, including Polaris Partners, Premier Partners, Scripps Research, and Vertex Ventures HC joined the round, along with existing investors Alexandria Venture Investments, Altitude Life Science Ventures, ARCH Venture Partners, Biomatics Capital, GV (formerly Google Ventures), Johnson & Johnson Innovation – JJDC, Inc. (JJDC), and Mercury Fund. In connection with the financing, Brian Chee, a managing partner at Polaris Partners, Lori Hu, a managing director at Vertex Ventures HC, and Julie Sunderland, a managing director at Biomatics Capital joined BlackThorn’s board as directors.”Making personalized medicine for mental health a reality requires the ability to gather, integrate and analyze a wide variety of data at scale,” said Paul Berns, Executive Chair of BlackThorn and a Venture Partner at ARCH Venture Partners. “BlackThorn has positioned itself at the forefront of these efforts by building the largest library of deeply phenotyped clinical neurobiological data and a cloud-based platform powered by artificial intelligence and machine learning (AI/ML) to inform rational, targeted drug discovery and development.”

“BlackThorn was founded to bring new therapies to patients by applying advances in computational sciences to address patient heterogeneity, one of the biggest historical challenges in the field of neuropsychiatric drug development,” said Bill Martin, Ph.D., BlackThorn’s president and chief operating officer. “Three years later, insights from our data-driven approaches are yielding patient enrichment strategies that could increase the probability of clinical trial success and improve patient outcomes. We are grateful for our investors’ support to continue advancing our platform and therapeutic pipeline as we build out a world-class team at the intersection of technology and clinical neuroscience.”

BlackThorn also announced two appointments to its executive management team: Jane Tiller, MBChB, FRCPsych, as chief medical officer, and Laura Hansen, Ph.D., as vice president, corporate affairs. Dr. Tiller, who brings extensive clinical psychiatry and drug development experience, will lead BlackThorn’s clinical and regulatory efforts. Dr. Hansen, who brings extensive strategic communications experience, is responsible for public and investor relations, scientific communications, and patient advocacy.

“I am thrilled to join BlackThorn particularly at this time when the nexus between artificial intelligence and the latest advances in neuroscience promises to modernize the way we understand and treat behavioral disorders,” said Dr. Tiller.

About Jane Tiller, MBChB, FRCPsych

Jane Tiller, MBChB, FRCPsych, is chief medical officer at BlackThorn. Dr. Tiller has deep experience in clinical psychiatry and drug development experience and was most recently head of European markets, Australia and Canada, at Bristol Myers Squibb (BMS), where she oversaw all medical functions. During her tenure at BMS, Dr. Tiller also served as vice president of global medical for neuroscience, virology and immunoscience and as full development team lead for the Alzheimer’s program. Prior to joining BMS, Dr. Tiller held positions of increasing responsibility at Cephalon, and, as vice president of neuroscience and pain, was responsible for all clinical development activities including programs for schizophrenia, bipolar disorder, anxiety and sleep disorders. Prior to joining the industry, Dr. Tiller was Clinical Director at the Maudsley Hospital, London, where she was responsible for clinical services for Southwark and across several London teaching hospitals. She was a Consultant Psychiatrist (Attending) and Hon. Senior Lecturer. Dr. Tiller is a Fellow of the Royal College of Psychiatrists, UK. Dr. Tiller obtained her medical degree from Glasgow University, an executive MBA from Drexel University, and a MPhil in Organizational Dynamics from the University of Pennsylvania. She trained at the Maudsley Hospital and Institute of Psychiatry in London and at Duke University as visiting faculty.

About Laura Hansen, Ph.D.

Laura Hansen, Ph.D., is vice president, corporate affairs at BlackThorn. Dr. Hansen is a strategic communications leader with two decades of experience in the biotech industry. Before joining BlackThorn, she was vice president, investor relations at Aimmune Therapeutics, Inc., a leading food allergy therapeutics company. Prior to that, she held positions in corporate communications at Threshold Pharmaceuticals, Inc., and FibroGen, Inc. At both companies, she was also responsible for scientific communications related to novel therapeutic platforms in oncology, fibrosis, and anemia. Dr. Hansen holds a Ph.D. in Biological Sciences from The University of Texas at Austin.

About BlackThorn Therapeutics, Inc.

BlackThorn Therapeutics, Inc., is a clinical-stage neurobehavioral health company pioneering the next generation of artificial intelligence technologies to advance its pipeline of targeted therapeutics for treating brain disorders. The company has engineered PathFinder™, a cloud-based computational psychiatry and data platform, to enable the collection, integration and analysis of multimodal data at great speed and scale. BlackThorn applies its data-driven approaches to create an understanding of the core underlying pathophysiology of neurobehavioral disorders and uses these insights to generate objective neuromarkers, which support drug target identification, patient stratification and objective clinical trial endpoints. By identifying more homogenous patient subgroups who share underlying neurobiology, BlackThorn aims to direct its drug candidates to neurobiologically-defined patient populations most likely to respond. BlackThorn is headquartered in San Francisco, California. For more information, please visit blackthornrx.com

Source: BlackThorn Therapeutics Lands $76M

Arch Oncology Raises in $50M Series B

Arch Oncology Raises in $50M Series B

BRISBANE, CA, Clinical-stage immuno-oncology company announced a successful $50 million Series B financing.

Click here for more funding data on Arch Oncology
To export Arch Oncology funding data to PDF and Excel, click here

Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of best-in-class anti-CD47 antibody therapies, today announced a successful $50 million Series B financing. The Company plans to use the proceeds from this financing to advance its anti-CD47 antibody AO-176’s ongoing Phase 1 clinical trial in select solid tumors, as well as its pipeline.This financing included Arch Oncology’s existing investors, RiverVest Venture Partners, Roche Venture Fund, and 3×5 Partners, and was led by new investor Lightchain (Scottrade Founder and former CEO Rodger Riney’s family office).

“Our investors share our commitment to the exciting work we are doing to develop best-in-class antibodies aimed at improving treatment options for patients with cancer,” said Julie M. Cherrington, Ph.D., President and Chief Executive Officer of Arch Oncology. “This financing supports our ongoing Phase 1 clinical trial for AO-176, our highly-differentiated anti-CD47 antibody, as we continue to dose patients. Additionally, these proceeds enable us to advance our discovery-stage pipeline. With the backing of our investors and the hard work of our experienced team, we look forward to developing new cancer treatment options for patients.”

“Over the past year, the Arch Oncology team under Julie’s leadership has successfully executed on plans to advance AO-176 from the laboratory, through IND submission, and into the clinic,” said John McKearn, Ph.D., Managing Director, RiverVest Venture Partners and Chairman of the Board of Arch Oncology. “We believe AO-176 has a best-in-class profile among agents in the anti-CD47 space and we are excited to see the progress advancing the pipeline.”

About Arch Oncology

Arch Oncology, Inc. is a privately-held, clinical-stage immuno-oncology company focused on the discovery and development of best-in-class antibody therapies for the treatment of patients with cancer. The Company’s next-generation anti-CD47 antibodies are highly differentiated, with the potential to improve upon the safety and efficacy profile relative to other agents in this class. Arch Oncology’s lead product candidate AO-176 is in a Phase 1 clinical trial for the treatment of patients with select solid tumors. In addition, the Company is advancing a number of pipeline programs, including anti-signal regulatory protein (SIRP) antibodies. Arch Oncology’s leadership team has successfully developed new drugs for patients before and is backed by leading investors, including RiverVest Venture Partners, Roche Venture Fund, 3×5 RiverVest Partners II-B, and Lightchain. For more information please visit www.archoncology.com.

Source: Arch Oncology Raises in $50M Series B

FDA approves Merck’s new-kind of cancer drug

FDA approves Merck’s new-kind of cancer drug

Source: Wall Street Journal: By Peter Loftus
Published: Sept 4, 2014 2:57 p.m. ET

U.S. regulators on Thursday approved a new kind of cancer drug from Merck & Co. that is designed to unleash the body’s immune system against tumors and could generate billions of dollars in sales.

The drug, which Merck plans to sell under the brand name Keytruda, is part of a long-anticipated wave of medicines that could transform cancer treatment and forge a large new market for pharmaceutical companies.

The Food and Drug Administration cleared the drug, pembrolizumab, for the treatment of a deadly form of skin cancer, melanoma. The approval followed a swift review of data from a relatively early-stage human trial–an unusual move reflecting the medical community’s keen interest in pembrolizumab.

The infused drug is a new type of immunotherapy, a category of treatments that harness the immune system to fight cancer. It was approved for people who’ve failed to respond adequately to Yervoy, a Bristol-Myers Squibb Co. immunotherapy that works in a different fashion, and certain other drugs.

Pembrolizumab is the first so-called PD-1 inhibitor to hit the U.S. market. The drugs block a protein called programmed death receptor 1, or PD-1, which acts as a brake on certain immune-system cells to prevent them from attacking healthy tissue. Cancer cells can escape destruction by latching onto PD-1; PD1 inhibitors block this interaction at the site of the tumor, releasing the immune system brake and allowing it to destroy the cancer. Yervoy also lifts a brake on the immune system but does so earlier in the immune-cell activation process, which researchers say may cause more collateral destruction of normal tissue than with PD-1 blockers.

Pembrolizumab and other PD-1-targeting drugs–including those developed by Bristol-Myers and Roche Holding AG–have generated excitement among doctors because they appear to induce relatively high rates of tumor shrinkage and prolong average survival beyond historical norms in clinical studies. Researchers say the side effects associated with the drugs appear to be manageable.

“PD-1 is truly a game-changer. It’s active in a way that other drugs are not,” said Lynn Schuchter, a medical oncologist who heads the melanoma program at the Abramson Cancer Center of the University of Pennsylvania and has assisted in clinical trials of the Merck drug. “And what’s been interesting is the activity of PD-1 beyond melanoma. It looks to be active in bladder and renal and lung cancer. So this is bigger than melanoma.”

Some analysts believe total annual sales of cancer immunotherapies could reach about $32 billion by 2025, if more drugs make it to market to treat a range of cancers. Leerink Swann estimates Merck’s new drug alone could generate annual sales of more than $6 billion by then.

A competing PD-1 inhibitor, nivolumab, hit the market in Japan this month, at a price of $143,000 for a year’s worth of treatment for the average Japanese patient. The drug, from Bristol-Myers and Ono Pharmaceutical Co., is expected to be reviewed by U.S. regulators in coming months. Other PD-1 inhibitors are expected to have similarly high price tags, which could fuel more debate about the affordability of new drugs.

Merck didn’t immediately disclose the price for Keytruda on Thursday

Write to Peter Loftus at peter.loftus@wsj.com

Image source: http://www.dailymail.co.uk/health/article-1238967/Antibody-fights-advanced-prostate-cancer-discovered.html

Genentech’s Perjeta wins FDA OK with new approach to breast cancer

Monday, September 30, 2013, 11:26am PDT
Ron Leuty
San Francisco Business Times

Genentech Inc.’s Perjeta won accelerated approval Monday from the Food and Drug Administration for a specific type of breast cancer patient.

The approval is groundbreaking for the South San Francisco-based U.S. subsidiary of Swiss drug maker Roche and breast cancer treatment in general because the FDA for the first time approved a prior-to-surgery drug based on a different measure of its effectiveness, called pathological complete response.

“Together with the FDA, we’ve charted new territory,” Genentech Chief Medical Officer Dr. Hal Barron said in a company press release.

Perjeta — in combination with its blockbuster cancer drug Herceptin and the chemotherapy agent docetaxel — was recommended earlier this month by a panel of experts for pre-surgery, or neoadjuvant, treatment of women with HER2-positive, early-stage breast cancer.

Accelerated approval allows a company to sell a drug based on early data. It can shave years off of the approval process since companies can undertake a later-stage clinical trial after the drug is on the market.

But by using pathological complete response, or pCR, data, Genentech looked at whether pre-surgery use of Perjeta could shrink tumors so they are more easily removed during surgery.

Genentech has estimated that about 15,000 women with HER2-positive, early-stage breast cancer could receive neoadjuvant treatment with Perjeta each year.

HER2-positive breast cancer is an aggressive form of the disease with high recurrence and death rates. It affects about one in five people with breast cancer. It is caused by a gene mutation that causes the body to create excess HER2 protein that promotes the growth of cancer cells.

About 6,000 to 8,000 women in the United States die each year from the disease.

Perjeta, also known as pertuzumab, initially was approved in June 2012 to treat people with breast cancer that has spread to other parts of the body. The drug lands on the same HER2 receptor targeted by Herceptin, but it blocks cancer at a different point, preventing receptors from pairing.

It is that pairing — or not being able to prevent the pairing — that is one reason why Herceptin hasn’t worked for many breast cancer patients.

%d bloggers like this: