Category Archives: Oncology

Roche and SQZ expand cell therapy deal to more than $1.3bn

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US biotech SQZ Biotechnologies has expanded a collaboration with Roche to develop cancer therapies based on antigen presenting cells, which may be able to target solid tumours and which are cheaper to make than the recently approved CAR-T drugs.

The deal announced late yesterday expands a collaboration that began in 2015 to a deal worth more than $1.375 billion if all development targets are met.

SQZ’s technology is based around antigen presenting cells (APCs), which occur naturally in the body and present antigen on their surface to stimulate a T-cell response against that particular antigen.

SQZ is able to genetically engineer APCs with tumour antigens, that when injected into the body can produce powerful responses from CD8 T-cells – also known as killer T-cells.

The hope is that these killer T-cells will produce a strong response against any tumour target of interest, across a wide range of cancers.

Roche already has a cancer immunotherapy on the market – its Tecentriq (atezolizumab) is already approved in certain kinds of bladder and lung cancer.

But unlike Novartis and Gilead it does not have cell therapy approved yet and is looking to develop cell therapies that could be used in solid tumours, instead of blood cancer like its rivals’ CAR-T therapies.

Under the collaboration, SQZ may receive up to $125 million in upfront payment and near-term milestones.

SQZ could earn up to $250 million in clinical, regulatory and sales milestones per product that emerges from the collaboration.

The Massachusetts-based biotech may receive development milestone payments of over $1 billion. Within the collaboration, SQZ and Roche could share commercial rights for certain approved products.

Howard Bernstein, chief scientific officer of SQZ, said: “This collaboration allows for a SQZ APC product engine that could potentially generate products with more potent immunologic responses through a simplified, more efficient manufacturing process.”

Chimeric antigen receptor T-cell (CAR-T) drugs are potentially curative in the patients that respond – but are very expensive to make as they involve harvesting a patient’s T-cells, genetically modifying them in a lab, and then re-injecting them to fight cancer.

SOURCE: www.pharmaphorum.com/news

Ahead of the curve

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Pharma often criticises the NHS for failing to adopt the latest therapies, arguing that NICE’s technology appraisals can drag on and that hospitals often fail to provide the recommended therapies anyway.

However in the case of CAR-T therapies, it seems that it has responded to the criticism – at least in part, anyway.

Chimeric antigen receptor T-cell (CAR-T) therapies from Novartis and Gilead were approved by the European regulators in August – and the NHS was quick to strike deals to make them available to patients in England.

At the end of August, the European Commission approved Kymriah in children and young adults aged up to 25 with refractory acute lymphoblastic leukaemia (ALL), in relapse post transplant or in second or later relapse.

Within days the NHS had announced a deal with Novartis giving paediatric patients access to its CAR-T, Kymriah (tisagenlecleucel).

And although Gilead’s CAR-T, approved for adults with relapsed or refractory large cell lymphoma, was initially rejected by NICE, the manufacturer has managed to strike a deal with the NHS to allow patients access with reimbursement from the Cancer Drugs Fund.

Novartis’ CAR-T has been rejected by NICE in its adult indication, but this could well change if the Swiss pharma strikes a similar deal.

Horizon scanning

What stands out about the CAR-T story is that NHS officials saw that these therapies were heading to market quickly, after regulators allowed them to be approved on the basis of smaller trials, something that was possible because the therapies can be very effective in the patients that respond.

NHS chief executive Simon Stevens publicly said that getting CAR-Ts to patients is a priority – even though they are costly to manufacture, and patients need intensive monitoring to ensure they do not develop the fearsome side-effects associated with the therapy.

At Kisaco Research’s Combined CAR-T conference in Berlin earlier this year, experts revealed how the NHS had already begun to develop specialist centres capable of providing the therapies.

And a mock assessment by cost-effectiveness experts prior to approval had already indicated that the therapies could be good use of NHS resources, despite their high costs.

The NHS has built on this and is working on further CAR-T centres at hospitals across the country.

Speaking after the latest deal with Gilead, Stevens said: “CAR T-cell therapy is one of the most promising new treatments in a generation for lymphoma and leukaemia, and NHS patients will now be among the first in the world to benefit.”

Dr Alasdair Rankin, director of research and patient experience at the blood cancer charity Bloodwise, said: “CAR-T therapies have shown huge promise in treating patients with lymphoma who have no other chance of cure. It’s admirable that the NHS and the pharmaceutical company have worked hard to make this pioneering treatment available so quickly, giving hope to current patients and their families.”

But as Bloodwise’s Rankin points out, getting reimbursement in place is just a first step – the experience in the US shows that despite all the prep work by hospitals, getting the therapies to patients is still a logistical challenge.

The manufacturing process involves taking a patient’s own T-cells, sending them to a lab where they are genetically modifies, before sending them back to the patient where they are re-injected to fight the cancer.

Financial results from Novartis and Gilead, and anecdotal evidence, suggests that only a few patients have received the therapies outside of clinical trials as hospitals struggled through a backlog of eligible patients.

Rankin said in a statement: “The next big challenge for the NHS will be to deliver this new and complex treatment on a scale that ensures access for the hundreds of patients with these lymphomas who could benefit from CAR-T therapy each year.

Off-the shelf

The challenges posed by CAR-T therapies are immense – but the good news is that scientists are working on ‘off-the-shelf’ drugs that are made from banks of cells and can be administered to many different patients.

These therapies promise to have similar efficacy to CAR-T, but at a fraction of the price and without the costly and time consuming electrophoresis process used to harvest the T-cells.

At the CAR-T Congress earlier this year, researchers at MD Anderson Cancer Center at the University of Texas estimated that ‘off-the-shelf’ therapies derived from natural killer (NK) cells could be made available at 1% of the cost of CAR-T cells.

CAR-NK cells would be derived from cord blood, allowing them to be stored in banks and used on several patients, vastly reducing manufacturing expenses.

There is also the possibility that future cell therapies could target solid tumours, something that is not possible with Kymriah or Yescarta.

These therapies are not able to target the antigens present on solid tumours, and the CAR-T cells are not tough enough to infiltrate tumours.

Kymriah and Yescarta are just the start – whether the NHS is agile enough to keep pace with cell therapies for cancer and other diseases as they are developed remains to be seen.

Bloodwise’s Ranking concluded: “It is likely that we are only beginning to see the benefits that CAR-T therapy can bring. Treatments will continue to improve and become more effective over the coming decade and will benefit patients with other types of cancer.”

SOURCE: www.pharmaphorum.com/views-analysis-oncology

Study using DFMO shows positive results for children with high risk neuroblastoma

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A paper published September 27 in Scientific Reports shows the positive results of a phase II clinical trial using the oral medication DFMO to prevent relapse in children with High Risk Neuroblastoma (HRNB).

Neuroblastoma is a form of cancer that develops from immature nerve cells found in several areas of the body. It occurs most often in infants and young children, usually under the age of five. The disease remains a challenge in pediatric oncology and current treatments include therapies that have significant long-term side effects for patients.

HRNB accounts for 15 percent of all childhood cancer deaths, in part, due to the fact that nearly half of all patients who reach remission will relapse.

“These results are promising and have changed the outlook for our patients with high risk neuroblastoma,” said Giselle Sholler, MD, director of pediatric oncology research at Spectrum Health Helen DeVos Children’s Hospital and principal investigator of the study.

“By using DFMO for two years after finishing conventional therapy, we’ve seen an overall two-year survival rate for these children of 97 percent. This is a large increase in survival,” Sholler added. “Previously it was believed that children with refractory and relapsed neuroblastoma were considered incurable. This study shows more than 50 percent of patients remaining in remission up to four years.”

Beat Childhood Cancer’s trial studied the use of difluoromethylornithine (DFMO) as a single agent for enrolled patients at 20 children’s hospitals from June 2012 to February 2016. The children received two years of oral DFMO twice daily and were evaluated for outcomes of event free survival (EFS*) and overall survival (OS). The study used targeted oral therapy of an ODC inhibitor (DFMO), as a maintenance therapy to prevent relapse in HRNB patients after standard therapy. DFMO works by targeting specific cancer stem cell pathways and “turning off” the cells, thereby preventing the cancer from growing back.

There were two arms in this study, the first designed for patients who had completed standard therapy, and the second for children who were able to achieve remission after having previously relapsed. Both of these patient populations are at very high risk of relapsing after completing treatment and therefore can be very good candidates for using a maintenance therapy with the goal of preventing relapse.

With a median follow up of 3.5 years, the first arm of the study had 100 eligible patients. The results show that two-year EFS was 84 percent and two-year OS was 97 percent.

With a median follow up of 3.7 years, the study enrolled 39 previously relapsed patients and the results reported in the journal showed that two year EFS was 54 percent and two-year OS was 84 percent for these children who had previously relapsed.

“While these EFS and OS figures at two years are remarkable, the really exciting part of these results is that EFS and OS are stable out to four years,” said Patrick Lacey of Beat NB Cancer Foundation, one of the childhood cancer parent-led foundations that funded this clinical trial. “Not only did this oral drug lead to a prolonged and stable remission for the children in this study, but the drug was extremely safe and well tolerated in this patient population.”

“While many children have been able to attain remission with the current, albeit harsh, upfront therapies, these remissions are not historically durable,” Dr. Sholler added. “The current five-year survival curves have not changed significantly in the past two decades despite recent increases in two-year survival as a result of intensified therapies and new multimodal therapies.”

Principal Investigator at MUSC, Jaqueline Kraveka, MD, states survival for children with high-risk neuroblastoma remains a challenge. “These results are groundbreaking and very exciting for oncologists and their patient families. I am thrilled to have our confirmatory study open at so many sites across the USA and Canada, enabling children to receive this treatment close to home.”

SOURCE: www.news-medical.net/news/20181001

Bacterial therapy shows early promise in patients with advanced solid tumours

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Researchers have presented results of a Phase I clinical trial using bacterial Clostridium novyi-NT spores to target advanced solid tumours.

A Phase I clinical trial that investigated the use of bacterial Clostridium novyi-NT spores as an injectable monotherapy showed toxicities that were manageable and early clinical efficacy in patients with treatment-refractory solid tumour malignancies.

“Even after a single injection of this bacterial therapy, we see biological and, in some patients, clinically meaningful activity,” said Dr Filip Janku, Associate Professor at the Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Centre, Houston.

“This strategy is feasible, has manageable adverse effects, and could be clinically meaningful in patients with few therapeutic options.”

Previous therapies have tested the use of bacteria, but have often caused infection. In this study, the use of C. novyi-NT spores in the open-label, first-in-human study, the researchers explained how a hypoxic environemnt is necessary for the bacterium. It requires a feature of cancerous lesions to survive and proliferate, and thus does not affect healthy cells.

“By exploiting the inherent differences between healthy and cancerous tissue, C. novyi-NT represents a very precise anticancer therapeutic that can specifically attack a patient’s cancer,” Prof Janku said.

Between 2013 and 2017, 24 patients were enrolled with treatment-refractory solid tumors, with 15 patients having sarcoma, seven patients having diverse carcinoma and two with melanoma.

Tumours were injected with a single dose of C. novyi-NT, from 10,000 to 3 million spores. Patients administered with 3 million spores experienced dose-limiting toxicities of grade 4 sepsis, and as such the highest tolerated dose was determined to be 1 million spores.

Tumour shrinkage of greater than 10 percent was identified in 23 percent of the patients, and 21 had stable disease, measured by RECIST. Prof Janku mentioned that RECIST may not accurately capture results of the trial.

“Despite the absence of clinical signs of germination in some patients, we saw improved tumor-specific immune responses through the increased secretion of T-cell cytokines and increased presence of tumor infiltrating lymphocytes in injected tumors,” said Prof Janku.

“From these preliminary results, it appears that C. novyi-NT is able to activate the immune response besides causing tumor destruction.”

C. novyi-NT elicits an immune response, and as such Prof Janku believes this therapy will be synergistic with checkpoint inhibition.

“We were extremely encouraged by the results of this trial, especially in patients with advanced sarcomas, where immunotherapy hasn’t proven very efficacious,” Prof Janku concluded. “This bacteriolytic strategy has the potential to be clinically meaningful, especially in combination with checkpoint inhibitors, for patients with advanced solid tumors.”

The data was presented at the Fourth CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival.

SOURCE: www.europeanpharmaceuticalreview.com/news/79682

Ipsen appoints two leading R&D experts in bid to strengthen oncology arm

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French pharma firm Ipsen has announced the appointment of Dr. Yan Moore as Senior Vice President, Head of Oncology Therapeutic Area and Dr. Alexander “Sandy” McEwan, as Vice President, Head of Radiopharmaceuticals.

It is hoped that the move, which has seen the company take on two leading oncology specialists within a month of each other, will strengthen the company’s oncology arm.

Alexandre Lebeaut, Executive Vice President R&D and Chief Scientific Officer, Ipsen, commented: “I am thrilled to welcome Yan and Sandy as talented leaders who will assume pivotal roles in the next phase of our R&D transformation, and whose unique goal is to accelerate the development and deliver innovative therapeutic solutions to cancer patients.”

While Tel Aviv University graduate Dr Moore’s appointment with the Paris-headquartered company is effective immediately, Dr McEwan will join Ipsen on November 1st. Both R&D leaders will report to Dr. Alexandre Lebeaut, Executive Vice-President R&D and Chief Scientific Officer.

Dr Moore brings with him a wealth of experience from large multinationals including Bristol-Myers Squibb. Sanofi-Aventis and GlaxoSmithKline. Commenting Lebeaut said: “Yan is an outstanding biopharmaceutical executive who brings over 18 years of industry experience in oncology development across solid tumors, hematology‐oncology, gene and immune‐therapy. In his new role, Yan will lead and further strengthen our global oncology development powerhouse.”

Meanwhile McEwan, the author of more than 900 articles in peer reviewed journals and past President of the Society of Nuclear Medicine and Molecular Imaging, joins the organisation from the University of Alberta in which he held positions as Professor in the Department of Oncology and Adjunct Professor for the Department of Radiology and Diagnostic Imaging.

Lebeaut noted: “Sandy is a world-renowned expert in oncology and nuclear medicine who brings to Ipsen unique experience in this field. He will play a defining role in the acceleration of the development of Ipsen’s radiotherapeutics pipeline, providing strategic direction and managing the execution of the global clinical development of both satoreotide tetraxetan (IPN01072) and Satoreotide Trizoxetan (IPN01070) and also IPN01087 programs. Sandy will build and maintain trustworthy relationships with external oncology and nuclear medicine experts, academic networks, and professional organizations.”

SOURCE: www.pharmafile.com/appointment/518915

Cancer immunotherapy pioneers awarded Nobel medicine prize

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Cancer immunotherapy pioneers James Allison and Tasuku Honjo have been awarded this year’s Nobel Prize in Physiology or Medicine.

The Karolinska Institutet’s Nobel Assembly awarded the prize for their discovery of cancer therapy “by inhibition of negative immune regulation.”

The work by Allison and Honjo paved the way for drugs such as Bristol-Myers Squibb’s Yervoy (ipilimumab), which work by turning off the safety mechanisms in the immune system that prevents it from attacking the patient’s own body.

This allows the immune system to launch an attack against cancer – a mechanism that is fast becoming the basis for standard therapy in diseases such as melanoma and lung cancer.

Allison, currently professor and chair of Immunology and executive director, immunotherapy platform at the M. D. Anderson Cancer Center, studied a known protein, cytotoxic T-lymphocyte associated protein-4 (CTLA-4), that functions as a brake on the immune system.

He realised the potential of releasing the brake and thereby unleashing our immune cells to attack tumours. He then developed this concept into a brand new approach for treating patients.

Inhibition of CTLA-4 is the mechanism exploited by Bristol-Myers Squibb’s Yervoy (ipilimumab), the first checkpoint inhibitor approved by the FDA in 2011, to treat melanoma.

Honjo, now deputy director-general at the Kyoto University Institute for Advanced Study (KUIAS), discovered the programmed cell death protein (PD-1)  protein on immune cells.

After careful exploration of its function, he eventually revealed that it also operates as a brake, but with a different mechanism of action.

In inhibition of PD-1, or its ligand, PD-L1, it forms the basis for all the other checkpoint inhibitors approved so far, including Merck’s blockbuster Keytruda (pembrolizumab).

In its statement the Nobel assembly noted that although PD-1 had proved to be more effective overall, combining the two forms of therapy could be even more effective, as demonstrated in patients with melanoma.

(c) Nobel Media

James Allison

The committee concluded in its statement: “Allison and Honjo have inspired efforts to combine different strategies to release the brakes on the immune system with the aim of eliminating tumour cells even more efficiently.

(c) Nobel Media

Tasuku Honjo

“A large number of checkpoint therapy trials are currently underway against most types of cancer, and new checkpoint proteins are being tested as targets. For more than 100 years scientists attempted to engage the immune system in the fight against cancer. Until the seminal discoveries by the two laureates, progress into clinical development was modest. Checkpoint therapy has now revolutionised cancer treatment and has fundamentally changed the way we view how cancer can be managed.”

In a statement, Shigefumi More, director general and distinguished professor at KUIAS, said: “It is wonderful that the efficacy of cancer immunotherapy by PD-1 blockade has now been demonstrated worldwide, and that this therapy is actually saving the lives of many people. I would like to express my respect for his important work for human beings, and wish Distinguished Professor Honjo continued success in the future.”

SOURCE: www.pharmaphorum.com/news

Roche buys Tusk, plus cancer immunotherapy drug, for £62m

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Roche has bought immuno-oncology biotech firm Tusk Therapeutics for an upfront payment of £62 million.

Tusk’s shareholders will receive the upfront cash payment, plus additional contingent payments of up to £521 million, if and when certain milestones are achieved.

Tusk, which is based in Stevenage, has developed a first-in-class antibody, CD25, for the depletion of regulatory T-cells (TRegs), which suppress the body’s immune reaction to cancer cells.

This novel antibody enables the body’s other immune cells to fight tumours while leaving healthy tissue unharmed. Clinical trials are expected to start next year.

Luc Dochez, CEO of Tusk Therapeutics, said: “We are delighted that Roche will further develop this novel antibody and drive the development ahead.

“The remaining portfolio of our immune-oncology targets will be further developed by Black Belt Therapeutics, a newly formed company spun out of Tusk Therapeutics.”

Droia Oncology Ventures, Tusk’s majority shareholder, founded the company in 2014. Droia is a specialist investor, which focuses on fighting cancer.

It invests in promising new cancer therapies and accelerates their progress by actively supporting young drug development companies to achieve clinical proof of concept with their lead programmes. The deal will expand Roche’s oncology pipeline.

Also, Roche today announced a new collaboration with Novo Nordisk, which specialises in the treatment and management of diabetes and obesity.

The plan is to integrate insulin dosage information from Novo Nordisk’s connected pen technology into Roche’s open ecosystem, whereby it will communicate with its digital diabetes management solutions including mySugr, which allows people to monitor their glucose levels.

Marcel Gmuender, global head of Roche Diabetes Care, said: “The integration of insulin pen data in our digital health solutions such as mySugr will make it much easier for people with diabetes and their caregivers to track the effect of insulin on blood glucose levels.

“This enables more efficient and targeted decision support, as they can act on near real-time insights to optimise the personalised diabetes management, thereby reducing the risk of costly secondary complications and contributing to improved therapy outcomes and better quality of life.”

Anders Toft, corporate vice president of commercial innovation at Novo Nordisk, echoed this, adding: “Digital health solutions like mySugr are already helping thousands of patients. By integrating Novo Nordisk connected technology with mySugr, we can further ease the day-to-day burden of disease management and provide data-based insights to improve the dialogue between patients and caregivers.”

SOURCE: www.pharmaphorum.com/news

JM to offer a new process to synthesise CBD

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Johnson Matthey to offer a new process to synthesise ultra-pure cannabidiol, expanding on existing cannabinoid offerings.

Johnson Matthey, a global leader in science that enables a cleaner and healthier world has announced an expansion to its API and controlled substances portfolio by establishing a new synthetic method for ultra-pure cannabidiol, a medicinal component of the cannabis plant.

This synthesis will help Johnson Matthey (JM) support companies in developing novel treatments and medicines to help patients across a range of disease areas.

Cannabidiol (CBD) is one of the many chemical compounds in the cannabis plant and is known to possess medicinal and therapeutic properties. Unlike tetrahydrocannabinol (THC), another molecule in the cannabis plant, CBD does not cause intoxication or euphoria, two unwanted side-effects for medicines.

In light of CBD’s medicinal applications and the absence of psychoactive side-effects, demand for GMP-grade CBD from pharmaceutical companies has increased extensively in recent years.

It is now being investigated as a potential therapeutic treatment for various illnesses and diseases, including multiple cancers, seizures, dermatological conditions and anxiety.

JM has established more than 15 years’ experience in developing and commercialising a portfolio of ultra-pure synthetic cannabinoids and other controlled substances. By adding cannabidiol into this portfolio and filing a US drug master file (DMF) with a validated synthetic process, JM is excited to support companies looking to explore CBD’s medicinal applications further.

With manufacturing sites based in the US, JM is able to apply its knowledge of synthetic chemistry and purification techniques to CBD synthesis. In particular, JM’s solid form chemistry expertise has enabled the development of a free flowing crystalline powder, which is able to be particle size adjusted for a variety of formulation requirements.

Furthermore, JM has established a full suite of references of standards and impurities to facilitate CBD product development, which helps to ensure molecules are synthesised to an ultra-pure standard.

As well as synthetic chemistry expertise in controlled substances, JM also offers API manufacturing capabilities for botanical extraction and purification of cannabinoids. Based on the growing popularity of medicinal cannabinoids, JM is actively investigating the development of other cannabinoid compounds.

“As a leader in API development, we are delighted to add the high-value synthesis of cannabidiol to our expanding portfolio of Pharma solutions,” said Paul Evans, VP Generic Products and Solutions at JM.

“This will enable companies to easily explore the medicinal properties of cannabinoids, and combined with our development and manufacturing capabilities, deliver novel treatments and medicines to patients.”

SOURCE: www.manufacturingchemist.com/news

Boehringer Ingelheim joins the crowd and goes all-in on oncolytic viruses, buying ViraTherapeutics in $244M deal

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Boehringer Ingelheim decided 3 years ago it that would take an active role in fostering the oncolytics virus biotech ViraTherapeutics.

The German company’s venture arm invested in the fledgling’s biotech’s tiny $4 million A round in the summer of 2015. BI execs came back with a $230 million discovery deal — building in a buyout option — and then added a second program. And this morning they’re going all in, buying the company in a deal valued at $244 million.

BI is keeping the company — a spinout of Austria’s Medical University of Innsbruck — right where it is, adding the group and the regional connections they have on campus as a subsidiary as they look to jump into the clinic with a lead program.

Boehringer first tied up with ViraTherapeutics just months ahead of Amgen’s landmark approval of T-Vec, the world’s first marketed oncolytic virus. And since then the field has exploded with new research projects as dozens of new players brewed up to beat the pioneer.

Earlier this year J&J executed one of its classic billion-dollar deals to buy BeneVir. Merck’s R&D chief Roger Perlmutter — who steered the T-Vec deal at Amgen — bagged Viralytics for $394 million. A recent study from the Cancer Research Institute found 69 OVs in clinical development and another 95 in a preclinical program.

What’s the big deal?

Oncolytic viruses are the Trojan horse of immuno-oncology. The viruses are designed to infect cancer cells, invading the disease, and then exploding them, which subsequently signals the immune system to mount an attack on the survivors. There’s a clear clinical track record showing how they work. And now a host of rivals like PsiOxus and many, many others believe that systemic administration will do a better job.

ViraTherapeutics execs — led by MorphoSys vet Heinz Schwer — have also been busy engineering an OV therapy that they believe can do a better job of initially evading detection by the immune system, avoiding triggering any antibodies and theoretically making it possible to do repeat administrations.

Not surprisingly, BI also plans to whip up a pipeline of combination approaches, arming their OV with cancer drugs that can both amp up the immune system attack and charge directly at cancer cells.

SOURCE: www.endpts.com

Agios names former Celgene executive Jacqualyn Fouse as next CEO

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Agios Pharmaceuticals Inc on Tuesday said former Celgene Corp executive Jacqualyn Fouse would be its next chief executive officer, replacing longtime CEO David Schenkein.

Fouse, who rose through the ranks at Celgene to become president and chief operating officer before leaving the biotech company last year, is already a member of the Agios board. She will assume her new role on Feb. 1, 2019, the company said.

Schenkein, who took over as Agios CEO in 2009, will transition to the role of executive chairman and serve on the board’s Science & Technology Committee, the biotech said.

Schenkein led Cambridge, Massachusetts-based Agios from a research company to a $4.68 billion drugmaker with two approved cancer medicines.

Fouse is highly regarded by Wall Street and her name has been bandied about with each high profile executive opening in the biotech industry since her June 2017 “retirement” from Celgene. She also previously served as chief financial officer of food company Bunge Limited.

She said she intends to focus on existing drug candidates in development, as well as strategies for expansion in markets outside the United States, Fouse told Reuters in an interview.

Fouse, who led various divisions at Celgene before becoming president and COO, joined the Agios board last December. Agios has an oncology development deal with Celgene.

Agios in July received U.S. approval for Tibsovo to treat acute myeloid leukemia in patients with a specific genetic mutation. It is the company’s first wholly owned drug. Its first approved leukemia treatment, Idhifa, was partnered with Celgene.

Agios shares have risen 39 percent since the start of the year.

SOURCE: www.uk.reuters.com/article/agios-ceo