Category Archives: Conference

Chinese CAR-T results offer hope of myeloma cure

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This year’s ASCO conference has plenty of data from the CAR-T therapy contenders – but little known Chinese biotech Nanjing Biotech looks to have trumped all the established firms.

Nanjing’s therapy targets B-cell maturation protein (BCMA) in refractory multiple myeloma has produced spectacular results, so far producing a lasting remission in 14 out of 35 patients in the small-scale trial.

This CAR-T differs from most of its rivals, which target the CD19 protein.

Nanjing’s data comes from an early trial involving 35 patients with relapsed or treatment-resistant (refractory) multiple myeloma in a phase 1 trial.

But the objective response rate – a defined level of tumour shrinkage – was 100% and 33 (94%) of patients had an evident clinical remission of myeloma.

So far 19 patients have been followed for more than four months, a pre-set time for full efficacy assessment set by international experts.

Of the 19 patients, 14 have reached stringent complete response (sCR) criteria, one patient has reached partial response, and four patients have achieved very good partial remission (VgPR) criteria in efficacy.

There has been a single case of disease progression from partial response – and side effects seem to be manageable.

The dreaded cytokine release syndrome – a common and potentially dangerous side effect of CAR-T therapy – occurred in 85% of patients.

But effects were transient and only two patients experienced severe CRS (grade 3) but recovered upon receiving Roche’s Actemra to combat inflammation.

“Although recent advances in chemotherapy have prolonged life expectancy in multiple myeloma, this cancer remains incurable,” said study author Wanhong Zhao, MD, PhD, an associate director of haematology at The Second Affiliated Hospital of Xi’an Jiaotong University in Xi’an, China.

“It appears that with this novel immunotherapy there may be a chance for cure in multiple myeloma, but we will need to follow patients much longer to confirm that.”

There were no signs of any neurologic side effects, another common and serious complication from CAR-T.

New trial data send bluebird soaring

All of the 15 evaluable patients in active dose cohorts in bluebird’s trial in relapsed or refractory multiple myeloma trial achieved an objective response, with overall response being 89% across all cohorts.

Among evaluable patients, 73% achieved a very good partial response, with a 27% complete response rate across all cohorts.

The trial is investigating bb2121, an investigational CAR-T therapy bluebird is developing in partnership with Celgene, in heavily pretreated patients.

All had previously received Celgene’s Revlimid (lenalidomide) and Janssen’s Velcade (bortezomib), and some had been treated with up to five previous drugs including Janssen’s Darzalex (daratumumab).

Safety data was thin but bluebird said there were no “dose-limiting toxicities” observed. The data send the company’s shares up 8.5% on the Nasdaq, to $91.3.

Juno shares fall after new CAR-T safety scare

But new data from its CAR-T rival Juno sent shares sharply down by 10%, to $23.4. Also partnered with Celgene, Juno abandoned development of its lead CAR-T therapy JCAR015 in acute lymphoblastic leukaemia after five trial deaths.

The reason for the fall was that although Juno presented promising efficacy data for its JCAR017 in refractory CD19+ aggressive non-Hodgkin Lymphoma, there was one death on the 71-patient trial.

Juno said the death followed diffuse damage to lungs related to fludarabine, cyclophosphamide and JCAR017 treatment, in an 82 year-old patient who refused mechanical ventilation for progressive respiratory failure.

The patient was neutropenic on growth factors and broad spectrum antibiotics and antifungals.

Juno did its best to downplay the safety issue. But investors clearly feel the deaths last year, two of which occurred after a trial was quickly restarted, have damaged Juno’s reputation.

Kite Pharma, which has axicabtagene ciloleucel CAR-T under review with the FDA, said it plans a phase 2 trial of the therapy in relapsed acute lymphoblastic leukaemia at a lower dose, beginning in the fourth quarter. Novartis also has its CTL019 CAR-T inder review with the FDA in diffuse large B-cell lymphoma.

SOURCE: www.pharmaphorum.com/news

UK must prioritise $17bn medtech sector in face of Brexit, new report urges

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A new report from the Institution of Mechanical Engineers (IME) has highlighted the threat Brexit poses to the $17 billion UK medical technology sector, calling on industry to keep pace with EU regulation and funding in order to maintain jobs and investment.

In the time since the announcement of a snap general election in the UK, a number of life sciences organisations have published reports which stress the significance of the nation’s vote and its impact on the future of the industry, including the UK BioIndustry Association, and the ABPI. Both focus on the imperative of governmental cooperation with the industry and the strength of a fully-supported NHS.

The report Medical Devices & CE Marking –the Impact of Brexit outlines three key points: firstly, it is recommended that the government work with med tech firms to come to a compliancy agreement with the EU, supported by parallel policies, in order to secure long term investment and attract SMEs to the country.

Secondly, the report encourages a close relationship between the NHS and UK industry, based on any relevant post-Brexit arrangements, to maintain its influential power over EU regulation in the future. Lastly, it is advised that the current imbalance in EU research funding between small start-ups and large pharmaceutical companies is addressed.

“The UK Government must ensure that the Med Tech industry is high on its priority list as it prepares to negotiate the country’s departure from the EU,” Dr Helen Meese, Head of Healthcare at IME, explained. “Not only does this industry make a huge contribution to domestic and international healthcare ― from the design of artificial joints and organs through to the production of aids for independent living ― the sector is also worth £17 billion to the UK economy and supports 90,000 jobs. Leaving the EU without the UK medical technology industry suffering considerable long-term damage, particularly for small businesses, will be a huge challenge.

“As part of the UK’s Brexit deal, it is vital that the UK is able to maintain continuity with the EU CE certification processes, and enable UK manufacturers to export medical devices into the €100 billion European Med Tech market,” she continued. “Our Government should not forget to use the purchasing power of the NHS to help attract new business into the sector and retain influence over future European regulation. The Government also needs to outline exactly how UK Research and Innovation bodies such as InnovateUK and the Engineering and Physical Sciences Research Council will address the more than €1 billion a year funding short-fall from what the UK currently receives from the European Research Council.”

SOURCE: www.pharmafile.com/news/513958

Clegg to oppose NHS competition plans

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Taken from ITN (Online)
.Nick Clegg will oppose the idea of a regulator to promote competition in the health service – a key plank of the Government’s controversial NHS reforms.

The Deputy Prime Minister has signed off a policy document that states the health service must not be treated as if it were a “utility” with its “own economic regulator”.

He has instead called for a regulator that has a duty to push NHS collaboration rather than competition.
Mr Clegg’s stance directly opposes the one taken by Health Secretary Andrew Lansley, who is pushing to increase competition within the NHS to drive down prices.

In the blueprint of his Health and Social Care Bill, Mr Lansley has proposed that the watchdog Monitor, which currently scrutinises hospital finances, is also given the duty of promoting competition in the provision of health services.

However, Mr Clegg believes Monitor should instead promote and protect the interests of the patient.
Addressing fellow Liberal Democrat MPs and peers at a meeting, he said he would “never let the profit motive get in the way of the essential purposes of the NHS”.

Mr Clegg has vowed to veto the legislation – elements of which are deeply unpopular among Liberal Democrat MPs and activists – as part of efforts to demonstrate a greater influence by his party in the Tory-led coalition Government following disastrous results at the ballot box earlier this month.

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