BriaCell Expands Breast Cancer Platform Tech into Prostate, Melanoma, Lung Cancers

 

• BriaCell is expanding its breast cancer platform technology into other cancers including prostate, melanoma, and non-small cell lung cancer.

• Bria-OTS™, an off-the-shelf personalized immunotherapy for advanced breast cancer, remains on track to enter the clinic in 2021.

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX-V: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, announces the advancement of its targeted oncology therapeutics into several novel immunotherapy cell lines: Bria-Pros™ for prostate cancer, Bria-Mel™ for melanoma, and Bria-Lung™ for lung cancer.

BriaCell’s immunotherapy treatment appeared most effective in breast cancer when the patient human leukocyte antigen molecules (HLA-type) matched with the targeted immunotherapy, allowing BriaCell to potentially identify patients most likely to respond to the treatment. The novel approach uses an HLA-typing test - a simple and widely available test. Using its proprietary cell engineering technology, BriaCell is now developing off-the-shelf personalized immunotherapy, utilizing this “HLA-matching” platform technology, for multiple cancer indications:

Bria-Pros™: Bria-Pros™ is an off-the-shelf personalized immunotherapy for prostate cancer. Prostate cancer, aside from non-melanoma skin cancer, is the most common cancer among men in the United States. It is also one of the leading causes of cancer death in men. With over 200,000 new cases diagnosed each year, over 30,000 men died of prostate cancer in 2017. Current treatments for metastatic prostate cancer include immunotherapy, hormone therapy, chemotherapy and targeted treatments. However, none of these treatments are curative. Newer therapies are needed for advanced prostate cancer.

Bria-Mel™: Bria-Mel™ is an off-the-shelf personalized immunotherapy for melanoma. There are over 80,000 cases of melanoma diagnosed each year in the United States and over 8,000 deaths annually. Treatment for advanced melanoma includes immunotherapy, targeted therapy and chemotherapy. There remains a significant opportunity for safe and effective new therapies for melanoma.

https://finance.yahoo.com/news/briacell-therapeutics-expands-breast-cancer-120500557.html

Slashing 186 jobs, Novartis hands U.S. sales, marketing duties for migraine med to Amgen

 Novartis and Amgen were the first onto the CGRP scene with migraine drug Aimovig, but tensions ensued shortly into the drug's launch as both partners filed dueling lawsuits against each other. But now with the migraine market becoming increasingly crowded, Novartis will cede U.S. Aimovig operations over to Amgen. 

Novartis will hand previously shared joint U.S. business operations for Aimovig over to Amgen, including, but not limited to, sales, marketing and medical support functions, a spokesperson said on Tuesday.

As a result, Novartis will slash 186 jobs supporting Aimovig. Those include brand marketing and field sales positions that report to Novartis' U.S. headquarters in East Hanover, New Jersey. The layoffs, effective in September, were first filed on the state's Worker Adjustment and Retraining Notification website. Novartis' spokesperson said the move will "enhance operational efficiencies in the increasingly competitive migraine space."

Financial aspects of the U.S. collaboration, including "sharing the commercialization costs and receiving royalties on sales," will remain in tact. Novartis will also retain the right to sell Aimovig outside of the U.S., except in Japan. 

The move comes amid a court battle between the two drugmakers dating back to early 2019. Novartis first sued Amgen in Manhattan federal court for trying to inappropriately back out of their collaboration. Amgen originally had rights to the drug, but Novartis in 2015 partnered on Aimovig and spent more than $800 million on its development and commercialization, the lawsuit said. 

Amgen sued back, arguing that Novartis breached the agreement by helping bring a potential competitor to market. Novartis' Sandoz unit teamed with Alder BioPharmaceuticals on a rival CGRP drug known as eptinezumab. Lundbeck snapped up that drug, now FDA approved and sold as Vyepti, as part of its $2 billion buyout of Alder BioPharmaceuticals in late 2019. 

Novartis' latest move is for efficiency's sake and "does not resolve the litigation Novartis currently has with Amgen," the spokesperson said. The Swiss drugmaker said two claims in its U.S. litigation against Amgen related to commercialization expenses and the drug's launch will be resolved while the others remain pending.  

While Aimovig may have been the first preventative CGRP-target migraine therapy to score an FDA approval in 2018, it's since been followed by a slew of rival treatments. In the injectable monoclonal antibody market, Aimovig competes with Teva’s Ajovy and Eli Lilly’s Emgality. But while Aimovig had a head start, Eli Lilly's rival has since passed the first-mover in quarterly sales. Emgality generated $119 million during the first quarter, compared with $66 million for Aimovig.

Meanwhile, Biohaven Pharmaceutical's oral Nurtec ODT became the first FDA-approved option to both prevent and treat migraines in late May. The FDA is also reviewing an oral drug from AbbVie, known as atogepant, for the prevention of migraines. AbbVie's Ubrelvy won FDA approval in late 2019 as an acute treatment option.

The Novartis layoffs come amid a four-year restructuring process initiated in 2018 by CEO Vas Narasimhan. At the time, the Novartis chief outlined plans to reduce the company's overall footprint by at least 19%, from 124,000 employees to under 100,000 by 2022. The drugmaker currently has about 110,000 employees globally. 

https://www.fiercepharma.com/pharma/novartis-to-hand-over-u-s-aimovig-operations-to-amgen-amid-crowded-migraine-market-slashes

BerGenBio (BGBIO) : FDA grants fast track designation

 Edison Investment Research Limited

BerGenBio (BGBIO): FDA grants fast track designation 
16-Jun-2021 / 07:00 GMT/BST 
=---------------------------------------------------------------------------------------------------------------------- 
 
London, UK, 16 June 2021 
 
BerGenBio (BGBIO): FDA grants fast track designation 
BerGenBio (BGBIO), a pioneer in AXL biology and the development of AXL inhibitors, has two clinical-stage assets: 
selective tyrosine kinase inhibitor bemcentinib and functional blocking monoclonal antibody tilvestamab. FDA has 
granted bemcentinib fast track designation in combination with an anti-PD-L1 agent for the treatment of AXL-positive 
advanced/metastatic NSCLC patients (without driver mutations) who have progressed following first-line treatment. BGBIO 
has also presented data from the ongoing BGBC003 Phase II trial (in combination with LDAC) at EHA, which supports the 
safety and efficacy profile seen to date in elderly relapsed AML patients. Notably durable responses were observed in 
the relapsed AML setting (ORR of 31%; 5/16) and median overall survival of 13.3 months (data still immature). We value 
BGBIO at NOK4.72bn or NOK53.8/share. 
 
We value BerGenBio at NOK4.72bn or NOK 53.8/share. Our forecasts remain unchanged. The drivers are bemcentinib in 
second-line NSCLC (peak sales USD1.2bn, NOK37.2/share) and AML (peak sales USD598m, NOK12.2/share) plus the COVID-19 
opportunity (peak sales USD300m, NOK5.4/share), offset by payments due to Rigel. 
Click here to view the full report or here to sign up to receive research as it is published. 
 
All reports published by Edison are available to download free of charge from its website 
www.edisongroup.com 

https://www.marketscreener.com/quote/stock/BERGENBIO-ASA-34541487/news/BerGenBio-BGBIO-nbsp-FDA-grants-fast-track-designation-35617503/

AVITA Medical Announces Preliminary Fourth Quarter 2021 Financial Results

 AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, today announced preliminary, unaudited financial results for the fiscal fourth quarter 2021.

For the fiscal quarter ending June 30, 2021, AVITA Medical has to date realized total revenue in excess of its fiscal fourth quarter guidance range of $8.2 million to $8.6 million. Based on the strength of both RECELL® commercial revenue and BARDA related revenue, the Company is raising fiscal Q4 guidance to be in the range of $9.5 - $9.7 million, consisting of $6.0 - $6.2 million of RECELL® commercial revenue and $3.5 million of RECELL® revenue associated with BARDA, the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority within the Office of the Assistance Secretary for Preparedness and Response. RECELL® commercial revenue as revised in the guidance reflects a 55% to 60% increase over the prior year period and 30% to 34% increase over the third quarter of 2021.

“As people begin to return to normal activities after the confines of the COVID-19 pandemic, we have seen an increase in burn accidents requiring treatment with the RECELL® System in burn centers across the country,” said Dr. Mike Perry, AVITA Medical’s Chief Executive Officer.

The Company expects to announce fourth quarter financial and operating results on August 25, 2021. More details about the upcoming earnings announcement, including the time and webcast details, will be provided at a later date.

The preliminary unaudited revenue results described in this press release are estimates only and subject to revision until we report our Q4 2021 financial results in our Annual Report on Form 10-K.

https://finance.yahoo.com/news/avita-medical-announces-preliminary-fourth-220800698.html

UK ministers to be advised against mass vaccination for children

 Ministers will be advised against the mass rollout of COVID-19 vaccinations to children below the age of 18 in the UK until scientists obtain more data on the risks, The Telegraph reported on Tuesday (Jun 15). 

Experts on the country's Joint Committee on Vaccination and Immunisation (JCVI) are understood to be preparing an interim statement for release as soon as the end of the week following a meeting on Tuesday, the report added. 

"Scientists want to see more data from the US and elsewhere before taking a firm stand either way. Nobody is going to make a final decision at this point. The JCVI will want to weigh up the benefits against the risks before vaccinating children, and it wants more data," a government source told the paper.

JCVI and Britain's Department of Health and Social Care did not immediately respond to a Reuters request for comment outside business hours.

The report also added that committee members are understood to have voiced ethical concerns about vaccinating children as they rarely suffer severe COVID-19.

Earlier this month, Britain's medicines regulator extended approval of the COVID-19 vaccine developed by Pfizer and BioNTech for children aged 12 to 15 years.

The regulator said it would now be up to JCVI to decide whether to go ahead and inoculate this age group as part of Britain's vaccination roll-out plan.

https://www.channelnewsasia.com/news/world/uk-ministers-to-be-advised-against-mass-vaccination-for-children-15023280

Regeneron COVID-19 Therapy Cuts Deaths Among Hospitalised Patients Who Lack Antibodies

 Regeneron Pharmaceuticals Inc's COVID-19 antibody cocktail reduces deaths in hospitalised patients who have not mounted their own antibody response, a large British study published on Wednesday found.

The therapy, REGEN-COV, has been granted emergency use authorisation for people with mild-to-moderate COVID-19 in the United States, but results from the RECOVERY trial provide the clearest evidence of its effectiveness among hospitalised patients.

It found that the antibody therapy reduced by a fifth the 28-day mortality of people admitted to hospital with COVID-19 whose immune system had not mounted an antibody response, known as seronegative.

The result translates into six fewer deaths for every 100 seronegative patients treated with the therapy, researchers said.

There was no discernible effect of the treatment on those who had generated natural antibody responses and were seropositive.

"People have been very, very sceptical, that any treatment against this particular virus would work by the time people get in hospital," Martin Landray, the joint chief investigator on the trial, told reporters.

"If you haven't raised antibodies of your own, you really would benefit from getting some," he said.

The treatment also shortened the hospital stay of those who were seronegative and reduced their chances of needing a mechanical ventilator, Landray said.

Regeneron had previously said its treatment had shown enough promise in hospitalised patients to warrant continuing its trial. This data provides the first large-scale confirmation of that assertion.

There were 9,785 patients hospitalised with COVID-19 who were randomly allocated to receive usual care plus the antibody combination therapy or just usual care, of which 30% were seronegative.

The RECOVERY trial also showed the steroid dexamethasone and Roche's arthritis drug Actemra (tocilizumab) cut deaths in hospitalised patients.

While those treatments focus on inflammation caused by reaction to the coronavirus, Regeneron's therapy, which belongs to a class of biotech drugs called monoclonal antibodies, mimic natural antibodies the body produces to fight off the infection.

"This is the first time we've got one that's actually targeting the virus itself," Landray said, adding that it could be used along with the other treatments.

"It's not that you do one thing or another thing. These benefits are additive in these patients," he said.

POSSIBILITY FOR OTHERS

Other companies have been developing similar treatments.

U.S. emergency use authorization has been granted to antibody treatments developed by Eli Lilly and Co as well as by Vir Biotechnology Inc with GlaxoSmithKline Plc. Both are approved for use in mild-to-moderate cases.

On Tuesday, AstraZeneca said its antibody therapy had shown no evidence of protecting people from developing the disease following exposure, although other trials of its cocktail as a prevention or a treatment are ongoing.

Landray said the RECOVERY results should give developers of other monoclonal antibody therapies optimism that they can also be used in some hospitalised patients.

"This opens up the possibility for many, many others," he said.

"People see a few negative trials and they say 'well that'll never work' and they opt out and go off and do something else. (But) this is very, very clear, the picture that we've got from this trial."

https://www.usnews.com/news/top-news/articles/2021-06-16/regeneron-covid-19-therapy-cuts-deaths-among-hospitalised-patients-who-lack-antibodies-study

U.S. authorizes another batch of Johnson & Johnson Covid-19 vaccine, reported m 14M doses

 The U.S. Food and Drug Administration on Tuesday authorized around 14 million more doses of Johnson & Johnson’s Covid-19 vaccine manufactured at a problem-plagued Baltimore factory, according to two sources familiar with the plans.

The FDA confirmed it had authorized a batch of the one-dose vaccine made at Emergent BioSolutions’ plant, but did not say how many doses were in the batch.

All the J&J doses authorized from the plant to date are expected to be exported to other countries, one of the sources said. The doses are already in vials, ready for use, the other source said.

Production of J&J’s vaccine at the Baltimore site was halted by U.S. authorities in April following the discovery that ingredients from AstraZeneca’s Covid-19 vaccine, also being produced at the plant at the time, contaminated a batch of J&J’s vaccine.

An FDA inspection also turned up a long list of sanitary problems and bad manufacturing practices at the Emergent plant. J&J was put in charge of manufacturing at the plant and AstraZeneca’s shot is no longer being made there.

The agency said it was still not ready to authorize the Emergent plant to restart making the J&J vaccine.

Last week, the U.S. drug regulator cleared for use around 10 million doses of the vaccine, according to two sources familiar with the matter, but said J&J had to throw away millions more the shot that were manufactured there.

The New York Times said the batches being discarded amount to around 60 million doses, citing people familiar with the matter.

The FDA said additional batches already produced at the plant are still under review and the agency will inform the public when those reviews are finished.

Safety concerns about the J&J vaccine paired with flagging U.S. demand for vaccinations in general have slowed rollout of the one-shot vaccine to a crawl. Just under 10 million out of the 21 million doses produced for the United States sit unused.

https://www.cnbc.com/2021/06/15/us-authorizes-another-batch-of-johnson-johnsons-covid-19-vaccine.html