Karolinska Development’s portfolio company Aprea Therapeutics reports results from Phase 3 study of eprenetapopt in MDS
STOCHOLM, SWEDEN – December 28, 2020. Karolinska Development AB (Nasdaq Stockholm: KDEV) announces today that its portfolio company, Aprea Therapeutics, has reported results from a pivotal Phase 3 study evaluating the efficacy of eprenetapopt in combination with azacitidine (AZA) versus AZA alone in TP53 mutant myelodysplastic syndromes (MDS). The trial failed to meet its primary endpoint of complete remission (CR) rate. Analysis of the primary endpoint at this data cut demonstrated a higher CR rate in the experimental arm receiving eprenetapopt with AZA versus the control arm receiving AZA alone, but did not reach statistical significance.In the intention-to-treat population of 154 patients, the CR rate in the eprenetapopt with AZA arm was 33.3% (95% CI: 23.1% – 44.9%) compared to 22.4% (95% CI: 13.6% – 33.4%) in the AZA alone arm (P = 0.13). CR rate was 53% higher in eprenetapopt with AZA arm compared to AZA alone, but did not reach statistical significance.“Following the top-line results from Aprea Therapeutics’ Phase 3 study of eprenetapopt we are now looking forward to the forthcoming in-depth data analysis, to get a better understanding of the consequences for the further development of eprenetapopt in myelodysplastic syndromes and other potential indications”, said Karolinska Development’s CEO, Viktor Drvota.Eprenetapopt (APR-246) is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein by restoring wild-type p53 conformation and function – thereby inducing programmed cell death in human cancer cells. Pre-clinical anti-tumor activity has been observed with eprenetapopt in a wide variety of solid and hematological cancers, including myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and ovarian cancer. For further information on the additional ongoing clinical trials of eprenetapopt in hematologic malignancies and solid tumors and Aprea Therapeutics additional candidate drug, APR-548, please visit www.aprea.comKarolinska Development’s holding in Aprea Therapeutics, through KDev Investments AB, amounts to 8,4 %.For further information, please contact: Viktor Drvota, CEO, Karolinska Development AB Phone: +46 73 982 52 02, e-mail: firstname.lastname@example.orgFredrik Järrsten, CFO and deputy CEO, Karolinska Development AB Phone: +46 70 496 46 28, e-mail: email@example.comTO THE EDITORSAbout Karolinska Development AB Karolinska Development AB (Nasdaq Stockholm: KDEV) is a Nordic life sciences investment company. The company focuses on identifying breakthrough medical innovations in the Nordic region that are developed by entrepreneurs and leadership teams. The Company invests in the creation and growth of companies that advance these assets into commercial products that are designed to make a difference to patients’ lives while providing an attractive return on investment to shareholders.Karolinska Development has access to world-class medical innovations at the Karolinska Institutet and other leading universities and research institutes in the Nordic region. The Company aims to build companies around scientists who are leaders in their fields, supported by experienced management teams and advisers, and co-funded by specialist international investors, to provide the greatest chance of success. Karolinska Development has a portfolio of ten companies targeting opportunities in innovative treatment for life-threatening or serious debilitating diseases. The Company is led by an entrepreneurial team of investment professionals with a proven track record as company builders and with access to a strong global network.For more information, please visit www.karolinskadevelopment.comThis information is information that Karolinska Development AB (publ) (Nasdaq Stockholm: KDEV) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of Viktor Drvota, at 16:20 CET on 28 December, 2020Attachment * KD PR Aprea P3 2020-12-28 Eng
Pfizer vaccine delay means BC is prioritizing second doses | News – Daily Hive
BC’s top doctor says the province’s most vulnerable residents should all receive their COVID-19 vaccine by the end of March, despite Pfizer’s shipping delay.
The vaccine manufacturer is making upgrades to its European facility to increase the number of doses it can produce. But in the short term, countries receiving shipments from that facility will get fewer doses.
Such delays are to be expected in a large and global vaccine rollout, Dr. Bonnie Henry said at her Monday news conference.
“It’s a bit of a setback but is only a delay,” she said. “We are still on track to protect the most vulnerable by the end of March.”
Due to the delay, a higher proportion of vaccine doses the province has on hand will be going toward second doses and fewer will be used for first doses. BC is still confident second doses can be administered at the 35-day mark.
In the meantime, it’s important that people keep their distance, wear masks, wash their hands, and don’t participate in social gatherings, Henry said.
The most significant impact of Pfizer’s shipping delays will be felt in late January and early February.
During the week of January 25, Pfizer will only deliver one-quarter of Canada’s expected COVID-19 vaccine doses. In the first two weeks of February, the company will deliver half of the expected doses.
Ontario's first major COVID-19 vaccination site will pause after just 5 days due to supply shortage – CTV Toronto
Toronto Fire Chief Matthew Pegg says a pilot COVID-19 vaccination clinic that just opened today at the Metro Toronto Convention Centre will have to pause vaccinations on Friday because of a shortage of vaccine supply in the province.
The proof-of-concept clinic opened Monday and is meant to help develop a blueprint for how shots should be administered in non-medical settings as soon as this spring. So far, COVID-19 vaccines have only been administered at long-term care homes and at 19 hospital sites across Ontario.
Pegg said last week the facility would be “scale-able” and capable of increasing output with little notice, with an initial target of 250 doses per day.
But at the city’s media briefing on Monday, he said the province has now asked the city to pause vaccinations at the new clinic by the end of Friday.
“We were all disappointed to learn that the delivery of Pfizer vaccine to Canada is expected to be delayed as a result of manufacturing delays in Europe. As a result, we have now been advised by the province that we will only be able to operate this proof of concept clinic for an initial five days due to the lack of availability of COVID-19 vaccine,” Pegg said.
He said anyone with an appointment at the clinic from Jan. 23 on should expect that their appointment will be cancelled.
Peg said those who receive their first dose at the clinic this week will still be able to get their second dose within the proper timeframe.
The clinic will resume vaccinations once it gets word from the province that it may do so. In the meantime, Pegg said the city is continuing to plan for a quick rollout of the vaccine when more doses become available.
“We are continuing to explore all options to accelerate our ability to administer vaccines to Toronto residents once larger quantities of vaccine are available,” he said. “This will include planning for extended hours of clinic operations, expanded clinic capacity targets and implementing innovative delivery methods that meet the needs of our city, including mobile vaccine clinics, priority neighborhood response, hospital-led clinic operations and widespread public access via pharmacies and primary care physicians.”
The site had been expected to run for at least six weeks in order to gather data about how best to host vaccination drives in larger settings.
Ontario Premier Doug Ford and Tory toured the site at MTCC’s North Building just on Sunday.
While the clinic was meant to use the Moderna vaccine, the Pfizer delays mean that some of that supply will now be redistributed to other parts of the province.
Couche-Tard to pursue other deals after Carrefour failure – BNN
Executives at Alimentation Couche-Tard Inc. defended a failed bid for Carrefour SA and said they would still like to buy the French grocer some day, but will turn their focus to other potential deals.
The Canadian convenience store operator made a US$20 billion offer that was shot down by French Finance Minister Bruno Le Maire on Friday. The bid caught investors off guard because Couche-Tard does not operate supermarkets.
The shares tumbled nearly 11 per cent last week. On Monday, they were up 2.4 per cent to $38.90 as of 9:36 a.m. in Toronto.
In response to criticism of the deal, Couche-Tard executive chairman Alain Bouchard said previous large deals — including the 2003 acquisition of Circle K — also surprised the market, but they worked out.
“Over the last decades while growing our business we have made many bold moves, some of which were not always obvious to our stakeholders,” Bouchard said on a conference call with investors Monday.
“Was I hoping our bold approach to Carrefour would have turned out differently? Of course. Yet I’m tremendously proud that Couche-Tard had the financial strength and acumen to make such an offer.”
The companies announced the end of negotiations on Saturday, four days after Bloomberg first reported the talks, and said they’ll work instead on a looser alliance in areas including fuel purchasing and product distribution.
Couche-Tard executives gave few details on that alliance Monday, calling the talks exploratory. Chief Executive Officer Brian Hannasch said there is a “robust” set of other acquisitions to examine as it pursues a five-year goal of doubling profit by 2023.
Hannasch said the door is open to a future Carrefour merger if the political climate in France changes.
“I’m old enough to believe there’s no such thing as permanently,” he said. “We’d love to do the transaction, so if we got signals that the environment could change or would change from the French government or the key stakeholders, we’d love the opportunity to re-engage — under the right conditions and assuming we haven’t found another way to create more value for our shareholders.”
The Laval, Quebec-based company has been making headway on its growth plans even without a major acquisition in recent years. Analysts expect adjusted earnings per share to be 16 per cent higher for the fiscal year that ends in April, according to data compiled by Bloomberg. Even so, its valuation has dipped.
The chain has been improving its coffee and adding fresh food offerings, which come with higher margins. It’s digging into analytics to improve pricing and promotions, and planning to roll out electric vehicle charging stations in North America after learning from its experience in Norway.
Couche-Tard strengthened its foothold in Asia by buying about 370 stores in Hong Kong and Macau that previously were Circle K brand licensees. But a large takeover has remained elusive since it signed a US$4 billion purchase of Texas-based CST Brands Inc. in 2016.
In April, the company walked away from a US$5.6 billion proposal for gas station chain Caltex Australia Ltd. (now known as Ampol Ltd.), citing pandemic uncertainty. And it missed out on Marathon Petroleum Corp.’s Speedway gas stations, which were scooped up in August by Japan’s Seven & i Holdings Co., the world’s largest convenience store operator, for US$21 billion.
Couche-Tard executives have scoffed at the valuation of Speedway. Addressing shareholders at the company’s annual meeting in September, Bouchard cited it as an example of the company’s discipline around acquisitions.
The balance sheet leaves it in a good place to hunt for deals. The company had about US$5.5 billion in net debt at the end of its October quarter, according to data compiled by Bloomberg. It’s earned US$3.5 billion in operating profit in the last four quarters.
Chief Financial Officer Claude Tessier told analysts in November that the current debt ratio is at half of Couche-Tard’s comfort level.
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