Bayer Acquires Noria and PSMA Therapeutics to Expand Pipeline in Prostate Cancer

 

• Broadens company’s oncology platform of Targeted Alpha Therapies (TATs)
• Acquisition includes actinium-225 labeled differentiated prostate-specific membrane antigen (PSMA) small molecule being studied as an investigational compound in prostate cancer

 

WHIPPANY, N.J.--(BUSINESS WIRE)-- Bayer today announced that it has entered into an agreement to acquire Noria Therapeutics Inc. (Noria) and PSMA Therapeutics Inc. Through this acquisition, Bayer will obtain exclusive rights to a differentiated alpha radionuclide investigational compound based on actinium-225 and a small molecule directed towards prostate-specific membrane antigen (PSMA). The acquisition broadens Bayer’s existing oncology portfolio of targeted alpha therapies (TATs), which currently includes Xofigo^® (radium Ra 223 dichloride), which is approved for metastatic castration resistant prostate cancer (mCRPC) with symptomatic bone metastases and no known visceral metastases, and the proprietary platform of investigational TATs based on thorium-227.

The pre-IND program focuses on the treatment of prostate cancer, the second most commonly diagnosed cancer in men.¹

“Bayer is focused on addressing the various medical needs of cancer patients, providing treatments that have the potential to improve patient outcomes throughout the different stages of the disease,” said Robert LaCaze, Member of the Executive Committee of the Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer. “This acquisition is another important milestone in enhancing Bayer’s oncology portfolio through both in-house expertise and strategic collaborations and agreements.”

The companies acquired by Bayer, Noria and PSMA Therapeutics, have exclusive world-wide rights to technology licensed from Weill Cornell Medicine (New York, NY, USA) and Johns Hopkins University (Baltimore, MD, USA). Noria was founded by Dr. John Babich, Chief, Radiopharmaceutical Sciences in Radiology at Weill Cornell Medicine.

“Weill Cornell Medicine is committed to bringing our faculty’s innovations to market so that patients can benefit from the latest therapeutics,” said Dr. Lisa Placanica, Senior Managing Director Center for Technology Licensing at Weill Cornell Medicine. “Bayer’s acquisition of Noria and PSMA Therapeutics which have nurtured Dr. Babich’s radiopharmaceutical and diagnostic technology, is an important milestone in drug development, and we look forward to the advances this collaboration can make to enhance prostate cancer therapies.”

With the first and only approved targeted alpha therapy Xofigo, Bayer has successfully established Xofigo as a TAT for men with mCRPC, symptomatic bone metastases and no known visceral metastases. Adding actinium-225-labeled small molecule to the company’s platform of investigational targeted thorium conjugates, supports our commitment to researching differentiated treatment options for cancer patients.

“Despite increased cancer survivorship overall, there continues to be a significant unmet need in oncology,” said Marianne De Backer, MBA, PhD, Member of the Executive Committee of the Pharmaceuticals Division and Head Strategy and Business Development & Licensing at Bayer. “We remain committed to exploring collaborations for innovative and pioneering scientific research for patients with unmet needs.”

Financial terms of the agreement were not disclosed.

https://www.biospace.com/article/releases/bayer-acquires-noria-and-psma-therapeutics-to-expand-pipeline-in-prostate-cancer/

VBL Adds Progression Free Survival as Second Primary Endpoint in Ovarian Cancer Study

 

• Second primary endpoint added following discussion with the U.S. Food and Drug Administration
• Successfully meeting either PFS or OS primary endpoints expected to be sufficient for submitting a BLA for potential full FDA approval
• PFS endpoint readout expected in 2022; BLA submission could be possible one year earlier than previously projected with OS endpoint alone
• Clinical trial amendment reported in an OVAL Clinical Trial in Progress poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting

https://www.globenewswire.com/news-release/2021/06/03/2241149/0/en/VBL-Therapeutics-Announces-Addition-of-Progression-Free-Survival-as-a-Second-Primary-Endpoint-in-OVAL-a-Phase-3-Registration-Enabling-Study-of-VB-111-in-Ovarian-Cancer.html

Replimune Updates on RP1, RP2 Programs, to Expand RP2/3 Beyond Phase 1

 High rate of complete responses in RP1 skin cancer cohorts underscore the potential for profound patient benefit and supports the ongoing registration directed development programs

RP2 data confirms the signal with RP1 in anti-PD1 failed melanoma, uveal melanoma and in treating patients whose cancer has metastasized to the liver

Announces plans to initiate broad Phase 2 development of RP2 and/or RP3 in tumor types that commonly metastasize to the liver

Virtual investor event to be held at 8:00 am ET

Investor event and webcast information

Replimune will host a virtual investor event today, Thursday, June 3, 2021 at 8:00 a.m. ET. The webcast and slides will be accessible live under “Events & Presentations” on the Investors page of the Company’s website at www.replimune.com or by clicking here. A replay of the event will be available on Replimune’s website.

https://www.globenewswire.com/news-release/2021/06/03/2241138/0/en/Replimune-Provides-Data-Update-from-its-RP1-vusolimogene-oderparepvec-and-RP2-Programs-and-Announces-Plans-to-Expand-the-Development-of-RP2-3-Beyond-Phase-1.html

Ocugen Expands COVAXIN™ Commercialization Rights to Include Canada

 Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, and Bharat Biotech, a global leader in vaccine innovation, today announced that they have entered into an amendment to their Co-development, Supply, and Commercialization Agreement to expand Ocugen’s exclusive territory to commercialize COVAXIN™ to now also include Canada, in addition to Ocugen’s existing rights to commercialize COVAXIN™ in the United States.

“This amendment to expand our rights to commercialize COVAXIN™ into Canada speaks to our strong relationship with Bharat Biotech and our joint dedication to bring this unique yet traditional vaccine to additional countries. As we work towards the submission of the emergency use application in the US, we will simultaneously seek authorization under interim order for emergency use in Canada. We believe COVAXIN™ has the potential to play a key role in saving lives from COVID-19 in the US and Canada, as well as across the globe, due to the strong immune response it generates against multiple antigens,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

“COVAXIN™ has demonstrated an excellent safety record in human clinical trials and in vaccine administration under emergency use in India. Our goal for all vaccines developed at Bharat Biotech is to provide global access. With its potential effectiveness against multiple existing and emerging variants, we believe that COVAXIN™ is an important vaccine for everyone, including children, based on its unique yet traditional vaccine platform. We are diligently working with Ocugen to bring COVAXIN™ to the US market and now to the Canadian market,” said Dr. Krishna Ella, Chairman & Managing Director of Bharat Biotech.

As consideration for Bharat Biotech’s grant of the rights to commercialize COVAXIN™ in Canada, Ocugen will make an upfront payment and milestone payment upon first commercial sale in Canada to Bharat Biotech, in addition to sharing the profit from sales of COVAXINTM in Canada. Similar to the US profit share arrangement, Ocugen will retain 45% of the profits from sales of COVAXINTM in Canada.

https://www.globenewswire.com/news-release/2021/06/03/2241211/0/en/Ocugen-Expands-COVAXIN-Commercialization-Rights-to-Include-Canada.html

Canada recommends mixing and matching AstraZeneca, Pfizer and Moderna COVID-19 vaccines

 

NACI guidance based on early research from U.K., Spain that shows mixing shots is safe and effective

Canada is changing its guidelines on mixing and matching second doses of COVID-19 vaccines and is now advising Canadians to combine either the AstraZeneca-Oxford, Pfizer-BioNTech or Moderna shots interchangeably in certain situations.

The National Advisory Committee on Immunization (NACI) updated its guidance to provinces and territories Tuesday and recommended that a first shot of the AstraZeneca vaccine can be followed by either Moderna or Pfizer.

For Canadians who have had a first dose of Moderna or Pfizer, NACI recommends they can now take either of the two shots as a second dose — because they both use a similar mRNA technology — if the same first dose is unavailable or unknown.

The updated NACI guidance is based on emerging research from Spain and the United Kingdom that found mixing and matching AstraZeneca and Pfizer vaccines was both safe and effective at preventing COVID-19.

CBC News first reported the details of the recommendation changes Tuesday morning, based on information from sources with direct knowledge of the decision who spoke on condition of anonymity. The details of the shift in guidance were confirmed publicly by officials from the Public Health Agency of Canada during a news conference Tuesday afternoon. 

Canada's Chief Public Health Officer Dr. Theresa Tam said the decision to combine mRNA vaccines interchangeably was "nothing new" and that the same principle had been applied to different types of vaccines in the past — including shots for influenza and Hepatitis A.

"This is not a new concept, so having a multi-dose series in terms of vaccines given by manufacturers is something that public health have used over time for many other vaccines," Tam said. "When vaccines programs and supplies change this is not an unusual thing to do." 

The updated NACI recommendations state, "No data currently exist on the interchangeability of COVID-19 mRNA vaccines," but Tam said there are "ongoing studies" on the effectiveness of the approach that have yet to be published. The decision was made based on the similar makeup of the vaccines, which both target the spike protein of the coronavirus, she said.

The recommendations will have a major impact on Canada's vaccine rollout, with previous NACI guidelines stating that a vaccination series that begins with AstraZeneca should follow up with the same type of shot and that mRNA vaccines should only be used interchangeably if the same first dose is unavailable or unknown.

The updated guidelines follow moves by some provinces to combine different shots due to issues with the supply of AstraZeneca and a rare but serious type of blood clot that can result after the shot called vaccine-induced immune thrombotic thrombocytopenia (VITT), which NACI also cited as a reason for its decision in its guidance. 

More than 13 million people have received at least one dose of the Pfizer vaccine in Canada, in contrast to over 3.5 million of the Moderna vaccine and more than 2.1 million of the AstraZeneca vaccine as of May 22, according to the latest available federal government data.

Tam said that NACI deemed the "mounting" data on following AstraZeneca with an mRNA vaccine sufficient to update its guidance, and that Canadians need to look at "all the information in front of them" about the risks of the AstraZeneca vaccine. 

"The rate of [VITT] after the second dose seems to be lower than after the first dose, but this could increase over time and I think people need to know that kind of information," she said. "Right now it's 1 in 600,000 people who got that second dose that is having [VITT] — but that could change." 

Prof. Alyson Kelvin, an assistant professor at Dalhousie University and virologist at the Canadian Center for Vaccinology and the Vaccine and Infectious Disease Organization in Saskatoon said the guidelines were "appropriate" given available data.

Kelvin said she believes the Pfizer and Moderna vaccines could be effectively interchanged because of the similarity between the clinical trial data and the real world research on the two mRNA-based vaccines. 

"I don't have any concerns with the mixing and matching, knowing the components of the vaccine," she said, adding there were only slight differences in non-serious side effects with Pfizer having slightly higher reports of mild symptoms. "They're fairly on par."\

Provinces move to change vaccine dose orders

Dr. Zain Chagla, an infectious diseases physician at St. Joseph's Healthcare Hamilton and an associate professor at McMaster University, says the proposed approach to mixing and matching COVID-19 vaccines by NACI is reasonable based on available international data. 

"[Pfizer and Moderna] are so interchangeable, I doubt there's going to be any difference between the two," he  said. "Their immune responses should be pretty similar."

Manitoba health officials announced Monday that residents who got a first dose of the AstraZeneca vaccine can receive a second dose of either the Pfizer-BioNTech or Moderna vaccine if they meet provincial eligibility requirements.

B.C. Provincial Health Officer Dr. Bonnie Henry said during a press conference Monday that British Columbians who had an initial dose of Moderna or Pfizer will have the option of receiving either mRNA vaccine as a second shot, with more guidance expected this week on AstraZeneca. 

Quebec officials announced in April the province would begin administering second doses to its most vulnerable residents — even if the second dose didn't match the first.

The Public Health Agency of Canada (PHAC) now estimates the rate of VITT in Canadians who have received the AstraZeneca vaccine is between 1 in 83,000 and 1 in 55,000, with a fatality rate of between 20 and 50 per cent, but that is subject to change as more data emerges. 

PHAC said in a statement to CBC News Thursday there have been 27 confirmed cases of VITT to date in Canada out of two million doses administered, with five deaths among those cases.

Chagla said Canadians who want to have a second dose of AstraZeneca will have access in the coming weeks, but says once supply of Pfizer and Moderna shots are more readily available in Canada it will likely be phased out. 

"Second doses make sense," he said. "First doses are starting to get a little bit tricky with so much vaccine coming to Canada." 

Kelvin said the future use of the AstraZeneca vaccine needs to "go hand in hand" with the development of a screening mechanism for the condition to identify who's most at risk for the rare blood clots. 

"Until we can do that, then we need to at least provide information on what your risk is in general, and discuss using other vaccines as your second dose," she said. 

"Having a profile to identify who might be at risk for severe blood clots after the AstraZeneca vaccine would be important moving forward." 

Early research shows mixing vaccines safe and effective

The Spanish study that informed NACI's guidance analyzed 670 volunteers between the ages of 18 and 59 who had already received a first dose of the AstraZeneca vaccine, with 450 volunteers given a Pfizer dose.

The study found those who had an initial dose of AstraZeneca vaccine and got a second shot of Pfizer had an increase in IgG antibodies — which are commonly found in the bloodstream and play a key role in creating memory cells that fight the virus — that were 30 to 40 times higher than in a control group who only received one AstraZeneca dose.

Results from the Spanish study were announced in a press conference May 18 and also found the presence of neutralizing antibodies rose sevenfold after a Pfizer dose — significantly more than after a second AstraZeneca shot.

"If you looked at the actual immune response, the study from the Spanish trial showed that if you measure antibody response in someone who got AstraZeneca and then had the second dose as Pfizer — they mounted a really robust immune response," Tam said. "So that boosting response that you want to see is very much present."

The Spanish study also found that just 1.7 per cent of the participants reported severe side effects, which were limited to headaches, muscle pain and general malaise.

Early results from another recent study out of the U.K., which also informed NACI's guidance, found that mixing different COVID-19 vaccines for second doses could increase the chance of someone having mild or moderate reactions like fatigue, headache or a fever — symptoms which could signal a strong immune response. 

The findings were published May 12 as correspondence in The Lancet medical journal and came from the Oxford Vaccine Group's Com-Cov vaccine trial, which is studying the use of different combinations of approved COVID-19 vaccines for first and second doses.

https://www.cbc.ca/news/health/canada-mixing-covid-19-vaccines-astrazeneca-pfizer-moderna-naci-1.6048152

Despite vaccines, nursing homes struggle with outbreaks

 Jeannie Wells had hoped that regular visits would resume at her elderly mother’s New York nursing home once all the residents were fully vaccinated against COVID-19.

Around Easter, her wish finally came true, and she was able to hold the 93-year-old’s hand more than a year after bringing her mother to the facility for rehabilitation for a fractured hip and knee.

But that reunion was short-lived. Visits were quickly stopped for about six weeks after an employee tested positive for COVID, and Wells said visits are still far from normal even when there haven’t been outbreaks.

COVID-19 vaccines have allowed nursing homes in the U.S. to make dramatic progress since the dark days of the pandemic, but senior care facilities are still experiencing scattered outbreaks that are largely blamed on unvaccinated staff members. The outbreaks and ensuing shutdowns have jolted family members who were just starting to enjoy in-person visits with loved ones for the first time in a year.

While the outbreaks inside nursing homes now are much smaller, less frequent and less severe than during the height of the pandemic, there continue to be hundreds of deaths each week attributed to the coronavirus. According to federal data, 472 nursing home deaths were related to COVID-19 in the first two weeks of May, down from 10,675 in the first two weeks of January.

“There is this notion among some that vaccines were administered in long-term care, so we’re done, and that would be a perilous mistake,” said Dr. David Gifford, chief medical officer for the American Health Care Association, a national nursing home trade association, in a recent statement. “Nursing homes and assisted living communities have a constant flow of new residents, whether coming from the hospital or the community, and many of them haven’t been vaccinated yet.”

In addition, the CDC has warned that low rates of vaccination among health care workers in skilled nursing facilities raises risks of outbreaks.

A March outbreak involving a variant at a Kentucky nursing home, where most residents had been vaccinated for COVID-19, was traced to an infected, unvaccinated worker, according to a CDC report. Among the 46 cases identified, 26 residents and 20 workers became infected, including 18 residents and four workers who were fully vaccinated 14 days before the outbreak.

Three of the nursing home’s residents who contracted COVID-19 died, including two who were not vaccinated. So-called “breakthrough” infections among vaccinated individuals were also identified in nursing homes in Chicago, according to another recent CDC report.

In Connecticut, Gov, Ned Lamont has likened the challenge of keeping the virus out of nursing homes to patching up “leaky boats.” The state Department of Public Health launched Operation Matchmaker to match nursing homes with certain pharmacies to ensure new residents and staff get shots. Hospitals are also working to vaccinate patients before they’re released to a nursing facility.

Given staffing shortages around the country, there’s been a hesitance among long-term care providers to mandate vaccinations for their workers, said Dr. Vivian Leung, director of the state’s Department of Health’s Healthcare Associated Infections Program.

“We’re working with the long-term care industry to really increase the pressure on getting those staff vaccinated,” Leung said.

Tim Brown, director of marketing and communications at Athena Health Care Systems, which operates 48 facilities in Connecticut, Rhode Island and Massachusetts, recently estimated about 50% to 60% of staff have been vaccinated so far, with as many as 80% in some buildings.

“Throughout our network, we are seeing onesies and twosies, mostly with employees, though, that have not been vaccinated. That’s really where we’re seeing them,” Brown said of he infections. If a staff member tests positive, he said, buildings are put under quarantine and visits are put on hold while another round of staff testing is conducted. Unvaccinated staff are being tested regularly.

“If there are no other cases, or if the employee did not work on a specific wing, then we allow visitation for that wing or for for the wings that are not affected by the positive employee,” he said.

Mairead Painter, Connecticut’s long-term care ombudsman, said recent guidance from the state has clarified how facilities should handle these scattered outbreaks in order to minimize the impact they can have on the rest of residents and their families. She said that’s led to fewer complaints fielded by her office.

But Debra Ellis, whose 88-year-old wife Jackie lives in a Meriden, Conn. nursing home, said the rules still differ by facility. Until recently, she had been frustrated by the strict visitation limits, including sudden multi-day shutdowns when staff members have tested positive. Both she and her wife are vaccinated.

By mid-May, things finally eased up and she’s been allowed to go inside her wife’s room. Yet Ellis hears from relatives of residents at other nursing homes that that’s not the case at other facilities in Connecticut.

Ellis is part of a group that’s pushing for both state and federal legislation allowing nursing home residents to have essential caregivers. She said that could have helped her wife, who suffers from heart problems and relied on Ellis before the pandemic for emotional support and exercises to keep her legs strong.

“She could get up and walk a very small distance around the room to move to the bed to a chair or whatever,” she said. “She’s not longer able to do that.”

That’s a similar experience for Wells, who said the nursing home where her mother lives still has no communal dining, group activities or hairdressing services. Wells, who lives in Rochester, said it was only last week that she was offered the opportunity to meet with her mother outside and without masks. But after spending so much time isolated during the pandemic, Wells said her mother no longer knows who she is, other than someone who cares about her.

She said it pains her to see her mother, who used to get her hair done weekly, looking unkept, with bangs hanging in her eyes and hair down to her shoulders.

“This nursing home never allowed us into their rooms. We have to stay in an ugly dining room that’s been stripped and all the furniture stacked in the corner and in four little pods of tables pushed together and staff staring at you the whole time,“ she said, adding: “None of that has changed because they’re allowing nursing homes to do their own thing.”

https://apnews.com/article/business-nursing-homes-coronavirus-pandemic-health-4575fbefb2cf87e96c82043ef94e5ff3

Biological E ties up with Canada's Providence for mRNA Covid-19 vaccine

 Biopharma player Biological E has joined hands with Canadian player Providence Therapeutics Holdings Inc for licencing the latter’s mRNA vaccine PTX-Covid-19-B

As part of the agreement, Providence will provide the necessary technology transfer for Biological E to manufacture mRNA vaccines in India, with a minimum production capacity of 600 million doses in 2022 and a target capacity of 1 billion doses.
Apart from this, Providence will also export 30 million doses to India from its existing North American capacity.
Biological E said it will be responsible for all clinical development and regulatory activities, including applying for emergency use authorisation (EUA), for the mRNA vaccine in India and other jurisdictions licensed by Biological E. However, Biological E did not disclose the financial terms of the transaction.

According to the Hyderabad-based vaccine maker, the two players have executed a term sheet for a definitive licensing and collaboration agreement that also outlines the terms for sale by Providence of up to 30 million doses of Providence’s proprietary messenger RNA vaccine to Biological E and other end-buyers.
“The mRNA platform has emerged as the front runner in delivering the first vaccines for emergency use to combat the Covid19 pandemic. Biological E. is very pleased to be able to work with Providence on its promising mRNA vaccine candidate. We hope to provide India and other countries yet another option to ramp up their efforts towards achieving herd immunity against Covid-19,” Biological E managing director Mahima Datla said.

Mahima Datla, MD, Biological E

“This sale represents the sale of all the remaining 2021 Providence production, plus a portion of the early 2022 Providence production, after accounting for the first sale of Providence vaccines to the Province of Manitoba, Canada,” Biological E said.
“This initiative is an important commitment by a Canada-based company to help India and other nations vaccinate their citizens against COVID19. Providence was founded to serve patients, and this commitment by Biological E allows us to achieve that essential goal,” said Brad Sorenson, CEO of Providence in a statement.

https://timesofindia.indiatimes.com/india/biological-e-ties-up-with-canadas-providence-for-mrna-covid-19-vaccine/articleshow/83141302.cms