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Merck May Have A Competition For Ever-scarce BCG
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Good morning! Today, we learn more about studying tumors at the International Space Station, study the buzzy Amgen weight loss drug MariTide, and find a lawsuit in which a former Spark Therapeutics executive is accusing ex-colleagues of sexism.
The need-to-know this morningThere so much buzz around Amgen's experimental obesity drug, MariTide. The company simply saying it was "very encouraged" about interim Phase 2 data led to a 12% spike in Amgen's stock — even though no new data were shared. STAT's Elaine Chen answers some hot questions about the closely watched injectable.
Early data show MariTide, a monoclonal antibody drug, could potentially offer more profound weight loss than other treatments on the market. But it's already difficult to manufacture peptide drugs like Wegovy and Zepbound — and antibodies are more complex molecules.
Although Novo and Lilly's stocked dropped a little on Friday, the companies are dominating the space and it'd be hard for competitors to catch up. The two companies are also developing next-generation candidates that are further ahead than MariTide. So even if other companies have strong contenders in the obesity space, they'd be years away from an FDA approval and "so far behind [Novo and Lilly] that it's still going to probably be hard to see how they catch up," one analyst said.
Read more.
Studying stem cells and cancer in low Earth orbitTurns out, the microgravity of low Earth orbit allows scientists to study cancer growth at an accelerated clip. Catriona Jamieson of UCSD's Sanford Stem Cell Institute is working with NASA to send tumors and stem cells into space — ferried aboard SpaceX and Axiom-3 flights to the International Space Station. STAT's Nicholas St. Fleur chatted with Jamieson about why aging and oncology could potentially be better understood so far away from our planet.
She was inspired by a 2019 NASA study that showed that after 340 days in space, astronaut Scott Kelly came back 2 inches taller than his earthbound twin.
"But then I noticed he had inversions and translocations in his chromosomes. His chromosomes were kind of mixed up in the immune cells, which can happen if you have preleukemic conditions developing in your blood, so that doesn't look good," she said. "I thought, maybe space is a way to understand stem cell aging when it starts to be premalignant and fully malignant but in an abbreviated time frame."
Read more.
Former Spark CTO suing for alleged discriminationThe former chief technical officer of Spark Therapeutics alleges she experienced discrimination and sexism while working there, the Philadelphia Business Journal writes. Cynthia Pussinen led nearly 400 employees in Spark's technical development and operations unit from February 2021 to December 2022.
Pussinen said she faced "repeated and ongoing acts and practices of sex discrimination by some of her male peers and colleagues, most notably by Federico Mingozzi," who was the company's chief scientific officer before leaving this past November. The lawsuit said that CEO Ron Philip allegedly told Pussinen in March 2022 that he was aware of Mingozzi's "mistreatment" of women. But instead of sanctioning him, she alleges Philip told her to "make it work" because everyone but Mingozzi is "expendable" and that "we need him more than he needs us."
Pussinen, who is now CEO of a small regenerative medicine company called Sernova, is seeking unspecified economic damages, along with compensatory damages for pain and suffering and emotional distress.
Merck may have a competition for ever-scarce BCGThere's long been a global shortage of the BCG vaccine, which has long been used to treat bladder cancer. This may change, as FiercePharma points out. A couple of weeks back, ImmunityBio won FDA approval for Anktiva, an immunotherapy that's meant to be used along with the BCG vaccine to treat patients with bladder cancer. Now, ImmunityBio has partnered with the Serum Institute of India to manufacture BCG globally.
ImmunityBio framed it in a press release as "a long-term solution to chronic BCG supply shortage issues" and intends to produce the treatment "at large scale" so it can be used in combination with Anktiva. Merck has been the only U.S. Purveyor of BCG since 2012, after Sanofi and another competitor bowed out due to manufacturing issues. In 2020, Merck laid out plans to boost BCG production, but that will likely not come to fruition until at least next year. It's been rationing BCG since 2019.
Notably, an oncolytic virus-based therapeutic made by CG Oncology showed a complete response in about 75% of patients with late-stage bladder cancer, new Phase 3 data show. If approved, the drug could be used without the aid of BCG.
More readsThis Is The Coronavirus Vaccine Study That Anti-vaxxers Need To See
More than 20 COVID-19 vaccine candidates are in development right now, and the World Health Organization (WHO) said it will work on an initiative to make the new drugs widely available once they're approved. Some of these potential cures are already in Phase 1 of human trials, and some of them could be ready for emergency use as soon as this fall. But they may take up to 18 months to be ready for the general population.
Inoculating as many people as possible with a drug meant to provide immunity to a terrible illness may seem like a no-brainer. Still, there may be people out there who would oppose this life-saving treatment. Some anti-vaxxers have even claimed the pandemic wasn't real in the past few weeks, but we have undoubtedly reached a point where nobody can deny the seriousness of the novel coronavirus. And the vaccine-hesitant out there should check out a brand new coronavirus study that shows how important vaccines can be.
Reports from Australia a few days ago said researchers in the country will study the effects of a 100-year-old vaccine against COVID-19. The BCG drug, which is administered to more than 130 million people every year to prevent tuberculosis, may be able to boost immunity in patients and enhance their response to the novel coronavirus. The BCG vaccine isn't a COVID-19 vaccine per se, but it's theorized that it could assist medical professionals in fighting the disease. And it's healthcare workers who are getting the shot in the Australian study.
But other countries already have mandatory vaccine programs that include the BCG shot, and this is where things get interesting. Euronews spotted a brand new study earlier this week that looks at the correlation between the universal BCG vaccination policy and reduced morbidity for COVID-19.
One of the most significant discrepancies comes from the Iberian Peninsula, home of Spain and Portugal. Spain had a COVID-19 caseload of nearly 147,000 at the time of this writing, compared to Portugal's 13,100+ cases. When it comes to fatalities, Spain has a staggering body count of 14,555 compared to just 380 in Portugal. The BCG vaccine policy is a possible explanation.
"We found that countries without universal policies of BCG vaccination (Italy, Netherlands, USA) have been more severely affected compared to countries with universal and long-standing BCG policies," the study reads.
"There have been reports that BCG vaccination can produce a broad protection against respiratory infections," Gonzalo Otazu, one of the authors, said on Twitter. "So we looked at the data: countries that never implemented a universal BCG vaccination were being hit hard by COVID-19, with high number of deaths per inhabitant."
Italy never had a universal tuberculosis vaccination policy. More than 17,100 people died in the country of more than 135,500 cases. Japan has a universal BCG vaccine program. Only 93 people died out of the more than 4,250 cases in the region. Japan did not enforce stringent social distancing measures, either.
The researchers also found that Iran, which started a mandatory BCG vaccination program in 1984, has a high death toll (nearly 4,000 out of over 64,500 cases), compared to Japan. The latter started vaccinating the population against tuberculosis in 1947. The conclusion seems to be that early BCG vaccination gave more protection to older people who are now exposed to COVID-19.
"Countries that have a late start of universal BCG policy (Iran, 1984) had high mortality, consistent with the idea that BCG protects the vaccinated elderly population," the authors wrote. "We also found that BCG vaccination also reduced the number of reported COVID-19 cases in a country."
The same discrepancies can be seen in Europe, where countries in the east that were under the Soviet Union's sphere of influence had mandatory BCG vaccination programs. As a result, those regions have lower case counts than western countries. Germany is the best example of that. The states that made up East Germany until 1990 had fewer COVID-19 cases per 100,000 people than states that belonged to West Germany, according to Germany's Koh Institute that is managing the coronavirus outbreak.
These are early findings, of course, but there appears to be a correlation between a vaccine that's not even targeting the novel coronavirus and the COVID-19 fatality rate. Once a vaccine that can kill the SARS-CoV-2 virus becomes widely available, we could potentially eradicate the disease, assuming everyone is immunized.
The study was published on medRxiv in pre-print form, and it's available in full at this link.
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ImmunityBio Partners With Serum Institute For BCG Vaccines
ImmunityBio has entered an exclusive worldwide agreement with the Serum Institute of India to secure a supply of Bacillus Calmette-Guerin (BCG) vaccine for all cancer types.
The partnership focuses on producing the standard BCG (sBCG) approved for use outside the US, and a next-generation recombinant BCG (iBCG) currently undergoing tests.
iBCG is intended for use along with ImmunityBio's ANKTIVA (nogapendekin alfa inbakicept-pmln) for approved and additional future indications, contingent on regulatory approvals.
The collaboration aims to increase the availability of sBCG immediately for ongoing trials, while also accelerating the Phase II clinical trials of iBCG in Europe.
The iBCG has shown safety advantages over the standard BCG and enhanced immunogenicity in stimulating CD8+ and CD4 T cells.
The strategic partnership follows the US Food and Drug Administration's approval of ImmunityBio's ANKTIVA for non-muscle invasive bladder cancer with carcinoma in situ.
The increased supply of BCG is intended to mitigate shortages of the combination therapy with ANKTIVA.
ImmunityBio plans further trials to evaluate both iBCG and sBCG produced by the Serum Institute, in combination with ANKTIVA for treating bladder and other cancer types.
The supply of BCG for these trials will become available on receipt of FDA authorisation of the trial protocol.
ImmunityBio will submit the trial protocol to the FDA and other global regulatory authorities by the beginning of June 2024.
ImmunityBio executive chairman and global chief scientific and medical officer Patrick Soon-Shiong stated: "The opportunity to initiate a trial of an immunogenic recombinant BCG, which has already demonstrated enhanced safety compared to standard BCG in Phase I/II studies, is exciting.
"We look forward to exploring ANKTIVA in combination with BCG in non-muscle invasive bladder cancer and across other tumour types. With our ability to overcome immune evasion of the tumour to BCG when BCG is given alone, and by converting a MHC- negative cold tumour to a MHC+ positive hot tumour with the combination of ANKTIVA with BCG, we will now further expand the development of our therapeutic cancer vaccine with BCG."
"ImmunityBio partners with Serum Institute for BCG vaccines" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.
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