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Friday, April 2, 2021

Proteomics firm SomaLogic eyes $1.2B public valuation via SPAC

 SomaLogic is a unicorn among unicorns: Not only did the company, which builds AI-powered technology for protein analysis, wait to close its series A funding round until it had more than two decades of experience under its belt, but it has quickly followed up its $214 million fundraising late last year with new plans to go public.

“The weird thing about SomaLogic, of course, is that we had our series A at age 21, so that puts us at a slightly different category than most companies that are doing their series A as real startups,” CEO Roy Smythe told Fierce Medtech in an interview. “We had already been thinking about public transition plans, and it was really a combination of market dynamics and competitive dynamics that made us decide to speed up.”

In a deal valuing the not-quite-starting startup at $1.23 billion, SomaLogic will link up with CM Life Sciences II—a blank check company backed by Corvex Management and Casdin Capital that recently filed its own $240 million IPO in February for the sole purpose of pursuing an acquisition like this.

The decision to go public with the help of a special purpose acquisition company, or SPAC, rather than following the traditional IPO pathway, was an easy one, Smythe said.

“If you have the right SPAC partner, then you get more than just money—you get some expertise and help to grow the business beyond just the cash that you bring in,” he said.

“This just allows us to more quickly double down on a more comprehensive approach to proteomics, in both measurement and applications, in ways that might be hard for some of our competitors to recapitulate over the next period of time,” he continued. “It also allows us to bring more minds and assets to the table to help us build the business.”


The deal is projected to close in the third quarter of 2021, when CMLS II will take on the SomaLogic name and be listed on the Nasdaq as SLGC. SomaLogic’s existing management team will continue to oversee operations, but several more life sciences industry leaders will be added to the board of directors after the deal is complete, and Smythe said the company may add some of CMLS II’s directors to the board as well.

In the process, SomaLogic will receive up to $651 million in cash from CMLS II’s IPO earnings and common stock purchases from a handful of investors, bringing its total amount of cash available after various transaction-related expenses to $686 million.

But the influx of capital won’t change SomaLogic’s strategy in any way—“It’s just that we can actually do it now,” Smythe said. After the deal closes and public trading begins, the company will be able to direct more funding to R&D and the partnerships needed to further develop its technology and to significantly speed up that development.


SomaLogic creates proteomics assays that can measure thousands of human proteins at once, churning out data that can be used for drug development and other life sciences research. Those measurements are further analyzed by AI and machine learning algorithms alongside a database of more than 450,000 samples for diagnostic purposes.

Currently, available tests can determine cardiovascular risks, glucose tolerance, body fat percentage, resting energy rate and more, and a recent paper demonstrated the technology’s ability to monitor the long-term effects of COVID-19 on the heart.

https://www.fiercebiotech.com/medtech/proteomics-company-somalogic-to-go-public-through-reverse-merger-deal-1-2b-valuation

Breast cancer studies pinpoint potential new drug targets to fight resistance

 Several types of treatments are used against breast cancer, including chemotherapy, immunotherapy and drugs that target specific genes and proteins. But not all patients respond to them, so new options for reducing treatment resistance are in high demand.

Now, two research groups from Italy and the University of California, San Francisco (UCSF) have identified different mechanisms in breast cancer that they say could inspire the development of new drugs to improve response to existing treatments.

The Italian team, led by Francesco Nicassio from the Center for Genomic Science at the Italian Institute of Technology in Milan, focused on cancer stem cells, which can self-renew and give rise to new cancer cells. These stem cells are considered an attractive target in cancer research, not just because they promote tumor formation and progression, but also because they’re often resistant to traditional radiation therapy and chemotherapy.

Nicassio and colleagues hypothesized that short non-coding RNA molecules called microRNAs might assist cancer stem cells by regulating mRNA to control the types and amounts of proteins the cells make.

“We wanted to identify microRNAs required for the maintenance of normal mammary stem cells that are inherited by cancer stem cells and could represent potential therapeutic targets in breast cancer,” Nicassio explained in a statement.

The team pinpointed two related microRNAs, miR-146a and miR-146b, that are present in both breast cancer stem cells and normal adult stem cells. The two microRNAs were found to be elevated in aggressive breast cancers bearing a high number of cancer stem cells.

According to the study, published in the Journal of Cell Biology, the researchers showed that the two molecules are essential for maintaining cancer cell populations. Patient-derived cancer cells without these two miroRNAs showed a reduced ability to form new tumors when transplanted into mice.

Removing miR-146a/b made breast cancer stem cells over 20 times more sensitive to methotrexate, a chemotherapy that works by inhibiting cancer cells from replicating its DNA. The researchers suggested that mir-146a/b regulates processes that are key for cell metabolism and DNA replication.

“While the molecular details remain to be determined, our results clearly show that reducing miR-146a/b levels represents an attractive approach to overcome some forms of drug resistance in the clinical setting, unmasking a 'hidden vulnerability' exploitable for the development of anti-cancer stem cell therapies,” Nicassio said.


The UCSF team focused on the extracellular matrix surrounding triple-negative breast cancer cells (TNBC) for clues to fighting treatment resistance. They pointed to NF-kB, a transcription factor that regulates genes related to inflammation, as a possible target, according to a study published in the Journal of Experimental Medicine. Its activation has been linked to enhanced cancer cell proliferation and survival.

The UCSF team started by analyzing the extracellular matrix that surrounds TNBC cells that were taken from patients’ tumor samples. This matrix offers structural and nutritional support to the cells, with protein collagen its main component.

In untreated TNBC, the collagen proteins in the matrix were aligned in a way that made the matrix stiffer than it is in healthy breast tissue, the team found. But after chemotherapy, the collagen fibers in the surviving tumor became much softer.

“This raised the intriguing possibility that the softened, remodeled extracellular matrix might be causally linked to the pathogenesis of the treatment-resistant, residual tumor tissue,” team leader Valerie Weaver said in a statement.

Indeed, in both lab dishes and mice, tumors surrounded by a softer extracellular matrix were found to be more resistant to radiation and the widely used chemotherapy paclitaxel.

In that matrix, the activation of NF-kB counteracted another signaling protein called JNK, the team found. Cancer cells grown in a stiff matrix activated JNK, which made the cells prone to dying in response to stress.

The researchers treated mice with an NF-kB inhibitor and showed it could improve response when combined with radiotherapy. The team suggested that therapies that modulate NF-kB or JNK might be useful in improving treatment outcomes for TNBC patients.

https://www.fiercebiotech.com/research/breast-cancer-studies-pinpoint-potential-new-drug-targets-to-fight-resistance

Regeneron eyes longer Eylea dosing interval in diabetic retinopathy with NIH data

 When Regeneron snagged an FDA nod for eye drug Eylea in diabetic retinopathy in 2019, the agency opted against approving a 16-week dosing schedule despite positive data from a pivotal trial. Now, the drugmaker hopes a new study from the National Institutes of Health will change that.

In patients with non-proliferative diabetic retinopathy (DR), Eylea cut the risk of disease progression to vision-threatening complications—namely center-involved diabetic macular edema or proliferative diabetic retinopathy—by 68% compared with placebo after two years. The team published the results in the journal JAMA Ophthalmology.

The investigators tested Eylea at a dosing interval of every 16 weeks after an initial four doses given more frequently in the first four months.

At two years, 43.5% of placebo patients in the trial developed center-involved diabetic macular edema with vision loss or proliferative DR, compared with 16.3% for 16-week Eylea.

Currently, the anti-VEGF drug only carries an approval for a eight-week dosing regimen—even though the phase 3 Panorama trial used to win that FDA clearance included a 16-week arm. Now, the company said it will take findings from both trials to the FDA to discuss the 16-week dosing interval.

If eventually approved, the longer dosing interval could offer a convenience that further sets Eylea apart from Roche and Novartis’ rival VEGF inhibitor Lucentis, which is administered once a month for DR.


In the Panorama trial, Eylea given every 16 weeks following an initial dosing period cut the risk of proliferative DR or anterior segment neovascularization by 85% over control after one year of treatment, while the eight-week arm slashed that risk by 88%.

On the trial’s primary endpoint, 65% of patients on 16-week Eylea experienced at least a two-step improvement in a DR severity scale after one year, while 80% of patients on the eight-week dosing could say that. Only 15% of the control patients experienced such an improvement.

While all these data are displayed on Eylea’s label, the FDA only recommends the eight-week interval in the “dosage and administration” section.

Last year, Regeneron unveiled two-year data from Panorama showing Eylea reduced the likelihood of vision-threatening events by at least 75% over the period. About 50.4% of patients in the sham group developed a complication, versus 16.3% of those treated every 16 weeks with Eylea and 18.7% of patients who got Eylea every eight weeks.


Both Eylea and Lucentis have extended their dosing intervals before, but only in the bigger wet age-related macular degeneration (AMD) indication. Both are now allowed to go as long as 12 weeks between doses in that disease, although the FDA specifically said on their labels that the less frequent dosing is “not as effective” as their respective recommended dosing schedules. The FDA recommends Eylea every eight weeks and Lucentis once a month for AMD.

Regeneron and its ex-U.S. partner Bayer are trying to prolong Eylea’s intervals even further with a high-dose formulation of 8 mg versus the current 2 mg. Clinical trials are ongoing for high-dose Eylea in wet AMD and diabetic macular edema.

That could help the pair fend off looming competition from Roche, which is developing a VEGFxAng2 bispecific antibody called faricimab that just matched Eylea in wet AMD in two pivotal trials. That drug is administered up to every 16 weeks.

https://www.fiercepharma.com/marketing/regeneron-shoots-for-eylea-longer-dosing-interval-diabetic-retinopathy-nih-data

Emergent : QC Systems Detected Single Failed Covid-19 Vaccine Batch

Johnson & Johnson Covid-19 vaccine contract manufacturer Emergent BioSolutions Inc. said its quality checks had worked, detecting a batch of vaccines that didn't meet standards.

"Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process," the company said in a statement Thursday.

Emergent BioSolutions didn't specify the number of doses affected or what had happened, but The Wall Street Journal, citing anonymous sources, reported that the batch was contaminated.

One of those people, The Journal reported, estimated the error at the Baltimore plant affected approximately 15 million doses of the vaccine's main ingredient.

J&J, which also didn't discuss what had happened, said it would be able to make enough doses to meet production targets for the U.S. in the coming months. J&J's plant in the Netherlands has been making the main ingredient for the initial U.S. supply of its vaccine, including the nearly four million doses that were distributed immediately after it was authorized in late February.

Emergent also makes at the same plant the main ingredient for AstraZeneca PLC's Covid-19 vaccine, which hasn't been authorized for use in the U.S.

https://www.marketscreener.com/quote/stock/EMERGENT-BIOSOLUTIONS-INC-36547/news/Emergent-BioSolutions-nbsp-Quality-Control-Systems-Worked-to-Detect-Single-Covid-19-Vaccine-Batch-32867177/

FDA Probes Cause of Failed Johnson & Johnson Covid-19 Vaccine Batch

 The Food and Drug Administration is investigating what caused a batch of the active ingredient for Johnson & Johnson's Covid-19 vaccine to be scrapped for failing to meet quality standards at a contract manufacturing plant, according to a person familiar with the matter.

The FDA may send an inspection team to assess the situation at the Baltimore plant operated by contractor Emergent BioSolutions Inc., the person said.

The regulatory scrutiny follows J&J's disclosure Wednesday that a batch of the main ingredient for its Covid-19 vaccine manufactured at the Emergent plant didn't meet standards. The batch didn't reach the vial-filling and finishing stage, and no doses from it were distributed.

J&J says the quality lapse didn't affect vaccine doses that have been distributed in the U.S. since the vaccine was authorized in late February, and the company still has enough supply to meet near-term commitments. J&J also makes the main ingredient for the vaccine at its own plant in the Netherlands.

Emergent BioSolutions, of Gaithersburg, Md., said in a statement Thursday that it isolated the batch of vaccine ingredients because it didn't meet specifications and quality standards. Emergent said it would dispose of the batch properly.

The company said that discarding a batch is disappointing but occasionally happens during the complex vaccine manufacturing process.

The White House said Thursday it didn't expect the issue to affect the promised U.S. supply of J&J's vaccine. J&J expects to deliver about 100 million doses for use in the U.S. by midyear, under the terms of a $1 billion purchase agreement with the federal government.

"We have been assured that they expect to meet those deadlines," White House press secretary Jen Psaki said at a briefing.

Ms. Psaki said "the issue was identified as part of rigorous quality control system checks," and the Department of Health and Human Services notified the White House late last week.

Asked if the White House should have revealed the problem publicly earlier, Ms. Psaki said the plant hasn't yet been FDA-approved. "This is probably the process of working as it should," she said. Drug plants can manufacture ingredients for a drug or vaccine but finished products can't be released until the FDA authorizes them.

J&J's vaccine is the third to be authorized in the U.S., after shots from Pfizer Inc. with its partner BioNTech SE, and Moderna Inc. Health authorities have been counting on the arrival of the single-shot J&J vaccine to boost the overall supply of shots and to simplify vaccinations because it doesn't require a second dose.

Emergent said that it was confident in its ability to meet FDA requirements.

Emergent makes the main ingredient for AstraZeneca PLC's Covid-19 vaccine at the same plant, though that vaccine isn't authorized for use in the U.S. An AstraZeneca spokeswoman said the company was "aware of the reports regarding the facility and we understand Emergent is investigating the matter."

Emergent Chief Executive Robert Kramer told CNBC Thursday "it wasn't the case where an ingredient from one vaccine contaminated or impacted the other." He said the J&J batch didn't meet quality specifications but he didn't elaborate on what happened.

Vaccine manufacturing experts say the issues at the Emergent plant have to be addressed, but the detection of the problem before doses from the batch were released was an encouraging sign.

"It's definitely alarming but it also shows that this is a system that eventually works," said Tinglong Dai, associate professor of operations management and business analytics at Johns Hopkins University's Carey Business School, who has researched the vaccine supply chain. "I have high confidence in the error detection part."

J&J said it was sending additional experts in manufacturing, technical operations and quality to be on-site at Emergent to oversee all manufacturing of the J&J vaccine there.

https://www.marketscreener.com/quote/stock/JOHNSON-JOHNSON-4832/news/FDA-Probes-Cause-of-Failed-Johnson-Johnson-Covid-19-Vaccine-Batch-32867447/

China Sinovac: Reached 2B doses annual capacity for COVID-19 vaccine

 

China's Sinovac Biotech said on Friday its third production plant for its COVID-19 vaccine was ready and had started manufacturing procedures for bulk vaccine ingredient, doubling its annual capacity to 2 billion doses.

A Sinovac spokesman said the third facility, in Beijing, had started cultivating cells where the coronavirus would be grown, a procedure that could take a relatively long time.

Sinovac did not say when it will actually produce 2 billion doses of the vaccine.

More than 200 million doses of Sinovac's vaccine named CoronaVac have been delivered globally, up from 160 million doses announced on March 22.

The firm said it estimated over 100 million doses have been administered worldwide.

https://www.marketscreener.com/quote/stock/SINOVAC-BIOTECH-LTD-5714593/news/Sinovac-Biotech-nbsp-China-Sinovac-says-it-reached-two-billion-doses-annual-capacity-for-COVID-19-32868005/

Opposition grows against UK vaccine passports

 More than 70 British lawmakers have signalled their opposition to the introduction of so-called vaccine passports that the government is considering bringing in to help to open the economy as it starts lifting COVID-19 lockdown restrictions.

The government is reviewing the idea of asking people to show proof of a COVID-19 vaccination to access crowded spaces such as pubs or sports events, with Prime Minister Boris Johnson having already said that a certificate is likely to be needed for international travel.

The Daily Telegraph newspaper reported on Saturday that trials of COVID passports would begin within weeks during pilots at major sports events and possibly a music awards ceremony in the next two months to assess their impact.

On Friday Johnson said that a combination of immunity factors - if people have had the disease, a vaccination or had a COVID-19 test - would give businesses confidence.

“So those three things working together will, I think, be useful for us as we as we go forward,” Johnson said.

But there has been mounting concern from some in his own Conservative Party, as well as opposition lawmakers and civil rights groups, about the prospect of vaccine certificates.

“We oppose the divisive and discriminatory use of COVID status certification to deny individuals access to general services, businesses or jobs,” said a statement signed by a group of more than 70 lawmakers from across the political spectrum.

Under the government’s planned “roadmap” out of the pandemic, pubs will be allowed to serve people outdoors later this month, with a further easing of restrictions in mid-May before all measures are lifted near the end of June.

Johnson suggested last month that some pubs might require customers to produce vaccine certificates. Culture minister Oliver Dowden, meanwhile, has said that such certificates could help get more people into theatres.

No decision has yet been made and Johnson has instructed senior minister Michael Gove to review the possible role of certificates, saying there are deep and complex ethical issues to explore. Gove is due to report back shortly.

More than 31 million Britons have already received their first vaccine dose in the fastest inoculation programme in Europe.

https://www.reuters.com/article/us-health-coronavirus-britain-vaccinepas/opposition-grows-against-uk-vaccine-passports-idUSKBN2BP0H1