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Digital health platform Xealth strikes partnership with another big health IT vendor

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Xealth, a startup working to solve some of the logistical challenges faced by digital health companies, struck a partnership with Cerner. The Seattle-based company makes it easier to prescribe digital health tools and integrate them with health record systems.

The partnership is intended to make it easier for patients and their health teams to keep track of engagement with digital health tools and the effect on patients’ health.

“In order for digital health to have lasting impact, it needs to show value and ease for both the care team and patient,” Xealth CEO and Co-Founder Mike McSherry said in a news release. “We strongly believe that technology should nurture deeper patient-provider relationships and facilitate information sharing across systems and the care settings. It is exciting to work with Cerner to simplify meaningful digital health for its health partners.”

Cerner and venture capital firm LRVHealth also invested $6 million into Xealth. Last year, the company raised $14 million in series A funding, with investors including Providence Ventures and the Cleveland Clinic.

David Bradshaw, senior vice president of consumer and employer solutions for Cerner, said the partnership would give patients the opportunity to participate in their own treatment plans.

“Patients want greater access to their health information and are motivated to help care teams find the most appropriate road to recovery,” he said in a news release.

Xealth had already been integrated into Epic, and with this partnership, it will be tied into the two most widely used EHRs. The company is integrated with more than 30 different digital health solutions, ranging from diabetes management platforms such as Omada and Glooko, to Resmed’s connected sleep apnea machines, and patient engagement platforms like Twistle.

One of the startup’s clients, Providence St. Joseph Health, used Twistle in combination with Xealth’s platform to monitor patients with Covid-19 symptoms at home. It helped them keep track of patients’ temperature and oxygen saturation by providing an easy form for them to record their metrics.

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Livongo’s stock slightly higher after president talks Dexcom partnership

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At the StartUp Health Conference, Livongo President Jennifer Schneider said the company’s work with Dexcom would create a new stream of data for both companies.

A day after Livongo’s president spoke in detail about the data partnership the company struck with Dexcom, a top continuous glucose monitoring company, its stock edged up — to nearly $31.

Since the company’s public debut back in July, it is yet to attain IPO levels of nearly $45.

The deal itself wasn’t necessarily surprising — Dexcom has been striking interesting partnerships with tech companies ever since it received FDA approval for its interoperable continuous glucose monitor. But it was interesting in that it brought together two different user groups: Livongo’s software primarily targets type 2 diabetes patients, while patients with type 1 diabetes primarily use CGMs.

At the StartUp Health Conference, Livongo President Jennifer Schneider said the main draw of the deal was the data that the two companies would collect.

“With a CGM, you’re collecting data and marrying that with our insights,” Schneider said in a discussion moderated by MedCity News Editor-in-Chief Arundhati Parmar. “It will help really get the member a better outcome and reduce clinical costs overall.”

Livongo, which went public in July, pairs type 2 diabetes patients with health coaches. The company’s app sends users “nudges”, or notifications related to a patient’s health. For example, if a user had high blood sugar levels after waking up, it might direct them to eat dinner earlier in the evening.

The company reported more than 200,000 users across 771 clients in November. Since its IPO, Livongo’s financials have been steady. In the third quarter, the company reported revenues of $46.7 million, up 148 percent year-over year. But it also reported a net loss of $19.7 million. The company’s stock just tipped over $30 on Tuesday, after news broke of the partnership.

Currently, most of Livongo’s members use glucometers and testing strips to track their blood sugar levels. Roughly 10 to 20 percent of them use CGMs, Schneider said.

The partnership would let users opt to share the blood sugar data that is constantly being collected by Dexcom’s CGM with Livongo’s software. In turn, Livongo would be able to push out “nudges,” insights and notifications related to a user’s health. Both companies seem hopeful that the deal will help them get more users in the massive — and growing — type 2 diabetes market, with 32 million people diagnosed with the condition.

“Dexcom’s had incredible success predominately with type 1. We have the ability to monitor people on finger sticks and notice who’s not doing well, who will benefit, and offer continuous glucose monitors,” Schneider said. “I don’t see this as either or. I think it’s absolutely together. Our ability to drive insights and the wrap-around services component are very complementary to the device component that Dexcom has done.”

The partnership is expected to launch this quarter, though some details still need to be worked out. Type 2 diabetes and type 1 diabetes and two very different conditions, and different strategies will be required to manage them.

Still, the deal should be a boost for Livongo, along with another important development going into 2020. Livongo was named the preferred provider for diabetes and hypertension on Express Scripts’ first digital health formulary, a distinction that Schneider said would help them speedily bring their solutions to the market.

Having big partners is helpful, but winning over employers is still a challenge that many digital health companies face, including Livongo. The company says that use of its platform is associated with savings of $88 per employee or member, but studies have shown that employers are investing in health and wellness programs but can’t quantify a benefit.

The retrospective study, published in the Journal of Medical Economics, was funded by Eli Lilly and Company and was not randomized. Schneider explained that the company conducted the study this way because running a randomized, controlled trial on cost would take about two-and-a-half years.

And in response to a question about why the stock has fallen from its IPO level, she seemed to suggest that the market doesn’t understand the company well, yet.

“We’ve been performing and executing very well in our plan. We are building a company of value. We know that. We have customers that continue to stay with us and sign up,” she said. “What we’re doing is different. It takes people a little bit of time to understand what’s different.”

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Express Scripts strikes partnership with Prime Therapeutics

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Pharmacy service providers Express Scripts and Prime Therapeutics launched a three-year partnership to negotiate lower drug costs. The deal would allow Prime to use Express Scripts’ retail pharmacy network and pharmaceutical contracts.

Combined, the two companies will be able to leverage a large customer base. Express Scripts, the large pharmacy benefit company that Cigna acquired last year, covers more than 75 million customers across 3,000 health plans. Prime Therapeutics, which is owned by 18 Blue Cross and Blue Shield plans, covers 28 million customers across 23 health plans.

Express Scripts President Tim Wentworth said in a news release that the two companies could use their capabilities to deliver more affordable care.

Prime CEO Ken Paulus added the collaboration “…will improve outcomes while still maintaining flexibility and transparency to the clients we proudly serve.”

The two PBMs claimed the partnership would result in more affordable care for clients and plan members, though they did not specify how much it would save them. Express Scripts expects the deal will begin to contribute to its income starting in 2021. Last year, Express Scripts contributed $2.6 billion to Cigna’s pharmacy revenues.

“How members see savings is a decision that ultimately resides with payers but typically savings are used to control overall premium rates,” Express Scripts Spokeswoman Jennifer Luddy wrote in an emailed statement. “Additionally, once implemented, we do expect some members, especially those in high deductible health plans or with co-insurance, will benefit from lower costs on medicines at their pharmacies.”

Both companies will still negotiate independently with pharmaceutical managers, and the companies will also separately manage relationships related to value-based contracting. Relationships with caregivers, members and other stakeholders will also remain independent.

The news follows heavy consolidation between PBMs and health insurance plans. Cigna closed its $67 billion purchase of Express Scripts at the end of 2018, and a federal judge approved the CVS-Aetna merger in September. Most recently, UnitedHealth Group announced plans for its subsidiary OptumRx to acquire specialty pharmacy company Diplomat for $300 million.

 

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Celgene invests $75M in cell therapy company Immatics as part of T-cell receptor partnership

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T-cells attacking cancer cell illustration of microscopic photosT-cells attacking cancer cell illustration of microscopic photos

A large biotech company is pouring tens of millions of dollars into a German firm under a partnership to develop cell therapies in oncology.

Immatics Biotechnologies, based near Munich, said Wednesday that it had entered the partnership with Summit, New Jersey-based Celgene to develop T-cell receptor therapies, or TCRs, a type of cell therapy that differs in terms of structure and function from the more familiar CAR-Ts.

The deal includes a $75 million investment in the company by Celgene. Immatics would develop TCRs against solid tumor cancers using its in-house technology. It would be responsible for their development and validation through the lead candidate stage, at which point Celgene would have opt-in rights and assume responsibility for their global development, manufacturing and commercialization.

Both CAR-Ts and TCRs consist of T cells engineered to target proteins in cancer cells and are known in the field as adoptive T-cell therapies. However, whereas CAR-Ts recognize proteins on the surface of cancer cells, TCRs can recognize those inside them. A disadvantage to TCRs is that they are HLA-matched, meaning they can only be used in patients who harbor specific genetic profiles.

Two CAR-Ts are currently approved, both of which attack the cell-surface antigen CD19 in blood cancers: Novartis’ Kymriah (tisagenlecleucel) and Gilead Sciences’ Yescarta (axicabtagene ciloleucel). No TCRs have regulatory approval.

Immatics’ pipeline includes a variety of product candidates with different therapeutic modalities, including bispecific antibodies.

Celgene is already among the companies developing TCR therapies in solid tumors, through subsidiary Juno Therapeutics, which it acquired in January 2018 for $9 billion; Celgene itself is currently pending acquisition by Bristol-Myers Squibb, under a $74 billion deal announced in January of this year. Gilead is also developing TCRs, through the Kite Pharma subsidiary that originally developed Yescarta. A TCR Kite has in development is KITE-718, which targets the MAGE-A3/A6 pathway and is currently in a 75-patient Phase I clinical trial for tumors that carry the antigen. Adaptimmune is another company specializing in TCR therapies and currently has candidates in development that target MAGE-A4, MAGE-A10 and A2AFP in solid tumors.

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Boehringer Ingelheim, MD Anderson to develop cancer drugs under research partnership

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A German drugmaker and one of the largest cancer treatment and research centers in the U.S. have a new partnership to develop new therapies in oncology, including gastrointestinal and lung cancers.

Ingelheim, Germany-based Boehringer Ingelheim and The University of Texas MD Anderson Cancer Center in Houston said they had started a research collaboration, calling it a “virtual research and development center.” A spokesperson for MD Anderson explained in an email that this means investigators from both organizations will work closely together, but there will not be a physical location specifically tied to it.

The partnership will allow projects to enter at different stages – research and development as well as clinical development – over the course of several years. It will include Boehringer’s drug pipeline as well as MD Anderson’s Therapeutics Discovery division. The latter of those comprises clinicians and researchers involved in drug discovery and development.

“Together, we hope to transform the treatment landscape for these diseases by tackling their root causes and drivers that have so far remained elusive, exploring new and smart ways of killing cancer cells,” the company’s global head of oncology, Victoria Zazulina, said in a statement. “Our innovative oncology pipeline, coupled with strong partnerships like this, will contribute to unravelling the complexities of these diseases and bringing innovative solutions to people with various types of cancers.”

Areas of focus include research on the inhibition of KRAS, a protein widely expressed in cancers, but long regarded as “undruggable” due to its general absence of binding pockets. Amgen is currently testing AMG 510, an inhibitor of KRAS G12C, in solid tumors, while several startups have been exploring KRAS inhibitors as well. Another drug the Boehringer-MD Anderson partnership will explore is an antibody that targets a protein called TRAILR2.

Gastrointestinal and lung cancers are particularly common among solid tumors. The World Health Organization estimates that more than 4.1 million people due from them worldwide every year. Lung cancers include two main types – small-cell and non-small cell – while gastrointestinal cancers include those affecting the esophagus, stomach, liver, pancreas and intestines.

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CVS Health launches new social care network in partnership with Unite Us

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social determinants of health,

The concept of addressing social barriers to health as a central part of medical care has continued to gain steam as research has shown its outsized effect on overall health and healthcare costs.

CVS Health has made the idea a key part of its strategy as it continues its integration with Aetna in the wake of the two companies’ $69 billion mega-merger.

The company hopes its new Destination: Health offering – can successfully connect high-need members to social services. CVS is working in concert with Unite Us, a New York startup that builds networks of local social service providers and provides software to connect individuals with those organizations, track outcomes and collaborate on care.

“Both Aetna and CVS Health have a long track record in supporting local community-based providers from a corporate social responsibility and foundation-giving perspective, but the question is how do we embed it as a core part of the business?” said Leila Nowroozi, a leader in CVS Health/Aetna business strategy division

If this news sounds familiar, that’s probably because Unite Us was the partner  recently chosen by Kaiser Permanente to build out its Thrive Local network, a system with the same broad strokes mission to integrate non-clinical services like transportation and housing support into its larger offerings.

Kaiser’s network is meant to scale across the organization’s 12 million members over the next three years if all goes according to plan.

CVS Health hasn’t set as strong of a public timetable for the expansion of its own network and put its own near-term goals as seeing results from the network through metrics like member satisfaction, the usage rates of linked services and the impact on community-based organizations

Eventually the ambition is to have a measurable impact on Aetna’s claims through a reduction in downstream healthcare spending. A key part of moving towards this ultimate goal is developing an infrastructure where outcomes can be reliably measured

“There’s a void in that type of feedback loop, many of these community partners are under resourced entities who are focused on trying to improve people’s lives and not on reporting data,” Nowroozi said. “These collaborations through Unite Us helps with the whole industry migration towards better data and evidence-gathering.”

The Destination: Health network will launch later this year with Aetna Medicaid members in Louisville, Kentucky and Aetna dual-eligible special needs plan members in Tampa, Florida and Southeastern Louisiana.

As for what services the company hopes to prioritize? That depends on the market, according to Garth Graham, CVS Health’s vice president of community health and impact.

“It’s really what’s defined locally as necessary. That’s why the partnership with Unite Us is key since they are the ones building these local networks,” Graham said. “All health is local, so each community has its own set of challenges.”

As part of its collaboration with Unite Us, Kaiser became a strategic investor of the company, which Graham said that was one option being explored by CVS.

Medicaid looks to be an initial major focus for the company as it looks to grow out its network. Aetna currently offers Managed Medicaid plans to more than 2 million beneficiaries across 16 states.

While Unite Us will eventually make it possible individual members able to identify and select social care providers, CVS Health officials say that selected Aetna members will initially be linked to local providers through nurse case managers and community liaisons.

The large retail footprint of CVS pharmacies are certain to play a role in the build out of the Destination: Healthcare network, but executives are short on details on what exactly that could look like.

One possibility – especially as the company continues to grow its HealthHUB model – is that stores could become distribution points where members could meet with local case managers, access supportive housing services and get warm hand-offs and introductions to local community resources.

The company’s effort to address social determinants are also being expanded among its commercially insured population through the rollout of new analytics tool to help plan sponsors identify where there are specific socially-related vulnerabilities among their patient population.

This data could shape the development of new plan design. For example, Aetna plans that emphasize primary care and chronic care management provided through CVS clinic locations.

CVS Health’s initiative is meant to build on a previous pledge made earlier this year soon after the closure of its Aetna acquisition to direct $100 million over five years toward areas including free health and wellness screenings, donations to nonprofits working in areas like substance abuse recovery and financial and volunteer support for local community organizations.

Housing has also been a major philanthropic priority for the company, which is slated to invest more than $50 million in 2019 toward the construction or rehabilitation of more than 1,600 affordable housing units across six states.

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An inside look at UnityPoint Health’s new partnership with startups

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help, aid

Many health systems have created teams to invest in startups and commercialize their own technology, either to scale it within their own institutions or offer it to others. But from the outside looking in, the process startups need to navigate can vary from one institution to the next.

Utilizing programs that work with healthcare startups to assess their technology and integrate it, as well as foster innovation from within, UnityPoint Health aims to ease this process as well as support its strategic priority of driving innovation in healthcare.

UnityPoint Health, a Des Moines, Iowa-based healthcare organization, is taking part in the MedCity INVEST Population Health conference in New Orleans May 22, where the role of startups in supporting healthcare innovation will be part of the conversation.

Matthew Warrens

Matthew Warrens is the managing director of innovation with UnityPoint Health, having previously served in a similar role with OSF Healthcare. In an interview, he highlighted how the group screens and works with startups.

The health system takes a few different approaches to developing a pipeline of startups for its initial screening. It uses informal relationships with accelerators like MATTER, Plug and Play, and Mass Challenge. It also works with Medical Alley, Sprint in Kansas City and BioSTL in St Louis.

But it’s also important for ambitious entrepreneurs to know the best way to reach Warrens.

“I get dozens of unsolicited pitches a day from LinkedIn and email, but I really prefer to be introduced to a startup through someone I know.”

An innovation team at UnityPoint Health meets weekly to determine which startups should get invited to pitch and which of their experts will need to be on hand, whether it is a neurologist or director of revenue cycle management. The innovation team are generalists, but the team also relies on experts within its organization when they need a deeper level of insight.

Founders and the leadership team for those companies are evaluated as closely as the technology they develop. Warrens said it’s common to meet with a team that has a good idea only for the organization to conclude it doesn’t have confidence that the team can scale the business. On the flip side, it has also met with great leadership teams that have a lackluster solution.

“The magic moment is when they have both. It’s a ‘no’ much more often than a ‘yes’, but it’s rarely ‘never’”.

Some factors that might produce a no beyond the previous reasons are a change in leadership, change in priorities, and other factors that startups have no control over.

There is an expression that’s born out of frustration from the way some institutions work with healthcare entrepreneurs — death by a thousand pilots or a program that never seems to move beyond testing mode for startups. For UnityPoint Health, Warrens says this is a non-issue — the kind of things some startups needlessly fixate on.

“At UnityPoint Health, we don’t do pilot contracts. When we work with a company, we already know what the scaling costs are and the scope of what we will do for scaling as well. Our goal isn’t to do the pilot to test the technology. We want to test the cost with decision makers. It’s really about change management.”

The group always goes into a pilot with a solid plan — including implementation, communication, and how it impacts clinician workflows and patients. The goal is to change clinical workflows as little as possible. Warrens refers to it as developing  “a culture of change management”.

Although UnityPoint Heath’s’s startup program is only halfway through its first year, it is currently doing three pilots across its nine geographic regions. It hopes to complete six by end of year and seeks to double that figure in the second year. It tries to avoid running multiple pilots in the same region at the same time.

As for the specific needs UnityPoint Health is looking to address, Warrens says this year, they are interested in technology for care management, behavioral health, and the patient experience.  

Warrens also shared some of what he has learned from the experience of working with startups.

“The key to creating speed-to-value of this work is you have to have a dedicated, experienced team to manage this — a venture team, an internal commercialization team, and a strategic partner team that helps deploy those solutions.

At UnityPoint Health, we work closely with dedicated clinical resources teams, and our innovation department can pay fees  to get pilots started. The following year, the innovation budget will be refreshed to take on more pilots.”

It’s also important to work with the IT team to ensure there are enough hours to assess the technology of startups and internal innovators. The group reserves IT hours on an annual basis to help with implementation and integration of these solutions, even though they may not know what the actual products will be in the planning cycle.

As for specific advice for startups, Warrens has this to say: Spend less time on the pain points in healthcare your company seeks to address and more time on the technology you have developed. He would also extend that advice to pitch competitions.

I’m always surprised how much time a startup spends describing what the problem is. We already know what the problems are, so tell me more about your innovative solution.”

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AstraZeneca, Daiichi Sankyo’s $6.9B breast cancer drug partnership bears fruit in less than two months

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The growing field of antibody-drug conjugates may soon get a new member with positive Phase II data in breast cancer.

Anglo-Swedish drugmaker AstraZeneca and Japan-based Daiichi Sankyo said Wednesday that its Phase II DESTINY-Breast01 study of trastuzumab deruxtecan met the primary endpoint of overall response rate among patients with refractory HER2-positive metastatic breast cancer. The company did not disclose what the response rate was, but stated that it confirmed the “unprecedented” clinical activity of the drug shown in a Phase I study published last month. The Phase II results announced Wednesday were among patients who had failed or discontinued treatment with another antibody-drug conjugate, Roche’s Kadcyla (ado-trastuzumab emtansine).

The companies said they plan to file for regulatory approval based on the Phase II results in the second half of this year. Shares of AstraZeneca were up more than 1 percent on the London Stock Exchange following the news. Daiichi Sankyo’s shares were mostly flat on the Tokyo Stock Exchange. The companies announced a partnership to develop the drug, which uses Daiichi Sankyo’s antibody-drug conjugate technology, at the end of March. The deal included a $1.35 billion upfront payment from AstraZeneca, plus up to $5.55 billion in potential milestone payments.

Results of the Phase I trial were published in two manuscripts in The Lancet last week. In one manuscript, the response rate was 59.5 percent among 115 patients, while disease control rate was 93.7 percent. The median progression-free survival was 22.1 months, while the overall survival median was not yet reached, with 55 patients – representing 48 percent of the total – remaining on treatment. In the second manuscript, with data on 44 patients, the ORR and DCR were 43.2 percent and 79.5 percent, respectively.

Both trastuzumab deruxtecan and Kadcyla are derived from Roche’s Herceptin (trastuzumab), a HER2-targeting monoclonal antibody. Currently, there are four Herceptin biosimilars approved by the Food and Drug Administration. The first to win approval was Mylan’s Ogivri (trastuzumab-dkst), in December 2017, while the latest is Pfizer’s Trazimera (trastuzumab-qyyp), approved in March.

Antibody-drug conjugates, also known as ADCs, consist of a monoclonal antibody with an attached pharmaceutical payload. In addition to Kadcyla, other approved ADCs include Seattle Genetics’ Adcetris (brentuximab vedotin), for Hodgkin’s lymphoma and certain T-cell lymphomas; and two from Pfizer, namely Mylotarg (gemtuzumab ozogamicin), for acute myeloid leukemia, and Besponsa (inotuzumab ozogamicin), for acute lymphoblastic leukemia. Seattle Genetics also has numerous other ADCs in its pipeline.

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TytoCare signs first major retail partnership with Best Buy for its self-exam devices

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TytoCare’s TytoHome product will be offered online through BestBuy.com and brick-and-mortar stores in Minnesota. Availability is also coming soon to locations in California, North Dakota and South Dakota.

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Alnylam, Regeneron form $1B partnership to develop eye, central nervous system drugs

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A drugmaker focused on RNA interference and another firm developing drugs for a range of rare diseases have formed a partnership worth up to $1 billion focused on diseases of the eye and central nervous system.

Tarrytown, New York-based Regeneron Pharmaceuticals and Cambridge, Massachusetts-based Alnylam Pharmaceuticals announced the partnership Monday, which will be focused on discovery, development and commercialization of RNAi-based drugs. The partnership includes an $800 million upfront cash and equity investment in Alnylam, and up to $200 million in near-term milestones.

The two companies have an existing partnership, announced last year, to develop drugs for nonalcoholic steatohepatitis, also known as NASH.

Under the partnership, both companies will work to discover RNAi drugs for eye and CNS diseases, while Regeneron will lead development and commercialization for all programs targeting eye diseases, potentially entitling Alnylam to milestone and royalty payments. Meanwhile, for CNS programs, the companies will jointly advance leadership and also alternate, with the company leading a project retaining global responsibility for development and commercialization.

The Food and Drug Administration approved Alnylam’s Onpattro for peripheral nerve disease caused by hereditary transthyretin-mediated amyloidosis, or hAATR, in August 2018 marking the first-ever FDA approval of an siRNA drug.

In addition to eye and CNS diseases, the companies will also work together on some programs focused on liver diseases. These include a plan to combine Regeneron’s drug REGN3918 (pozelimab) with Alnylam’s cemdirsan, which Regeneron will lead. Pozelimab has completed a Phase I study among healthy volunteers, while cemdirsan is in a Phase II study recruiting patients with immunoglobulin A nephropathy.

Both pozelimab and cemdirsan target complement protein C5, which is the same target as Alexion Pharmaceuticals’ drug Soliris (eculizumab) and its successor, Ultomiris (ravulizumab-cwvz). Soliris is approved for paroxysmal nocturnal hemoglobinuria, or PNH, and atypical hemolytic uremic syndrome, or aHUS, while Ultomiris is only approved for PNH. Amgen is developing a biosimilar to Soliris, ABP 959, with a Phase III trial comparing it to Soliris expected to start recruiting patients at the end of this month. The study is expected to enroll 40 PNH patients.

Cemdirsan has also completed a Phase I/II trial in PNH and was the subject of a Phase II study in aHUS, but the latter study was withdrawn early due to lack of enrollment.

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