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Gilead is to buy immuno-oncology firm Forty Seven for $4.9 billion, adding an antibody targeting several blood cancers to its research pipeline.

Forty Seven is based in Menlo Park, a short drive away from Gilead’s base in Foster City, and is developing magrolimab, which is targeting myelodysplastic syndrome (MDS), acute myeloid leukaemia (AML), and diffuse large B-cell lymphoma (DLBCL).

The deal values shares in Forty Seven at $95.50 each valuing the biotech at $4.9 billion and is expected to close in Q2 after unanimous approval from both boards, as long as it clears competition regulators.

Rumours that the two companies were in talks over a merger had already emerged last week, as Gilead builds an immuno oncology franchise while sales of its hepatitis C drugs wane.

Gilead’s CEO Daniel O’Day said the acquisition will complement a pipeline of cell therapies brought in from Kite, which Gilead acquired for $11.9 billion in 2017.

O’Day joined from Roche nearly a year ago and has been tasked with rebuilding momentum at Gilead as the pool of patients eligible to receive its hepatitis C drugs such as Sovaldi shrinks.

A potential first-in-class therapy, magrolimab targets CD47, which produces a “do not eat me” signal that allows cancer cells to avoid destruction.

By targeting CD47 it’s hoped that magrolimab will allow the patient’s own innate system to engulf and eradicate cancer cells.

The company presented promising results from a phase 1b study of magrolimab in patients with MDS and AML at the American Society of Hematology meeting in December.

O’Day said: “Magrolimab complements our existing work in hematology, adding a non-cell therapy programme that complements Kite’s pipeline of cell therapies for hematological cancers. With a profile that lends itself to combination therapies, magrolimab could potentially have transformative benefits for a range of tumour types.”

Forty Seven also has a rival developing CD47-based drugs – Canada’s Trillium Therapeutics saw its shares soar ahead of the takeover announcement as it has a CD47-targeting drug in clinical development.

Progress on new pump hardware, a wider age indication for its new insulin dosing algorithm, and the ability to control dosing from a phone app are among Tandem Diabetes’ focuses for 2020, execs outlined on an earnings call Monday.

Annual revenue nearly doubled to about $362 million in 2019 from a year earlier, Tandem reported after markets closed, well exceeding the $270 million high predicted early last year. Over the course of those 12 months, the company shipped more than 73,000 of its pumps, up 113% compared to 2018.

Still, fourth quarter results — which marked comparatively underwhelming 42% year-over-year sales growth — didn’t blow Wall Street analysts away, coming in largely as expected. Shares were down 7% in late morning trade Tuesday.

Stifel analysts noted further share price appreciation is contingent nearly entirely on better-than-expected revenue.

“Multiple variables all need to skew in [Tandem’s] favor, which while possible, doesn’t yet feel probable/inevitable to us,” they wrote.

Those factors include a high level of new pump customers, more transitions from patients currently on multiple daily injection therapy, and acceleration of competitor switches.

Execs said the company now has close to 20% of the U.S. insulin pump market and predict sales to reach up to $465 million in 2020, forecasting growth between 24% and 28%. Gross margins rose five points over 2019 to 54%, where Tandem expects them to stay steady in 2020.

Ability to administer bolus doses of insulin via a phone is “the number one feature that people would desire,” CEO John Sheridan told analysts on an investor call. An FDA filing is planned for this summer for a new mobile app that allows for remote bolusing.

Sheridan said the submission will be “a bit of uncharted territory as there is not a commercial precedent for mobile control from an insulin pump using an unrestricted mobile device,” making FDA timing hard to predict, though it estimates the feature will be available in the second half of this year.

Tandem also noted its future FDA submission of a smaller insulin pump called t:sport will come in two filings, because pump users will have the choice to either operate the device via a phone or from a separate handheld device. The company plans to prioritize the latter and file it this summer, with plans to submit the full control from a mobile app version later. Tandem does not plan to launch the new pump until each of the two submissions are OK’ed by FDA and is currently targeting the first half of 2021.

Impact of Control-IQ

The company previously cautioned investors that some customers may have been waiting until FDA greenlighted its automated insulin dosing algorithm known as Control-IQ to buy a new pump.

“It is difficult to quantify the impact of the timing of Control-IQ had on 2019,” CFO Leigh Vosseller said Monday, but said the company estimates around 2,000 customers will purchase a pump in 2020 “who would have otherwise purchased a pump last year.”

After a review that lasted just shy of five months, FDA in December authorized Control-IQ through the De Novo pathway — designed for medical technologies that can be sufficiently regulated as Class I or II devices with general and/or special controls, but for which no predicate device exists.

The go-ahead for Control-IQ created the third and final category necessary for having an automated insulin dosing system, following FDA’s designation of Dexcom’s G6 CGM as an integrated continuous glucose monitor and of Tandem’s own t:slim X2 insulin pump as an alternate controller enabled pump.

The company plans to file a regulatory submission this quarter to allow Control-IQ for people as young as age 6. When first awarded the De Novo, Tandem’s technology was authorized for use in individuals 14 years old and up.

Tandem also plans to roll out improvements to the Control-IQ algorithm in 2021, which it’s having to work through with regulators. “We are working with the FDA to segment various features by level of clinical risks to ultimately determine the regulatory path that will allow us to make incremental updates to our Control-IQ technology and then deliver new benefits to our customers on a regular basis,” Sheridan said.

If competitor Insulet’s intentions to bring its own automated insulin delivery system to market in 2020 go according to plan, Tandem will likely face stiffer competition at the end of the year. Major continuous glucose monitor manufacturers Dexcom and Abbott each outlined plans last week to integrate their devices with Insulet’s system, called Horizon. Insulet is scheduled to report earnings after markets close Tuesday.

Control-IQ currently operates in tandem with Dexcom’s G6 CGM. Tandem and Abbott announced last October they “intend to develop and commercialize integrated diabetes solutions” but offered few details on when an Abbott-Tandem-compatible system may be available and what it might look like. On Monday’s call, Sheridan offered few additional details, saying the companies are still working on their agreement and he’s confident “we’re going to get this thing been taken care of in the near future.”

While the pharmacy has been an increasingly popular point of sale for CGM counterparts, Vosseller told analysts Tandem isn’t necessarily looking to move away from its durable medical equipment selling model.

Dive Brief:

• As part of an ongoing clinical trial of its implanted vagus nerve stimulation (VNS) system in people with hard-to-treat depression, LivaNova is partnering with Verily to offer a wearable device and mobile app meant to help gather additional information on study participants’ behavior.
• Using technology and analytics developed by Google-parent Alphabet’s life sciences research organization, the goal is to “further understand depressive episodes and a patient’s response to treatment,” LivaNova said in the announcement Wednesday.
• LivaNova’s RECOVER study is part of a protocol approved by CMS for the device to be reimbursed through its coverage with evidence development pathway.

• Dive Insight:

  The VNS implant sends electrical pulses to the brain, aiming to reduce depression symptoms. First authorized by FDA for the treatment-resistant depression indication in 2005, the neuromodulation approach is meant for people who have failed to gain adequate relief from multiple therapeutic interventions for depression.

  LivaNova said clinical trial participants with an Android device can elect to be part of a sub-study with the Verily Study Watch and a phone app “to measure passive and interactive data.” Additional data on heart rate, activity level and quality of sleep, paired with patient-recorded voice logs, can more thoroughly assess the trajectory of a patient’s depression and its impact on daily life, LivaNova said.

  The Verily Study Watch has received 510(k) clearance for an electrocardiogram feature and an irregular pulse monitor.

  The collaboration could expand into other areas of research in the future, the companies said.

  LivaNova recently changed its descriptor for the condition from “treatment-resistant” depression to “difficult-to-treat” depression, or DTD, following an international consensus statement published in the Journal of Affective Disorders suggesting the latter term better encompasses “depression that continues to cause significant burden despite usual treatment efforts.”

  CMS greenlit the study protocol six months ago, with LivaNova aiming to enroll up to 500 unipolar and 500 bipolar patients at up to 100 U.S. sites. RECOVER could ultimately enroll an additional 5,800 participants as part of a longitudinal study and continue through 2030, according to the study’s listing on ClinicalTrials.gov. 

  Formed in 2015, Verily is building its brand — it presented for the first time at J.P. Morgan Healthcare Conference in January — and remains a hot partner for life sciences companies.

  Its medtech collaborations include collaborating on Dexcom’s continuous glucose monitor device due out next year and working on atrial fibrillation technologies with iRhythm. The company is also developing microelectronics and digital technologies for ophthalmology with Japanese pharma Santen and studying undiagnosed and untreated sleep apnea with ResMed in hopes of fashioning software to better identify and treat the condition.

  Verily has also seen recent changes on key medtech projects. Sanofi, which worked with Verily to launch virtual diabetes clinic Onduo in 2016, pulled back investment from the joint venture late last year. Verily recently exited a multiyear robotic surgery partnership with Johnson & Johnson when the pharma and devices giant opted to buy out its remaining stake in Verb Surgical.

  News of the LivaNova-Verily partnership came hours after LivaNova reported fourth quarter financial results, which showed sales in the neuromodulation division, which houses VNS, inched up 0.4% year-over-year to $424.5 million.

  LivaNova CEO Damien McDonald said on an earnings call Wednesday the company expects depression device-related sales of roughly $20 million in 2020 from the RECOVER study and replacement implants for CMS-eligible patients, as well as “a modest benefit” from commercial payer efforts.

Dive Brief:

• FDA has issued a flurry of warning letters against medical device companies shortly after an agency official predicted an uptick in enforcement activity.
• The number of medical device warning letters issued annually fell almost 90% from 2015 to 2019. With a reorganization the Center for Devices and Radiological Health pointed to as a source of slowdown now complete, the agency has said vigilance over industry’s compliance failings may rebound. 
• FDA took a step toward fulfilling the prediction by publicly disclosing warning letters on Tuesday sent to Biomedix WAI, CPAPNEA Medical Supply and Unetixs Vascular.
  

  Dive Insight:

  FDA thinks reorganizing its teams so staff specialized in particular areas follow products throughout their life cycles, rather than handle all devices at a certain stage in the life cycle, will bring benefits. However, the agency acknowledges the move to the new model caused disruption.

  In its 2021 budget justification, FDA said the reorganization, and resulting need to train staff, was a reason for its failure to hit its target of reading 90% of the most serious device adverse event reports within 72 hours of receipt. FDA officials have also cited the reorganization as a driver of the sharp fall in the number of medical device warning letters issued in recent years.

  The completion of the reorganization was expected to enable FDA to focus more on enforcement. Over the first seven weeks of 2020, FDA appeared to send only one medical device-related warning letter.  FDA issued and published six medical device warning letters (to LC Medical Concepts, Circulatory Technology, American Preclinical Services, Datascope, Total Thermal Imaging and a cosmetic surgeon entrepreneur) over the same period of 2019, before the reorganization began.

  This week, a potential early sign of uptick in enforcement arrived. All three warning letters originated from divisions within the Office of Medical Device and Radiological Health.

  FDA hit Biomedix with a warning letter after its inspector found fault with the production of the company’s SELEC-3 gravity I.V. administration sets. According to FDA, Biomedix failed to identify or investigate 233 “anomalous or apparently failed test results.” FDA also found Biomedix failed to validate a process that can be fully verified by subsequent inspection and test, an observation the agency also made in a 2013 warning letter.

  The CPAPNEA warning letter calls the device company out for promoting its Optipillows EPAP mask as a treatment for obstructive sleep apnea, despite only having 510(k) clearance covering its use in the alleviation of snoring. FDA also criticized CPAPNEA for failing to establish procedures for corrective and preventative actions, complaint handling and quality audits.

  Unetixs received its warning letter after FDA found design controls implemented during development of the MultiLab Series ROODRA vascular diagnostic device were inadequate. FDA also found Unetixs accepted four lots of motherboards that failed voltage output. That observation is a repeat of one of the criticisms FDA made in a 2017 warning letter to Unetixs.

  The disclosure this week of warning letters to the three companies appears to nearly double the total number of device-related warning letters posted to FDA’s Warning Letters database to seven so far in 2020, by a count of database listings, although many of those were actually sent in 2019. Other recent recipients include low level LED light therapy device manufacturerVevazz, patient monitoring systems maker Draeger Medical Systems, compression limb therapy company Won Industry Co., and Curewave Lasers.

A new law being implemented by the most populous U.S. state could attract the eyes of FDA as regulators continue to work through guidance on addressing rising cybersecurity threats to medical devices. 

California’s connected devices security law, which took effect Jan. 1, requires manufacturers to equip connected devices with “reasonable security” that protects consumers from attackers gaining access to those devices.

While certain medical device makers — including those covered by some federal laws — may be exempt, the California law does explicitly cover a broad range of so-called Internet of Things (IoT) or connected devices, including wearables and connected home health devices, in addition to computers, security cameras, and smart meters.

And experts say the FDA may be watching the law’s implementation as the agency further develops recommendation on medical device cybersecurity.

“The state lawmakers knew, when they were drafting the law, that the FDA had cybersecurity guidance [it is working on] … States are trying to fill the spaces where you don’t have federal cybersecurity regulation,” Richard Borden, a partner at the law firm of White and Williams, told MedTech Dive.

The FDA did not respond to a query as to how the California law could inform its own federal guidance.

Market research firm IDC estimates close to 42 billion connected devices will generate 79.4 zettabytes of data by 2025. And the connected devices market in North America is forecast by Statista to reach $540 billion by 2022, so the economic impact of the new law could be significant as most major connected device manufacturers sell products in California, a state with an economy bigger than many Western nations.

Report after report in recent years has found healthcare organizations vulnerable to cyber criminals, blamed on over-reliance on legacy systems, employees bending rules about security, among other factors.

The law defines a connected device as “any device, or other physical object that is capable of connecting to the Internet, directly or indirectly, and that is assigned an Internet Protocol address or Bluetooth address.”

A connected device manufacturer is required to equip the device with a “reasonable security feature” that is “appropriate to the nature and function of the device; appropriate to the information it may collect, contain, or transmit; [and] designed to protect the device and any information contained therein from unauthorized access, destruction, use, modification, or disclosure.”

One key area of uncertainty surrounds the meaning of “reasonable security feature,” according to Daniel Pepper, partner at the law firm of BakerHostetler.

In addition, “there is still some question as to what the rest of the requirements will need to be to ‘protect the device and any information within from unauthorized access, destruction, use, modification, or disclosure’,” he told MedTech Dive.

Biogen and Sangamo have begun a collaboration to develop gene regulation therapies for neurological diseases including Parkinson’s and Alzheimer’s in a collaboration worth more than $2.7 billion.

Sangamo, which was famously the first company to edit human DNA, only recently completed the transfer of haemophilia A gene therapy to Pfizer before Christmas under a separate agreement and has followed this up through this collaboration with Biogen that will pay $350 million up front.

This initial payment will include a licence fee and an equity investment in Sangamo, and the California biotech could receive a further $2.37 billion in other payments if certain goals are met.

The agreement will focus on the development and marketing of ST-501 for diseases linked with rogue tau proteins including Alzheimer’s disease.

It also covers ST-502 for diseases related to abnormal aggregates of alpha-synuclein protein in the nervous system and brain, including Parkinson’s.

The deal also covers a third undisclosed neuromuscular disease target, and up to nine additional undisclosed neurological disease targets.

The companies will use Sangamo’s proprietary zinc finger protein (ZFP) technology delivered via adeno-associated virus to change the expression of genes involved in these diseases.

Biogen will get exclusive global rights to ST-501 for tauopathies including Alzheimer’s disease, ST-502 for synucleinopathies including Parkinson’s disease, and a third undisclosed neuromuscular disease target.

Massachusetts-based Biogen also has exclusive rights to nominate up to nine additional undisclosed targets over a target selection period of five years.

Sangamo will perform early research activities, costs for which will be shared by the companies, aimed at the development of the combination of proprietary CNS delivery vectors and ZFP transcription factors targeting therapeutically relevant genes.

Biogen will be responsible for pre-clinical and clinical studies, discussions with regulators, and global marketing.

Sangamo will be responsible for GMP manufacturing activities for the initial clinical trials for the first three products of the collaboration and plans to leverage its in-house manufacturing capacity.

Biogen will assume responsibility for GMP manufacturing activities beyond the first clinical trial for each of the first three products.

The announcement comes as Biogen prepares to file its Alzheimer’s drug aducanumab with the FDA, using data cobbled together from failed clinical trials that seem to show an effect at a higher dose.

The U.S. Food and Drug Administration (FDA) approved Ann Arbor, Michigan-based Esperion’s Nexlizet (bempedoic acid and ezetimibe) for lowering LDL-Cholesterol (LDL-C). The drug is an oral, once-daily, non-statin indicated with diet and maximally tolerated statins for adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who need additional help lowering LDL-C.

Last week, the agency approved Nexletol (bempedoic acid) for the same indications.

“The approval of Nexlizet underscores Esperion’s commitment to providing patients and their healthcare providers with innovative non-statin medicines that fit into their everyday routines to lower elevated levels of bad cholesterol in adult patients with ASCVD or HeFH on maximally tolerated statins,” said Tim M. Mayleben, president and chief executive officer of Esperion. “This is the first non-statin combination medicine ever approved for lowering LDL-C. We are truly grateful to all the patients and healthcare providers who put their confidence in Esperion’s team of lipid experts”

Nexlizet’s approval was supported by the Phase III Fixed Combination Drug Product LDL-C Lowering program in addition to safety data from the Nexletol tablet global pivotal Phase III LDL-C lowering program and the existing safety profile of ezetimibe. In the trials, Nexlizet decreased LDL-C by a mean of 38% compared to placebo when added to the maximum tolerated dose of statins.

The drug was generally well-tolerated. There are warnings and precautions about hyperuricemia and the possible development of gout as well as increased risk of tendon rupture or injury. The most common adverse events, which were about the same as in the placebo group, were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in the extremities, anemia, elevated liver enzymes, diarrhea, arthralgia, sinusitis fatigue, and influenza.

Nexlizet is expected to be on the market in the U.S. in July 2020. Nexletol will be marketed in the U.S. on March 30, 2020. Both are prescription only.

The company indicates plans to price the drugs “at parity,” and suggest that some patients with commercial drug insurance plans may pay as little as $10 per fill-up to a three-month supply.

“Nexlizet provides significant additional LDL-C lowering for adult patients with ASCVD or HeFH when added to maximally tolerated statin medicine, including those patients for whom maximally tolerated statin may be no statin at all,” said Christie M. Ballantyne, chairman of Esperion’s Phase III Executive Committee and professor and chief of cardiology at Baylor College of Medicine in Houston. “I believe this one-of-a-kind combination medicine which has two complementary, non-statin medications can provide highly effective additional reductions in LDL-C when added to statin therapy. It also has the conventional, oral, once-daily administration which can prove beneficial to patients struggling to meet their cholesterol goals with the currently available statin options in their daily regimen.”

About 40 million people in the U.S. take statins to lower their cholesterol. Esperion’s drugs are targeted at the approximately 8.5 million people who take statins whose cholesterol doesn’t decrease to the desired levels. The company will also target another 9.5 million patients who can’t take statins for a variety of reasons. It is estimated that in the U.S. about 100 million people have one type of high cholesterol.

Apple and Johnson & Johnson have begun enrolling patients in a study that will investigate whether the Apple Watches could be used to detect early signs of atrial fibrillation (AFib).

The tech firm has joined with Johnson & Johnson to answer that question, testing the electrocardiogram (ECG) technology that is already embedded in Apple Watches.

J&J’s Janssen unit has announced the Heartline Study, which involves iPhone and Apple Watch users aged over 65.

Those taking part in the two-year study must also be US resident, and own an iPhone 6s or later, and must be enrolled on the state-backed Medicare plan for older people.

The study was first announced last year and is being run by Michael Gibson, CEO of the Baim Institute for Clinical Research and founder of the Perfuse Study Group at Harvard Medical School.

Gibson, who has studied cardiology for 38 years has joined with cardiologist John Spertus, Daniel J. Lauer/Missouri Endowed Chair in Metabolic and Vascular Disease Research at the University of Missouri–Kansas City, who is study co-lead.

Those on the study will participate in health surveys and other activities in the dedicated Heartline app.

They will receive points for the time and effort spent completing the activities. Depending on the study group patients are assigned to, these points may be redeemed for $150 or more in monetary awards.

Apple currently has FDA clearance for monitoring with its latest Apple Watch, so long as it isn’t used to replace traditional methods of diagnosis or treatment, but the link-up with J&J could give it a clinical pathway to seek an approved health claim in AFib, including stroke prevention.

While AFib typically causes warning symptoms such as dizziness and shortness of breath in around a third of cases it can go undiagnosed, putting people at risk of life-threatening complications such as a stroke. Having AFib gives a four- to five-fold increased risk of stroke, and it kills around 130,000 people in the US every year.

Apple has competitors in the market for its EC-enabled Watch, including Withings which unveiled its MOVE ECG sensor at last year’s Consumer Electronics Show in Las Vegas, and AliveCor, which has an ECG system that has six leads to provide more accuracy.

Roche’s recent spate of billion-dollar plus alliances has continued with a deal with UK biotech Bicycle Therapeutics – worth up to $1.7 billion – in the area of cancer immunotherapy.

The agreement is firmly geared towards the back end with an upfront fee of $30 million that gives Roche’s Genentech unit a buy-in to Bicycle’s bicyclic peptide drug discovery platform across a range of immuno-oncology targets.

The UK company says its bicyclic peptides or ‘bicycles’ have targeting properties that are similar to those of monoclonal antibodies, but act more like small-molecule drugs, which makes it easier for them to be manufactured, dosed and reach target tissues in the body.

The time the peptides stay in the body can also be fine-tuned, allowing for precise control of drug exposure, says the company, which notes none of its current pipeline of drugs are included in the deal.

The two partners will make use of Bicycle’s screening approach to identify bicyclic peptides that are active against drug targets, including novel targets nominated by Roche.

“Bicycles represent a novel therapeutic modality and have shown promise as modulators of several types of tumour-killing immune cells,” said Roche’s head of pharma partnering James Sabry, giving a hint of the direction the collaboration will take.

Bicycle is responsible for discovery and preclinical development of bicycles against “multiple targets”, with Roche taking over promising programmes once they advance to the clinical testing stage.

It’s the latest in a series of $1 billion-plus pipeline-building deals for Roche as it starts to feel the impact of biosimilar competition of its ‘big three’ antibody drugs Rituxan/MabThera (rituximab), Herceptin (trastuzumab).

Since the start of 2019, the company has signed a $2.85 billion partnership with Sarepta for Duchenne muscular dystrophy candidate SRP-9001 and a $2 billion alliance with Adaptive Biotech on T-cell receptor therapies for solid tumours.

It has also agreed a pair of two gene-silencing deals, including one worth $2 billion with Skyhawk Therapeutics focusing on cancer and neurological diseases, and another with Dicerna for hepatitis B virus drugs valued at $1.7 billion.

Meanwhile, Roche isn’t the first big pharma partner Bicycle has attracted for its bicyclic peptide technology. In 2016 it started a $1 billion tie-up with AstraZeneca to hunt for  drugs that could be used to treat respiratory diseases, and extended that in 2018 to include cardiovascular and metabolic disorders.

It also has alliances with Oxurion in the area of ophthalmology, as well as with Cancer Research UK and the Dementia Discovery Fund.

The company’s lead in-house project is BT1718 – a bicycle toxin conjugate (BTC) drug that combines targeting of MT1-MMP on cancer cells with a cell-killing payload – which is being tested in a phase 1/2a trial in solid tumours sponsored by CRUK.

Following just behind is BT5528, described as a second-generation BTC targeting EphA2 which is also in a phase 1/2 study in advanced solid tumours.

CAMBRIDGE, Mass.–(BUSINESS WIRE)– Gemini Therapeutics, a clinical stage precision medicine company developing innovative treatments for dry Age-related Macular Degeneration (AMD) and linked ocular disorders, today announced a collaboration with the Singapore Eye Research Institute (SERI) to expand knowledge and identify new targets associated with AMD.

Under the terms of the agreement, SERI and Gemini will explore the link between genetic and potential biomarkers in patients diagnosed with polypoidal choroidal vasculopathy (PCV). This approach will leverage Gemini’s experience using precision medicine to develop potential therapeutics for genetically defined patient populations. Gemini will use this information to increase its understanding of the links between genetic variants, the impact on the expression of specific genes, and the diagnosis of PCV. PCV and AMD are related diseases, and there are shared genetic causes between the two conditions. This collaboration will inform future development of more targeted therapies for both conditions.

Talking about the collaboration, Prof Gemmy Cheung, who heads AMD research at SERI said, “Polypoidal choroidal vasculopathy represents a significant proportion of patients with neovascular AMD, especially in Asia. Currently there are limited or no specific treatment options for PCV. Exploring the molecular impact of specific genes linked to PCV in this SERI-Gemini collaboration will provide important new information towards designing innovative therapies in future. We are very excited indeed.”

“Our collaboration with SERI is an important extension of the work we’re doing at Gemini to increase understanding and improve the treatment of AMD. As we progress our current clinical program of GEM103, a recombinant Complement Factor H therapy, in dry AMD, expanding our understanding of related ocular diseases and taking a genetic starting point to develop therapeutic options for those patients is a natural next step,” said Jason Meyenburg, Chief Executive Officer of Gemini. “SERI is one of the foremost centers for the study of major eye diseases in the world and we are thrilled to collaborate with them on this important project.”

About PCV

Polypoidal choroidal vasculopathy (PCV) is a disease affecting the blood vessels in the choroid which supports the retina. Abnormal branching of the blood vessels in the choroid results in aneurysms known as polyps, which can cause leakage of blood and fluid under the retina, causing elevations in the retina and substructures. Patients with PCV may eventually experience irreversible central vision loss in one or both eyes. PCV has a prevalence of between 23 and 54% in Asian populations diagnosed with AMD. In Caucasian populations between 4 and 10% of patients diagnosed with AMD and the genetic basis of the condition is being explored. Current treatments for PCV can involve laser or intravitreal injections, but the response is variable and the preferred treatment for PCV remains unclear.

Singapore Eye Research Institute

Singapore Eye Research Institute (SERI) is Singapore’s national research institute for ophthalmic and vision research. It is the research arm of Singapore National Eye Centre, and has close working relationships with A*STAR Research Institutes, Nanyang Technological University and other biomedical institutions and eye centers in Singapore and throughout the world. SERI’s national mandate drives the organization to constantly explore areas of synergy, and opportunities for multidisciplinary collaborative research partnerships with various public healthcare eye institutes, and biomedical research institutions. Since its establishment in 1997, SERI has grown to become one of the largest research institutes in Singapore and the largest eye research institute in the Asia-Pacific. As of September 2019, SERI has amassed an impressive array of publications amounting to more than 3,700 scientific papers, and has secured more than 340 external peer-reviewed competitive grants. SERI’s faculty has been awarded with more than 610 national and international prizes and filed more than 130 patents. As a non-profit entity that is heavily reliant on competitive grants as the main source of funding, SERI has always adopted a lean and optimal approach in fund utilization via leveraging on shared resources to support our research projects. More info at www.snec.com.sg/research-innovation

Gemini Therapeutics

Gemini Therapeutics is a clinical stage precision medicine company developing innovative treatments for age-related macular degeneration (AMD) and linked ocular disorders that are matched to molecular abnormalities found in patients with high clinical unmet need. The company has generated a rich pipeline including recombinant proteins, monoclonal antibodies, and gene therapies. Gemini’s CLARITY natural history study is designed to provide unprecedented insight into the role of genetic risk in common retinal diseases and began in December 2018. Gemini was launched with funding from leading life science investors and powered by academic partnerships globally.

For more information, visit www.GeminiTherapeutics.com.