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Ro makes the weight loss product Plenity commercially available to everyone in the US

In what could be the first step in the development of a significant new line of business for the telemedicine prescription provider Ro, the company is finally announcing the general commercial availability of weight loss product, Plenity.

Developed by Gelesis, a biotech company that makes treatments for gastro-intestinal disorders, Plenity is a weight loss treatment that uses citric acid and cellulose to create a non-toxic paste that makes people feel more full after they ingest it. Taken before meals, the pill becomes a substance that expands to take up about 25% of the stomach, so people eat less.

The product has been approved by the U.S. Food and Drug Administration and is available for a much broader segment of the population than other weight loss products. While most prescription medicines are intended for people who are obese, the Gelesis product is made for people who are overweight, too.

“That’s adults who have a BMI from 25 up to 40. That’s 150 million Americans,” according to Gelesis chief commercial and operating officer, David Pass.

Plenity received FDA approval last April, and Gelesis started working with Ro soon after, according to Pass. The idea was to craft a strategy that could get the treatment, which is classified as a medical device and not a drug, in the hands of as many patients as quickly as possible.

For Ro, the agreement with Gelesis is a sign of potential things to come. The company is the exclusive online provider of the Plenity treatment and Ro founder Zachariah Reitano said that there’s an incredible potential to engage in more of these types of deals.

“We would love to be able to partner with pharmaceutical companies to decrease the cost of distribution,” said Reitano. “We were excited to build an exciting treatment solution for weight management. Our high-level mission is to be the patient’s first call.”

With the Gelesis partnership Ro can add another highly desirable treatment to its roster of therapies — and one that can be a contributing factor to increasing the severity of other conditions that the company already provides treatment for, Reitano said. 

“There are a few conditions that we currently treat that are exacerbated by a patient being overweight or obese. People who struggle with weight management will also experience ED. Obesity can lead to heart failure, stroke, coronary heart disease, hypertension, depression,” Reitano said. “The breadth of the label is interesting. Only FDA approved with a BMI from 25 to 40. FDA approved treatment have been between 30 and 40. [It] makes the treatment more accessible to a wider variety of people.”

As the only online provider of the treatment, Ro has developed an onboarding process to ensure that the Plenity therapy isn’t abused by people who suffer from eating disorders.

“During our onboarding we not only ask questions to patients about their weight management. There’s a consecutive set of images that need to be uploaded and taken with the provider. That’s something we’ve taken a lot of time and energy to make sure about,” said Reitano. 

Like the other treatments Ro offers, Plenity is a cash-pay prescription, because the weight loss treatments aren’t typically covered by insurance, he said.

The benefit of working with an online pharmacy like Ro to provide distribution for a new therapy was obvious to both startups.

“We turned this market on its head by putting the consumer at the heart of everything we do,” said Pass. The treatment costs $98 per month, compared to other therapies or branded medications that could be as much $300 and $350 per month, according to Pass.

One reason that Gelesis is able to reduce the price of the drug is that it won’t have to hire a massive sales force to pitch it. The company has Ro for that.

“Normally you have a pharmaceutical company that would have to hire a sales force and go door to door and it increases the cost of a new drug. [Ro] can make a new, innovative treatment, like Plenity, available nationwide,” Reitano said. 

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Mission Bio raises $70 million to help scale its tech for improving the development of targeted cancer therapies

California-based startup Mission Bio has raised a new $70 million Series C funding round, led by Novo Growth and including participation from Soleus Capital and existing investors Mayfield, Cota and Agilent. Mission Bio will use the funding to scale its Tapestri Platform, which uses the company’s work in single-cell multi-omics technology to help optimize clinical trials for targeted, precision cancer therapies.

Mission Bio’s single-cell multi-omics platform is unique in the therapeutic industry. What it allows is the ability to zero in on a single cell, observing both genotype (fully genetic) and phenotype (observable traits influenced by genetics and other factors) impact resulting from use of various therapies during clinical trials. Mission’s Tapestri can detect both DNA and protein changes within the same single cell, which is key in determining effectiveness of targeted therapies because it can help rule out the effect of other factors not under control when analyzing in bulk (i.e. across groups of cells).

Founded in 2012 as a spin-out of research work conducted at UCSF, Mission Bio has raised a total of $120 million to date. The company’s tech has been used by a number of large pharmaceutical and therapeutic companies, including Agios, LabCorp and Onconova Therapeutics, as well as at cancer research centers including UCSF, Stanford and the Memorial Sloan Kettering Cancer Center.

In addition to helping with the optimization of clinical trials for treatments of blood cancers and tumors, Mission’s tech can be used to validate genome editing — a large potential market that could see a lot of growth over the next few years with the rise of CRISPR-based therapeutic applications.

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Lucid Lane has developed a service to get patients off of pain meds and avoid addiction

Four years ago, Adnan Asar, the founder of the new addiction prevention service Lucid Lane, was enjoying a successful career working as the founding chief technology officer at Livongo Health. It was the serial senior tech executive’s most recent job after a long stint at Shutterfly and he was shepherding the company through the development of its suite of hardware and software for the management of chronic conditions.

But when Asar’s wife was diagnosed with non-Hodgkin’s Lymphoma, he stepped away from the technology world to be with his family while she underwent treatment.

He did not know at the time that the decision would set him on the path to founding Lucid Lane. The company’s mission is to help give patients who have been prescribed medications to address pain and anxiety ways to wean themselves off those drugs and avoid addiction — and its purpose is born from the struggle Asar witnessed as his wife wrestled with how to stop taking the medication she was prescribed during her illness.

Asar’s wife isn’t alone. In 2018, there were roughly 168.2 million prescriptions for opioids written in the United States, according to data from the Centers for Disease Control and Prevention. Lucid Lane estimates that 50 million people are prescribed opioids and another 13 million are prescribed benzodiazepines each year either after surgery or in conjunction with cancer treatments — all without a plan for how to manage or taper the use of these highly addictive medications.

For Asar’s wife, it was the benzodiazepine prescribed as part of her cancer treatment that became an issue. “She was hit by very severe withdrawal symptoms and we didn’t know what was going on,” Asar said. When they consulted her physician he gave the couple two options — quitting cold turkey or remaining on the medication.

“My wife decided to go cold turkey,” Asar said. “It was really debilitating for the whole family.”

It took nine months of therapy and regular consultations with psychiatrists to help with tailoring medication dosages and tapering to get her off of the medication, said Asar. And that experience led to the launch of Lucid Lane.

“Our goal is to prevent and control medication and substance dependence,” Asar said.

The company’s telehealth solution is built on a proprietary treatment protocol meant to provide continuous daily support and interventions, along with proactive monitoring of a personalized treatment plan — all on an ongoing basis, said Asar. 

And the COVID-19 pandemic is only accelerating the need for telehealth services. “COVID-19 has made telehealth a mandatory service instead of a discretionary service,” said Asar. “There’s a surge in anxiety, depression, substance use and medication use. We’re seeing a surge of patients who are reaching out to us.”

Asar sees Lucid Lane’s competitors as companies like Lyra Health and Ginger, or point solutions building digital diagnostics to detect anxiety and depression. But unlike some companies that are launching to treat addiction or addictive behaviors, Asar sees his startup as preventing dependency and addiction.

“A lot of people are sliding into these addictions through something that happens at the doctor’s office,” said Asar. ” Our solution does not prescribe any of these medications.”

The company is working on clinical studies that are set to start at the Palo Alto VA hospital, and has raised $4 million in seed funding from investors including Battery Ventures and AME Cloud Ventures, the investment firm founded by Jerry Yang.

“We see great potential for Lucid Lane, as it has developed a scalable solution to one of the biggest problems facing society today,” said Battery general partner Dharmesh Thakker, in a statement. “Telehealth solutions have emerged as highly capable of addressing complex problems, and Lucid Lane has embraced remote care from its beginning. Its design enables care anytime, anywhere for patients in their moment of need. This can make a tremendous difference in the battle between recovery and relapse. We believe that it will help millions of people lead better lives.”

Joining Asar in the development of the company and its healthcare protocols are a seasoned team of health professionals, including Dr. Ahmed Zaafran, a board certified anesthesiologist at Santa Clara Valley Medical Center and assistant professor of anesthesiology (affiliated) at Stanford University School of Medicine; and advisors like Dr. Vanila Singh, who was also previously chairperson of the HHS Task Force in conjunction with the DOD and the VA to address the opioid drug crisis; Dr. Carin Hagberg, the chair of anesthesiology, perioperative and pain medicine of MD Anderson Cancer Center; and Sherif Zaafran, the president of the Texas Medical Board and chair of multiple national committees on pain management, including the subcommittee Taskforce on Pain Management Services for HHS, as well as the department’s Pain Clinical Pathways Committee.

“Lucid Lane provides a patient-centered solution that allows for the best clinical outcomes for patients after surgery and those bravely finishing chemotherapy,” said Dr. Singh, in a statement. “For the many patients who require short-term opioids and benzodiazepine medications, Lucid Lane’s treatment can limit the risk of prolonged dependence of these medications while also ensuring effective pain control with a resulting improved quality of life and functioning.”

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SkyCell raises $62M for smart containers and analytics to transport pharmaceuticals

While human travel has become severely restricted in recent months, the movement of goods has remained a constant priority — and in some cases, has become even more urgent. Today, a startup out of Switzerland that builds hardware and operates a logistics network designed to transport one item in particular — pharmaceuticals — is announcing a significant round to fuel its growth.

SkyCell — a designer of “smart containers” powered by software to maintain constant conditions for drugs that need to be kept at strict temperatures, humidity levels, and levels of vibration, which are in turn used to transport pharmaceuticals around the globe on behalf of drug companies — is today announcing. that it has raised $62 million in growth funding.

This latest round is being led by healthcare investor MVM Partners, with participation also from family offices, a Swiss insurance company that declined to be named, as well as previous investors the Swiss Entrepreneurs Fund (managed by Credit Suisse and UBS), and the BCGE Bank’s growth fund.

The company was founded in 2012 Switzerland when Richard Ettl and Nico Ros were tasked to design a storage facility for one of the big Swiss pharma giants. The exec charged with overseeing the project brainstormed that the work they were putting in could potentially be applied to transportation containers, and thus SkyCell was born.

Today, Ettl (who is the CEO, while Ros is the CTO), said in an interview that the company now works with eight of the world’s biggest pharmaceutical companies and has been in validation trials with a further seven. These use SkyCell’s network of some 22,000 air freight pallets to move their products around the world.

The new capital will be used to expand that reach further, specifically in the U.S. and Asia, and to double its fleet to become the biggest pharmaceutical transportation company globally. With 30 of the 50 biggest-selling drugs in the world being temperature sensitive (and some generics for one of the biggest-selling, the arthritis medication Humira, now also coming out), this makes for a huge opportunity.

And unsurprisingly, several of SkyCell’s customers are working on COVID-19 medications, Ettl said, either to help ease symptoms or potentially to vaccinate or eradicate the virus, and so it’s standing at the ready to play a role in getting drugs to where they need to be.

“We are well positioned in case there is a vaccine developed. Out of the six pharma companies developing these right now, four of them are our customers, so there is a high likelihood we would transport something,” Ettl said.

For now, he said SkyCell has been involved in helping to transport “supportive” medications related to the outbreak, such as flu shots to make sure people are not falling ill with other viral infections at the same time.

SkyCell is not disclosing its valuation but we understand that it’s in the many hundreds of millions of dollars. The company had raised some $36 million in equity and debt before this, bringing the total outside funding now to $98 million.

In a market that’s estimated to be worth some $2.8 billion annually and growing at a rate of between 15% and 20% each year, there are a number of freight businesses that focus on the transportation of pharmaceuticals. They include not only freight companies but airlines themselves, which often buy in containers from third parties. (And for some more context, one of its competitors, Envirotainer, was acquired for over $1 billion in 2918; while another, CSafe, has raised significantly more funding.)

But there was virtually no innovation in the market, and most pharmaceutical companies factored in failure rates of between 4% and 12% depending on where the drugs were headed.

One key differentiator with SkyCell has been its containers, which are able to withstand temperatures as high as 60 degrees Celsius or as low as negative 10 degrees Celsius, and have tracking on them to better monitor their movements from A to B.

These came to the market at a time when incumbents were only able to (and some still are only able to) guarantee insulation for temperatures as high as 40 degrees, which was not as pressing an issue in the past as it is today, in part because of rising temperatures around the globe, and in part because of the growing sophistication of pharmaceuticals.

“We’ve found that the number of days where [one has to consider] temperature extremes has been going up,” Ettl said. “Last year, we had 30 days where it was warmer than 40 degrees Celsius across our network of countries.”

On top of the containers themselves, SkyCell has built a software platform that taps into the kind of big data analytics that are now part and parcel of how modern companies in the logistics industry work today, in order to optimise movement and best routing for packages.

The conditions it considers include not only the obvious ones around temperature, humidity and vibration, but distance and time of travel, as well as overall carbon emissions. SkyCell claims that its failure rate comes out at less than 0.1%, with CO2 emissions reduced by almost half on a typical shipment.

Together, the hardware and software are covered by some 100 patents, the company says.

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YourChoice Therapeutics is developing unisex, non-hormonal birth control

The options available to women who want to avoid getting pregnant today are bad. Most, like the widely used birth control pill, feed man-made estrogen and progestin hormones to women, which are capable of causing a number of awful side effects.

YourChoice Therapeutics — a startup launched by a team of Berkeley researchers, including two experts in sperm physiology and sperm-egg interactions — dreams of producing a unisex, non-hormonal alternative to existing contraceptives. The company has raised $400,000 in funding to date, plus a $150,000 check from Y Combinator. YourChoice will make its big pitch at Y Combinator Demo Days next week.

It’s seeking $2 million in venture capital funding to continue research on its sperm cell-targeting novel method of contraception, as well as to build out its team of chemists. Founders Akash Bakshi and Nadja Mannowetz tell TechCrunch they plan to have a contraceptive ready to market by 2025. Together, with co-founder and advisor Dr. Polina V. Lishko of Berkeley’s department of cell and molecular biology, they hope to reach women and men all over the world, in the process tapping a market expected to be worth $37 billion by 2023.

“There are perhaps ways that we could cut that time in half or just get something to market,” said Bakshi, YourChoice’s chief executive officer, whose background is in technology commercialization, research and development within the life sciences industry. “But we need to do this right so that we can benefit as many women as possible.”

Their first product will be a vaginal contraceptive to be applied before intercourse, then, the startup plans to release oral contraceptives for both genders. The team has discovered that the natural compound lupeol is capable of blocking a protein on sperm that is required for fertilization. YourChoice‘s non-hormonal approach doesn’t impact a cells’ ability to function or gene expression, so women and men are not at an increased risk of blood clots, cancer or other side effects associated with mainstream birth control methods’ use of added hormones.

“The bottom line is men don’t have good options and women apparently have so many choices, yet they are all really bad,” Mannowetz, a Ph.D. in sperm physiology, told TechCrunch. “They’re all based on that over 60-year-old idea of hormone-based drugs.”

YourChoice’s planned debut product will be applied directly in the vagina during the period of the month in which the woman is fertile. Whether that be a tablet, a gel or some other form factor is still up in the air. YourChoice’s second product will be an oral contraceptive because they believe that is the most convenient, universally accepted method.

“For women who have an implant … I understand that this might be a step backward, but women who have been on the pill for decades, for them, it wouldn’t be a big change,” Mannowetz said. “We totally understand we will not serve every woman out there but we need to get started with a product and then take it from there.”

“If the last 60 years have taught us anything, it’s that delivery is something that can continue to be developed,” she continued. “We need to develop a new mode of action.”

There are a number of startups innovating in the contraception space, as TechCrunch has written, though most of those businesses are focused on the access problem. Birth control can be very difficult for many to access and startups like The Pill Club or Nurx solve that problem by delivering the pill directly to women’s doorsteps. Other early-stage companies in the space lack experts in the field of reproductive biology necessary to improve contraceptive options. YourChoice’s team says seeking change to the actual medication with an advanced team sets them apart from other upstarts.

For YourChoice, it helps that venture capital investment in the reproductive tech space is increasing, making this a great time for YC to support these businesses (YourChoice isn’t the only reproductive tech startup in the latest YC cohort) and for YourChoice to successfully nab private investment.

“I personally think the industry is satisfied; they are making really good money, right? So why should they change anything,” Mannowetz said. “Millennials are the starting point of change happening. I think now, women stand up and say, ‘we are sick of it.’ ”

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BenevolentAI, which uses AI to develop drugs and energy solutions, nabs $115M at $2B valuation

In the ongoing race to build the best and smartest applications that tap into the advances of artificial intelligence, a startup out of London has raised a large round of funding to double down on solving persistent problems in areas like healthcare and energy. BenevolventAI announced today that it has raised $115 million to continue developing its core “AI brain” as well as different arms of the company that are using it specifically to break new ground in drug development and more.

This venture round values the company at $2.1 billion post-money, its founder and executive chairman Ken Mulvaney confirmed to TechCrunch. Investors in this round include previous backer Woodford Investment Management, and while Mulvaney said the company was not disclosing the names of any other investors, he added it was a mix of family offices and some strategic backers, with a majority coming from the U.S., but would not specify any more. Notably, BenevolentAI does not have any backing from more traditional VCs, which more generally have been doubling down on investments in AI startups. Founded in 2013, the company has now raised more than $200 million to date.

The core of BenevolentAI’s business is focused around what Mulvaney describes as a “brain” built by a team of scientists — some of whom are disclosed, and some of whom are not, for competitive reasons; Mulvaney said: There are 155 people working at the startup in all, with 300 projected by the end of this year. The brain has been created to ingest and compute billions of data points in specific areas such as health and material science, to help scientists better determine combinations that might finally solve persistently difficult problems in fields like medicine.

The crux of the issue in a field like drug development, for example, is that even as scientists identify the many permutations and strains of, say, a particular kind of cancer, each of these strains can mutate, and that is before you consider that each mutation might behave completely differently depending on which person develops the mutation.

This is precisely the kind of issue that AI, which is massive computational power and “learning” from previous computations, can help address. (And BenevolventAI is not the only one taking this approach. Specifically in cancer, others include Grail and Paige.AI.)

But even with the speed that AI brings to the table, it’s a very long, long game for BenevolentAI. The division of BenevolentAI that is focused on drugs, called Benevolent Bio, currently has two drugs in more advanced stages of development, Mulvaney said, although neither of those happen to be in the area of cancer. A Parkinson’s drug is currently in Phase 2B clinical trials, after years of work.

And an ALS medication currently in development — which Mulvaney says will aim to significantly extend the prospects for those who have been diagnosed with ALS — is about five years away from trials. It’s worth the effort to try, though: The best ALS medications on the market today at best only add about three months to a patient’s life expectancy.

Some of the long period of development is because with drugs, there is a large regulatory framework a company must go through. “But we benefit from that,” Mulvaney said, “because it means you can actually then offer something in the market.” (Blood tests à la Theranos are very different in terms of regulatory requirements, he said.)

In part because of that long cycle, and also because BenevolentAI has spotted an adjacent opportunity, the company has more recently also been extending applications from its “brain” to other adjacent areas that also tap into chemistry and biology, such as material science.

One area Mulvaney said is of particular interest is to see if Benevolent can create materials that can both withstand extreme heat — to allow engines to work at higher rates without risks — as well as chemicals that could essentially create the next generation of efficient batteries that could provide more power in smaller formats for longer periods.

“There has been little development beyond a lithium-ion battery,” he noted, which may be fine for the Teslas of the world today. “But there is not enough lithium on this planet for us all to go electric, and there is not nearly enough energy density there unless you have thousands of batteries working together. We need other technology to provide more energy donation. That tech doesn’t exist yet because chemically it’s very difficult to do that.” And that spells opportunity for BenevolentAI.

Other areas where the startup hopes to move into over the coming months and years include agriculture, veterinary science, and other categories that sit alongside those BenevolentAI is already tapping.

 

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