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IPOs abound in the time of coronavirus, as Forma Therapeutics pencils in $150M Nasdaq debut

IPOs abound in the time of coronavirus, as Forma Therapeutics pencils in $150M Nasdaq debut

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The IPO engine is thriving, never mind the rampage of the coronavirus crisis on R&D timelines.

On Friday, along with synthetic lethality-focused biotech Repare Therapeutics, another Bristol Myers partner Forma Therapeutics also unveiled its plans to vault on to the Nasdaq — penciling in a target of $150 million.

Frank Lee

The Watertown, Massachusetts-based company — which poached senior Genentech executive Frank Lee to take over the reins last year after more than a decade under founder Steve Tregay — raised a plump $100 million late last year, while shepherding its sickle cell disease (SCD) drug through an early-stage trial.

Last November, the FDA ushered in the approval of two SCD therapies, injecting some optimism into an otherwise barren treatment landscape for patients with the blood disorder that is characterized by atypical hemoglobin molecules, which can distort red blood cells into a sickle, or crescent, shape. Novartis’ therapy, Adakveo, is designed to prevent periodic episodes of searing pain called vaso-occlusive crises (VOCs) that deprive the deprive the body of oxygen-rich blood, while Global Blood Therapeutics’ voxelotor is designed to work by increasing hemoglobin’s affinity for oxygen.

Instead of addressing symptoms of SCD, Forma’s lead therapy, FT-4202, is designed to change the course of the disease as an activator of the enzyme pyruvate kinase-R (PKR) to improve red blood cell metabolism, function and survival, potentially resulting in both increased hemoglobin levels and fewer VOCs. Forma is in a crowded field of therapies in development, with other drugmakers including bluebird bio, Imara, and partners CRISPR Therapeutics and Vertex, also working on their own drugs.

Meanwhile, Forma also plans to evaluate the use of FT-4202 in beta thalassemia. The company also has a brimming pipeline, including an AML drug and a NASH therapy in mid-stage development, as well as earlier-stage compounds for NASH, NHL (partnered with Bristol Myers Squibb)  and solid tumors (in collaboration with Boehringer Ingelheim).

There has been a flurry of biopharma IPO’s in recently — Generation Bio, Avidity and Vaxcyte set their sights on a combined $325 million and the week before ADC Therapeutics raked in $233 million in an upsized offering — despite the general pandemonium on Wall Street due to Covid-19. But the life sciences sector has emerged largely immune from the rout.

Sweden’s Calliditas, which last week said it was eyeing a $75 million raise (a modest sum compared to some of the splashier public debuts seen in recent weeks), on Monday indicated it was commencing an investor roadshow. The company, which is developing a therapy for an orphan kidney disease, already has a Swedish listing.

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Spread & Containment

Industry groups call to block WTO IP waiver expansion to Covid-19 therapeutics

The WTO’s TRIPS Council in mid-October is expected to debate whether to extend the IP waiver for Covid-19 vaccines to therapeutics and diagnostics too.
While…

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The WTO’s TRIPS Council in mid-October is expected to debate whether to extend the IP waiver for Covid-19 vaccines to therapeutics and diagnostics too.

While the Biden administration backed the original vaccine waiver, which critics note has not done much to expand access to vaccines as demand has dried up, US trade officials haven’t offered any perspective yet on whether to expand the waiver to Covid treatments.

The US Chamber of Commerce, as well as industry groups BIO and EFPIA, this week expressed “strong opposition” to any expansion of the WTO TRIPS waiver to therapeutics or diagnostics, arguing that waived IP protections damage the nation’s ability to innovate and compete.

Kevin O’Connor

Illinois-based IP attorney Kevin O’Connor at Neal, Gerber & Eisenberg told Endpoints News in a phone interview that he doesn’t think the vaccine waiver has done much so far.

“I don’t think it was the right solution for a demand problem,” O’Connor said. And an extension to therapeutics “would double down” on the same concept, except small molecule manufacturing is more straightforward than vaccine manufacturing. There’s also the question of whether there is a need for an extension given the voluntary licensing already in place.

BIO also noted that the expansion of a TRIPS waiver to therapeutics can create problems for therapeutics used for other indications too as these other indications “may be their only path to financial viability and sustained investment to fund future R&D initiatives.”

The industry group also noted the lack of a “supply and demand challenge globally that justifies the extension of an IP waiver” considering the fact that manufacturers are supplying therapeutics at a rate that outpaces demand.

The US Chamber of Commerce also noted that in the case of Covid-19 vaccine IP, “the waiver’s realization came long after its ostensible purpose was mooted by a large and growing surplus of COVID-19 vaccine supplies.”

Peter Maybarduk

But Public Citizen’s Peter Maybarduk told Endpoints these are “specious arguments and scare tactics,” adding, “Pharma is worried and that is a good thing for people.”

WTO members and developing countries pledged support for the waiver extension last summer, according to a read out of a meeting. Some even called for this extension to be discussed “with a sense of urgency given the fact that many least developed countries (LDCs) lack access to life-saving drugs and testing therapeutics.”

But other member countries “cautioned that more time was needed to conduct domestic consultations on a possible extension of the waiver to therapeutics and diagnostics” while:

Some members also flagged the importance of an evidence-based negotiation as there was no evidence that intellectual property did indeed constitute a barrier to accessing COVID-19 vaccines. Some also reiterated the need for members to fully make use of all the flexibilities that already exist in the TRIPS Agreement (including compulsory licensing) before requesting new flexibilities.

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Economics

Covid-19 roundup: Swiss biotech halts in-patient PhII study; Houston-based vaccine and Chinese mRNA shot nab EUAs in Indonesia

Another Covid-19 study is hitting the breaks as a Swiss biotech is pausing its Phase II trial in patients hospitalized with Covid-19.
Kinarus Therapeutics…

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Another Covid-19 study is hitting the breaks as a Swiss biotech is pausing its Phase II trial in patients hospitalized with Covid-19.

Kinarus Therapeutics announced on Friday that the Data and Safety Monitoring Board (DSMB) has reviewed the company’s Phase II study for its candidate KIN001 and has recommended that the study be stopped.

According to Kinarus, the DSMB stated that there was a low probability to show statistically significant results as the number of Covid-19 patients that are in the hospital is lower than at other points in the pandemic.

Thierry Fumeaux

“As many of our peers have learned since the beginning of the pandemic, it has become challenging to show the impact of therapeutic intervention at the current pandemic stage, given the disease characteristics in Covid-19 patients with severe disease. Moreover, there are also now relatively smaller numbers of patients that meet enrollment criteria, since fewer patients require hospitalization, in contrast to the situation earlier in the pandemic,” said Thierry Fumeaux, Kinarus CMO, in a statement.

Fumeaux continued to state that the drug will still be investigated in ambulatory Covid-19 patients who are not hospitalized, with the goal of reducing recovery time and the severity of the virus.

The KIN001 candidate is a combination of the small molecule inhibitor pamapimod and pioglitazone, which is currently used to treat type 2 diabetes.

The news has put a dampener on the company’s stock price $KNRS.SW, which is down 22% since opening on Friday.

Houston-developed vaccine and Chinese mRNA shot win EUAs in Indonesia

While Moderna and Pfizer/BioNTech’s mRNA shots to counter Covid-19 have dominated supplies worldwide, a Chinese-based mRNA developer and IndoVac, a recombinant protein-based vaccine, was created and engineered in Houston, Texas by the Texas Children’s Hospital Center for Vaccine Development  vaccine is finally ready to head to another nation.

Walvax and Suzhou Abogen’s mRNA vaccine, dubbed AWcorna, has been approved for emergency use for adults 18 and over by the Indonesian Food and Drug Authority.

Li Yunchun

“This is the first step, and we are hoping to see more families across the country and the rest of the globe protected, which is a shared goal for us all,” said Walvax Chairman Li Yunchun, in a statement.

According to Walvax, the vaccine is 83% effective against the “wild-type” of SARS-CoV-2 infection with the strength against the Omicron variants standing at around 71%. The shots are also not required to be stored in deep freeze conditions and can be put in storage at 2 to 8 degrees Celsius.

Walvax and Abogen have been making progress on their mRNA vaccine for a while. Last year, Abogen received a massive amount of funding as it was moving the candidate forward.

However, while the candidate is moving forward overseas, it’s still finding itself stuck in regulatory approval in China. According to a report from BNN Bloomberg, China has not approved any mRNA vaccines for domestic usage.

Meanwhile, PT Bio Farma, the holding company for state-owned pharma companies in Indonesia, is prepping to make 20 million doses of the IndoVac COVID-19 vaccine this year and 100 million doses by 2024.

IndoVac’s primary series vaccines include nearly 80% of locally sourced content. Indonesia is seeking Halal Certification for the vaccine since no animal cells or products were used in the production of the vaccine. IndoVac successfully completed an audit from the Indonesian Ulema Council Food and Drug Analysis Agency, and the Halal Certification Agency of the Religious Affairs Ministry is expected to grant their approval soon.

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Science

Frontiers Health Steering Committee spotlight: Eugene Borukhovich

With Frontiers Health 2022 mere weeks away, we continue to interview members of the steering committee, gaining insight
The post Frontiers Health Steering…

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With Frontiers Health 2022 mere weeks away, we continue to interview members of the steering committee, gaining insight into what to expect from Milan. In this latest coverage, pharmaphorum speaks with Eugene Borukhovich.

Formerly global head of digital health at Bayer, these days Borukhovich is travelling the entrepreneurial path, co-founder and COO of YourCoach.Health, together with his wife, Marina, who is also herself a health coach.

Borukhovich has been on such a journey before. Now on his third venture, in fact, he was involved in a start-up doctor rating platform over a decade ago. Borukhovich’s entrepreneurial spirit, it seems, is indeed strong.

“I kind of always joke around that I’m either a recovering executive or a recovering entrepreneur, but I’m always recovering,” he says.

After starting off in the entertainment and finance industries, Borukhovich entered pharmacy benefit management at a time wherein it quickly became clear to him that his skills could be applied to helping people get better – or even reverse disease. Two decades later, “never say never”, but he doesn’t see himself leaving the health industry:

“Notice, I don’t say ‘health care’ because, ultimately, I think we are striving for health, whatever version that is for each of us,” he says. “We really are saying the ‘health industry’ and that is what gets us up in the morning.”

A system for change, humanly

YourCoach.Health styles itself as an operating system for behaviour change, but is not itself classed as a digital therapeutics service. Health and wellness coaches can use the tool to manage their customers, programs, and payments. YourCoach.Health then leverages that technology to identify coaches and convert them to its contractors. Then, there’s the other side:

“On the revenue stream side, our customers are actually digital therapeutic companies, digital healthcare companies; broadly, virtual care companies that want to surround or embed their products into services with health coaching services,” Borukhovich explains. “In one sentence, we’re a tech-enabled health coaching service that is powered by this practice management solution of gig economy coaches.”

An important focus for Borukhovich is not losing sight of the direct impact on individuals that can be made not just by using technology, but also by interacting with the human being behind the technology.

“One of the things we say is that ‘human eye is still better than AI for foreseeable future’,” Borukhovich said. “Now, there’re certain things that can be automated, for sure, but that level of empathy and let’s call it a human touch, whether it’s virtual or physical, does not go away today.”

An agenda of absolute relevance

Borukhovich is hesitant to compare this year’s conference with the 2021 event.

“I don’t know if you ever watch Bachelor or Bachelorette,” he jokes. “My girls watch it, and it’s like, ‘This is the best season yet!’’

But he does admit a considerable excitement about Frontiers Health 2022.

“I think all the topics on the agenda are absolutely relevant,” he says. “We’re expecting many more people than last year, so I think first and foremost is to reconnect with individuals and connect with new ones. From the investment flows and M&A perspective, to the overall digital therapies and tools and how that’s been proceeding beyond the last two or three years – as the FDA got their hands a little bit around the digital therapies and digital therapeutics market – many more are coming to the scene.”

He expects to see many new faces presenting, speaking in panel discussions, and much more:

“That’s where you get the real deal information, right? These events are great on stage, but also in understanding what’s coming next.”

Steering a passion for digital health

Even though YourCoach.Health is US-centred, Borukhovich has been a fan of Frontiers Health from its early days, even when he was a sponsor with Bayer. What ignites his interest is the drive of the individuals to show up at the event.

“You can tell the passion. Honestly, for us it’s just to reconnect. We will be having a session on health coaching on day two of the agenda, to educate the digital health community on the benefits, the science behind it, and kind of generally what health coaching is,” he says. “Our focus is very much on the US market and here we’re just planting seeds and getting to know about the people.”

Addressing key issues in digital health

In the early days of Frontiers Health, discussion often centred on the importance of evidence. From prescribing digital therapies to doctors’ adoption of digital health tools – the key response was always a request for more evidence. And now there’s evidence in ample supply.

“A lot of the protocols, a lot of the procedures, a lot even of the reimbursements and codes have now been established,” Borukhovich says. “It’s really the commercialisation component of this and adoption, and the adoption is trying to figure out for a lot of these digital health companies: what are the right channels?”

Another aspect to consider is scaling.

“Technology can only go so far. Once again, human beings are a key component of our health and care system. It’s not going away any time soon. We all still need the human touch,” he says.

Pandemic legacy

A choice between the two was taken away, however, when COVID-19 struck, and the impacts of the pandemic have been even more far reaching.

“All of a sudden, deals were getting done because there was literally no choice […] If you look at health systems, that had to be done online or even ‘hospital at home’. If we look at insurers, during the kind of peak of the pandemic, insurers were not paying out, so, there was in theory lots of cash saved up for further investments. The impacts of this, as we’ve seen, are insurers are on an acquisition spree at the moment,” Borukhovich says.

“[However], if we look at digital therapeutics companies, with the FDA guidance, many companies released into the wild […] their tools prior to FDA approval, so, there’s a lot of real-world data that was gathered during that time. Now, from a regulatory perspective, people are trying to figure out, does this stay, does it go, how do we advance this, how do we not snap back fully to physical presence?”

Gazing into the crystal ball

While ‘hospital at home’ investments are continuing, Borukhovich has considered even further into the future and thinks it will be a case of blending different mediums.

“If I had a crystal ball, it’s going to be a spectrum,” he says. “I think people are absolutely frustrated about finding the right care, so, a lot of the self-care tools and digital therapies and digital health tools are here to stay.”

“At some point, we need help from others and, honestly, this is where we see health coaching as a kind of preventative service, as the next level from self-paced tools, then going into clinical services, as needed, beyond that. Augmented by technology, but not replaced by technology throughout that process.”

Although YourCoach.Health has done trend predictions in the past, this year the crystal ball has yet to be angled towards 2023:

“Running a business, with your head down: we haven’t gotten there yet,” Borukhovich says. “It’s only September. Happy to come back to that one post-Thanksgiving.”

Or perhaps at Frontiers Health 2022…

Frontiers Health 2022 is to be held on 20th and 21st October at the Palazzo del Ghiaccio in Milan Italy, as well as online. Click here to register.

And check out Eugene’s fireside chat from last year’s event below.

The post Frontiers Health Steering Committee spotlight: Eugene Borukhovich appeared first on .

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