Brad Lon­car­'s AS­CO19 pre­view: 5 big ideas to watch for at the ul­ti­mate can­cer show of the year

Friday marks the beginning of yet another ASCO Annual Meeting. For those of us who follow cancer research closely, this will always be one of the most special times of the year. It is a moment to take stock of the industry’s progress but also consider the challenges ahead. Genomics, advances in antibody engineering, immunotherapy, cell therapy, and other tools are changing how researchers and clinicians think about cancer. The industry’s momentum is unmistakable. At the same time, there will never be a shortage of unmet needs and too many patients are without good treatment options today.

One thing I have noticed a lot when talking with people ahead of this year’s meeting is that many are calling 2019 a down year. It feels like there are not as many weighty presentations as in the past and that the “wow factor” is just plain missing. While there might be some truth to that (ASCO stalwarts Merck and Bristol are not even holding analyst events this year), consider that this might also be a sign that the way companies are presenting data throughout the year is evolving. Perhaps ASCO’s role is as well.

Put simply, there are more medical meetings throughout the year than ever before. They are well attended by the research community and covered so widely by the media that there is less of a reason to hold data for this one big event. We are also living in a real-time era. A good illustration of the changing times is last year’s 1L lung cancer presentations at AACR. Those were probably the most important data releases in oncology in years, yet they were presented at a conference that is known for focusing on preclinical and early stage research. What mattered most to the companies was not the venue but getting the data out in a timely manner.

That is not to say that ASCO’s role is diminished. It will always be the biggest, most esteemed, and frankly best conference of the year. It will also always be the premier venue for clinicians to gather and discuss new trends and best practices with others in the industry. But I do think how data is presented there and the way some of us use ASCO is truly changing, and that’s ok. To me, it is the ultimate big ideas conference. I try to take a macro view and use it as a barometer of how oncology is progressing over the long term and how new treatments might fit in. If you view it that way, I think 2019 is most definitely not a down year.

Below is what I think are five “big ideas” at this year’s conference to look for. I’ll also include some notes afterwards on smaller items that have intrigued me as well. Note: these are things I’m personally interested in and it is definitely not an exhaustive list for the entire conference.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 76,800+ biopharma pros reading Endpoints daily — and it's free.

Ven­ture Cap­i­tal as a Strate­gic Part­ner: Fu­el­ing In­no­va­tion be­yond Fi­nance

The average level of investment required for a biotech start-up to succeed is increasing every year, elevating the pressure even further on venture capital to make smart financial investments. Financial investment alone, however, does not always guarantee that exciting innovations can be transformed into real businesses that make a meaningful difference to patients.

Beyond just capital

At Astellas Venture Management (AVM) – a wholly-owned venture capital organization within Astellas, headquartered in the San Francisco Bay Area – capital is just one of the ingredients we offer to add value to our biotechnology investments and partnerships. We generally take a strategic investor approach for companies in our invested portfolio, providing access to expertise, technology and/or resources in addition to the injection of finance. An equity investment from AVM can include access to Astellas’ research and development (R&D) capabilities and expertise, and a global network of partner academic institutions and biotechnology companies, to help advance and accelerate the start-up’s innovation.

UP­DAT­ED: Ver­tex joins Mer­ck, Pfiz­er — re­vamp­ing multi­bil­lion-dol­lar tri­al strat­e­gy as biotech R&D crum­bles

You can add Pfizer, Merck and — as we found out Friday morning — Vertex to the growing list of pharma giants hitting the pause button on a range of clinical trials. But not everyone in R&D is getting a red light.

Vertex says that it’s doing its best to keep working its pipeline strategy, coming up with a plan “to enable virtual clinic visits and home delivery of study drug to ensure study continuity and medical monitoring, and to facilitate study procedures.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 76,800+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: In­ter­cept, blue­bird and a grow­ing list of biotechs feel the pain as pan­dem­ic man­gles FDA, R&D sched­ules

Around 100 staffers at Boston area hospitals have now tested positive for Covid-19, spotlighting the growing risk that the pandemic will sideline many of the most essential workers in healthcare as caseloads peak in the US and around the globe. With more than 3,400 deaths, Spain has become the latest country to surpass the official death count attributed to the new coronavirus in China, where the outbreak originated. As of Thursday morning, confirmed global cases had crossed 470,000 and the death count eclipsed 21,000.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 76,800+ biopharma pros reading Endpoints daily — and it's free.

Af­ter crit­ics lam­bast­ed Gilead for grab­bing the FDA's spe­cial rare drug sta­tus on remde­sivir, they're giv­ing it back

Two days after Gilead won orphan drug status for remdesivir as a potential treatment for Covid-19, they’re handing it back.

The company was slammed from several sides after Gilead reported that the FDA had come through with the special status, which comes with 7 years of market exclusivity, the waiver of FDA fees and some tax credits as well. Typically, everyone who can get orphan status lands it without much of a fuss, but Democratic presidential candidate Bernie Sanders, Public Citizen and other consumer groups were outraged.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 76,800+ biopharma pros reading Endpoints daily — and it's free.

Mod­er­na CEO Stéphane Ban­cel out­lines a short path for emer­gency use of a coro­n­avirus vac­cine

NIAID director Anthony Fauci has left no doubts that it takes 12 to 18 months to get a new vaccine tested and in commercial use, in the best of circumstances. But in times of a global emergency — like these — maybe there’s another, faster route to follow.

In an SEC filing on Tuesday, Moderna $MRNA staked out a record-setting pathway to getting their mRNA vaccine into the frontline of the healthcare response as early as this fall. The SEC filing notes that CEO Stéphane Bancel told Goldman Sachs that an emergency use approval could allow the vaccine to go to healthcare workers and certain individuals in a matter of months — presumably provided the NIH sees the safety and efficacy data they would need from the Phase I.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 76,800+ biopharma pros reading Endpoints daily — and it's free.

Caught in a Covid-19 mael­strom, Eli Lil­ly locks down clin­i­cal tri­als as multi­bil­lion-dol­lar R&D ops de­rail

The Covid-19 pandemic has derailed Eli Lilly’s $6 billion R&D operations.

The pharma giant reported Monday morning that it has decided to hit the brakes on most new study starts and pause enrollment for most ongoing studies. Lilly adds that it is continuing dosing for ongoing studies, “but with study-by-study consideration.”

The pandemic has severely disrupted healthcare systems around the globe, says Lilly, making it difficult or impossible to conduct studies at many research sites. And there’s no timeline for when it expects to get back on track.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 76,800+ biopharma pros reading Endpoints daily — and it's free.

As share buy­backs come un­der scruti­ny, what's in store for the bio­phar­ma in­dus­try?

Stock buybacks are not to be permitted for companies that will be bailed out in the coronavirus stimulus package, Congressional leaders have signaled. To what degree the biopharma industry has relied on buybacks for earnings growth in recent years, and if the trend continues, are the big questions as scrutiny into the practice heightens and balance sheets weaken with the coronavirus pandemic wreaking havoc on global economies.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 76,800+ biopharma pros reading Endpoints daily — and it's free.

A Sin­ga­pore VC rais­es $200M for a new round, but will Covid-19 pre­vent it from rais­ing the rest?

A top Singaporean biotech venture fund is nearly halfway toward its largest ever fund, but in a sign of what could be in store for VCs amid a global economic freeze, said they could face headwinds raising the other half.

Vickers Venture Partners has secured $200 million out of a targeted $500 million for its 6th fund, first announced in early 2018. They’ve given themselves 13 months to complete the financing, Vickers founder Finian Tan told Deal Street Asia, but the financial frost settling amid the Covid-19 pandemic could slow efforts.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 76,800+ biopharma pros reading Endpoints daily — and it's free.

Strug­gling Unum ex­ecs are ready to con­sid­er a sale, merg­er or any deal that comes its way

Unum $UMRX is working its way through a survival plan of sorts.

After getting hit with a trio of FDA holds in its brief public history and triggering its second pivot to a new lead drug program while laying off 60% of the staff, the troubled penny stock biotech Unum Therapeutics has hatched new plans to secure financial backing while lining up a go-forward strategy for the company.

First, Lincoln Park Capital Fund has agreed to buy up to $25 million of the long-suffering stock, as Unum directs. And the executive team — led by CEO Chuck Wilson — has put everything on the table for consideration: a sale, acquisition, merger, licensing deal, you name it. The ACTR707 program, meanwhile, is being formally wrapped up — their second failed lead program.