Launching a Biotech in 2020: 3 Challenges Faced, and 3 Avoided

Common sense would say that during a global pandemic is not the best time to launch a biotech company – and it certainly wasn’t a deliberate part of our plans!

The theme of 2020 has been facing and overcoming adversity on every level – organization, industry, and personal. However, in retrospect, Elevation Oncology has actually been well positioned to sidestep some of the challenges we originally expected to face once COVID-19 became our everyday reality.

To round out our launch year, I’d like to share 3 challenges we faced, and 3 challenges we anticipated, but largely avoided.

Launching a company, a clinical study, and a collaborative network

First, a quick look back at the launch of Elevation Oncology:

We publicly emerged on July 21, 2020 following a series A financing of $32.5 million in 2019 led by Aisling Capital, Vertex Ventures HC, Qiming Venture Partners USA, Driehaus Capital Management, and BVF Partners, and a year in stealth. Alongside the corporate launch, we launched the CRESTONE study, a Phase 2 clinical trial in solid tumors with NRG1 fusions with registrational intent via an accelerated approval pathway.

Notably, CRESTONE is designed as a tumor-agnostic basket study exploring seribantumab (a HER3 monoclonal antibody) as a targeted therapy for any solid tumor harboring an NRG1 fusion. That same day, we also announced four diagnostic collaborations enabling accelerated identification and enrollment of patients with these rare genomically-defined tumors.


3 Challenges Faced

Challenge #1: COVID-19 drove a shift in investor focus

When COVID-19 hit, it inevitably caught companies at widely differing financing and runway scenarios. Investors were understandably anxious to know whether their investments would be able to navigate the changing landscape.

As a venture-backed company, our investors wanted to know what specific challenges we anticipated, how we would keep to our timelines, and, should the situation worsen, what budget levers would we be able to pull to allow us to extend our cash runway.

I can’t stress enough how important it is to understand your budget and have a clear view of the options at your disposal for managing cashflow. If there are operational delays, such as at the clinical site level, what can you delay or reduce?

Typical options for biotech companies include:

  • Chemistry, manufacturing and controls (CMC) – If projections for trial enrollment or prescription are changing, rethink your manufacturing needs.
  • Clinical trial startup – Consider the potential to delay opening sites.
  • Overheads and personnel – Review whether there are any cost savings to be made. Here, we found it particularly advantageous to be a virtual company by design.

For Elevation Oncology, the biggest impact was a short-term deviation in focus from full-on launch planning to accommodate an ad hoc budget review. While we ultimately did not need to pull the majority of our budget levers, the exercise itself has been invaluable for ongoing strategic planning.


Challenge #2: Working with extended CMO timelines

COVID-19 had a significant impact on manufacturing and the global supply chain in every industry.

Under normal conditions, drug manufacturing campaigns could typically be scheduled 9-12 months in advance. However, manufacturing organizations are saturated and with COVID-related manufacturing taking precedent, manufacturing slots are filling up fast. We’re seeing increased lead times across the industry and would encourage companies to plan 12-24 months in advance.

In addition, it’s not just manufacturing slots that are in short supply. Sourcing raw materials, reagents, and even packaging has become a significant bottleneck. Companies would be wise to proactively stock up on materials that you anticipate using in the next few years (don’t hoard!), no matter how mundane.

For example, Elevation has recently pre-purchased all of the plastic bags used in drug product fill that will be needed for our manufacturing runs over the next few years. They definitely were not top of mind items, but it turns out a shortage would have significantly impacted our production capabilities and may have even hindered our ability to move forward with the planned vial size! Getting ahead of this domino effect is crucial.


Challenge #3: Extended FDA timelines

When the pandemic struck, the FDA was inundated with COVID-19-related requests (new drug trials, vaccines, etc.), putting considerable strain on their resources.

Following our Type C meeting in December 2019, we had been expecting responses from the FDA within 30 days. However, most responses were instead taking the full allotted 60 days – not because the FDA didn’t recognize that we were addressing an unmet need, but because industry demand was causing significant delays.

Going forward, I believe it’s inevitable that such delays will continue as more vaccines and therapies come into play. As such, we must expect delays, be accommodating and make plans accordingly.

Use any delays to consider activities that can be undertaken in parallel to add value to your program. For example, during the delays we encountered, we turned our focus to finalizing more diagnostic partnerships to aid identification of potential NRG1-fusion positive patients for our CRESTONE study.


3 Challenges Avoided

One of the most interesting realizations as we reflect on 2020 is the emergence of “non” challenges: expected problems that were greatly anticipated, but actually turned out to have minimal impact on our existing operations.

(Non) Challenge #1: A virtual operation

The COVID-19 pandemic brought a move to virtual operations across many industries, with employees working from home wherever possible. While this was a new way of working for many, Elevation Oncology had been virtual from the start and we have no near-term plans to establish a physical headquarters until things have improved around the COVID-19 pandemic.

By operating without a physical office, not only is overhead reduced, but operations are not restricted to a particular location. This has made it easier to build out our team and to draw on a much broader pool of talent to find the best people. When consultants are brought in to support the team, we find that a fully virtual environment also helps to minimize the cultural divide. We have seen strong engagement and ownership throughout our team, whether FTE or consultant.

In building a strong virtual culture, frequent and intentional communication is more important than ever. Clear, consistent digital communications can be just as effective as in-person interactions for building credibility and alignment both internally and externally.

In addition, the little notes that may have seemed like over-communication before are now invaluable tools for communicating recognition and appreciation. When you don’t have personal interactions to fall back on, a simple e-mailed “thank you” in response goes a long way in building goodwill and comradery.

The flip side of this new virtual world is that companies who incorporate ‘old school’ approaches may actually stand out. To cut through the monotony of virtual SIVs and update meetings, we have continued to produce printed materials for our clinical trial sites, providing tangible educational resources for our staff during set up and on-hand materials to share with patients.

Today, it is totally viable to run a completely virtual biotech in particular if you don’t have a need for lab space. Our initial virtual approach turned out to be a very prescient decision and as the COVID-19 pandemic continues to play out, we have no need or immediate plans to acquire a physical headquarters.


(Non) Challenge #2: Delays in clinical site activation

Delays in clinical site activation were a primary concern and driver in our budget review. The fact that this was ultimately a non-challenge for us, I believe, demonstrates the value of focusing on truly unmet clinical needs and developing something that has the ability to be best in class, a real game changer.

There have clearly been clinical trial delays across the industry, and investigators are having to prioritize studies. Early Phase 1 trials using low therapeutic doses where patients are unlikely to see a benefit or where any potential benefits are incremental are likely to be de-prioritized. However, we are seeing that investigators are not slowing down for novel therapies with robust scientific rationale in particular in genomically-defined patient populations.

Because of this, we have seen minimal delays in site activation for our CRESTONE study. The current unmet clinical need for NRG1 fusion patients, combined with a well-designed trial based on a genomically-defined population with no other treatment options, has driven investigators to prioritize the CRESTONE study ahead of others.

When setting up a trial, we would advocate for the selection of good partners and respecting their drive and commitment. Where people are dedicated, they will find ways to make the work happen.


(Non) Challenge #3: Slowdown in patient enrollment

It’s important to recognize that patients with cancer always need hope, regardless of what else is going on in the world. While there has been a drastic decrease in preventative and elective procedures, patients with aggressive tumors do not have the option of putting their treatment on hold.

In our CRESTONE study, patient enrollment has progressed as projected. Even though NRG1 fusion positive tumors are extremely rare, patients are proactively finding us in the hope of joining the trial.

Once an eligible patient is identified, it is our job to find ways to meet our patients where they are. While the pandemic setting has not decreased the drive for patients to find solutions, we have seen an increased reluctance to travel, even with travel support.

This is why we have partnered with a number of leading diagnostic providers to enable a ‘Just-in-time’ site activation model. This allows us to quickly open up a new clinical trial site either directly at or near the location of an eligible patient that has been diagnosed, most often within 14 days.

This model is not only an operational innovation to more efficiently identify and enroll patients, it has become a crucial, precedence setting differentiator among precision oncology companies. Listening to our patients’ needs has opened up a new path forward, allowing us to bring the CRESTONE study directly to our patients.


Top Tips

So, what are our top tips having launched a biotech amid a global pandemic?

  • Find ways to meet your patients and partners where they are: everyone is adapting and looking for ways to move forward
  • Invest in scientific integrity: there is decreased tolerance at every level for activities with a low return on investment (ROI)
  • Plan (way) ahead – particularly on your CMC timelines
  • There is no better time to innovate. Everyone is rethinking the status quo. If you ever wanted to try doing something differently, now is the moment.
  • The biotech engine hasn’t stopped, it’s only accelerating. There is no need to wait for a ‘better time’ to launch a biotech company.

Looking Ahead to 2021

While this year has been tough, it has also been exciting and rewarding. Despite the challenges, we were still able to successfully launch Elevation Oncology and immediately follow up with meeting a number of key operational milestones. Notably, we announced a fifth partnership with US Oncology Research, expanding the reach of CRESTONE to more than 600 clinical sites nationwide while only carrying the site overhead for a fraction of those sites given the innovative operational model we have put in place. We embraced the virtual meeting format to release our first data presentation at ENA 2020 showcasing novel preclinical results that support our scientific rationale for the Phase 2 CRESTONE study. And, we most recently secured $65 million in our Series B crossover financing, led by new investors venBio and Cormorant.

As we look ahead to 2021, we will continue to adapt and face challenges head on. We anticipate sharing the first clinical results from the CRESTONE study, and are constantly evaluating opportunities to acquire additional products or form strategic partnerships.

So, I would encourage you to follow your passion, innovate and focus on delivering value for patients. Even in the midst of uncertainty, the importance of our mission has not, and will not change.

With best wishes for a successful and prosperous 2021,

Shawn


This article was originally published on LinkedIn. Follow us on our journey to #ElevatePrecisionMedicine.