Suliman anticipates filing an Investigational New Drug application with the FDA for the PCD asset this year, and next year filing one for the cystic fibrosis asset.
ReCode CEO Dr. Shehnaaz Suliman/courtesy ReCode Therapeutics
As a physician treating HIV patients in South Africa, Shehnaaz Suliman, M.D. saw numerous patients from the poorest sectors of the nation lose their battle with the deadly infectious disease due to a lack of access to therapeutics. Knowing how the outcome for many of those patients could have been different, Suliman was driven to enter the drug development field in order to ensure broader access to life-saving treatments.
That was more than 25 years ago. Her industry road took her to companies such as Gilead Sciences, a leader in HIV therapies, Genentech, Theravance, and most recently, Alector, LLC, where she served as president and chief operating officer. Today, she stands atop her field as the newest chief executive officer of ReCode Therapeutics, a company developing mRNA-based medications for pulmonary diseases. Although she has quickly risen through the ranks of the industry, Suliman has never forgotten that sense of justice and the desire to do the right thing for all patients, regardless of their economic situation.
And it’s that desire to do the right thing that drew her to ReCode, a company on the cusp of developing innovative, lifelong therapeutics for inherited genetic disorders of the lungs such as cystic fibrosis and primary ciliary dyskinesia (PCD) through its proprietary lipid nanoparticle (LNP) delivery platform. At ReCode, Suliman said she found a company filled with people who are both passionate about their work and compassionate about the patient population they serve.
“The LNP platform opens a world of possibilities,” Suliman told BioSpace in an interview about a week after taking the helm from David Lockhart, who has transitioned into the role of president and chief scientific officer. “There is vast untapped potential in RNA medicines and the delivery of genetic payloads to modify and potentially remedy a wide variety of life-limiting diseases.”
As Lockhart explained in a previous interview, ReCode’s exclusive LNP platform can be used to safely and accurately carry a wide range of therapeutic payloads into the body, including mRNA, DNA and CRISPR. ReCode’s LNP platform is dubbed SORT, which stands for selective organ targeting. The name captures the platform’s ability to hone in on a target without compromising the liver or other organs. Additionally, ReCode’s LNP platform has no strict size limitations, nor does it have protein or viral components, which means it can be re-administered. Adding her own thoughts to the LNP platform, Suliman said there is a sense of vast potential in transforming serious diseases.
“It’s still early days, but it’s so exciting about the potential of what can be done with the platform,” Suliman said.
ReCode’s therapies are showing potential in preclinical assessments. Over the past summer, the company posted preclinical data for its cystic fibrosis candidate. Data from that study showed that ReCode’s LNP program is able to deliver a fibrosis transmembrane conductance regulator (CFTR) mRNA drug that can restore CFTR function in the CF patient-derived hBE cell model.
The company is also seeing potential with its inhaled mRNA-based program aimed at PCD. Data showed ReCode’s LNP platform was able to successfully deliver DNA/1 mRNA directly to the lungs in order to target human bronchial epithelial (hBE) cells in animal models.
With the preclinical data available, Suliman now aims to drive ReCode’s products into the clinic. She anticipates filing an Investigational New Drug application with the U.S. Food and Drug Administration (FDA) for the PCD asset this year, and next year filing one for the cystic fibrosis asset.
“If we can prove that we can fundamentally correct the mutations in CD and PCD, the transformative potential of the platform becomes more real,” she said, adding that getting these medications to patients will be at the forefront of her thoughts.
Suliman said her industry experience will play a key role in ReCode’s clinical validation of its LNP platform. Calling it her “sweet spot,” Suliman said at Genentech and other companies, she oversaw the early development of multiple portfolio assets, from discovery through Phase II development.
In the coming days and weeks, Suliman will look at ways to appropriately scale the company to ensure a strong infrastructure and to maximize the potential of the platform. Following the $80 million Series B financing round last year, the company has sufficient funding through 2023, but maintaining a sure financial footing is also at the forefront of her mind.
Additionally, Suliman said she is excited about potential collaborations with larger pharmaceutical companies that are taking heed of the company’s preclinical successes. She said ReCode has “phenomenal inbound interest” that could yield multiple strategic partnerships around its LNP platform.
“There is a myriad of deal options that could be done. Each will be relevant strategically at a different point in the company’s life cycle. I’m feeling tremendously encouraged that we can sustain ourselves quite comfortably through strategic partnering,” she said.
As she settles into her new role, Suliman said she will lean on Lockhart, her predecessor who has a skillset complementary to her own. Having him remain with the company was critical to her decision to join ReCode, she said. With Lockhart remaining, it allowed her to hit the ground running and rapidly align with the mission and values of the company, Suliman added.
She noted that her taking over as CEO of a pharmaceutical company is also an important achievement for diversity. She said there is a groundswell of momentum for representation but noted that there is a need for more diverse leaders.
“Patients need to see people running companies that look like them. We’re all here to make a difference,” she said. “That’s never been more true and salient for me in my life. I’m always going to be a champion for the poorest of the poor. I understand what that looks and feels like.”
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