Niven R. Narain, PhD, President and CEO of BPGbio

After investing around $400 million to develop its artificial intelligence (AI)-based platform and the company formed to commercialize it, Berg has placed its drug and diagnostic pipelines in the hands of an investor group that has completed its purchase of the 14-year-old company.

BPGbio will not disclose how much it paid for privately-held Berg or other financial details of the deal. BPGbio is chaired by the investor group’s leader and key funder Daniel Elliott, managing partner of private equity group Phoenix Genesis.

But in an interview with GEN Edge, BPGbio’s president and CEO Niven R. Narain, PhD—a co-founder of Berg and its former CEO—said BPGbio plans to build upon at least some of Berg’s operations while exploring whether and how to partner some of the acquired company’s assets.

Those assets begin with the Berg-developed Interrogative Biology® platform, which gathers multi-omics data from the company’s biobank of more than 100,000 samples, then uses proprietary AI software and the Frontier supercomputer at Oak Ridge National Laboratory and its peak performance of 1.6 exaflops to generate insights to be applied in clinical trials.

In a commentary published by GEN last year, Narain wrote about how AI held the potential to catalyze drug discovery for some of the most challenging and debilitating diseases. “Beyond understanding our biology, we need to use all the weapons at our disposal, and one of our best is artificial intelligence.”

Berg had assembled a portfolio of more than 400 U.S. and international granted and pending patents as it has worked to apply the platform to develop its pipeline of drug candidates. BPGbio’s drug pipeline is led by BPM 31510, an intravenous formulation of ubidecarenone (coenzyme Q10) being developed for pancreatic cancer and several other cancers. BPM 31510 targets metabolism in cancer cells by re-engaging the mitochondria to generate energy, shifting metabolism to that observed in the normal cell. According to BPGbio, BPM31510 results in the reactivation of pathways that detect cell damage, triggering apoptosis.

In pancreatic cancer, BPM 31510 has completed a 49-patient Phase II open-label, non-randomized trial (NCT02650804) that examined the drug’s safety and effectiveness in advanced pancreatic cancer patients as second- or third-line therapy. Patients received continuous intravenous (IV) infusion of BPM 31510 over 144-hours (two 72-hour 110mg/Kg doses) in combination with gemcitabine.

Assessing commercial plan

“We’re in the process of reviewing our end of Phase II data and assessing what would be our commercial plan on pancreatic cancer, either to partner out, or also to look at the right type of phase III plan,” Narain said.

BPM 31510 is also in development for:

  • Glioblastoma multiforme in a non-randomized, open-label Phase II trial (NCT04752813) assessing the drug with radiation therapy, concurrent temozolomide (TMZ) chemotherapy, and Vitamin K1, led by researchers at Stanford Medicine. BPGbio wants to expand the number of sites in that trial, both within the U.S. as well as in Europe and the U.K.
  • Epidermolysis Bullosa (EB), specifically wound healing management in EB patients, through a topical (3.0% cream) version of BPM 31510 for which the company is assessing investigators, CROs, and sites for a late-stage trial planned to start later this year. BPGbio said a Phase I study (NCT02793960) showed the treatment to be well tolerated and also potentially effective, having shown initial proof of concept for preventing hair loss by stopping the anagen phase of the hair follicle.
  • Sarcopenia induced by chemotherapy, the indication of an oral version of BPM 31510 which BPGbio plans to advance into a Phase II trial set to recruit 40 patients between ages 65-90. The company will also use its Interrogative Biology platform to assess biomarker changes associated with treatment in both muscle and blood samples. Oral BPM 31510 showed safety and tolerability in a Phase I study in volunteers.

The FDA in 2018 granted its orphan drug designation to BPM 31510 in pancreatic cancer and EB.

Also in BPGbio’s pipeline is BPM 31543, a topical formulation of calcitriol that is indicated for alopecia associated with chemotherapy and other cancer treatments. BPM 31543 has completed a Phase I trial (NCT01588522) where it showed safety and tolerability.

“What we have seen in Phase I is that the asset is well tolerated, but in a significant percentage of women it was able to significantly reduce the hair loss in women who were using taxane-inducing chemotherapy. So we’re going to be assessing how we deal with that asset and really exciting on a pipeline,” Narain said.

As part of its deal for BERG, BPGbio has also inherited Berg’s preclinical pipeline. It includes BRG-399 for solid and liquid tumors; as well as candidates for Parkinson’s disease and Huntington’s disease—the latter receiving the FDA’s orphan drug designation.

Avoiding failed approaches

BPGbio says its Parkinson’s and Huntington’s candidates will avoid approaches that have largely failed; published review articles have pegged the success rate of clinical trials for Parkinson’s drugs at 14.9% and Huntington’s, at just 3.5%.

The approach that we’re taking is not one that would just go after comorbidities or extraneous components,” Narain said. “The approach that BPGbio wants to take is to use our platform to find novel biological trigger points in in the disease areas, and then use that disease biology understanding, then, to pro offer the right types of chemical modalities.”

BPGbio also inherited form Berg its pipeline of diagnostic candidates, most indicated for the same diseases as the company’s drugs, and measuring biomarkers gleaned from the Interrogative Biology platform. A prostate cancer diagnostic designed to distinguish between the disease and benign prostate hyperplasia (BPH) has achieved clinical validation.

BPGbio said it plans to fund commercial acceleration of the prostate cancer diagnostic, as well as several diagnostic candidates now pursuing clinical validation in pancreatic cancer, Parkinson’s, and breast cancer. A liver cancer diagnostic is in discovery phases.

Based in Framingham, MA, Berg is named for its founder, real estate investor Carl Berg, who sought to build biopharma’s first fully integrated AI and patient biology platform years before AI was widely used in drug development. Berg founded his namesake company in 2009; four years later he made the Forbes 400 list of top billionaires.

With its acquisition of Berg, BPGbio has grown to 40 people. Narain said executives from the combined company will soon meet to decide how many more people to add to its headcount, though he added: “I will say it’s going to be supportive towards enabling the expansion of the impact of the platform.”

“[BPGbio] has been supportive of really hiring around the commercial and finance groups, but also to fill in key scientific and clinical roles,” he added.

Narain said the deal had been in the works since the late summer. BPGbio persuaded Berg’s board and members of the Berg family that the investor group could best advance Berg’s drug and diagnostic pipelines through clinical trials, as well as build financial and commercial operations strong enough to create the most value for those products, whether by continuing to develop them, partnering them, or selling them off.

“We have been sitting on some really unique insights on the biology of cancer, on neurological diseases, on rare diseases and inflammation. We wanted to see who would be committed to taking the science to the next chapter.”

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