Genetics Update: Q2 2018 in Review

An industry founded deep within people’s genomic makeup, the thriving genetics industry is continuing to prove an interesting ground for investors.

While the genetics industry relies just as heavily on the US Food and Drug Administration (FDA) as other life science companies, it operates a bit differently by having a much stronger reliance on the genomic makeups, often in reliance to diseases.

Over Q2 2018, the genetics industry saw a strong amount of acquisitions, collaborations and study results among other things. On that note, here the Investing News Network (INN) is taking a look back on what happened during the quarter.

Genetics Q2 2018 update: Agreements and collaborations in focus

Often as a method to break into new global markets, with the opportunity to a new range of treatment options, agreements and collaborations were a big focus for genetics companies over Q2. Similar to collaborations, these agreements are generally mutually beneficial for each company involved either to expand development portfolios or the countries in which products are commercialized.

This was the case with HTG Molecular (NASDAQ:HTGM) and private company Firalis, a bioanalytical services and biomarket-based products provider and services.

The two announced a non-exclusive and supply agreement in May, enabling Firalist to commercialize a next‑generation sequencing (NGS)‑based theranostic product and services to predict rheumatoid arthritis patients response to anti‑TNFα therapy. It also enables other research products and services for mRNA, incluindg profiling of inflammatory‑autoimmune disorders.

Wave Life Sciences (NASDAQ:WVE) and private-company Deep Genomics announced a collaboration to discover novel therapies for genetic neuromuscular disorders. This biotech and genetics collaboration is seeking to build a new universe of genetic medicines using Deep Genomics biomedical platform to identify cause-and-effect relationships specific to neuromuscular-related targets.

Deep Genomics is developing an artificial intelligence-powered discovery platform to create new therapeutic targets using a combination of automation, biomedical knowledge and data and machine learning.

Later in the quarter, Ophthotech (NASDAQ:OPHT) entered into a license agreement with the University of Florida Research Foundation and the University of Pennsylvania. Together Ophthotech and the institutions will develop and commercialize a novel adeno-associated virus (AAV) gene therapy product to treat rhodopsin-mediated autosomal dominant retinitis pigmentosa.

This builds and expands Ophthotech’s gene therapy portfolio. The company expects to initiate a Phase 1 clinical trial in early 2020 as per the license agreement.

Genetics Q2 2018 update: Approvals

While diagnostic and genetic drug approvals are some of the biggest highlights for the genetics investing space, clinical trials approved to move onto the next Phase are almost equally celebrated events.

Hemostemix (TSXV:HEM) was among the companies to receive a clinical trial approval. The approval will allow the company to expand its Phase 2 clinical trial for critical limb ischemia (CLI) with ACP-01. The trial already received Health Canada approval.

Back in February the company secured a manufacturing agreement with an FDA current good manufacturing practices certified laboratory in Florida, Aspire Health Sciences, which will be used to manufacture ACP-01 for the Phase 2 trial. In short, this means the company should be ready to start the trial, other than securing trial sites and patient enrollment.

Another company to receive FDA clearance for its trial was Pluristem (NASDAQ:PSTI), which is a company working on placenta-based cell therapy products. The clearance was for its Phase 3 study of PLX-PAD cell therapy to treat muscle injury following surgical repair (arthroplasty) of the hip joint due to fracture.

Pluristem is in discussions with some European countries about to approve this study in Europe and plans to begin patient enrollment in both regions during 2018. In addition, the European Union’s largest research and innovative program, Horizon 2020 granted Pluristem US$8.7 million for the study.

As for FDA drug approvals in the genetics sector, Genentech, a member of the Roche Group (OTCQX:RHHBY) received approval for Rituxan (rituximab) to treat adults with moderate to severe pemphigus vulgaris (PV).

With this approval Rituxan is now approved to treat four autoimmune diseases, it’s also the first biologic therapy for PV.

Genetics Q2 2018 update: IPOs to watch

While there may have not been an abundance of genetics initial public offerings (IPOs) during the quarter, there were still a few that keen investors interested in the space may want to follow.

Translate Bio (NASDAQ:TBIO) priced its initial public offering close to the end of the quarter at US$121.6 million with 9.35 million shares. The company is based on developing clinical-stage messenger RNA (mRNA) therapeutics and a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction.

In Translate Bio’s pipeline there’s two programs for lung indications, the first has a milestone to initiate its Part 1B trial by the end of 2018, where as the second expects to initiate its Phase 1 trial in the first half of 2019 following investigational new drug application approval, by the FDA.

The next genetics IPO was Avrobio (NASDAQ:AVRO), priced at US$99.7 million at US$19.00 a share. The company is working on four programs in its pipeline including Fabry disease, Gaucher disease, Pompe disease and Cystinosis.

Avrobio’s goal for these gene therapy programs is to delivery lasting and meaningful benefits for patients with genetic diseases, by restoring normal gene function and enzyme/protein production.

Another IPO, which took place near the end of Q1, but closed in early Q2 was for Genprex (NASDAQ:GNPX). The IPO was priced at US$5.00 with 192 million shares. This gene therapy company is using a very non-traditional method to treat cancer, based on a novel proprietary technologies platform. The technologies are designed to administer cancer fighting generes by encapsulating them into nanoscale hollow spheres called nanovesicles, which are given to patients intravenously.

The tumor cells then take up the nanovesicles where they express proteins that are missing or found in low quantities. Genprex’s initial product candidate is Oncoprex, an immunogene therapy for non-small lung cancer.

Investor Takeaway

The genetic investing space continues to differ itself by unique technologies and new collaboration efforts to expand. Time may tell where the industry goes, but from the previous quarter it’s the industry is showing no signs of slowing down.

Don’t forget to follow @INN_LifeScience for real-time updates!

Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.