3 Things In Biotech, May 25: A CLL Game Changer

by: Zach Hartman

AbbVie is about to change the CLL game again?

Little Krystal Biotech looks to attack epidermolysis bullosa.

CytomX allowed to unleash its probody drug conjugate on cancer.

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Welcome to another edition of "3 Things In Biotech," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.

AbbVie is about to change the CLL game again?

Company: AbbVie (ABBV) and Johnson & Johnson (JNJ)

Therapy: Ibrutinib

Disease: Chronic lymphocytic leukemia (CLL)

News: ABBV announced the top-line findings from the phase 3 iLLUMINATE study, which assessed the ibrutinib-obinutuzumab compared with chlorambucil-obinutuzumab for untreated CLL. Patients in the study either had to be older (>65 years) or high-risk features precluding standard chemoimmunotherapy. This study met its primary endpoint of progression-free survival improvement, and the companies intend to present or publish these data later this year.

Looking forward: Another coup for ABBV in the CLL space. These data are likely to lead to the first "chemotherapy-free" combination regimen for the disease, making it presumably suitable for patients who cannot take intensive chemotherapy, such as the elderly (in many cases, at least). I look forward to seeing a more complete readout of the data, but you can expect this study to have major consequences for all players, including Roche (OTCQX:RHHBF), which are building up obinutuzumab as an heir apparent to rituximab (read more about that here).

Little Krystal Biotech looks to attack epidermolysis bullosa

Company: Krystal Biotech (KRYS)

Therapy: KB103

Disease: Dystrophic epidermolysis bullosa

News: KRYS announced that the FDA has granted fast track designation to its topical collagen-delivering gene therapy KB103 for the treatment of dystrophic epidermolysis bullosa. This therapy is being explored in a phase 1/2 study at this time, with the intention of assessing safety as well as signs of improved wound healing.

Looking forward: KRYS could very well set itself apart here, since theirs is the first topically delivered gene therapy that I've seen. I will say, though, even with fast track, this has quite a ways to go, and it will be an uphill climb. Still, I'm rooting for it, as this disease can cause serious complications and remains an unmet need. I would keep an eye out for this company as the trial develops, since it could generate a lot of momentum if it finds something encouraging.

CytomX allowed to unleash its probody drug conjugate on cancer

Company: CytomX (CTMX)

Therapy: CX-2029

Disease: Various cancers

News and looking forward: CTMX announced that the FDA has approved its investigational new drug application, allowing the company to move forward with clinical testing of its anti-CD71 probody drug conjugate CX-2029. Probodies are designed to be inactive antibodies until they reach the site of disease, at which time they are processed, bind the tumor target of interest, and deliver a lethal payload, thus combining several principles of cancer therapy at once.

The fact that CTMX is partnered with ABBV on this project gives it some serious legs, and the company realized a $25 million milestone payment upon acceptance of this IND. If successful in early-stage development, ABBV will take over later-stage development and commercialization, providing perhaps as easy a channel as you're going to find in cancer research. Of course, this has also driven a lot of hype, and I would be cautious about buying in just at this time, with current valuation just north of $1 billion for a company still in early stage development.

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