Small biotech — big am­bi­tions. Vi­r­a­lyt­ics’ on­colyt­ics ther­a­py makes the show­case round at #AACR17 with pos­i­tive com­bo snap­shot

PHO­TO: © AACR/Todd Buchanan 2017


WASH­ING­TON, DC — When you talk to Vi­r­a­lyt­ics CEO Mal­colm Mc­Coll, he has a habit of re­mind­ing his lis­ten­ers about just how small his pub­lic Aus­tralian biotech is. Small staff, small stud­ies. And there are just so many things a small biotech can do.

Mal­colm Mc­Coll

But he and his com­pa­ny {ASX: VLA} have some very big am­bi­tions in the hot on­colyt­ics field, build­ing their hopes around a ther­a­py called Cox­sack­ievirus A21 (or CVA21 or Ca­vatak). And to­day the pow­ers that be at AACR are steer­ing their lat­est da­ta in­to the show­case morn­ing round.

At the time of the da­ta cut­off for AACR, the com­pa­ny had evalu­able re­spons­es from 22 pa­tients in a small melanoma study com­bin­ing their ther­a­py — us­ing a non­genet­i­cal­ly al­tered cold virus to in­fect can­cer cells, de­signed to de­stroy them and re­cruit T cells for a fol­lowup at­tack — with Yer­voy.

In­ject­ed di­rect­ly in­to le­sions, re­searchers tracked an over­all re­sponse rate of 50%, with 4 pa­tients reg­is­ter­ing a com­plete re­sponse and 7 pa­tients ex­pe­ri­enc­ing a par­tial re­sponse. The me­di­an du­ra­tion of re­sponse was not yet reached, “with a num­ber of re­spons­es greater than six months and sev­er­al still on­go­ing” — a sig­nal of po­ten­tial dura­bil­i­ty.

Among 11 pa­tients who had dis­ease pro­gres­sion fol­low­ing ear­li­er treat­ment with an im­mune check­point in­hibitor, 4 had a re­sponse. The oth­er 7 re­spon­ders had not been treat­ed ear­li­er with a check­point.

“The pre­lim­i­nary over­all re­sponse rate of 50% is very pos­i­tive be­cause pre­vi­ous re­ports in­di­cate an 11% over­all re­sponse rate for ip­il­i­mum­ab alone and an ap­prox­i­mate­ly 28% over­all re­sponse rate for CVA21 alone,” said Bren­dan Cur­ti, the pri­ma­ry in­ves­ti­ga­tor who runs a melanoma clin­ic in Port­land.

The safe­ty pro­file al­so looked good. Of 25 pa­tients who could be eval­u­at­ed for safe­ty, two had grade 3 or high­er ip­il­i­mum­ab-re­lat­ed ad­verse events. No CVA21-re­lat­ed ad­verse events of grade 3 or high­er were re­port­ed.

The next step, says Mc­Coll, will be to add sev­er­al dozen pa­tients to the study who have failed a check­point ther­a­py and then see if they have the kind of re­sults that can be used to mount a reg­is­tra­tion study.

It’s con­ceiv­able, he says, that reg­u­la­tors could sign off on a sin­gle arm study with a cou­ple of hun­dred pa­tients for that piv­otal try, that’s “some­thing a small Aus­tralian com­pa­ny could take on.”

Vi­r­a­lyt­ics has jumped on to a stage that in­cludes a grow­ing num­ber of on­colyt­ics play­ers, like PsiOxus, which re­cent­ly signed a stand­out $936 mil­lion deal to part­ner with Bris­tol-My­ers, which was al­ready help­ing with a com­bo of Op­di­vo plus their on­colyt­ic virus.

All these com­pa­nies are com­ing in be­hind Am­gen’s T-Vec, the pi­o­neer­ing drug in the field which they be­lieve is ripe for sur­pass­ing its re­sults in the clin­ic.

So far, Mc­Coll’s small Aus­tralian com­pa­ny has paid the freight on the work, with Mer­ck pro­vid­ing Keytru­da for com­bi­na­tions in the clin­ic. At some point, if things con­tin­ue to progress, Mc­Coll al­so ex­pects to strike a mon­ey/mar­ket­ing deal.

“I don’t think a small Aus­tralian com­pa­ny will be mar­ket­ing a drug in the US,” he says with a smile. Af­ter to­day, he might find a few new op­por­tu­ni­ties on that score.

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Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

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