Boast­ing new dis­cov­er­ies from Xtan­di, Er­lea­da in­ven­tors, ORIC pitch­es $86M IPO on can­cer drugs tar­get­ed at re­sis­tance

Months af­ter kick­ing off Phase Ib tri­als, a group of sea­soned can­cer drug de­vel­op­ers out of the Bay Area have filed for an $86 mil­lion IPO in an­tic­i­pa­tion of a pre­lim­i­nary look on whether their glu­co­cor­ti­coid re­cep­tor an­tag­o­nist works against prostate can­cer and oth­er sol­id tu­mors.

Charles Sawyers

As ORIC Phar­ma­ceu­ti­cals’ name — which is ac­tu­al­ly an acronym — sug­gests, the com­pa­ny wants to “over­come re­sis­tance in can­cer.”

They fur­ther break it down in the S-1:

Our re­sis­tance plat­form is fo­cused on three ar­eas: (1) in­nate re­sis­tance, which de­rives from an un­ad­dressed onco­genic dri­ver that pro­motes tu­mori­ge­n­e­sis; (2) ac­quired re­sis­tance, the re­sult of an in­duced or en­riched onco­genic dri­ver that aris­es in re­sponse to treat­ment; and (3) by­pass re­sis­tance, the ac­ti­va­tion of a com­pen­sato­ry sig­nal­ing path­way in re­sponse to treat­ment.

Rich Hey­man

Charles Sawyers and Rich Hey­man, two of the co-founders of ORIC, were be­hind some of these ex­ist­ing treat­ments, in­clud­ing Xtan­di (which Sawyers li­censed to Medi­va­tion be­fore it was bought by Pfiz­er) and Er­lea­da (which Hey­man steered at Aragon un­til J&J snapped it up). Af­ter Sawyers’ lab at Memo­r­i­al Sloan Ket­ter­ing showed that tu­mor cells switch to glu­co­cor­ti­coid re­cep­tor (GR) sig­nal­ing to by­pass an­ti-an­dro­gen ther­a­py, they be­gan putting the the­o­ry to the test at ORIC.

The re­sult­ing small mol­e­cule drug, ORIC-101, is in two Phase Ib stud­ies — one in com­bi­na­tion with Xtan­di in prostate can­cer and an­oth­er paired with chemother­a­py in ad­vanced or metasta­t­ic sol­id tu­mors. If every­thing works well, a dose ex­pan­sion por­tion will be ap­pend­ed.

As for in­nate re­sis­tance, the team has ze­roed in on CD73, which they call “a key node in the adeno­sine path­way be­lieved to play a cen­tral role in re­sis­tance to chemother­a­py- and im­munother­a­py-based treat­ment reg­i­mens.” An IND for ORIC-533 is planned for next year, while oth­er pre­clin­i­cal pro­grams are in lead iden­ti­fi­ca­tion and un­der­go­ing in vit­ro stud­ies.

Ja­cob Chacko

Ja­cob Chacko leads the biotech as CEO, flanked by CMO Pratik Mul­tani, a col­league from his Igny­ta days. They took home com­pen­sa­tion pack­ages worth $672,129 and $535,156, re­spec­tive­ly, last year, while CFO Do­minic Piscitel­li was re­ward­ed $1,236,705.

Piscitel­li joined last year as ORIC was com­plet­ing a com­plete over­haul of the C-suite, bring­ing in Genen­tech vet Lori Fried­man as CSO and woo­ing CBO Matthew Panuwat from Prothena.

Lori Fried­man

The in­vestors who par­tic­i­pat­ed in both rounds of its in­sti­tu­tion­al fi­nanc­ing — The Col­umn Group (22.39%), Top­spin Fund (15.56%), Or­biMed (11.67%) and EcoR1 Cap­i­tal (5.83%) — re­main the biggest share­hold­ers.

Join­ing ORIC in the Nas­daq queue is NLS Phar­ma­ceu­tics, a Swiss biotech de­vel­op­ing con­trolled re­lease ver­sions of an old ap­petite sup­pres­sant called mazin­dol for rare dis­eases of the cen­tral ner­vous sys­tem. They are seek­ing $40 mil­lion.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Matt Kapusta, uniQure CEO

In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

John Leonard, Intellia CEO

In­tel­li­a's CRISPR pro­gram that ed­its genes di­rect­ly in pa­tients shows dura­bil­i­ty in AT­TR amy­loi­do­sis

The first in vivo CRISPR/Cas9 gene editing program has some new durability data showing sustained reduction of a toxic protein in ATTR amyloidosis at all four dose levels in a small 15-patient study.

Intellia Therapeutics presented the much-anticipated data for its Regeneron-collaborated NTLA-2001 Friday morning, adding to the initial Phase I results it first delivered almost a year ago to the day.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”