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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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Aptinyx eval­u­ates fu­ture of the com­pa­ny fol­low­ing two failed tri­als, 60% lay­offs

This year has been tough for Aptinyx — two failed trials, a 60% cut in its workforce, and now the company has brought on a firm to help evaluate the future of the company.

The press release noted it’s working with the firm Ladenburg Thalmann as its financial advisor to assist in exploring and evaluating “strategic alternatives” — a process that a growing group of struggling biotechs has embarked on, sometimes ending in a merger, asset sale or wind-down.

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Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.