Alessan­dro Ri­va ex­its top No­var­tis on­col­o­gy post, heads to a trou­bled — but wealthy — Gilead

Alessan­dro Ri­va

With its pipeline mired in bad da­ta and se­r­i­al set­backs and an­a­lysts de­mand­ing some sort of co­her­ent strate­gic re­sponse to the omi­nous down­turn in its hep C fran­chise, Gilead $GILD has man­aged to re­cruit one of the top names in on­col­o­gy drug de­vel­op­ment to head up its can­cer R&D ef­forts.

Alessan­dro Ri­va is turn­ing in his Big Phar­ma cre­den­tials at No­var­tis $NVS to move in­to the big biotech, which has tak­en a drub­bing at the hands of dis­ap­point­ed an­a­lysts this year.

In the can­cer field, Gilead was forced to halt a slate of 6 stud­ies for Zy­delig in the spring of 2016 due to safe­ty is­sues. And that came af­ter the drug was clear­ly los­ing a race with Im­bru­vi­ca from J&J and Ab­b­Vie on leukemia and lym­phoma. Ab­b­Vie and Roche’s vene­to­clax, mean­while, is ex­pect­ed to gain mar­ket ground in CLL.

Then in No­vem­ber came sub­par da­ta for mo­melo­tinib, which has been strug­gling to dis­tin­guish it­self from Jakafi for myelofi­boris.

Clin­i­cal set­backs, though, are all the rage at Gilead, which has been rack­ing up fail­ures through­out 2016, in­clud­ing 4 straight flops late in the year.

What Gilead does have is cash, and plen­ty of it. Ri­vas may have less to do in the clin­ic right now than at the deal ta­ble, where Gilead may yet spend a sig­nif­i­cant amount of its cash re­serves on M&A and li­cens­ing. Gilead clear­ly needs to do more in on­col­o­gy/hema­tol­ogy.

Bri­an Abra­hams at Jef­feries thinks that could be the case. He not­ed:

We be­lieve the rel­a­tive­ly high-pro­file heme/onc chief hire sig­nals an in­creas­ing fo­cus in on­col­o­gy, a wel­come de­vel­op­ment, and ex­pect GILD to more ag­gres­sive­ly pur­sue BD to build out a broad­er can­cer pipeline– some­thing not sub­stan­tial­ly baked in­to most ex­pec­ta­tions but which we be­lieve could help im­prove sen­ti­ment around the name and LT rev­enue prospects. We ex­pect spec­u­lat­ed (s)mid-cap M&A can­di­dates like IN­CY could al­so trade up on this an­nounce­ment.

“I have al­ways ad­mired Gilead for its sci­en­tif­ic fo­cus and da­ta-dri­ven ap­proach to drug de­vel­op­ment,” Ri­va said in a state­ment. “I look for­ward to work­ing along­side Gilead’s ded­i­cat­ed and pas­sion­ate col­leagues through­out the R&D or­ga­ni­za­tion to tack­le the can­cer re­search and de­vel­op­ment chal­lenge with a goal of im­prov­ing the lives of pa­tients.”

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.

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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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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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.

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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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.

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.

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.