Sanofi beefs up can­cer drug pipeline, pay­ing cash hun­gry Im­muno­Gen $30M for full rights to on­col­o­gy port­fo­lio

Sanofi $SNY is once again re­jig­ging its part­ner­ship with Im­muno­Gen $IMGN. But two years af­ter punt­ing a can­cer drug as the phar­ma gi­ant over­hauled its can­cer drug pipeline, Sanofi is pay­ing $30 mil­lion in cash to grab added com­mer­cial­iza­tion rights for a string of on­col­o­gy as­sets — in­clud­ing a late-stage drug — as Im­muno­Gen builds up its cache of cash for its lead pro­gram.

At the top of the list is isat­ux­imab (SAR650984), an an­ti-CD38 an­ti­body in Phase III for mul­ti­ple myelo­ma. Then there’s SAR566658, an an­ti­body-drug con­ju­gate tar­get­ing CA6 in Phase II de­vel­op­ment for triple neg­a­tive breast can­cer; SAR408701, an an­ti-CEA­CAM5 ADC stud­ied for the treat­ment of sol­id tu­mors; “and an ad­di­tion­al ADC di­rect­ed to an undis­closed tar­get.”

The two com­pa­nies al­so agreed to change their 2013 deal, giv­ing Sanofi ex­clu­sive rights to SAR428926, an an­ti-LAMP1 ADC for sol­id tu­mors.

In ex­change for the cash, Im­muno­Gen is giv­ing up co-pro­mo­tion rights as well as roy­al­ty streams on any ap­proved ther­a­pies that come out of the pact.

Mark Enyedy

This is all part of a months-long ef­fort by Im­muno­Gen CEO Mark Enyedy to cash in on as­sets and come up with enough fund­ing to con­cen­trate ef­forts on their Phase III study of mirve­tux­imab so­rav­tan­sine. A few days ago Im­muno­Gen sold off its CD37-tar­get­ing ADC IMGN529 to De­bio­pharm for $25 mil­lion up front.

“Im­por­tant­ly,” not­ed RBC’s Matthew Eck­ler at the time of the De­bio­pharm deal, “this will fund op­er­a­tions through fu­til­i­ty analy­sis of the Phase III FOR­WARD I tri­al of mirve­tux­imab in ovar­i­an can­cer, ex­pect­ed 1H18. The sale of ’529 rep­re­sents con­tin­ued ex­e­cu­tion of re­struc­tur­ing ef­forts an­nounced last fall, which are pri­or­i­tiz­ing mirve­tux­imab and the IGN-pay­load pipeline. Un­der this plan, man­age­ment is al­so seek­ing to mon­e­tize coltux­imab rav­tan­sine (CD19-tar­get­ing ADC), which could rep­re­sent an ad­di­tion­al near-term source of non-di­lu­tive cap­i­tal.

“Amend­ing these agree­ments al­lows us to con­tin­ue to fo­cus on the de­vel­op­ment of our lead pro­gram, mirve­tux­imab so­rav­tan­sine, while ad­vanc­ing our ear­li­er-stage port­fo­lio and fur­ther strength­en­ing Im­muno­Gen’s cash po­si­tion,” stat­ed Enyedy,  “We be­lieve Sanofi pos­sess­es the right re­sources to com­plete the de­vel­op­ment of these in­no­v­a­tive can­di­dates and po­ten­tial­ly bring them to pa­tients around the globe.”

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.
Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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In­vestors could emerge from Neil Wood­ford de­ba­cle with £1B loss, in­ter­nal analy­sis re­veals

When Link Fund Solutions announced that it is closing Woodford Equity Income Fund permanently and kicking out Neil Woodford, it was implied that investors probably won’t get back everything they entrusted to the fund manager. But nobody knew just how much they would lose.

An internal analysis commissioned by Link suggested that the collective loss could amount to £1 billion — out of a fund last valued at £3.1 billion — Citywire has revealed.

GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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FDA Vas­cepa re­view spot­lights new safe­ty sig­nals, pos­si­ble min­er­al oil spoil­er as Amarin hunts a block­buster ap­proval

An in-house FDA review of Amarin’s Vascepa raises a set of hurdles the biotech will have to clear if the biotech expects to get the long-awaited FDA approval that could set it on a path to superstar status. But it appears that Amarin has survived another potential setback without introducing a major new threat to its prospects.

The stakes don’t get much higher, with analysts saying a win this week for Amarin could lead to billions in new sales — provided the agency stamps it with an OK. And investors liked what they say in the FDA review this morning, bumping the stock $AMRN 17%.

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FDA puts Sol­id Bio’s lead gene ther­a­py pro­gram on hold — again — af­ter an­oth­er pa­tient is hurt by SGT-001

Solid Biosciences continues to be plagued by safety issues.

Close to 18 months after the gene therapy biotech was able to quickly shed an FDA hold on their lead Duchenne muscular dystrophy program for SGT-001, regulators have stepped back in to force another halt after another patient was hit hard by a set of serious adverse events remarkably similar to the first set.

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FDA slaps a hold on an AML tri­al as Mark­er scraps a fail­ing ovar­i­an can­cer pro­gram, sink­ing shares

The FDA has placed a hold on a Phase II AML trial from the small immuno-oncology biotech Marker Therapeutics. Marker disclosed the issue two weeks after responding to FDA concerns, adding it to the Q3 release Tuesday. The company also announced it was scrapping a Phase II ovarian cancer program it determined was unlikely to succeed.

The agency’s concern centers around two reagents used in manufacturing for their trial for acute myeloid leukemia patients who have received a stem cell transplant. The reagents are from third parties and not present in the final product, Marker said.

Eli Lil­ly-backed biotech grabs $100M to dis­patch an­ti­body-oligonu­cleotide con­ju­gates af­ter mus­cu­lar dy­s­tro­phy

Hold up your hand. Make a fist. Now open it. And again.

If you can do it fully and with ease, then the proteins in your hand are likely working properly. If you can’t then they may not be. In people with myotonic muscular dystrophy, something more atomic is going on.

In those folks, the problem is RNA. Certain base pairs repeat far beyond normal, up to 11,000 superfluous letters in some cases. The extended strands form “clumps.” Proteins misform and can’t function properly. They often allow one movement but not the reverse, a condition called myotonia that gives the dystrophy its name.