Madeleine Armstrong
@ByMadeleineA
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Senior reporter at @ApexOnco ; cat lover; Croydon Harrier
London, England
Joined May 2008
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Personal news: today I've joined
@ApexOnco
as senior reporter, where I'll again be working with the legend Jacob Plieth. I'm excited about getting stuck back into work and covering the biggest sector in our industry...only a couple of weeks until Esmo!
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It's official: I no longer work for Evaluate Vantage. I'll be taking a bit of a break but, like Arnie, I'll be back
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The most thrilling news I've had all year - I've won a fiction writing prize. Don't think there's enough money in this to give up biotech reporting just yet, though
I can't believe this - my heart is going crazy. I've actually won?! Thank you,
@hhpublish1
. This is the best Christmas present I could've hoped for!
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Sad not to be at
#JPM20
but looking after a baby is kind of similar: sleep deprived, mainlining coffee, eating whatever junk I can get my hands on, and going crazy seeing the same four walls and hearing the same tune over and over again...
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Just pulled together a table of the CD47 clinical pipeline, sure you'll let me know if anything's missing! $PFE $TRIL
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Personal news: today is my last day of work before I go on maternity leave. I'm sad to be missing Ash and JPM, but sure I'll have other things on my mind by then. See you in 2020!
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First clinical data with $RVMD's multi-RAS inhibitor RMC-6236 in NSCLC & pancreatic cancer, plus safety. Liver enzyme elevations don't look like a huge issue
#ESMO23
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The latest gene therapy safety scare, from $BMRN, hits just after a benign FDA panel meeting. My take, via
@evaluatevantage
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I spotted what looked like an error in the $LPTX slide deck yesterday and pointed it out to the company. Slide 40 in the deck has been changed, now 43% ORR in Avastin-naive pts (vs 36% previously)
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Quick cross-trial comparison of older adult RSV vaccines from $MRNA $GSK & $PFE. With the usual caveats, $MRNA looks competitive on efficacy, but will adverse events prove troublesome? Also interested to see more info on durability, given what we saw with the mRNA Covid vaccines
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Investors brush off CAR-T scare, but the FDA's investigation looks like worse news for autoimmune than cancer players. After yesterday's bombshell, I had a look at the BCMA and CD19 CAR-T pipelines for
@ApexOnco
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The sickle cell race hots up at
#ASH22
as $SGMO presents early data on its new manufacturing process and $CRSP / $VRTX & $BLUE approach regulators. My take via
@evaluatevantage
$EDIT
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$ARWR delivers in the lung. After yesterday's promising but early data with ARO-RAGE I spoke to the company's CEO, Chris Anzalone, for
@evaluatevantage
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$VRTX raises hopes of type 1 diabetes cure, while $SEOVF also tries to get in on the act at
#ADA2023
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So happy with my time at
@LondonMarathon
today, especially as a few months ago I wasn’t even sure I could run it. And very proud do do it in a
@harrierscroydon
vest. Now for a celebratory 🍺
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Colorectal cancer could be $MRTX’s golden ticket. Data just revealed in an
#ESMO21
late-breaking abstract make adagrasib look better than $AMGN's Lumakras. Via
@evaluatevantage
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$ABBV said it expected response rates with its SEZ6-targeted ADC ABBV-706 to improve from those in the
#ASCO24
abstract, and they have: 61% in SCLC (vs 40% previously) & 28% in NEN (Vs 6% previously)
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Cross-trial comparison of $TAK's Tyk2 inhibitor and $BMY's Sotyktu in psoriasis. The Pasi-100 response with the highest dose of TAK-279 is particularly impressive, but the drugs look similar on PGA0/1 score. Awaiting more info on adverse events from the presentation
#AAD2023
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$ARWR is touting target knockdown with its inhaled RNAi asthma project ARO-RAGE. A lot of questions still & a lot to prove, but if it really unlocks lung delivery of RNAi this could be a big deal
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Day four of
#ASCO
and I just did an interview with
@bradloncar
about all the exciting things I've seen 🤓
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Launching drugs can be hard for small companies, as shown by
@evaluatevantage
's latest analysis. Still, there are some winners despite Covid-19 $BCRX $HZNP $GBT $MOR $ESPR
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The
@evaluatevantage
team Xmas lunch. Think this is the first time we’ve all been together for over two years!
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ASH Annual Meeting: Previewing Sunday (Day 2) of
#ASH23
with
@ApexOnco
's
@ByMadeleineA
.
$SNDX $KURA $INCY $ACLX $AUTL $GRCL $REGN
Full video:
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Krazati Q1 sales. $BMY paid nearly $5bn for this...
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Updated CB-010 swimmers plot: ORR falls to 76%, CR rate to 46%. Pivotal trial start delayed to H2 2025 following new HLA partial matching strategy $CRBU
#ASCO24
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Factor XI inhibitors were meant to be the next big thing in anticoagulation, but disappointing results with milvexian & asundexian today at
#ESCCongress
raise questions about multi-billion-dollar forecasts. My take, via
@evaluatevantage
$BMY $JNJ
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Bernstein's Ronny Gal is joining $NVS as chief strategy & growth officer from August. Big move!
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$AZN gets into Tregs, following deals by $REGN & $LLY earlier this year. I interviewed Astra's new partner Quell and had a look at the space for
@evaluatevantage
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$AZN is like that boyfriend who's let you down so many times, then you think they've finally got their shit together and give them another chance, only for them to disappoint you again. FFS
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Look who came to visit the
@Vantageanalysis
team. Welcome to London
@bradloncar
! (
@ByJonGardner
, you’re still on the wall of fame)
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$SMMT peaks on ivonescimab surprise. My take on yesterday's Harmoni-2 win, and data from Harmoni-A presented at
#ASCO24
today on the PD-1 x VEGF bispecific in NSCLC
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More data on $ARWR's inhaled RNAi, being developed for asthma. Knockdown in healthy volunteers went up again with highest dose. Looking forward to more granular data on the asthma pts. Here's my interview based on the previous data drop
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Made it to Boston without getting thwarted by Covid! Now it’s just a small matter of running 26.2 miles on Monday. Had a look at the finish line today for some extra inspiration
#BostonMarathon
#Boston126
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Why is $CRSP not down more than 7% this morning? Last night's news could take out CTX110, 120 & 130. That leaves CTX001 and a load of v early stage stuff. Is a beta-thal/sickle cell project worth $7bn?!
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$PFE sneaks Bavencio Javelin Lung 100 trial failure into Q4 results release
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FVIII levels with Bayer/ $RARE's haemophilia A gene therapy BAY 2599023/DTX201 at
#ASH20
. On first glance doesn't look like it'll be troubling $SGMO / $PFE or $BMRN
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Gene therapy pipeline looks surprisingly healthy - analysis post-Strimvelis EU approval $GSK
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$CRSP wasn't the only one with results today on a sickle cell project targeting BCL11A. Here's my quick take on the NEJM data with $BLUE's short hairpin RNA approach, via
@evaluatevantage
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So proud of
@JacobPlieth
, winner of the
#mediscienceawards
commentator of the year...as dignified as ever
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Following $GSK's deal with $ITOS today, here's
@JacobPlieth
's most recent table of Tigit-targeting projects, via
@evaluatevantage
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Another failure for $ARGX, this time in pemphigus, and looks like bullous pemphigoid is now in doubt too. Here's my take on the previous ITP stumble, for
@ApexOnco
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$RVMD sets the bar in pan-KRAS inhibition. "Early but promising" seemed to be the consensus at
#ESMO23
, but there are still questions to be answered:
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If anyone fancies a change from biotech news, check out my first ever fiction publication! Hopefully the first of many...
My first ever published story, Blood Is Murkier Than Water, has just gone live! It was accepted in September so it's great to see it out in the world. Thank you,
@flashficmag
and to Joy Saler Drees for the near-painless editing process
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Still a small n, but $SGMO $PFE haemophilia A data continue to look decent, now with 5 patients at highest dose and over longer term
#ASH19
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Looks like $SGMO has started dosing patients in its first Car-Treg trial, in kidney transplant recipients. Here's my previous take on the Treg space via
@evaluatevantage
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$MDNAF looks for a cytokine renaissance, but more data are needed to say that IL-2 is back. My take, via
@ApexOnco
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Gene editing: overhyped or unstoppable tide? Click here to read my new FREE report, featuring interviews with $VERV, $BEAM, $PRME, $EDIT & many more! Via
@evaluatevantage
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Why $GSK should buy $BHVN – and four other acquisitions that could make sense for the UK company $CVAC $TPTX $ADAP $ALPN via
@evaluatevantage
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4 deaths with $JNJ’s KLK2-targeting radioTx JNJ-6420, plus ORR 13% & PSA50 46% – not as impressive as some other recent early mCRPC data
#ASCO24
$JANX $FGEN $AMGN $XNCR $NVS
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$VRTX gets more in vivo gene editing $VERV, but many questions remain unanswered. My take via
@evaluatevantage
(click for full table)
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With M&A back on the agenda, how often do deals pay off?
@EdwinElmhirst
crunched the numbers for
@evaluatevantage
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My first
#ASH22
preview, focused on non-oncology projects and sickle cell disease in particular: waiting for $EDIT, via
@evaluatevantage
$BLUE $CRSP $VRTX $NTLA $NVS $SGMO
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Sad day for a company that always seemed to have interesting technology but never quite delivered $SGMO
Sangamo basically saying it doesn't have the money to push its gene therapy for Fabry or CAR-Treg work, both in PhI/II trials, any further. Who will buy them?
Sangamo lays off 40% of US staff, closes facility, cuts pipeline to lower costs -
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$CLVS CEO puts up "for sale" sign: "Everyone knows where to find me. And every company in this space is for sale"
#JPM19
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So let me get this straight, $SRPT's DMD gene therapy failed in its placebo-controlled trial, so now it's presenting results from placebo patients who crossed over and is comparing them to historical controls?
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Will Nestle have to sell it for...peanuts? Thank you very much, I'm here all week
Nestle said it would explore options for Palforzia. Although it is the world's only approved peanut allergy drug, it has so far proved a flop.
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$SGMO builds its case for a haemophilia A gene therapy with data from two more patients at
#ISTH2019
. My take via
@Vantageanalysis
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$MRK CFO: we plans to resume share repurchases (boo!) but BD will remain higher priority (yay!)
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Despite bempegaldesleukin's demise cytokine players keep the faith. I had a look at the next wave of companies in this space including $MDNA, Aulos, Asher & Sotio. Click for full (massive) table, via
@evaluatevantage
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Quick cross-trial comparison in IgAN - atacicept not looking competitive and $VERA is down 48% premarket $KDNY $TVTX $ALNY $CALT
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Another example of why the FDA should publish meeting minutes instead of relying on companies' interpretations $SESN
Not that familiar with $SESN but this seems quite damaging. Protocol violations,signs of tox not mentioned in filings etc
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Funny how analysts at the same organisation can have such different takes on which Kras inhibitor will prevail 🤨 $AMGN $MRTX
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My take on some encouraging but early data on PD-1 x CTLA-4 bispecifics at
#ESMO20
, via
@evaluatevantage
$MGNX $XNCR $AZN
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Following recent slip ups in geographic atrophy from $NGM and $RHHBY, I had a look at the pipeline, including $LCTX's Roche-partnered cell therapy project. Via
@evaluatevantage
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Very excited that I just got my first Covid vaccine. Even more excited that it was $PFE / $BNTX
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Some $NVS M&A ideas, tell me why I'm wrong.
$AUPH: why not?
$ALNY: Novartis doesn't mind paying top dollar
$CRSP: See above, plus presence in both SCD & Car-T (never mind problems with allogeneic Car-T)
$QURE: would be like Novartis to double down on gene therapy right now
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Catching up on the $ABOS ACU193 phase 1 presentation at
#AAIC23
. Interesting that no ApoE4 homozygotes developed Aria-E (this group was particularly at risk of Aria with $BIIB / $EASLF's Leqembi). Aria-E rate with ACU193 was ~10%, vs ~13% for Leqembi in ph3 Clarity AD
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$KZR data don't look quite as good when you include the 4 dropouts. Getting closer to the Wells Fargo "base case" scenario (NB mean steroid dose at 9.1mg at end of treatment)
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$BMY gets out of IL-12 but it's not the only one. A look at the pipeline by me and
@ByAmyBrown
shows an exit by $AZN & $MRNA, among others $ONCS $IMNN $PDSB
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$GILD has removed an $RCUS Tigit inhibitor from its pipeline....not domvanalimab but AB308, which is Fc-enabled (dom is Fc silent)
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$RVMD’s KRAS revolution promise draws fans at
#Targets23
- and there will be more data from its RAS(ON) approach at
#ESMO2023
. My take for
@ApexOnco
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There's also this. No wonder $GERN shares are down 17%
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Interesting efficacy with Jacobio's Kras G12C/SHP2 combo, especially in 1L lung, but the discussant highlights the tox profile, saying "the combo is not easy"
#ESMO23
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$BNTX bails out $AUTL. My quick take on today's deal, which had manufacturing at its centre, via
@ApexOnco
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After $PNT's big Splash falls short, shares are now back at the $12.50 $LLY offer price; Point should just take Lilly's money and run. My take, via
@ApexOnco
$LNTH $NVS
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Which deals unexpectedly brought in megablockbusters? Clue: $MRK's purchase of Schering-Plough, which gave it the preclinical asset pembrolizumab, is one. Story with
@EdwinElmhirst
via
@Vantageanalysis
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We just knocked up this chart, which suggests that $MOR has got the better end of this deal than $RPRX $CNST
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Latest biomarker data with $SGMO's Fabry disease (left) vs previous data cut (right). Company says 5 pts have now been weaned off ERT, so looking forward to seeing more data post-ERT withdrawal
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Aren't you supposed to do the fundraising after the data? $KURA
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#JPM22
: $BEAM and Mammoth hook big pharma partners in $PFE and Bayer. My take on today's in vivo gene editing deals, via
@evaluatevantage
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And we think of Roche as a cancer company $RHHBY
"Roche’s top five growth drivers – Vabysmo (severe eye diseases), Ocrevus (multiple sclerosis), Hemlibra (haemophilia), Polivy (blood cancer) and Evrysdi (spinal muscular atrophy)"
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5
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A more detailed analysis of the $AMGN KRAS data presented at
#ASCO19
yesterday, and a broader look at other KRAS inhibitors in development, via
@Vantageanalysis
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$PFE hopes $GILD CD47 issues aren’t catching. And the (many) other CD47 players might be nervous too (click for full table). My take, via
@evaluatevantage
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Efficacy data with $HARP DLL3-targeting T-cell engager in SCLC and NEPC. This is with the 1mg priming dose - the company had to drop down to this after tox with the 2mg priming dose
#ESMO23
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