Christoph Nowak

MD (Oxford), PhD (Uppsala); former Assistant Professor at Karolinska Institutet. Chief Medical and Business Officer.

[Christoph Nowak @Chris___Nowak]

There’s a lot of magicking and buzzwording around #AI and #MachineLearning in #drugdiscovery

I thought I’d do a thread on a concrete example of using ML to discover a drug candidate about to enter Phase 2a for a stroke disorder:

@RecursionPharma’s $RXRX REC-994

[Stian Kildal @stiankildal]

Vilken otrolig känsla att äntligen släppa nyheten om hur vi tänker ta vår produkt 💊 till marknaden!! Och vilket år det har varit!! Jag är personligen riktigt stolt över vad vi har åstadkommit på så kort tid, givet hotet om likvidering av bolaget, då. En lång tråd... 🙂🧵👇

[Dr Peter A Senior @IsletTx]

Congrats to our friends @Diamyd
I'm sure that all in the #t1d consortium @CPathInstitute will be delighted

[Christoph Nowak @Chris___Nowak]

@suspendedJoey Kanske. Mycket tidigt, ju, fas 1 pg. ¿Säkerhet?

[Christoph Nowak @Chris___Nowak]

(my guess w Accel Appr - trying to get C-peptid accepted as a reasonably likely primary EP with FDA)

[Christoph Nowak @Chris___Nowak]

$SNY $PRVB PROTECT Ph 3 new-onset #T1D results wTeplizumab/TZIELD: sign. primary (C-peptide), only numerical benefit for 2 secondaries (TIR, insulin dose). Hidden in #Sanofi's Q2 report. No info on regulatory strategy, effect size, pval. May try for Accel Appr.
Underwhelming (?)

[Christoph Nowak @Chris___Nowak]

https://t.co/mDQlMu8WLK

[Christoph Nowak @Chris___Nowak]

Top 15 European cities by VC deal value

Source: PitchBook

[Christoph Nowak @Chris___Nowak]

Operae pretium est interrogare if "same drug" definition applies to Atra- vs Spars given the latter's dual MoA (Plac vs Irbes comp arms also make it difficult to assess whether the 2nd drug is "shown to be clin superior to the 1st drug" if FDA considers both as the "same drug".

[Christoph Nowak @Chris___Nowak]

FDA considers Sparsentan an "endothelin and angiotensin II receptor antagonist" (https://t.co/ryAnRHNdCu). Atrasentan shares only the ET (A) receptor antagonist MoA. Hence, $KDNY's ALIGN Ph3 compares to Placebo, whilst $TVTX DUPLEX Ph3 compares to AT-IIR antagonist irbesartan.

[MuddyWatersResearch @muddywatersre]

Making it even harder for $KDNY atrasentan to get FDA approval is a competing drug, sparsentan, has exclusive orphan drug approval. Atrasentan would have to show it is more efficacious and/or safer. Comparing trial data, atrasentan seems to be inferior https://t.co/j2TYNV7ZGz

[Christoph Nowak @Chris___Nowak]

FDA orphan exclusivity applies to "the same drug" in the same indication (https://t.co/cAxol4X1Ri). In this case, for small molecules, "same drug" requires "same active moiety" (ie core molecule or ion of a drug ... responsible for the physiol or pharmacol action of a drug subst)

[Christoph Nowak @Chris___Nowak]

OMG - $GSK k��per $BLU Bellus Health med ca. 100% premie för $14.75/sh - $2BN!

Wow, andra uppköp >100% i portföljen inom 2 månader - kom in under $7.

Congratulations @rbellini!

https://t.co/gbqTS7JttQ

[Christoph Nowak @Chris___Nowak]

Index fund ownership of #biotech at ATH

- Torreya/Stifel

[Christoph Nowak @Chris___Nowak]

@waccattacc Följt aktien sedan flera år tillbaka o trejdat en del på upp/nedgångar. 1a sjukdomsmod lm för typ-1 diab. Otroligt unmet need/värde. Co-commerc m SNY. Mest att man tror sig "känna" aktien så pass bra att kunna tolka flödena o rörelserna. Superhög risk ju, ingen rekommendtn &c Tur

[Christoph Nowak @Chris___Nowak]

Sanofi to acquire Provention Bio

$PRVB $SNY

$25/sh vs. $6.70 stängningskurs i fredags

omg

42% av portföljen, $8.77 GAV (sålde efter godkännande med GAV $4, och köpte tillbaka nyss)

https://t.co/klAl1hXqo0

[Christoph Nowak @Chris___Nowak]

Apropos $CABA #CabalettaBio

Pivot transaction case study?

Source: Torreya biopharm sector update 20 feb 23

[Christoph Nowak @Chris___Nowak]

@Pecunia30 @Interikan_ @Kasatono Går inte inte helt problemfritt för $NVS:
Trial recruitment has been slow, delaying expected submissions by a “few months”, but Novartis still expects pivotal data in both uses this year, in line with previous guidance.
https://t.co/MGnbtfrD2X

[Christoph Nowak @Chris___Nowak]

What's keeping $ACHV down?

- Risk for FDA req extra trial (head-to-head vs SoC)?

- Weak IP protection - risk for generics (already appr in other countries)?

- Cash runway (need for raise 2023, prob'ly on back of ORCA-3)

- Lack of strong institutional owners?

- What else?

[Christoph Nowak @Chris___Nowak]

(Had a very quick look only)

What's holding $ACHV Achieve Life Sciences back?

- Cytisine for smoking cessation

- MC $43M, funding into late '23

- Better AE profile, similar efficacy as main competitor varenicline/Champix (but: cross-trial comp)

[Christoph Nowak @Chris___Nowak]

- 1st Ph3 ORCA-2 (vs plac): good data, share flat/down

- H1'23E 2nd Ph3 ORCA-3 (vs plac): high PoS IMO

- Prob'ly ok to file w FDA based on it if similar saf&eff as ORCA-2

(In Apr'22, pre ORCA-2 read-out, s.o. on Seekg Alpha rated Buy w TP $70 when priced $7-8 - now $2.5 🤔)