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$IVA positive topline results from Phase II clinical trial evaluating lanifibranor in patients with T2D and NAFLD.
44% reduction of hepatic fat after 24 weeks treatment a.o.
Lanifibranor also promising with respect to NASH.
$IVA Market cap $143 M
4/n
CONCLUSION: Multi-arm comparative studies are urgently needed to determine which 2L therapy actually works best in HER2-pos. or HER2 amplified advanced or metastatic BTC.
3/n
PFS data are not yet known for DESTINTY-PanTumor02 trial.
mPFS Zani in HERIZON-BTC-01 trial (IHC 3+/2+ ISH+) = 5.5 months.
Interestingly, in the NIFTY study, mPFS = 7.1 months was achieved with the combo irinotecan + fluorouracil + leucoverin in 2L mBTC.
2/n
The respective IHC 3+ collectives seem comparable with the usual caveat: ORR Enhertu 56% vs. zani 52%, Enhertu collective presumably more pretreated, ISH unknown there, in zani positive.
1/n
Enhertu $AZN is likely to become a serious competitor to zanidatamab $ZYME $JAZZ in advanced or metastatic BTC. See recent ASCO presentations on DESTINTY-PanTumor02 trial and HERIZON-BTC-01 trial (see also Lancet 2023).
2/n
use are still unclear)?
The track record of $PIRS is disastrous so far. In the past, the cooperation with Allergan, Sanofi, Takeda, Daiichi Sankyo, Zydus, Aska, Stellis and Roche has already been discontinued.
1/n
Bad news from $PIRS: Pieris and Genentech's joint respiratory program will be discontinued "for scientific reasons."
I wonder if there are also problems with ADA's here (as according to the patent specification already with PRS-060, there, however, the effects for prolonged
@jfais20 $BGNE has had the opportunity to review the complete datasets of the
DisTinGuish study and as a result - despite favorable financial terms - did not pull the option for DKN-01. This calls for caution.
$LPTX
Jonathan Faison
$LPTX (NP)
$85M MC @ 130M diluted shares, -$15M EV
$102M cash= at least 1.5 year runway
New LT data from 1L GEA trial at ASCO, Initial data for CRC triplet also due midyear
CRC enrollment target was 33, now expanding to 130 in randomized portion (seeing a signal?)
According to the recent $PIRS presentation, only 2 programs are still active in the Collaboration with $AZN (there were 3 in Nov 2022, and 4 in early Jan 2022).
According to the recent $PIRS presentation, there are only two programs still active in the Collaboration with $AZN (there were 3 in Nov 22, and 4 in early Jan 22).
The combo isatuximab (anti-CD38, $SNY) + evorpacept (anti-CD47, $ALXO) is not useful, since isatuximab has no ADPC. It would be much more promising to combine evorpacept with daratumumab or felzartamab (both anti-CD38's with pronounced ADPC function).
Updated end date according to Clinicaltrials now February 26, 2024. Actually, the trial (originally designed to be much larger) was supposed to end in April 2022. $PIRS
A major problem in study NCT04643158 (PRS-060 in asthma) is reportedly that a large proportion of screened patients cannot be randomized because the strict inclusion criteria (FeNO etc.) are not met. For this reason, there are always major delays in the study process. $PIRS $AZN
Despite today's price increase, $ALXO still has a neg EV. Rationally, this is not comprehensible. ALX148 is the most promising anti-CD47 (inactive Fc, low mol weight, high affinity), comments from study patients are extremely positive. I am looking forward to ASPEN-06 results.
$PIRS PRS-343 + ram + pac in ≥ 2L GEA look good at first glance #AACR23. However, on closer inspection there are the following to consider:
▪ mDOR only 3.8 mo
▪ all patients IHC 3+
▪ n=5
▪ SAEs: 3 from 5 patients
I just read in the $IFRX Form 20-F of March 22, 2023, that the Board of Directors have adjusted the exercise price of all outstanding and unexercised options held by active employees or directors from $3.95 and $3.35 to $1.86 per share.
Like in a self-service store ...
The purchase of the anti-CTLA-4 mAB NC-392 by $BNTX two weeks ago was already questionable ($PFE had previously returned the rights to ONC-392 to OncoImmune).
Too much cash apparently makes you blind. $BNTX buys an overpriced Chinese anti HER2 ADC. In view of the existing competitive situation, this is an incomprehensible licensing deal.
9/n
It would be interesting to know if $PIRS could back out of OPT-IN at a later date. If there were such an option, decisions on raising capital could be made in a phased and risk-adjusted manner on acceptable terms.
8/n
Given these circumstances, it is likely to be difficult for $PIRS to raise capital at a sufficient offering price.
In particular, if $AZN decides to also initiate a COPD trial ATST, $PIRS may not be able to raise the funds for an OPT-IN.
The situation is complicated.
7/n
the publication has to be postponed again or if the results are unsatisfactory.
However, should the data look good, there would still be the problem with ADAs, which could only be addressed in a subsequent study.
6/n
The new postponement of the topline data of the PRS-060 P2a study is very regrettable.
OTOH, it is of course better for shareholders if there is no need to dilute before the data are published. OTOH, $PIRS may run into major financing difficulties if