|Over a week ago|
Centessa to present on OX2R agonist discovery pipeline » 08:4009/2009/20/22
Centessa Pharmaceuticals announced that non-clinical data from its oral orexin receptor 2 agonist discovery pipeline have been accepted for poster presentation at the 26th Conference of the European Sleep Research Society meeting being held on September 27-30, 2022, in Athens, Greece. Centessa's OX2R agonists are designed to directly target the underlying pathophysiology of orexin neuron loss in narcolepsy type 1, with potential expansion into narcolepsy type 2, and other sleep disorders. The poster presentation will feature the non-clinical activity profiles of small-molecule OX2R agonists from multiple lead chemical series developed using structure-based drug design with an OX2R protein stabilized in the agonist conformation together with CryoEM and high-resolution protein crystallography. These novel OX2R agonist compounds showed high potency in activating recombinant human and endogenous mouse OX2Rs, with more than a thousand-fold selectivity for OX2R compared to OX1R. The OX2R agonists also showed efficacy in promoting wakefulness and in reducing cataplexy events in NT1 model mice, and increased wakefulness in healthy mice.
Centessa announces ODD granted to SerpinPC for treatment of hemophilia B » 09:0809/1409/14/22
Centessa Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has granted Orphan Drug Designation, ODD, to SerpinPC, a novel inhibitor of activated protein C, APC, for the treatment of hemophilia B. Centessa plans to begin registrational studies of SerpinPC in the fourth quarter of 2022. SerpinPC is a biological drug candidate, based on the serpin family of proteins that is designed to allow more thrombin to be generated by inhibiting APC, thus rebalancing coagulation in hemophilia patients. "We believe SerpinPC has the potential to offer patients with hemophilia B a convenient subcutaneous option that is designed to prevent and reduce bleeds without the risk of thrombosis," said Saurabh Saha, MD, PhD, Chief Executive Officer of Centessa. "This designation from the FDA is an important milestone in the development of SerpinPC and underscores the need for new, innovative treatment options for patients with hemophilia B. We look forward to initiating registrational studies for SerpinPC later this year, as well as reporting the two-year follow-up data from the SerpinPC Phase 2a open label extension study in the fourth quarter."
Centessa announces NHPs PK, safety data for LB101 » 07:1909/1209/12/22
Centessa Pharmaceuticals announced non-clinical pharmacokinetic, PK, and safety data in non-human primates, NHPs, for LB101, its first LockBody candidate for solid tumors. Findings from these data reinforce the potential of its LockBody platform to minimize the systemic effects of potent immune effectors and significantly improve the therapeutic index. "These data, together with the non-clinical data presented at ASCO earlier this year, continue to validate our novel LockBody pharmacology, which leverages the natural cleaving of the human IgG-derived hinge to deliver powerful effectors like anti-CD47 into the tumor environment," said Saurabh Saha, MD, PhD, Chief Executive Officer of Centessa. "Whereas current therapies targeting CD47 are encumbered with severe toxicities due to peripheral activity on circulating red blood cells, LB101 has the potential to optimally deliver anti-PD-L1 activity plus targeted anti-CD47 activity to the tumor micro-environment. These new non-clinical data demonstrate systemic delivery of high doses of LB101 without hematological toxicity in non-human primates, resulting in the potential to achieve an enhanced therapeutic index, increased anti-tumor activity, and enable meaningful treatment for patients with solid tumors. We look forward to advancing LB101 into the clinic and plan to submit an IND late this year." In the study, male and female cynomolgus monkeys were administered LB101 intravenously, every 7 days over 28 days at doses of 5mg/kg, 20mg/kg, and 50mg/kg. The pharmacokinetics of LB101 were assessed and exhibited a typical IgG1-like PK profile. There were no adverse changes in hematologic parameters, no changes in body weights and no adverse toxicology findings.
|Over a month ago|
Street Wrap: Today's Top 15 Upgrades, Downgrades, Initiations » 09:3408/1208/12/22
CIEN, PRQR, CNTA, SIX, OLO, LAW, ELF, MSFT, GDRX, MREO, BB, ADM, LNT, SNY, SAFE
Centessa double downgraded to Underweight from Overweight at Morgan Stanley » 05:3608/1208/12/22
Morgan Stanley analyst…
Morgan Stanley analyst Matthew Harrison double downgraded Centessa to Underweight from Overweight with a price target of $5, down from $10. Harrison tells investors in a research note that he was "clearly wrong" on his assessment of Centessa's pipeline, with three of the late stage assets being discontinued following the failure of lixivaptan. While management has enough cash and early stage assets to potentially drive long-term value, Harrison is moving to Underweight to reflect the lack of near-term upside for Centessa and the need to wait for other early stage pipeline programs to mature before they can contribute meaningful value.
Centessa downgraded to Underweight from Overweight at Morgan Stanley » 05:2908/1208/12/22
Morgan Stanley analyst…
Morgan Stanley analyst Matthew Harrison downgraded Centessa to Underweight from Overweight with a price target of $5, down from $10.
Centessa price target lowered to $11 from $19 at BMO Capital » 07:0308/1108/11/22
BMO Capital analyst…
BMO Capital analyst Kostas Biliouris lowered the firm's price target on Centessa to $11 from $19 but keeps an Outperform rating on the shares. The analyst is adjusting his model following the company's announcement yesterday that it is discontinuing development of ZF874 following a recent report of an adverse event. Biliouris adds however that Centessa's hemophilia program remains intact, and he believes that the management team can successfully develop SerpinPC further, maintaining his assumed SerpinPC probability of success at 30%.
Centessa reports Q2 EPS (69c) vs. (65c) a year ago » 06:3708/1008/10/22
Cash and Cash…
Cash and Cash Equivalents: $484.2M as of June 30, which the company expects will fund operations into 2026, without drawing on the remaining available tranches under the Oberland credit facility.
Centessa to discontinue development of ZF874 » 06:3608/1008/10/22
The company announced…
The company announced its decision to discontinue development of ZF874 following a recent report of an adverse event involving elevated liver enzymes in a PiMZ subject dosed with 5 mg/kg BID of ZF874 in the Phase 1 study. ZF874, a pharmacological chaperone designed to rescue the folding of the Z variant of alpha-1-antitrypsin, was in a Phase 1 study for the treatment of AATD. As previously reported in November 2021, elevated liver enzymes were observed in a subject dosed with 15 mg/kg BID of ZF874 in the first cohort of patients within Part B of the Phase 1 study. Based on the results observed to date, the company concluded that ZF874 was unlikely to achieve the desired target product profile. Dr. Saha concluded, "While this is disappointing news for the A1AT patient community, we continue to believe that the pharmacological chaperone approach has the potential to address both the lung and liver manifestations of AATD. We are analyzing data from the Phase 1 study to help inform potential future development plans for our back-up compounds."
Centessa appoints Rotmas as SVP, Regulatory Affairs » 08:0907/2507/25/22
Centessa Pharmaceuticals announced the appointment of Harris Rotman, PhD, as Senior Vice President, SVP, Regulatory Affairs. Prior to joining Centessa, Dr. Rotman served as Senior Vice President, Head of Regulatory Affairs at SwanBio Therapeutics, where he was responsible for managing the company's neuromuscular disease gene therapy programs.