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    Andrew Berens • Leerink Partners

    Andrew Berens's questions to Agios Pharmaceuticals Inc (AGIO) leadership

    Andrew Berens's questions to Agios Pharmaceuticals Inc (AGIO) leadership •

    Question

    Andrew Berens from Leerink Partners asked if tebapivat (AG-946) was tested at doses higher than 5mg in the Phase IIa trial and about its dosing headroom. He also questioned what measures are in place to prevent issues like sepsis and malaria at African sites in the RISE UP trial, similar to what was reported for the Oxbryta trial.

    Answer

    CMO Dr. Sarah Gheuens clarified the Phase IIa study only tested the 5mg dose, with higher doses (10, 15, 20mg) now being evaluated in the Phase IIb. Regarding trial site safety, she noted that while malaria is endemic in some regions, the RISE UP study has a good global geographic distribution and that the issues seen with Oxbryta have not been observed with other drugs like hydroxyurea in Africa.

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    Andrew Berens's questions to Agios Pharmaceuticals Inc (AGIO) leadership • Q2 2025

    Question

    Andrew Berens from Leerink Partners asked if the sickle cell trial protocol was altered after the liver injury risk was identified and questioned the rationale for using lower doses of tebipivat in the sickle cell trial compared to the MDS trial.

    Answer

    CMO Dr. Sarah Gheuens confirmed that protocols for the sickle cell trial and its open-label extension were updated to include monthly liver monitoring for the first six months. She explained the tebipivat dosing difference is due to observed metabolic rates, with sickle cell patients metabolizing the drug slower than MDS patients.

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    Andrew Berens's questions to Agios Pharmaceuticals Inc (AGIO) leadership • Q1 2025

    Question

    Speaking for Andrew Berens of Leerink Partners, an analyst asked for details on the Phase II tebapivat study in sickle cell disease, including any differences in patient selection or endpoints compared to the mitapivat RISE UP study, and whether tebapivat has shown any liver safety signals.

    Answer

    CMO Dr. Sarah Gheuens described the tebapivat Phase II as a standard dose-finding study with hemoglobin response as the primary endpoint for proof of concept. She confirmed that no liver signal has been observed with tebapivat to date. She explained that the design of a potential Phase III trial will be informed by these Phase II results and the evolving market landscape following the readout from the mitapivat RISE UP study, reflecting a disciplined, data-driven approach.

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    Andrew Berens's questions to Compass Therapeutics Inc. (CMPX) leadership

    Andrew Berens's questions to Compass Therapeutics Inc. (CMPX) leadership • Q2 2025

    Question

    Andrew Berens of Leerink Partners inquired about the potential impact of patient crossover on the overall survival (OS) data for Tivesimig, the number of crossovers, the company's plans for seeking Breakthrough Therapy Designation, and the specifics of the DLL4 biomarker test.

    Answer

    CEO Thomas Schuetz confirmed that about half the patients in the control arm crossed over and explained that the statistical plan uses a rank-preserving structural failure time model to adjust for this. He acknowledged that Tivesimig could be extending survival even in the third-line setting. Regarding Breakthrough Designation, Schuetz stated it's something the company is 'thinking very, very, very seriously about.' He also clarified that the DLL4 biomarker test is the same one used in Korean trials, which was tech-transferred to the US.

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    Andrew Berens's questions to Exelixis Inc (EXEL) leadership

    Andrew Berens's questions to Exelixis Inc (EXEL) leadership • Q2 2025

    Question

    Andrew Berens of Leerink Partners asked if the STELLAR-303 trial has demonstrated 'contribution of parts' to satisfy regulators and questioned the importance of showing benefit in liver-metastases patients specifically.

    Answer

    EVP & CMO Amy Peterson asserted that 'contribution of components' was demonstrated in the STELLAR-001 study data presented at ASCO GI, which showed a benefit for adding atezolizumab to zanzalutinib. She reiterated that the trial is positive based on the ITT OS result and that full subgroup data will be shared later.

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    Andrew Berens's questions to Exelixis Inc (EXEL) leadership • Q1 2025

    Question

    An analyst on behalf of Andrew Berens asked about the zanzalitinib data shown in the ITT population for STELLAR-303, the expected performance of the control arm, and whether the STELLAR-304 update would include OS data.

    Answer

    Chief Medical Officer Amy Peterson referenced data from the STELLAR-001 study, which showed a median OS of 11.7 months for zanzalitinib plus atezolizumab in the ITT population. She noted this compares favorably to the historical benchmark of 6-8 months for the control arm, regorafenib. The question regarding STELLAR-304's OS data was not directly addressed.

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    Andrew Berens's questions to BGNE leadership

    Andrew Berens's questions to BGNE leadership • Q1 2025

    Question

    Andrew Berens asked about BeiGene's CDK4 inhibitor program, specifically how it differs from Pfizer's atirmociclib and its potential positioning in breast cancer. He also inquired about the potential for developing BRUKINSA beyond oncology, such as in autoimmune diseases, and whether the company has an oral SERD in its portfolio.

    Answer

    Lai Wang, Global Head of R&D, explained that their CDK4 inhibitor was designed to be more potent and selective than Pfizer's molecule and is advancing aggressively toward a Phase III trial in combination with a SERD. He confirmed a Phase III trial for BRUKINSA is ongoing in membranous nephropathy but stated the company does not have an oral SERD.

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    Andrew Berens's questions to Beigene Ltd (ONC) leadership

    Andrew Berens's questions to Beigene Ltd (ONC) leadership • Q1 2025

    Question

    Andrew Berens inquired about BeiGene's CDK4 inhibitor program, asking how it differs from Pfizer's atirmociclib and its potential positioning in breast cancer therapy. He also asked about the company's interest in developing BRUKINSA for autoimmune diseases, either internally or with a partner.

    Answer

    Wang Lai, Global Head of R&D, explained that their CDK4 inhibitor was designed to be more potent and selective than atirmociclib. The plan is to initiate a Phase III trial in second-line breast cancer in combination with a SERD. Regarding BRUKINSA, Lai confirmed an ongoing Phase III trial in membranous nephropathy, an autoimmune-related kidney disease.

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    Andrew Berens's questions to Beigene Ltd (ONC) leadership • Q4 2024

    Question

    Andrew Berens of Leerink Partners asked about expectations for the gastric cancer readout, the company's commitment to breast cancer, and the potential for off-label use of BRUKINSA in fixed-duration regimens.

    Answer

    Global Head of R&D Lai Wang stated the gastric cancer trial aims to broaden the tislelizumab label, with a readout expected in H2 2025. GM of North America Matt Shaulis noted that while they don't promote off-label use and lack a BTK+ approval, recent data from the BOVIN study could influence future thinking on fixed-duration use.

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    Andrew Berens's questions to Arvinas Inc (ARVN) leadership

    Andrew Berens's questions to Arvinas Inc (ARVN) leadership • Q1 2025

    Question

    Andrew Berens inquired about the future of Arvinas's neuroscience efforts with LRRK2, the level of degradation considered clinically relevant, and whether it would ultimately be a combination therapy.

    Answer

    CEO John Houston expressed high excitement for the LRRK2 program. CMO Noah Berkowitz added that the goal is to achieve over 50% degradation to normalize elevated protein levels in Parkinson's patients without complete elimination. He confirmed it would be developed as an add-on to the current standard of care, such as L-Dopa, as a disease-altering treatment.

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    Andrew Berens's questions to Incyte Corp (INCY) leadership

    Andrew Berens's questions to Incyte Corp (INCY) leadership • Q4 2024

    Question

    Andrew Berens from Leerink Partners noted that the Cmax for Jakafi XR was not commented on and asked how it looked. He also questioned if there were any other factors gating the drug's approval besides the ongoing stability studies.

    Answer

    Pablo Cagnoni, President, Head of R&D, clarified that replicating the Cmax of a twice-daily drug with a once-daily formulation is not expected or required by the FDA. The key bioequivalence metrics were AUC and Cmin, both of which were met. He confirmed that completing the stability studies is the only remaining gating factor for the resubmission.

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    Andrew Berens's questions to Incyte Corp (INCY) leadership • Q3 2024

    Question

    An analyst on behalf of Andrew Berens from Leerink Partners asked about the commercial dynamics for povorcitinib in hidradenitis suppurativa (HS), specifically how a potential JAK class black box warning might impact the drug's commercial prospects.

    Answer

    Steven Stein, an executive, acknowledged there is a reasonable chance the drug will have class effect labeling, including a black box warning. However, he emphasized that a JAK inhibitor's broad coverage of multiple inflammatory pathways could result in superior disease control compared to a biologic targeting a single pathway, as suggested by the strong Phase II data, which would be a key differentiator.

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