Roche’s strong sales growth of 9% (CER) continues in the third quarter of 2024; Group sales increase 6% in the first nine months

On October 23, 2024 Hoffmann-La Roche reported strong sales growth of 9% (CER) continues in the third quarter of 2024 (Press release, Hoffmann-La Roche, OCT 23, 2024, View Source [SID1234649078]).

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Ipsen delivers strong sales momentum in the first nine months of 2024 and increases its full-year guidance

On October 23, 2024 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported its performance for the year to date and the third quarter of 2024 (Press release, Ipsen, OCT 23, 2024, View Source [SID1234648245]).

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BostonGene to Participate in the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics

On October 23, 2024 BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, reported that it will participate in the 36th edition of the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (ENA 2024), taking place October 23-25, 2024, at the International Barcelona Convention Center in Barcelona, Spain (Press release, , OCT 23, 2024, View Source [SID1234647358]). The event will bring together academics, scientists and industry leaders from around the world to discuss innovations in drug development, target selection and translational cancer research. ENA 2024 offers a valuable platform for in-depth scientific discussions on preclinical and phase I studies and for sharing insights on advancements in molecular targets and cancer therapeutics, with a focus on the implications of molecular biology discoveries.

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Joe Lennerz, MD, PhD, Chief Scientific Officer at BostonGene, will be a featured speaker during the symposium. Dr. Lennerz will participate in a workshop titled "Innovation and Biomarkers in Cancer Drug Development," where he will deliver a presentation, "FDA’s Oversight of Laboratory Developed Tests: Taming the Wild West in Daily Practice." The presentation is scheduled for October 23, from 16:15 to 16:40 PM, in Room 113+114. Dr. Lennerz will discuss the critical role of regulatory oversight in advancing laboratory-developed tests and their impact on clinical practice, addressing current challenges and exploring solutions to ensure accuracy, reliability and patient safety.

"BostonGene is excited to engage with the international community at ENA 2024," said Dr. Lennerz. "We are eager to share our insights on the regulatory landscape and the importance of biomarkers in shaping the future of cancer therapeutics. The presentation will underscore the need for robust regulatory frameworks to support innovation, speed up drug discovery and ultimately enhance patient outcomes in this rapidly evolving field."

Visit the ENA 2024 website for more information.

Schrödinger Presents SGR-3515 Preclinical Data at 2024 EORTC-NCI-AACR Symposium

On October 23, 2024 Schrödinger (Nasdaq: SDGR) reported new preclinical data on SGR-3515, its investigational Wee1/Myt1 inhibitor, during a poster session at the 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium (ENA 2024) (Press release, Schrodinger, OCT 23, 2024, View Source [SID1234647357]). The data demonstrate that in preclinical models, treatment with SGR-3515 results in synergistic anti-tumor activity that leads to deeper and more durable responses compared to inhibitors that target only Wee1 or Myt1. The preclinical data also show that SGR-3515 has a favorable pharmacological profile and dosing schedule that supports evaluating intermittent dosing in patients.

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Wee1 and Myt1 kinases regulate the cell cycle and DNA damage response, allowing time for DNA repair before cell division takes place. Concurrent loss of function or inhibition of Wee1 and Myt1 confers selective vulnerability in cancer cells, a mechanism referred to as synthetic lethality, which has become an emerging therapeutic strategy for a range of cancers. A Phase 1 dose-escalation study of SGR-3515 in patients with advanced solid tumors is ongoing in the U.S. and Canada, and initial data from the clinical study is expected in the second half of 2025.

Schrödinger will also present preclinical data from its PRMT5-MTA program during a poster session on October 25. Schrödinger scientists have identified a novel series of selective, potent PRMT5-MTA inhibitors and are optimizing lead compounds for use in peripheral and brain tumors.

"We are pleased to share these encouraging preclinical data on SGR-3515, a potential best-in-class treatment for patients with a broad range of solid tumors, including uterine and ovarian cancers, two patient populations with high unmet need," stated Karen Akinsanya, Ph.D., president of R&D therapeutics at Schrödinger. "We also look forward to presenting preclinical data on the discovery of a novel series of compounds for our PRMT5-MTA inhibitor program. These programs highlight how we are deploying our computational platform at scale to discover highly optimized molecules to address diseases with significant medical need, and we believe the future of our therapeutics portfolio is very promising."

SGR-3515 Data at ENA 2024
The presentation (Abstract # 147), "Discovery of SGR-3515, a first-in-class Wee1/Myt1 inhibitor with differentiated pharmacological properties in xenograft tumor models," includes preclinical data demonstrating superior anti-tumor activity of SGR-3515 compared to inhibitors of Wee1 or Myt1 alone due to strong target engagement of both Wee1 and Myt1. The data show that SGR-3515 is a more potent co-inhibitor of both Wee1 and Myt1 than previously disclosed inhibitors of either target. These data are consistent with prior preclinical observations demonstrating that SGR-3515 has a unique and differentiated pharmacological profile that supports evaluating an intermittent dosing schedule of three days on and 11 days off, as well as five days on and nine days off, which maintained anti-tumor activity while allowing recovery from any mechanism-based hematological toxicity in preclinical models.

The preclinical data also demonstrate superior kinase selectivity and in vitro cell potency of SGR-3515 across a broad cell line panel compared to other known Wee1 and Myt1 inhibitors. These new data suggest that SGR-3515 is significantly more selective than existing compounds with low potential for drug-drug interaction.

PRMT5-MTA Data at ENA 2024
Additionally, Schrödinger will present new preclinical data on its PRMT5-MTA inhibitor program at a poster session during the meeting on October 25 from 9:00 a.m. – 3:00 p.m. CEST. The presentation (Abstract # 372), "Discovery of a highly MTA-synergistic series of PRMT5 inhibitors for the treatment of MTAP-deficient tumors by virtual screening technology," will include preclinical data on the discovery of highly selective PRMT5-MTA inhibitors. The poster will describe how Schrödinger’s virtual screening platform facilitated the identification of structurally distinct chemical matter with a high degree of MTA-synergy for compounds within a novel chemical series in vitro and in cellular contexts. Schrödinger has identified a novel series of selective, potent PRMT5-MTA inhibitors that did not show major off-target liabilities such as hERG inhibition in preclinical studies and may be suitable for use in combinations across tumor types.

Repare Therapeutics Announces Updated Positive Safety and Tolerability Results from the Phase 1 MYTHIC Clinical Trial

On October 23, 2024 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported updated data highlighting the benefits of its individualized schedule for the management of anemia in the Phase 1 MYTHIC clinical trial treating patients with the combination of lunresertib, a first-in-class PKMYT1 inhibitor, and camonsertib, a potential best-in-class oral small molecule ATR inhibitor (lunre+camo) (Press release, Repare Therapeutics, OCT 23, 2024, View Source [SID1234647356]).

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Lunre+camo in the MYTHIC clinical trial (NCT04855656) previously demonstrated promising clinical activity in molecularly selected patients across multiple tumor types. In this analysis, Repare followed patients for approximately nine months at the recommended Phase 2 dose (RP2D) to assess the effectiveness of an individualized schedule. The analysis demonstrated a successful approach to mitigating mechanism-based anemia while maintaining clinical benefit. Further, Repare observed no thrombocytopenia of any grade nor serious neutropenia in these patients.

Dr. Martin Højgaard of Rigshospitalet, Denmark presented this data in a poster titled, "Individualized schedule improves rates and severity of anemia in patients treated with lunresertib, a PKMYT1 inhibitor, and camonsertib, an ATR inhibitor, in the Phase I MYTHIC study (NCT04855656)" at the 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium on Molecular Targets and Cancer Therapeutics, being held October 23-25, 2024 in Barcelona, Spain.

"This individualized schedule in heavily pretreated patients with advanced cancers from our MYTHIC clinical trial met its goal of maintaining antitumor activity while reducing rates of grade 3 anemia," said Maria Koehler, MD, PhD, Executive Vice President and Chief Medical Officer of Repare. "We believe that these data demonstrate a favorable and differentiated tolerability profile versus both current and emerging therapies. We look forward to sharing efficacy data from the gynecological cancer expansion cohort of the MYTHIC clinical trial in December 2024."

Key Clinical Trial Findings:

The individualized schedule mitigated mechanism-based anemia based on entry hemoglobin observed in a minority of patients
Overall clinical benefit was maintained after schedule change with generally maintained radiographic regressions and molecular responses:
– Despite the change in schedule, deepening of target lesion regression was noted in some patients
– After 9 weeks on therapy, there was no observed impact on Progression Free Survival (PFS) in patients who started on or switched to the schedule of 2 weeks on / 1 week off of treatment
Dose optimization meaningfully reduced Grade 3 anemia (22.6% vs. 51.4%, previously) in all patients:
– Baseline marrow function was the key reason for Grade 3 anemia as opposed to exposure to therapy
– Baseline hemoglobin, prior therapies, and treatment intensity (weekly vs. 2 weeks on / 1 week off) predicted Grade 3 anemia frequency with lunre+camo
– Anemia reduction was greatest in patients with baseline hemoglobin less than 11g/dL (Grade 3 anemia at week 12: 34% vs. 68%, previously; overall risk reduction: 58%)
– Red blood cell transfusions (13% vs. 43%, previously), dose interruptions (13% vs. 23%) and dose reductions (6% vs. 17%) were also reduced with the new schedule
– Other Grade 3 events were already uncommon (<5% incidence) and remained consistently low, regardless of schedule