On December 2, 2024 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that it has commenced an underwritten public offering to sell up to $600.0 million of shares of its common stock (Press release, Revolution Medicines, DEC 2, 2024, View Source [SID1234648724]). All of the shares of common stock are being offered by Revolution Medicines. In addition, Revolution Medicines intends to grant the underwriters a 30-day option to purchase up to an additional $90.0 million of shares of common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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J.P. Morgan, TD Cowen, Goldman Sachs & Co. LLC and Guggenheim Securities are acting as joint book-running managers for the proposed offering. UBS Investment Bank is acting as lead manager.

A shelf registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission (SEC) on March 4, 2024, and automatically became effective upon filing. This offering is being made solely by means of a prospectus. A copy of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by email at [email protected] and [email protected]; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, New York 10017, by telephone at (855) 495-9846 or by email at [email protected]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526 or by email at [email protected]; and Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, New York 10017, by telephone at (212) 518-9544 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On December 2, 2024 Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) and Novocure (NASDAQ: NVCR) reported that the pivotal, Phase 3 PANOVA-3 trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) versus control. PANOVA-3 evaluated the use of Tumor Treating Fields (TTFields) therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma (Press release, Zai Laboratory, DEC 2, 2024, View Source [SID1234648741]).

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"As a researcher and clinician, I have experienced the challenges of developing treatments in pancreatic cancer. It is exciting to see the PANOVA-3 trial achieve the positive primary endpoint of overall survival, a landmark outcome for this field," said Vincent Picozzi, M.D., medical oncologist and investigator in the PANOVA-3 trial. "These data for Tumor Treating Fields are very promising, especially in this difficult to treat patient population."

In the intent-to-treat population, patients treated with TTFields therapy concomitant with gemcitabine and nab-paclitaxel had an mOS of 16.20 months compared to 14.16 months in patients treated with gemcitabine and nab-paclitaxel alone, a statistically significant 2.0-month improvement (hazard ratio=0.819; P=0.039) (N=571). The survival rate benefit for patients treated with TTFields therapy increased over time with a 13% improvement in the overall survival rate at 12 months and a 33% improvement in survival rate at 24 months. TTFields therapy was well-tolerated, and safety was consistent with prior clinical studies.

"PANOVA-3 is the first and only Phase 3 trial to demonstrate a statistically significant benefit in overall survival specifically in unresectable, locally advanced pancreatic cancer, and is Novocure’s third positive Phase 3 clinical trial in the last two years," said Nicolas Leupin, M.D., PhD, Chief Medical Officer, Novocure. "We are grateful to the patients and investigators for their participation in the trial, and we look forward to sharing the full data at an upcoming medical conference."

"There are approximately 134,000 new cases of pancreatic cancer diagnosed annually in China, and this cancer is one of the most challenging to treat globally, with limited effective treatment options and poor survival outcomes," said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "Demonstrating a statistically significant and clinically meaningful improvement in overall survival for patients with unresectable, locally advanced pancreatic cancer is an important achievement. We are pleased to have been able to contribute to the PANOVA-3 study, and we look forward to working with Novocure to bring this therapy to patients as soon as possible."

Novocure plans to file for regulatory approval of TTFields in unresectable, locally advanced pancreatic adenocarcinoma based on PANOVA-3 and plans to submit the PANOVA-3 results for presentation at an upcoming medical congress. Zai Lab plans to file for regulatory approval in China.

About PANOVA-3

PANOVA-3 is a prospective, randomized open-label, controlled Phase 3 clinical trial designed to test the efficacy and safety of Tumor Treating Fields (TTFields) therapy used concomitantly with gemcitabine and nab-paclitaxel, as a first-line treatment of locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone.

The primary endpoint is overall survival. Secondary endpoints include progression free survival, local progression free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity.

A total of 571 patients were enrolled in the study, randomized 1:1 and followed for a minimum of 18 months.

About Pancreatic Cancer in China

Pancreatic cancer is one of the most common and deadliest cancers globally. In China, there were an estimated 134,374 new cases in 2022, and it is now the eighth most common cancer type1. The current median survival of patients with locally advanced, unresectable pancreatic cancer is nine to twelve months, and the five-year survival rate was 7.2%2, making it the malignancy with the lowest survival rate in China.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

On December 2, 2024 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, reported key clinical updates from its RAS(ON) inhibitor portfolio. The data to be presented during an investor webcast today at 8:00 a.m. Eastern Time (ET) will focus on updated clinical data from the Phase 1 RMC-6236 monotherapy study in pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC) (Press release, Revolution Medicines, DEC 2, 2024, View Source [SID1234648725]). In addition, new clinical data will be provided from several combination studies, including those evaluating RMC-6236 with pembrolizumab, RMC-6291 with pembrolizumab, and the first-of-its-kind RAS(ON) inhibitor doublet combination of RMC-6291 and RMC-6236.

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"Our mission is to revolutionize treatment for patients with RAS-addicted cancers, and our ongoing progress is supported by the clinical milestones we continue to achieve in patients with a range of RAS mutant tumor types, stages of disease and lines of therapy," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "We’ve now reported initial clinical validation of three differentiated RAS(ON) inhibitors, shown evidence of promising initial clinical activity and tolerability profiles in patients with three common, difficult-to-treat RAS-addicted tumors, and shared growing evidence of clinical impact delivered through three potential treatment paradigms – as monotherapy, in combination with pembrolizumab, and as RAS(ON) inhibitor doublets. With these compelling results, we are in a strong position to pursue an expansive set of late-stage development opportunities on behalf of patients with RAS-addicted cancers, beginning with the ongoing and pending pivotal trials."

RMC-6236 Monotherapy Study
RMC-6236-001 is a multicenter, Phase 1/1b study designed to evaluate RMC-6236, a RAS(ON) multi-selective inhibitor, as monotherapy, in patients with advanced solid tumors. As of September 30, 2024, a total of 436 patients were treated across NSCLC (n=132) and PDAC and other solid tumors (n=304) cohorts. Patients were treated across a range of doses, from 10 mg to 400 mg once daily (QD).

PDAC Cohort
As an update to data reported at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) conference in October 2024, the company shared a new analysis of safety and activity data from the July 23, 2024 data cutoff date in patients with previously treated PDAC treated with a 300 mg QD dose, the same dose used in the ongoing RASolute 302 Phase 3 PDAC trial.

Key findings:

In 76 patients with RAS mutant PDAC, RMC-6236 at 300 mg QD was generally well tolerated and showed an overall safety profile consistent with the results reported at ENA. No differentiated safety signals were observed.

The most common treatment-related adverse events (TRAEs) were rash and gastrointestinal (GI)-related toxicities that were primarily Grade 1 or 2 in severity. No Grade 3 or higher TRAEs were observed in greater than 10% of patients.

There were no treatment discontinuations due to TRAEs and the mean dose intensity was 89%.

In 37 patients with 2L RAS mutant PDAC, RMC-6236 at 300 mg QD demonstrated compelling antitumor activity.

Patients with PDAC harboring a KRAS G12X mutation (n=22) achieved a median PFS of 8.8 months (95% confidence interval (CI), 8.5 months – not estimable (NE)), while the median OS was not estimable (95% CI, NE – NE). Patients with PDAC harboring any RAS mutation (n=37) achieved a median PFS of 8.5 months (95% CI, 5.9 months – NE), while the median OS was not estimable (95% CI, 8.5 months – NE).

The proportion of patients who remained alive six months after starting treatment with RMC-6236 was 100% and 97% in patients with PDAC harboring a KRAS G12X mutation and patients with PDAC harboring any RAS mutation, respectively.

The objective response rate (ORR) was 36% and 27% in patients with PDAC harboring a KRAS G12X mutation and patients with PDAC harboring any RAS mutation, respectively.

RASolute 302, the company’s randomized Phase 3 study of RMC-6236 versus standard of care chemotherapy in 2L patients with previously treated metastatic PDAC, is currently ongoing.

Next steps:

Based on the encouraging monotherapy data update, the company aims to advance RMC-6236 into earlier lines of therapy for patients with metastatic PDAC.

NSCLC Cohort
As an update from a smaller initial cohort reported at ESMO (Free ESMO Whitepaper) 2023, data from a September 30, 2024 data cutoff date were reported for 124 patients with previously treated RAS mutant NSCLC who received RMC-6236 at clinically active doses in the range of 120 mg to 300 mg QD.

Key findings:

In patients with previously treated NSCLC, RMC-6236 was generally well tolerated at doses of 120 mg to 220 mg QD, while the 300 mg QD dose demonstrated a higher frequency and severity of TRAEs.

In the 120 mg to 220 mg dose range, the most common TRAEs were rash and GI-related toxicities that were primarily Grade 1 or 2 in severity. No Grade 3 or higher TRAEs were observed in greater than 10% of these patients. In the 120 mg to 220 mg dose range, TRAEs leading to dose modification occurred in 41% of patients with 4% of patients discontinuing treatment due to TRAEs and the mean dose intensity was 88%.

RMC-6236 at 120 mg to 220 mg QD demonstrated encouraging antitumor activity in the population of 40 efficacy-evaluable 2L or third-line (3L) patients with NSCLC who had received immunotherapy and platinum chemotherapy but had not received docetaxel.

These patients achieved a median PFS of 9.8 months (95% CI, 6 – 12.3 months), a median OS of 17.7 months (95% CI, 13.7 months – NE) and an ORR of 38%.

Next steps:

The company expects to initiate RASolve 301, a randomized Phase 3 study of RMC-6236 versus docetaxel in patients with previously treated, locally advanced or metastatic RAS mutant NSCLC, in the first quarter of 2025.

RAS(ON) Inhibitor Combination Studies

RMC-6236 with Pembrolizumab
RMC-LUNG-101B is an arm of the Phase 1b study of RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with RAS mutant NSCLC. A total of 20 patients treated with RMC-6236 at 200 mg QD and pembrolizumab at the standard dose of 200 mg once every three weeks (Q3W) were evaluated as of an October 28, 2024 data cutoff date. The median duration of treatment for these patients was 2.3 months.

The combination of RMC-6236 with pembrolizumab was generally well tolerated and the safety profile was consistent with previously reported results for the individual agents. TRAEs of Grade 1 aspartate aminotransferase (AST) elevation were reported in two patients (10%) and a TRAE of Grade 2 AST elevation was reported in one patient (5%). A TRAE of Grade 1 alanine transaminase (ALT) elevation was reported in one patient (5%) and a TRAE of Grade 3 ALT elevation was reported in one patient (5%). The mean dose intensity for RMC-6236 was 97%.

Next steps:

The company believes the data from this study support continued evaluation of the combination of RMC-6236 with pembrolizumab in 1L NSCLC patients.

RMC-6291 and RMC-6236 RAS(ON) Inhibitor Doublet
RMC-6291-101 is a Phase 1b study of RMC-6291 in combination RMC-6236 in patients with RAS G12C mutant solid tumors. The study has evaluated RMC-6291 at doses of 100 mg or 200 mg BID and RMC-6236 at a dose range of 100 mg to 300 mg QD. As of an October 28, 2024 data cutoff date, 74 patients were evaluated for safety with a median duration of treatment of 2.3 months.

The combination of RMC-6291 with RMC-6236 was generally well tolerated across all dose levels evaluated. The most common TRAEs were rash and GI-related toxicities that were primarily Grade 1 or 2 in severity. No Grade 3 or higher TRAEs were observed in greater than 5% of patients. One Grade 4 TRAE of hypokalemia was associated with Grade 3 diarrhea. TRAEs leading to dose interruption or reduction occurred in 30% and 10% of patients, respectively. The mean dose intensities for RMC-6291 and RMC-6236 were 95% and 92%, respectively.

A subset of efficacy-evaluable patients with colorectal cancer (CRC) who were previously treated with a KRAS(OFF) G12C inhibitor was evaluated for antitumor activity on treatment with RMC-6291 with RMC-6236. As reference values, the company also reported that the ORR for patients with CRC treated with RMC-6236 monotherapy at a dose of 300 mg daily in the RMC-6236-001 study as of a data cutoff date of September 30, 2024 was 9%, and the ORR for patients with CRC previously treated with a KRAS(OFF) G12C inhibitor who were subsequently treated with RMC-6291 monotherapy at a dose of 200 mg twice daily in the RMC-6291-001 study as of a data cutoff date of October 28, 2024 was 0%. In the combination study, patients with CRC who were previously treated with a KRAS(OFF) G12C inhibitor and who received their first doses of the two study drugs at least 8 weeks prior to data cutoff were included in the analyses (n=12). The ORR was 25%, including one patient with an unconfirmed complete response, and the DCR was 92%. The median treatment duration was 2.3 months.

Next steps:

The company believes the data from this combination study support continued development of RAS(ON) doublets in a broad range of tumor types and earlier lines of therapy.

RMC-6291 with Pembrolizumab
RMC-LUNG-101A is an arm of the Phase 1b study of RMC-6291, a RAS(ON) G12C-selective inhibitor, in combination with pembrolizumab, with or without chemotherapy, in patients with RAS G12C mutant NSCLC. A total of 15 patients treated with RMC-6291 at 200 mg twice daily (BID) and pembrolizumab at the standard dose of 200 mg Q3W were evaluated as of an October 28, 2024 data cutoff date. As of this date, 47% of these patients had been on treatment for 60 days or more.

The combination of RMC-6291 with pembrolizumab was generally well tolerated and the safety profile was consistent with previously reported results for the individual agents. A TRAE of Grade 1 AST elevation was reported in one patient (7%) and a TRAE of Grade 1 ALT elevation was reported in one patient (7%). There were no TRAEs of Grade 2 or higher AST or ALT elevations reported. The mean dose intensity for RMC-6291 was 98%.

Next steps:

The company believes the three pairwise combinations of RMC-6291 with RMC-6236, RMC-6236 with pembrolizumab and RMC-6291 with pembrolizumab justify investigation of the triplet combination of RMC-6291 and RMC-6236 with pembrolizumab as a potential chemotherapy-sparing option for patients with 1L NSCLC.

Investor Webcast
The Revolution Medicines investor webcast will begin at 8:00 a.m. Eastern Time. A link to participate in the live webcast can be accessed here and is also available on the Events and Presentations section of Revolution Medicines’ investor website at View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

On December 2, 2024 Agendia, Inc. reported the publication of a pivotal secondary analysis from the IDEAL randomized Phase 3 clinical trial in JAMA Network Open (Press release, Agendia, DEC 2, 2024, View Source [SID1234648742]). The study highlights the ability of the MammaPrint (MP) genomic assay to predict benefit of extended endocrine therapy (EET) in post-menopausal patients with early-stage, hormone receptor positive (HR+) breast cancer.

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The published study, titled Selection of Patients with Early-Stage Breast Cancer for Extended Endocrine Therapy: A Second Analysis of the IDEAL Randomized Clinical Trial, corroborates prior findings published from the NSABP B-42 trial, demonstrating that MP can identify patients who benefit most from EET and those with minimal benefit who can avoid associated side effects, thus optimizing adjuvant treatment decisions beyond traditional clinical risk factors.

This secondary analysis focused on MammaPrint’s predictive capacity of EET in preventing late recurrences among a translational cohort of 515 IDEAL patients. The cohort consisted of post-menopausal, hormone receptor-positive early breast cancer patients who were randomized to receiving 2.5- or 5-years of extended letrozole therapy after completing an initial 5 years of endocrine therapy. The original study did not show any benefit of 5 years over 2.5 years of endocrine therapy, however, through analysis using genomic profiling with MammaPrint, this study was able to identify a subset of patients who will benefit from EET. Key findings from the study include:

Significant benefit for MP Low-Risk Patients: MP Low-Risk patients derived the largest benefit from extended letrozole treatment at 10 years post-randomization. Researchers found an absolute benefit of 10.1% for distant recurrence (DR), 11.7% for recurrence-free interval (RFI), and 9.7% for breast cancer-free interval (BCFI) for MP Low-Risk patients. The effect of letrozole on the 10-year RFI rate was significantly dependent on MammaPrint classification.
No EET Benefit for MP High-Risk Patients: Patients with MP High-Risk tumors are more likely to relapse within the first 5 years of diagnosis and as evidenced by the results of the study, derive less benefit from extending endocrine therapy beyond the initial 5-years post-diagnosis.
Ultra-Low-Risk Findings: Although few patients in the cohort had a MP Ultra-Low tumor, they did not derive any EET benefit for the above endpoints, which is consistent with B42 where a larger number of ultralow patients were analyzed.
"By demonstrating MammaPrint’s ability to predict the benefit from extended endocrine therapy based on genomic risk, particularly the recurrence-free interval for Low-Risk patients, physicians are now better equipped to identify which patients will benefit from this treatment," said Laura van ‘t Veer, PhD, Professor of Laboratory Medicine, Co-Leader of the Breast Oncology Program and Director of Applied Genomics at the Helen Diller Family Comprehensive Cancer Center, University of California, Chief Research Officer and Co-Founder of Agendia. "These findings provide clinicians with a powerful tool to optimize endocrine treatment duration, potentially sparing MP High-Risk patients from unnecessary extended therapy while ensuring MP Low-Risk patients receive the full protective benefits they need."

"These data build upon the evidence gathered from the NSABP-42 study, providing further validation of MammaPrint’s genomic profiling to help refine treatment strategies and identify patients who are more likely to benefit from extended endocrine therapy," said William Audeh, MD, MS, Chief Medical Officer of Agendia. "We know that some hormone-positive breast cancer may have a risk for late recurrences, beyond five years, and these data show that MammaPrint can predict which of those recurrences are preventable by EET. Because MammaPrint looks at the biology of the tumor early in the treatment cycle, it can distinguish Low-Risk patients who will derive substantial benefit from extended endocrine therapy from High-Risk patients who will not. This approach not only optimizes therapeutic efficacy, but also minimizes unnecessary treatment for those unlikely to benefit, thereby enhancing overall patient care."

The data from both IDEAL and NSABP-B42 validate MP’s predictive ability to determine which patients will benefit from EET and which can avoid it, potentially improving long-term survival outcomes and quality of life. These findings expand MP’s clinical utility beyond guiding neoadjuvant and adjuvant chemotherapy decisions and towards optimizing the duration of adjuvant endocrine treatment.

On December 2, 2024 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to R289 for the treatment of patients with previously-treated transfusion dependent lower-risk myelodysplastic syndrome (LR-MDS) (Press release, Rigel, DEC 2, 2024, View Source [SID1234648726]). R2891, Rigel’s potent and selective dual inhibitor of IRAK1 and IRAK4, is being studied in an ongoing Phase 1b study evaluating the safety, tolerability, pharmacokinetics and preliminary activity in patients with LR-MDS who are relapsed or refractory to prior therapies.

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"We are pleased that R289 has been granted Fast Track designation, which underscores the significant unmet need for patients with transfusion dependent lower-risk MDS," said Raul Rodriguez, Rigel’s president and CEO. "By targeting inflammatory signaling, we believe that R289 has the potential to meaningfully improve the lives of those living with this disease."

"Lower-risk MDS affects a primarily elderly patient population that faces progressive cytopenias, particularly anemia, and treatment options for transfusion-dependent patients are limited," said Lisa Rojkjaer, M.D., Rigel’s chief medical officer. "This designation is based on initial data from the ongoing Phase 1b study and highlights the potential of R289 to be a new therapeutic option for these patients. We look forward to working closely with the FDA to advance the clinical development of R289."

Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. A drug that receives Fast Track designation may benefit from more frequent interactions with the FDA over the course of drug development. In addition, the Fast Track program allows for eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.

About R289
R289 is a prodrug of R835, an IRAK1/4 dual inhibitor, which has been shown in preclinical studies to block inflammatory cytokine production in response to toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) family signaling. TLRs and IL-1Rs play a critical role in the innate immune response and dysregulation of these pathways can lead to various inflammatory conditions. Chronic stimulation of both these receptor systems is thought to cause the pro-inflammatory environment in the bone marrow responsible for persistent cytopenias in lower-risk MDS patients.