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JP Morgan Healthcare Conference Day 2: Ideaya, Amgen, Revolution Medicines, Monte Rosa, and More

NEW YORK – The 40th Annual JP Morgan Healthcare Conference is being held virtually this week due to the ongoing coronavirus pandemic. The first day was very busy for firms operating in the precision oncology drug and testing markets, and our coverage of those presentations can be found here.  

Below are brief reports on individual presentations webcast by companies or through the JP Morgan conference portal on day two. 

Ideaya Biosciences 

In the coming year, Ideaya Biosciences expects to advance several precision oncology programs, including bringing two preclinical drugs closer to the clinic and expanding Phase I studies of its MAT2A inhibitor IDE-397.  

In the first half of 2022, the company expects to begin a Phase I trial of IDE-397 in combination with chemotherapy or an undisclosed drug in solid tumors with MTAP deletions, including non-small cell lung and gastric cancers. In a study of single-agent IDE-397, Ideaya hopes to expand patient cohorts to further explore the monotherapy in NSCLC and gastric cancer with MTAP deletions. 

Ideaya CEO Yujiro Hata highlighted that IDE-397 is designed to overcome the potency and toxicity issues that have limited the use of other drugs targeting MTAP deletions. "This compound is extremely potent in the MTAP deletion space, about 20 to 30 times more potent relative to the peer group," Hata explained. "The molecule is very selective. In this space, there have been other molecules that have had some off-target toxicity, specifically around liver injury and an enhanced bilirubin effect. Today, we have not observed any indication of liver effects in our studies." 

Additionally, Ideaya is collaborating with GlaxoSmithKline on combination studies involving IDE-397. Hata noted that in the first half of 2022, GSK will have the opportunity to option development of IDE-397. Under the terms of their collaboration, Ideaya was responsible for early clinical development of IDE-397 and GSK could option the drug for further development for an additional $50 million.  

The company is also working to file investigational new drug applications with the US Food and Drug Administration in 2022 for two of its preclinical programs, one targeting PARG and another targeting Pol Theta. Ideaya plans to file an IND for the PARG inhibitor in Q4 2022 and will begin IND-enabling studies for the Pol Theta candidate in the first half of the year, Hata said. 

As of Q3 2021, Ideaya, based in South San Francisco, California, had $386 million in cash that the company expects to fund operations through 2025. 

"We believe all of the programs in our portfolio have the opportunity to be a potential first in class agents," Hata said. "Synthetic lethality is an area that requires an integration of multiple technologies and multiple functional expertise spanning from cancer biology, bioinformatics, clinical development, diagnostic testing, and a very good understanding of clinical translational biology. We believe we're positioned to be the industry leader in synthetic lethality." 


Amgen's KRAS G12C inhibitor sotorasib (Lumykras in the EU; Lumakras in the US) is now available as a treatment for KRAS G12C-mutated advanced non-small cell lung cancer in 35 countries and is under regulatory review in several others around the world. Just this week, the European Commission granted conditional marketing authorization to sotorasib for KRAS G12C-mutated advanced NSCLC patients who have progressed on systemic therapy. Amgen CEO Robert Bradway described oncologists' adoption of sotorasib (Lumakras) to date in the NSCLC setting "pleasantly surprising." 

Last month, Amgen published data from the CodeBreaK 100 trial showing more modest efficacy of single-agent sotorasib in KRAS G12C-mutated advanced colorectal cancer patients, which raises questions about whether the drug has pan-tumor potential.  

However, Amgen is studying sotorasib within more than 11 combination regimes against lung cancer and other solid tumor types. Based on the recent data it has generated for sotorasib with its anti-EGFR monoclonal antibody panitumumab (Vectibix), for example, Bradway said that the firm will initiate a Phase III study of the combination in colorectal cancer. 

Beyond sotorasib, Amgen has several agents in its pipeline that it believes could generate growth during the second half of the decade. One such agent is bemarituzumab, a targeted drug in late-stage development for FGFR2b-positive, non-HER2-positive, gastric cancer patients. Amgen brought this agent into its pipeline when it acquired Five Prime Therapeutics for $1.9 billion this year. Bemarituzumab is in Phase III registrational studies in the gastric cancer space, but Amgen is also evaluating it in a Phase Ib trial for squamous NSCLC. 

Revolution Medicines 

In the first half of 2022, Revolution Medicines plans to submit investigational new drug applications with the US Food and Drug Administration for two of its most advanced RAS(ON) inhibitors, RMC-6236, which targets several KRAS mutation subtypes including KRAS G12C, G12D, G12V, and G12R; and RMC-6291, which targets KRAS G12C mutations. 

In preclinical research, RMC-6236 showed anti-tumor activity across lung, pancreatic, and colorectal cancers with common RAS variants. The drug could have efficacy in 137,000 new patients with KRAS-mutant cancers annually, estimated Revolution Medicines CEO Mark Goldsmith. The company plans to submit an IND in the coming months, which will allow for the start of a Phase I single-agent dose escalation trial involving patients with KRAS-mutant solid tumors. 

RMC-6291, the KRAS G12C inhibitor, is in a space that already has one approved drug, sotorasib (Amgen's Lumakras), for advanced non-small cell lung cancer. Revolution's goal with the Phase I trial of RMC-6291 is to "demonstrate clinical superiority to the first generation KRAS G12C inhibitors," said Goldsmith.

During the year, Redwood City, California-based Revolution expects to begin IND-enabling studies for two new programs — RMC-9805 and RMC-8839 — and file INDs with the FDA in 2023. RMC-8839 targets KRAS G13C mutations, which occur primarily in lung and certain colorectal cancers, while RMC-9805 targets KRAS G12D mutations, which occur in more than 50,000 newly diagnosed colorectal, lung, and pancreatic cancer patients each year. With the addition of these two drugs, Goldsmith noted that Revolution's pipeline now covers "virtually all of the RAS variants that cause pancreatic cancer." 

"We're on the verge of beginning to treat patients with some of these compounds, and the prospect of converting pancreatic cancer broadly into a treatable disease is now a realistic possibility within our viewfinder that deserves to be tested in the clinic," Goldsmith said. 

The company's RAS Companion programs, involving the SHP2 inhibitor RMC-4630 and the mutant TORC1 inhibitor RMC-5552, are also advancing in both monotherapy and combination studies in KRAS-mutant cancers.  

Beyond these four programs, Revolution has other agents in discovery phase that target various RAS hotspot mutations. The company said it will identify a fifth drug candidate to advance toward the clinical in the second half of 2022.  

As of Sept. 30, 2021, Revolution had $608 million in cash, cash equivalents, and marketable securities, which is expected to fund operations through the end of 2023. 

Monte Rosa 

Monte Rosa Therapeutics, a Boston-based biotech company that started trading on the Nasdaq this past June, is eyeing an investigational new drug filing in mid-2022 for its lead product MRT-2359, a molecular glue-based protein degrader designed to target GSPT1, a synthetic lethal target in various cancers driven by the MYC family of transcription factors. 

In the Phase I trial, Monte Rosa is planning to start by enrolling patients with non-small cell lung cancer and small cell lung cancer as well as patients with large B-cell lymphoma and other solid tumors. The trial will progress to a dose expansion phase and branch into multiple cohorts. One cohort will involve NSCLC patients enriched for high L- and N-MYC expression; a second cohort will involve SCLC patients enriched for high L- and N-MYC expression; and a third cohort will involve patients with solid tumor specifically selected based on L- or N-MYC amplification. 

Monte Rosa CEO Markus Warmuth said the company is using "established clinical assays" to determine L- and N-MYC amplification in study participants but did not specify which tests. For the MYC expression-enriched lung cancer cohorts, he said Monte Rosa has prespecified cutoff levels based on cell-line and xenograft model data as well as real-world data for MYC expression. The L- or N-MYC amplification cohort will include patients screened using established assays, likely with cutoffs of six copy gains, Warmuth said.  

He emphasized that the company is still in the process of developing this trial's final protocol, so details are not set in stone, but the trial protocol will mandate pre- and post-treatment biopsies to perform additional biomarker analyses. 

Beyond the GSPT1 candidate, Monte Rosa has publicly disclosed four additional programs in the discovery stage, including a CDK2-targeted therapy that it plans to develop for ovarian and breast cancers.  

As of the end of September last year, the drugmaker had $367 million available in cash.

Sophia Genetics 

Sophia CFO Ross Muken provided a first update on DEEP-Lung-IV, a multimodal study of metastatic non-small cell lung cancer that the firm announced at the Radiological Society of North America conference last month. The company is partnering with research institutions to conduct deep learning-based analysis of clinical, biological, genomic, and radiomic data to find and validate markers that might predict immunotherapy response.  

Plans are to follow 4,000 patients at 30 sites worldwide. Sophia said it has signed up 12 sites in five countries so far, including the Carbone Comprehensive Cancer Center at the University of Wisconsin and Assistance Publique-Hôpitaux de Paris in France.  

Myriad Genetics 

In the first quarter of 2022, Myriad Genetics will launch a testing service, called Precise Oncology Solutions, that oncologists can use to simultaneously garner insights about a cancer patient's hereditary cancer risk as well as the drugs they'll likely respond to.

The Salt Lake City-based company has been developing the testing service under a collaboration with Intermountain Health and Illumina that was announced last year. The service will allow doctors to order, at the same time, Myriad's myRisk germline test for hereditary cancer risk; its myChoice CDx for assessing homologous recombination deficiency in ovarian cancer patients and predicting response to PARP inhibitors; and a comprehensive tumor panel developed by Intermountain, called Precise Tumor, that is based on Illumina's TSO 500 assay and can identify treatment opportunities with a variety of targeted drugs and immunotherapies.   

Myriad CEO Paul Diaz noted that although myChoice CDx is currently only available to direct the use of PARP inhibitors for ovarian cancer patients, the test is being evaluated in more than a dozen clinical trials with drugs for breast, prostate, and pancreatic cancer, which together represent a $2 billion annual market opportunity for the test. Myriad is hoping to launch myChoice CDx in new indications starting in 2024.

The company is also eyeing the liquid biopsy market, both for therapy selection and for measurable residual disease detection to track progression and cancer relapse. The company is in discussions with potential partners about developing a liquid biopsy therapy selection test that it hopes to launch sometime in 2023. For the MRD test, Myriad is hoping to leverage whole-exome sequencing and other technologies it has access to through existing partnerships and to develop a differentiated test for the market in 2024 or 2025. 

"We're going to go about it in a different way," Diaz said, recognizing that the MRD market is a crowded one. "A lot of people are ahead of us." But he noted that Myriad has a lot of in-house capabilities, as well as expertise and technologies it can leverage through its partnerships with Illumina and Intermountain, that will allow it to advance a differentiated MRD product.  

"We don't think we can take over the [liquid biopsy] market," he said. "But we think we can own our fair share of the market."