On January 4, 2024 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, reported a clinical update, including its roadmap for advancing Nana-val’s clinical development in 2024 (Press release, Viracta Therapeutics, JAN 4, 2024, View Source [SID1234638985]). Nana-val (nanatinostat in combination with valganciclovir), is the company’s all-oral investigational therapy targeting Epstein-Barr virus-associated cancers.

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Anticipated Key 2024 Milestones
Pivotal NAVAL-1 study of Nana-val in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphomas

Complete enrollment of Stage 2 in the R/R EBV+ peripheral T-cell lymphoma (PTCL) cohort of patients treated with Nana-val (n=11) in the first quarter of 2024.
Report Stage 1 data from both arms of the R/R EBV+ PTCL cohort (in patients treated with nanatinostat, with [n=10] or without [n=10] valganciclovir) in the first half of 2024.
Meet with the U.S. Food and Drug Administration (FDA) to discuss additional requirements for accelerated approval by mid-2024.
Enroll patients with R/R EBV+ PTCL into the post-Phase 2 expansion cohort to support potential accelerated approval.
Present Stage 2 data from patients with R/R EBV+ PTCL in the second half of 2024.
Report Stage 1 data from patients with R/R EBV+ diffuse large B-cell lymphoma (DLBCL) and R/R EBV+ post-transplant lymphoproliferative disorder (PTLD) by year-end 2024.
Phase 1b/2 study of Nana-val in patients with advanced EBV+ solid tumors (Study 301)

Determine the recommended Phase 2 dose (RP2D) by investigating the novel split daily dosing (SDD) regimen at higher dose levels of Nana-val in the second half of 2024.
Initiate a dose-optimization cohort to confirm the RP2D as part of the study’s Phase 2 expansion by year-end 2024.
"Our primary focus in 2024 is the speed to market strategy for Nana-val in patients with relapsed or refractory EBV-positive PTCL, supported by its accelerating pace of enrollment into Stage 2 and plans to engage with the FDA to discuss Nana-val’s potential accelerated approval pathway in mid-2024," said Mark Rothera, President and Chief Executive Officer of Viracta. "Additionally, we are encouraged by the progress of the Phase 1b/2 trial of Nana-val in patients with advanced EBV-positive solid tumors, which is now enrolling and treating patients with the novel split daily dosing regimen, and we remain on track to expand the study into Phase 2 in 2024. The growing clinical data together with the recent orphan drug designation granted by FDA for the treatment of nasopharyngeal carcinoma further positions Nana-val as a tumor-agnostic approach to address the high unmet medical need for patients with EBV-associated cancers, including both lymphomas and solid tumors. With an anticipated cash runway into 2025, we are well-positioned for a successful 2024."

Recent Clinical Trial Updates
Pivotal NAVAL-1 study of Nana-val in patients with R/R EBV+ lymphomas

Completed enrollment of Stage 1 in the R/R EBV+ PTCL cohort of patients, and enrollment into Stage 2 continues to accelerate, as nearly half of the Stage 2 patients have been enrolled.
The protocol was amended to additionally enable enrollment of second-line R/R EBV+ DLBCL patients and R/R EBV+ PTLD patients, including pediatric EBV+ PTLD patients ≥ 12 years of age.
Phase 1b/2 study of Nana-val in patients with advanced EBV+ solid tumors (Study 301)

Initiated enrollment of the sixth dose cohort of patients with recurrent or metastatic (R/M) EBV+ nasopharyngeal carcinoma (NPC) evaluating the new SDD regimen.
In December 2023, the FDA granted an orphan drug designation (ODD) to Nana-val for the treatment of NPC, the fifth ODD granted to Nana-val by the FDA and the seventh ODD for Nana-val globally.
Confirmed partial responses without dose-limiting toxicities through the initial five dose cohorts. Further, new preclinical data presented at ESMO (Free ESMO Whitepaper) Asia Congress 2023 support continued dose-escalation to enhance Nana-val’s antitumor activity.
Best responses through the fifth dose cohort included two confirmed partial responses and five stable diseases out of 17 patients.
About NAVAL-1
NAVAL-1 (NCT05011058) is a global, multicenter, clinical trial of Nana-val in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma. This trial employs a Simon two-stage design where, in Stage 1, participants are enrolled into one of three indication cohorts based on EBV+ lymphoma subtype. If two objective responses are achieved within a lymphoma subtype in Stage 1 (n=10), then additional patients will be enrolled in Stage 2 for a total of 21 patients. EBV+ lymphoma subtypes demonstrating promising antitumor activity in Stage 2 may be further expanded following discussion with regulators to potentially support registration.

About the Phase 1b/2 Study of Nana-val in Patients with Advanced EBV+ Solid Tumors (Study 301)
This Phase 1b/2 trial (NCT05166577) is an open-label, multinational clinical trial evaluating Nana-val alone and in combination with pembrolizumab. The Phase 1b dose escalation part is designed to evaluate safety and to select the recommended Phase 2 dose (RP2D) of Nana-val in patients with recurrent or metastatic (R/M) Epstein-Barr virus-positive (EBV+) nasopharyngeal carcinoma (NPC). Along with the U.S. Food and Drug Administration’s Project Optimus initiative, at the start of Phase 2, up to 40 patients with R/M EBV+ NPC will be randomized to receive either the RP2D or a dose level below the RP2D in a dose-optimization cohort. Once the RP2D has been confirmed, up to 60 patients with R/M EBV+ NPC will be randomized to receive Nana-val at the RP2D with or without pembrolizumab to further evaluate antitumor activity, safety and tolerability, pharmacokinetics, and potential pharmacodynamic biomarkers. Additionally, patients with other advanced EBV+ solid tumors will be enrolled to receive Nana-val at the RP2D in a Phase 1b dose expansion cohort.

About Nana-val (Nanatinostat and Valganciclovir)
Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which are key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed or refractory (R/R) EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 clinical trial in patients with recurrent or metastatic (R/M) EBV+ NPC and other advanced EBV+ solid tumors.

About EBV-Associated Cancers
Approximately 90% of the world’s adult population is infected with EBV. Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of cells for the duration of the patient’s life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV-positive (EBV+) lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden including lymphoma, nasopharyngeal carcinoma (NPC), and gastric cancer.

On January 4, 2024 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported corporate updates on its research and development programs and upcoming milestones (Press release, Sensei Biotherapeutics, JAN 4, 2024, View Source [SID1234638984]).

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"In 2023, we significantly advanced our lead clinical asset while prudently maintaining our strong balance sheet," said John Celebi, President and Chief Executive Officer. "We believe SNS-101, which has demonstrated potentially best-in-class pharmacokinetics and tolerability at clinical doses far beyond other VISTA-targeted immunotherapies, has strong potential as a transformative option in multiple cancer indications. Given the favorable data thus far, we are expanding the SNS-101 Phase 1/2 clinical trial to include additional patients in a more focused set of indications as an intermediate stage to further optimize the Phase 2 study design with additional patient data while we prepare for an anticipated end of Phase 1 meeting with FDA by Q4 2024. As a result, we are dedicating additional resources to support this expanded clinical program while pausing the IND-enabling studies originally planned for our next TMAb product candidate. We expect these adjustments to extend our cash runway into the fourth quarter of 2025."

Highlights and Milestones

SNS-101

SNS-101 is a conditionally active antibody harnessing the acidic tumor microenvironment to target the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation). VISTA is implicated in numerous cancer indications and its expression correlates with low survival rates. Sensei is conducting a multi-center Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101 as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced solid tumors. Recent updates include:

As of January 2, 2024:
A total of 25 patients have been treated with SNS-101 across various dose levels, with 16 patients in the monotherapy arm and nine patients in the combination arm. There have been no dose limiting toxicities (DLT) observed across both the monotherapy arm and the combination arm.
In the monotherapy dose escalation arm, patients have cleared all planned dosing cohorts of 0.3, 1, 3, 10 and 15 mg/kg.
In the combination dose escalation arm, six patients have been enrolled in the first cohort and have cleared the DLT period at a dose level of 3.0 mg/kg SNS-101 + Libtayo. The second cohort at a dose level of 10.0 mg/kg SNS-101 + Libtayo has been enrolled and is pending clearance of the DLT period as determined by the study safety monitoring committee.
Following completion of dose escalation and prior to initiating the Phase 2 portion, the Company plans to enroll up to 40 additional patients in both monotherapy and in combination with Libtayo in specific tumor types to further optimize the design of the Phase 2 trial.
In the monotherapy dose expansion arm, Sensei plans to enroll up to 10 patients with microsatellite stable (MSS) colorectal cancer (CRC) at a dose level of 15 mg/kg.
In the combination dose expansion arm, Sensei plans to enroll up to 30 patients with MSS CRC, head and neck cancer (H&N), non-small cell lung cancer (NSCLC), and melanoma. The dose level will be determined following completion of the combination dose escalation phase of the study.
The solid tumor types were selected to focus the cancer indications on a basket of more commonly occurring histologies, including both "hot" (NSCLC, H&N, Melanoma) and "cold" (CRC) tumors where we believe SNS-101 has potential to provide clinical benefit based on VISTA biology and supporting preclinical data. All patients with "hot" tumors enrolling into the expansion arm are expected to have been previously treated with a PD1/L1 checkpoint inhibitor. Additional tumor types and doses may be considered for both the monotherapy and combination expansion arms.
Sensei expects to open enrollment in the monotherapy expansion arm later this month. The combination expansion arm will begin following completion of the combination dose escalation phase of this study.
Anticipated milestones for the SNS-101 Phase 1/2 clinical trial include:

Initial safety and pharmacokinetic data for the combination dose escalation arm of SNS-101 and Libtayo in Q1 2024
Topline data for the SNS-101 monotherapy dose escalation arm in Q2 2024
Topline data for the combination dose escalation arm of SNS-101 and Libtayo in Q3 2024
Initial data for the SNS-101 dose expansion cohorts by the end of 2024
Additional Corporate Updates

Sensei announces that Ron Weitzman, M.D., F.A.C.P., has joined Sensei as part-time Chief Medical Officer. Dr. Weitzman joined Sensei as a consultant in August 2022 and has been instrumental in the design and implementation of the ongoing Phase 1/2 clinical trial. Dr. Weitzman brings over 25 years experience leading oncology clinical studies ranging from early to late-stage clinical development, including a pivotal study for cabozantanib that led to its FDA approval. Dr. Weitzman has held leadership roles at various global biopharmaceutical companies, including Exelixis, Genentech and Novartis, and has served as a consulting CMO to various biotechnology companies for nearly a decade. Dr Weitzman is board-certified by the American Board of Internal Medicine in Medical Oncology and is an active member of the American College of Physicians.
Sensei has decided to realign its resources to fully support the Phase 1/2 clinical trial of SNS-101. As a result, Sensei will pause IND-enabling work on its preclinical-stage TMAb programs, including SNS-102 (VSIG4), SNS-103 (CD39) and SNS-201 (VISTAxCD28). During this time, preclinical work to characterize selected lead antibodies, including their mechanisms of action, and target biology is expected continue.
In 2023, Sensei selected lead candidates for both SNS-102 and SNS-201. SNS-102 is a conditionally active antibody targeting VSIG4 that is 585-fold more selective for VSIG4 at low pH conditions. SNS-201 is a bispecific antibody incorporating a CD28 agonist arm and a pH-sensitive anti-VISTA arm designed to conditionally activate CD28 under low pH conditions, such as those found in the tumor microenvironment, leading to T cell activation in the tumor while minimizing off-tumor toxicity.
This realignment of resources is expected to extend cash runway into the fourth quarter of 2025.

On January 4, 2024 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported the pricing of its previously announced public offering for the purchase and sale of 12,000,000 shares of common stock (or common stock equivalents in lieu thereof) and accompanying warrants to purchase up to an aggregate of 12,000,000 shares of common stock at a combined purchase price of $0.75 per share and accompanying warrant, resulting in total gross proceeds of $9.0 million, before deducting placement agent commissions and other estimated offering expenses (Press release, Sellas Life Sciences, JAN 4, 2024, View Source [SID1234638983]). The warrants have an exercise price of $0.75 per share, are immediately exercisable and will expire five years from the date of issuance.

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A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering.

The closing of the offering is expected to occur on or about January 8, 2024, subject to the satisfaction of customary closing conditions.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-255318) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). The offering will be made only by means of a prospectus supplement and accompanying prospectus. The preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the preliminary prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that SELLAS has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about SELLAS and such offering.

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 January 4, 2024 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported a collaboration with CONNECT, an international collaborative network of pediatric cancer centers, to conduct a Phase 2 clinical trial to evaluate REZLIDHIA (olutasidenib) in combination with temozolomide as maintenance therapy in newly diagnosed pediatric and young adult patients with high-grade glioma (HGG) harboring an isocitrate dehydrogenase-1 (IDH1) mutation (Press release, Rigel, JAN 4, 2024, View Source [SID1234638982]).

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Under the collaboration, CONNECT will include olutasidenib in CONNECT’s TarGeT-D, a molecularly guided Phase 2 umbrella clinical trial for HGG. The Rigel-sponsored arm will study post-radiotherapy administration of olutasidenib in combination with temozolomide followed by olutasidenib monotherapy as maintenance treatment in newly diagnosed pediatric and young adult patients (less than 39 years old) with IDH1 mutation positive HGG, including diffuse intrinsic pontine glioma (DIPG), an aggressive brain tumor with limited treatment options. Rigel will provide funding up to $3 million and study material over the four-year collaboration.

"We are excited to collaborate with CONNECT to evaluate olutasidenib in high grade glioma," said Raul Rodriguez, Rigel’s president and CEO. "We believe olutasidenib has potential in a variety of cancers where mIDH1 plays an important role and we look forward to generating new data in this disease state, which has a high unmet need. This collaboration builds on our hematology-oncology pipeline expansion strategy and enables us to explore the potential of olutasidenib in a focused and efficient manner."

This open label Phase 2 trial will be overseen by Drs. Santosh Valvi and Nicholas Gottardo, Perth Children’s Hospital, Dr. Michael J Fisher, Children’s Hospital of Philadelphia, and Dr. Maryam Fouladi, Nationwide Children’s Hospital, and aims to enroll approximately 60 patients. The primary objective of the olutasidenib arm of the trial is to estimate progression-free survival. The study will also characterize the safety, tolerability, and pharmacokinetics of olutasidenib in pediatric and young adult patients. The study is estimated to begin enrolling patients in the first half of 2024 and will fulfill Rigel’s post-marketing pediatric study requirement related to the FDA approval of REZLIDHIA in relapsed or refractory (R/R) AML.

In January 2023, data was published in the peer-reviewed journal Neuro-Oncology from a multicenter, open label, Phase 1b/2 trial of 26 patients with R/R and predominantly enhancing gliomas harboring an IDH1 mutation. The data showed that olutasidenib 150 mg BID was well tolerated and demonstrated preliminary evidence of clinical activity and prolonged disease control in this heavily pretreated population. The authors noted that olutasidenib is a potent, brain-penetrant, selective inhibitor of mutant IDH1.1 The paper, titled "Olutasidenib (FT-2102) in patients with relapsed or refractory IDH1-mutant glioma: A multicenter, open-label, phase Ib/II trial" can be accessed here.

REZLIDHIA is FDA-approved for the treatment of adult patients with R/R acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.

About REZLIDHIA
INDICATION
REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

WARNINGS AND PRECAUTIONS
Differentiation Syndrome
REZLIDHIA can cause differentiation syndrome. In the clinical trial of REZLIDHIA in patients with relapsed or refractory AML, differentiation syndrome occurred in 16% of patients, with grade 3 or 4 differentiation syndrome occurring in 8% of patients treated, and fatalities in 1% of patients. Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal. Symptoms of differentiation syndrome in patients treated with REZLIDHIA included leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, fever, edema, pyrexia, and weight gain. Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after treatment or after dose interruption of REZLIDHIA. Differentiation syndrome occurred as early as 1 day and up to 18 months after REZLIDHIA initiation and has been observed with or without concomitant leukocytosis.

If differentiation syndrome is suspected, temporarily withhold REZLIDHIA and initiate systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours) for a minimum of 3 days and until resolution of signs and symptoms. If concomitant leukocytosis is observed, initiate treatment with hydroxyurea, as clinically indicated. Taper corticosteroids and hydroxyurea after resolution of symptoms. Differentiation syndrome may recur with premature discontinuation of corticosteroids and/or hydroxyurea treatment. Institute supportive measures and hemodynamic monitoring until improvement; withhold dose of REZLIDHIA and consider dose reduction based on recurrence.

Hepatotoxicity
REZLIDHIA can cause hepatotoxicity, presenting as increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased blood alkaline phosphatase, and/or elevated bilirubin. Of 153 patients with relapsed or refractory AML who received REZLIDHIA, hepatotoxicity occurred in 23% of patients; 13% experienced grade 3 or 4 hepatotoxicity. One patient treated with REZLIDHIA in combination with azacitidine in the clinical trial, a combination for which REZLIDHIA is not indicated, died from complications of drug-induced liver injury. The median time to onset of hepatotoxicity in patients with relapsed or refractory AML treated with REZLIDHIA was 1.2 months (range: 1 day to 17.5 months) after REZLIDHIA initiation, and the median time to resolution was 12 days (range: 1 day to 17 months). The most common hepatotoxicities were elevations of ALT, AST, blood alkaline phosphatase, and blood bilirubin.

Monitor patients frequently for clinical symptoms of hepatic dysfunction such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Obtain baseline liver function tests prior to initiation of REZLIDHIA, at least once weekly for the first two months, once every other week for the third month, once in the fourth month, and once every other month for the duration of therapy. If hepatic dysfunction occurs, withhold, reduce, or permanently discontinue REZLIDHIA based on recurrence/severity.

ADVERSE REACTIONS
The most common (≥20%) adverse reactions, including laboratory abnormalities, were aspartate aminotransferase increased, alanine aminotransferase increased, potassium decreased, sodium decreased, alkaline phosphatase increased, nausea, creatinine increased, fatigue/malaise, arthralgia, constipation, lymphocytes increased, bilirubin increased, leukocytosis, uric acid increased, dyspnea, pyrexia, rash, lipase increased, mucositis, diarrhea and transaminitis.

DRUG INTERACTIONS

Avoid concomitant use of REZLIDHIA with strong or moderate CYP3A inducers.
Avoid concomitant use of REZLIDHIA with sensitive CYP3A substrates unless otherwise instructed in the substrates prescribing information. If concomitant use is unavoidable, monitor patients for loss of therapeutic effect of these drugs.
LACTATION
Advise women not to breastfeed during treatment with REZLIDHIA and for 2 weeks after the last dose.

GERIATRIC USE
No overall differences in effectiveness were observed between patients 65 years and older and younger patients. Compared to patients younger than 65 years of age, an increase in incidence of hepatotoxicity and hypertension was observed in patients ≥65 years of age.

HEPATIC IMPAIRMENT
In patients with mild or moderate hepatic impairment, closely monitor for increased probability of differentiation syndrome.

Click here for Full Prescribing Information, including Boxed WARNING.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

REZLIDHIA is a registered trademark of Rigel Pharmaceuticals, Inc.

On January 4, 2024 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, reported that Mark A. Goldsmith, M.D., Ph.D., the company’s chief executive officer and chairman, will deliver a corporate presentation as part of the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024, at 11:15 a.m. PT (Press release, Revolution Medicines, JAN 4, 2024, View Source [SID1234638981]).

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To access the live webcast of the presentation, please visit the "Events & Presentations" page of Revolution Medicines’ website at View Source Additionally, a replay of the webcast will be available on the "Events & Presentations" page of the Revolution Medicines website for at least 14 days following the conference.