About Us | ScientistRAIN Rain Therapeutics Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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Milademetan (RAIN-32)
Intimal sarcoma
|
Phase 2
Phase 2
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Phase 2 trial to be initiated early 2022.
|
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Milademetan (RAIN-32) - (basket trial)
Solid tumors
|
Phase 2
Phase 2
|
Phase 2 trial to be initiated 2H 2021.
|
|
Milademetan (RAIN-32) - (MANTRA)
Liposarcoma
|
Phase 3
Phase 3
|
Phase 3 trial initiation announced July 20, 2021.
|
Latest News
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NEWARK, Calif., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Rain Therapeutics Inc., (NASDAQ:RAIN) a late-stage company developing precision oncology therapeutics, today announced it will report financial results for the second quarter that ended June 30, 2021 and highlights of recent progress, on Tuesday, August 10, 2021. On that day, management will host a conference call and webcast at 1:30 p.m. PT (4:30 p.m. ET) to discuss the Company's business and financial results.
Conference Call and Webcast Details:
Date: August 10, 2021
Time: 1:30 p.m. PT (4:30 p.m. ET)
Dial In Numbers: 1 (800) 708-4539 (U.S. Toll Free) / 1 (847) 619-6396 (U.S. Toll)
Passcode: 50202648
Webcast Link: https://edge.media-server.com/mmc/p/4ar5rh24The call will be recorded and available for replay on the Company's website for approximately 30 days after the call.
About Rain Therapeutics Inc.
Rain Therapeutics Inc. is a late-stage precision oncology company developing therapies that target oncogenic drivers for which it is able to genetically select patients it believes will most likely benefit. This approach includes using a tumor-agnostic strategy to select patients based on their tumors' underlying genetics rather than histology. Rain's lead product candidate, milademetan (RAIN-32), is a small molecule, oral inhibitor of MDM2, which is oncogenic in numerous cancers. In addition to milademetan, Rain is also developing a preclinical program that is focused on inducing synthetic lethality in cancer cells by inhibiting RAD52. For more information, visit www.rainthera.com.Media Contact for Rain:
Grace Fotiades
LifeSci Communications
+1.646.876.5026
[email protected]
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The randomized, multi-center, open-label Phase 3 trial will evaluate the efficacy and safety of milademetan in patients with de-differentiated (DD) liposarcoma (LPS)
Multiple patients with liposarcoma have demonstrated long-term therapy with milademetan monotherapy now exceeding 4 years
NEWARK, Calif., July 20, 2021 (GLOBE NEWSWIRE) -- Rain Therapeutics Inc., a clinical-stage company developing precision oncology therapeutics, today announced that the first patient has been randomized in the multicenter, open-label, Phase 3 registrational study (MANTRA) evaluating milademetan (RAIN-32), an oral mouse double minute 2 (MDM2) inhibitor, for the treatment of DD LPS.
"The start of our Phase 3 MANTRA study evaluating milademetan marks an important step forward in addressing a high unmet need for patients with DD LPS," said Richard Bryce, MBChB, Chief Medical Officer at Rain Therapeutics. "We are proud to have advanced milademetan into a pivotal study less than 12 months after acquiring the program, and believe it has the potential to be the best-in-class MDM2 inhibitor."
The MANTRA trial, a randomized, multicenter, open-label, Phase 3 registrational study, is designed to evaluate the safety and efficacy of RAIN-32 compared to trabectedin, a current standard of care, in patients with unresectable or metastatic DD LPS with or without a well-differentiated (WD) LPS component that has progressed on one or more prior systemic therapies, including at least one anthracycline-based therapy. Approximately 160 patients are expected to be randomized in a 1:1 ratio to receive milademetan or trabectedin. The primary objective of the trial is to compare progression-free survival (PFS) by blinded independent review between the milademetan treatment arm and the trabectedin control arm. Secondary endpoints include overall survival, PFS by investigator assessment, objective response rate, duration of response, disease control rate, safety and patient reported outcomes.
The Company also provided an update on patients continuing to receive RAIN-32 monotherapy from the previously concluded Phase 1 dose escalation and expansion study. As of July 1, 2021, three WD/DD LPS patients received therapy with milademetan monotherapy for greater than 51 months. Two of these patients continue to receive therapy with durations now at 51 and 57 months without disease progression, and an additional patient received therapy for greater than 59 months before discontinuation in the second quarter of 2021. This highlights the potential for a favorable milademetan long-term tolerability and safety profile.
About Well-Differentiated/Dedifferentiated Liposarcoma
Liposarcoma is a rare cancer originating from fat cells located in the soft tissues of the body. It is a malignant cancer that can spread to other parts of the body. Well-differentiated LPS is less aggressive and tends to be a large painless mass found in deeper tissues. Dedifferentiated (DD) LPS is more aggressive, arising from WD LPS, and is usually found in tissue behind the abdominal area or the extremities. WD/DD LPS are the most frequent subtypes of LPS and share common genomic abnormalities, predominately MDM2 gene amplification. The incidence of LPS is estimated at approximately 3,000 patients annually in the U.S. for which there are few effective treatment options.About RAIN-32
Milademetan (RAIN-32) is a small molecule, oral inhibitor of MDM2, which is oncogenic in numerous cancers. Milademetan has already demonstrated meaningful antitumor activity in an MDM2-amplified subtype of LPS and other solid tumors in a Phase 1 clinical trial, validating a rationally-designed dosing schedule to mitigate safety concerns and widen the therapeutic window of MDM2 inhibition. In addition to the ongoing Phase 3 clinical trial evaluating milademetan in patients with LPS, Rain Therapeutics anticipates commencing a Phase 2 tumor-agnostic basket trial in certain solid tumors in the second half of 2021 and a Phase 2 trial in intimal sarcoma by early 2022. Milademetan has received U.S. Food and Drug Administration Orphan Drug Designation for patients with LPS.About Rain Therapeutics Inc.
Rain Therapeutics Inc. is a clinical-stage precision oncology company developing therapies that target oncogenic drivers for which it is able to genetically select patients it believes will most likely benefit. This approach includes using a tumor-agnostic strategy to select patients based on their tumors' underlying genetics rather than histology. Rain's lead product candidate, milademetan (RAIN-32), is a small molecule, oral inhibitor of MDM2, which is oncogenic in numerous cancers. In addition to milademetan, Rain is also developing a preclinical program that is focused on inducing synthetic lethality in cancer cells by inhibiting RAD52. For more information, visit www.rainthera.com.Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, Rain's ongoing and planned studies for RAIN-32 (milademetan). Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "plans," "will", "anticipates," "goal," "potential," "expects" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Rain's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Rain's business in general and limited operating history, difficulty enrolling patients in our clinical trials given the relatively small LPS patient population, Rain's reliance on third parties to conduct and support its preclinical studies and clinical trials, and the other risks described in Rain's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Rain undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.Media Contact for Rain:
Grace Fotiades
LifeSci Communications
+1.646.876.5026
[email protected] -
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NEWARK, Calif., June 03, 2021 (GLOBE NEWSWIRE) -- Rain Therapeutics Inc., a clinical-stage company developing precision oncology therapeutics, today announced a master program and a genomic analysis platform agreement for comprehensive genomic profiling tests utilizing artificial intelligence and precision medicine company Tempus' genomic analysis platform. Under the terms of the agreement, Tempus will provide both centralized tumor testing and patient matching services using their Connect & TIME Trial® Network for the planned Phase 2 MDM2-amplified tumor-agnostic basket trial for RAIN-32, an oral MDM2 inhibitor in patients with certain solid tumors with pre-specified MDM2 amplification levels and wild type p53. The study is expected to commence in the second half of 2021.
"We are excited to enhance our tumor agnostic, MDM2-amplified basket trial strategy through this collaboration with Tempus, a company that shares our patient-centric mission," said Robert Doebele, M.D., Ph.D., cofounder and chief scientific officer at Rain Therapeutics. "Tempus' suite of DNA- and RNA-based tumor sequencing capabilities, including Tempus|xT and Tempus|xE, and comprehensive tumor profiling tests for solid tumors, will be invaluable as we seek to genetically identify and enroll patients with MDM2-dependent tumors in our novel Phase 2 basket trial evaluating RAIN-32."
"Roughly two-thirds of the U.S. population is located within 100 miles of an active TIME Trial site, giving patients access to genomically matched clinical trials with cutting-edge investigative therapies closer to home," said Dr. Kimberly Blackwell, Chief Medical Officer at Tempus. "We look forward to collaborating with Rain Therapeutics on their exciting Phase 2 asset, RAIN-32, and making this trial option available to patients facing MDM2-amplified cancer."About RAIN-32
RAIN-32 (milademetan, formerly known as DS-3032), is a small molecule, oral inhibitor of mouse double minute 2 (MDM2), which is oncogenic in numerous cancers. Rain in-licensed RAIN-32 in September 2020 based on the results of a Phase 1 clinical trial, which demonstrated meaningful antitumor activity in an MDM2-amplified subtype of liposarcoma (LPS) and other solid tumors. This trial also validated a rationally-designed dosing schedule that has been shown to mitigate safety concerns and widen the therapeutic window of MDM2 inhibition, unlocking the potential for RAIN-32 in a broad range of MDM2-dependent cancers. Based on these data, we anticipate commencing a pivotal Phase 3 trial in LPS in the second half of 2021, a Phase 2 tumor-agnostic basket trial in certain solid tumors in the second half of 2021 and a Phase 2 trial in intimal sarcoma by early 2022. RAIN-32 has received U.S. Food and Drug Administration (FDA) Orphan Drug Designation for patients with liposarcoma.
About Rain Therapeutics Inc.
Rain Therapeutics Inc. is a clinical-stage precision oncology company developing therapies that target oncogenic drivers for which it is able to genetically select patients it believes will most likely benefit. This approach includes using a tumor-agnostic strategy to select patients based on their tumors' underlying genetics rather than histology. Rain's lead product candidate, RAIN-32 (milademetan, formerly known as DS-3032), is a small molecule, oral inhibitor of MDM2, which is oncogenic in numerous cancers. In addition to RAIN-32, Rain is also developing a preclinical program that is focused on inducing synthetic lethality in cancer cells by inhibiting RAD52.For more information, visit www.rainthera.com.Media Contact for Rain:
Grace Fotiades
LifeSci Communications
+1.646.876.5026
[email protected] -
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NEWARK, Calif., June 02, 2021 (GLOBE NEWSWIRE) -- Rain Therapeutics Inc. ("Rain"), a clinical-stage company developing precision oncology therapeutics, today announced a patient referral partnership with Caris Life Sciences ("Caris"). Under the terms of the partnership, Caris will provide patient referral services using their molecular intelligence (MI) trials platform for Rain's planned Phase 2 MDM2-amplified tumor-agnostic basket trial for RAIN-32, an oral MDM2 inhibitor in patients with certain solid tumors with pre-specified MDM2 amplification levels and wild type p53.
"We are thrilled to partner with Caris, a company that shares our precision oncology mission, to identify patients for our tumor agnostic, MDM2-amplified basket trial strategy," said Robert Doebele, M.D., Ph.D., co-founder, president and chief scientific officer of Rain. "Caris' whole exome and whole transcriptome tumor sequencing assays will be critical for enrollment for the Phase 2 study, which is expected to commence in the second half of 2021."
"Caris puts the patient at the center of everything we do, and we are pleased to partner with Rain on this novel tissue-agnostic clinical study," said Brian Lamon, Ph.D., Chief Business Officer, Head of BioPharma Business Development for Caris. "As the pioneer and industry leader in molecular profiling, this partnership builds upon our mission to save and extend patients' lives through the most comprehensive molecular and artificial intelligence available in the industry."
About RAIN-32
RAIN-32 (milademetan, formerly known as DS-3032), is a small molecule, oral inhibitor of mouse double minute 2 (MDM2), which is oncogenic in numerous cancers. Rain in-licensed RAIN-32 in September 2020 based on the results of a Phase 1 clinical trial, which demonstrated meaningful antitumor activity in an MDM2-amplified subtype of liposarcoma (LPS) and other solid tumors. This trial also validated a rationally-designed dosing schedule that has been shown to mitigate safety concerns and widen the therapeutic window of MDM2 inhibition, unlocking the potential for RAIN-32 in a broad range of MDM2- dependent cancers. Based on these data, we anticipate commencing a pivotal Phase 3 trial in LPS in the second half of 2021, a Phase 2 tumor-agnostic basket trial in certain solid tumors in the second half of 2021 and a Phase 2 trial in intimal sarcoma by early 2022. RAIN-32 has received U.S. Food and Drug Administration (FDA) Orphan Drug Designation for patients with liposarcoma.About Rain Therapeutics Inc.
Rain Therapeutics Inc. is a clinical-stage precision oncology company developing therapies that target oncogenic drivers for which it is able to genetically select patients it believes will most likely benefit. This approach includes using a tumor-agnostic strategy to select patients based on their tumors' underlying genetics rather than histology. Rain's lead product candidate, RAIN-32 (milademetan, formerly known as DS-3032), is a small molecule, oral inhibitor of MDM2, which is oncogenic in numerous cancers. In addition to RAIN-32, Rain is also developing a preclinical program that is focused on inducing synthetic lethality in cancer cells by inhibiting RAD52. For more information, visit www.rainthera.com.About Caris Life Sciences
Caris Life Sciences® is a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine through quality and innovation. The company's suite of market-leading molecular profiling offerings assesses DNA, RNA and proteins to reveal a molecular blueprint that helps physicians and cancer patients make more precise and personalized treatment decisions. MI Exome™ whole exome sequencing with 22,000 DNA genes, and MI Transcriptome™ whole transcriptome sequencing with 22,000 RNA genes along with cancer-related pathogens, bacteria, viruses and fungi analysis run on every patient provides the most comprehensive and clinically relevant DNA and RNA profiling available on the market.Caris is also advancing precision medicine with Caris Artificial Intelligence, combining its market leading service offering, Caris Molecular Intelligence® with its proprietary artificial intelligence analytics engine, DEAN™, to analyze the whole exome, whole transcriptome and complete cancer proteome. This information, coupled with mature clinical outcomes on thousands of patients, provides unmatched molecular solutions for patients, physicians, payers and biopharmaceutical organizations.
Caris Pharmatech™ is changing the paradigm and streamlines the clinical trial process by connecting biopharma companies with research-ready oncology sites for clinical trials. With over 420 research sites within the Caris Pharmatech Just-In-Time (JIT) Oncology Network, biopharma companies can identify and enroll more patients, faster. Caris Pharmatech Just-In-Time Clinical Trial Solutions focus on rapid site activation and patient enrollment to streamline the drug development process. By implementing Caris' Just-In-Time Trial-Matching System, Caris will automatically match patients to clinical trials and sites can be activated and eligible to enroll patients within one week.
Headquartered in Irving, Texas, Caris Life Sciences has offices in Phoenix, Denver, New York, and Basel, Switzerland. Caris provides services throughout the U.S., Europe, Asia and other international markets. To learn more, please visit CarisLifeSciences.com or follow us on Twitter (@CarisLS).
Forward Looking Statements
Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, our expectations regarding our clinical trials. Words such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "promises," "estimate," "predict," "potential," "develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While we believe these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in our filings with the U.S. Securities and Exchange Commission (the "SEC")), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include: expectations regarding the initiation our Phase 2 clinical trial; expectations regarding the partnership with Caris and other risks and uncertainties identified in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, filed with the U.S. SEC. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.Rain Media Contact:
Grace Fotiades
LifeSci Communications
+1.646.876.5026
[email protected]Caris Life Sciences Media Contact:
Lindsey Bailys
GCI Health
1-212-798-9884
[email protected] -
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NEWARK, Calif., May 27, 2021 (GLOBE NEWSWIRE) -- Rain Therapeutics Inc. ("Rain"), a clinical-stage company developing precision oncology therapeutics, today announced that Avanish Vellanki, co-founder, chairman and chief executive officer of Rain, will present a corporate overview and participate in one-on-one investor meetings at the Goldman Sachs 42nd Annual Global Healthcare Conference taking place virtually from June 8-11, 2021.
Presentation details can be found below:
Date: Thursday, June 10, 2021
Time: 5:30 p.m. ET
Location: Webcast Link – or at the company's website (click here)A replay of the presentation will be available by visiting the "Events & Presentations" section of the Rain website after the conclusion of the presentation and will be archived on the Rain website for 30 days.
About Rain Therapeutics Inc.
Rain Therapeutics Inc. is a clinical-stage precision oncology company developing therapies that target oncogenic drivers for which it is able to genetically select patients it believes will most likely benefit. This approach includes using a tumor-agnostic strategy to select patients based on their tumors' underlying genetics rather than histology. Rain's lead product candidate, RAIN-32 (milademetan, formerly known as DS-3032), is a small molecule, oral inhibitor of MDM2, which is oncogenic in numerous cancers. In addition to RAIN-32, Rain is also developing a preclinical program that is focused on inducing synthetic lethality in cancer cells by inhibiting RAD52. For more information, visit www.rainthera.com.Media Contact:
Grace Fotiades
LifeSci Communications
+1.646.876.5026
[email protected]