PMVP PMV Pharmaceuticals Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
PC14586
Solid tumors
|
Phase 1/2
Phase 1/2
|
Phase 1/2 dosing of first patient announced November 23, 2020.
|
Latest News
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- Presented late breaking preclinical data on PC14586, the Company's first-in-class, tumor-agnostic, investigational small molecule p53 Y220C reactivator at the American Association for Cancer Research Annual Meeting 2021
- Expanded Board of Directors with the appointment of Charles M. Baum, M.D., Ph.D.
- Appointed Guillermina (Gigi) Lozano, Ph.D. to the Scientific Advisory Board
CRANBURY, N.J., May 14, 2021 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (NASDAQ:PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants, today reported financial results for the quarter ended March 31, 2021 and provided corporate highlights.
"PMV had a successful first quarter. We continued to advance our clinical and discovery programs, and our presentation at AACR provided compelling evidence that PC14586 selectively reactivates the p53 Y220C mutant protein, both in vitro and in vivo," said David Mack, Ph.D., President and Chief Executive Officer. "Enrollment in our Phase 1/2 trial of PC14586, our first in class p53 Y220C reactivator, is progressing as planned. We are also thrilled to have welcomed Chuck Baum to our Board and Gigi Lozano to our SAB and look forward to leveraging their deep expertise in precision therapeutics and genetic drivers of cancer."
Corporate Highlights:
- In March 2021, PMV Pharma presented late breaking preclinical data on PC14586, the Company's first-in-class, tumor-agnostic, investigational small molecule p53 Y220C reactivator at the American Association for Cancer Research Annual Meeting 2021. The Oral presentation titled, "PC14586: The First Orally Bioavailable Small Molecule Reactivator of Y220C Mutant p53 in Clinical Development" was given by Melissa L. Dumble, Ph.D., Vice President Preclinical Development and Translational Science of PMV.
- PMV Pharma continued to enroll patients in the Phase 1 portion of a Phase 1/2 clinical trial of PC14586 (NCT04585750). PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation.
- Appointment of Charles Baum, M.D., Ph.D., to the Board of Directors. Dr. Baum is the President and Chief Executive Officer and a Board Member of Mirati Therapeutics Inc.
- Expanded Scientific Advisory Board with the appointment of p53 pioneer Dr. Guillermina (Gigi) Lozano, Professor and Chair, Department of Genetics, MD Anderson Cancer Center.
- PMV Pharma is the process of relocating to a state-of-the-art laboratory and office building located in Princeton, NJ.
First Quarter 2021 Financial Results
- PMV Pharma ended the fourth quarter with $348.4 million in cash, cash equivalents, and marketable securities, compared to $361.4 million as of December 31, 2020. Net cash used in operations was $12.9 million for the three months ended March 31, 2021 compared to $8.1 million for the three months ended March 31, 2020.
- Net loss for the quarter ended March 31, 2021 was $11.6 million compared to $7.3 million for the quarter ended March 31, 2020.
- Research and development (R&D) expenses were $7.5 million for the three months ended March 31, 2021 compared to $6.0 million for the three months ended March 31, 2020. The increase in R&D expenses was primarily related to increased headcount and clinical expenses for advancing development of PC14586, the Company's lead drug candidate.
- General and administrative (G&A) expenses were $4.2 million for the three months ended March 31, 2021, compared to $1.7 million for the three months ended March 31, 2020. The increase in G&A expenses was primarily due to expanding the infrastructure necessary for operating as a public company.
About p53
p53 plays a pivotal role in preventing abnormal cells from becoming a tumor by inducing programmed cell death. Mutant p53 takes on oncogenic properties that endow cancer cells with a growth advantage and resistance to anti-cancer therapy. The p53 Y220C mutation is associated with many cancers, including but not limited to breast, non-small cell lung cancer, colorectal, pancreatic, and ovarian cancers.
About PC14586
PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have the p53 Y220C mutation and has been granted Fast Track designation by the U.S. FDA.
About PMV Pharma
PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants. p53 mutations are found in approximately half of all cancers. The field of p53 biology was established by our co-founder Dr. Arnold Levine when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize over four decades of p53 biology, PMV Pharma combines unique biological understanding with pharmaceutical development focus. PMV Pharma is headquartered in Cranbury, New Jersey. For more information, please visit www.pmvpharma.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. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company's future plans or expectations for PC14586, including expectations regarding the timing for patient enrollment and success of its current clinical trial for PC14586; the future plans or expectations for the Company's discovery platform; and the period over which the Company estimates its existing cash and cash equivalents will be sufficient to fund its current operating plan. Any forward-looking statements in this statement are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the Company's product candidate development activities and planned clinical trials, the Company's ability to execute on its strategy and operate as an early clinical stage company, the potential for clinical trials of PC14586 or any future clinical trials of other product candidates to differ from preclinical, preliminary or expected results, the Company's ability to fund operations, and the impact that the current COVID-19 pandemic will have on the Company's clinical trials, supply chain, and operations, as well as those risks and uncertainties set forth in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on March 3, 2021, the Company's Quarterly Report on Form 10-Q filed with the SEC on May 14, 2021 and its other filings filed with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
PMV Pharmaceuticals, Inc.
Consolidated Balance Sheet Data
(unaudited, in thousands)March 31,
2021
(unaudited)December 31,
2020Assets Current assets: Cash and cash equivalents $ 208,783 $ 361,422 Marketable securities, current 122,706 — Prepaid expenses and other current assets 3,464 3,339 Total current assets 334,953 364,761 Property and equipment, net 697 569 Marketable securities, noncurrent 16,891 — Right-of-use assets, operating leases 828 — Other assets 1,024 201 Total assets $ 354,393 $ 365,531 Liabilities, Convertible Preferred Stock, and Stockholders' Equity Current liabilities: Accounts payable $ 1,252 $ 1,607 Accrued expenses 3,878 4,803 Operating lease liability, current 666 — Total current liabilities 5,796 6,410 Operating lease liability, noncurrent 302 — Total liabilities 6,098 6,410 Stockholders' equity: Common stock — — Additional paid-in capital 469,790 469,001 Accumulated deficit (121,482 ) (109,880 ) Accumulated other comprehensive loss (13 ) — Total stockholders' equity 348,295 359,121 Total liabilities and stockholders' equity $ 354,393 $ 365,531 PMV Pharmaceuticals, Inc.
Statements of Operations and Comprehensive Loss
(unaudited, in thousands, except share and per share amounts)Three Months Ended March 31, 2021 2020 Operating expenses: Research and development $ 7,500 $ 5,955 General and administrative 4,174 1,699 Total operating expenses 11,674 7,654 Loss from operations (11,674 ) (7,654 ) Other income (expense): Interest income, net 128 406 Other expense (52 ) (5 ) Total other income 76 401 Loss before provision for income taxes (11,598 ) (7,253 ) Provision for income taxes 4 2 Net loss (11,602 ) (7,255 ) Unrealized gains (losses) on marketable securities, net of tax (13 ) (80 ) Comprehensive loss $ (11,615 ) $ (7,335 ) Net loss per share -- basic and diluted $ (0.26 ) $ (2.38 ) Weighted-average common shares outstanding 44,785,226 3,046,200 Contact
For Investors & Media:
Winston Kung
Chief Financial Officer
[email protected]
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CRANBURY, N.J., May 05, 2021 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (NASDAQ:PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants, today announced that David H. Mack, Ph.D., President & Chief Executive Officer, will present at the Bank of America Healthcare Conference on Thursday, May 13, 2021. The company will also participate in one-on-one investor meetings at the conference.
Details on the presentation can be found below.
Bank of America Healthcare Conference Date: Thursday, May 13, 2021 Time: 12:30 PM ET Webcast: http://www.veracast.com/webcasts/bofa/hc2021/idMy79HJ.cfm A replay of the presentation will be available by visiting the "Events & Presentations" section of the PMV Pharmaceuticals website.
About PMV Pharma
PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants. p53 mutations are found in approximately half of all cancers. The field of p53 biology was established by our co-founder Dr. Arnold Levine when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize over four decades of p53 biology, PMV Pharma combines unique biological understanding with pharmaceutical development focus. PMV Pharma is headquartered in Cranbury, New Jersey. For more information, please visit www.pmvpharma.com.
Contact
For Investors & Media:
Winston Kung
Chief Financial Officer
[email protected] -
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- PC14586 selectively stabilizes the p53 Y220C mutant and restores p53 activity
- Robust in vivo tumor regression observed with once daily oral dosing
- Pharmacodynamic biomarkers of p53 activation developed for clinical trials
- PC14586 is being tested in a Phase 1/2 clinical trial in patients with advanced solid tumors that have a p53 Y220C mutation
CRANBURY, N.J., April 10, 2021 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (NASDAQ:PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants, today presented preclinical data on PC14586, the Company's first-in-class, tumor-agnostic, small molecule p53 reactivator at the American Association for Cancer Research Annual Meeting 2021.
"The preclinical data provide compelling evidence that PC14586 selectively reactivates the p53 Y220C mutant protein, both in vitro and in vivo," said David Mack, Ph.D., President and Chief Executive Officer of PMV. "PC14586 stabilization of the p53 Y220C mutant in the wild-type conformation reactivates p53 activity, which leads to robust tumor regression in mouse xenograft models and has the potential to offer a novel treatment for patients with Y220C genetically defined cancers."
Key Presentation Highlights:
Oral presentation titled, "PC14586: The First Orally Bioavailable Small Molecule Reactivator of Y220C Mutant p53 in Clinical Development" presented by Melissa L. Dumble, Ph.D., Vice President Preclinical Development and Translational Science of PMV.
- PC14586 non-covalently binds to and stabilizes the p53 Y220C mutant in the wild-type conformation
- PC14586 selectively reactivates p53-mediated transcription in cells harboring the p53 Y220C mutation, with no observed activity in wild-type cells or those with other p53 mutations
- PC14586 inhibits proliferation across cell lines harboring the p53 Y220C mutation, with no effects on p53 knock-out or wild-type cells
- Once daily oral administration of PC14586 results in robust tumor regression in a NUGC3 human gastric cancer xenograft mouse model
- Pharmacodynamic biomarkers of p53 activity (e.g. target gene expression, p21, MDM2 and MIC-1 protein expression) have been developed and modeled for clinical implementation
- Enrollment is ongoing in a Phase 1/2 clinical trial of PC14586 in patients with advanced solid tumors with a p53 Y220C mutation. For information on the Phase 1/2 trial, please visit www.clinicaltrials.gov (NCT study identifier NCT04585750)
About p53
p53 plays a pivotal role in preventing abnormal cells from becoming a tumor by inducing programmed cell death. Mutant p53 takes on oncogenic properties that endow cancer cells with a growth advantage and resistance to anti-cancer therapy. The p53 Y220C mutation is associated with many cancers, including but not limited to breast, non-small cell lung cancer, colorectal, pancreatic, and ovarian cancers.
About PC14586
PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have the p53 Y220C mutation.
About PMV Pharma
PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants. p53 mutations are found in approximately half of all cancers. The field of p53 biology was established by our co-founder Dr. Arnold Levine when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize over four decades of p53 biology, PMV Pharma combines unique biological understanding with pharmaceutical development focus. PMV Pharma is headquartered in Cranbury, New Jersey. For more information, please visit www.pmvpharma.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. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company's future plans or expectations for PC14586, including expectations regarding the success of its current clinical trial for PC14586; and the future plans or expectations for the Company's discovery platform. Any forward-looking statements in this statement are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, among others, the factors set forth in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on March 3, 2021, and its other filings filed with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Contact
For Investors & Media:
Winston Kung
Chief Financial Officer
[email protected] -
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CRANBURY, N.J., April 06, 2021 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (NASDAQ:PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants, today announced the appointment of Charles M. Baum, M.D., Ph.D., to its Board of Directors.
"Chuck is a recognized biopharma leader who has made significant contributions in the advancement of precision oncology," said David Mack, Ph.D., President and Chief Executive Officer of PMV. "His strong track record of success in building innovative oncology portfolios, from development through commercial launch, will be an ideal complement to our Board as we navigate our lead candidate, PC14856, through the clinic. We are thrilled to welcome him to the Board and look forward to leveraging his deep expertise in precision therapeutics that target the genetic drivers of cancer as we advance our pipeline of tumor-agnostic p53 reactivators."
Dr. Baum said, "PMV's unmatched expertise in p53 biology and innovative approach to precision oncology has the potential, for the first time, to address the most commonly mutated gene in cancer. I am enthusiastic about the Company's platform of small molecules that restore the wild-type function of mutated p53 for targeted, and tumor agnostic, therapies. I am excited to join the Board of PMV and look forward to providing my guidance as the Company continues their execution, both in the clinic and across their development pipeline."
Dr. Baum has served as the President and Chief Executive Officer and as a Board Member of Mirati Therapeutics Inc. since 2012. Under his leadership, Mirati has transformed into a precision oncology company focused on advancing its drug discovery and research and delivering novel therapeutics that target the genetic and immunologic drivers of cancer.
Prior to joining Mirati, Dr. Baum was at Pfizer from 2003 to 2012, most recently as Senior Vice President for Biotherapeutic Clinical Research within Pfizer's Worldwide Research & Development division, and prior to that, serving in roles of increasing responsibility, including Vice President, Head of Oncology Development and Chief Medical Officer for Pfizer's Biotherapeutics and Bioinnovation Center. He was responsible for the development of Pfizer's oncology portfolio, including Inlyta,* Xalkori* and the approval of Sutent.* Prior to Pfizer, Dr. Baum was at Schering-Plough where he was responsible for the Phase I-IV development of several oncology compounds, including Temodar.* Dr. Baum started his career with academic and clinical positions at Stanford and Emory Universities. He currently serves as Chairman of the Board at OncoMyx Therapeutics, Board of Directors member at BCTG Acquisition Corp and on the Scientific Advisory Board at ALX Oncology. He served as a member of the Board of Array Biopharma from 2014 to 2019 when it was acquired by Pfizer and Immunomedics from 2019 to 2020 when it was acquired by Gilead.
Dr. Baum received his M.D. (Medicine) and Ph.D. (Immunology) degrees from Washington University School of Medicine and completed his post-graduate training at Stanford University. Additionally, he has received research support from the National Institutes of Health and the American Cancer Society, published more than 50 peer-reviewed manuscripts and holds a number of patents and patent applications.
* Trademarks are property of their respective owners.
About p53
p53 plays a pivotal role in preventing abnormal cells from becoming a tumor by inducing programmed cell death. Mutant p53 takes on oncogenic properties that endow cancer cells with a growth advantage and resistance to anti-cancer therapy. The p53 Y220C mutation is associated with many cancers, including but not limited to breast, non-small cell lung cancer, colorectal, pancreatic, and ovarian cancers.
About PC14586
PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation.
About PMV Pharma
PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants. p53 mutations are found in approximately half of all cancers. The field of p53 biology was established by our co-founder Dr. Arnold Levine when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize over four decades of p53 biology, PMV Pharma combines unique biological understanding with a pharmaceutical development focus. PMV Pharma is headquartered in Cranbury, New Jersey. For more information, please visit www.pmvpharma.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. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company's future plans or expectations for PC14586, including expectations regarding the success of its current clinical trial for PC14586; and the future plans or expectations for the Company's discovery platform. Any forward-looking statements in this statement are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the Company's product candidate development activities and planned clinical trials, the Company's ability to execute on its strategy and operate as an early clinical stage company, the potential for clinical trials of PC14586 or any future clinical trials of other product candidates to differ from preclinical, preliminary or expected results, the Company's ability to fund operations, and the impact that the current COVID-19 pandemic will have on the Company's clinical trials, supply chain, and operations, as well as those risks and uncertainties set forth in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on March 3, 2021, and its other filings filed with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Contact
For Investors and Media:
Winston Kung
Chief Financial Officer
[email protected] -
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CRANBURY, N.J., March 10, 2021 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (NASDAQ:PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants, today announced that the company will present at the American Association for Cancer Research (AACR) Annual Meeting 2021 taking place April 10-15, 2021.
Details on the abstract and presentation can be found below.
Title: PC14586: The First Orally Bioavailable Small Molecule Reactivator of Y220C Mutant p53 in Clinical Development Authors: Melissa Dumble, Lizhong Xu, Romyr Dominique, Binbin Liu, Hong Yang, Mary-Kate McBrayer, Dafydd Thomas, Bruce Fahr, Hongju Li, Kuo-Sen Huang, Kimberly Robell, Chris Mulligan, Brandon Russo, Anna Puzio-Kuter, Thomas Davis and Binh Vu Abstract:
Session:
Date:LB006
Late-Breaking Minisymposium 1
April 10, 2021Time: 1:30 PM - 3:30 PM About p53
p53 plays a pivotal role in preventing abnormal cells from becoming a tumor by inducing programmed cell death. Mutant p53 takes on oncogenic properties that endow cancer cells with a growth advantage and resistance to anti-cancer therapy. The p53 Y220C mutation is associated with many cancers, including but not limited to breast, non-small cell lung cancer, colorectal, pancreatic, and ovarian cancers.
About PC14586
PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation.
About PMV Pharma
PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants. p53 mutations are found in approximately half of all cancers. The field of p53 biology was established by our co-founder Dr. Arnold Levine when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize over four decades of p53 biology, PMV Pharma combines unique biological understanding with pharmaceutical development focus. PMV Pharma is headquartered in Cranbury, New Jersey. For more information, please visit www.pmvpharma.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. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company's future plans or expectations for PC14586, including expectations regarding the success of its current clinical trial for PC14586; and the future plans or expectations for the Company's discovery platform. Any forward-looking statements in this statement are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, among others, the factors set forth in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on March 3, 2021, and its other filings filed with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Contact
For Investors & Media:
Winston Kung
Chief Financial Officer
[email protected]