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CytomX Therapeutics Clinical Programs Highlighted at American Society of Clinical Oncology ASCO20 Virtual Scientific Program | ||
By: GlobeNewswire - 29 May 2020 | Back to overview list |
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- First Presentation of Clinical Data for CX-2029, a Probody Drug Conjugate, - Data Updates for CX-2009 Support Phase 2 Investigations in Breast Cancer - - Favorable Tolerability Profile Demonstrated for Anti-PD-L1 and Anti-CTLA-4 Probody Therapeutics - - Company to Host Webcast Today, May 29, 2020 at 5:00 p.m. ET/ 2:00 p.m. PT - SOUTH SAN FRANCISCO, Calif., May 29, 2020 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody® therapeutic technology platform, today announced the availability of oral and poster presentations at the American Society of Clinical Oncology’s (ASCO) ASCO20 Virtual Scientific Program taking place from May 29 - May 31, 2020. “A comprehensive body of evidence was presented today at ASCO 2020 that continues to validate our approach to conditional antibody activation and therapeutic target engagement with the Probody platform,” said Amy Peterson, M.D., chief development officer of CytomX Therapeutics. “The seven presentations collectively highlight the potential of the Probody platform to enable successful engagement of previously undruggable targets, like CD71 and CD166, and create next generation immune-checkpoint inhibitors such as the anti-PD-L1 Probody therapeutic, CX-072, and BMS-986249, a Probody version of ipilimumab. The findings underpin the advancement of all four drug candidates into Phase 2 and our commitment to bringing meaningful advances to patients living with cancer.” CX-2029: Validating CD71 As A First-in-Class Oncology Target In the oral abstract 3502, Dr. Melissa Johnson of the Sarah Cannon Research Institute at Tennessee Oncology, presented preliminary clinical data from the first-in-human, dose-escalation, monotherapy Phase 1 study of CX-2029, a Probody drug conjugate (PDC) targeting CD71 (transferrin receptor). CX-2029 is conjugated to the cytotoxic payload MMAE and is being developed by CytomX in partnership with AbbVie. As of an April 20, 2020 data cutoff, 45 patients with advanced solid tumors were enrolled into 8 escalating dose cohorts between 0.1 mg/kg – 5 mg/kg CX-2029 administered intravenously every three weeks.
CX-2029 Waterfall Plot (Doses 2–5 mg/kg) Figure 1 is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/51129ea3-a850-4d2f-9c41-4da88807669f Safety Profile Supports Recommended Phase 2 Dose of 3 mg/kg, Every Three Weeks
“Targeting CD71 with this novel approach has the potential to address areas of unmet medical need in difficult to treat tumor types, improving patient benefit,” said Melissa L. Johnson, M.D., CX-2029 principal study investigator and associate director of lung cancer research at Sarah Cannon Research Institute at Tennessee Oncology. "This first-in-human data of CX-2029 establishes the transferrin receptor as a high potential anticancer target addressable with CytomX’s Probody technology.” CX-2009: Encouraging Clinical Activity Supports Advancement in HER2 Negative Breast Cancer Durable Clinical Activity Observed in HER2 Negative (HER2-) Breast Cancer
CX-2009 Waterfall Plot and Spider Plot: HER2- Breast Cancer (?4 mg/kg Every 3 Weeks) Figure 2 is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3d8523cb-3517-4ae7-b428-19700c46a749 Safety Profile Supports Recommended Phase 2 Dose of 7mg/kg, Every 3 Weeks
In December 2019, CytomX announced the initiation of a Phase 2 expansion study of CX-2009 monotherapy at 7 mg/kg administered every three weeks in up to 40 patients with hormone receptor (ER, PR) positive, HER2 negative breast cancer. In March 2020, CytomX announced the decision to temporarily pause new patient enrollment and new site activation in this study due to the impact of the COVID-19 pandemic. CytomX continues to closely monitor emerging Health Authority guidance and IRB/Ethics Committee recommendations and intends to resume the CX-2009 clinical program as soon as practicable. “Patients with advanced breast cancer continue to need treatment options, this is especially true for patients with hormone receptor positive and HER2 negative breast cancer that is refractory to hormonal based therapies,” said Alison L. Hannah, M.D., chief medical officer of CytomX Therapeutics. “We believe that targeting CD166, previously considered undruggable as an oncology target, using our Probody drug conjugate platform, may provide a unique treatment opportunity for this patient population. The data in patients with triple negative breast cancer are equally interesting and support the advancement of CX-2009 monotherapy into Phase 2 where we will also evaluate CX-2009 in combination with CX-072, our Probody therapeutic directed against PD-L1.” CX-072: Anti-PD-L1 Probody Checkpoint Inhibitor
CX-072 Monotherapy Waterfall Plots and Spider Plots (10 mg/kg) Figure 3 is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/daf244be-f486-43cc-9cf1-b50b60a8dce9 Continued Dr. Hannah “Our ASCO20 clinical, translational, and pharmacokinetic presentations on CX-072 reinforce previously presented data and show clear evidence of anti-cancer activity and favorable tolerability for this unique checkpoint inhibitor. These integrated data support a differentiated profile for CX-072 that we believe can be of potential utility as a unique combination partner for other anti-cancer agents, including CX-2009.” BMS-986249: Anti-CTLA-4 Probody Demonstrates Encouraging Safety Profile in Phase 1 Trial Bristol Myers Squibb presented dose escalation data from their Phase 1/2 trial of BMS-986249, a Probody version of the anti-CTLA-4 antibody ipilimumab in Abstract 3508. This trial assessed the safety, pharmacokinetics and pharmacodynamics of escalating doses of BMS-986249 as monotherapy or in combination with the anti PD-1 antibody nivolumab in patients with advanced cancers. The doses of BMS-986249 ranged from 240 mg to 2400 mg (approximately 3 - 30 mg/kg). BMS-986249 was generally well tolerated as monotherapy and in combination with nivolumab. Bristol Myers Squibb has initiated a randomized clinical trial to explore various doses of BMS-986249 in combination with nivolumab in patients with advanced melanoma. Copies of the ASCO20 presentations and posters are available under the Scientific Publications section of the CytomX website at www.CytomX.com. Conference Call and Webcast CytomX senior management will host a conference call and live webcast with slides today, Friday, May 29, 2020, from 5:00 p.m. – 6:00 p.m. ET/ 2:00 p.m. – 3:00 p.m. PT to discuss these presentations. This event can be accessed in three ways:
About CytomX Therapeutics CytomX Therapeutics Forward-Looking Statements This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy or progress of CytomX’s or any of its collaborative partners’ product candidates, the potential benefits or applications of CytomX’s Probody platform technology, and CytomX’s ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of CX-2009 and CX-2029. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the unproven nature of CytomX’s novel Probody Platform technology; CytomX’s clinical trial product candidates are in the initial stages of clinical development and its other product candidates are currently in preclinical development, and the process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties, including the risk that the COVID-19 worldwide pandemic may continue to negatively impact the business, research and clinical operations of CytomX or its partners, including the development of preclinical drug candidates due to delays in and disruption of research activities and the development of clinical drug candidates due to delays in or disruption of clinical trials, including impacts on the enrollment of patients in clinical trials or other clinical trial disruptions; the possibility that the results of early clinical trials may not be predictive of future results; the possibility that CytomX’s clinical trials will not be successful; the possibility that current pre-clinical research may not result in additional product candidates; CytomX’s dependence on the success of CX-2009, CX-2029, BMS-986249, BMS-986288, and CX-072; CytomX’s reliance on third parties for the manufacture of the company’s product candidates; and possible regulatory developments in the United States and foreign countries. Additional applicable risks and uncertainties include those relating to our preclinical research and development, clinical development, and other risks identified under the heading "Risk Factors" included in CytomX’s Quarterly Report on Form 10-Q filed with the SEC on May 7, 2020. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise. |
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