CytomX Therapeutics Announces Second Quarter 2020 Financial Results and Provides Business Update
“CytomX made broad progress across our clinical and preclinical programs during the second quarter as we further advanced our technology platform, partnerships, and lead drug candidates to several important inflection points,” said
SECOND QUARTER BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS
Clinical Pipeline Progress: ASCO20 Data Presentations and Program Next Steps
In May, CytomX presented broad clinical pipeline progress at the
- CX-2029 and CX-2009, Probody Drug Conjugates designed to target the previously undruggable targets, CD71 and CD166, respectively
- BMS-986249, a Probody version of the anti-CTLA-4 immunotherapeutic antibody, ipilimumab (Yervoy®) and
- CX-072, a Probody immunotherapeutic targeting PD-L1.
CX-2029 Phase 1 Data: Preliminary Validation of CD71 as a Novel Oncology Target and Advancement to Phase 2 Expansion Cohorts
- CytomX and its partner AbbVie presented preliminary clinical data from the first-in-human, Phase 1 dose-escalation study of CX-2029, a Probody drug conjugate targeting the previously undruggable target, CD71 (transferrin receptor), in patients with solid tumors.
- Evidence of target lesion reduction was seen at doses of ≥2 mg/kg including confirmed partial responses in squamous non-small cell lung cancer (sqNSCLC) and squamous head and neck cancer (HNSCC), which were observed at 3 mg/kg.
- CX-2029 was generally well tolerated with anemia and infusion-related reactions being the most common adverse events, supporting 3 mg/kg as the Phase 2 expansion dose.
- Phase 2 expansion cohorts are expected to be initiated in the second half of 2020 in patients with sqNSCLC, HNSCC, esophageal cancer, and diffuse large B-cell lymphoma.
CX-2009: Phase 2 Strategies Focused in HER2 Negative Breast Cancer Subtypes
- CytomX presented updated clinical data from the first-in-human, dose-escalation, monotherapy Phase 1 study of CX-2009, a Probody drug conjugate targeting the previously undruggable target, CD166, in seven selected tumor types.
- Evidence of target lesion reduction was observed at doses of ≥4 mg/kg including confirmed and unconfirmed partial responses in patients with HER2- breast cancer.
- CX-2009 was generally well tolerated at doses up to 7 mg/kg, the dose selected for Phase 2 expansion studies.
- The previously initiated Phase 2 expansion study of CX-2009 study in HER2 negative/hormone receptor positive (HER2-/HR+) breast cancer was paused in
March 2020due to the impact of the COVID-19 pandemic. In the intervening period, this study strategy has been revised to further focus patient enrollment criteria and is expected to be re-initiated during the second half of 2020. The revised Phase 2 study will continue to evaluate CX-2009 as monotherapy at 7 mg/kg administered every three weeks and enroll at least 40 patients.
- CytomX also expects to initiate a Phase 2 expansion study during the second half of 2020 evaluating CX-2009 as monotherapy and in combination with CX-072, the Company’s anti-PD-L1 Probody therapeutic candidate, in patients with triple negative breast cancer (TNBC).
BMS-986249: Anti-CTLA-4 Probody Immunotherapeutic
- Bristol Myers Squibb presented safety data from the dose escalation stage of a Phase 1/2a trial of BMS-986249, a Probody version of the anti-CTLA-4 antibody ipilimumab.
- 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 (Opdivo®) 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. The types of treatment-related adverse events were consistent with CTLA-4 blockade, and the overall data align with the proposed Probody mechanism of action. No new safety signals were observed.
- Bristol Myers Squibb has initiated the Part 2a randomized cohort expansion of the ongoing Phase 1/2a trial of BMS-986249 in combination with nivolumab in patients with metastatic melanoma.
During the second quarter, Bristol Myers Squibb also presented a comprehensive preclinical dataset from the anti-CTLA-4 Probody immunotherapeutics, BMS-986249 and BMS-986288, a non-fucosylated Probody of ipilimumab, at the American Association of Cancer Research’s (AACR) 2020 Virtual Annual Meeting II. These data support the strategy of expanding the therapeutic index for CTLA-4 therapy using CytomX’s Probody technology and provides rationale for the ongoing clinical studies of these agents.
CX-072: Anti-PD-L1 Probody Immunotherapeutic
- CytomX presented data from seven expansion cohorts evaluating CX-072, an anti-PD-L1 Probody therapeutic administered at 10 mg/kg. CX-072 demonstrated durable anti-tumor activity in patients with IO-sensitive tumors such as TNBC, anal squamous cell carcinoma, cutaneous squamous cell carcinoma, and tumors with high mutational burden.
- Grade 3/4 TRAEs were 10% and 5.9% for those patients who received monotherapy < 6 months and ≥ 6 months, respectively. Long term patients experienced fewer immune-related adverse events (irAEs) and had no grade 3+ irAEs.
- The clinical profile of CX-072 continues to be consistent with this agent being a differentiated combination therapy partner. CX-072 will next be evaluated in combination with CX-2009 in TNBC.
Preclinical Pipeline Progress
CX-904 EGFR-CD3 Probody Bispecific
- CytomX continued to advance CX-904, the lead candidate from the Epidermal Growth Factor Receptor-CD3 T-Cell Bispecific program, towards IND-enabling studies. CX-904 is partnered with Amgen as part of a global co-development agreement.
CX-2043 EpCAM Probody Drug Conjugate
- CytomX continued to advance CX-2043, the lead candidate from the epithelial cell adhesion molecule (EpCAM)-targeting Probody Drug Conjugate program, towards IND-enabling studies.
- CytomX launched discovery activities within the Astellas strategic collaboration that was announced in the first quarter and focused on the discovery, research, development, and commercialization of novel T-cell engaging bispecific antibodies.
COVID-19 Pandemic and Business Continuity
CytomX is committed to ensuring the health, safety and well-being of its clinical study participants, study site staff, and our employees. CytomX continues to closely monitor the COVID-19 pandemic situation and is following local, state, and federal guidelines, including emerging Health Authority guidance and IRB/Ethics Committee recommendations with respect to the conduct of our worldwide clinical trials. In accordance with state and local guidelines, CytomX is following a work-from-home protocol for many of its employees with only select staff, including those in research functions that require laboratory access, having access to CytomX’s corporate offices where multiple layers of safety measures have been put in place.
Second Quarter 2020 Financial Results
Cash, cash equivalents and short-term investments totaled
Research and development expenses decreased by
General and administrative expenses decreased by
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About CytomX Therapeutics
CytomX is a clinical-stage, oncology-focused biopharmaceutical company with a vision of transforming lives with safer, more effective therapies. We are developing a novel class of investigational antibody therapeutics, based on our Probody® technology platform, for the treatment of cancer. CytomX has strategic drug discovery and development collaborations with AbbVie, Amgen, Astellas and Bristol Myers Squibb.
Probody therapeutics are designed to remain inactive until they are activated by proteases in the tumor microenvironment. As a result, Probody therapeutics are intended to bind selectively to tumors and decrease binding to healthy tissue, to minimize toxicity and potentially create safer, more effective therapies. As leaders in the field, our innovative technology is designed to turn previously undruggable targets into druggable targets and to enable more effective combination therapies. CytomX and its partners, comprised of leading biotechnology and pharmaceutical companies, have developed a robust pipeline of potential first-in-class therapeutic candidates against novel, difficult to drug targets and potential best-in-class immunotherapeutic candidates against clinically validated targets. The CytomX clinical stage pipeline includes first-in-class product candidates against previously undruggable targets, including a CD166-targeting Probody drug conjugate wholly owned by CytomX (CX-2009) and a CD71-targeting Probody drug conjugate partnered with AbbVie (CX-2029). CD166 and CD71 are among cancer targets that are considered to be inaccessible to conventional antibody drug conjugates due to their presence on many healthy tissues. The CytomX clinical stage pipeline also includes cancer immunotherapeutic candidates against validated targets such as our wholly owned anti-PD-L1 Probody therapeutic, CX-072, and the CTLA-4-targeting Probody therapeutics, BMS-986249 and BMS-986288, partnered with Bristol Myers Squibb. For additional information about CytomX Therapeutics, visit www.cytomx.com and follow us on LinkedIn and Twitter.
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
Probody is a
Yervoy and Opdivo are registered trademarks of Bristol Myers Squibb.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
|Three Months Ended||Six Months Ended|
|Research and development||24,066||30,835||66,880||67,211|
|General and administrative||8,680||9,411||18,252||19,085|
|Total operating expenses||32,746||40,246||85,132||86,296|
|Loss from operations||(16,138||)||(31,233||)||(18,931||)||(47,798||)|
|Other income (expense), net||5||(88||)||16||(149||)|
|Loss before income taxes||(15,679||)||(28,960||)||(17,385||)||(43,091||)|
|Benefit from income taxes||—||—||(13,911||)||(6||)|
|Net loss per share, basic and diluted||$||(0.34||)||$||(0.64||)||$||(0.08||)||$||(0.95||)|
|Shares used to compute net loss per share, basic and diluted||46,057,063||45,340,023||45,890,510||45,231,239|
|Other comprehensive income (loss):|
|Unrealized gain (loss) on short-term investments, net of tax||(320||)||136||(41||)||291|
|Impact of adoption of new accounting pronouncement||—||—||—||11|
CONDENSED BALANCE SHEETS
(in thousands, except share and per share data)
|Cash and cash equivalents||$||291,388||$||188,425|
|Income tax receivable||13,061||—|
|Prepaid expenses and other current assets||6,898||7,177|
|Total current assets||366,566||303,335|
|Property and equipment, net||7,461||7,372|
|Intangible assets, net||1,240||1,312|
|Operating lease right-of-use asset||23,967||25,382|
|Liabilities and Stockholders' Equity|
|Deferred revenue, current portion||72,711||51,381|
|Total current liabilities||98,785||85,590|
|Deferred revenue, net of current portion||221,542||178,858|
|Operating lease liabilities - long term||23,323||24,871|
|Other long-term liabilities||—||850|
|Commitments and contingencies|
|Convertible preferred stock,
|Additional paid-in capital||479,516||468,285|
|Accumulated other comprehensive income||16||57|
|Total stockholders' equity||58,829||51,113|
|Total liabilities and stockholders' equity||$||402,479||$||341,282|
(1) The condensed balance sheet as of
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Source: CytomX Therapeutics Inc.