ONCORUS, INC. Item 1.01 Entry into a Material Definitive Agreement.
On
In connection with the parties' entry into the License Agreement, the Company
has agreed to pay Gaeta an up-front fee of
The Company has the worldwide right under the License Agreement to grant multiple sublicenses under the Patent Rights in the Field, provided that the terms of the License Agreement are binding upon any sublicensees. In the event that the Company grants such sublicenses, the Company is obligated to pay a low single-digit percentage of any sublicensing fees received by the Company pursuant to such sublicense, including upfront, milestone and royalty payments, and payments made during development and commercialization. In addition, in the event that the Company sublicenses the Patent Rights to a third party independent of a Product or any Company patent rights or know-how, the Company is obligated to pay Gaeta a mid-double-digit percentage of all fees associated with the sublicense.
The Company is obligated to provide Gaeta with periodic reports summarizing major events in development and commercialization of its Product, with additional information related to net sales and other metrics to be provided following the first commercial sale of the Product. The License Agreement includes customary representations and warranties on behalf of the Company and Gaeta as are customarily found in transactions of this nature, including representations and operative provisions as to the licensed intellectual property, regulatory matters and compliance with applicable laws. The License Agreement also provides for certain mutual indemnities for breaches of representations, warranties and covenants.
The License Agreement shall terminate upon the last to expire of any patent included in the Patent Rights. Additionally, Gaeta may terminate the License Agreement for cause upon written notice to the Company if (i) the Company directly or indirectly opposes or disputes the grant of letters patent or any patent application within the Patent Rights, (ii) the Company is in material breach of the License Agreement and fails to remedy such breach within sixty days of Gaeta providing notice thereof in writing, or (iii) the Company is deemed bankrupt or insolvent or becomes subject to similar proceeding. The Company may terminate the License Agreement with or without cause upon sixty days' prior written notice to Gaeta. In the event that UZH terminates the Head License, the Company has the right to become a direct licensee of UZH with substantially the same rights and obligations as it is entitled to under the License Agreement, subject to certain qualifications.
The foregoing description of the License Agreement is qualified in its entirety
by reference to the full text of the License Agreement, a copy of which ,
subject to applicable confidential treatment, will be filed as an exhibit to the
Company's Annual Report on Form 10-K for the fiscal year ending
Item 7.01 Regulation FD Disclosure.
On
In addition, on
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The information in this Item 7.01, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation by reference language in such a filing, except as expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
On
The data presented at SITC include preliminary findings from Part 1 of the Phase
1 clinical trial of ONCR-177, including data from 14 patients in the fully
enrolled and completed dose escalation cohorts and five patients enrolled in the
dose expansion monotherapy, as of
In the fully enrolled and completed surface lesion dose escalation portion of the Phase 1 clinical trial, ONCR-177 administered to heavily pretreated patients with advanced, injectable solid tumors was well tolerated with no dose-limiting toxicities. In addition, the recommended Phase 2 dose ("RP2D") was determined to be 4x108 PFU in 4 mL. No treatment-related adverse events exceeded Grade 3, and the most common Grade 1 and 2 adverse events were fatigue, chills, nausea, and mild, dose-dependent cytokine release syndrome ("CRS"). No infectious virions were detected in skin swabs, consistent with the Company's expectations with respect to ONCR-177's safety profile.
As of
The four evaluable monotherapy expansion patients referred to above are in
addition to four evaluable monotherapy escalation patients treated at the RP2D.
As of
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Partial response in a patient with cutaneous melanoma as measured by calipers
per Response Evaluation Criteria in Solid Tumors ("RECIST") 1.1 (the surface
tumor was not measurable by CT scan);
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Investigator-reported clinical response in a SCCHN patient in injected lymph
node after four weeks; and
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Stable disease in a patient with mucosal melanoma as measured by RECIST 1.1 with
improvement in cancer-related symptoms.
Several findings from the study thus far suggest immune stimulation of the tumor microenvironment, including mild, dose-dependent CRS in association with increased interferon-g (IFN-g) and T-cell proliferation in blood, as well evidence of tumor PD-L1 expression and immune cell infiltration.
The Company plans to initiate patient enrollment in the surface lesion dose combination expansion (Part 2 of the clinical trial) and the visceral lesion dose monotherapy escalation (Part 3 of the clinical trial) by the end of 2021. The Company also plans to report additional surface lesion monotherapy expansion data in mid-2022, and initial surface lesion combination expansion data (ONCR-177 administered in combination with Merck's KEYTRUDA® (pembrolizumab)) and visceral lesion monotherapy dose escalation data in late 2022.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the clinical development of ONCR-177, including expectations regarding timing for reporting additional data from the ongoing Phase 1 clinical trial, as well as the product candidate's therapeutic potential and clinical benefits and the utility and potential of the Company's HSV Platform; the possibility that additional patients will experience clinical benefits when dosed with ONCR-177 and whether such treatment effects will be amplified when ONCR-177 is dosed in combination with Keytruda; and other early findings with respect to the ONCR-177 clinical trial suggesting broader immune stimulation or being predictive of trial results to come. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "expect," "estimate," "seek," "predict," "future,"
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"project," "potential," "continue," "target" and similar words or expressions
are intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Any forward-looking
statements in this Current Report on Form 8-K are based on management's current
expectations and beliefs and are subject to a number of risks, uncertainties and
important factors that may cause actual events or results to differ materially
from those expressed or implied by any forward-looking statements contained in
this Current Report on Form 8-K, including, without limitation, risks associated
with: the risk that the results of preclinical studies and early results from
clinical trials may not be predictive of future clinical trial results; the
impact of COVID-19 on the Company's operations and the timing and anticipated
results of its ongoing and planned clinical trials; the Company's ability to
successfully demonstrate the safety, tolerability and efficacy of ONCR-177, or
any future product candidates, and obtain regulatory approval thereof; the
Company's ability to obtain the requisite components for its product candidates
manufactured in accordance with regulatory requirements; the expansion of the
Company's in-house manufacturing capabilities; the adequacy of the Company's
cash resources and availability of financing on commercially reasonable terms;
and the Company's ability to obtain, maintain and protect its intellectual
property. These and other risks and uncertainties are described in greater
detail in the section entitled "Risk Factors" in the Company's Annual Report on
Form 10-K for the year ended
Item 9.01 Financial Statements and Exhibits.
99.1 Press release issued byOncorus, Inc. onNovember 12, 2021 104 Cover Page Interactive Data File (embedded within the inline XBRL document)
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