XOMA Earns $35 Million Milestone Payment as Anti-TGFβ Antibody Enters Phase 3 Clinical Study in Metastatic Pancreatic Cancer

Rhea-AI Summary

XOMA Corporation (Nasdaq: XOMA) has announced a significant development as NIS793, an anti-TGFβ monoclonal antibody, progresses to Phase 3 trials, triggering a $35 million milestone payment from Novartis. The trial aims to evaluate NIS793's efficacy and safety in treating first-line metastatic pancreatic ductal adenocarcinoma. NIS793 has also received Orphan Drug Designation from the FDA. This milestone is part of a potential $410 million in milestone payments from Novartis, with tiered royalties on future sales based on successful commercialization.

Positive

• NIS793 advancing to Phase 3 trials, indicating clinical progress.
• $35 million milestone payment received from Novartis boosts capital.
• Potential for up to $410 million in additional milestone payments.
• Tiered royalties on future sales could provide ongoing revenue.

Negative

• Efficacy and safety of NIS793 not yet established; still investigational.
• No guarantee of commercial availability for NIS793.

EMERYVILLE, Calif., Nov. 04, 2021 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq: XOMA) announced today NIS793, an anti-TGFβ monoclonal antibody licensed from the Company, has advanced to the Phase 3 development stage, triggering a $35 million milestone payment from Novartis.  The Phase 3 trial (NCT04935359) is designed to assess the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo, in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).  In July, Novartis announced the U.S. Food and Drug Administration has granted Orphan Drug Designation to NIS793 in combination with standard of care chemotherapy for the treatment of pancreatic cancer.

“Pancreatic cancer claims far too many lives every year, and we appreciate that Novartis chose to pursue it as the first indication for late-stage development with NIS793.  We are grateful to the patients and their families who are participating in all of the NIS793 clinical studies,” stated Jim Neal, Chief Executive Officer of XOMA.  “NIS793 represents one of several important assets in our partner-funded portfolio.  This $35 million milestone gives us additional capital to acquire the rights to potential future milestone and royalty economics from biotech companies who can then use the capital to pursue their goal of curing a disease or condition by advancing their clinical development activities.”

More information about the NIS793 Phase 3 clinical study, NCT04935359, titled “Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)” can be found at ClinicalTrials.gov.

Under the terms of the 2015 anti-TGFβ development and commercialization agreement with Novartis, XOMA has the potential to earn up to $410 million in additional milestone payments.  Should Novartis receive regulatory approval to commercialize NIS793, XOMA will receive tiered royalties on net product sales that range from mid-single digit to low double digits.

NIS793 is an investigational compound.  Efficacy and safety have not been established.  There is no guarantee that NIS793 will become commercially available.

About XOMA Corporation
XOMA has built a significant portfolio of products that are licensed to and being developed by other biotech and pharmaceutical companies.  The Company’s portfolio of partner-funded programs spans multiple stages of the drug development process and across various therapeutic areas.  Many of these licenses are the result of XOMA’s pioneering efforts in the discovery and development of antibody therapeutics.  The Company’s royalty-aggregator business model includes acquiring additional milestone and royalty rights associated with drug development programs with third-party funding.  For more information, visit www.xoma.com.

Forward-Looking Statements/Explanatory Notes
Certain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the potential of XOMA’s portfolio of partnered programs and licensed technologies generating substantial milestone and royalty proceeds over time, creating additional value for the stockholders, cash sufficiency forecast, economic outlook, and potential impact of the COVID-19 pandemic.  In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will, “would,” “could” or “should,” the negative of these terms or similar expressions.  These forward-looking statements are not a guarantee of XOMA’s performance, and you should not place undue reliance on such statements.  These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry, including those related to the fact that our product candidates subject to out-license agreements are still being developed, and our licensees may require substantial funds to continue development which may not be available; we do not know whether there will be, or will continue to be, a viable market for the products in which we have an ownership or royalty interest; if the therapeutic product candidates to which we have a royalty interest do not receive regulatory approval, our third-party licensees will not be able to market them, and the impact to the global economy as a result of the COVID-19 pandemic.  Other potential risks to XOMA meeting these expectations are described in more detail in XOMA's most recent filing on Form 10-K and in other SEC filings.  Consider such risks carefully when considering XOMA's prospects.  Any forward-looking statement in this press release represents XOMA's beliefs and assumptions only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date.  XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law.

EXPLANATORY NOTE: Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development.  Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development.

As of the date of this press release, NIS793 and all assets in XOMA’s milestone and royalty portfolio are investigational compounds.  Efficacy and safety have not been established.  There is no guarantee that NIS793 or any of these assets will become commercially available.

Investor contacts:
Juliane Snowden	Justin Frantz
XOMA	Solebury Trout
+1-646-438-9754	+1-973-441-9731
juliane.snowden@xoma.com	jfrantz@troutgroup.com
Media contact:
Kathy Vincent
KV Consulting & Management
+1-310-403-8951
kathy@kathyvincent.com

FAQ

What is the purpose of the NIS793 Phase 3 trial?

The NIS793 Phase 3 trial aims to assess the efficacy and safety of NIS793 in combination with standard chemotherapy for treating first-line metastatic pancreatic ductal adenocarcinoma.

What milestone payment did XOMA receive from Novartis?

XOMA received a $35 million milestone payment from Novartis due to the advancement of NIS793 to Phase 3 clinical trials.

What is NIS793's potential in terms of financial benefits for XOMA?

XOMA could earn up to $410 million in additional milestone payments from Novartis, plus tiered royalties on net product sales if NIS793 receives regulatory approval.

Has NIS793 received any designations from regulatory authorities?

Yes, NIS793 has received Orphan Drug Designation from the U.S. FDA for its use in treating pancreatic cancer.

What risks are associated with NIS793's development?

The primary risks include the uncertainty of achieving efficacy and safety in clinical trials and the potential lack of a viable market if regulatory approval is not obtained.