On November 22, 2021 Chimeric Therapeutics (ASX:CHM, "Chimeric"), a clinical-stage cell therapy company and the ASX leader in cell therapy, reported to highlight key additional data released with the final presentation of two CLTX CAR T abstracts at the Society for Neuro-Oncology (SNO) 26th annual scientific meeting (Press release, Chimeric Therapeutics, NOV 22, 2021, View Source [SID1234595874]).

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Abstract CTIM-29, "Clinical evaluation of chlorotoxin-directed CAR T cells for patients with recurrent glioblastoma" provides insight into the initial clinical data for CLTX while abstract EXTH-10, "Exploration of a novel toxin-incorporating CAR T cell: how does chlorotoxin recognize glioblastoma cells?" expands on the translational understanding of Chlorotoxin (CLTX) activity.

The clinical data presented in abstract CTIM-29 is from the ongoing CLTX CAR T phase 1 clinical trial in patients with MMP2+ recurrent or progressive glioblastoma. The data focuses on the four patients enrolled in dose level 1 of the trial, treated with 44 X 106 CLTX CAR T cells through a single route of intratumoral administration. Dose escalation in this trial is planned across four dose levels to a total dose of 440 X 106 CLTX CAR T cells administered through dual intratumoral and intraventricular routes of administration

Of significant note, during the final presentation MRI scans presented of patient 487 demonstrated no recurrence of tumour in the left frontal lobe where CLTX CAR T cells were infused, two months after the CLTX CAR T cell infusion. Tumour progression was seen only in the left temporal lobe which did not receive CLTX CAR T infusion. Like all patients in this dose level, patient 487 received a dose of 44 X 106 CLTX CAR T cells through a single intratumoral route of administration. LEVEL 3, 62 LYGON STREET CARLTON VIC 3053 AUSTRALIA

This finding, that tumour recurrence was prevented in the area where the CLTX CAR T cells were infused and tumour progression occurred in areas away from where the CLTX CAR T cells were infused, is important as it suggests that the dual routes of administration (intratumoral and intraventricular) of the CLTX CAR T cells in dose levels 2-4 may provide additional hope for patients. In the initial abstract presentation of patients treated at the 1st dose level, a disease control rate of 75% was shown as 3 out of the 4 patients treated achieved a best response of stable disease assessed by RANO criteria. Additional details provided within the final presentation demonstrated that the disease control observed was durable for approximately 5-8 weeks.

The final presentation of the CLTX CAR T CTIM-29 abstract also provided additional insight into the generally well tolerated adverse event profile of CLTX CAR T, showing that there were no CRS events, an adverse event often associated with CAR T cell therapy. Confirmation that the one grade 3 cerebral edema event was only possibly attributed to the CAR T cells was also presented. Cerebral edema is an adverse event commonly observed in patients with glioblastoma.

Chimeric’s CEO and Managing Director Jennifer Chow said: "Being able to see tumour control where the CLTX CAR T cells were administered in the brain and tumour progression where they were not administered is very promising – particularly at this low initial dose. That, in addition to the durability of the disease control for up to 8 weeks gives us great reason for optimism as we progress to more active dose levels with dual routes of administration."

In addition, the presentation of abstract EXTH-10 provided early confirmation of the role of MMP-2 expression in CLTX CAR T tumour recognition and killing. Data presented showed that MMP-2 expression levels increased with tumour grade and that CLTX CART T cells preferentially kill tumour target cells with higher MMP-2 expression, suggesting that CLTX CAR T may be effective even against the most aggressive cancers.

Within the presentation, early staining of a melanoma cell line was also presented confirming strong MMP-2 expression and providing early support for expanding the clinical development program for CLTX CAR T into additional solid tumours, including melanoma. LEVEL 3, 62 LYGON STREET CARLTON VIC 3053 AUSTRALIA

About the CLTX CAR T (CHM1101) Clinical Trial:
The CLTX CAR T phase 1 clinical trial is currently in progress at a single site in California with plans to expand to a multi-site trial in 2022. The design is a single arm, open label trial in patients with MMP2+ recurrent or progressive glioblastoma.

The primary endpoints of the trial are to assess the safety of CLTX CAR T cells, determine the maximum tolerated dose schedule and a recommended Phase 2 dosing plan. Secondary endpoints include bioactivity and efficacy measures.

The trial is designed with 4 dose levels ranging from 44 X 106 to 440 X 106 CLTX CAR T cells and studies both single and dual routes of administration of cells. Dose level 1 was completed with no dose limiting toxicities in April 2021.

Investor webinar
Chimeric Therapeutics CEO and Managing Director Jennifer Chow will hold an investor webinar today, Monday 22 November 2021, at 11:30am AEDT to elaborate on this announcement and take questions.

Click the link below to register: View Source

After registering, you will receive a confirmation email about how to join the webinar. A recording of the webinar will be available at the same link shortly after the conclusion of the session.

On November 21, 2021 CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, and Jiangsu Hengrui Pharmaceuticals ("Hengrui", SHSE: 600276) reported a strategic partnership and exclusive licensing agreement on anti-CTLA-4 mAb CS1002 in the Greater China region (Press release, CStone Pharmaceauticals, NOV 21, 2021, View Source [SID1234595870]). This strategic partnership marks another milestone in CStone’s mission to introduce innovative oncology therapies in China after the commercial launch of two first-in-class drugs this year.

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Under the terms of the agreement, CStone will be eligible for an upfront payment and potential milestone payments up to $200 Mn in addition to double-digit royalties. Hengrui will obtain the exclusive rights for research, development, registration, manufacturing, and commercialization of anti-CTLA-4 mAb CS1002 in Greater China. CStone will retain the rights to develop and commercialize of CS1002 outside of Greater China.

Cytotoxic T lymphocyte associated antigen 4 (CTLA-4) is one of the few clinically validated targets for IO combination therapies. There is only one anti-CTLA-4 monoclonal antibody approved globally, and it is also approved in China. According to EvaluatePharma, the annual global revenue of the product in 2020 was approximately $1.69 billion. CS1002 is an investigational anti-CTLA-4 monoclonal antibody being developed by CStone currently in clinical development. Results from the ongoing Ph1a/1b study showed that differentiated dosing schedules of CS1002 in combination with CS1003 (anti-PD-1) were well-tolerated and demonstrated very encouraging efficacy in anti-PD-(L)1-refractory melanoma, anti-PD-(L)1-refractory hepatocellular carcinoma, and anti-PD-(L)1-naïve, pretreated microsatellite instability high/deficient mismatch repair (MSI-H/dMMR) tumors.

Dr. Frank Jiang, Chairman and CEO of CStone, said, "We are happy to reach the partnership with Hengrui. As a leading global China pharmaceutical company with an extensive oncology pipeline and strong integrated capabilities in commercialization, we are very confident that Hengrui will bring the full potentialities of CS1002 into the Greater China market. Through this collaboration, we believe we will join forces to bring forward more high-quality innovative oncology therapies to patients."

Dr. Lianshan Zhang, Member of the Board, Senior Vice President and President of global R&D of Hengrui, said, "We are happy to enter into this collaboration with CStone on the backbone immune-oncology asset of CS1002. With its combination therapy potential, CS1002 will further synergize our pipeline, enrich the oncology portfolio and strengthen our competitiveness. As a leading Chinese biopharmaceutical company, CStone has demonstrated its outstanding research and development capabilities with impressive early-stage clinical data and differentiated dosing schedules of CS1002. We have full confidence in the future development of it to provide more innovative drugs for Chinese patients."

About CS1002 (anti-CTLA-4 antibody)

CS1002 is an investigational anti-CTLA-4 monoclonal antibody being developed by CStone. CS1002 is differentiated from prior CTLA-4 targeting drug in its dosing schedules that have been tested in early development and the encouraging efficacy and safety in three indications providing proof-of-concept for CS1002 as a potential backbone for IO combinations. Cytotoxic T lymphocyte associated antigen 4 (CTLA-4), also known as CD152, is a transmembrane protein encoded by the CTLA-4 gene that can down-regulate the activity of T cells when binding with its ligand, B7, a pathway also used by tumor cells to avoid T lymphocyte attack. Consequently, blockade of the CTLA-4 pathway can stimulate T cell activation and proliferation to induce or enhance anti-tumor immune responses. CTLA-4 provides a new immuno-therapeutic approach to a number of human cancers.

On November 21, 2021 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported the Company’s stock is included in the Hang Seng China Enterprises Index (HSCEI) according to the Hang Seng Indexes Company’s latest results of review (Press release, Innovent Biologics, NOV 21, 2021, View Source [SID1234595869]). The inclusion will take effect on December 6, 2021.

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The HSCEI is one of the most influential indexes in the Hong Kong and global stock markets, as constituted by 50 leading China enterprises listed on the Hong Kong Stock Exchanges with outstanding market cap and trading volume. Innovent is the first and only biopharmaceutical company listed under Chapter 18A of the Hong Kong Stock Exchanges to be included in the HSCEI, and the inclusion could indicate potential additional capital inflow from passive index funds.

Mr. Ronald Ede, Executive Director and CFO of Innovent, stated, "We are excited that our stock is included into the HSCEI, following the successful inclusion in the Hang Seng Composite Index and the Stock Connect last year. The recognition by capital market is another key milestone in the tenth year’s journey of Innovent. As for the next decade, Innovent will be fully committed to transforming ourselves from a leading Chinese biopharma to a world-class global biopharma company equipped with the strategy of innovation and globalization. We sincerely appreciate the long-term trust from our patients, medical community, employees and shareholders along the journey. We will continue being devoted to our mission of’To develop and commercialize high-quality biopharmaceutical products that are affordable to ordinary people.’"

On November 21, 2021 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported first interim analysis results of the randomized, double-blinded, multi-center Phase 3 ORIENT-31 study conducted in China evaluating sintilimab and anti-VEGF antibody combination therapy (i.e., sintilimab plus BYVASDA [bevacizumab biosimilar injection] combined with chemotherapy [pemetrexed and cisplatin]) in patients with EGFR-mutated non-squamous non-small cell lung-cancer (nsqNSCLC) who progressed after EGFR-TKI therapy in an oral presentation at the ESMO (Free ESMO Whitepaper) (European Society for Medical Oncology) Virtual Plenary: November 2021 (Abstract #300) (Press release, Innovent Biologics, NOV 21, 2021, View Source [SID1234595868]).

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In the first interim analysis reviewed by the Independent Data Monitoring Committee (IDMC), in the intent-to-treat (ITT) population, based on assessment by the Independent Radiographic Review Committee (IRRC), Arm A (sintilimab plus BYVASDA[bevacizumab biosimilar injection] in combination with chemotherapy group) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with Arm C (chemotherapy group), with a HR of 0.464 (95%CI: 0.337, 0.639; p<0.0001). The median progression-free survival (PFS) (95%CI) was 6.9 months (6.0, 9.3) in Arm A, and 4.3 months (4.1, 5.4) in Arm C. The prespecified PFS futility analysis that compares Arm A to Arm B (sintilimab and chemotherapy group) did not cross futility stopping boundary (HR=0.726, 95%CI: 0.528, 0.998). A numerical benefit of adding BYVASDA (bevacizumab biosimilar injection) to sintilimab and chemotherapy combination was observed (based on IRRC assessment). Additionally, the key secondary endpoints of objective response rate (ORR) and duration of response (DOR) were improved in Arm A compared with Arm C, and the results of PFS, ORR and DOR assessed by the investigator were consistent with the results assessed by IRRC. The PFS data of Arm B vs Arm C was immature yet, with a numerical benefit observed as well. The safety profile of this study was consistent with that observed in previously reported studies of sintilimab and BYVASDA (bevacizumab biosimilar injection), without new unexpected safety signals. Innovent plans to review these results and file the supplemental New Drug Application (sNDA) to the National Medical Products Administration (NMPA) in China in the near future.

The principal investigator of the ORIENT-31, Prof. Shun Lu from the Oncology Department of Shanghai Chest Hospital, stated, "Despite initial clinical response to EGFR-TKI, virtually all advanced EGFR-mutated NSCLC inevitably acquire resistance mechanisms and progress after treatment with an EGFR-TKI. For those patients with EGFR-mutated advanced nsqNSCLC who have progressed following EGFR-TKI treatment, platinum-based chemotherapy is the current standard of care, but with limited benefit. New treatment options are imperative for this unmet medical need. Globally, ORIENT-31 is the first prospective, double-blind Phase 3 study to demonstrate significant PFS benefit of combination therapy of PD-1 and VEGF inhibitors with chemotherapy compared to standard care of therapy in this patient population. The study has shown the clinical value of adding sintilimab plus BYVASDA (bevacizumab biosimilar injection) to platinum-based chemotherapy. I am honored to have this opportunity to share the results of this study as an oral presentation at this year’s ESMO (Free ESMO Whitepaper) Virtual Plenary. This modified regimen brings forth a new and more effective treatment option and provides clinically meaningful benefits to patients with EGFR-mutated nsqNSCLC following treatment with an EGFR TKI."

Dr. Hui Zhou, Senior Vice President of Innovent, stated, "Lung cancer is one of the most prevalent cancers and remains the leading cause of cancer-related mortality both in China and worldwide. EGFR-mutated NSCLC is the most prevalent molecular subtype in Chinese lung cancer patients, accounting for 40% to 50% of nsqNSCLC. While immunotherapy has greatly changed the treatment paradigm for many malignancies, it has not yet conquered driver genes mutated cancers. Drug resistance is unavoidable for patients with EGFR-mutated advanced NSCLC after first, second and third generation EGFR-TKIs treatments, with limited treatment options, representing a large unmet medical need. The ORIENT-31 data at this year’s ESMO (Free ESMO Whitepaper) indicates the potential of combination therapy to prolong lives of these patients. We are grateful for all the contributions made by the investigators and patients in the ORIENT-31 study – together we accomplished this meaningful milestone."

About Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the leading cause of cancer death worldwide, and the second most commonly diagnosed tumor type. Non-small cell lung cancer (NSCLC) accounts for about 80% to 85% of all lung cancer, in which about 70% of NSCLC patients present with locally advanced or metastatic disease that is not suitable for surgical resection at diagnosis. In China, nsqNSCLC accounts for 70% of NSCLC, in which about 40% to 50% of nsqNSCLC patients have an EGFR mutation. The standard first-line treatment for patients with advanced EGFR-mutated NSCLC is a third generation EGFR TKI, or first or second generation EGFR TKI. For patients who have progressed following EGFR-TKI treatment, platinum-based chemotherapy is still the standard therapy with limited benefit, representing a large unmet medical need.

About the ORIENT-31 Study

ORIENT-31 is a randomized, double-blind, multi-center Phase 3 clinical study conducted in China evaluating sintilimab, with or without BYVASDA (bevacizumab biosimilar injection), combined with chemotherapy (pemetrexed and cisplatin) in patients with EGFR-mutated locally advanced or metastatic nsqNSCLC who have progressed following EGFR TKI treatment (ClinicalTrials.gov, NCT003802240). The primary endpoint is PFS as assessed by BIRRC based on RECIST v1.1. The secondary endpoints include overall survival (OS), PFS as assessed by investigators, ORR and safety.

Eligible patients included: patients with disease progression following first or second generation EGFR TKI and confirmed as T790M negative, or T790M positive but further progressed on third generation EGFR-TKI treatment, or patients with disease progression following third generation EGFR TKI as first line treatment.

Patients were randomized in a 1:1:1 ratio to receive sintilimab plus BYVASDA (bevacizumab biosimilar injection) combined with pemetrexed and cisplatin (Arm A), sintilimab plus placebo 2 combined with pemetrexed and cisplatin (Arm B), or placebo 1 plus placebo 2 combined with pemetrexed and cisplatin (Arm C). After 4 cycles of combination treatment, patients will receive maintenance treatment of sintilimab plus BYVASDA and pemetrexed, sintilimab plus placebo 2 and pemetrexed, placebo 1 plus placebo 2 and pemetrexed, until radiographic disease progression, unacceptable toxicity or any other conditions that required treatment discontinuation. Target accrual is 480 patients. By the data cutoff date of the first interim analysis, 444 patients were enrolled.

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Sintilimab is an immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab worldwide, to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved for four indications, including:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of nonsquamous non-small cell lung cancer
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer
In combination with BYVASDA (bevacizumab biosimilar injection) for the first-line treatment of hepatocellular carcinoma
Additionally, Innovent currently has two regulatory submissions accepted for review in China for sintilimab monotherapy for the first-line treatment of esophageal squamous cell carcinoma, and for sintilimab in combination with chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.

Additionally, three clinical studies of sintilimab have met their primary endpoints:

Phase 2 study as second-line treatment of esophageal squamous cell carcinoma
Phase 3 study as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy
Phase 3 study in combination with BYVASDA (bevacizumab biosimilar injection) and chemotherapy (pemetrexed and cisplatin) for EGFR-mutated nonsquamous NSCLC following EGFR-TKI treatment.
In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer.

Sintilimab was included in China’s National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year.

About BYVASDA (bevacizumab biosimilar injection)

BYVASDA, also known as IBI305, is a bevacizumab biosimilar and a recombinant humanized anti-VEGF monoclonal antibody drug. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF-A selectively with high affinity and blocks its binding to VEGF-2 receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. BYVASDA produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. Since its launch, bevacizumab has been approved for the treatment of patients with multiple malignant tumors globally, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. The efficacy and safety of bevacizumab in these tumor types have been well recognized worldwide.

In China, BYVASDA (bevacizumab biosimilar injection) is approved for indications including advanced non-small cell lung cancer, metastatic colorectal cancer, adult recurrent glioblastoma, and advanced or unresectable hepatocellular carcinoma.

On November 21, 2021 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, and Zenas BioPharma ("Zenas"), a global biopharmaceutical company based in the USA and China committed to the development and delivery of immune-based therapies, reported that Zenas has acquired from Xencor exclusive worldwide rights to develop, manufacture and commercialize the investigational antibody obexelimab (Press release, Xencor, NOV 21, 2021, View Source [SID1234595866]).

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Obexelimab is a potential first-in-class bifunctional antibody that targets CD19 with its variable domain and uses Xencor’s XmAb Immune Inhibitor Fc Domain to target FcγRIIb, a receptor that inhibits the function of B-cells, which are important components in the immune system. Xencor demonstrated through early-stage clinical studies that obexelimab effectively inhibits B-cell function without depleting the cells and generates an encouraging treatment effect in patients with multiple autoimmune diseases.

"Zenas is advancing a broad pipeline of differentiated drug candidates that are intended to bring best-in-class innovation to patients with underserved medical needs," said Hua Mu, Ph.D., MD, president and chief executive officer at Zenas. "Today, we are pleased to add obexelimab to our portfolio, and based on its clinical profile, we believe it is positioned as a first-in-class candidate with the potential to treat numerous autoimmune diseases."

"Obexelimab’s highly potent and broad blockade of B-cell activation—without depleting B cells—differentiates it from other B-cell targeting therapies, and it has demonstrated disease-modifying activity in settings where B-cell inhibition is a proven strategy," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "In Zenas BioPharma, we have found a partner committed to broadly and aggressively developing therapeutics like obexelimab for patients with autoimmune diseases, enabling Xencor’s continued focus on the growing opportunities provided by our XmAb bispecific antibody and cytokine pipeline."

Under the terms of the new agreement, Zenas will issue to Xencor a warrant giving Xencor the right to acquire additional Zenas equity, such that Xencor’s total equity in Zenas would be 15% of its fully diluted capitalization following the closing of Zenas’ next round of equity financing, subject to certain requirements. Xencor previously received equity in Zenas under a separate license agreement. Xencor is also eligible to receive up to $480 million based on the achievement of certain clinical development, regulatory and commercialization milestones and is eligible to receive tiered, mid-single digit to mid-teen percent royalties upon commercialization of obexelimab, dependent on geography. Zenas will have sole responsibility for advancing the research, development, regulatory and commercial activities of obexelimab worldwide.