On April 19, 2022 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that the empty capsule material that comprises its pancreatic cancer clinical trial product candidate does not cause systemic toxicity (Press release, PharmaCyte Biotech, APR 19, 2022, View Source [SID1234612504]).

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "Another important study has been conducted and concluded. This time the study evaluated the potential toxicity of the capsule component of our CypCaps clinical trial product candidate. We are pleased to announce that there was no evidence of toxicity in this animal study in any of the parameters examined and that the study confirms previous data that the capsule material is inert."

The study, which was performed by a third-party Contract Research Organization, involved the ISO compliant testing of an extract of empty cellulose sulphate capsules provided by Austrianova for potential acute systemic toxicity in mice, according to ISO 10993-11: 2017(E), an FDA recognized consensus standard. Upon intraperitoneal injection of capsule extract, the mice were observed for clinical signs of toxicity at 30 to 40 min, 1 hour, 2 hours and 4 hours post dosing on day 1. On days 2, 3, 7 and 14, all of the animals were observed once daily for clinical signs and twice daily for mortality.

The body weight of the mice was recorded prior to administration of the capsule extract on day 1 and on days 2, 3, 4, 7 and 14 during the observation period. At the end of observation period, all the animals were examined for signs of toxicity. The analyses revealed that none of the mice died or showed any clinical signs of toxicity or gross pathological changes as compared to control mice. Moreover, no treatment related changes were noted in body weight and percent change in body weight with respect to day 1 values and all animals revealed a normal increase in body weight during the observation period.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On April 19, 2022 Kite, a Gilead Company (Nasdaq: GILD), reported the U.S. Food and Drug Administration (FDA) has approved commercial production at the company’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland (Press release, Kite Pharma, APR 19, 2022, View Source [SID1234612503]). The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer.

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The Maryland site joins Kite’s existing manufacturing facilities in Southern California and Amsterdam, Netherlands to form the largest, dedicated in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing. With today’s announcement, and through a variety of optimization efforts across Kite’s global CAR T-cell therapy manufacturing network, Kite estimates network capacity will be increased by 50%, enabling more patients to be served now and in the future.

"The FDA approval of our Maryland site marks an important milestone within our global CAR T-cell therapy manufacturing network, and will enable us to significantly expand our production capacity and further strengthen our ability to meet the needs of people living with difficult-to-treat blood cancers," said Christi Shaw, Chief Executive Officer of Kite. "Manufacturing is central to every decision we make at Kite. Our teams hold patients’ cells in their hands every day, which could mean the difference between getting a chance to live or possibly losing their battle with cancer. It must be fast and extremely high quality to give patients the best outcome."

CAR T-cell therapies are individually manufactured for each patient using their own T-cells extracted from their white blood cells. The patient’s T-cells are sent to Kite’s manufacturing facilities where they are modified with a Chimeric Antigen Receptor (CAR) to recognize, attack and destroy their cancer cells. Once the individualized therapy is created for a patient, the cells are carefully preserved, packed and sent back to the hospital to be infused back into the patient. Unlike most cancer treatments, CAR T-cell therapy is a one-time treatment, available through authorized treatment centers (ATCs), or hospitals, that have experience with CAR T-cell therapy. Kite therapies are available at over 275 ATCs around the world, including more than 110 leading cancer hospitals in the U.S.

Kite began construction of the 275,000 square foot facility in Maryland on 20 acres in 2019. The site has unfinished space to add future capacity, which will allow Kite to accommodate potential new scientific and technological advances in the field of cell therapy. The new Maryland facility is purpose-built for cell therapy, incorporating learnings from across the Kite manufacturing network as well as incorporating automation for some previously manual processes, allowing more therapies to be produced to meet growing patient demand.

"As the global leader in cell therapy, it is important to keep innovating as manufacturing in cell therapy is unlike anything else in the biologics or pharmaceutical space – each production run is made to order for one patient – and we do it at scale, with a 96% success rate in returning our specialized treatments on time and to specification," said Charles Calderaro, Kite’s Global Head of Technical Operations. "Manufacturing quality, reliability, and speed are critically important to us as we know patients are waiting. Our median cycle time is industry leading at 16 days in the U.S., from apheresis to finished product, which includes many processes that are heavily regulated for safety."

The company is invested in the future of the cell therapy workforce and anticipates having more than 400 employees working at the Maryland site by the end of 2022. The site is also committed to training and developing the region’s cell therapy talent through partnerships with local academic institutions as well as community and government organizations.

Kite’s manufacturing and process development expertise in cell therapy make it a partner of choice, and this expertise is a key component of partnership pipeline deals for the next generation of cell therapies, including previously announced deals with Appia Bio and Shoreline Biosciences.

On April 19, 2022 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company) a leader in the development of targeted radiotherapies for patients with unmet needs reported that highlighted its activity at the upcoming Transplantation & Cellular Therapy (TCT) Tandem Meetings of ASTCT and CIBMTR, the combined annual meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) being held April 23 – 26, 2022 virtually and in Salt Lake City, Utah (Press release, Actinium Pharmaceuticals, APR 19, 2022, View Source [SID1234612502]).

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Updated data from the fully enrolled pivotal Phase 3 SIERRA trial (Study of Iomab-B versus Conventional Care in Elderly, Relapsed or Refractory Acute Myeloid Leukemia) will be highlighted in an oral presentation by Boglarka Gyurkocza, M.D., investigator from Memorial Sloan Kettering Cancer Center, which was the highest enrolling trial site in the SIERRA trial. In addition, Actinium will be conducting medical affairs activity at TCT by engaging with the bone marrow transplant (BMT) community including featuring Iomab-B in a continuing medical education (CME) symposium titled "Landmarks Across the Patient Journey in AML, Applying Evidence with Novel Therapeutics Pre- and Post-AlloHCT" that will be led by Dr. Naval Daver, from The University of Texas MD Anderson Cancer Center and Dr. James Foran from the Mayo Clinical Cancer Center in Jacksonville, Florida.

Dr. Avinash Desai, Actinium’s Chief Medical Officer, stated, "We are excited to attend the TCT Tandem Meetings and once again feature Iomab-B and the SIERRA trial at this preeminent bone marrow transplant and cell therapy conference. Iomab-B has the potential to lead a paradigm shift in targeted conditioning aimed at increasing access to potentially curative treatments like BMT and improving patient outcomes with its differentiated targeted radiotherapy mechanism. Data from the SIERRA trial has shown a consistent 100% rate of BMT access and engraftment in all patients receiving Iomab-B compared to only 17% of patients in the control arm who received multiple therapies including recently approved targeted therapies such as Venetoclax, FLT-3 and IDH inhibitors. In addition, patients receiving Iomab-B have had lower rates on non-relapse transplanted related mortality 100-days post-transplant and lower rates of adverse events including statistically significant lower rates of sepsis and lower rates of febrile neutropenia, which we believe is attributed to the targeted nature of Iomab-B. With topline data from SIERRA expected in the third quarter of this year, we look forward to SIERRA data being featured in an oral presentation and highlighting it in the numerous interactions we have planned with BMT physicians, scientists and care givers at TCT."

Iomab-B TCT Presentation Details:

Presentation Title: High Rates of Transplantation in the Phase III SIERRA Trial Utilizing Anti-CD45 (Iodine) 131-I-Apamistmab (Iomab-B) Conditioning with Successful Engraftment and Tolerability in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) Patients after Lack of Response to Conventional Care and Targeted Therapies

Date and Time: Saturday, April 23, 2022, 6:30 PM ET

Location: Salt Palace Convention Center – Ballroom I

Sandesh Seth, Actinium’s Chairman and CEO, added, "TCT is always a highly impactful conference for Actinium as we get to showcase Iomab-B to the largest gathering of transplant physicians. This year is particularly exciting as we will highlight the strong data from 100% patient enrollment showing a 5-times greater number of Iomab-B patients potentially evaluable for the primary endpoint than control arm in the SIERRA trial at 100-days post BMT. With topline data in sight, this is a great time to be engaging the BMT community. Assuming success with Iomab-B, we see an opportunity to be the leading developer of targeted conditioning regimens based on our Iomab-B and Iomab-ACT radiotherapies that can make BMT, CAR-T and other adoptive cell therapies as well as gene therapies more accessible and bring potential cures closer in reach for patients with high unmet needs."

About the Tandem Meetings

The Tandem Meetings I Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR are the combined annual meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR). Administrators, clinicians, data manager / clinical research professionals, fellows-in-training, investigators, laboratory technicians, MD/PhDs, nurses, nurse practitioners, pharmacists, physician assistants, and other allied health professional attendees benefit from a full scientific program that addresses the most timely issues in hematopoietic cell transplantation and cellular therapy.

About Iomab-B

Iomab-B (I-131 apamistamab), via the monoclonal antibody apamistamab, targets CD45, an antigen widely expressed on leukemia and lymphoma cancer cells, immune cells and bone marrow stem cells. Apamistamab is linked to the radioisotope iodine-131 (I-131) and once attached to its target cells emits energy that travels about 100 cell lengths, destroying a patient’s cancer cells and ablating their bone marrow. By carrying iodine-131 directly to the bone marrow in a targeted manner, Iomab-B may avoid the side effects of non-targeted chemotherapy and external radiation on most healthy tissues while effectively killing the patient’s cancer (induction) and marrow cells (myeloablation) including those in bone marrow niches due to the "crossfire" effect enabled by the I-131 radioisotope.

Iomab-B was licensed from the Fred Hutchinson Cancer Research Center where it was studied in nearly 300 patients, in multiple clinical trials in 6 blood cancer indications. Iomab-B is being studied in the pivotal Phase 3 SIERRA (Study of Iomab-B in Relapsed or Refractory AML) trial, a 150-patient, randomized controlled clinical trial in patients with active, relapsed or refractory Acute Myeloid Leukemia (AML) who are age 55 and above. If granted approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, in a potentially more efficacious manner and with a more beneficial safety profile than the non-targeted intensive chemotherapy conditioning that is the current standard of care in bone marrow transplant conditioning. A bone marrow transplant is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B has been granted Orphan Drug Designation from the U.S. FDA and the European Medicines Agency (EMA). Iomab-B also has patent terms extending to at least 2036/2037 in the US and EU. In addition, Actinium received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the EMA indicating that the Phase 3 SIERRA trial design, primary endpoint and planned statistical analysis are acceptable as the basis for a Marketing Authorization Application.

About the SIERRA Phase 3 Trial

The SIERRA trial is a 150-patient, randomized clinical trial, studying Iomab-B compared to physician’s choice of salvage therapy in patients with active, relapsed or refractory acute myeloid leukemia (r/r AML) age 55 and above. The SIERRA trial completed enrollment in the third quarter of 2021 with the last patient receiving a BMT in the fourth quarter of 2021. Topline data from the SIERRA trial is expected in the third quarter of 2022. In SIERRA, patients receiving Iomab-B, those achieving a remission after salvage therapy or those patients not achieving remission after salvage therapy that crossed over to receive Iomab-B were offered a BMT, which is the only treatment option with curative potential for patients with active r/r AML. The SIERRA trial is the only randomized Phase 3 trial to offer BMT to this patient population. The control arm of SIERRA included over 20 single agents or combination treatment options based on physician’s choice, including salvage chemotherapy and recently approved targeted agents including Bcl-2 inhibitor (Venetoclax), FLT3 inhibitors and IDH 1/2 inhibitors as there is no standard of care for this patient population. The SIERRA trial enrolled patients at 24 leading transplant centers in the United States and Canada.

On April 19, 2022 ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting misfolded proteins such as toxic oligomers implicated in the development of neurodegenerative diseases, reported that it has appointed Larry Altstiel M.D. Ph.D., as Chief Medical Officer (Press release, ProMIS Neurosciences, APR 19, 2022, View Source [SID1234612501]).

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"Larry Altstiel has been a respected leader for over twenty years in the Alzheimer’s clinical research community, and we are delighted to welcome him to the ProMIS team", stated Gene Williams, ProMIS Chairman and CEO. "His deep knowledge of clinical research, regulatory pathways, and the neurodegenerative disease community will be a tremendous asset to ProMIS as we develop our portfolio of differentiated product candidates."

"ProMIS has shown compelling scientific rationale for the differentiation of PMN310 in Alzheimer’s disease" according to Dr. Altstiel. "ProMIS has developed unique and valuable methods for identification of misfolded proteins and toxic oligomeric forms of these proteins that may contribute to the development of a number of neurodegenerative diseases. In particular this approach supports the likely differentiation of PMN310 from other antibody approaches targeting other forms of Abeta. ProMIS’ unique technology platform has also led to the generation of potentially differentiated therapies in ALS and other neurodegenerative diseases. I look forward to helping advance this exciting portfolio in the clinic."

Larry Altstiel, M.D., Ph.D. brings decades of medical expertise in neurodegenerative diseases and experience in the pharmaceutical industry. At Pfizer, as vice president and head of neuroscience clinical research, Larry led the selection of drug candidates, development and oversight of multiple preclinical studies and clinical studies from Phase 1 through Phase 3. He is currently part time Chief Medical Officer at Pinteon Therapeutics. He received his Ph.D. in cell biology, virology, and physical chemistry from The Rockefeller University, completed a postdoctoral fellowship in cell biology at Harvard University and received an M.D. from the University of Miami Leonard M. Miller School of Medicine. He also completed a residency in Neurology at the Neurological Institute of New York, Columbia University College of Physicians and Surgeons.

On April 19, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported the presentation of updated data analyses from the Phase 3 RATIONALE-309 trial of tislelizumab, a humanized anti-PD-1 monoclonal antibody, in combination with chemotherapy versus chemotherapy plus placebo as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (RM-NPC), at the virtual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series on April 19, 2022 (Press release, BeiGene, APR 19, 2022, View Source [SID1234612500]). Updated efficacy analyses showed that, at a median follow-up of 15.5 months, tislelizumab in combination with chemotherapy continued to demonstrate a clinically significant progression-free survival (PFS) benefit over chemotherapy alone for patients with RM-NPC. The safety profile of the tislelizumab and chemotherapy combination was generally manageable and consistent with known risks of each treatment agent.

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"In these updated findings from the RATIONALE-309 trial, tislelizumab in combination with chemotherapy continued to demonstrate PFS benefit over chemotherapy in patients with advanced nasopharyngeal carcinoma, while also showing benefit across a range of other survival endpoints"

"These updated findings further support tislelizumab in combination with chemotherapy as a potential standard-of-care first-line therapy for patients with RM-NPC," said Mark Lanasa, Chief Medical Officer, Solid Tumors at BeiGene. "This study’s acceptance for presentation as part of the high-profile virtual ASCO (Free ASCO Whitepaper) Plenary Series underscores the potential for tislelizumab plus chemotherapy to be a practice-changing option for patients with this disease."

An updated analysis of the primary endpoint (PFS) and two secondary endpoints (PFS2, OS) was performed based on the latest database cutoff as of Sept. 30, 2021. At a median follow-up of 15.5 months, patients administered a 200 mg dose of tislelizumab in combination with chemotherapy achieved a median PFS of 9.6 months (stratified hazard ratio (HR)=0.50 [CI: 0.37, 0.68]) compared to 7.4 months for patients dosed with placebo control and chemotherapy, as assessed by an independent review committee (IRC).

"In these updated findings from the RATIONALE-309 trial, tislelizumab in combination with chemotherapy continued to demonstrate PFS benefit over chemotherapy in patients with advanced nasopharyngeal carcinoma, while also showing benefit across a range of other survival endpoints," said Li Zhang, M.D., professor at the Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China and Sun Yat-sen University Cancer Center, and the principal investigator for the study. "These results continue to support the potential for tislelizumab in combination with chemotherapy as a standard-of-care treatment in first-line RM-NPC."

This trial’s cross over design allows patients from the placebo plus chemotherapy group to receive tislelizumab monotherapy after disease progression. Disease progression or death after next-line therapy (PFS2) was recorded to explore the optimal treatment sequence. For patients treated with tislelizumab plus chemotherapy, median PFS2 was not yet reached compared to 13.9 months for those treated with placebo plus chemotherapy (HR=0.38 [95% CI: 0.25, 0.58]). A positive overall survival (OS) trend was also observed with median OS not yet reached in the tislelizumab combination arm and 23 months for the chemotherapy plus placebo arm (HR=0.60 [95% CI: 0.25, 1.01]).

Biomarker analyses to be presented were performed for exploratory endpoints including PD-L1 and gene expression profiling (GEP). An improvement in PFS for tislelizumab in combination with chemotherapy was observed regardless of PD-L1 status. GEP analysis identified a subgroup of patients who had ‘hot’ tumor immune profiles, which was characterized by the highest expression of immune cells, including T cells, natural killer cells, dendritic cells, and antigen presentation machinery. The greatest PFS benefit of tislelizumab in combination with chemotherapy was observed in patients exhibiting ‘hot’ tumor microenvironment profiles.

In August 2021, the China National Medical Products Administration (NMPA) accepted a supplemental New Drug Application (sNDA) for tislelizumab in combination with chemotherapy as a first-line treatment of adult patients with RM-NPC. BeiGene continues to support planned regulatory filings by Novartis for first-line NPC in the United States and Europe.

ASCO Plenary Series Program
Tuesday, April 19, 2022; 3 – 4 p.m. ET

This livestream event presented by ASCO (Free ASCO Whitepaper) will feature a presentation of abstract #384950, "RATIONALE-309 Updated progression-free survival (PFS), PFS after next line of treatment, and overall survival from a phase 3 double-blind trial of tislelizumab versus placebo, plus chemotherapy, as first-line treatment for recurrent/metastatic nasopharyngeal cancer" by Dr. Zhang. Participants may register for free at: View Source

About Nasopharyngeal Carcinoma

Nasopharyngeal carcinoma (NPC) is a rare cancer in which malignant cells form in the tissues of the nasopharynx and accounts for approximately 133,000 new diagnoses and 80,000 deaths per year worldwide.1

Recurrent or metastatic NPC exhibits a high prevalence in Southeast Asia, among other emerging markets. Known risk factors include ethnic background exposure to the Epstein-Barr virus. The prognosis for patients with recurrent or metastatic NPC treated with first-line chemotherapy remains poor, highlighting the unmet need for effective interventional therapy in the second line or later.

About RATIONALE-309

RATIONALE-309 is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial (NCT03924986) designed to evaluate the efficacy and safety of tislelizumab combined with gemcitabine and cisplatin (Arm A) versus placebo combined with gemcitabine and cisplatin (Arm B) as a first-line treatment for patients with RM-NPC.

The primary endpoint of the trial is progression-free survival (PFS) in the intent-to-treat (ITT) population as assessed by an independent review committee (IRC) per RECIST v1.1 criteria; secondary endpoints include IRC-assessed overall response rate (ORR), IRC-assessed duration of response (DoR), overall survival (OS), investigator-assessed PFS, time to second objective disease progression (PFS2), and safety.

A total of 263 patients were enrolled in the trial, with 131 and 132 randomized to Arm A and Arm B, respectively, with balanced baseline characteristics between both arms. Interim results from the trial were presented in December at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Congress. Those data showed that at a media follow-up time of 10 months, tislelizumab demonstrated a statistically significant improvement in terms of extending progression-free survival (PFS), a clinically meaningful benefit compared to chemotherapy alone on other survival endpoints, and a generally manageable safety profile.

About Tislelizumab

Tislelizumab is an anti-programmed death receptor-1 (PD-1) inhibitor designed to help aid the body’s immune cells to detect and fight tumors. Tislelizumab, a humanized monoclonal antibody, is specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene has initiated or completed more than 20 potentially registration-enabling clinical trials in 35 countries and regions, including 17 Phase 3 trials and four pivotal Phase 2 trials.

Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for eight indications, including multiple approvals in non-small cell lung cancer (NSCLC). Tislelizumab has been submitted for regulatory review in one additional indication in China and as a potential treatment for unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic therapy in the U.S., and in NSCLC and ESCC in Europe. In January 2021, BeiGene partnered with Novartis to accelerate the clinical development and marketing of tislelizumab in the U.S., Europe and Japan.

BeiGene Oncology

BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the U.S., China, the European Union and U.K., Canada, Australia and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under U.S. Food and Drug Administration (FDA) review, BeiGene and Novartis announced an option, collaboration and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.