On September 9, 2024 NiKang Therapeutics Inc. ("NiKang"), a clinical-stage biotech company focused on developing innovative small molecule oncology medicines to bring transformative therapies to patients in need, reported that preliminary data from its ongoing Phase 1/2 clinical trial evaluating NKT2152 for the treatment of previously treated advanced clear cell renal cell carcinoma (ccRCC) will be presented in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2024 Congress on September 13, 2024, in Barcelona, Spain (Press release, NiKang Therapeutics, SEP 9, 2024, View Source [SID1234646463]).

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"This oral presentation marks an important milestone in the clinical development of NKT2152, a highly selective, potent and orally available HIF2α inhibitor with a potential best-in-class profile. The findings strengthen our belief that deep inhibition of HIF2α can lead to meaningful clinical benefits in patients at dose levels that are generally well tolerated," said Zhenhai Gao, Ph.D., co-founder, president and CEO of NiKang. "These data demonstrate NKT2152’s robust anti-tumor activity in heavily pretreated, high risk advanced ccRCC patients. They also support the hypothesis that NKT2152’s potency and improved systemic exposure have the potential to enhance the current standard of care."

Details for the presentation are as follows:

Presentation Title: NKT2152, a novel oral HIF2α inhibitor, in participants (pts) with previously treated advanced clear cell renal cell carcinoma (accRCC): Preliminary results of a Phase 1/2 study
Session Title: Proffered paper session 1: GU tumors, non-prostate
Session Date and Time: Friday, September 13, from 14:00 – 15:30 CET (8:00 – 9:30am ET)
Presentation Number: 1690O
Presenter: Eric Jonasch, MD (MD Anderson Cancer Center, Houston, TX)
Location: Santander Auditorium – Hall 5

After the oral presentation, the full presentation will be available at Science & Pipeline – NiKang Therapeutics (www.nikangtx.com).

About NKT2152

NKT2152 is a potent, selective and orally available small molecule HIF2α inhibitor which binds to HIF2α allosterically and disrupts the HIF2α/HIF1β transcription factor complex, thereby reducing the production of proteins which lead to tumorigenesis. NKT2152 is currently under evaluation in a Phase 1/2 clinical study in ccRCC as a single agent (NCT05119335) and a Phase 2 clinical study in ccRCC in combination with palbociclib and sasanlimab (NCT05935748). A third clinical study, sponsored by F. Hoffman-La Roche Ltd., evaluating the combination with standard-of-care atezolizumab (Tecentriq) and bevacizumab (Avastin) in first-line unresectable/advance hepatocellular carcinoma (HCC) (NCT04524871) is planned.

On September 9, 2024 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the 2024 World Conference on Lung Cancer ("WCLC24") in San Diego, USA, and the European Society for Medical Oncology ("ESMO") Congress 2024, taking place in Barcelona, Spain (Press release, Hutchison China MediTech, SEP 9, 2024, View Source [SID1234646432]).

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Results from the FLOWERS study, a prospective, two-arm, randomized, multicenter Phase II clinical trial of osimertinib with or without savolitinib as first-line treatment in EGFRm, MET-aberrant advanced non-small cell lung cancer ("NSCLC") patients, will be presented at WCLC24. As of May 28, 2024, the median follow-up was 8.2 months. Patients treated with osimertinib plus savolitinib (Cohort 2, N=21) showed deeper and more durable response over osimertinib monotherapy (Cohort 1, N=23) along the study follow-up. The confirmed objective response rate (ORR) in Cohort 1 and Cohort 2 were 60.9% and 90.5%, respectively, with disease control rate (DCR) of 87% and 95.2%, respectively. Immature progression-free survival ("PFS") data also showed a positive trend in favor of the combination therapy, with median PFS of 9.3 months and 19.6 months in the cohort 1 and cohort 2 with maturity of 34.8% and 23.8%, respectively. Safety profiles of osimertinib monotherapy and osimertinib plus savolitinib were as expected, tolerable and manageable.

Abstract title Presenter / Lead author Presentation details

WCLC24 – INVESTIGATOR-INITIATED STUDIES

Osimertinib with or without savolitinib as 1L in de novo MET aberrant, EGFRm advanced NSCLC (CTONG 2008): A Phase II trial Jinji Yang,
Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, Southern Medical University, Guangzhou, China PL04.10
Plenary Session
PL04 Presidential Symposium 2,Plenary Hall
Monday, September 9, 2024 at 8:30 AM PDT
Study of Surufatinib Combined with Low Dose Topotecan in Second or Third-Line Multiple Distant Organ Metastatic ES-SCLC Yingying Du, The First Affiliated Hospital of Anhui Medical University, Hefei, China; Hesheng Qian, Fuyang Cancer Hospital, Fuyang, China EP.13A.04A
ePoster
Saturday, September 7, 2024
Surufatinib Plus Docetaxel in Patients with Relapsed Advanced Driver-Negative Non-Squamous NSCLC: A Phase Ib/II Study Qitao Yu, Wei Jiang,
Guangxi Medical University Cancer Hospital, Nanning, China P3.12C.08
Poster
Monday, September 9, 2024 at 8:30 AM PDT

Further analysis of fruquintinib’s FRESCO-2 study in metastatic colorectal cancer and FRUTIGA study in gastric cancer, a biomarker study of savolitinib in gastric cancer as well as investigator-initiated studies of fruquintinib and surufatinib will be presented at the ESMO (Free ESMO Whitepaper) Congress 2024. Details of the presentations are as follows:

Abstract title Presenter / Lead author Presentation details
ESMO 2024 – SPONSORED STUDIES
Efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer with and without liver metastasis: A subgroup analysis of the phase 3 FRESCO-2 trial Rocio Garcia-Carbonero,
Hospital Universitario 12 de Octubre, lmas12, UCM, Madrid, Spain 520P
Poster Session – Colorectal cancer
Monday, 16 September 2024
Efficacy and safety of fruquintinib in refractory metastatic colorectal cancer: A FRESCO-2 subgroup analysis by age Maria Elena Elez Fernandez,
Vall d’Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain 526P
Poster Session – Colorectal cancer
Monday, 16 September 2024
Efficacy of fruquintinib plus paclitaxel (F+PTX) in patients (pts) with prior immunotherapy (prior-IO): subgroup analysis from FRUTIGA study Lin Shen,
Peking University Cancer Hospital & Institute, Beijing, China 1410P
Poster Session – Oesophagogastric cancer
Monday, 16 September 2024
Impact of subsequent anti-tumor therapies in patients (pts) with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma receiving fruquintinib (F) plus paclitaxel (PTX) or placebo plus PTX in FRUTIGA study Ruihua Xu,
Sun Yat-sen University Cancer Center, Guangzhou, China 1434P
Poster Session – Oesophagogastric cancer
Monday, 16 September 2024
Association between Fruquintinib-induced Hypertension and Clinical Outcomes from FRUTIGA, a Phase 3 Study of Fruquintinib plus Paclitaxel in Previously Treated Advanced Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma Shukui Qin,
Chinese People’s Liberation Army Cancer Center of Nanjing Bayi Hospital, Nanjing, China 1443P
Poster Session – Oesophagogastric cancer
Monday, 16 September 2024
Analysis of MET gene alterations in cfDNA samples from a phase II study of savolitinib in patients (pts) with MET-amplified gastroesophageal junction adenocarcinomas or gastric cancer (GEJ/GC) Zhi Peng,
Peking University Cancer Hospital & Institute, Beijing, China 1461P
Poster Session – Oesophagogastric cancer
Monday, 16 September 2024
ESMO 2024 – INVESTIGATOR-INITIATED STUDIES
A phase II clinical study of fruquintinib (Fru) combined with toripalimab (Tor) and short-course radiotherapy (SCRT) as neoadjuvant therapy for locally advanced rectal cancer (LARC) Zhiping Li, Ye Chen,
West China Hospital of Sichuan University, Chengdu, China 570P
Poster Session – Colorectal cancer
Monday, 16 September 2024
Stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab in metastatic colorectal cancer: Updated findings from a single-arm, prospective phase II trial (RIFLE) Zhen Zhang, Yajie Chen,
Fudan University Shanghai Cancer Center, Shanghai, China 537P
Poster Session – Colorectal cancer
Monday, 16 September 2024
Fruquintinib combined with sintilimab and chemotherapy as the first-line treatment in advanced naïve EGFR- and ALK-negative non-squamous non-small cell lung cancer (nsq-NSCLC): Updated results Yongqian Shu, Pei Ma,
Jiangsu Province Hospital/The First Affiliated Hospital of Nanjing Medical University, Nanjing, China 1329P
Poster Session – NSCLC, metastatic
Saturday, 14 September 2024
Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment for advanced G/GEJ cancer: A phase 1b/2 clinical trial (FUNCTION) Xiaobing Chen, Beibei Chen,
Henan Cancer Hospital/ Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China 1475TiP
Poster Session – Oesophagogastric cancer
Monday, 16 September 2024
Fruquintinib combined with nab-paclitaxel and gemcitabine (AG) as the first-line treatment for pancreatic ductal adenocarcinoma (PDAC) with liver metastases: An open-label, single-arm, single-center phase II clinical study Xianjun Yu, Miaoyan Wei,
Fudan University Shanghai Cancer Center, Shanghai, China 1529P
Poster Session – Pancreatic cancer
Monday, 16 September 2024
A phase II study of Fruquintinib in the 1L or 2L treatment of unresectable metastatic soft tissue sarcoma Zhiguo Luo, Xiaowei Zhang,
Fudan University Shanghai Cancer Center, Shanghai, China 1743P
Poster Session – Sarcoma
Saturday, 14 September 2024
Surufatinib combined with anti-PD-1/PD-L1 antibody in the second line or monotherapy in third line treatment of advanced hepatocellular carcinoma: A single-arm, open-label, multi-center phase II study Fuxiang Zhou,
Zhongnan Hospital, Wuhan University, Wuhan, China 974P
Poster Session – Hepatocellular carcinoma (HCC)
Monday, 16 September 2024
Updated results of Surufatinib plus transarterial embolization versus surufatinib monotherapy in neuroendocrine tumor with liver metastasis: a prospective, randomized, controlled trial Dan Cao,
West China Hospital, Sichuan University, Chengdu, China 1155P
Poster Session – Neuroendocrine tumours
Monday, 16 September 2024
Surufatinib plus toripalimab combined with pemetrexed (A), and platinum (P) in patients (pts) with advanced non-squamous non-small cell lung cancer (nsq-NSCLC): Updated results of a single-center, phase II trial Li Zhang, Wenfeng Fang,
Sun Yat-Sen University Cancer Center, Guangzhou, China 1345P
Poster Session – NSCLC, metastatic
Saturday, 14 September 2024
Surufatinib combined with gemcitabine in soft tissue sarcoma (STS) patients failed with anthracyclines chemotherapy or monotherapy post-anlotinib progression: a multi-center, phase II trial Xiaohui Niu, Yuhong Zhou,
Zhongshan Hospital, Fudan University, Shanghai, China 1740P
Poster Session – Sarcoma
Saturday, 14 September 2024

On September 9, 2024 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported an oral presentation of updated results from a pivotal Phase 2 clinical trial of Dupert（fulzerasib）for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation at the 2024 World Conference on Lung Cancer (WCLC) (Press release, Innovent Biologics, SEP 9, 2024, View Source [SID1234646448]).

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Fulzerasib is a novel, orally active, potent KRAS G12C inhibitor. Based on the results from this single-arm registrational Phase 2 clinical study (NCT05005234).

Dupert (fulzerasib) received approval by the NMPA in August 2024 for the treatment of adult patients with advanced NSCLC harboring the KRAS G12C mutation who have received at least one systemic therapy.

As of the data cutoff date (Dec 13, 2023), a total of 116 NSCLC subjects were enrolled and evaluable.

Fulzerasib showed encouraging antitumor activity. The confirmed objective response rate (ORR) assessed by the Independent Radiology Review Committee (IRRC) was 49.1% (95% CI: 39.7-58.6). The disease control rate (DCR) was 90.5% (95%CI: 83.7, 95.2). The median duration of response (DoR) has not yet been reached, while the median progression-free survival (PFS) was 9.7 months (95%CI: 5.6-11.0). Median overall survival (OS) has not been reached.
Fulzerasib was generally well-tolerated, with no additional safety signals observed. Treatment-related adverse events (TRAEs) occurred in 92.2% of patients (107 individuals), mostly Grade 1-2. The most common TRAEs included anemia, increased alanine aminotransferase, increased aspartate aminotransferase, asthenia and proteinuria.
Professor Yi-Long Wu from Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, stated: "As a potent KRAS G12C inhibitor, Dupert monotherapy has demonstrated encouraging efficacy in advanced lung cancer with KRAS G12C mutations, with the pivotal registry study meeting the prespecified primary endpoints and overall favorable safety profile. As the first KRAS G12C inhibitor approved in China, Dupert provides a new treatment option for cancer patients harboring this gene mutation in China. We look forward to seeing more KRAS G12C-mutated patients with advanced lung cancer benefit from this drug soon."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to share the latest clinical data from the registration study of Dupert at the WCLC. Thanks to the exceptional efficacy and good tolerability demonstrated in this study, Dupert was recently approved as the first KRAS G12C inhibitor in China. Moving forward, we remain committed to advancing Dupert as both a monotherapy and in combination treatments, aiming to maximize the clinical value of this innovative targeted drug and benefit more patients."

About Dupert (Fulzerasib, KRAS G12C Inhibitor)

The RAS protein family is categorized into KRAS, HRAS and NRAS categories. KRAS mutation are detected in nearly 90% of pancreatic cancers, 30-40% of colon cancers, and 15-20% lung cancers. The KRAS G12C mutation is more prevalent than the combined occurrence of ALK, ROS1, RET and NTRK 1/2/3 mutations.

Fulzerasib is a novel, orally active and potent KRAS G12C inhibitor designed to effectively target the GTP/GDP exchange—an essential step in pathway activation—by covalently and irreversibly modifying the cysteine residue of KRAS G12C protein. Preclinical cysteine selectivity studies demonstrated high selectivity of fulzerasib towards G12C, leading to inhibition of downstream signaling, resulting in tumor cells apoptosis and cell cycle arrest.

In September 2021, Innovent and GenFleet Therapeutics entered an exclusive license agreement for the development and commercialization of fulzerasib (Innovent R&D code: IBI351, GenFleet R&D code: GFH925) in China, including mainland China, Hong Kong, Macau and Taiwan.

In January 2023, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation (BTD) to fulzerasib for the treatment of patients with advanced NSCLC harboring KRAS G12C mutation who have received at least one prior systemic therapy. In May 2023, another BTD was granted for the treatment of advanced CRC patients with KRAS G12C mutation who had undergone at least two systemic therapies.

As of August 2024, the CDE of NMPA has approved fulzerasib for the treatment of adult patients with advanced NSCLC harboring the KRAS G12C mutation who have received at least one systemic therapy.

On September 9, 2024 Candid Therapeutics, Inc. ("Candid"), a biotechnology company dedicated to developing potentially transformative drugs to address autoimmune diseases, reported its official launch today (Press release, Candid Therapeutics, SEP 9, 2024, View Source [SID1234646464]).

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Recent groundbreaking clinical data has showcased the pivotal role of a specific subset of immune cells, B lymphocytes, in autoimmune diseases. B lymphocytes lead to autoimmune pathology by producing autoantibodies that attack the body’s own tissues and also through antigen presentation and cytokine release. Selective depletion of B lymphocytes has shown unprecedented clinical efficacy in highly refractory patients across multiple autoimmune diseases such as rheumatoid arthritis and myasthenia gravis. Candid is developing T-cell engager ("TCE") antibodies that can deplete specific B lymphocyte cell populations and aims to be the first company to bring these novel therapies to market.

To accelerate development of and position Candid to become the leader in TCE antibodies for autoimmune diseases, Candid acquired Vignette Bio and TRC 2004 through a simultaneous three-way merger and multi-step financing. This acquisition integrates two cutting-edge bispecific TCEs:

CND106, a BCMAxCD3 bispecific antibody from Vignette Bio, which was initially founded by Foresite Labs who exclusively licensed ex-China rights for the drug candidate from EpimAb Biotherapeutics.
CND261, a CD20xCD3 bispecific antibody from TRC 2004, which was established through a collaboration between Two River and Third Rock Ventures who exclusively licensed ex-China rights for the drug candidate from Genor Biopharma.
CND106 and CND261 have both completed Phase 1 dose escalation studies with combined data in over 130 oncology patients. Both drug candidates have shown potential to become best-in-class therapies for various autoimmune diseases.
The founding Candid team includes an accomplished set of seasoned entrepreneurs who have repeatedly advanced nascent ideas into late-stage development products and commercialization.

Ken Song, MD as Chairman, President and CEO has successfully led several life science companies with over $5.5 billion in realized shareholder value. Most recently he led RayzeBio, a radiopharmaceutical company, from concept to Phase 3 in just over 3 years and negotiated a $4.1 billion sale of the company earlier this year to Bristol Myers Squibb.
Timothy Lu, MD, PhD as Chief Medical and Scientific Officer was instrumental in the clinical development of novel oral IL-17 drugs for autoimmune diseases at DICE Therapeutics which was acquired last year by Eli Lilly, where he stayed on until joining the Candid team.
Bernie Huyghe, PhD as Chief Technology Officer has over 30 years of experience in manufacturing of biologics and other complex therapeutic products and prior to Candid, was overseeing two Phase 3 antibody programs at Viridian Therapeutics.
Arvind Kush as Chief Financial and Business Officer has had an illustrious career first as a managing director in healthcare banking at Bank of America before transitioning to RayzeBio as CFO where he navigated a highly successful oversubscribed IPO in September 2023.
In conjunction with the merger, Candid has successfully raised over $370 million in capital from an extensive roster of investors, which includes a recently completed financing co-led by Venrock Healthcare Capital Partners, Fairmount, TCGX, and venBio Partners. Other notable healthcare investors supporting the company include Foresite Capital, Third Rock Ventures, Fidelity Management & Research Company, Samsara BioCapital, Qiming Venture Partners USA, OrbiMed, Boxer Capital, Redmile Group, Vida Ventures, Two River, Franklin Templeton, LifeSci Venture Partners, Mirae Asset Capital Life Science, Polaris Innovation Fund, Soleus Capital and other reputable institutional and mutual fund investors. This substantial financial backing highlights strong investor confidence in Candid’s purposeful approach and strategic vision, positioning the company for significant impact in bringing forth first-in-class therapies to patients with autoimmune diseases.

"TCE antibodies have the most promise as scalable and patient friendly drugs to deplete B cells for treatment of a myriad of autoimmune conditions and represents a once in a generation development opportunity," said Dr. Ken Song, Chairman, President, and CEO of Candid Therapeutics. "The drugs we are developing at Candid have the potential to go above and beyond the clinical and commercial success of Humira and Rituxan and I am thrilled to be leading the Candid team knowing we can possibly make history by changing the paradigm in how autoimmune diseases are treated."

On September 9, 2024 Immunotherapy innovator ImmunityBio, Inc. (NASDAQ: IBRX), reported positive results from its QUILT 3.055 trial demonstrating long-term extended survival of 14 months to as much as five years for patients with advanced non-small cell lung cancer (NSCLC) being treated with checkpoint inhibitors (CPI) (Press release, ImmunityBio, SEP 9, 2024, View Source [SID1234646433]). An oral presentation of the data was presented by John Wrangle, M.D., MPH, Associate Professor, Medical University of South Carolina, at the World Congress on Lung Cancer in San Diego on Sunday, September 8 in the session titled "Novel Immunotherapy Strategies and Combinations."

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The phase 2b study of ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with checkpoint inhibitors KEYTRUDA or OPDIVO in multiple tumor types including NSCLC who failed CPI showed long-term overall survival of 57 percent (49/86) and 34 percent (29/86) at 12 and 18 months respectively, exceeding the current standard of care.

"Most NSCLC patients experience progression following checkpoint inhibitors, with average survival well under a year when checkpoint inhibitor-based therapies fail our patients," said Dr. Wrangle. "The QUILT-3.055 study enrolled patients relapsed after CPI and CPI in combination with chemotherapy and showed that, regardless of prior therapy, adding the IL-15-based superagonist ANKTIVA to their therapy could rescue checkpoint activity likely through activation of NK cells, CD4+, CD8+, and memory T cells. The survival rate in these patients on their 2nd or 3rd line of cancer therapy is impressive and exceeds what you might expect from the current standard of care."

About the QUILT-3.055 Study

Non-small cell lung cancer occurs when malignant cells form in the lung’s tissue and it accounts for approximately 85% of all lung cancer cases. Lung cancer is by far the leading cause of cancer death in the U.S., accounting for about 1 in 5 of all cancer deaths, according to the American Cancer Society.

The QUILT-3.055 study examined overall survival in 86 patients with 2nd and 3rd line+ NSCLC who were previously treated and failed either CPI alone or failed CPI in combination with chemotherapy. These patients had received no intervening therapy. Patients received ANKTIVA 15 mcg/kg subcutaneously every 3 weeks in combination with the same checkpoint inhibitor they previously received and on which they had progressed.

The median OS (n=86) was 14.1 months (95% CI 11.7, 17.4) with survival ranging up to 58 months. Overall survival for PDL1+ve (>1%) (N=53) was 13.8 months (95% CI 10.2, 16.2) versus PDL1-ve (N=33) of 15.8 months (95% CI 11.5, 24.0). The ANKTIVA adverse event profile was consistent with CPI alone with no cytokine release syndrome observed. Only 10% of participants had any grade ≥3 ANKTIVA-related adverse events. The study demonstrates long-term survival at ≥12 and ≥18 months of 49/86 (57%) and 29/86 (34%) patients respectively.

ANKTIVA plus CPI therapy in 2nd line or greater NSCLC demonstrated long-term median OS, independent of PDL1 status, and independent of prior lines of therapy in patients with acquired resistance to CPI. These findings support the novel mechanism of action of ANKTIVA to rescue CPI activity through the activation of NK and T cells, driving long-term memory, with median overall survival of 57% and 34% at 12 and 18 months, respectively, exceeding the standard of care.

Based on the results of the QUILT 3.055 study and other trials involving ANKTIVA with checkpoint inhibitors, ImmunityBio is opening Phase 3 trials of ANKTIVA plus KEYTRUDA or OPDIVO in 1st and 2nd line NSCLC.

"The clinical trial protocol was designed such that the duration of experimental therapy with ANKTIVA plus CPI was 24 months, and thereafter no further ANKTIVA doses were administered. Despite this, the results demonstrated that 27% of the participants survived beyond the 2-year therapy period, indicating the potential benefit of ANKTIVA to activate memory T cells and prolonged therapeutic benefit after study treatment was completed," said Patrick Soon-Shiong, M.D., Executive Chairman, Founder and Global Chief Scientific and Medical Officer at ImmunityBio. "Based on this study, the ResQ studies have been activated as randomized Phase 3 trials in both 1st. and 2nd line NSCLC by combining ANKTIVA with pembrolizumab or nivolumab versus standard of care. The current results presented at World Congress on Lung Cancer confirm that by activating the body’s natural immune system and proliferating natural killer cells, killer T cells, and memory T cells, this IL-15 superagonist boosts, or rescues, the checkpoint inhibitor likely by reactivating MHC1 expression on the tumor. We are excited at the potential of converting a MHC-ve cold tumor to a MHC+ve hot tumor and evolving the field of immunotherapy beyond T cells."

About ANKTIVA

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.

ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.

ANKTIVA was recently approved by the FDA for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit Anktiva.com.

Indication and Important Safety Information

INDICATION AND USAGE

ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS

Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle invasive or metastatic bladder cancer, which can be lethal. If patient with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION

For lntravesical Use Only. Do not administer by subcutaneous or intravenous routes. Instill intravesically only after dilution. Total time from vial puncture to the completion of the intravesical instillation should not exceed 2 hours.

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS

The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia.

For more information about ANKTIVA, please see the Full Prescribing Information at www.anktiva.com. You are encouraged to report negative side effects of prescription drugs to FDA.

Visit www.FDA.gov/medwatch or call 1-800-332-1088. You may also contact lmmunityBio at 1-877-ANKTIVA (1-877-265-8482)