On June 5, 2022 Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that yesterday on June 4, 2022, in the Industry Expert Theater during the ASCO (Free ASCO Whitepaper) 2022 conference, Dr. Marnix Bosch made a presentation discussing the Company’s DCVax-L technology for personalized dendritic cell vaccines, the Sawston, UK facility, the manufacturing technology, the development of automation, and preparations for manufacturing scale-up (Press release, Northwest Biotherapeutics, JUN 5, 2022, View Source [SID1234615615]). In addition, a video presentation about the DCVax-L clinical program was screened in the Company’s exhibit booth in the ASCO (Free ASCO Whitepaper) Exhibit Hall.

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These presentations are now available online at View Source

The Industry Expert Theater is not an official event of the ASCO (Free ASCO Whitepaper) Annual Meeting. It is not sponsored, endorsed or accredited by ASCO (Free ASCO Whitepaper), CancerLinq, or Conquer Cancer the ASCO (Free ASCO Whitepaper) Foundation. It is not CME-accredited.

On June 5, 2022 JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported the latest data of three clinical studies on Carteyva (relmacabtagene autoleucel injection, hereafter abbreviated as relma-cel) at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, including a two-year follow-up result of RELIANCE study, a multicenter phase 2 trial of Carteyva in Chinese patients with relapsed/refractory large B-cell lymphoma, preliminary safety and efficacy of Carteyva as second-line therapy for primary refractory Chinese patients with large B-cell lymphoma (LBCL) from an open-label, multicenter, single-arm phase I study, and a two-year survival update of a phase I study of Carteyva in relapsed and refractory B-cell non-Hodgkin lymphoma (Press release, JW Therapeutics, JUN 5, 2022, View Source [SID1234615596]).

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Two-year follow-up result of RELIANCE study, a multicenter phase 2 trial of relmacabtagene autoleucel in Chinese patients with relapsed/refractory large B-cell lymphoma (abstract number: 7529)

RELIANCE study was the first pivotal CD19 CAR-T study received IND approval by NMPA. A total of 59 patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL) received single infusion of relma-cel, and completed 2-year follow-up. Results include:

Relma-cel demonstrated sustained response and long-term survival benefit. Among the 58 efficacy evaluable patients, best overall response rate (ORR) and complete response rate (CRR) were 77.6% and 53.5%, respectively. 2-year overall survival (OS) rate was 69.0%.
Relma-cel showed a manageable safety profile with relatively low rate of cytokine release syndrome (CRS) and neurotoxicity (NT). The incidence of CRS of any grade and Grade≥3 were 47.5%, 5.1%, respectively. The incidence of NT of any grade and Grade≥3 were 20.3%, 3.4%, respectively. The most common Grade≥3 adverse events (AEs) were neutropenia and leukopenia.
2-year follow-up data of RELIANCE study showed that relma-cel delivered sustained response and long-term survival with a manageable safety profile and a relatively low incidence of CAR-T related toxicity.
Preliminary safety and efficacy of relmacabtagene autoleucel (relma-cel) as second-line therapy for primary refractory Chinese patients with large B-cell lymphoma (LBCL): Results from an open-label, multicenter, single-arm phase I study (abstract number: e19509)

This was an open-label, single-arm, multi-centre, phase I study, aiming to evaluate the safety and efficacy of relma-cel in patients with primary refractory disease after first-line standard of care (R-CHOP). A total of 12 patients received relma-cel infusion and completed 9 months follow-up.

Data showed relma-cel was tolerable. No Grade≥3 CRS or NT was observed. 6 patients had Grade ≤2 CRS, and 2 patients experienced NT (Grade 1). The most common treatment related Grade≥3 treatment emergent adverse events (TEAEs) was cytopenia.

The best ORR and CRR were 75.0% and 33.3%, 3-month ORR and CRR were 41.7% and 33.3%, respectively. Median duration of response (DOR) and OS were not yet reached.

Relma-cel (JWCAR029) in relapsed and refractory B-cell non-Hodgkin lymphoma: A two-year survival update of a phase I study (abstract number: e19555)

This was an open-label, dose-escalating phase I study of relma-cel for relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL). A total of 22 patients with r/r B-NHL received single dose of relma-cel and completed 2-year follow-up.

Based on the efficacy analysis set comprising 20 patients, the best ORR and CRR were 85.00% and 70.00%, respectively. The progression-free survival (PFS) rates of 1-year and 2-year were both 55.0%, and the OS rates were both 68.6%. Neither median PFS nor median OS was reached. No grade 3 and above CRS or NT were found.

# # #

About Relmacabtagene Autoleucel Injection (trade name: Carteyva)

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel was approved by the China National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, making it the first CAR-T product approved as Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designations.

On June 5, 2022 Eisai reported new investigational data from the platinum-resistant ovarian cancer (PROC) cohort expansion of a Phase 1 study (Study 101) evaluating the antibody drug conjugate (ADC) co-developed by Eisai and Bristol Myers Squibb, farletuzumab ecteribulin (MORAb-202) (Press release, Eisai, JUN 5, 2022, View Source [SID1234615595]). The safety and efficacy findings are being featured in a poster discussion at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (#ASCO22), a hybrid meeting in Chicago from June 3 to 7 (NCT03386942; Abstract: #5513). Farletuzumab ecteribulin is composed of Eisai’s in-house developed farletuzumab, a humanized IgG1 monoclonal antibody that binds to the folate receptor alpha (FRα), and Eisai’s anticancer agent eribulin, a microtubule dynamics inhibitor, using an enzymatically cleavable linker.

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"We are encouraged by the clinical safety and efficacy results, as measured by the preliminary antitumor activity observed in patients with platinum-resistant ovarian cancer being treated with each dose of farletuzumab ecteribulin, and with varying levels of folate receptor alpha expression," said Shin Nishio, MD, PhD, Principal Investigator and Associate Professor, Department of Obstetrics and Gynecology, Kurume University School of Medicine, Fukuoka, Japan. "Based on the data from pre-clinical studies, farletuzumab ecteribulin has the clinical potential to elicit a bystander effect through an enzymatically cleavable linker that releases a toxic payload from the antibody, therefore acting not only on the folate receptor alpha-positive cancer cells, but also the folate receptor alpha-negative cancer cells surrounding the folate receptor alpha-positive cancer cells. As the field of targeted therapy continues to evolve, antibody drug conjugates are anticipated to become a key modality in the treatment of recurrent, platinum-resistant disease."

Ovarian cancer is typically diagnosed at advanced stages of disease, with most patients facing a poor prognosis because of high rates of recurrence and subsequent development of chemoresistance.1 High-grade serous ovarian cancer (HGSOC) is the most common type of ovarian cancer and tends to spread before it can be detected.2-3 Ovarian tumors express a great number of tumor-antigens that can be used to guide targeted medicines, including the FRα biomarker, which is often overexpressed in epithelial ovarian carcinomas.4-5 FRα is considered as a marker of tumor aggressiveness and is associated with poorer response rates to treatment.6

"As part of our human health care mission, Eisai remains dedicated to exploring novel treatment approaches with the goal of addressing unmet needs of people living with cancer," said Dr. Takashi Owa, President, Oncology Business Group at Eisai. "The data for our first antibody drug conjugate, which was discovered in-house with Eisai technology, demonstrate the company’s commitment to working to advance precision medicine to improve care for women in need of additional treatment options. We look forward to sharing further results assessing farletuzumab ecteribulin as a potential treatment for patients with platinum-resistant ovarian cancer."

Trial Design
The primary objective of this Phase 1 study conducted in Japan (Study 101) was to determine the safety and tolerability of farletuzumab ecteribulin. Selected secondary objectives included determining the recommended dose of farletuzumab ecteribulin for future studies, pharmacokinetic characterization and an efficacy assessment, including objective response rate (ORR) and disease control rate (DCR). Doses of farletuzumab ecteribulin from 0.3 to 1.2 mg/kg, administered by intravenous (IV) fusion every 3 weeks (Q3W), were then evaluated. The dose-escalation part of Study 101 suggested that treatment with farletuzumab ecteribulin led to antitumor activity in patients with FRα-positive solid tumors, including patients with ovarian cancer. Based on the efficacy and safety results from the dose-escalation part of this study, farletuzumab ecteribulin 0.9 mg/kg (Cohort 1) and 1.2 mg/kg (Cohort 2) administered by IV fusion Q3W were selected for the expansion part of this study in patients with platinum-resistant ovarian cancer. Patients were required to have FRα-positive tumors, assessed by immunohistochemistry assay, with positive expression defined as > 5% of cells stained on a slide at 1+, 2+ or 3+ intensity level. In the expansion phase of this study, tumor assessments were performed based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) at baseline and every 6 weeks until week 36, thereafter every 8 weeks, and at treatment discontinuation (or as clinically indicated). Complete and partial responses required confirmation of the next response at ≥ 4 weeks. Interstitial lung disease (ILD)/pneumonitis assessment in 0.9 mg/kg dose group was performed by external ILD experts committee before moving to 1.2 mg/kg dose group. In the case of ILD/pneumonitis, dosing of farletuzumab ecteribulin could be modified, interrupted or permanently discontinued depending on the severity. Other management options for ILD/pneumonitis included pulmonology consult, radiographic imaging, monitoring for signs and symptoms, prednisolone administration, or treatment according to local practice guidelines.

Safety and Efficacy Results
Interstitial lung disease/pneumonitis was the most common treatment-emergent adverse event (TEAE) (Cohort 1: 37.5%; Cohort 2: 66.7%) and was of low-grade severity in most patients in Cohort 1 (Grade 1: 33.3%; Grade 2: 4.2%; Grades 3-5: 0) and Cohort 2 (Grade 1: 28.6%; Grade 2: 33.3%; Grade 3: 4.8%; Grades 4-5: 0). The next most common TEAEs of any grade after ILD were pyrexia (Cohort 1: 33.3%; Cohort 2: 42.9%), headache (Cohort 1: 12.5%; Cohort 2: 47.6%) and nausea (Cohort 1: 25.0%; Cohort 2: 33.3%). Grade ≥3 TEAEs occurred in 33.3% of patients in Cohort 1 and 28.6% of patients in Cohort 2.

Treatment with farletuzumab ecteribulin resulted in an ORR of 25.0% (6 patients) in Cohort 1 (n=24) and 52.4% (11 patients) in Cohort 2 (n=21). In patients with HGSOC, ORR was 31.6% (6 out of 19 patients) in Cohort 1 and 50.0% (10 out of 20 patients) in Cohort 2. For patients with FRα-expression levels of less than 50.0%, treatment with farletuzumab ecteribulin led to an ORR of 33.3% (2 out of 6 patients) in Cohort 1 and 50.0% (1 out of 2 patients) in Cohort 2. For patients with FRα-expression levels of greater than or equal to 50.0%, treatment with farletuzumab ecteribulin led to an ORR of 22.2% (4 out of 18 patients) in Cohort 1 and 52.6% (10 out of 19 patients) in Cohort 2 (Table 1).

Table 1. Tumor Responses as Assessed by Investigator per RECIST v1.1

Parameter

Cohort 1

farletuzumab ecteribulin 0.9 mg/kg

n=24

Cohort 2

farletuzumab ecteribulin 1.2 mg/kg

n=21

CR, n (%)

1 (4.2)

0

PR, n (%)

5 (20.8)

11 (52.4)

SD, n (%)

10 (41.7)

9 (42.9)

PD, n (%)

8 (33.3)

1 (4.8)

ORR, n (%), (95% CI)

6 (25.0), (9.8–46.7)

11 (52.4), (29.8–74.3)

ORR by FRα status,

n of n (%), (95% CI)

FRα < 50%

FRα ≥ 50%

2 of 6 (33.3), (4.3-77.7)

4 of 18 (22.2), (6.4-47.6)

1 of 2 (50.0), (1.3-98.7)

10 of 19 (52.6), (28.9-75.6)

ORR by HGSOC status,

n of n (%), (95% CI)

HGSOC

Non-HGSOC

6 of 19 (31.6), (12.6-56.6)

0 of 5, (0)

10 of 20 (50.0), (27.2-72.8)

1 of 1 (100), (2.5-100)

DCR, n (%), (95% CI)

16 (66.7), (44.7–84.4)

20 (95.2), (76.2–99.9)

Median DOR, months (95% CI)

10.6 (3.9-NE)

7.6 (4.3-10.8)

Data cutoff date: October 31, 2021.

CI, confidence interval; CR, complete response; ORR, objective response rate (CR+PR); DCR, disease control rate (CR+PR+SD [≥ 5 weeks]); DOR, duration of response; FRα, folate receptor alpha; HGS, high-grade serous; NE, not estimable; PD, progressive disease; PR, partial response; RECIST v1.1; Response Evaluation Criteria in Solid Tumors; SD, stable disease.

Poster Presentation Featuring Analyses Based on PK/PD Modeling/Simulations for Dose Optimization of Farletuzumab Ecteribulin Including Findings for Body Surface Area-Based Dosing (Abstract: #3090)

Eisai presented a poster featuring analyses from Study 101 based on PK/PD modeling/simulations for dose optimization of farletuzumab ecteribulin at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. Based on the results of these simulations, body surface area-based (BSA) dosing is predicted to lower the exposure-dependent ILD risk in patients with higher body weight while maintaining clinical efficacy, compared to body weight-based dosing. BSA-based dosing is common with ADC therapies. Optimization of body surface area-based dosing is ongoing to evaluate the potential benefits and risks of treatment with farletuzumab ecteribulin in a Phase 1/2 clinical study (NCT04300556; Study 201) in the United States.

About Farletuzumab Ecteribulin (MORAb-202)
Farletuzumab ecteribulin is Eisai’s first antibody drug conjugate (ADC) that is composed of Eisai’s in-house developed farletuzumab, a humanized IgG1 monoclonal antibody that binds to the folate receptor alpha (FRα), and Eisai’s in-house developed anticancer agent eribulin, using an enzymatically cleavable linker. Eisai has entered into an exclusive global strategic collaboration agreement with Bristol Myers Squibb for the co-development and co-commercialization of farletuzumab ecteribulin. Eisai is currently conducting a Phase 1 clinical study in Japan (NCT03386942) and a Phase 1/2 clinical study in the United States (NCT04300556), respectively, for farletuzumab ecteribulin targeting FRα-positive solid tumors. Other studies are in development by Eisai and Bristol Myers Squibb. After farletuzumab ecteribulin enters the target FRα-positive cancer cells, it is thought that the linker is enzymatically cleaved, releasing eribulin from the antibody leading to its antitumor activity. When the anticancer agent and antibody components of an ADC are separated inside a targeted antigen-positive cancer cell, it is theorized that the released anticancer agent also has a bystander effect on neighboring antigen-negative cancer cells and the component cells of the tumor microenvironment. In pre-clinical studies, farletuzumab ecteribulin demonstrated a bystander effect, with antitumor activity on the FRα-negative cancer cells surrounding the FRα-positive cancer cells.

The payload eribulin was the first in the halichondrin class of microtubule dynamics inhibitors. Structurally, eribulin is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai, and functions by inhibiting the growth phase of microtubule dynamics which prevents cell division.

About Ovarian Cancer
Ovarian cancer begins in the ovary or related areas of the fallopian tube or peritoneum, and is characterized by uncontrolled growth of cells in these areas.7 It is the eighth most commonly diagnosed cancer in women worldwide.8 In 2022, nearly 20,000 new cases of ovarian cancer will be diagnosed in the U.S. and about 13,000 women will die from the disease.2 About 90% of cases are epithelial ovarian cancer, the majority of which are high-grade serous tumors (HGSOC), which have the fewest established risk factors and worst prognosis.2 Ovarian cancer typically presents at an advanced stage and while initial chemotherapy response rates are favorable, a majority of patients experience recurrence with the subsequent development of chemoresistance.1 Treatment of platinum-resistant ovarian cancer is particularly challenging, with less than 15% of patients responding to subsequent chemotherapy.9

On June 5, 2022 Lytix Biopharma AS ("Lytix" or the "Company"), a clinical-stage company with an in situ vaccination technology platform, reported data from its ATLAS-IT-04 trial in patients with progressive metastatic soft tissue sarcoma (STS) (Press release, Lytix Biopharma, JUN 5, 2022, View Source [SID1234615594]). The data from this Phase II proof of concept study shows that LTX-315 in combination with Adoptive Cell Therapy (ACT) was able to stabilize the disease in 3 out of 4 fully treated patients in this hard-to-treat patient population, and that the LTX-315 treatment generated tumor-specific T cells.

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The data is presented June 5th, 2022, as a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting, Chicago, IL, U.S.A.

The ATLAS-IT-04 trial was an open label, exploratory, Phase II trial assessing the effect of LTX-315 when used in combination with ACT in patients with metastatic STS. ACT with tumor infiltrating lymphocytes (TILs) is a potent treatment that can induce complete and durable tumor regression as documented in patients with melanoma. The use of ACT with TILs for patients with advanced STS has not previously been reported.

Patients with advanced stages of STS have few effective treatment options and respond poorly to current treatment as well as to immunotherapy tested in clinical trials. The trial design of ATLAS-IT-04 included intratumoral injections of LTX-315 ahead of surgical removal of tumors, followed by in vitro expansion of T cells as the first step. In a second step, the expanded T cells were infused back to the patients and the effect of LTX-315 on the tumor microenvironment was assessed.

LTX-315 is a first-in-class non-viral oncolytic molecule, representing a new and superior in situ therapeutic vaccination principle to boost the clonal expansion of T cells that kill tumor cells through a targeted immune response. In a recent Phase I/II study LTX-315 has been shown to increase TILs in malignant solid tumors after intratumoral injection.

The immune response data from the ATLAS-IT-04 trial demonstrates that the treatment induce both new and tumor-specific T cells which provides proof to the concept that LTX-315 generates an immune response that targets the tumor. Moreover, the data shows that LTX-315 induce expansion of a heterogenous pool of T-cell clones in blood, and a pool of these are also present in tumor tissue after treatment.

"This trial demonstrates that the combination of LTX-315 and ACT is not only feasible and tolerable, but that tumor-specific T cells can be expanded in vitro from tumors that have been pretreated with the oncolytic molecule LTX-315", Inge Marie Svane, PI and Professor at the National Center for Cancer Immune Therapy, Department of Oncology, Copenhagen University Hospital, comments.

She adds: "This combination therapy invokes tumor specific T cells that can be cultured and infused as part of an adoptive transfer regimen for several subtypes of soft tissue sarcoma, and its treatment schedule should be further optimized to achieve superior signs of efficacy."

The poster is presented June 5th at the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting.

On June 5, 2022 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, and IASO Biotherapeutics ("IASO Bio"), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, reported that the China National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for Equecabtagene Autoleucel (Innovent R&D code: IBI326，IASO Bio R&D code: CT103A) , a fully human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy for the treatment of relapsed and/or refractory multiple myeloma (R/R MM) (Press release, Innovent Biologics, JUN 5, 2022, View Source [SID1234615593]).

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Equecabtagene Autoleucel is the first CAR-T therapy in China that is self-developed with proprietary whole-process product development and the first BCMA-targeting CAR T-cell therapy in China with its NDA formally accepted by the NMPA. It is an innovative therapy co-developed by IASO Bio and Innovent. In February 2021, Equecabtagene Autoleucel was granted "Breakthrough Therapy Designation" by the NMPA.

The acceptance of NDA is based on data from a single-arm, open-label, multi-center phase 1/2 study（NCT05066646）being conducted in China. Study results showed that Equecabtagene Autoleucel has excellent safety and efficacy profiles, low immunogenicity given a fully-human scFv, robust expansion and prolonged persistence in vivo. It will potentially offer a breakthrough treatment option for patients with R/R MM. The data from the phase 1/2 clinical study of Equecabtagene Autoleucel was presented in an oral presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Abstract #547) and the updated data was accepted as an oral presentation at the 27th Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper)（EHA）Virtual Meeting (Abstract #S187) , held on June 9-12, 2022.

"Multiple Myeloma (MM) is the second-most-common hematologicmalignancy. Although the survival in MM patients has been dramatically extended to 7-10 years on average with recent drug development, the disease is still incurable and relapse or refractory after standard therapies is common for most MM patients. The later lines of treatment the patients are receiving, the shorter of survival time for those patients. Usually, the median progression-free survival of MM patients who had received at least third-line of prior therapy is only 3-6 months, and the overall survival time is less than 1 year. In recent years, there have been some encouraging breakthroughs in drugs and therapeutic interventions for the treatment of MM. The most exciting progress is BCMA CAR-T cell immunotherapy." said the two principal investigators at the primary study sites – Prof. Lugui Qiu, MD, from the Chinese Academy of Medical Science Hematology Hospital and Prof. Chunrui Li, MD, PhD, from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology. "At the 63rd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in 2021, we reported the results of the clinical study on Equecabtagene Autoleucel injection. The study was conducted in 14 clinical centers and enrolled 79 patients with MM who had received at least third-line of prior therapy. Of the 79 patients, the overall response rate(ORR) was 94.9% and the complete response/stringent complete response (CR/sCR) rate was 58.2%. These study results showed that Equecabtagene Autoleucel has excellent safety and efficacy profiles. In addition, Equecabtagene Autoleucel also demonstrated favorable efficacy in patients with extramedullary multiple myeloma and patients who had received prior CAR-T therapy. These results suggest that Equecabtagene Autoleucel is potentially a new and effective immunotherapy treatment option for patients with multiple myeloma. We hope that Equecabtagene Autoleucel can be launched in China soon, bringing long-term benefits to patients."

Dr. Yongjun Liu, President of Innovent, said, "We are glad about the NDA acceptance of Equecabtagene Autoleucel, a product candidate co-developed by Innovent and IASO Bio, and it will potentially to be the domestic first approved and launch-to-market BMCA CAR-T therapy for multiple myeloma. In the clinical studies, Equecabtagene Autoleucel demonstrated impressive efficacy and favorable safety profiles. We hope that this breakthrough therapy could be approved in the near future and we will actively coordinate with all parties including the government authorities, hospitals, commercial insurance and charity funds to bring benefit to more multiple myeloma patients.

"IASO Bio currently has more than 10 innovative pipeline products under development. Equecabtagene Autoleucel is China’s first domestically developed CAR T-cell therapy with global intellectual property rights and the first BCMA-targeting CAR T-cell therapy with its NDA formally accepted by the NMPA. This is a significant milestone for IASO Bio. IASO Bio’s over 100,000 ft² manufacturing facility in Nanjing, which has end-to-end manufacturing capability that covers the entire CAR-T production process, received its drug manufacturing license earlier this year, will be the future commercial production site for Equecabtagene Autoleucel." said Wen (Maxwell) Wang, M.D., Ph.D., Chief Executive Officer and Chief Medical Officer of IASO Bio.

"In 2018, Professor Jianfeng Zhou of Tongji Hospital，Tongji Medical College led a team of clinicians and biologists to initiate clinical study of the world’s first fully-human BCMA CAR T-Cell therapy (Equecabtagene Autoleucel) for the treatment of multiple myeloma. The first patient of the study has maintained strict complete remission (sCR) for over 40 months." Maxwell added, "Many thanks to Professor Jianfeng Zhou for his unremitting efforts to promote the development of novel cell therapies and provide the impetus for the continuous innovation of CAR-T therapy. We look forward to the commercialization of Equecabtagene Autoleucel to bring hope to more multiple myeloma patients."

Innovent and IASO Bio are actively advancing the clinical development of Equecabtagene Autoleucel. In February 2022, it was granted "Orphan Drug Designation (ODD)"by the Office of Orphan Products Development (OOPD) of the U.S. Food and Drug Administration (FDA). In January 2022, IASO Bio and Innovent have jointly granted non-exclusive commercial rights of the fully-human BCMA CAR construct used in Equecabtagene Autoleucel to Sana Biotechnology (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, for use in its in vivo gene therapy and ex vivo hypoimmune cell therapy applications. Sana’s clinical and commercial development could further enhance the potential value of IBI326, benefitting a broader patient population. In addition to multiple myeloma, the NMPA has accepted IND application of Equecabtagene Autoleucel for the new expanded indication of Neuromyelitis Optica Spectrum Disorder (NMOSD).

About Multiple Myeloma (MM)

In the United States, MM accounts for nearly 2% of new cancer cases, and more than 2% of all cancer-related deaths. According to Frost & Sullivan, the number of new MM cases in the United States rose from 30,300 in 2016 to 32,300 in 2020 and is expected to increase to 37,800 by 2025. Additionally, the total number of patients diagnosed with MM increased from 132,200 in 2016 to 144,900 in 2020 and is expected to rise to 162,300 by 2025. In China, the number of new MM cases rose from 18,900 in 2016 to 21,100 in 2020 and is expected to increase to 24,500 by 2025. The total number of patients diagnosed with MM in China increased from 69,800 in 2016 to 113,800 in 2020 and is expected to rise to 182,200 by 2025.