On June 6, 2021 Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported that the results of the Phase 1 study in Chinese patients with advanced solid tumors were released today at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2021 (Press release, Innovent Biologics, JUN 6, 2021, View Source [SID1234583619]).

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This is a Phase 1 study to evaluate the pharmacokinetic (PK), pharmacodynamic (PD) and safety of pemigatinib in Chinese patients (pts) with advanced malignancy. Moreover, potential efficacy of pemigatinib was explored in a broad spectrum of fibroblast growth factor receptor (FGFR) alteration in variety of cancer types. 12 patients with 5 different cancer types (colorectal cancer, gastric cancer, cholangiocarcinoma, esophageal carcinoma and breast cancer) and FGF/FGFR1-3 alterations were enrolled. All the subjects were failed to prior standard therapy. As of Jan 31, 2021, all patients received at least once treatment, the safety was controllable with the most common treatment related adverse events (TRAE) of hyperphosphatemia, decreased appetite and diarrhea. Two patients reported ≥ grade 3 TRAEs, which were hyponatremia and proteinuria. There were no TEAEs leading to death or treatment discontinuation. Among 11 efficacy evaluable patients, 2 of them had partial responses (PR) as evaluated by investigators with 1 cholagiocarcinoma harboring FGFR2 point mutation (p.F276C) and the other esophageal carcinoma carrying FGFR1 mutation (p.A354V). 3 patients had a best overall response of stable disease (SD). The objective response rate (ORR) was 16.7% (95%CI: 2–48%) and disease control rate was 41.7% (95%CI: 15–72%).

Professor Yi Ba from Tianjin Medical University Cancer Institute and Hospital said," Pemigatinib had an acceptable and manageable toxicity in Chinese patients with advanced malignancy. A significant implication of the data is that it extended the population that potentially benefit from pemigatinib other than FGFR2 fusion/rearrangement."

"Several FGFR inhibitors are being in clinical stage" said Dr. Hui Zhou, Senior Vice President of Clinical Development, Innovent Biologics. "Innovent has multiple clinical trials of pemigatinib for the treatment of cholangiocarcinoma and other types of tumors. Currently we are preparing the New Drug Application (NDA) of pemigatinib in China. We presented the data at the ASCO (Free ASCO Whitepaper) Annual Meeting, which highlighted our capability of small molecules. In the future, we will conduct in-depth clinical development of pemigatnib to explore its treatment in other indications. We are looking forward to providing innovative therapies for more cancer patients in the future."

About Pemazyre (pemigatinib)

In April 2020, the U.S. Food and Drug Administration (FDA) approved Incyte’s Pemazyre (pemigatinib), a selective, oral inhibitor of FGFR isoforms 1, 2 and 3, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as detected by an FDA-approved test. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer with a FGFR2 fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Pemazyre is marketed by Incyte in the United States, Europe and Japan.

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates discovered and developed by Incyte, including pemigatinib (FGFR1/2/3 inhibitor). Under the terms of the agreement, Innovent has received the rights to develop and commercialize the three assets in Mainland China, Hong Kong, Macau and Taiwan.

Pemazyre is a trademark of Incyte Corporation.

On June 6, 2021 OriginCell Therapeutics (Shanghai) Co., Ltd. ("OriginCell"), together with Lishui Central Hospital affiliated to Zhejiang University and Shanghai Changzheng Hospital, reported the updated data from the on-going trial of Ori-CAR-001, a GPC3 CAR-T cell therapy for the treatment of relapsed/refractory hepatocellular carcinoma (HCC), at the 2021 annual meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, Shanghai OriginCell Therapeutics, JUN 6, 2021, View Source [SID1234583618]). Preliminary results from the study show promising safety and efficacy of Ori-CAR-001 in patients with GPC3-positive relapsed/refractory HCC.

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(PRNewsfoto/Yuanqi Biological Technology (Shanghai) Co., Ltd.)(PRNewsfoto/Yuanqi Biological Technology (Shanghai) Co., Ltd.)
Session type: Poster Session
Abstract Title: An armored GPC3-directed CAR-T for refractory or relapsed hepatocellular carcinoma in China: A phase I trial
Date and time: 06/04/2021, 9:00 AM (EDT)
Abstract ID: 4095
Link: View Source

A breakthrough Cell Therapy against Solid Tumors

As of March 10, 2021, a total of 11 patients were enrolled into this study. All subjects had advanced HCC and had failed prior lines of treatment including chemotherapy, TACE, and targeted therapies. All subjects had BCLC stage C (late stage) HCC except for one subject with stage B (mid stage). All subjects had multiple lesions, of which 6 (54%) had distant metastasis. Two subjects dropped out early and were not evaluable. Among the 9 evaluable subjects, 4 achieved partial response (PR), 3 achieved stable disease (SD), and 2 had disease progression (PD). The objective response rate was 44.4%, and the disease control rate reached 77.8%. A partial response lasting for more than 6 months was observed in Subject 007 at the time of data cutoff, whose tumor volume was reduced by more than 80% one month post cell therapy infusion. (As of June 2021, this subject had exceeded 8 months of disease control, follow-up is still ongoing). Good tumor response was also seen in Subject 012, who has advanced and diffuse massive HCC and joined the study after failing in radiotherapy, targeted drug and 12 times of TACE.

Barcelona Clinic Liver Cancer (BCLC) is a liver cancer staging system developed by the European Association for the Study of Liver, to help assess patients’ conditions, select the right therapies for the right patients, and predict patients’ prognosis. The BCLC system classifies HCC mainly as stages of 0, A, A1,A2,A3,A4, B, C,and D.

On day 28 post infusion with CAR-T cells, the target tumor lesion decreased from 133mm in diameter at baseline to 9mm, a reduction of more than 93%. Currently, the subject is being evaluated for month 3 post CAR-T cell infusion, MRI scan showed near complete tumor response. In addition, AFP level (alpha-fetoprotein, a specific tumor marker for primary liver cancer) decreased from a baseline value of >80,000/ng/ml to 1148.9 ng/ml on month 1, and to 746.7 ng/ml at month 3 post infusion (normal range <40ng/ml), demonstrating significant preliminary efficacy of Ori-CAR-001 in patients with advanced HCC.

Good Safety Profile

Ori-CAR-001 CAR-T infusion demonstrated good safety and tolerability in 11 patients. Cytokine release syndrome (CRS) was observed in 9 patients (7 cases grade 1-2 and 2 cases grade 4), which were resolved after treatment with steroids and tocilizumab. No neurotoxicity was observed.

Regarding the results from this exploratory study, Professor Ji Jiansong, principal investigator of Lishui Central hospital, who is also Chief scientist of the National Key R&D Program, director of Key Laboratory of Imaging Diagnosis and Minimally Invasive Intervention Research of Zhejiang China, said, "There is currently no effective treatment for relapsed/refractory hepatocellular carcinoma. Many challenges such as the tumor micro environment is difficult to overcome and have limited the therapeutic effects of cell therapy in solid tumors. However, Ori-CAR-001, developed by OriginCell Therapeutics, has managed to achieve an objective response rate of 44% and a disease control rate of 77% in patients with relapsed/refractory HCC, demonstrating a level of safety and anti-tumor activity that cannot be achieved by currently available drugs. Given its preliminary promising efficacy and safety data, we are confident in the future development prospects of Ori-CAR-001 and will continue our research studies. We take great pride and hope Ori-CAR-001 will one day become a new treatment option for patients with advanced HCC.

Dr. He Xiaowen, co-founder and chief scientific officer of OriginCell Therapeutics, said, " Although Immuno-cell therapies have produced remarkable clinical responses in hematological tumors, they have limited efficacy against solid tumors. OrginCell will continue to explore the broader unmet needs in this space, with the hope to bring more effective immuno-cell therapies to clinicians and patients with advanced stage cancer."

About Ori-CAR-001

Ori-CAR-001 is a next generation autologous chimeric antigen receptor T cell therapy targeting GPC3 for the treatment of refractory/ relapsed hepatocellular carcinoma (HCC). The construct of Ori-CAR-001 is comprised of humanized anti-GPC3 scFv, a CD8-derived hinge region, a transmembrane domain linked to 4-1BB co-stimulatory domain, a CD3z intracellular signaling domain, and Ori2 components simultaneously expressed through T2A. Compared with conventional CAR-T cells, Ori-CAR-001 has significantly higher proportion of memory stem T cells, which may translate to improved expansion and persistence in the body, thereby increasing their anti-tumor activity.

It is worth noting that, in addition to the preliminary safety and efficacy data of Ori-CAR-001 presented at 2021 ASCO (Free ASCO Whitepaper) annual meeting, OriginCell and study investigators also carried out translational medicine studies, in which the mode of administration, dosing, PK/PD, and biomarkers were explored. This will futher promote the application and development of cell therapy for solid tumors.

OriginCell will plan more clinical development programs to further explore Ori-CAR-001’s potential based on existing data, and the Investigational New Drug (IND) application with the National Medical Products Administration (NPMA) is currently in progress.

About ASCO (Free ASCO Whitepaper)

With more than 40,000 members from more than 100 countries, the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) is the world’s leading academic organization for physicians and oncology professionals caring for people with cancer. Its mission is to prevent cancer and improve cancer care, and promote the translation of research findings into clinical practice. By providing access to a global network of oncology expertise, the ASCO (Free ASCO Whitepaper) annual meeting is recognized as the world’s most influential academic congress in the field of oncology.

On June 6, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported updated clinical data for lifileucel from Cohort 2 in the C-144-01 clinical study in patients with advanced melanoma (Press release, Iovance Biotherapeutics, JUN 6, 2021, View Source [SID1234583614]). The data were presented in an oral presentation at the ASCO (Free ASCO Whitepaper) 2021 Annual Meeting.

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Omid Hamid, M.D., Chief of Research/Immuno-Oncology, The Angeles Clinic & Research Institute, stated, "Anti-PD-1 therapy is a mainstay class of treatment offering several therapeutic options for metastatic melanoma. For patients who progress on anti-PD-1 therapy, there is an unfulfilled need for efficacious and durable treatment options. The latest results with lifileucel suggest that early intervention with lifileucel TIL therapy, immediately upon progression on anti-PD-1 therapy, may offer better outcomes and longer duration of response. These data offer evidence that patients have had positive treatment experiences with lifileucel, and I believe TIL therapy has the potential to become an important option within the melanoma treatment landscape."

Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, "Our latest data for Cohort 2 in the C-144-01 clinical study are very exciting and continue to support the durability of responses after lifileucel in challenging to treat patients with melanoma. Median DOR has still not been reached at 33 months of median study follow up. We are also reporting the important observation that a shorter duration of prior anti-PD-1 therapy is associated with longer duration of response after lifileucel. We are committed to bringing lifileucel to patients as soon as we can."

The long-term follow-up data for Cohort 2 in the C-144-01 clinical study continue to demonstrate durability and depth of lifileucel TIL therapy response. Median DOR was not reached at 33.1 months of median study follow up (range: 2.2 to 38.5+ months) and Overall Response Rate, or ORR, remained at 36.4% (data extraction: April 2021). Responses deepened over time and one patient converted from partial to complete response at 24 months post lifileucel infusion.

A multivariable model showed that for every six-month decrease in cumulative duration of prior anti-PD-1 therapy, DOR to lifileucel will be nearly doubled. These results suggest that early intervention with lifileucel at the time of initial progression on anti-PD-1 therapy may maximize benefit.

All patients in Cohort 2 had high baseline disease burden and were heavily pretreated (3.3 mean prior therapies), including anti-PD1 and BRAF/MEK inhibitors if BRAFV600 mutation positive. The adverse event profile was consistent with the underlying advanced disease, lymphodepletion and IL-2 regimens, with no new safety risks identified for lifileucel during long-term follow-up.

Iovance Presentation at ASCO (Free ASCO Whitepaper) 2021
Title: Lifileucel (LN-144), a cryopreserved autologous tumor infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma: Evaluation of impact of prior anti-PD-1 therapy.
Authors: James M. G. Larkin, et al.
Session Title: Melanoma/Skin Cancers
Session Type: Oral Abstract Session
Abstract Number: 9505
Location: ASCO (Free ASCO Whitepaper) Meeting Library at View Source and View Source
Session Date and Time: Sunday, June 6, 2021 from 8:00 – 11:00 a.m. ET
Webcast and Conference Call
Iovance will host a webcast and conference call on Sunday, June 6, at 12:00 p.m. ET to discuss ASCO (Free ASCO Whitepaper) clinical data updates for lifileucel alone and in combination with pembrolizumab in patients with advanced melanoma. Iovance senior leadership, together with Dr. Hamid, will present a summary of the ASCO (Free ASCO Whitepaper) data from Cohort 1A in the IOV-COM-202 study as well as the oral presentation of updated Cohort 2 data from the C-144-01 clinical study.

The conference call dial-in numbers are 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and the access code is 4858337. The live webcast can be accessed in the Investors section of the company’s website at View Source The archived webcast will be available for a year in the Investors section at www.iovance.com.

On June 5, 2021 Samsung Pharm Co., Ltd. reported that the company presented the results of a phase III clinical trial of its pancreatic cancer immunotherapeutic drug candidate called ‘RIAVAX (GV1001)’ conducted in Korea at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting (Press release, GemVax, JUN 5, 2021, View Source;gemvax-present-pancreatic-cancer-immunotherapeutic-drug-riavax-phase-iii-results-at-asco-2021-301306066.html [SID1234583623]).

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ASCO 2021, which celebrates its 57th anniversary this year, runs from June 4th to June 8th and will be held virtually due to COVID-19. Some 4500 experts in the field gather every year to share and discuss the results of leading clinical research and advance cancer research and development.

‘RIAVAX ( GV1001)’ is a peptide drug derived from human telomerase consisting of 16 amino acids. It has been developed as an immunotherapeutic drug for pancreatic cancer which works to activate immune cells to attack the cancer cells. It is known to extend survival in pancreatic cancer patients with high serum eotaxin levels when administered in combination with the current chemotherapy, Gemcitabine/Capecitabine.

The RIAVAX Phase III clinical trial was conducted to investigate safety and efficacy when given in combination with Gemcitabine/Capecitabine in 148 patients with locally advanced and metastatic pancreatic cancer at 16 hospitals across Korea, including the Severance Hospital.

The results of the clinical trial showed median overall survival (OS) of 11.3 months in the treatment group compared to 7.5 months in the control group, with statistically significant improvement (p=0.021). Another key endpoint which is time to tumor progression (TTP) also showed a statistical significance with 7.3 months in the treatment group compared with 4.5 months in the control group (p=0.021). No specific safety issues were reported. These results indicate that RIAVAX should be considered as one of the treatment options for patients with locally advanced and metastatic pancreatic cancer with high serum eotaxin levels.

Samsung Pharm in-licensed domestic rights to RIAVAX from its affiliate, GemVax & KAEL Co., Ltd. in 2014. GemVax & KAEL conducted a large-scale Phase III clinical trial of RIAVAX (‘TeloVac’) in the United Kingdom from 2007 to 2011, with 1,062 locally advanced and metastatic pancreatic cancer patients. The results of the TeloVac study were presented at 2013 ASCO (Free ASCO Whitepaper) followed by the presentation an analysis of the correlation between the high eotaxin level and improved survivals in pancreatic cancer patients administered with GV1001 at 2014 ASCO (Free ASCO Whitepaper).

On June 5, 2021 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that data from the landmark MINDACT study will be shared at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in an oral presentation (Press release, Agendia, JUN 5, 2021, View Source [SID1234583617]). The presentation will detail an additional risk threshold previously established within the MammaPrint Low Risk category, identifying patients with an Ultra Low Risk of distant recurrence, essentially meaning the patient’s tumor is very unlikely to recur or metastasize over at least 20 years of follow-up, according to prior studies. This information could be helpful in further tailoring adjuvant treatment for patients with early stage breast cancer.

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In the oral presentation, titled "Outcome of patients with an ultralow risk 70-gene signature in the MINDACT trial," Josephine Lopes Cardozo, MD, first author of the abstract, PhD Candidate at the Netherlands Cancer Institute and fellow at the EORTC, will outline that in the MINDACT study, patients with an UltraLow Risk signature have an excellent prognosis, with 8-year breast cancer specific survival above 99% regardless of clinical risk status, and an 8-year distant metastasis free interval of 97%. The presentation, part of ASCO (Free ASCO Whitepaper) 2021’s Breast Cancer track, can be accessed here.

"The Ultra Low threshold identifies patients who may be candidates for further de-escalation of treatment," said Dr. Lopes Cardozo. "To give the patient’s care team this kind of prognostic insight at the time of diagnosis will hopefully allow for many patients to avoid over treatment and further reduce the risk of side effects while maintaining excellent survival."

The MINDACT trial, an independent, phase III, prospective, randomized clinical trial sponsored by the European Organization for Research and Treatment of Cancer (EORTC), was conducted with the primary goal of determining whether Agendia’s 70-gene MammaPrint test could be used to de-escalate clinically high risk patients with early stage breast cancer from chemotherapy treatment. The study enrolled nearly 7,000 patients with newly-diagnosed breast cancer, and at median long-term follow-up of 8.7 years, 46% of clinically high risk patients with a MammaPrint Low Risk result could forgo chemotherapy without negatively affecting their outcomes. These data were recently published in The Lancet Oncology.

The current study to be presented at ASCO (Free ASCO Whitepaper) focuses on the clinical characteristics and outcomes of the 1,000 women with a MammaPrint Ultra Low risk status enrolled in MINDACT. Consistent with three prior studies presented since 2017, these data show a nearly 100% breast cancer specific survival at 8 years, with 5 years of anti-estrogen therapy, and excellent outcomes (97.8% DMFI) for the 157 Ultra Low Risk women who received no systemic therapy.

"The confirmation of the clinical importance and excellent prognosis of the MammaPrint Ultra Low Risk category provides further support for the inclusion of this information in the management of endocrine therapy, particularly for those women experiencing severe side effects, and struggling to remain on their prescribed treatment," said William Audeh, MD, Chief Medical Officer at Agendia. "We are extremely proud to have contributed to the EORTC’s MINDACT study, which has influenced the clinical treatment of patients and will inspire ongoing translational research that will contribute to the library of data we need to personalize the treatment of breast cancer."

Beyond answering the traditional adjuvant chemotherapy question, the MINDACT study continues to produce a wealth of insights with immediately meaningful clinical implications and access to an unprecedented full genome dataset for further research, resulting in widespread health system cost savings.

At ASCO (Free ASCO Whitepaper) 2021, Agendia also presented a larger suite of data from the company’s groundbreaking FLEX registry, a large-scale, prospective, observational breast cancer study using whole transcriptome sequencing, recruiting patients from various ethnicities, ages and genders representative of the total breast cancer population as part of an ongoing effort to increase representation of diverse populations and data in clinical trials.