On May 24, 2021 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported that the first patient has been successfully enrolled and dosed in the clinical trial of pemigatinib (IBI375), a fibroblast growth factor receptor 1/2/3 (FGFR1/2/3) inhibitor, for the treatment of unresectable or metastatic cholangiocarcinoma in China (Press release, Innovent Biologics, MAY 24, 2021, View Source [SID1234580505]). The study is a key component of the global Phase 3 clinical trial, which evaluates the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin in first-line treatment of participants with unresectable or metastatic cholangiocarcinma with a fibroblast growth factor receptor 2 (FGFR2) rearrangement.

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Dr. Hui Zhou, the Senior Vice President of Innovent, stated: ‘Cholangiocarcinoma is the second most common primary liver cancer with a high incidence in Asia due to relatively widespread infection of HBV and parasites.’ He emphasized that a significant portion of patients receive an initial diagnosis of unresectable and/or metastatic status and that first-line systemic therapy is typically gemcitabine plus cisplatin, with a response rate of 26%, median progression-free survival (mPFS) of 8 months and overall survival (mOS) of 11.7 months. ‘The poor prognosis and the side effects associated with systematic chemotherapy increase the urgency of improving upon the treatment efficacy as well as the quality of life of patients with cholangiocarcinoma. Data from previous clinical trials of pemigatinib in participants with advanced cholangiocarcinoma with FGFR2 fusion as second line or later treatment has not only shown satisfactory safety results but also revealed compelling efficacy signals. The results demonstrate that pemigatinib has an objective response rate (ORR) of 35.5%, mPFS of 6.9 months and estimated OS of 21.1 months. With the refractory subjects being seen as the more challenging population and based on the promising data, we believe that participants with FGFR2 rearrangement may benefit from targeted therapy like pemigatinib. We are looking forward to see the therapeutic contribution of pemigatinib in the treatment of cholangiocarcinoma as the pre-NDA process of the drug in China is under preparation’, Dr. Zhou highlighted.

About Advanced Cholangiocarcinoma and FGFR2 Rearrangement

Cholangiocarcinoma is a malignant tumour originated from biliary epithelium cells and it is categorized as intrahepatic or extrahepatic based on anatomical location of origin. The incidence of cholangiocarcinoma has been increasing progressively over the past decade. Surgery is the first priority for patients with resectable disease. However, most cholangiocarcinomas has been in advanced and/or metastatic status at diagnosis and lost the chance for surgical resection. The treatment options for patient who relapse after surgery or have advanced / metastatic disease are limited and the recommended therapy method is systemic chemotherapy with gemicitabine plus cisplatin, which has a medium overall survival of less than a year.

Aberrant signaling through FGFR resulting from gene amplification or mutation, chromosomal translocation, and ligand-dependent activation of the receptors has been demonstrated in multiple types of human cancers. Fibroblast growth factor receptor signaling contributes to the development of malignancies by promoting tumor cell proliferation, survival, migration, and angiogenesis. Results from early clinical studies of selective FGFR inhibitors, including pemigatinib, have shown a tolerable safety profile for the class and preliminary signs of clinical benefit in participants with FGF/FGFR alterations.

About Pemigatinib (Pemazyre)

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. In March 2020, Innovent announced that the first patient was dosed in the pivotal registrational trial evaluating pemigatinib in patients with advanced cholangiocarcinoma in China.

Pemazyre is a trademark of Incyte Corporation.

On May 24, 2021 Brooklyn ImmunoTherapeutics LLC (NYSE American: BTX) ("Brooklyn"), a biopharmaceutical company currently focused on exploring the role that cytokine and gene editing/cell therapy can have in treating patients with cancer and blood disorders, reported it has completed a $20M financing to progress the development of the mRNA gene editing and cell therapies technology recently licensed from Factor Biosciences and Novellus Therapeutics (Press release, Brooklyn ImmunoTherapeutics, MAY 24, 2021, View Source [SID1234580502]).

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The Company intends to utilize the funds to commence translation of the gene editing, cellular therapy and nanolipid particle platform into its emerging clinical programs with a focus on orphan diseases, such as sickle cell anemia, familial amyloidosis and cell therapies for cancer.

"Our exclusive license of Factor Biosciences and Novellus Therapeutics platform technology represents a key component in our overall corporate strategy, and each progressive step toward the development of new therapeutics from this license brings us one step closer to realizing our vision of becoming a platform company with multiple products in a pipeline of next-generation immunotherapeutics and cellular therapies," commented Howard J. Federoff, M.D., Ph.D., Brooklyn ImmunoTherapeutics’ Chief Executive Officer and President.

The exclusive license includes utilizing an extensively patented process to develop gene editing compounds using mRNA, which preclinical data suggest to be more efficient, non-immunogenic and non-mutagenic, to develop treatment for several solid tumor and liquid indications, sickle cell anemia, as well as a number of additional inherited disorders.

The licensed platform also includes two additional applications. The first is an mRNA cell reprogramming method, which is considered to be of the highest efficiency as well as a footprint-free technology that can be applied to both allogeneic and autologous cells, and is combined with an mRNA-based gene editing – along with a proprietary gene editing protein – to eliminate off-target effects. It also includes the proprietary ToRNAdo lipid delivery system that provides efficient non-viral vector-based delivery of mRNA ex vivo and in vivo to skin, brain, eye and lung tissue.

On May 24, 2021 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that updated results from the Phase 1 MajesTEC-1 study, the first-in-human dose-escalation study of teclistamab, an off-the-shelf T-cell redirecting bispecific antibody, in the treatment of patients with relapsed or refractory multiple myeloma (NCT03145181) (Press release, Johnson & Johnson, MAY 24, 2021, View Source [SID1234580501]).1 With a median follow-up of 6.1 months (range 1.2-12.2), an overall response rate (ORR) of 65 percent was observed at the recommended subcutaneous (SC) Phase 2 dose (RP2D) in a cohort of heavily pretreated patients (n=40) who had received a median of five prior lines of therapy.2 These data will be featured during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting as an oral presentation on Tuesday 8 June (Abstract #8007).2

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Study results showed that responses were durable and deepened over time – 58 percent of patients receiving teclistamab achieved a very good partial response (VGPR) or better, and 40 percent achieved a complete response (CR) or better at the RP2D SC dose of 1500μg/kg. The median time to first confirmed response was one month.2 The median duration of response was not reached. After a median follow-up of 7.1 months (range, 3.0–12.2 months), median duration of response was not reached and 85 percent (22/26) of responders were alive and continuing treatment.2

There were no dose-limiting toxicities at the RP2D in part 1 of the study. Grade 1 neurotoxicity was reported in one patient (1 percent) treated at RP2D.2 The most common adverse events at the RP2D were cytokine release syndrome (70 percent; all Grade 1/2) and neutropenia (65 percent; 40 percent Grade 3/4). The promising safety, efficacy, pharmacokinetics and pharmacodynamics confirm the selection of the 1500 ug/kg SC as the RP2D.2

Forty patients were treated with the RP2D, identified as 1500 µg/kg SC.2 Patients receiving the RP2D of teclistamab in this study had received a median of five prior lines of therapy (range 2–11);100 percent were triple-class (proteasome inhibitor [PI], immunomodulatory drug (IMiD), CD38 antibody) exposed; 65 percent (n=26) were penta-drug (2 PIs, 2 IMiDs, CD38 antibody) exposed; 83 (n=33) percent were triple-class refractory; 38 percent (n=15) were penta-drug refractory; 83 percent (n=33) were refractory to their last line of therapy.2 Patients with triple-class refractory and penta-drug refractory multiple myeloma often experience poor survival outcomes as treatment options are limited.3

"We reported initial findings for teclistamab at ASCO (Free ASCO Whitepaper) 2020, and study updates have observed a deepening of responses that have shown to be durable in a significant percentage of patients with relapsed or refractory multiple myeloma," said Amrita Y. Krishnan, M.D., Director of the Judy and Bernard Briskin Center for Multiple Myeloma Research and Chief, Division of Multiple Myeloma, Department of Hematology and Hematopoietic Cell Transplantation at City of Hope, and study investigator*. "Teclistamab exposure was sustained across the dosing interval and exceeded target levels, and consistent T-cell activation was observed. With this latest follow-up data, we present further evidence of promising clinical activity in heavily pre-treated patients, who are in urgent need of new therapeutic options."2

The primary objectives of the Phase 1 study were to identify the RP2D (part 1) and characterise the safety and tolerability of teclistamab at the RP2D (part 2).2 As of March, 2021, the study had enrolled 157 patients with multiple myeloma whose disease was relapsed, refractory, or intolerant to established therapies.2

"We remain committed to investigating new treatments and approaches for patients with multiple myeloma, including off-the-shelf, T-cell redirecting bispecific antibodies like teclistamab," said Yusri Elsayed, M.D., M.HSc., Ph.D., Vice President, Global Head, Hematologic Malignancies, Janssen Research & Development, LLC. "The encouraging efficacy data reported at ASCO (Free ASCO Whitepaper) and the especially the durability of the deep responses support the further investigation of teclistamab use as a monotherapy and in combination with other agents."

"Despite significant treatment advances in multiple myeloma over the last decade, it remains a disease with high unmet need," said Edmond Chan, EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. "These study findings are an important step forward in enabling us to address these needs and may potentially provide a valuable alternative treatment option in the future."

Additional data for teclistamab will be highlighted in a poster at ASCO (Free ASCO Whitepaper) on Friday 4 June (Abstract #8047).4 The study evaluated soluble B-cell maturation antigen (sBCMA) in patients with relapsed or refractory multiple myeloma treated with teclistamab or the bispecific antibody talquetamab (GPRC5DxCD3) and showed that both bispecific therapies induced changes in levels of sBCMA that correlated with clinical activity.4

# ENDS #

About Teclistamab

Teclistamab is an investigational, t-cell redirecting bispecific antibody targeting both BCMA and CD3. BCMA, B-cell maturation antigen, is expressed at high levels on multiple myeloma cells.5,6,7,8 Teclistamab redirects CD3-positive T-cells to BCMA-expressing myeloma cells to induce cytotoxicity of the targeted cells.8 Results from preclinical studies demonstrate that teclistamab kills myeloma cell lines and bone marrow-derived myeloma cells from heavily pre-treated patients.6

Teclistamab is currently being evaluated in a Phase 2 clinical study for the treatment of relapsed or refractory multiple myeloma (NCT04557098)9 and is also being explored in combination studies (NCT04586426, NCT04108195, NCT04722146).10,11,12 In 2020, the European Commission and the U.S. Food and Drug Administration each granted teclistamab orphan designation for the treatment of multiple myeloma.

About Multiple Myeloma

Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.13 In Europe, 50,918 people were diagnosed with MM in 2020, and more than 32,400 patients died.14 Around 50 percent of newly diagnosed patients do not reach five-year survival,15 and approximately 10 percent of patients with multiple myeloma will die within one year of diagnosis.16

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.17 Refractory MM is when a patient’s disease progresses on or within 60 days of their last therapy.18 Relapsed cancer is when the disease has returned after a period of initial, partial or complete remission.19 While some patients with MM have no symptoms at all, others are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.20 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and require new therapies for continued disease control.21

On May 24, 2021 The Janssen Pharmaceutical Companies of Johnson & Johnson reportedfollow-up data from the MonumenTAL-1 Phase 1 first-in-human dose-escalation study of investigational product talquetamab, the only off-the-shelf, T-cell redirecting bispecific antibody in clinical development to target both GPRC5D, a novel multiple myeloma target, and CD3 on T-cells (NCT03399799).1,2,3 With a median follow-up of 6.3 months (range 1.4-12.0) for responders, updated results in 30 patients with relapsed or refractory multiple myeloma treated with talquetamab by subcutaneous (SC) administration at the recommended Phase 2 dose (RP2D) showed an overall response rate (ORR) of 70 percent, with 60 percent of patients achieving a very good partial response (VGPR) or better among those who had received a median of six prior lines of therapy (Press release, Johnson & Johnson, MAY 24, 2021, View Source [SID1234580500]). The median time to first confirmed response was one month (range 0.2–3.8 months).4 These data will be featured during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting as an oral presentation on Tuesday 8 June (Abstract #8008).4

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"Most patients diagnosed with multiple myeloma will relapse over the course of their disease. Patients in this study had progressed, had relapsed after, or were refractory to numerous multiple myeloma therapies. There is a significant need for new treatments for multiple myeloma," said Jesus G. Berdeja, M.D., Director of Myeloma Research Sarah Cannon Research Institute, Tennessee Oncology, and principal study investigator*. "We are encouraged that just six months after announcing the first talquetamab results at this dose, we already have follow-up data that suggest time to initial response is rapid (0.2–3.8 months) and that a number of patient responses deepen with continuous therapy, supporting the further exploration of targeting both GPRC5D and CD3 in patients with multiple myeloma."4

The MonumenTAL-1 Phase 1 study consists of two parts: dose escalation (part 1) and dose expansion (part 2). As of April 18, 2021, 184 patients with relapsed or refractory multiple myeloma had received talquetamab. Study results established the RP2D as weekly SC 405 μg/kg, with 10.0 and 60.0 μg/kg step-up doses during the first week of therapy. Patients treated at RP2D (n=30) were a median age of 61.5 years (range, 46–80 years) and had received a median of six prior lines of therapy (range, 2.0–14.0 months).4 Eighty-seven percent (n=26) were refractory to the last line of therapy; 77 percent (n=23) were triple-class (proteasome inhibitor [PI], immunomodulatory drug [IMiD], CD38 antibody) refractory; 20 percent (n=6) were penta-drug (2 PIs, 2 IMiDs, CD38 antibody) refractory, and 27 percent (n=8) received prior B-cell maturation antigen (BCMA) therapy.4

A response was observed in 70 percent of patients including 65 percent (15/23) of triple-class refractory patients and 83 percent (5/6) of penta-drug refractory patients. With a median follow-up of 6.3 months (range, 1.4–12.2 months), the median duration of response was not reached and 81 percent (17/21) of responders continued on treatment, suggesting that responses were durable and deepened over time for a significant number of responders at the RP2D.4 At the RP2D, pharmacodynamic data demonstrated consistent T-cell activation, and exposure was maintained over the maximum EC90 target level from an ex vivo cytotoxicity assay.4

The most common adverse events (AEs) at the RP2D were cytokine release syndrome (73 percent; 2 percent Grade 3), neutropenia (67 percent; 60 percent Grade 3/4), anemia (57 percent; 27 percent Grade 3/4) and dysgeusia (60 percent; all Grade 1/2). Infections were reported in 37 percent of patients (3 percent Grade 3/4), neurotoxicity was experienced in 7 percent of patients (all Grade 1/2) and skin-related AEs occurred in 77 percent of patients (27 percent with nail disorders). No dose-limiting toxicities occurred at the RP2D in part 1.4

"These new, updated efficacy and safety data suggest that talquetamab is a promising therapeutic candidate for the treatment of patients with multiple myeloma who have relapsed after multiple therapies or who are refractory to other treatments," said Sen Zhuang, M.D., Ph.D., Vice President, Oncology Clinical Research, Janssen Research & Development, LLC. "As the only investigational bispecific antibody directed against the novel GPRC5D, we are committed to fully exploring talquetamab, including new subcutaneous dosing strategies in multiple myeloma."

"The development of effective bispecific treatment options is an important step in challenging the unmet needs of patients with relapsed refractory multiple myeloma," said Edmond Chan, EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. "The study results are not only encouraging but also reflect our commitment to exploring innovative treatment approaches."

Additional data for talquetamab will be highlighted in a poster at ASCO (Free ASCO Whitepaper) on Friday, June 4 (Abstract #8047).3 The study evaluated B-cell maturation antigen (sBCMA) in relapsed or refractory multiple myeloma patients treated with talquetamab or the bispecific antibody teclistamab (BCMAxCD3) and showed that both bispecific therapies induced changes in levels of sBCMA that correlated with clinical activity.3

About Talquetamab

Talquetamab is a first-in-class investigational bispecific antibody targeting both GPRC5D, a novel multiple myeloma target, and CD3, the T-cell receptor.5 CD3 is involved in activating T-cells and GPRC5D is highly expressed on multiple myeloma cells.4,6,7 Results from preclinical studies in mouse models demonstrate that talquetamab induces T-cell-mediated killing of GPRC5D-expressing multiple myeloma cells through the recruitment and activation of CD3-positive T-cells and inhibits tumor formation and growth.5

Talquetamab is currently being evaluated in a Phase 1/2 clinical study for the treatment of relapsed or refractory multiple myeloma (NCT03399799) and is also being explored in combination studies (NCT04586426).8,9

About Multiple Myeloma

Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.10 In Europe, 50,918 people were diagnosed with MM in 2020, and more than 32,400 patients died.11 Around 50 percent of newly diagnosed patients do not reach five-year survival,12 and approximately 10 percent of patients with multiple myeloma will die within one year of diagnosis.13

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.14 Refractory MM is when a patient’s disease progresses on or within 60 days of their last therapy.15 Relapsed cancer is when the disease has returned after a period of initial, partial or complete remission.16 While some patients with MM have no symptoms at all, others are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.17 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and require new therapies for continued disease control.18

On May 24, 2021 AMSURG, a division of Envision Healthcare and a national leader in outpatient care, and Icahn School of Medicine at Mount Sinai, world-renowned for its groundbreaking research, reported that new findings on colorectal cancer (CRC), which support several recommendations to lower the screening age from 50 to 45 for people who are at average risk for CRC (Press release, Mount Sinai Hospital, MAY 24, 2021, View Source [SID1234580499]). The findings were presented at the Digestive Disease Week 2021 virtual scientific meeting on May 23.

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The Mount Sinai team analyzed approximately 3 million colonoscopies performed at more than 120 AMSURG ambulatory surgery centers across the country in the last six years. The study specifically looked at de-identified data from patients aged 18 to 54 who received a screening or diagnostic colonoscopy and were not undergoing a colonoscopy to monitor previously detected polyps, cancer, inflammatory bowel disease or genetic conditions predisposing to cancer. Results show:

Colorectal cancer was detected in 0.58 percent of patients aged 45 to 49 and in 0.53 percent of patients aged 40 to 44
Polyps that had the greatest possibility of becoming cancerous were found in 7.5 percent of patients aged 45 to 49 and in 5.8 percent of patients aged 40 to 44
A significant portion of patients had polyps present even if they did not have a documented family history of colorectal cancer
"These findings are significant and can make a meaningful difference in the healthcare system’s ability to save patients’ lives. With early and routine colonoscopies, we can prevent polyps from becoming cancerous and even detect and remove cancerous polyps while giving patients a better chance of recovery and survival. These data support efforts to begin screening at age 45 and communicate the importance of on-time screening by early messaging to patients and providers," said John Popp, MD, Medical Director for AMSURG.

Colorectal cancer is the second leading cause of cancer death in the U.S. and one of the most preventable. The incidence of CRC in patients under 50 has nearly doubled since the early 1990s.1 Consensus in the medical community is building that patients who are at average risk for CRC should begin screening at age 45.

"This study can inform additional research directed at CRC screening in younger populations. More importantly, it helps physicians inform patients about the importance of early screening several years before they reach screening age; we believe that this will encourage younger patients to get routine screenings on time, at the appropriate age, and with close attention to the individual’s risk factors and symptoms," said primary investigator, Steven Itzkowitz, MD, Professor of Medicine, Oncological Sciences and Medical Education, and Director of the GI Fellowship Program at Icahn School of Medicine at Mount Sinai.

Risk factors include a family history of CRC or pre-malignant polyps, inflammatory bowel disease and lifestyle habits, such as diet, smoking and obesity. CRC also disproportionately impacts the Black community. While symptoms are not always easy to recognize, they can include a change in bowel habits, such as diarrhea and constipation. Additionally, rectal bleeding, abdominal discomfort or a feeling that the bowel does not completely empty can be a cause for concern. Individuals are urged to listen to their bodies and consult their physicians if they have questions or require medical care.

As a leading provider of colonoscopies, AMSURG submits a larger colonoscopy dataset than any provider to a national endoscopic registry called the GI Quality Improvement Consortium (GIQuIC).The AMSURG data reviewed for this study was obtained from the registry.

This research on CRC trends in the United States is the first of an ongoing collaboration between AMSURG and Mount Sinai.