On March 23, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and MSD K.K. (Headquarters: Tokyo, President: Kyle Tattle, "MSD"), a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A., reported that LENVIMA (generic name: lenvatinib mesylate), the multiple receptor tyrosine kinase inhibitor discovered by Eisai, has been approved in Japan for the additional indication of treatment of unresectable thymic carcinoma (Press release, Eisai, MAR 23, 2021, View Source [SID1234577001]). This marks the first approval for LENVIMA for unresectable thymic carcinoma in Japan.

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The approval was based on the results of an open-label, single-arm, multicenter, investigator-initiated clinical phase II study (REMORA study) conducted in 8 centers across Japan including the National Cancer Center Hospital, evaluating LENVIMA as a single agent in 42 patients with thymic carcinoma previously treated with at least one platinum-based regimen.

LENVIMA met the study’s primary endpoint of objective response rate (ORR) as assessed by independent imaging review, demonstrating an ORR of 38.1% (90% confidence interval (CI): 25.6-52.0). The lower value of the CI exceeded the pre-specified statistical criteria with a threshold ORR of 10%. The most common three treatment-related adverse events were hypertension (88.1%), proteinuria (71.4%), and palmar-plantar erythrodysesthesia syndrome (69.0%), which is consistent with the safety profile observed in the previously approved indications.

Thymic carcinoma is an extremely rare disease with low prevalence. It is estimated that there are about 140 patients in Japan. For unresectable thymic carcinoma, platinum-based first-line therapy is recommended. However, since the standard treatment has not yet been established for second-line or later therapy, this is an area of high unmet medical need. In June 2020, LENVIMA received orphan drug designation in Japan for unresectable thymic carcinoma.

Eisai and MSD have been collaborating through the provision of information on LENVIMA in Japan since October 2018, and will work together to expedite the maximization of LENVIMA’s contribution to patients with cancer.

1. About LENVIMA (generic name: lenvatinib mesylate)
LENVIMA, discovered and developed by Eisai, is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, lenvatinib decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone. Currently, LENVIMA has been approved for monotherapy as a treatment for thyroid cancer in over 70 countries including Japan, in Europe, China and in Asia, and in the United States for radioiodine-refractory differentiated thyroid cancer. In addition, LENVIMA has been approved for monotherapy as a treatment for unresectable hepatocellular carcinoma in over 65 countries including Japan, the United States, in Europe, China and in Asia. It is also approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 60 countries, including the United States, in Europe and in Asia. In Europe, the agent was launched under the brand name Kisplyx for renal cell carcinoma. In addition, it is approved in combination with KEYTRUDA as a treatment for advanced endometrial cancer that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation in over 10 countries including the United States, Canada and Australia. Continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials.

2. About REMORA study (NCCH1508 study)1
This study is an open-label, single-group, multicenter, investigator initiated clinical phase II study (8 centers across Japan including the National Cancer Center Hospital). Forty-two patients with unresectable advanced or metastatic thymic carcinoma were enrolled who had progressed after at least one prior platinum-based therapy. The primary endpoint is Objective Response Rate (ORR) by independent image review using RECIST1.1, and secondary endpoints include Progression Free Survival (PFS), Disease Control Rate (DCR), Overall Survival (OS) and safety. Lenvatinib was administered at a starting dose of 24 mg once daily in 4-week cycles, and the dose was appropriately reduced according to the patient’s condition until the disease progressed or unacceptable adverse events was observed.

For efficacy analysis2, ORR was 38.1% (90% Confidence Interval (CI): 25.6-52.0) and the best overall response was 38.1% for partial response, 57.1% for stable disease, and 4.8% for disease progression. PFS (median) was 9.3 months (95% CI: 7.7-13.9), DCR was 95.2% (95% CI: 83.8-99.4), and the median OS was not reached (95% CI: 16.1-NR (not reached)) at the data cutoff date (Feb 22, 2019). The major treatment-related adverse events3 (more than 30%) were hypertension (88.1%), proteinuria (71.4%), palmar-plantar erythrodysesthesia syndrome (69.0%), hypothyroidism (64.3%), diarrhea (57.1%), thrombocytopenia (54.8%), decreased appetite (42.9%), weight loss (40.5%), dysphonia (40.5%), increased aspartate aminotransferase (33.3%), malaise (33.3%), and stomatitis (33.3%).

1 Jun Sato, Miyako Satouchi, Shoichi Itoh, Yusuke Okuma, Seiji Niho, Hidenori Mizugaki, Haruyasu Murakami, Yasuhito Fujisaka, Toshiyuki Kozuki, Kenichi Nakamura, Yukari Nagasaka, Mamiko Kawasaki, Tomoaki Yamada, Ryunosuke Machida, Aya Kuchiba, Yuichiro Ohe, Noboru Yamamoto; Lenvatinib in patients with advanced or metastatic thymic carcinoma (REMORA): a multicenter, phase 2 trial. The Lancet Oncology, 2020, Vol.21, No. 6, p843-850

2 Based on the package insert.

3 The adverse event data has been updated from the data in the paper.

3. About the Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Strategic Collaboration
In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as a monotherapy and in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.’s anti-PD-1 therapy KEYTRUDA (generic name: pembrolizumab).

In addition to ongoing clinical studies evaluating the LENVIMA plus KEYTRUDA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in 14 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer, pancreatic cancer and triple-negative breast cancer) across 20 clinical trials.

On March 23, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that it has obtained manufacturing and marketing approval for the anticancer agent "Remitoro for Intravenous Drip Infusion 300μg" (denileukin diftitox (genetic recombinant)) with the indications of relapsed or refractory Peripheral T-cell Lymphoma (PTCL) and relapsed or refractory Cutaneous T-cell Lymphoma (CTCL), in Japan (Press release, Eisai, MAR 23, 2021, View Source [SID1234577000]). This agent was evaluated by the Ministry of Health, Labour and Welfare (MHLW) as a drug with high medical need at the "Study Group for Unapproved Drugs/Off-Label Drugs for High Medical Need". Hence, Eisai has been working on the development of the agent thereof in Japan, and applied for manufacturing and marketing approval in March 2020, based primarily on data from a Phase II clinical study (Study 205).

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Study 205 is a multicenter, open-label, single-arm Phase II clinical study, conducted in Japan to evaluate the efficacy and safety of the agent in patients with relapsed or refractory PTCL or CTCL.

This study achieved the primary endpoint target and exceeded a prespecified tumor response threshold with statistical significance: the objective response rate (ORR) of PTCL and CTCL patients in total (n=36) was 36.1% (95% confidence interval (CI): 20.8-53.8). The ORRs of each subtype were 41.2% (95%CI: 18.4-67.1) for PTCL (n=17) and 31.6% (95% CI: 12.6-56.6) for CTCL (n=19).

The five most frequent treatment-emergent adverse events observed in this study were increased aspartate aminotransferase (AST) (89.2%), increased alanine aminotransferase (ALT) (86.5%), hypoalbuminaemia (70.3%), lymphopenia (70.3%), and pyrexia (51.4%).

Eisai will conduct a post-marketing special use results survey (all-case surveillance) in all patients who are administered the agent until a pre-determined number of patients has been reached in accordance with an approval condition imposed by the MHLW.

The agent is a fusion protein consisting of interleukin-2 (IL-2) and partial sequence of diphtheria toxin, and specifically binds to the IL-2 receptor on the surface of tumoral lymphocytes. The antitumor effect of denileukin diftitox depends on the intracellular delivery of diphtheria toxin fragment which inhibits protein synthesis and induces cell death. Eisai retains exclusive development and marketing rights for the agent in Japan and Asia.

Eisai aims to make continuous efforts to meet the diversified needs of and increase the benefits provided to patients with cancer, their families, and healthcare professionals, by delivering "Remitoro" as a new treatment option for relapsed or refractory PTCL and relapsed or refractory CTCL in Japan.

1. About Remitoro for Intravenous Drip Infusion 300μg (Denileukin Diftitox (Genetic Recombinant))

This agent is a fusion protein consisting of interleukin-2 (IL-2) and partial sequence of diphtheria toxin. The antitumor effect of denileukin diftitox depends specific binding to the IL-2 receptor on the surface of tumoral lymphocytes followed by intracellular delivery and release of diphtheria toxin fragment which inhibits protein synthesis and induces cell death.

Eisai retains exclusive development and marketing rights for the agent in Japan and Asia, and in other regions, Dr. Reddy’s Laboratories Ltd. has development and marketing rights.

2. About Phase II Clinical Study (Study 205)

Study 205 is a multicenter, open-label, single-arm phase II clinical study evaluating the efficacy and safety of denileukin diftitox (genetic recombinant) conducted in Japan for patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL) or Cutaneous T-cell Lymphoma (CTCL). The patients who participated in this study received a final histopathological definitive diagnosis by the Central Committee for Pathological Diagnosis, which is independent of the clinical study site. The histopathological subtypes of participants consisted of 17 patients with PTCL, 19 patients with CTCL, and 1 patient with other malignant lymphoma. The efficacy of the agent was evaluated in 36 patients with PTCL or CTCL, and the safety was evaluated in 37 patients. The agent was administered by intravenous drip infusion over 60 minutes at a dose of 9μg / kg / day for five consecutive days from day 1 to day 5 to complete a cycle, with one cycle every three weeks and a maximum of up to 8 cycles conducted. In this study, the primary endpoint was objective response rate, and the efficacy of the agent was evaluated on the basis that the lower limit of the confidence interval (CI) was above a predetermined threshold.

3. About Peripheral T-cell Lymphoma (PTCL)

PTCL is a type of T-cell non-Hodgkin’s lymphoma that is classified as an intermediate-grade lymphoma. PTCL is often detected in advanced stages, and has symptoms such as swelling and lumps in the lymph nodes, fever, heavy night sweats, and weight loss. Among PTCLs, Anaplastic Lymphoma Kinase (ALK)-positive anaplastic large cell lymphoma, which occurs in the 20s and 30s, has a favorable prognosis and is curable. However, other types of PTCL often occur around the age of 60, and may have a poor prognosis or be difficult to treat. Therefore, PTCL is still a disease with extremely high-unmet medical need. It is estimated that the number of patients with PTCL in Japan is less than 6,000.1

4. About Cutaneous T-cell Lymphoma (CTCL)

CTCL is a type of non-Hodgkin’s lymphoma of primary cutaneous disease with various other manifestations in additional sites like lymph nodes and peripheral blood. In CTCL, some of the T cells (a type of lymphocyte involved in the immune system) become cancerous, causing skin lesions and reducing the patient’s QOL (Quality of Life) due to pain and pruritus. CTCL is generally a low-grade lymphoma, with initial patch and plaque skin lesions, but it progresses slowly and advances to the tumor stage over several years to over a dozen years. CTCL is still a disease with extremely high unmet medical need because it has a high malignancy when it reaches the tumor stage and has a poor prognosis. It is estimated that the number of patients with CTCL in Japan is less than 4,000.1

5. About Study Group for Unapproved Drugs/Off-Label Drugs for High Medical Need

The Study Group was set up within the Ministry of Health, Labour and Welfare with the purpose of contributing to enhancing the development of drugs and indications that have not been approved in Japan (unapproved drugs/off-label drugs) by pharmaceutical companies. In addition to evaluating the medical needs of unapproved drugs/off-label drugs, their responsibilities include evaluating the applicability of the drug to an Application with Public Knowledge, and the adequacy of additional clinical studies that need to be conducted for filing applications for approval, and so on.

1. Vital Statistics/Patient Survey in 2017 (Statistics and Information Department, Minister’s Secretariat, Ministry of Health, Labour and Welfare, Japan.) (available in Japanese only)

On March 23, 2021 Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported its Q4 and full year 2020 financial results and provides a business update (Press release, Pulmatrix, MAR 23, 2021, View Source [SID1234576998]).

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"In recent months, we have made important progress advancing iSPERSE enabled programs that both strengthen our foundation in respiratory indications and expand the reach of our platform to lung cancer and acute migraine," said Ted Raad, Chief Executive Officer of Pulmatrix. "Our strengthened balance sheet fully funds our operations through key data milestones across our ongoing and planned studies including the PUR1800 Phase 1b study, the PUR3100 Phase 1 / Phase 2 study and Pulmazole Phase 2b study. We look forward to a milestone rich 2021 which includes toxicology and clinical data packages from ongoing PUR1800 studies, potential license option execution from Johnson & Johnson, and continued execution as we advance therapies to address significant unmet need."

Q4 and Recent Highlights:

PUR1800

Initiated the Phase 1b clinical study of PUR1800, dosing 4 of 15 patients to date. Study endpoints include safety, tolerability and exploratory biomarkers to demonstrate target engagement and anti-inflammatory effect. Ph1b top-line data is expected in Q4 2021, shortly after data from 6 and 9-month toxicology studies.
Completion of the PUR1800 Phase 1b will trigger a $2M milestone payment as part of the kinase inhibitor licensing and development agreement with the Lung Cancer Initiative (LCI) at Johnson & Johnson*, which was previously on January 2, 2020.
Pulmazole

Successfully completed a Type C Meeting with the U.S. FDA for the further clinical development of Pulmazole.
Based on feedback from the Type C Meeting, and in accordance with our collaboration with Cipla, Pulmatrix intends to initiate a Phase 2b clinical study of Pulmazole in allergic bronchopulmonary aspergillosis (ABPA) in Q1 2022, dependent on assessment of COVID-19 impact on patient safety and study operations.
PUR3100

Declared PUR3100 development candidate, a dry powder iSPERSE formulation of DHE for pulmonary delivery in acute migraine.
Completed dog PK study of PUR3100, demonstrated similar exposure kinetics to modelled kinetics from published data with MAP0004, the MAP Pharmaceuticals pMDI inhaled formulation of DHE.
Progressing IND-enabling studies with Phase 1/Phase 2 clinical study anticipated to begin Q1 2022.
Corporate:

Completed a registered direct offering with gross proceeds of $40 million extending the Company’s cash through data readouts across its development pipeline including PUR1800 Phase 1b, PUR3100 Phase 1 / Phase 2, and Pulmazole Phase 2b studies.
Financials

As of December 31, 2020, Pulmatrix had $31.7 million in cash and cash equivalents, compared to $23.4 million for the year ended December 31, 2019.

Revenue for 2020 was $12.6 million, compared to $7.9 million for 2019. The increase resulted from an increase in revenue recorded of $6.9 million as a result of the JJEI License Agreement and includes reimbursement of pass-through expenses, partially offset by a decrease in revenue recorded of $2.2 million as a result of the Cipla Agreement.

Research and development expense was $15.6 million in 2020 compared to $12.8 million in 2019. The increase year–over–year was primarily due to increased spending on manufacturing, clinical, and preclinical study costs of $4.4 million and $0.3 million, on the PUR1800 and PUR3100 programs, respectively, $1.1 million on employment costs in support of our programs, $0.6 million in allocated fixed expenses and lab services which were partially offset by a decrease of $3.6 million on the Phase 2 Pulmazole clinical trial costs.

General and administrative expense was $6.9 million for 2020 and $8.5 million for 2019. The decrease year-over-year was primarily due to decreased employment costs of $1.2 million because of lower share-based compensation expense and salary costs, $0.1 million in patent and legal expenses and $0.3 million of a milestone payment to the CFFT made in 2019.

Goodwill was not impaired in 2020 compared to a $7.3 million impairment charge in 2019.

Net loss for 2020 was $19.3 million. The net loss in 2020 was primarily attributable to Pulmazole project costs as we advanced our Phase 2 clinical study and PUR1800 manufacturing, preclinical, and clinical study costs for the upcoming Phase 1b clinical study.

On March 23, 2021 Incyte (Nasdaq:INCY) reported that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Pemazyre (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene1, worsening after cancer chemotherapy (Press release, Incyte, MAR 23, 2021, View Source [SID1234576994]).

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"The MHLW approval of Pemazyre is an important milestone for the BTC community, and underscores our commitment to finding and delivering solutions for patients with significant unmet medical needs," said Lothar Finke, M.D., Ph.D., General Manager, Incyte Asia. "BTC is a rare and serious condition, and we are proud that with the support of the MHLW we will be able to bring a new targeted treatment to more patients around the world."

BTC is a rare cancer that forms in the bile duct. Cholangiocarcinoma, a subtype of BTC, is classified based on its origin: intrahepatic, which occurs in the bile duct inside the liver and extrahepatic, which occurs in the bile duct outside the liver. Patients with BTC are often diagnosed at a late or advanced stage when the prognosis is poor2,3. FGFR2 fusions or rearrangements, which occur almost exclusively in intrahepatic cholangiocarcinoma, are observed in a small percentage of Japanese patients with BTC4,5,6,7.

The approval is based on data from the FIGHT-202 study evaluating the safety and efficacy of pemigatinib in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status. In FIGHT-202 patients harboring FGFR2 fusions or rearrangements (Cohort A), Pemazyre monotherapy resulted in an overall response rate of 36% (primary endpoint), and median DOR of 7.49 months (secondary endpoint). The most frequent treatment-emergent adverse event (TEAE) were grade ≤2 hyperphosphatemia (58.2%). Other frequent TEAEs (all grades) observed in ≥30% of patients were alopecia, diarrhea, fatigue, dysgeusia, nausea, constipation, stomatitis, dry mouth and decreased appetite. The majority of these TEAEs were grade ≤2. The TEAE with grade ≥3 that occurred in ≥10% of patients was hypophosphatemia.

Previously, the MHLW granted Orphan Drug Designation for Pemazyre – a designation granted to investigational compounds intended to treat rare diseases that affect fewer than 50,000 people in Japan, and for which there is a high medical need8. Designated orphan drugs are eligible for priority review for marketing authorizations to ensure supply to clinical settings at the earliest opportunity8.

About FIGHT-202

The FIGHT-202 Phase 2, open-label, multicenter study (NCT02924376) is evaluating the safety and efficacy of pemigatinib – a selective fibroblast growth factor receptor (FGFR) 1, 2, 3 inhibitor – in adult (age ≥ 18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status.

Patients were enrolled into one of three cohorts – Cohort A (FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genetic alterations) or Cohort C (no FGF/FGFR genetic alterations). All patients received 13.5 mg pemigatinib orally once daily (QD) on a 21-day cycle (two weeks on/one week off) until radiological disease progression or unacceptable toxicity.

The primary endpoint of FIGHT-202 is overall response rate (ORR) in Cohort A, assessed by independent review per RECIST v1.1. Secondary endpoints include ORR; progression free survival (PFS), overall survival (OS), duration of response (DOR), disease control rate (DCR) and safety in all cohorts.

For more information about FIGHT-202, visit View Source

About FIGHT

The FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program includes ongoing Phase 2 and 3 studies investigating safety and efficacy of pemigatinib therapy across several FGFR-driven malignancies. Phase 2 monotherapy studies include FIGHT-202, as well as FIGHT-201 investigating pemigatinib in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 mutations or fusions/rearrangements; FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 fusions/rearrangements; FIGHT-207 in patients with previously treated, locally-advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or fusions/rearrangements, irrespective of tumor type.

FIGHT-302 is a Phase 3 study investigating pemigatinib as a first-line treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.

About Pemazyre (pemigatinib)

Pemazyre is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test9. This indication is approved under accelerated approval based on overall response rate and duration of response. 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 (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy.

Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.

Pemazyre is marketed by Incyte in the United States and will be marketed by Incyte in Japan. Incyte has granted Innovent Biologics, Inc. rights to develop and commercialize pemigatinib in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. Incyte has retained all other rights to develop and commercialize pemigatinib outside of the United States.

Additionally, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization of pemigatinib for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Pemazyre is a trademark of Incyte Corporation.

On March 23, 2021 Oxford Vacmedix, the UK-based biopharma company focused on the development of cancer vaccines reported the appointment of Dr. Thomas Morris BSc, MB BCh, LlM, MRCP FFPM as Chief Medical Officer (Press release, Oxford Vacmedix, MAR 23, 2021, View Source [SID1234576993]). Tom originally worked as a physician in the NHS before joining industry, including many years at Astra Zeneca where he led the global clinical development of several oncology compounds. He has been responsible for the design, implementation and subsequent analysis of many study protocols, including several first in man clinical trials. Tom has wide experience in scientific interactions and in negotiation with the US, European and Japanese regulatory agencies on clinical development plans pre-phase III.

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William Finch, Chief Executive Officer of Oxford Vacmedix said;
"I am delighted to welcome Tom to the team at Oxford Vacmedix at this critical time, as move our lead cancer vaccine, OVM-200, into the clinic. His extensive experience in oncology and in clinical development will be invaluable for the next phase of the development of our vaccines as monotherapy and in combination with immune-oncology agents, to meet the needs of cancer patients."

Dr Morris qualified in Physiology and Medicine from the University of Wales in 1987 and went on to gain a master’s degree in Law from the University of Cardiff. He was awarded the Fellowship of the Faculty of Pharmaceutical Medicine from the Royal College of Physicians in 2003 and was appointed to the role of Registrar and Board Member of the Faculty in 2015. Tom also served as a member of the Faculty’s Coordination Committee and as a Speciality Adviser, responsible for overseeing training in pharmaceutical medicine, and was previously Chair of the Ethical Issues Committee and member of the Professional Standards Committee of the Faculty.

Tom Morris commented;
"I am very pleased to be joining Oxford Vacmedix to lead the clinical development of these novel cancer vaccines. The underlying ROP technology offers great hope to provide safe and effective therapies to help people with cancer live longer and better lives, and I look forward to making a positive contribution to the company."