On June 3, 2021 Seagen Inc. (Nasdaq:SGEN) reported that improvements in overall survival (OS) and progression-free survival (PFS) were maintained with long-term follow up from the pivotal HER2CLIMB trial evaluating the addition of TUKYSA (tucatinib) to trastuzumab and capecitabine in patients with HER2-positive metastatic breast cancer (MBC) with and without brain metastases (Press release, Seagen, JUN 3, 2021, View Source [SID1234583437]). Data from the pre-specified exploratory analysis will be presented (Abstract #1043) as part of the virtual scientific program of the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The overall survival benefit seen with TUKYSA at the time of the primary analysis was maintained after an additional 15.6 months of follow-up (total of 29.6 months), demonstrating a 5.5-month improvement in median OS (24.7 months (95% CI: 21.6, 28.9) for the TUKYSA regimen vs. 19.2 months (95% CI: 16.4, 21.4) for capecitabine and trastuzumab alone). This benefit continued to be generally consistent across pre-specified patient subgroups.

"Late-stage, HER2-positive metastatic cancer has proven difficult to treat," said Giuseppe Curigliano, M.D., Ph.D., Head of the Division of Early Drug Development at the European Institute of Oncology, IRCCS, and Associate Professor of Medical Oncology, University of Milano, Italy. "These data further support that treatment with the tucatinib regimen helps patients live longer compared to trastuzumab and capecitabine alone. These benefits were observed across all prespecified subgroups of patients in the trial, including those with or without brain metastases."

"These results support the significant impact that a TUKYSA regimen can have for patients with HER2-positive metastatic breast cancer," said Roger D. Dansey, M.D., Chief Medical Officer of Seagen. "The long-term data from the HER2CLIMB trial showed that the survival benefit was sustained with median overall survival longer than that observed at the primary analysis."

Overall Survival (OS):

Median OS in the TUKYSA arm was 24.7 months (95% CI: 21.6, 28.9) compared to median OS of 19.2 months (95% CI: 16.4, 21.4) in the control arm (HR=0.73 [95% CI: 0.59-0.90]; p=0.004).
Progression Free Survival (PFS):

The median PFS in the TUKYSA arm was 7.6 months (95% CI: 6.9, 8.3), compared to median PFS of 4.9 months (95% CI: 4.1, 5.6) in the control arm (HR=00.57 [95% CI: 0.47-0.70]; p<0.00001).
Safety

The safety profile was generally consistent with the primary analysis. The most common adverse events occurring in more than 20 percent of patients who received TUKYSA included diarrhea, palmar-plantar erythrodysaesthesia syndrome, nausea, fatigue, vomiting, decreased appetite, stomatitis, headache, increased aspartate aminotransferase, anemia, increased alanine aminotransferase, and increased blood bilirubin.
Grade 3 or greater adverse events occurring in more than five percent of patients in either arm were diarrhea (13.1% TUKYSA vs. 8.6% for the control arm), palmar-plantar erythrodysaethesia syndrome (14.1% vs. 9.1%), fatigue (5.4% vs. 4.1%), and increased alanine aminotransferase (5.7% vs. 0.5%).
Discontinuations due to adverse events were infrequent in both arms of the trial, with 5.9 percent in the TUKYSA arm and 4.1 percent in the control arm.
TUKYSA in combination with trastuzumab and capecitabine was approved by the U.S. Food and Drug Administration (FDA) in April 2020 for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. In February 2021, the European Medicines Agency (EMA) and U.K. Medicines and Healthcare products Regulatory Agency (MHRA) each approved TUKYSA in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens. TUKYSA is also approved in Canada, Switzerland, Singapore and Australia.

In September 2020, Seagen granted Merck, known as MSD outside the U.S. and Canada, exclusive rights to commercialize TUKYSA in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe.

About HER2CLIMB

HER2CLIMB is a multinational randomized (2:1), double-blind, placebo-controlled, active comparator, pivotal clinical trial comparing tucatinib in combination with trastuzumab and capecitabine compared with trastuzumab and capecitabine alone in patients with locally advanced unresectable or metastatic HER2-positive breast cancer who were previously treated with trastuzumab, pertuzumab and T-DM1. The primary endpoint of the trial was PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by blinded independent central review (BICR) in the first 480 patients enrolled in the trial. HER2CLIMB enrolled a total of 612 patients to support the analyses of key secondary endpoints, including overall survival, PFS per BICR in patients with brain metastases at baseline and confirmed objective response rate. Safety data were evaluated throughout the study.1

About HER2-Positive Breast Cancer

Patients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. In 2018, more than two million new cases of breast cancer were diagnosed worldwide, including 522,513 in Europe. 2 Between 15 and 20 percent of breast cancer cases are HER2-positive.3 Historically, HER2-positive breast cancer tends to be more aggressive and more likely to recur than HER2-negative breast cancer.3,4,5 Up to 50 percent of metastatic HER2-positive breast cancer patients develop brain metastases over time.6,7,8

About TUKYSA (tucatinib)

TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.

U.S. Important Safety Information
Warnings and Precautions

Diarrhea – TUKYSA can cause severe diarrhea including dehydration, hypotension, acute kidney injury, and death. In HER2CLIMB, 81% of patients who received TUKYSA experienced diarrhea, including 12% with Grade 3 diarrhea and 0.5% with Grade 4 diarrhea. Both patients who developed Grade 4 diarrhea subsequently died, with diarrhea as a contributor to death. The median time to onset of the first episode of diarrhea was 12 days and the median time to resolution was 8 days. Diarrhea led to dose reductions of TUKYSA in 6% of patients and discontinuation of TUKYSA in 1% of patients. Prophylactic use of antidiarrheal treatment was not required on HER2CLIMB.

If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
Hepatotoxicity – TUKYSA can cause severe hepatotoxicity. In HER2CLIMB, 8% of patients who received TUKYSA had an ALT increase >5 × ULN, 6% had an AST increase >5 × ULN, and 1.5% had a bilirubin increase >3 × ULN (Grade ≥3). Hepatotoxicity led to dose reduction of TUKYSA in 8% of patients and discontinuation of TUKYSA in 1.5% of patients.

Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatotoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
Embryo-Fetal Toxicity – TUKYSA can cause fetal harm. Advise pregnant women and females of reproductive potential risk to a fetus. Advise females of reproductive potential, and male patients with female partners of reproductive potential, to use effective contraception during TUKYSA treatment and for at least 1 week after the last dose.
Adverse Reactions

Serious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in ≥2% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock.

Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in ≥1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in ≥2% of patients were hepatotoxicity (8%) and diarrhea (6%).

The most common adverse reactions in patients who received TUKYSA (≥20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.

Lab Abnormalities

In HER2CLIMB, Grade ≥3 laboratory abnormalities reported in ≥5% of patients who received TUKYSA were: decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.

Drug Interactions

Strong CYP3A or Moderate CYP2C8 Inducers: Concomitant use may decrease TUKYSA activity. Avoid concomitant use of TUKYSA.
Strong or Moderate CYP2C8 Inhibitors: Concomitant use of TUKYSA with a strong CYP2C8 inhibitor may increase the risk of TUKYSA toxicity; avoid concomitant use. Increase monitoring for TUKYSA toxicity with moderate CYP2C8 inhibitors.
CYP3A Substrates: Concomitant use may increase the toxicity associated with a CYP3A substrate. Avoid concomitant use of TUKYSA where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, decrease the CYP3A substrate dosage.
P-gp Substrates: Concomitant use may increase the toxicity associated with a P-gp substrate. Consider reducing the dosage of P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicity.
Use in Specific Populations

Lactation: Advise women not to breastfeed while taking TUKYSA and for at least 1 week after the last dose.
Renal Impairment: Use of TUKYSA in combination with capecitabine and trastuzumab is not recommended in patients with severe renal impairment (CLcr < 30 mL/min), because capecitabine is contraindicated in patients with severe renal impairment.
Hepatic Impairment: Reduce the dose of TUKYSA for patients with severe (Child-Pugh C) hepatic impairment.

On June 3, 2021 Replimune Group, Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported updated interim data from the Phase 2 skin cancer cohorts combining RP1 (vusolimogene oderparepvec) with Opdivo* (nivolumab) and data from RP2 alone and in combination with Opdivo that continues to provide strong support for development in its lead indications (Press release, Replimune, JUN 3, 2021, View Source [SID1234583436]). Additionally, Replimune announced plans to initiate a Phase 2 clinical trial program in tumor types that metastasize to the liver. A virtual investor event will be held today at 8:00 a.m. ET to discuss the updated data.

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"As our data matures there are some clear themes emerging," said Philip Astley-Sparke CEO of Replimune. "In our longest-running clinical trial of RP1 combined with Opdivo in melanoma and in non-melanoma skin cancers including cutaneous squamous cell carcinoma (CSCC), we are seeing a clear trend that partial responses tend to convert to complete responses over time, providing many patients with the potential for a cure while also having a transformative long-term impact on quality of life. Our updated data further support our two registration-directed studies in skin cancers. We look forward to seeing if we can replicate the data we have seen with RP1 in skin cancers in anti-PD1/L1 failed non-small cell lung cancer (NSCLC), where we recently dosed our first patient. The signal with RP1 in patients who have failed anti-PD1 is continuing with RP2 and reinforces the potential utility of our platform for treating patients who have failed prior immune checkpoint therapy. Finally, the signal with RP1 indicating the potential to treat patients with liver metastases, who in general have a very poor prognosis, has been further confirmed with RP2, where we are now planning to move into Phase 2 development with RP2/3 in tumor types that commonly metastasize to the liver, including colon cancer, lung cancer and breast cancer."

Updated clinical data from the Phase 2 cohort with RP1 in combination with Opdivo in patients with CSCC and other non-melanoma skin cancers continues to support the CERPASS registration-directed clinical trial of RP1 in combination with Libtayo* (cemiplimab) in CSCC

The data continues to demonstrate that RP1 in combination with Opdivo is well tolerated and that it drives deep and durable responses in patients with CSCC with the number of complete responses (CRs), a dual independent primary endpoint in the CERPASS study, continuing to increase. At the current data cut off (n=15), seven of the nine responses are complete responses with a current CR rate of 46% and overall response rate (ORR) of 60%. Another potentially eighth complete response will require biopsy confirmation. The Company believes this data provides clear differentiation versus anti-PD1 therapy alone and provides strong validation of Replimune’s current registration-directed clinical development plan, with the initial readout of the CERPASS study expected in 2022.

Updated clinical data evaluating RP1 in combination with Opdivo in anti-PD1 failed melanoma patients continues to strongly support the Company’s registration-directed cohort in the IGNYTE clinical trial

Sixteen anti-PD1 failed cutaneous melanoma patients were enrolled into the previously reported 30 patient cohort in melanoma (which included anti-PD1 naïve cutaneous melanoma, mucosal and uveal melanoma, in addition to anti-PD1 failed cutaneous melanoma). The status of the anti-PD1 failed melanoma patients is as follows:

Five of these patients have so far met the formal criteria for response; four of which had previously failed both anti-PD1 and anti-CTLA-4 therapies, with a current ORR of 31%.
Of two further patients on study one remains a surgical complete response at 18 months from the start of treatment (classified as stable disease according to the study protocol) and the second patient with local progression following an extended period of stable disease has reinitiated RP1 treatment and is responding to therapy.
Despite improvements in therapy, many melanoma patients treated with anti-PD1 therapy have primary resistance or acquire resistance to immune checkpoint blockade following initial response. The clear activity of RP1 in combination with Opdivo in anti-PD1 failed patients, including in patients with extensive visceral disease, represents a new potential therapeutic option for these patients. Based on the initial data with RP1 in melanoma, the Company initiated a registration-directed 125-patient cohort of anti-PD1 failed melanoma which is expected to read out in 2022. The signal with RP1 in anti-PD1 failed melanoma indicating that the Replimune series of product candidates may provide an effective therapy for these patients has also been further confirmed with RP2 (see below), although there are no current plans to independently develop RP2 in cutaneous melanoma.

Based on the emerging data indicating that RP1 can be safely administered to tumors in the lung and the evidence of clinical activity in patients with lung metastases from other tumor types, including in patients with anti-PD1 failed disease, the Company has commenced dosing into a 30 patient cohort of patients with anti-PD1/L1 failed NSCLC.

Updated RP2 monotherapy data continues to show compelling durability of response and new data in combination with Opdivo provides initial additional evidence of the clinical utility of RP2 in patients with hard-to-treat cancers

RP2 leverages Replimune’s platform to express an anti-CTLA-4 antibody, in addition to GALV-GP R- and GM-CSF expressed by RP1. After fully enrolling patients in the RP2 monotherapy cohort (n=9) in the Phase 1 clinical trial with RP2, 27 of the target number of 30 patients have now been enrolled in the cohort evaluating RP2 in combination with Opdivo. With limited follow up available, initial data shows:

The data with RP2 combined with Opdivo in anti-PD1 failed cutaneous melanoma has further confirmed the signal previously seen with RP1 in this setting. Of the nine anti-PD1 failed cutaneous melanoma patients enrolled, four have so far achieved a partial response.
The signal in uveal melanoma with RP1 combined with Opdivo and with single-agent RP2 has been further confirmed with RP2 combined with Opdivo, with clear evidence of anti-tumor activity.
Signals of activity with RP2 combined with Opdivo have also been seen in patients with other tumor types beyond melanoma and uveal melanoma, including a partial response in anti-PD1 failed squamous cell head and neck cancer. RP2 single-agent activity had also previously been reported in a patient with anti-PD1 failed esophageal cancer and in a patient with salivary gland cancer where partial and complete responses respectively remain ongoing at 18 and 15 months from treatment initiation.
Replimune plans to conduct clinical trials with RP2/3 in patients with liver metastases from a range of tumor types

Based on the observation of clinical responses in patients with liver metastases following treatment with both RP1 and with RP2, and the fact that treating liver metastases is a considerable unmet need in patients with advanced cancer, Replimune plans to initiate a clinical development program with RP2 and/or RP3 specifically in patients with liver metastases from various cancer types.
The intended program includes:
Expanding the Phase 1/2 study with RP2 to provide further signal confirmation for the treatment of patients with liver metastases from various cancer types.
Plans to initiate a Phase 2 clinical trial program with RP2 and/or RP3 with cohorts of patients with liver metastases from a range of solid tumor types in the first half of 2022.
Details of the clinical trial design will be announced at a later time and is intended to include a range of tumor types where metastasis to the liver are common. This includes highly prevalent tumors such as colorectal and other gastrointestinal cancers, lung cancer and breast cancer.
Whether RP2 or RP3 is used for particular tumor types will depend on the clinical data as it continues to emerge.
"Patients with liver metastases across tumor types have a poorer prognosis than those without, and their treatment presents a considerable clinical challenge. Liver metastases across tumor types are also associated with systemic resistance to immune checkpoint blockade," commented Professor Mark Middleton, Professor of Experimental Cancer Medicine in the Department of Oncology, consultant Medical Oncologist at the Oxford Cancer and Haematology Centre and Head of the Department of Oncology at the University of Oxford, who will also present the latest data with RP1 and RP2 at today’s investor event. "Treatment of patients with liver metastases with RP1 or RP2, including patients with anti-PD1/L1 failed disease, has resulted in durable and systemic clinical benefit and offers the potential to provide a new standard of care for this large patient group."

The data from this clinical update and an overview of the rationale and development strategy for patients with liver metastases can be found in the presentation for today’s investor event, linked here.

Investor event and webcast information

Replimune will host a virtual investor event today, Thursday, June 3, 2021 at 8:00 a.m. ET. The webcast and slides will be accessible live under "Events & Presentations" on the Investors page of the Company’s website at www.replimune.com or by clicking here. A replay of the event will be available on Replimune’s website.

About CERPASS
CERPASS is Replimune’s registration-directed randomized, global Phase 2 clinical study to compare the effects of Libtayo (cemiplimab) alone versus a combination of Libtayo and Replimune’s investigational oncolytic immunotherapy RP1. The clinical trial will enroll 180 patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who are naïve to anti-PD1 therapy. The trial will evaluate complete response (CR) rate and overall response rate (ORR) as its two primary efficacy endpoints as assessed by independent review, as well as duration of response, progression-free survival (PFS), and overall survival (OS) as its secondary endpoints. The study is being run under a clinical trial collaboration agreement with Regeneron in which the costs of the trial are shared and full commercial rights retained by Replimune. Libtayo is being jointly developed by Regeneron and Sanofi.

About IGNYTE
IGNYTE is Replimune’s multi-cohort Phase 1/2 trial of RP1 plus Opdivo (nivolumab). There are 4 tumor specific cohorts currently enrolling in this trial including a 125-patient extension cohort of RP1 combined with Opdivo in anti-PD-1 failed cutaneous melanoma. This cohort was initiated after completing enrollment in a prior Phase 2 cohort in the same trial of approximately 30 patients with melanoma. The additional thirty patient cohorts are studying RP1 in combination with Opdivo in non-melanoma skin cancers which includes both naïve and anti-PD-1 failed CSCC, in microsatellite instability high, or MSI-H/dMMR tumor types and anti-PD-1 failed non-small cell lung cancer, or NSCLC. This trial is being done under a collaboration and supply agreement with Bristol Myer Squibb.

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead Immulytic product candidate and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response.

About RP2 & RP3
RP2 and RP3 are derivatives of RP1 that express additional proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses the immune co-stimulatory pathway activating proteins CD40L and 4-1BBL. RP2 and RP3 are intended to provide targeted and potent delivery to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic immune-based efficacy on tumors and limiting off-target toxicity.

On June 3, 2021 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Goldman Sachs Healthcare Conference on June 9 and 10, 2021 (Press release, Eli Lilly, JUN 3, 2021, View Source [SID1234583435]). Anne White, senior vice president and president, Lilly Oncology and Jake Van Naarden, CEO, Loxo Oncology at Lilly, will participate in a virtual fireside chat on Wednesday, June 9 at 8:50 a.m., Eastern Time .

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On June 3, 2021 Kyowa Kirin Co., Ltd. (President and CEO: Masashi Miyamoto, "Kyowa Kirin", TSE: 4151) reported that it will make a change in its organization as of July 1, 2021 (Press release, Kyowa Hakko Kirin, JUN 3, 2021, View Source [SID1234583433]).

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Outline of the change:
R&D Quality Assurance Department will be newly established within the Quality Division.

Purpose of the organizational change:
By integrating quality assurance activities of clinical and non-clinical studies into the Quality Division, execute drug development and post-marketing clinical trials activities in a more reliable organizational structure.

On June 2, 2021 Pacylex Pharmaceuticals, an oncology company unlocking a new approach to cancer therapy, and Greenfire Bio, a new Life Science development and investment company, reported the closing of Series A financing for Pacylex (Press release, Pacylex Pharmaceuticals, JUN 2, 2021, View Source [SID1234645063]). These funds will be used to support the initial Phase 1 clinical investigation of PCLX-001, a first-in-class N-myristoyltransferase (NMT) inhibitor, in Diffuse Large B-Cell Lymphoma and solid tumor patients. Pacylex is leading the development of novel therapies targeting the biological process of myristoylation in cancer.

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"We are excited to be a catalyst for this new innovation in oncology" said Ajit Gill, CEO of Greenfire Bio. "Our goal is to build a portfolio of potential breakthroughs in medicine, and we look forward to seeing PCLX-001 move into the clinic."

"The support from Greenfire Bio is essential for our transformation into a clinical stage company", said Michael Weickert, CEO of Pacylex. "Pioneering a new target and first-in-class therapy is extraordinarily important to expand cancer treatment options and improve patient outcomes. We are delighted to find the right investor with an appreciation for this groundbreaking work."

Clinical site preparations are underway for the open label, dose escalation, Phase 1 clinical trial, principally to evaluate the safety of PCLX-001. The study will enroll 20-30 patients and the Company anticipates that enrollment will begin within the next month. A No Objection Letter from Health Canada was received by Pacylex on March 8, 2021, authorizing the planned Phase 1 Trial of PCLX-001 in relapsed/refractory B-cell Non-Hodgkin Lymphoma and advanced solid malignancies. PCLX-001 is believed to be the first NMT inhibitor that will be clinically tested. Three principal investigators will oversee the clinical study at three clinical sites in Canada: Dr. John Kuruvilla at Princess Margaret Cancer Centre in Toronto, Dr. Randeep Sangha at the Cross Cancer Institute in Edmonton and Dr. Laurie Sehn at the British Columbia Cancer Center in Vancouver.

PCLX-001

PCLX-001 is a small molecule, first-in-class NMT inhibitor, originally developed by the University of Dundee Drug Discovery Unit as part of a program to treat African sleeping sickness funded by Wellcome Trust. Pacylex is developing PCLX-001, which has excellent oral bioavailability, to treat leukemia and lymphoma. PCLX-001 selectively kills cancer cells and completely regresses (eliminates) tumors in animal models of acute myeloid leukemia (AML), diffuse large B-cell lymphoma (DLBCL) and Burkitt lymphoma (BL). PCLX-001 has also been shown to inhibit the growth of lung and breast cancer tumors in animal models. In leukemia, lymphoma and breast cancer patients, the level of NMT2 is correlated with survival, suggesting an important biological role in these cancers. In tests using cultured cancer cells in vitro, PCLX-001 is at least ten times as potent as ibrutinib (Imbruvica) and dasatinib (Sprycel), two clinically approved drugs currently used to treat hematologic malignancies.