On March 11, 2021 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, reported fourth quarter and year-end 2020 financial results and provided an update on the cytisinicline clinical development program (Press release, OncoGenex Pharmaceuticals, MAR 11, 2021, View Source [SID1234576509]).

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Recent Events & Highlights

Initiated the Phase 3 ORCA-2 clinical trial evaluating the efficacy and safety of 3 mg cytisinicline dosed 3 times daily compared to placebo in 750 adult smokers at 15 clinical sites in the United States

Presented data on smoker and e-cigarette user attitudes and perceptions on quitting at the Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting on February 24, 2021

Closed financing of $17.3 million, prior to deducting underwriting discounts and commissions and estimated offering expenses, in December 2020

Facilitated Smoking Cessation Key Opinion Leader Virtual Roundtable in November 2020

"We concluded 2020 in the best financial position since the Company’s inception and with the Phase 3 ORCA-2 trial underway at 15 well-established smoking cessation research centers in the United States. As we look to the year ahead, our focus will continue to be on execution of this pivotal trial, completion of additional NDA-enabling activities, and exploration of new opportunities for expansion into additional populations, such as vaping and e-cigarette users, who may benefit from a new cessation therapeutic option like cytisinicline," commented John Bencich, Chief Executive Officer of Achieve.

Phase 3 ORCA-2 Trial

Achieve’s first Phase 3 ORCA-2 trial was initiated in October 2020 and will randomize 750 U.S. smokers to one of three study arms to determine the efficacy and safety of cytisinicline administered for either 6 or 12 weeks, compared to placebo. The primary endpoint is biochemically verified continuous abstinence during the last 4 weeks of treatment in the 6 and 12-week cytisinicline treatment arms compared to placebo. Each treatment arm will be compared independently to the placebo arm and the trial will be determined to be successful if either or both of the cytisinicline treatment arms show a statistical benefit compared to placebo. The trial is expected to complete enrollment by the middle of the 2021.

Data Highlighting Smoker Dissatisfaction with Available Treatments Presented at SRNT

Achieve data presented at the SRNT Annual Meeting in February 2021 provided insights into current and former smokers’ perceptions on currently available cessation treatment options. In a survey of 1,122 individuals, overall satisfaction and perceived efficacy with available therapies was low, with the best performing treatment leading to satisfaction in less than one-third of the respondents. The study found a majority of prescription cessation medication users do not complete their full 3-month

course of therapy, with 53% reporting less than 1 month of use. Smokers reported side effects and lack of efficacy as the most common reason for discontinuation or lack of initiation with varenicline or bupropion.

Data Elucidating Vaping/e-Cigarette Users Behavior and Quitting Intentions Presented at SRNT

Two Achieve posters were presented at the SRNT Annual Meeting in February 2021 reporting findings from a survey of 508 users of nicotine vape products. The results showed that the primary reason to initiate e-cigarettes/vaping was to quit combustible cigarettes. While proven successful in the cohort of subjects who only utilize vape, dual users, those who vape but also continue to smoke, reported 2-times heavier nicotine use than their counterparts. Additionally, the data indicated that 73% of e-cigarette/vape users intend to quit vaping in the next 3-12 months. Of those who intend to do so in the next 3 months, more than half reported they would be "very/extremely likely to try a new prescription product" to help them quit.

Completed $17.3 Million Financing in December 2020

In December 2020, Achieve announced the closing of an underwritten public offering of 2,472,500 shares of its common stock at a public offering price of $7.00, for total gross proceeds of $17.3 million, prior to deducting underwriting discounts and commissions and estimated offering expenses. This included the full exercise of the underwriter’s over-allotment option to purchase an additional 322,500 shares of common stock.

Virtual Smoking Cessation KOL Roundtable on November 17, 2020

Achieve hosted a virtual roundtable on cytisinicline and smoking cessation in November 2020. Five esteemed experts in the field of smoking cessation discussed the ongoing Phase 3 ORCA-2 trial, reviewed recent cytisinicline data, and presented evidence supporting the importance of smoking cessation in the midst of the COVID-19 pandemic.

Financial Results

As of December 31, 2020, the company’s cash, cash equivalents, and restricted cash was $35.9 million. Total operating expenses for the fourth quarter and year ended December 31, 2020 were $4.7 million and $14.8 million, respectively. Total net loss for the fourth quarter and year ended December 31, 2020 was $4.7 million and $14.7 million, respectively.

As of March 11, 2021, Achieve had 6,149,917 shares outstanding.

Conference Call Details

Achieve will host a conference call at 4:30pm Eastern time today, Thursday, March 11, 2021. To access the webcast, log on to the investor relations page of the Achieve website at View Source Alternatively, access to the live conference call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 9395238. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

On March 11, 2021 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic myeloid malignancies, reported financial results for the fourth quarter and year ended December 31, 2020 (Press release, Geron, MAR 11, 2021, View Source [SID1234576508]). The Company ended fiscal year 2020 with $260 million in cash and marketable securities, which is expected to fund operations until the end of 2022.

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"Geron’s vision is to be recognized as a leader in the treatment of hematologic malignancies by changing the course of these diseases and thereby improving and extending the lives of patients," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "In 2020, we made important progress toward realizing that vision through two ongoing Phase 3 clinical trials, presentation of new data and analyses providing strong evidence of imetelstat’s disease-modifying potential that differentiates imetelstat from other treatments today, and raising the capital necessary to support future activities. With this momentum from 2020, in 2021, we plan to complete enrollment in IMerge Phase 3, advance site initiation and enrollment in IMpactMF, and begin activities to prepare for Geron’s first NDA filing and potential commercial launch. With a strong team in place and the financial resources to support these plans, we believe our vision can be attained."

Dr. Scarlett added, "We are hopeful that clinical site operations will normalize in the next several months since vaccine distribution has commenced in many countries and the number of COVID-19 cases is declining. However, the fluid and dynamic nature of the pandemic continues to create uncertainty and unpredictability on our clinical trial activities. Taking into account these challenges and under current planning assumptions, we expect IMerge Phase 3 to be fully enrolled in the second half of 2021. Depending on the timing of full enrollment, we expect top-line results from IMerge Phase 3 to be available from the end of 2022 to the first half of 2023. For IMpactMF, under current planning assumptions, we expect the pace of enrollment to be slower and now project the event-driven analyses for the trial to occur in 2024 for the interim analysis and 2025 for the final analysis."

Company Highlights and Upcoming Milestones

Ongoing Phase 3 Clinical Trials

IMerge in Lower Risk Myelodysplastic Syndromes (MDS)

In December 2020, 50% of the planned enrollment in IMerge was achieved and today, 65% have been enrolled. In the fourth quarter of 2020, the first meeting of the Independent Data Monitoring Committee (IDMC) was held, and the IDMC recommended that the trial continue without modification.

In the past few winter months, the resurgence of COVID-19 cases caused delays in clinical site openings, as well as patient screening and enrollment, and such delays may be ameliorated with broader vaccine distribution and other public health safety measures. With the current decline in the number of COVID-19 cases, the Company expects its trial operations to begin to normalize in the next several months. However, the pace at which any normalization may occur remains uncertain and unpredictable. Taking into account these dynamic and evolving circumstances, under current planning assumptions, the Company expects IMerge Phase 3 to be fully enrolled in the second half of 2021. Depending on the timing of full enrollment, the Company expects top-line results from IMerge Phase 3 to be available during the time period from the end of 2022 to first half of 2023. To address the delays in enrollment, the Company continues to pursue enrollment boosting activities, including opening new sites, engaging clinical science liaisons and employing a social media campaign. Currently, 105 sites are open for enrollment, and the Company expects to open the remaining 15 additional planned sites over the next few months.

IMpactMF in Refractory Myelofibrosis (MF)

IMpactMF, the only Phase 3 clinical trial in MF with overall survival (OS) as a primary endpoint, opened for screening and enrollment in December 2020 with three clinical sites in the United States. However, as with IMerge Phase 3, COVID-19 has negatively impacted clinical trial activities. In addition, in 2020 a number of competing trials were initiated in MF and other oncology indications in the countries where IMpactMF is planned to be conducted. As a result of these factors, site personnel resources are constrained at many clinical sites, causing delays in site initiation activities. Although the Company has expanded the number of countries and sites planned to conduct the trial, the Company now expects IMpactMF to be fully enrolled in 2024. The Company currently plans to engage over 180 sites to participate in IMpactMF across North America, South America, Europe, Australia and Asia.

Under current planning assumptions around enrollment and median overall survival for each treatment arm, the Company expects to conduct the interim analysis in 2024 and the final analysis in 2025. The final analysis for OS is planned to be conducted after more than 50% of the patients enrolled in the trial have died. An interim analysis of OS is planned to be conducted after approximately 70% of the total projected number of events for the final analysis have occurred. If the pre-specified, statistically significant difference in OS between the two treatment arms is met at the interim analysis, it is possible that data from the interim analysis could support a registration filing. Both the planned interim and final analyses are event-driven and could occur on different timelines than currently expected.

New Drug Application (NDA) and Commercial Readiness Activities in 2021

The Company has begun preparations for the future submission of an NDA for imetelstat in lower risk MDS. Assuming the results of IMerge Phase 3 are supportive, the Company plans to submit the completed NDA in 2023.

The Company is beginning pre-commercial activities, including building the internal infrastructure to support a commercial launch. Assuming approval of the NDA, the Company forecasts the commercial launch of imetelstat in lower risk MDS in the United States to be in 2024.

Presentations and Publications of Phase 2 Data and Analyses

More Mature Clinical Data from IMerge Phase 2 Continue to Differentiate Imetelstat in Lower Risk MDS

In October 2020, more mature data of 38 patients in IMerge Phase 2 were published in the Journal of Clinical Oncology (JCO) highlighting the durability of transfusion independence achievable with imetelstat treatment in the trial. Durability of transfusion independence continues to differentiate imetelstat with 29% (11/38) of patients being transfusion-free for more than one year, and a median duration of transfusion independence of 20 months. Such durability provides significant and meaningful clinical benefit to lower risk MDS patients given their chronic anemia. In addition, the JCO publication reported observations from the IMerge Phase 2 of depletion of cytogenetic abnormalities and reductions in key driver mutations for lower risk MDS which provide strong evidence of disease-modifying activity of imetelstat. These observations were further strengthened through the correlation of molecular data with clinical benefits of transfusion independence.

The data from the JCO publication were also reported in an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2020. Further analyses of IMerge Phase 2 data are expected to be presented at medical conferences in 2021.

New Analyses of IMbark Phase 2 Data Support OS Outcome and Disease-Modifying Potential of Imetelstat

In December 2020, new analyses of IMbark Phase 2 data were reported in oral and poster presentations at the ASH (Free ASH Whitepaper) Annual Meeting. These analyses described dose-related improvements in OS that were correlated to other clinical benefits, such as symptom response and spleen volume reduction, which support previously reported improvement in OS for MF patients in the trial. Furthermore, (i) reductions in the variant allele frequency of key driver mutations in MF, indicating imetelstat targets the underlying malignant clone, and (ii) improvements in bone marrow fibrosis were correlated to improvement in OS, which provide further evidence of imetelstat’s disease-modifying potential.

Fourth Quarter and Full Year 2020 Results

For the fourth quarter of 2020, the Company reported a net loss of $23.8 million, or $0.07 per share, compared to $29.1 million, or $0.15 per share, for the fourth quarter of 2019. Net loss for the full year of 2020 was $75.6 million, or $0.28 per share, compared to $68.5 million, or $0.36 per share, for the full year of 2019.

Revenues for the three and twelve months ended December 31, 2020 were $50,000 and $253,000, respectively, compared to $171,000 and $460,000 for the same periods in 2019. Revenues in 2020 and 2019 primarily reflect estimated royalties from sales of cell-based research products from the Company’s divested stem cell assets. In connection with the divestiture of Geron’s human embryonic stem cell assets, including intellectual property and proprietary technology, to Lineage Cell Therapeutics, Inc. (formerly BioTime, Inc., which acquired Asterias Biotherapeutics, Inc.) in 2013, Geron is entitled to receive royalties on sales from certain research or commercial products utilizing Geron’s former intellectual property.

Total operating expenses for the three and twelve months ended December 31, 2020 were $23.3 million and $77.2 million, respectively, compared to $30.2 million and $73.0 million for the same periods in 2019. Research and development expenses for the three and twelve months ended December 31, 2020 were $16.2 million and $51.5 million, respectively, compared to $24.9 million and $52.1 million for the same periods in 2019. The overall decrease in research and development expenses, compared to the same periods in 2019, primarily reflects the net result of closing of the IMbark Phase 2 clinical trial, completion of the transition of the imetelstat program and reduced purchases of raw materials, drug substance and drug product, partially offset by increased costs for IMerge Phase 3 and start-up costs for IMpactMF. General and administrative expenses for the three and twelve months ended December 31, 2020 were $7.1 million and $25.7 million, respectively, compared to $5.3 million and $20.9 million, for the same periods in 2019. The overall increase in general and administrative expenses, compared to the same periods in 2019, primarily reflects increased personnel-related expenses for additional general and administrative headcount to support the development organization and higher legal costs.

Interest income for the three and twelve months ended December 31, 2020 was $243,000 and $1.8 million, respectively, compared to $925,000 and $4.2 million for the same periods in 2019. The overall decrease in interest income, compared to the same periods in 2019, primarily reflects lower yields on the Company’s marketable securities portfolio due to declining interest rates.

Interest expense for the three and twelve months ended December 31, 2020 was $754,000 and $760,000, respectively. In September 2020, the Company secured a new debt facility for up to $75 million.

The Company ended the 2020 fiscal year with $260 million in cash and marketable securities, which the Company believes is sufficient for its operations until the end of 2022.

Projected 2021 Financial Guidance

For fiscal year 2021, the Company expects its operating expense burn to range from $108 to $112 million, which includes costs for the two ongoing Phase 3 clinical trials; producing validation batches of imetelstat at contract manufacturers to enable future production of imetelstat for clinical and commercial purposes; and preparatory activities for NDA and commercial readiness.

As of December 31, 2020, the Company had 55 employees. The Company plans to grow to a total of approximately 80 to 85 employees by year-end 2021, of which the majority will be research and development personnel.

Conference Call

Geron will host a conference call at 4:30 p.m. ET on Thursday, March 11, 2021 to discuss fourth quarter and full year 2020 financial results and recent events.

A live, listen-only webcast will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.

Participants may access the conference call live via telephone by pre-registering online using the following link, View Source Upon registration, a phone number, Direct Event Passcode and unique Registrant ID will be sent via email. This information will be needed in order to enter the conference call. Participants are advised to pre-register at least 10 minutes prior to joining the call.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in hematologic myeloid malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.

About IMerge Phase 3

IMerge Phase 3 is a double-blind, randomized, placebo-controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 170 transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS), also referred to as lower risk MDS, who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The primary endpoint is the rate of red blood cell (RBC) transfusion independence (TI) for any consecutive period of eight weeks or longer, or 8-week RBC-TI rate. Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks, or 24-week RBC-TI rate, and the rate of hematologic improvement-erythroid (HI-E), defined as a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden.

IMerge Phase 3 is currently enrolling patients. For further information about IMerge Phase 3, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT02598661.

About IMpactMF

IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 320 patients with Intermediate-2 or High-risk myelofibrosis who are refractory to prior treatment with a JAK inhibitor, also referred to as refractory MF. Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete response, partial response, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes.

On March 11, 2021 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported financial results for the fourth quarter and year ended December 31, 2020, and highlighted recent corporate accomplishments (Press release, Galera Therapeutics, MAR 11, 2021, View Source [SID1234576507]).

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"In 2020, Galera presented positive interim data demonstrating that our dismutase mimetics have the potential to benefit the anti-cancer side of the therapeutic index of radiotherapy," said Mel Sorensen, M.D., President and CEO of Galera. "This encouraging interim data from our pilot placebo-controlled Phase 1/2 trial in patients with pancreatic cancer was presented at ASTRO in late 2020. We look forward to providing the final data readout from this trial in the second half of 2021 and advancing this regimen with the initiation of our Phase 2b GRECO-2 trial of GC4711 in combination with SBRT in patients with LAPC in the first half of 2021."

Dr. Sorensen continued, "We are excited for the year ahead, which we believe will be transformative for our company, with the topline data readout of our Phase 3 ROMAN trial. In anticipation, we continue our preparations for the commercial launch of avasopasem manganese."

Recent Corporate Highlights

Severe Oral Mucositis (SOM)

Continued enrollment in the Phase 3 ROMAN trial of avasopasem for the treatment of SOM in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy. The Company remains on track to complete enrollment in the first half of 2021 and report topline data in the second half of 2021.
Completed enrollment in the Phase 2a EUSOM multi-center trial in Europe assessing the safety of avasopasem in patients with HNC undergoing standard-of-care radiotherapy. The Company remains on track to report topline data in the second half of 2021.
Locally Advanced Pancreatic Cancer (LAPC)

Presented positive interim data from the pilot placebo-controlled Phase 1/2 anti-cancer trial of avasopasem in combination with SBRT in patients with LAPC at the American Society for Radiation Oncology (ASTRO) virtual Annual Meeting in late 2020. Data on all patients through a minimum follow-up of three months demonstrated better tumor outcomes, including overall survival, with avasopasem compared to placebo. The Company plans to provide final data from this trial with at least one year of follow-up data on all patients in the second half of 2021.
Remain on track to initiate the Phase 2b GRECO-2 trial of GC4711, Galera’s second superoxide dismutase mimetic candidate, in combination with SBRT in patients with LAPC in the first half of 2021. GRECO-2 is a randomized, double-blind, placebo-controlled trial to evaluate the effect of 100 mg of GC4711 versus placebo in combination with SBRT on overall survival in patients with LAPC. The trial is expected to enroll approximately 160 patients.
Non-Small Cell Lung Cancer (NSCLC)

Continued enrollment in the Phase 1/2 GRECO-1 trial of GC4711 in combination with SBRT in patients with NSCLC. The Phase 2 portion of GRECO-1 is randomized, double-blind, and placebo-controlled to evaluate the effect of 100 mg of GC4711 versus placebo. The Company continues to expect to report initial data in the first half of 2022.
Esophagitis

Continued enrollment in the Phase 2a AESOP trial of avasopasem evaluating its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer. The Company remains on track to report topline data in the first half of 2022.
Fourth Quarter 2020 Financial Highlights

Research and development expenses were $14.6 million in the fourth quarter of 2020, compared to $13.3 million for the same period in 2019. The increase was primarily attributable to avasopasem and GC4711 development costs, as well as higher employee-related costs due to increased headcount and share-based compensation expense. The increases were partially offset by decreased avasopasem and GC4711 preclinical spend.

General and administrative expenses were $4.3 million in the fourth quarter of 2020, compared to $2.9 million for the same period in 2019. The increase was primarily the result of employee-related costs from increased headcount and share-based compensation expense, and increased insurance, professional fees and other operating costs as a result of becoming a public company.

Galera reported a net loss of $(20.1) million, or $(0.80) per share, for the fourth quarter of 2020, compared to a net loss of $(16.7) million, or $(1.31) per share, for the same period in 2019.

As of December 31, 2020, Galera had cash, cash equivalents and short-term investments of $72.8 million. Galera expects that its existing cash, cash equivalents and short-term investments, together with the expected payments from Blackstone in the amount of $57.5 million upon the achievement of certain clinical enrollment milestones in the ROMAN trial and the anti-cancer program in combination with SBRT under the amended royalty agreement, will enable Galera to fund its operating expenses and capital expenditure requirements into the second half of 2022. We expect to achieve these clinical enrollment milestones in the first half of 2021.
Full Year 2020 Financial Highlights

Research and development expenses were $54.8 million for the year ended December 31, 2020, compared to $42.3 million for the year ended December 31, 2019. The increase was primarily attributable to avasopasem development costs due to increased expenses in the Phase 3 ROMAN trial, additional clinical trials including the Phase 2a AESOP trial and the Phase 2a EUSOM trial, and manufacturing scale-up activities. In addition, employee-related costs also increased due to increased headcount and share-based compensation expense.
General and administrative expenses were $15.7 million for the year ended December 31, 2020, compared to $8.4 million for the year ended December 31, 2019. The increase was primarily the result of employee-related costs from increased headcount and share-based compensation expense, and increased insurance, professional fees and other operating costs as a result of becoming a public company.
Galera reported a net loss of $(74.2) million, or $(2.98) per share, for the year ended December 31, 2020, compared to a net loss of $(51.9) million, or $(16.31) per share, for the year ended December 31, 2019.

On March 11, 2021 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a patient-first biotechnology company developing novel cannabinoid medicines to improve quality of life for cancer patients, reported that it has acquired an exclusive, perpetual license from Diverse Biotech, a biopharmaceutical company focused on developing new molecules for treating oncology and other debilitating diseases (Press release, Enveric Biosciences, MAR 11, 2021, View Source [SID1234576506]). Enveric plans to research and develop these new drugs with the goal of alleviating the side effects that cancer patients experience. Through the conjugation of cannabidiol (CBD) with existing, standard-of-care drugs via Diverse Biotech’s patented, advanced chemistry drug delivery platform, Enveric intends to expand its pipeline of development candidates that seek to deliver superior therapeutic outcomes for patients.

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"This exclusive licensing agreement with Enveric aims to expand our CBD conjugate platform into oncology supportive care indications for the first time," said Brian Longstreet, Interim CEO, Diverse Biotech. "We believe that our collaboration has the potential to advance this science more efficiently, ultimately bringing therapies to market faster to help serve unmet medical needs in this large patient population."

As part of the agreement, Enveric will add to the Company’s list of target indications by obtaining five molecules, four of which are dermatology-focused and one that is pain-focused. Enveric will also gain access to Diverse Biotech’s scientists and formulators to help synthesize and validate these drugs, as the company moves through pre-clinical and clinical activities.

"This is an exclusive, novel way of bringing together CBD and well-known, existing compounds that hold promise to create a new, improved drug class," added David Johnson, Chairman and CEO, Enveric Biosciences. "As a patient-centric company, Enveric is constantly looking for new ways to eliminate or minimize cancer treatment side effects for patients in need. With its anti-inflammatory properties, CBD holds so much potential to help these patients, especially since status-quo treatments are not an adequate solution. We are confident that, with this impressive team of experts and Diverse Biotech’s conjugate technology platform, this relationship can help us to expand our potential treatment options for cancer patients who continue to suffer around the globe."

Mr. Johnson concluded, "Enveric has a clear focus to serve cancer patients’ supportive care needs with our current pipeline consisting of innovative early-stage formulations. We intend to continue to add to that portfolio by moving forward internal development initiatives and targeted external business opportunities. Our new molecules from Diverse Biotech provide us with more options to address these difficult indications while building on our IP portfolio and expanding our access to leading scientific talent."

On March 11, 2021Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that it has received orphan drug designation for LENVIMA (generic name: lenvatinib mesylate), the orally available multiple receptor kinase inhibitor discovered by Eisai, with a prospective indication for uterine body cancer, by the Ministry of Health, Labour and Welfare (MHLW) (Press release, Eisai, MAR 11, 2021, View Source [SID1234576505]).

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In Japan, the estimated number of patients with uterine body cancer is approximately 30,000.1 It is estimated that in 2020, there were more than 17,000 new cases of uterine body cancer and more than 3,000 deaths from the disease.2 It is considered that more than 90% of uterine body cancers occur in the endometrium.3

The pivotal Phase 3 Study 309/KEYNOTE-775 evaluated LENVIMA in combination with KEYTRUDA (generic name: pembrolizumab) in patients with advanced endometrial cancer (advanced uterine body cancer in Japan), following at least one prior platinum-based regimen in Japan, the United States, Europe and other countries. In this study, LENVIMA plus KEYTRUDA met its dual primary endpoints, overall survival (OS) and progression-free survival (PFS), as well as its secondary efficacy endpoint of objective response rate (ORR). Currently, Eisai is preparing to submit an application for additional indications based on these results in various countries around the world including Japan.

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA.

Eisai positions oncology as a key therapeutic area and is aiming to discover innovative new medicines with the potential to cure cancer. Eisai is committed to expanding the potential clinical benefits of LENVIMA for cancer treatment, as it seeks to contribute addressing the diverse needs of, and increasing the benefits provided to, patients with cancer and their families.