On February 16, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing a drug to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, pancreatic cancer, castrate-resistant prostate cancer and leukemias, reported that Dr. Mark Erlander, chief executive officer of Cardiff Oncology will present at the upcoming LifeSci Partners Precision Oncology Day on February 17, 2021. The Company will also participate in one-on-one meetings (Press release, Cardiff Oncology, FEB 16, 2021, View Source [SID1234575114]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details on the presentation can be found below.
Date: Wednesday, February 17, 2021 Time: 1:30 PM ET
Format:
Corporate Presentation

A replay of the presentation will be available by visiting the "Events" section of the Cardiff Oncology website after the conclusion of the presentation and will be archived on the Company website for 90 days.

On February 16, 2021 InteRNA Technologies reported that the first patient has been dosed in the first cohort of its first-in-human Phase I study with the Company’s lead microRNA candidate, INT-1B3 (Press release, InteRNA Technologies, FEB 16, 2021, View Source [SID1234575133]). The trial will evaluate safety and initial signs of efficacy of INT-1B3, a microRNA-mimic of the endogenous tumor suppressor miR-193a-3p formulated in next-generation lipid nanoparticles, in patients with advanced solid tumors. INT-1B3 represents a promising novel therapeutic approach that could address multiple hallmarks of cancer simultaneously by directly targeting tumor cells and the tumor microenvironment by specific modulation of multiple relevant signaling pathway components triggering a long-term T cell-mediated immune response against the tumor.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The enrollment of the first patient in this trial, especially during the ongoing COVID-19 pandemic, is a significant milestone for InteRNA," said Dr. Roel Schaapveld, CEO of InteRNA Technologies. "microRNAs represent a new class of therapeutic agents that have the potential to change the treatment paradigm in immune-oncology, delivering a combination approach as a single regimen. We are very pleased that the first patient completed the first cycle without dose-limiting toxicity, and enrolment of the second cohort could already be initiated. The trial will allow us to generate further important insights on the potential and underlying mechanisms of INT-1B3 and reinforces our commitment to bringing this novel modality to patients, especially for the treatment of hard-to-treat solid tumors."

This two-part, open-label, multiple ascending dose Phase I/Ib trial (NCT04675996) will evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of INT-1B3. The dose escalation part of the study (part 1) will be conducted in trial sites located in the Netherlands and Belgium and will enroll approximately 30 patients with advanced solid tumors. The dose expansion part of the trial (part 2) will be conducted in multiple clinical study centers located in several European countries as well as in the United States and will enroll up to 50 patients with hepatocellular carcinoma or triple negative breast cancer. All patients will receive INT-1B3 via infusions twice per week in 21-day cycles. Topline results from the dose escalation part of the study are expected by the end of 2021.

About INT-1B3

INT-1B3’s unique mechanism of action addresses multiple hallmarks of cancer simultaneously. It directly targets tumor cells and the tumor microenvironment by specific modulation of multiple signaling pathway components across the PTEN tumor suppressor pathway and the oncogenic PI3K/Akt and Ras/MAPK pathways resulting in inhibition of proliferation and migration and induction of cell cycle arrest and apoptosis. The triggering of the immunogenic tumor cell death (ICD) process as well as downregulation of the adenosine-A2A receptor pathway through inhibition of CD39/CD73 leads to a decrease in immunosuppressive FoxP3/Lag3 regulatory T cells and monocytic myeloid-derived suppressor cells (mMDSCs), and maturation of dendritic cells. As a result, the immune system is activated, and long-term immunity is triggered by recruitment of CD8+ effector T cells leading to decreased metastasis development and improved animal survival compared to anti-PD1 treatment in preclinical models.

On February 16, 2021 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based medicine, reported the final results of its in-vivo study evaluating the efficacy of the company’s proprietary drug candidate RCC-33 for the treatment of colorectal cancer in nude-mice (Press release, Cannabics Pharmaceuticals, FEB 16, 2021, View Source [SID1234575150]). The final study results demonstrate a significant and robust inhibitory effect on tumor growth, as evidenced by a 33% reduction in tumor volume in mice exposed to RCC-33 in comparison with sham control mice (p ≤ 0.016).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Both the experimental and the control groups were inoculated with human colorectal cancer cells. Daily doses of intraperitoneal (IP) delivery of RCC-33 or sham control were initiated on day 5. Differences in tumor volume between the two groups were first observed after 5 days of treatment (day 10). Previously published interim results showing a 27% reduction in tumor volume were recorded after 12 days of treatment (day 17), with p value ≤ 0.022. The study was concluded after 16 days of treatment (day 21) when a member of the control group reached a predetermined tumor size. Final results recorded a significant and robust 33% reduction in tumor volume in RCC-33 treated mice in comparison with the control group, p value ≤0.016.

Eyal Barad, Cannabics Pharmaceuticals’ Co-founder and CEO said: "The outlook of the oncology market puts this sector’s therapeutics sales forecast at $250 billion by 2024, according to a recent McKinsey report. While this is the market we ultimately have in sight, our initial penetration efforts with RCC-33 are focused on developing a colorectal cancer treatment catering to a $10 billion market with a ‘massive unmet need’, as articulated in the same McKinsey report".

Gabriel Yariv, Cannabics Pharmaceuticals’ President and COO said: "Having successfully completed this in-vivo POC study, the company is now planning to finalize its product dossier preparation for a forthcoming submission to the FDA along with a request for a pre-IND meeting for RCC-33. We are paving the way with a potentially new treatment approach for colorectal cancer patients, one that could possibly have an important positive impact on a large group of patients, and we feel comfortable and look forward to bringing our scientific data before the regulatory authorities for review".

On February 16, 2021 GW Pharmaceuticals plc (Nasdaq: GWPH), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, reported financial results and operating progress for the fourth quarter and full-year ended December 31, 2020 (Press release, GW Pharmaceuticals, FEB 16, 2021, View Source [SID1234575093]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very proud of our strong financial performance and operational progress in 2020, as Epidiolex sales increased by more than 70% during the year despite the challenges of COVID-19. We are well positioned to build on our success and continue to deliver strong growth in 2021 in both the U.S. and Europe, where we continue to make progress preparing for several commercial launches that are expected later this year," said Justin Gover, chief executive officer of GW. "We have commenced our Phase 3 clinical program for nabiximols in the treatment of multiple sclerosis spasticity, which provides multiple opportunities for an NDA submission. Beyond nabiximols, we are advancing a diverse and robust neuroscience pipeline with several preclinical and clinical-stage pipeline candidates as part of our commitment to patients and to developing innovative medicines that address significant unmet needs. We have strong momentum and a tremendous opportunity to continue to build on our global cannabinoid leadership position as we prepare to join Jazz Pharmaceuticals and transform the lives of even more patients and families."

FINANCIAL RESULTS

Total revenue for the quarter ended December 31, 2020 was $148.2 million compared to $109.1 million for the quarter ended December 31, 2019.
Total revenue for the full-year 2020 was $527.2 million, a 69 percent increase compared to $311.3 million for the prior year period.
Net loss for the quarter ended December 31, 2020 was $29.1 million compared to net loss of $24.9 million for the quarter ended December 31, 2019.
Cash and cash equivalents at December 31, 2020 were $486.8 million.
OPERATIONAL HIGHLIGHTS

Epidiolex (cannabidiol) progress:
Total net product sales of Epidiolex of $144.1 million for the fourth quarter and $510.5 million for the year ended December 31, 2020.
U.S. commercial update
U.S. Epidiolex net product sales of $128.8 million for the fourth quarter and $467.6 million for the year ended December 31, 2020
TSC indication launched with high prescriber awareness and near universal payer coverage
Expanded payer coverage
More than 110 million lives with no/broad prior authorization (70% increase in 2020)
Ex-U.S. commercial update
Ex-U.S. Epidyolex Q4 2020 net product sales of $15.3 million and full-year 2020 sales of $42.9 million
Continued progress expanding global reach of Epidyolex:
Pricing and reimbursement approved in Germany, Finland and Israel
Swissmedic approval received for the adjunctive therapy of seizures associated with LGS and DS
Launches in France, Spain and Italy expected in H1 2021
EMA TSC approval expected H1 2021
Strengthening commercial exclusivity
Orphan exclusivity in both the U.S. and EU
14 patents listed in Orange Book, 13 of which expire in 2035
Patents include formulation and method of use
An additional patent has been granted and will be listed in the Orange Book in Q1 2021 and a further patent is expected to be granted and listed in the Orange Book in Q2 2021
Epidiolex composition patent application filed

Nabiximols development program:
MS Spasticity trials underway
Phase 3 placebo-controlled spasm frequency study (N=450)
Phase 3 placebo-controlled muscle tone study (N=52)
MS Spasticity trials due to commence
Phase 3 placebo-controlled muscle tone studies:
N=190; Expected start: Q2 2021
N=36 (nabiximols responders); Expected start: Q2 2021
Additional Phase 3 placebo-controlled spasm frequency study (N=200) in nabiximols responders expected start Q2 2021
Spinal Cord Injury (SCI) spasticity clinical program
First SCI trial underway
N=~100 observational clinical discovery study
SCI spasticity trials due to commence
N=~160 (muscle tone in nabiximols responders); Placebo-controlled parallel group design. Expected start: 2021
N=~400 (spasm frequency); Placebo-controlled parallel group design. Expected start: 2021
Additional pipeline programs:
Schizophrenia (GWP42003)
Phase 2b trial now actively recruiting
Autism:
CBD formulation Phase 2 study expected to commence in Q1 2021
CBDV investigator-led 100 patient placebo-controlled trial in autism underway
New botanical cannabinoid pipeline product (GW541)
Phase 1 trial underway
Potential targets within field of neuropsychiatry
Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program
Phase 1b safety study in patients continues to recruit
Orphan Drug and Fast Track Designations granted from FDA and EMA
Novel cannabinoid molecule synthesis and preclinical development
At least one program expected to enter Phase 1 in 2021
Several other molecules have demonstrated preclinical efficacy and are advancing towards the clinic
On Feb. 3, 2021, Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and GW announced the companies had entered into a definitive agreement for Jazz to acquire GW for $220.00 per American Depositary Share (ADS), in the form of $200.00 in cash and $20.00 in Jazz ordinary shares (subject to limitations on the maximum and minimum number of Jazz ordinary shares issuable per ADS), for a total consideration of $7.2 billion. The transaction is subject to the approval of GW shareholders, sanction by the High Court of Justice of England and Wales and other customary closing conditions, including regulatory approvals. Subject to the satisfaction or waiver of the closing conditions, the transaction is expected to close in the second quarter of 2021.
Conference Call/Earnings Materials

Given the recently announced agreement for GW to be acquired by Jazz Pharmaceuticals, GW will no longer hold conference calls. Earnings materials are available publicly on the Investor Relations page of GW’s website at View Source Questions may be directed to Investor Relations via e-mail at the contact information below.

On February 16, 2021 Amgen (NASDAQ:AMGN) reported that the U.S. Food and Drug Administration (FDA) has granted Priority Review for sotorasib for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy (Press release, Amgen, FEB 16, 2021, View Source [SID1234575115]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The FDA grants Priority Review to applications for medicines that offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. Based on the Priority Review designation, the Prescription Drug User Fee Action (PDUFA) date for sotorasib is Aug. 16, 2021, which is four months earlier than the standard review cycle.

The New Drug Application (NDA) is based on the Phase 2 results from the CodeBreaK 100 clinical trial that studied patients with locally advanced or metastatic NSCLC whose cancer had progressed despite treatment with chemotherapy and/or immunotherapy. Full results from the study were recently presented during the Presidential Symposium at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC).

Amgen submitted the sotorasib NDA on Dec. 16, 2020. The NDA is being reviewed by the FDA under its Real-Time Oncology Review (RTOR), a pilot program that aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Amgen submitted a Marketing Authorization Application (MAA) in the EU in Dec. 2020. Additionally, Amgen submitted MAAs for sotorasib in Australia, Brazil, Canada and the United Kingdom in Jan. 2021 to participate in the FDA’s Project Orbis initiative. Sotorasib has achieved Breakthrough Therapy Designation in the U.S. and China.

About Sotorasib
Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib, a KRASG12C inhibitor.1 Sotorasib was the first KRASG12C inhibitor to enter the clinic and is being studied in the broadest global clinical program exploring 10 combinations with clinical sites spanning five continents. In just over two years, the sotorasib clinical program has established the deepest clinical data set with more than 700 patients studied across 13 tumor types.

About Non-Small Cell Lung Cancer and the KRAS G12C Mutation
NSCLC accounts for 80%-85% of all lung cancers, and most patients (66%) have advanced or metastatic disease at initial diagnosis.2,3 KRAS G12C is one of the most common driver mutations in NSCLC and there is a high unmet need and poor outcomes associated in the second-line treatment of KRAS G12C driven NSCLC.4 In the U.S., approximately 25,000 new patients are diagnosed with KRAS G12C-mutated NSCLC each year.5

About CodeBreaK
The CodeBreaK clinical development program for Amgen’s investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers.

CodeBreaK 100, the Phase 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected in 2021.

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel (CodeBreaK 200) is currently recruiting patients with KRAS G12C-mutant NSCLC. Amgen also has more than 10 Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment.

For information, please visit www.codebreaktrials.com.

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

To learn more about Amgen’s innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. For more information, follow us on www.twitter.com/amgenoncology.