On May 26, 2022 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported positive initial clinical proof-of-concept data from its ongoing Phase 2 CRESTONE study evaluating the safety and efficacy of seribantumab in patients with advanced solid tumors that harbor NRG1 gene fusions (Press release, Elevation Oncology, MAY 26, 2022, View Source;utm_medium=rss&utm_campaign=elevation-oncology-to-present-initial-seribantumab-proof-of-concept-data-from-phase-2-crestone-study-in-patients-with-tumors-harboring-nrg1-fusions-at-asco-2022 [SID1234615077]). These data will be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held in Chicago from June 3-7, 2022.

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"The response rate observed in the Cohort 1 patient population, including complete and partial responses, together with early signs of durable responses and a well-tolerated safety profile, demonstrate the potential of seribantumab to become a best-in-class therapy with a differentiated profile for patients whose tumor harbors an NRG1 fusion," said Valerie Malyvanh Jansen, MD, PhD, Chief Medical Officer of Elevation Oncology. "These initial results further support our confidence in the tumor-agnostic clinical development strategy for seribantumab and targeting genomically defined patient populations. We look forward to continuing to advance seribantumab to address the significant unmet needs of patients with NRG1 fusions."

"NRG1 fusions have been identified in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian and colorectal cancers, among others, and patients with these tumors typically have a poor prognosis and limited response to available therapies," said Daniel Carrizosa, MD, Medical Oncologist at Atrium Health Levine Cancer Institute, and an investigator for the CRESTONE study. "These initial results, including the 33% response rate and disease control rate of greater than 90%, demonstrate clear, clinical proof-of-concept for seribantumab monotherapy, and support the potential opportunity to provide patients with a meaningful new treatment option. We look forward to sharing the data with the medical and scientific community at ASCO (Free ASCO Whitepaper) in June."

The efficacy data being presented are from 12 patients evaluable for investigator-assessed response per RECIST v1.1. All patients were treated with seribantumab monotherapy dosed at 3g weekly IV, in Cohort 1 of CRESTONE, which includes patients with no prior pan-ERBB, HER2 or HER3 targeted therapy, with centrally confirmed NRG1 gene fusion status via RNA-based next generation sequencing assay.

Key Findings from CRESTONE as of the data cut-off date of April 18, 2022

Enrollment consisted of 15 patients in Cohort 1 with non-small cell lung cancer (NSCLC) (n=14) or pancreatic cancer (n=1) whose tumors harbor an NRG1 fusion
12 patients were evaluable for response per RECIST v1.1, with a median age of 61 years (range 44-76), and a median of 1 line of prior systemic therapy (range 1-5)
Across all tumor types (n=12), the investigator-assessed objective response rate (INV-ORR) was 33%, including two complete responses (CRs; 17%) and two partial responses (PRs; 17%)
Disease control rate was 92%
Durations of response range from 1.4 – 11.5 months
75% of responding patients remain on treatment
In NSCLC (n=11), the INV-ORR was 36%, including two CRs (18%) and two PRs (18%)
Seribantumab demonstrated a favorable and tolerable safety profile across the 35 patients evaluable for safety, which was comprised of patients from Cohorts 1, 2 and 3, along with patients from the safety run-in portion of the study
Majority (80%) of adverse events (AEs) were mild or moderate (Grade 1 or 2) in severity
There were two Grade 3 treatment-related AEs (TRAEs), diarrhea (n=1) and vomiting (n=1), and no Grade 4 or 5 TRAEs
No patients discontinued seribantumab due to AEs
2 patients (6%) received dose reductions for AEs
77% of patients (27 of 35) received the optimized recommended Phase 2 dose of seribantumab (3g QW)
"We are pleased to be reporting these first-ever CRESTONE data of seribantumab in patients whose tumors harbor NRG1 gene fusions, and we remain on track to complete enrollment of the first 20 patients in Cohort 1 in mid-2022," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "We believe these initial data support the continued evaluation of seribantumab, and its potential ability to address the underlying drivers of tumor growth for this difficult-to-treat genomic alteration. We look forward to reporting additional data from CRESTONE in the first half of 2023."

Seribantumab was recently granted Fast Track designation by the U.S. Food and Drug Administration for the tumor-agnostic treatment of advanced solid tumors that harbor NRG1 gene fusions.

The full presentation can be accessed on the Elevation Oncology website at elevationoncology.com/resources/publications/ following completion of the live presentation at ASCO (Free ASCO Whitepaper).

Expected Upcoming Milestones

Complete enrollment of the first 20 patients in Cohort 1 of the CRESTONE study in mid-2022
Additional interim data from the CRESTONE Phase 2 study are expected in the first half of 2023
Topline data from the CRESTONE Phase 2 study results are expected in 2024
Ongoing target evaluation and continued execution of Elevation Oncology’s strategy for future pipeline expansion
Conference Call and Webcast Information

The Company will host an investor conference call and webcast today, Thursday, May 26, 2022, at 6:00pm ET to discuss the Phase 2 CRESTONE data. Elevation Oncology’s management team will be joined by Daniel R. Carrizosa, MD, a recognized thought leader in oncology and NRG1 fusions, and a principal investigator of the CRESTONE study. To access the live call, please dial 1-877-870-4263 (local) or 1-412-317-0790 (international) at least 10 minutes prior to the start time of the call and ask to be joined into the Elevation Oncology call. The live, listen-only webcast of the conference call can be accessed by visiting the "Events" page within the "Investors" section of the Company’s website at www.elevationoncology.com. An archived replay of the webcast will be available on the Company’s website approximately two hours after the event.

Details for the ASCO (Free ASCO Whitepaper) 2022 oral presentation are as follows:

Title: CRESTONE: Initial efficacy and safety of seribantumab in solid tumors harboring NRG1 fusions
First Author: Daniel R. Carrizosa, Atrium Health Levine Cancer Institute
Abstract Number: 3006
Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Date and Time: Tuesday, June 7, 2022, 11:45AM-11:57AM CT

About the Phase 2 CRESTONE Study

CRESTONE (Clinical Study of Response to Seribantumab in Tumors with Neuregulin-1 (NRG1) Fusions; NCT04383210) is a Phase 2 tumor-agnostic, three-cohort study evaluating seribantumab in patients with solid tumors that harbor an NRG1 fusion and have progressed after at least one prior line of standard therapy. The primary objective of the study is to describe the anti-tumor activity and safety of seribantumab as a monotherapy specifically in patients whose solid tumor is uniquely driven by an NRG1 gene fusion. CRESTONE offers a clinical trial opportunity for patients with advanced solid tumors who have not responded or are no longer responding to treatment. Patients are encouraged to talk to their doctor about genomic testing of their tumor. CRESTONE is open and enrolling today in the United States, Australia, and Canada. For more information visit www.NRG1fusion.com.

About Seribantumab and NRG1 Gene Fusions

Seribantumab is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (HER3). HER3 is traditionally activated through binding of its primary ligand, neuregulin-1 (NRG1). The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner protein to create chimeric NRG1 "fusion proteins". The NRG1 fusion protein is often also able to activate the HER3 pathway, leading to unregulated cell growth and proliferation. Importantly, NRG1 gene fusions are predominantly mutually exclusive with other known genomic driver mutations and are considered a unique oncogenic driver event associated with tumor-cell survival.

NRG1 fusions have been identified in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, neuroendocrine, cholangiocarcinomas, and sarcomas. In preclinical experiments, seribantumab prevented the activation of HER3 signaling in cells that harbor an NRG1 gene fusion and destabilized the entire ERBB family signaling pathway including the activation of HER2, EGFR, and HER4. In addition to extensive nonclinical characterization and testing, seribantumab has been administered to more than 800 patients across twelve Phase 1 and 2 studies, both as a monotherapy and in combination with various anti-cancer therapies. Seribantumab was granted Fast Track designation by the FDA for the tumor-agnostic treatment of patients whose solid tumors harbor NRG1 fusions and is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that harbor an NRG1 fusion.

On May 26, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, reported that the first patient has been dosed in a Phase 1 dose-escalation study of CX-904 (NCT05387265). CX-904 is a conditionally activated T-cell-engaging bispecific (TCB) designed to target the epidermal growth factor receptor (EGFR) on cancer cells and the CD3 receptor on T cells within the tumor microenvironment (Press release, CytomX Therapeutics, MAY 26, 2022, View Source [SID1234615076]).

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"The successful initiation of this first-in-human study represents another major milestone for CytomX, as it marks the third therapeutic modality to enter the clinic from our versatile Probody platform," said Amy C. Peterson, M.D., president and chief operating officer at CytomX Therapeutics. "Our conditionally activated TCB platform is designed to localize both target binding and T-cell activation selectively to the tumor microenvironment, minimizing extra-tumoral activation of T cells and potentially widening the therapeutic window for solid tumor-directed TCBs. This study underscores our commitment to destroying cancer differently and bolsters our leadership in the field of conditional activation in oncology."

Utilizing CytomX’s proprietary masking technology to reduce systemic target engagement, conditionally activated TCBs are constructed to direct the activity of CD3-positive, cytotoxic T cells to cancer cells expressing the target of interest, with the goal of improving the therapeutic window of these highly potent agents for the treatment of solid tumors. CytomX has shown in preclinical models that dual-masked, conditionally activated TCBs targeting EGFR and CD3 have the potential for an improved therapeutic window compared to conventional, unmasked TCBs.

"We look forward to exploring CX-904 in solid tumors," said Meredith Pelster, M.D., MSCI, a study investigator at Sarah Cannon Research Institute at Tennessee Oncology. "Given that EGFR is widely expressed in a number of solid tumors, the opportunity for this therapeutic candidate to address an unmet need in multiple tumor types is noteworthy."

On May 26, 2022 CTI BioPharma Corp. (Nasdaq: CTIC) reported a poster presentation from the Company’s pacritinib program at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held in Chicago and virtually, June 3-7, 2022 (Press release, CTI BioPharma, MAY 26, 2022, View Source [SID1234615075]).

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"These data reinforce pacritinib’s role as a safe, differentiated JAK inhibitor. Our risk-adjusted analysis demonstrates that the safety profile of pacritinib 200 mg twice a day is comparable to best available therapy, including ruxolitinib, and that pacritinib 200 mg twice daily could be a full-dose therapeutic option for patients with myelofibrosis, including those who experience severe thrombocytopenia," said Adam Craig, President and Chief Executive Officer of CTI BioPharma. "Earlier this year, VONJOTM (pacritinib) at 200 mg orally twice daily received accelerated FDA approval, becoming the first approved therapy that specifically addresses the needs of patients with cytopenic myelofibrosis. The NCCN Clinical Practice Guidelines in Oncology for Myeloproliferative Neoplasms also recently included VONJO as a recommended first- and second-line treatment. With a successful beginning to our commercial launch, these data reinforce VONJO’s value as a new standard of care for cytopenic myelofibrosis patients with platelet counts <50 × 109/L who have been waiting for new treatment options."

Presentation materials will be available at ctibiopharma.com.

Risk-adjusted safety analysis of pacritinib in patients with myelofibrosis (ASCO Poster #7058)
Pacritinib is a novel JAK2/IRAK1 inhibitor that has shown significant activity in patients with myelofibrosis, including those with platelet counts <50 × 109/L. This safety analysis focuses on toxicities of interest for patients treated with pacritinib 200 mg twice daily (BID) and best available therapy (BAT), including ruxolitinib, on the Phase 3 PERSIST-2 and Phase 2 PAC203 studies. Because the average treatment duration was longer for patients on pacritinib 200 mg BID on PERSIST-2 and PAC203 compared to BAT on PERSIST-2, this analysis presents adverse events rates in these patients corrected for duration of exposure.

This risk-adjusted analysis demonstrates that the safety profile of pacritinib 200 mg BID is comparable to BAT. In particular, rates of bleeding were not elevated on pacritinib 200 mg BID compared to BAT, both overall and in patients with PLT <50 x 109/L. Rates of fatal events, thrombosis, major adverse cardiac events (MACE) and non-melanoma skin cancer were higher on ruxolitinib than pacritinib. These results indicate that pacritinb 200 mg BID may represent a full-dose therapeutic option for patients with myelofibrosis, including those with thrombocytopenia.

The details of the poster presentation are as follows:

Abstract Title: Risk-adjusted safety analysis of pacritinib (PAC) in patients (pts) with myelofibrosis (MF)
Abstract Number: 7058
Session Name: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Session Date: Saturday, June 4, 2022
Presentation Time: 8:00 – 11:00 a.m. CDT (11:00 a.m. – 2:00 p.m. ET)
Presenter: Dr. Naveen Pemmaraju

About VONJO (pacritinib)
Pacritinib is an oral kinase inhibitor with activity against wild type Janus Associated Kinase 2 (JAK2), mutant JAK2V617F form and FMS-like tyrosine kinase 3 (FLT3), which contribute to signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. Myelofibrosis is often associated with dysregulated JAK2 signaling. Pacritinib has higher inhibitory activity for JAK2 over other family members, JAK3 and TYK2. At clinically relevant concentrations, pacritinib does not inhibit JAK1. Pacritinib exhibits inhibitory activity against additional cellular kinases (such as CSF1R and IRAK1), the clinical relevance of which is unknown.

VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Important VONJO Safety Information
Hemorrhage:
Serious (11%) and fatal (2%) hemorrhages have occurred in VONJO-treated patients with platelet counts <100 × 109/L. Serious (13%) and fatal (2%) hemorrhages have occurred in VONJO-treated patients with platelet counts <50 × 109/L. Grade ≥3 bleeding events (defined as requiring transfusion or invasive intervention) occurred in 15% of patients treated with VONJO compared to 7% of patients treated on the control arm. Due to hemorrhage, VONJO dose-reductions, dose interruptions, or permanent discontinuations occurred in 3%, 3%, and 5% of patients, respectively.

Avoid use of VONJO in patients with active bleeding and hold VONJO 7 days prior to any planned surgical or invasive procedures. Assess platelet counts periodically, as clinically indicated. Manage hemorrhage using treatment interruption and medical intervention.

Diarrhea:
VONJO causes diarrhea in approximately 48% of patients compared to 15% of patients treated on the control arm. The median time to resolution in VONJO-treated patients was 2 weeks. The incidence of reported diarrhea decreased over time with 41% of patients reporting diarrhea in the first 8 weeks of treatment, 15% in Weeks 8 through 16, and 8% in Weeks 16 through 24. Diarrhea resulted in treatment interruption in 3% of VONJO-treated patients. None of the VONJO-treated patients reported diarrhea that resulted in treatment discontinuation. Serious diarrhea adverse reactions occurred in 2% of patients treated with VONJO compared to no such adverse reactions in patients in the control arm.

Control pre-existing diarrhea before starting VONJO treatment. Manage diarrhea with antidiarrheal medications, fluid replacement, and dose-modification. Treat diarrhea with anti–diarrheal medications promptly at the first onset of symptoms. Interrupt or reduce VONJO dose in patients with significant diarrhea despite optimal supportive care.

Thrombocytopenia:
VONJO can cause worsening thrombocytopenia. VONJO dosing was reduced due to worsening thrombocytopenia in 2% of patients with pre–existing moderate to severe thrombocytopenia (platelet count <100 × 109/L). VONJO dosing was reduced due to worsening thrombocytopenia in 2% of patients with pre–existing severe thrombocytopenia (platelet count <50 × 109/L).

Monitor platelet count prior to VONJO treatment and as clinically indicated during treatment. Interrupt VONJO in patients with clinically significant worsening of thrombocytopenia that lasts for more than 7 days. Restart VONJO at 50% of the last given dose once the toxicity has resolved. If toxicity recurs hold VONJO. Restart VONJO at 50% of the last given dose once the toxicity has resolved.

Prolonged QT interval:
VONJO can cause prolongation of the QTc interval. QTc prolongation of >500 msec was higher in VONJO-treated patients than in patients in the control arm (1.4% vs 1%). QTc increase from baseline by 60 msec or higher was greater in VONJO-treated patients than in control arm patients (1.9% vs 1%). Adverse reactions of QTc prolongation were reported for 3.8% of VONJO-treated patients and 2% of control arm patients. No cases of torsades de pointes were reported.

Avoid use of VONJO in patients with a baseline QTc of >480 msec. Avoid use of drugs with significant potential for QTc prolongation in combination with VONJO. Correct hypokalemia prior to and during VONJO treatment. Manage QTc prolongation using VONJO interruption and electrolyte management.

Major Adverse Cardiac Events (MACE):
Another Janus associated kinase (JAK)-inhibitor has increased the risk of MACE, including cardiovascular death, myocardial infarction, and stroke (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which VONJO is not indicated.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with VONJO particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur.

Thrombosis:
Another JAK-inhibitor has increased the risk of thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which VONJO is not indicated.

Patients with symptoms of thrombosis should be promptly evaluated and treated appropriately.

Secondary Malignancies:
Another JAK-inhibitor has increased the risk of lymphoma and other malignancies excluding non-melanoma skin cancer (NMSC) (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which VONJO is not indicated. Patients who are current or past smokers are at additional increased risk.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with VONJO, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.

Risk of Infection:
Another JAK-inhibitor has increased the risk of serious infections (compared to best available therapy) in patients with myeloproliferative neoplasms. Serious bacterial, mycobacterial, fungal and viral infections may occur in patients treated with VONJO. Delay starting therapy with VONJO until active serious infections have resolved. Observe patients receiving VONJO for signs and symptoms of infection and manage promptly. Use active surveillance and prophylactic antibiotics according to clinical guidelines.

Interactions with CYP3A4 Inhibitors or Inducers:
Co-administration of VONJO with strong CYP3A4 inhibitors or inducers is contraindicated. Avoid concomitant use of VONJO with moderate CYP3A4 inhibitors or inducers.

Drug interruptions due to an adverse reaction occurred in 27% patients who received VONJO 200 mg twice daily compared to 10% of patients treated with BAT. Dosage reductions due to an adverse reaction occurred in 12% of patients who received VONJO 200 mg twice daily compared to 7% of patients treated with BAT. Permanent discontinuation due to an adverse reaction occurred in 15% of patients receiving VONJO 200 mg twice daily compared to 12% of patients treated with BAT.

Please visit View Source for full Prescribing Information and the Medication Guide.

About Myelofibrosis
Myelofibrosis is bone marrow cancer that results in formation of fibrous scar tissue and can lead to thrombocytopenia and anemia, weakness, fatigue and an enlarged spleen and liver. Within the United States, there are approximately 21,000 patients with myelofibrosis, 7,000 of which have severe thrombocytopenia (defined as blood platelet counts of less than 50 x109/L). Severe thrombocytopenia is associated with poor survival and high symptom burden and can occur as a result of disease progression or from drug toxicity with other JAK2 inhibitors, such as JAKAFI and INREBIC.

On May 26, 2022 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained regulatory approval for an additional indication of the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq Intravenous Infusion 1200 mg [generic name: atezolizumab (genetical recombination)] for the adjuvant treatment of PD-L1-positive non-small cell lung cancer (NSCLC) from the Ministry of Health, Labour and Welfare (Press release, Chugai, MAY 26, 2022, View Source [SID1234615074]).

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VENTANA OptiView PD-L1 (SP263), a pathological testing kit marketed by Roche Diagnostics K.K., should be used to detect PD-L1 expression. An expanded use of this test kit as a companion diagnostic for Tecentriq was approved on May 23, 2022 to allow physicians to identify patients with PD-L1-positive NSCLC who could benefit from Tecentriq.

"I am very pleased that we can offer Tecentriq as the first cancer immunotherapy for adjuvant treatment of NSCLC. This makes cancer immunotherapy available for certain patients with early-stage NSCLC," said Chugai’s President and CEO, Dr. Osamu Okuda. "In early-stage cancer, it is critical to prevent recurrence and increase the chance of cure, the ultimate goal of treatment. Tecentriq is the first cancer immunotherapy to demonstrate a reduction in the risk of recurrence or death in early-stage lung cancer, for which there has been no significant progress in treatment over the past decade. We will continue our efforts to provide information on the proper use of Tecentriq in order to contribute to postoperative adjuvant treatment of non-small cell lung cancer."

This approval is based on the results from phase III IMpower010 study examining Tecentriq as an adjuvant treatment in NSCLC. The study showed that treatment with Tecentriq following surgery and chemotherapy reduced the risk of disease recurrence or death (disease-free survival; DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88) in people with Stage II-IIIA NSCLC, whose tumors express PD-L1≥1%, compared with best supportive care (BSC). The most frequent adverse reactions (5% or more) included hypothyroidism, pruritus, rash, increased AST, increased ALT, hyperthyroidism, pyrexia, and arthralgia.

Approval Information *Newly added description
Indications:
Adjuvant treatment of PD-L1-positive non-small cell lung cancer

Dosage and administrations:
The usual adult dosage is 1200 mg atezolizumab (genetical recombination) administered by intravenous infusion over 60 minutes once every 3 weeks. The dosage period is up to 12 months. If the initial infusion is well tolerated, subsequent infusions can be delivered over 30 minutes.

Chugai Files for Additional Indication of Tecentriq for the Adjuvant Treatment of Non-small Cell Lung Cancer (July 7, 2021)
View Source

Pivotal Phase III data at ASCO (Free ASCO Whitepaper) show Roche’s Tecentriq helps certain people with early lung cancer live significantly longer without their disease returning (Press release by Roche issued on May 20, 2021)
View Source

About IMpower010 study
IMpower010 is a Phase III, global, multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomized 1,005 people with a ratio of 1:1 to receive either at most 16 cycles of Tecentriq or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomized Stage II-IIIA and ITT Stage IB-IIIA populations. Key secondary endpoints include OS in the overall study population, ITT Stage IB-IIIA NSCLC.

About non-small cell lung cancer (NSCLC)
In Japan, 122,825 people (82,046 men and 40,777 women; 2018) reportedly become afflicted with lung cancer each year. 75,585 people in Japan (53,247 men and 22,338 women; 2020) reportedly die as a result of the disease. Lung cancer is the leading cause of cancer death.1) Lung cancer can be broadly divided into small cell lung cancer and NSCLC, according to the tissue type. NSCLC has the largest number of patients, accounting for about 85% of all lung cancer cases.2)

About approval status of Tecentriq in Japan
Tecentriq was launched in Japan in April 2018 for unresectable, advanced or recurrent non-small cell lung cancer (NSCLC), followed by an approval for the additional dosing for the treatment of untreated unresectable, advanced or recurrent NSCLC in December 2018. In 2019, the drug obtained regulatory approval for additional indications of extensive-stage small cell lung cancer in August, PD-L1-positive hormone receptor-negative and HER2-negative inoperable or recurrent breast cancer in September, and for an additional dosing for the treatment of chemotherapy-naïve unresectable advanced or recurrent non-squamous NSCLC in November. In 2020, Tecentriq was approved for the treatment of unresectable hepatocellular carcinoma in September, followed by an approval for the additional dosing for the treatment of untreated PD-L1-positive, unresectable, advanced or recurrent NSCLC in December.

Trademarks used or mentioned in this release are protected by law.

Sources

Cancer Registry and Statistics. Cancer Information Service, National Cancer Center Japan from: View Source Accessed May 2022
American Cancer Society: What Is Lung Cancer? View Source Accessed May 2022

On May 26, 2022 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported financial results for the quarter ended March 31, 2022 (Press release, Can-Fite BioPharma, MAY 26, 2022, View Source [SID1234615073]).

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"Can-Fite is financially well positioned to conduct all our clinical development programs over the next year, and we continue to evaluate potential new distribution partnerships which may provide additional non-dilutive funding."

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Corporate and Clinical Development Highlights Include:

Fortified Balance Sheet – On March 31, 2022, Can-Fite had approximately $16.5 million in cash, cash equivalents, and short-term deposits.

Phase III Psoriasis Study Data Expected Q2 2022 – Topline results are expected in Q2 2022 in Can-Fite’s Phase III Comfort psoriasis study for both its 16 week primary endpoint and 32 week secondary endpoint. The study is designed to establish Piclidenoson’s superiority compared to placebo at 16 weeks and non-inferiority compared to Apremilast (Otezla) at 32 weeks. During the first quarter, a preclinical study showed Piclidenoson destroyed pathological skin cells, offering further evidence of potential efficacy in psoriasis.

Developing Topical Psoriasis Treatment – In a preclinical model, daily treatment with topical Piclidenoson significantly inhibited psoriasis as measured by the psoriasis area severity index (PASI) calculated based on observation of erythema, thickness, scaling, and a score of skin lesions. The topical treatment may serve as a complementary product to oral Piclidenoson.

Commenced Enrollment in Phase IIb NASH Study – In January, Can-Fite enrolled the first patient in its Phase IIb multicenter, randomized, double-blind, placebo-controlled study in 140 subjects with biopsy-confirmed NASH. The primary objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo as determined by a histological endpoint. In a prior Phase IIa study, Namodenoson met its primary endpoint by reducing liver fat, inhibiting fibrosis, and demonstrating an anti-inflammatory effect.

Granted U.S. Patent for Liver Fibrosis and Israeli Patent for NASH – The U.S. Patent and Trademark Office granted Can-Fite a patent for its invention titled "Method for Treating Fibrotic Liver Tissue Using CL-IB MECA", a broad patent that addresses markets for the treatment of all advanced liver fibrosis indications. The patent opens an opportunity for much broader market needs which entail all clinical conditions with advanced liver fibrosis including autoimmune hepatitis, primary biliary cirrhosis (PBC), nonalcoholic fatty liver disease (NAFLD), and alcoholic liver disease (ALD) among others. The Israel Patent Office granted Can-Fite a patent titled "An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation" which has been issued in approximately 40 other countries.

Opened Enrollment in Pivotal Phase III Liver Cancer Study – Can-Fite’s pivotal Phase III liver cancer study for Namodenoson opened for enrollment of approximately 450 patients diagnosed with hepatocellular carcinoma (HCC) and underlying Child Pugh B7 (CPB7) who have not responded to other approved therapies. An interim analysis will be conducted after 50% of patients are enrolled and treated. The primary endpoint is overall survival. Can-Fite has received Orphan Drug Designation in both the U.S. and Europe and has received the U.S. FDA’s Fast Track Status.

Presented Data on Cannabinoids in the Treatment of Liver Cancer at CannX – In March, Can-Fite delivered a presentation titled "Inhibition of Hepatocellular Carcinoma Growth and Liver Fibrosis by Nanomolar Cannabinoids Concentrations" at the CannX Medical Cannabis Conference in Tel Aviv. The findings were also published in the peer-reviewed scientific journal Medical Cannabis and Cannabinoids highlighting the ability of CBD-rich T3/C15 in nanomolar concentrations to inhibit the growth of hepatocellular carcinoma and liver stellate cells via A3AR activation and deregulation of the Wnt/β-catenin pathway.

"We look forward to announcing Phase III psoriasis results before the end of the second quarter as we enroll patients in our other advanced stage clinical trials for NASH and liver cancer," stated Can-Fite CEO Dr. Pnina Fishman. "Can-Fite is financially well positioned to conduct all our clinical development programs over the next year, and we continue to evaluate potential new distribution partnerships which may provide additional non-dilutive funding."

Financial Results

Revenues for the three months ended March 31, 2022 were $0.20 million, an increase of $0.05 million, or 38.5%, compared to $0.15 million for the three months ended March 31, 2021. The increase in revenues was mainly due to the recognition of a higher portion of advance payments received under a distribution agreement with Ewopharma than the advance payment received at the end of the first quarter of 2021.

Research and development expenses for the three months ended March 31, 2022 were $1.82 million, an increase of $0.52 million, or 39.8%, compared to $1.30 million for the three months ended March 31, 2021. Research and development expenses for the first quarter of 2022 comprised primarily of expenses associated with an ongoing Phase III study of Piclidenoson for the treatment of psoriasis and two studies for Namodenoson, a Phase III study in the treatment of liver cancer and a Phase IIb study for NASH. The increase is primarily due to costs incurred in the first quarter of 2022 associated with the two new studies for Namodenoson.

General and administrative expenses for the three months ended March 31, 2022 were $0.75 million a decrease of $0.26 million, or 25.8%, compared to $1.01 million for the three months ended March 31, 2021. The decrease is primarily due to the decrease in professional services for public relations and investor relations. We expect that general and administrative expenses will remain at the same level through 2022.

Financial expenses, net for the three months ended March 31, 2022 were $0.06 million compared to finance income, net of $0.29 million for the three months ended March 31, 2021. The decrease in financial income, net was mainly due to revaluation of our short-term investment which in 2021 was recorded as income and in 2022 was recorded as expense.

Net loss for the three months ended March 31, 2022 was $2.43 million compared with a net loss of $1.87 million for the three months ended March 31, 2021. The increase in net loss for the three months ended March 31, 2022 was primarily attributable to an increase in research and development expenses which was partly offset by a decrease in general and administrative expenses and a decrease in finance income, net.

As of March 31, 2022, Can-Fite had cash and cash equivalents and short term deposits of $16.5 million as compared to $18.9 million at December 31, 2021. The decrease in cash during the three months ended March 31, 2022 is due to the ongoing operation of the Company.

The Company’s consolidated financial results for the three months ended March 31, 2022 are presented in accordance with US GAAP Reporting Standards.