On June 17, 2021 Global pharma major Lupin Limited (Lupin) reported the achievement of key milestones for Lupin’s MEK inhibitor compound (LNP3794) that is planned for development by Boehringer Ingelheim in combination as potential targeted therapy for patients with difficult-to-treat cancers(Press release, Lupin, MAY 27, 2021, View Source [SID1234584116]).

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As part of the agreement, Lupin has received payment of USD 50 million from Boehringer Ingelheim for achievement of key milestones.

Lupin and Boehringer Ingelheim inked a licensing, development and commercialization agreement in 2019 for Lupin’s novel oncology compound to treat KRAS-driven cancers. Lupin’s MEK inhibitor developed as part of its oncology pipeline had previously shown pre-clinical activity as a single agent as well as in combination.

Lupin’s New Chemical Entity Research team is focused on building a pipeline of highly differentiated and innovative new chemical entities, primarily in the oncology space. Lupin’s NCE activities were started with the vision to use cutting-edge research in bringing novel molecules that address unmet medical needs in multiple therapeutic areas to market globally.

On May 27, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today that management will present an overview of the company’s business strategy and development-stage programs at two upcoming virtual investor conferences (Press release, Spectrum Pharmaceuticals, MAY 27, 2021, View Source [SID1234580675]):

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Jefferies Virtual Healthcare Conference 2021. A fireside chat presentation is scheduled for Thursday, June 3, 2021, at 9:30 a.m. ET.
JMP Securities Life Sciences Conference 2021. A fireside chat presentation is scheduled for Wednesday, June 16, 2021, at 1:30 p.m. ET.
A live webcast of each presentation will be available from the Investor Relations section of the company’s website at View Source with a replay available shortly after each event.

On May 27, 2021 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, 2021 (Press release, Can-Fite BioPharma, MAY 27, 2021, View Source [SID1234580693]).

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Clinical Developments and Corporate Highlights Include:

Signed Large Out-licensing Deal Worth $42.7 Million with Ewopharma –During the first quarter, Can-Fite signed a large out-licensing agreement with Swiss-based Ewopharma for distribution of its drug candidates in Central Eastern Europe and Switzerland, receiving $2.25 million upfront with up to an additional $40.45 million payable upon the achievement of regulatory and sales milestones, plus 17.5% royalties on net sales. Together with Ewopharma, Can-Fite’s existing out-licensing deals are worth a potential $130 million in future milestone payments plus double-digit royalties on net sales upon regulatory approvals. Can-Fite has received over $20 million in non-dilutive funding to date.

Phase III Psoriasis Study Achieves 75% Enrollment – The Phase III Comfort study completed enrollment of 75% of planned patients for the study which is designed to establish Piclidenoson’s superiority compared to placebo and non-inferiority compared to Apremilast (Otezla) in patients with moderate to severe plaque psoriasis. The majority of costs associated with the Phase III Comfort study have been previously paid. The Company expects to complete enrollment in Q3 2021 and report topline results in Q4 2021.

Phase II COVID-19 Study Expands to Europe – Can-Fite is enrolling 40 patients hospitalized with moderate to severe COVID-19 in its Phase II study, under a U.S. Food and Drug Administration (FDA) approved protocol, in Israel and Europe.

Phase IIb NASH Study Expected to Commence Q4 2021 – Based on a successfully concluded Phase IIa NASH/NAFLD study with Namodenoson which met its primary endpoint, Can-Fite completed the design of a Phase IIb study with the help of top NASH Key Opinion Leaders, Dr. Friedman and Dr. Harrison, and the Company plans to commence the Phase IIb study before the end of 2021.

Pivotal Phase III Liver Cancer Study Expected to Commence Q4 2021 – Can-Fite is preparing to commence its pivotal Phase III trial for the treatment of hepatocellular carcinoma (HCC) based on a protocol agreed upon with the U.S. FDA and the European Medicines Agency. Should the study meet its efficacy endpoint and be approved by the FDA and EMA, Namodenoson would become one of only a few drugs available to treat advanced liver cancer patients. Recently announced data from Can-Fite’s Phase II advanced liver cancer study included overall survival of 4 years in two patients. Additional findings show disappearance of ascites, normal liver function and good quality of life. A scientific paper titled, "Namodenoson in Advanced Hepatocellular Carcinoma and Child–Pugh B Cirrhosis: Randomized Placebo-Controlled Clinical Trial" published in the peer reviewed journal Cancers provided more in-depth data from the Phase II study including a significant 12-month overall survival benefit in the CPB7 population, the target population for the pivotal Phase III study.

Cannabis Compounds May Have Role in Treatment of Liver Diseases – Can-Fite’s preclinical studies of cannabis compounds found CBD rich T3/C15 induced inhibition of liver cancer cell growth and also had an inhibitory effect on liver fibrosis. Liver fibrosis is associated with increased liver disease including NAFLD/NASH, cirrhosis, and liver cancer. Can-Fite has filed patent applications to protect its discovery of cannabinoid-based therapies where the A3AR target is overexpressed.

Topical CF602 Shows Preclinical Efficacy in Erectile Dysfunction (ED) – A new preclinical study of Can-Fite’s drug candidate CF602 in the treatment of ED in a diabetes experimental rat model showed that topically applied CF602 resulted in a statistically significant improvement in ED compared to controls. CF602 may be an ideal candidate for development due to topical efficacy, as ED is a common complication of diabetes and is difficult to treat with systemic drugs due to the high risk profile of these patients.

"Our robust advanced stage clinical pipeline, including a pivotal trial in liver cancer expected to commence in the fourth quarter, is supported by our growing number of global distribution agreements and accompanying non-dilutive funding," stated Can-Fite CEO Dr. Pnina Fishman. "Recent efficacy findings in cannabis and ED create additional co-development and funding opportunities for Can-Fite with pharma partners."

Financial Results

Revenues for the three months ended March 31, 2021 were $0.15 million, a decrease of $0.05 million, or 25.2%, compared to $0.20 million for the three months ended March 31, 2020. The decrease in revenues was mainly due to the recognition of a lower portion of advance payments received under distribution agreements from Gebro, Chong Kun Dung Pharmaceuticals, and Cipher Pharmaceuticals which were offset by the recognition of an advance payment portion received under a distribution agreement with Ewopharma.

Research and development expenses for the three months ended March 31, 2021 were $1.30 million, a decrease of $2.47 million, or 65.5%, compared to $3.77 million for the three months ended March 31, 2020. Research and development expenses for the first quarter of 2021 comprised primarily of expenses associated with two studies for Piclidenoson, a Phase II study in COVID-19 and a Phase III study in the treatment of psoriasis. The decrease is primarily due to costs incurred in the first quarter of 2020 associated with Phase II studies for Namodenoson in the treatment of liver cancer and NASH, and a Phase III study of Piclidenoson for the treatment of rheumatoid arthritis partially offset by the two ongoing studies of Piclidenoson in the first quarter of 2021. We expect that the research and development expenses will increase through 2021 and beyond.

General and administrative expenses for the three months ended March 31, 2021 were $1.01 million an increase of $0.31 million, or 44.5%, compared to $0.70 million for the three months ended March 31, 2020. The increase is primarily due to the increase in salaries and related benefits due to the distribution of bonuses to employees. We expect that general and administrative expenses will remain at the same level through 2021.

Financial income, net for the three months ended March 31, 2021 were $0.3 million compared to finance expenses, net of $0.07 million for the three months ended March 31, 2020. The decrease in financial expense, net was mainly due to finance income recorded from revaluation of our short-term investment.

Net loss for the three months ended March 31, 2021 was $1.87 million compared with a net loss of $4.34 million for the three months ended March 31, 2020. The decrease in net loss for the three months ended March 31, 2021 was primarily attributable to a decrease in revenues in 2021, a decrease in research and development expenses which was partly offset by an increase in general and administrative expenses and a decrease in finance expenses, net.

As of March 31, 2021, Can-Fite had cash and cash equivalents and short term deposits of $11.24 million as compared to $8.26 million at December 31, 2020. The increase in cash during the three months ended March 31, 2021 is due to an aggregate of $2.74 million in net proceeds received through warrant exercises during the first quarter of 2021 and from an advance payment of $2.25 million from a distribution agreement with Ewopharma.

On May 27, 2021 Lantheus Holdings, Inc. (the "Company") (NASDAQ: LNTH), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, reported that the U.S. Food and Drug Administration (FDA) has approved PYLARIFY, an F 18-labeled prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent to identify suspected metastasis or recurrence of prostate cancer (Press release, Lantheus Medical Imaging, MAY 27, 2021, View Source [SID1234580710]). PYLARIFY is the first and only commercially available approved PSMA PET imaging agent for prostate cancer. The product will be immediately available in parts of the mid-Atlantic and southern regions and availability is expected to rapidly expand over the next six months with broad availability across the U.S. anticipated by year end.

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"The FDA approval of PYLARIFY is a significant milestone for Lantheus and the prostate cancer community in the United States. We believe PYLARIFY represents a paradigm shift in the identification and management of patients with suspected metastasis or recurrent prostate cancer, providing more accurate and earlier detection of disease than conventional imaging so that doctors, along with patients and their families, can make more informed treatment decisions," said Mary Anne Heino, President and Chief Executive Officer of Lantheus. "I would like to thank the patients who participated in our clinical trials, the study investigators and our employees, whose efforts made this achievement possible."

Identification of suspected metastatic disease in men considering initial definitive therapy is important to optimize treatment planning and to avoid futile interventions. Of men with localized prostate cancer who undergo initial curative intent/management, up to 50% may experience recurrence of their disease within ten years of treatment.1 Recurrent disease is often detected by a rise in serum prostate-specific antigen (PSA) levels; however, conventional imaging, especially at low PSA levels, is not able to identify the location and extent of the disease in the majority of cases.2,3

PYLARIFY was developed to target PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells.4 PYLARIFY binds to the target, enabling the reader of the PET scan to detect and locate the disease. Cyclotron production of F 18 offers high batch capacity and high image resolution, and F 18’s 110-minute half-life allows for wide geographic distribution.5,6

"Conventional imaging has significant limitations in detecting prostate cancer, both in initial staging and when the cancer has recurred or spread after initial primary treatment. Specifically, standard imaging poorly detects the early spread to distant organs, such as the lymph nodes, bones, and other organs," said Michael J. Morris, M.D., Prostate Cancer Section Head, Genitourinary Medical Oncology, Memorial Sloan Kettering Cancer Center and the Lead Study Investigator in the CONDOR trial and Study Investigator in the OSPREY trial. "PYLARIFY can detect the spread of disease well before standard imaging and can be a transformative diagnostic tool that helps clinicians develop treatment plans based on a much more accurate understanding of a patient’s distribution of disease."

"We believe today’s approval is a game-changer for men facing prostate cancer," said Jamie Bearse, Chief Executive Officer of ZERO – The End of Prostate Cancer, a Patient Advocacy Group. "Having a diagnostic tool that allows doctors to see suspected metastatic or recurrent prostate cancer earlier, anywhere in the body, is a significant step forward and will have a tremendous impact on patients’ lives."

The approval of PYLARIFY is based on data from two Company-sponsored pivotal studies (OSPREY and CONDOR) designed to establish the safety and diagnostic performance of PYLARIFY across the prostate cancer disease continuum. Results from OSPREY (Cohort A) demonstrated improvement in specificity and positive predictive value (PPV) of PYLARIFY PET imaging over conventional imaging in men at risk for metastatic prostate cancer prior to initial therapy. CONDOR studied men with biochemical recurrent prostate cancer. In patients with biochemical recurrent prostate cancer and non-informative baseline imaging, PYLARIFY demonstrated high correct localization and detection rates, including in patients with low PSA values (median PSA 0.8 ng/mL).

In the clinical trials, PYLARIFY was well tolerated. In OSPREY and CONDOR, 593 patients with various states of prostate cancer were exposed to a single dose of PYLARIFY. Adverse reactions (headache, dysgeusia and fatigue) were reported in ≤ 2% of patients within the studies. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reaction.

About PYLARIFY

PYLARIFY (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging2, the precision of PSMA targeting and the clarity of an F 18 radioisotope5 for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.1,5,7,8,9

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States — an estimated one in eight men will be diagnosed with prostate cancer in their lifetimes. The American Cancer Society estimates that in 2021, almost 250,000 new cases of prostate cancer will be diagnosed, and more than 30,000 men will die of the disease. Approximately 3.1 million men in the United States currently count themselves as prostate cancer survivors.10

PYLARIFY (piflufolastat F 18) Injection

Indication

PYLARIFY (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Important Safety Information

Contraindications

None.

Warnings and Precautions

Risk of Image Misinterpretation

Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Hypersensitivity Reactions

Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks

Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions

The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug interactions

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For important risk and use information about PYLARIFY Injection, please see Full Prescribing information.

On May 27, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that the Company will present at the Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021 at 11:00am EDT. Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D (Press release, Fusion Pharmaceuticals, MAY 27, 2021, View Source [SID1234583244]).

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors & Media" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 30 days following the presentation.