On November 30, 2023 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, reported financial results for the nine months ended September 30, 2023 (Press release, Can-Fite BioPharma, NOV 30, 2023, View Source [SID1234638063]).

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Clinical & Development Milestones Achieved

Namodenoson Drug Candidate:

Complete Response and 6.9 Year Survival Reported in Patient with Advanced Liver Cancer Treated with Namodenoson

A patient who had participated in Can-Fite’s prior Phase II liver cancer study who continues to receive treatment with Namodenoson under a compassionate use program now has overall survival of 6.9 years with the disappearance of ascites, normal liver function, and good quality of life, defined as a complete response. Enrollment is ongoing in Can-Fite’s pivotal Phase III study of Namodenoson in the treatment of advanced liver cancer. During the third quarter, the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) selected Can-Fite for the prestigious Breakthrough Abstract Award from Conquer Cancer for its abstract titled "A novel approach for the treatment of advanced hepatocellular carcinoma (HCC)".

Pancreatic Carcinoma Phase IIa Study with Namodenoson is Underway

Namodenoson inhibited the growth of pancreatic carcinoma in a pre-clinical study through a mechanism that entails the Ras pathway. The Company continues to receive awards and recognition from leading cancer associations, and articles summarizing Namodenoson’s robust anti-cancer effect in pancreatic carcinoma have been published. The American Association of Cancer Research (AACR) (Free AACR Whitepaper) accepted Can-Fite’s study titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via De-regulation of the Wnt/β-catenin Signaling Pathway" for a poster presentation at the AACR (Free AACR Whitepaper) Special Conference on Pancreatic Cancer. Biomolecules, a peer-reviewed scientific journal focused on the function and mechanism of bioactive molecules, published an article titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via Deregulation of the Wnt/β-catenin, NF-κB, and RAS Signaling Pathways".

Piclidenoson Drug Candidate:

Entered Rare Genetic Disease Market with Treatment for Lowe Syndrome

In preclinical studies, Piclidenoson has been found to be effective in Lowe Syndrome, a rare genetic disease with no treatment available, and an estimated $100 million treatment market in the U.S. alone. Lowe Syndrome usually develops in the first year of life, causing brain abnormalities associated with intellectual disabilities and a life span shortened to less than 40 years. The discovery of Piclidenoson’s efficacy in Lowe Syndrome was made by researchers at the University of Naples Federico II and The Telethon Institute of Genetics and Medicine in Italy after testing thousands of compounds in search of a treatment. Can-Fite and Fondazione Telethon signed an agreement outlining their collaboration for the development of Piclidenoson for the treatment of Lowe Syndrome. As a rare genetic disease in dire need of a treatment, Lowe Syndrome may qualify for an accelerated approval path, and Can-Fite plans to move into an advanced stage clinical study in this indication.

Harnessing Artificial Intelligence (AI) to Identify and Accelerate New Oncology Programs:

Through an agreement with Collaborations Pharmaceuticals, Can-Fite is utilizing AI and machine learning (ML) to develop and bring to market next-generation A3 adenosine receptor (A3AR) oncology drugs at a significantly reduced development time and cost. New molecules will be designed with high affinity and selectivity to A3AR, the target of Can-Fite’s platform technology.

"In addition to the several major value-driving milestones achieved during the third quarter, we continue to enroll and treat patients in our pivotal Phase III liver cancer study and Phase IIb study for NASH. Our pivotal Phase III study in psoriasis is expected to commence soon while we also prepare for a Phase IIa study in pancreatic cancer," stated Motti Farbstein, Can-Fite’s CEO and CFO. "We believe our advanced stage pipeline with multiple indications positions Can-Fite well for partnerships and for achieving regulatory and market success based on our robust portfolio."

Financial Results

Revenues for the nine months ended September 30, 2023 were $0.59 million compared to revenues of $0.61 million for the same period in 2022. Revenues for the nine months ended September 30, 2023 and September 30, 2022 comprised of recognition of a portion of advance payments received under distribution agreements with Gebro, CKD, Cipher and Ewopharma.

Research and development expenses for the nine months ended September 30, 2023 were $4.71 million compared with $5.30 million for the same period in 2022. Research and development expenses for the nine months ended September 30, 2023 comprised primarily of expenses associated with the completion of the Phase III study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase III study in the treatment of advanced liver cancer and a Phase IIb study for NASH.

General and administrative expenses were $2.23 million for the nine months ended September 30, 2023 compared to $2.31 million for the same period in 2022. The decrease is primarily due to the decrease in directors and officer’s insurance policy premium. We expect that general and administrative expenses will remain at the same level through 2023.

Financial income, net for the nine months ended September 30, 2023 was $0.38 million compared to financial expense, net of $0.14 million for the same period in 2022. The decrease in financial expense, net was mainly due to revaluation of our short-term investment and increase in interest income from deposits in 2023.

Net loss for the nine months ended September 30, 2023 was $5.98 million compared with a net loss of $7.15 million for the same period in 2022. The decrease in net loss for the nine months ended September 30, 2023 was primarily attributable to the decrease in research and development expenses and in general and administrative expenses.

As of September 30, 2023, Can-Fite had cash and cash equivalents and short term deposits of $7.94 million as compared to $7.98 million at December 31, 2022. The decrease in cash during the nine months ended nine 30, 2023 is due to the ongoing operations of the Company which was offset by the Company’s fundraise during January 2023. During November 2023, Can-Fite raised approximately $3 million from the exercise of certain warrants.

The Company’s consolidated financial results for the nine months ended September 30, 2023 are presented in accordance with US GAAP Reporting Standards.

On November 30, 2023 Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that the company will host its first Research and Development (R&D) Day on Thursday, December 14 (Press release, Bicycle Therapeutics, NOV 30, 2023, View Source [SID1234638062]). The event will take place in New York City from 8 a.m. to 12 p.m. Eastern Time and will be simultaneously webcast.

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Bicycle Therapeutics executives will provide investors and analysts with an overview of the company’s R&D strategy and pipeline opportunities, with an emphasis on clinical updates for BT8009, BT5528 and BT7480. The company will also highlight the broad capabilities of its novel Bicycle platform technology.

Analysts and investors who are interested in attending in person should contact [email protected]. A live webcast of the R&D Day will be accessible from the Investor section of the company’s website, www.bicycletherapeutics.com. A replay of the webcast will be archived and available following the event.

On November 30, 2023 AbbVie Inc. (NYSE: ABBV) and ImmunoGen, Inc. (NASDAQ: IMGN) reported a definitive agreement under which AbbVie will acquire ImmunoGen, and its flagship cancer therapy ELAHERE (mirvetuximab soravtansine-gynx), a first-in-class antibody-drug conjugate (ADC) approved for platinum-resistant ovarian cancer (PROC) (Press release, AbbVie, NOV 30, 2023, View Source [SID1234638061]). The acquisition accelerates AbbVie’s commercial and clinical presence in the solid tumor space. Additionally, ImmunoGen’s follow-on pipeline of promising next-generation ADCs further complements AbbVie’s ADC platform and existing programs.

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Under the terms of the transaction, AbbVie will acquire all outstanding shares of ImmunoGen for $31.26 per share in cash. The transaction values ImmunoGen at a total equity value of approximately $10.1 billion. The boards of directors of both companies have approved the transaction. This transaction is expected to close in the middle of 2024, subject to ImmunoGen shareholder approval, regulatory approvals, and other customary closing conditions.

"The acquisition of ImmunoGen demonstrates our commitment to deliver on our long-term growth strategy and enables AbbVie to further diversify our oncology pipeline across solid tumors and hematologic malignancies," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Together, AbbVie and ImmunoGen have the potential to transform the standard of care for people living with cancer."

ImmunoGen’s oncology portfolio has the potential to help drive long-term revenue growth for AbbVie’s oncology franchise. Ovarian cancer is the leading cause of death from gynecological cancers in the U.S. ELAHERE is the first targeted medicine to show meaningful survival benefit in PROC. As a fast-growing solid tumor therapy, ELAHERE provides AbbVie with a potential multi-billion-dollar on-market medicine with expansion opportunities in earlier lines of therapy and larger segments of the ovarian cancer market.

"With global commercial infrastructure and deep clinical and regulatory expertise, AbbVie is the right company to accelerate geographic and label expansion, and realize the full potential of ELAHERE as the first and only ADC approved in ovarian cancer," said Mark Enyedy, president and chief executive officer, ImmunoGen. "The addition of ImmunoGen’s pipeline, platform, and expertise to AbbVie’s oncology portfolio is an exciting opportunity for the combined companies to advance innovation in ADCs. This transaction is the culmination of our 40-year commitment to develop and deliver the next-generation of ADCs and more good days for people living with cancer."

ELAHERE is a first-in-class ADC targeting folate receptor alpha (FRα) with a maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. ELAHERE received U.S. Food and Drug Administration (FDA) accelerated approval in 2022 for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. The positive Phase 3 results from the MIRASOL confirmatory trial will support a Marketing Authorization Application (MAA) to the European Union and a supplemental Biologic License Application (sBLA) submission to the U.S. FDA in order to gain full approval. Ongoing clinical development programs are underway to expand into earlier lines of therapy and enter other large patient segments of the ovarian market over the next 5-10 years.

ImmunoGen’s follow-on pipeline of promising next-generation ADCs expands AbbVie’s growing oncology pipeline of potentially transformative programs across multiple different solid tumors and hematologic malignancies. ImmunoGen’s Phase 1 asset, IMGN-151, is a next-generation anti-FRα ADC for ovarian cancer with the potential for expansion into other solid tumor indications. Pivekimab sunirine, currently in Phase 2, is an anti-CD123 ADC targeting blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare blood cancer, which was granted FDA breakthrough therapy designation for the treatment of relapsed/refractory BPDCN.

Transaction Terms

AbbVie will acquire all outstanding ImmunoGen common stock for $31.26 per share in cash. The proposed transaction is subject to customary closing conditions, including receipt of regulatory approvals and approval by ImmunoGen stockholders. The proposed transaction is expected to be accretive to diluted earnings per share (EPS) beginning in 2027.

Conference Call Details

AbbVie will host an investor conference call today at 8:00 a.m. CT to discuss this transaction. The call will be webcast through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 9:00 a.m. CT. Presentation materials for the investor conference call are available here.

Advisors

AbbVie’s lead financial advisor is J.P. Morgan Securities LLC, which has delivered a fairness opinion for the transaction and Wachtell, Lipton, Rosen & Katz is serving as legal advisor. Morgan Stanley & Co. LLC is also serving as a financial advisor to AbbVie.

ImmunoGen’s financial advisors are Goldman Sachs & Co. LLC and Lazard, and Ropes & Gray LLP is serving as legal advisor.

AbbVie Inc. +1 (847) 938-9190
1 North Waukegan Road abbvie.com
North Chicago, IL 60064

On November 30, 2023 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported that it has commenced its registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial in prostate cancer, CLARIFY (NCT06056830)1, with the initiation of the first clinical site at the Urology Cancer Center / XCancer Omaha, NE (Press release, Clarity Pharmaceuticals, NOV 30, 2023, View Source [SID1234638051]).

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The aim of the CLARIFY study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA to detect regional nodal metastasis in participants with high-risk prostate cancer prior to radical prostatectomy. The study expects to recruit 383 participants at multiple clinical sites across the United States and Australia.

Evaluation will take place over 2 imaging timepoints, day 1 (day of administration) and day 2 (approximately 24 hours post administration). CLARIFY is expected to image the first participant in late 2023. As a registrational trial, the final study results are intended to provide sufficient evidence to support an application to the US FDA for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in prostate cancer.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to commence our first registrational Phase III trial with our optimised SAR-bisPSMA agent. The CLARIFY trial is based on compelling preclinical and clinical data, including our completed PROPELLER trial (NCT04839367)2,3. It demonstrated the excellent safety profile and superior performance of 64Cu-SAR-bisPSMA compared to 68Ga-PSMA-11 also in patients with prostate cancer prior to radical prostatectomy, guiding the study design for the CLARIFY trial. Despite the improvement of management and staging of patients with prostate cancer introduced by PSMA PET compared to other conventional imaging, low cancerous lesion uptake by PSMA agents may have an impact on clinical management. The PROPELLER trial showed significantly higher uptake of 64Cu-SAR-bisPSMA in PSMA-expressing lesions compared to an approved standard-of-care PSMA imaging agent, potentially enabling the diagnosis of additional and smaller lesions2,3. CLARIFY will also investigate the benefits of delayed imaging in this patient group, a feature that has shown real benefits to patients so far and is not available with the first-generation PSMA imaging agents using gallium-68 or fluorine-18, which have very short half-lives and exhibit low sensitivity in detecting cancerous lesions. Additionally, the extended shelf-life of up to 48 hours offered by 64Cu-SAR-bisPSMA not only provides greater flexibility for clinics in scheduling diagnostic scans, but also improves patient access to care, including areas with limited access to diagnostic radiopharmaceuticals in prostate cancer due to the short shelf-life of existing PSMA PET tracers.

"The prostate cancer market is a key focus area for Clarity as there is a high unmet need for diagnostics and therapy, and we believe our theranostic SAR-bisPSMA product has the potential to improve diagnosis, therapy and ultimately change patients’ lives. We look forward to progressing this trial to validate and expand upon the positive data we have accumulated so far with our SAR-bisPSMA product. With this trial, our aspiration is that with improved diagnostic tools, clinicians will be empowered to make more informed decisions regarding the best course of treatment for their patients."

On November 29, 2023 Phenomic AI ("Phenomic") reported that they have entered into a strategic collaboration and licensing agreement with Boehringer Ingelheim to discover targets important in stroma-rich cancers (Press release, Phenomic AI, NOV 29, 2023, View Source [SID1234638058]). The partners will leverage Phenomic’s expertise in target identification and stromal biology based on its scTx single-cell transcriptomics platform which will greatly enhance Boehringer’s efforts to develop first-in-class medicines to transform the lives of people with cancer by delivering meaningful advances with the ultimate goal to cure a range of cancers.

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Stroma-rich cancers, such as colorectal and pancreatic cancers, are amongst the hardest to treat in part because of the tumor stroma: a complex tissue that protects cancerous cells from therapies and supports cancer growth and metastasis. Phenomic’s platform aims to address this challenge by identifying targets to potentially overcome the barrier the tumor stroma creates to meaningfully extend patient lives.

"At Boehringer Ingelheim, we are committed to transforming patients’ lives. Through our new partnership with Phenomic, we aim to accelerate and expand our pipeline of first-in-class therapies for patients affected by stroma-rich cancers, which account for the vast majority of cancer deaths every year," said Theresa Goletz, VP Cancer Immunology and Immune Modulation, Boehringer Ingelheim. "This collaboration demonstrates our commitment to innovation by incorporating advanced AI and machine learning tools into drug discovery to address high unmet patient needs."

"Phenomic is committed to breaking through the barriers in drug discovery for cancer and developing novel therapies targeting tumor stroma. We are excited to be working with Boehringer Ingelheim, a global leader with expertise in delivering breakthrough medicines for cancer patients," stated Girish Aakalu, Ph.D., CEO of Phenomic. "Through this collaboration, we believe that we can improve outcomes for patients with difficult-to-treat solid tumors by applying our next-generation drug discovery and development tools."

Phenomic’s scTx platform uniquely integrates one of the world’s largest single-cell RNA datasets from human tissues with comprehensive analysis and validation tools. Advanced AI and machine learning algorithms enable the analysis of this highly diversified database including imaging, RNA sequencing, and spatial transcriptomics data to understand the biology of single cells sitting in complex multi-cell systems. Unique stromal models and experimental capabilities enable Phenomic to then assess the results and identify novel targets for therapeutics through an iterative process involving digital screening and experimental validation.

Under the agreement, Boehringer Ingelheim has the option to license targets discovered and functionally validated by Phenomic as a basis for novel cancer therapeutics. Boehringer Ingelheim will also be responsible for all non-clinical and clinical development, as well as commercialization of associated cancer therapies. Phenomic will receive upfront and near-term payments of approximately $9 million including research funding and collaboration milestones. Phenomic is also eligible to receive more than USD $500 million in licensing fees as well as clinical, regulatory and commercial milestones in addition to royalties on future product sales.