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Chemomab Therapeutics to Report Third Quarter 2023 Financial Results and Provide a Business Update

On October 30, 2023 Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, reported the company will release its third quarter 2023 financial results and a business update on November 9, 2023 at 8:00 am Eastern Time (Press release, Chemomab, OCT 30, 2023, View Source [SID1234636436]).

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Investors who would like to discuss the financial results or business update post-release are invited to contact the company at [email protected].

Can Fite: Namodenoson Inhibits Pancreatic Carcinoma Published in Leading Scientific Journal; Robust anti-Cancer Effect & Molecular Mechanism of Action

On October 20, 2023 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, reported that Biomolecules, a peer-reviewed scientific journal focused on 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", authored by Can-Fite’s CSO Dr. Pnina Fishman and others (Press release, Can-Fite BioPharma, OCT 30, 2023, View Source [SID1234636435]).

The article includes a summary on the robust inhibition of pancreatic carcinoma growth, both in vitro and in vivo and a definitive description of the molecular mechanism of action. The latter includes de-regulation of three signal transduction pathways known to play a pivotal role in the etiology and pathology of the disease, including the Wnt, NF-kB and the RAS signalling pathway. As a result, death of pancreatic carcinoma cells takes place via apoptosis. This mechanism is highly important since pancreatic carcinoma cells are resistant to the chemotherapy.

The Company is developing an exploratory Phase II study protocol that is designed to allow treatment of patients with pancreatic carcinoma who failed first line therapy. The study objectives will include safety and efficacy of the Namodenoson drug.

Currently, Namodenoson is being evaluated in a pivotal Phase III study that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

"We are very much encouraged by the excellent data in the pre-clinical studies demonstrating the impressive anti-cancer effect of Namodenoson against pancreatic carcinoma," stated Dr. Fishman, Can-Fite’s Chief Scientific Officer and Executive Chairman. "We plan to start treating patients very shortly and hope that Namodenoson, with its positive safety and efficacy profile, will prolong life for pancreatic cancer patients."

About Namodenoson

Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma (HCC), and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). It is currently in a Phase IIb trial for NASH and a pivotal Phase III for HCC. Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

Bristol Myers Squibb Prices $4.5 Billion of Senior Unsecured Notes

On October 30, 2023 Bristol Myers Squibb (NYSE: BMY) reported that it has priced a public offering (the "Offering") of senior unsecured notes in a combined aggregate principal amount of $4.5 billion (collectively, the "Notes") (Press release, Bristol-Myers Squibb, OCT 30, 2023, View Source [SID1234636434]). The Notes will be issued in four tranches: (i) $1,000,000,000 in aggregate principal amount of 5.750% notes due 2031, (ii) $1,000,000,000 in aggregate principal amount of 5.900% notes due 2033, (iii) $1,250,000,000 in aggregate principal amount of 6.250% notes due 2053, and (iv) $1,250,000,000 in aggregate principal amount of 6.400% notes due 2063. Bristol Myers Squibb expects that the closing of the Offering will occur on November 13, 2023, subject to the satisfaction of customary closing conditions.

Bristol Myers Squibb intends to use the net proceeds of the Offering for general corporate purposes, including, but not limited to, the financing of the previously announced proposed acquisition of Mirati Therapeutics, Inc. (the "Acquisition") and the fees and expenses in connection therewith and with the Offering. The Offering is not conditioned upon the consummation of the Acquisition.

Morgan Stanley & Co. LLC, Barclays Capital Inc., Citigroup Global Markets Inc., and J.P. Morgan Securities LLC are acting as joint book-running managers for the Offering.

The Offering of the Notes is being made pursuant to an effective shelf registration statement (including a prospectus and preliminary prospectus supplement) (File No. 333-261623) filed with the U.S. Securities and Exchange Commission (the "SEC"). You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, Bristol Myers Squibb, any underwriter or any dealer participating in the Offering will arrange to send you the prospectus and the preliminary prospectus supplement (or, if available, the prospectus supplement) if you request it by contacting Bristol Myers Squibb Investor Relations or Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, N.Y. 10014, or by email at [email protected], Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, N.Y. 11717, by telephone at 1-888-603-5847, or by email at [email protected], Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, N.Y. 11717, by telephone at 1-800-831-9146, or by email at [email protected], or J.P. Morgan Securities LLC, Attn: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, N.Y. 11717, or by telephone at 1-866-803-9204.

European Medicines Agency Validates Bristol Myers Squibb’s Application for Opdivo (nivolumab) in Combination with Cisplatin-Based Chemotherapy for the First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

On October 30, 2023 Bristol Myers Squibb (NYSE: BMY) reported that the European Medicines Agency (EMA) has validated its type II variation application for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma, based on results from the Phase 3 CheckMate -901 trial (Press release, Bristol-Myers Squibb, OCT 30, 2023, View Source [SID1234636433]). Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure.

"We know that approximately 20% to 25% of patients diagnosed with urothelial carcinoma will experience disease metastasis, and an additional 5% of patients present de novo with metastatic disease. As a result, first-line treatment options that may offer these patients a chance for durable responses and improved survival outcomes are needed," said Dana Walker, M.D., M.S.C.E., vice president, global program lead, genitourinary cancers, Bristol Myers Squibb. "We are pleased that the CheckMate -901 trial has displayed potential for Opdivo in combination with cisplatin-based chemotherapy to help address this unmet need and provide hope for patients and their loved ones. We are eager to continue working with the European Medicines Agency to discuss how we may bring this first-line regimen to appropriate patients across Europe."

In the CheckMate -901 study, the first Phase 3 trial with an immunotherapy-based combination to show statistically significant and clinically meaningful survival benefit over standard-of-care cisplatin-based chemotherapy in the treatment of this patient population, Opdivo in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvements in the primary efficacy endpoints of overall survival (OS) and progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR). The safety profile was tolerable and consistent with the known safety profiles of the individual components of the regimen. No new safety concerns have been identified. The OS and PFS data from CheckMate -901 were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023.

Opdivo and Opdivo-based combinations have shown significant improvements in OS in Phase 3 clinical trials across multiple tumors, including metastatic urothelial carcinoma, advanced renal cell carcinoma, non-small cell lung cancer, malignant pleural mesothelioma, metastatic melanoma and esophageal squamous cell carcinoma.

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -901 clinical trial.

About CheckMate -901
CheckMate -901 is a Phase 3, randomized, open-label trial evaluating Opdivo in combination with Yervoy or Opdivo in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy compared to standard-of-care chemotherapy alone, in patients with untreated unresectable or metastatic urothelial cancer.

In the CheckMate -901 study, evaluating Opdivo with cisplatin-based chemotherapy vs. standard-of-care chemotherapy, a total of 608 patients eligible for cisplatin-based chemotherapy were randomized to receive either Opdivo 360 mg in combination with cisplatin-based chemotherapy every 3 weeks followed by 480 mg/Q4 Opdivo monotherapy until disease progression or death up to a maximum of two years or chemotherapy alone. The primary endpoints of this study are overall survival (OS) and progression-free survival (PFS). The study is ongoing to assess Opdivo plus Yervoy vs. standard-of-care chemotherapy.

The OS and PFS outcomes for patients who are eligible for cisplatin-based chemotherapy are based on the final efficacy analyses of these endpoints.

About Urothelial Carcinoma
Bladder cancer is the 10th most common cancer in the world, with more than 573,000 new cases diagnosed annually. Urothelial carcinoma, which most frequently begins in the cells that line the inside of the bladder, accounts for approximately 90% of bladder cancer cases. In addition to the bladder, urothelial carcinoma can occur in other parts of the urinary tract, including the ureters and renal pelvis. The majority of urothelial carcinomas are diagnosed at an early stage, but approximately 50% of patients who undergo surgery will experience disease progression and recurrence within two-to-three years post-surgery. Approximately 20% to 25% of patients with urothelial carcinoma develop metastatic disease. The poor durability of responses seen with chemotherapy alone in the first-line setting presents a major challenge in the treatment of metastatic disease, and there are limited treatment options in the second-line setting for patients with advanced urothelial carcinoma.

bluebird bio Enters into Advance Agreement to Sell Priority Review Voucher, if Granted, for $103 Million

On October 30, 2023 bluebird bio, Inc. (NASDAQ: BLUE) ("bluebird bio" or the "Company") reported that it has entered into an agreement to sell a Rare Pediatric Disease Priority Review Voucher (PRV), if received, in connection with the potential approval of lovotibeglogene autotemcel (lovo-cel) for sickle cell disease (Press release, bluebird bio, OCT 30, 2023, View Source [SID1234636432]). Under the terms of the agreement, rights to the PRV will transfer to the buyer and the Company will receive $103 million upon closing of the sale, which is contingent upon the U.S. Food and Drug Administration’s (FDA’s) approval of the biologics license application (BLA) for lovo-cel and granting of the PRV.

The Company’s BLA for lovo-cel was previously accepted for priority review by the FDA for patients with sickle cell disease ages 12 and older who have a history of vaso-occlusive events (VOEs) and has a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2023. bluebird may be eligible for a PRV should lovo-cel be approved for patients under the age of 18.

"The potential sale of a priority review voucher would provide an important source of non-dilutive capital for bluebird ahead of the anticipated launch of lovo-cel," said Chris Krawtschuk, chief financial officer, bluebird bio. "As the FDA completes its review of lovo-cel, our team remains confident in the robustness and maturity of our BLA package for individuals 12 and older with sickle cell disease and looks forward to a regulatory decision by the end of this year."

Closing of the transaction remains subject to the approval of lovo-cel and receipt of a PRV from the FDA, as well as customary closing conditions.

About the Rare Pediatric Disease Priority Review Voucher Program

The Rare Pediatric Disease Priority Review Voucher Program is intended to encourage development of new drug and biological products for the prevention and treatment of certain rare pediatric diseases. Under this program, upon approval, the US Food and Drug Administration awards priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. The voucher can be redeemed to receive priority review of a subsequent marketing application for a different product. PRVs may be sold or transferred, and there is no limit on the number of times a PRV can be transferred.