On March 12, 2021 Cardinal Health (NYSE: CAH) reported that it has signed a definitive agreement to sell its Cordis business to Hellman & Friedman (H&F) for approximately $1 billion, which includes buyer’s assumption of certain liabilities and seller’s retention of certain working capital accounts (Press release, Cardinal Health, MAR 12, 2021, View Source [SID1234576623]). The transaction is expected to close in the first half of Cardinal Health’s fiscal year 2022, subject to customary closing conditions and regulatory clearances.

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Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

"Cordis has a long history of innovation in minimally-invasive cardiovascular technology, and we are confident that with H&F as its owner, Cordis will be well-positioned for growth, innovation and success," said Mike Kaufmann, CEO of Cardinal Health. "Cardinal Health and H&F have a shared passion for delivering high-quality medical products to customers and we are excited about the future for the Cordis business under H&F’s ownership."

"Our decision to divest Cordis demonstrates our disciplined approach to evaluating our portfolio and focusing our resources in our strategic growth areas where we are an advantaged owner," Kaufmann continued. "Looking forward, we remain committed to our medical distribution and global medical products businesses."

"Cordis is an excellent fit with our philosophy of investing in great businesses as a market-leading cardiovascular device manufacturer known for high-quality products, strong physician satisfaction and superb patient outcomes," said Hunter Philbrick, Partner at H&F. "We are excited to invest in the talented Cordis, Ajax and Zeus teams to drive industry leadership, therapeutic innovation and improved patient experiences."

"We at Ajax Health and Zeus Health are ecstatic about injecting growth into Cordis’ powerful platform, and will do so through investments in the core business and through an independent R&D engine – the ‘Cordis Accelerator’ – to develop and commercialize a new pipeline of products exclusively for Cordis," said Duke Rohlen, CEO of Ajax Health and Zeus Health, partners to H&F in the transaction, and Executive Chairman-designate of Cordis and CEO of Cordis Accelerator. "We see an unparalleled opportunity to partner with both existing Cordis leadership and H&F to combine a best-in-class innovation engine with a strong and robust commercial chassis. Together, we will establish Cordis as the standard bearer for medical device innovation."

After closing, most assets and liabilities associated with the Cordis business will transfer to H&F. Cardinal Health will retain full authority for lawsuits related to inferior vena cava filters in the United States and Canada, as well as liability associated with these matters. Cardinal Health estimates that, after completion of the transition services agreement, the divestiture of the Cordis business will decrease Medical segment profit by approximately $60 million to $70 million on an annual run-rate basis.

In connection with the entry into this definitive agreement, Cardinal Health will classify the Cordis business as held for sale, which Cardinal Health expects to result in a pre-tax loss of up to $120 million in the third quarter of its fiscal year 2021. Additionally, Cardinal Health was authorized to incur costs associated with the planned divestiture of up to $125 million, primarily in its fiscal years 2021 and 2022.

Advisors
J.P. Morgan Securities LLC is serving as exclusive financial advisor to Cardinal Health and Skadden, Arps, Slate, Meagher & Flom LLP served as the company’s legal advisor. UBS Investment Bank served as the sole financial advisor to Hellman & Friedman, with Kirkland & Ellis LLP providing the firm’s legal counsel and H&F’s committed financing for the transaction provided by Deutsche Bank Securities Inc. and UBS Securities LLC.

On March 12, 2021 Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported the pricing of an underwritten public offering of 28,572,000 shares of its common stock at a public offering price of $1.75 per share (Press release, Marker Therapeutics, MAR 12, 2021, View Source [SID1234576599]). The gross proceeds to Marker from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $50.0 million. In addition, Marker has granted the underwriters a 30-day option to purchase up to an additional 4,285,800 shares of its common stock. All of the shares to be sold in the offering are to be sold by Marker. The offering is expected to close on or about March 16, 2021, subject to customary closing conditions.

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Piper Sandler & Co. is acting as the sole active book-running manager for the offering. Cantor Fitzgerald & Co. is also acting as a book-running manager for the offering. Oppenheimer & Co. Inc. is acting as the lead manager and Roth Capital Partners is acting as the co-manager for the offering.

The offering is being made pursuant to a shelf registration statement, including a base prospectus, filed by Marker that was declared effective by the Securities and Exchange Commission ("SEC") on June 25, 2019. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. An electronic copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement, when available, and the accompanying prospectus relating to the offering may be obtained by contacting Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924 or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets Department, 499 Park Avenue, New York, NY 10022, or email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On March 12, 2021 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that long-term follow up data from MINDACT, the prospective, randomized trial designed to further confirm the clinical utility of MammaPrint risk scoring when determining a breast cancer patient’s need for chemotherapy, was published in The Lancet Oncology, and can be viewed online here (Press release, Agendia, MAR 12, 2021, View Source [SID1234576598]).

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As previously reported at the ASCO (Free ASCO Whitepaper) conference in May 2020, the European Breast Cancer Conference in October 2020, and highlighted in an oral presentation at SABCS in December 2020, the data published in The Lancet Oncology confirm MINDACT as a positive de-escalation study, and show that nearly half of women who would have received chemotherapy may avoid it and achieve the same excellent results.

Additional key findings include:

With 5-year data available for 92 percent of enrolled patients, the study’s primary endpoint continued to be met. Distant metastasis free survival (DMFS) at 5 years in women with breast cancer who were clinically-high risk but genomically-Low Risk and were not treated with chemotherapy was 95.1 percent, demonstrating that MammaPrint Low Risk patients have excellent outcomes without adjuvant chemotherapy.
The difference in 5-year DMFS between patients in this cohort treated with and without chemotherapy is now a non-significant 0.9 percent, a notable decrease from the 1.5 percent previously reported in the New England Journal of Medicine in 2016.
When stratifying clinically high risk/MammaPrint Low Risk patients by age, investigators found that for women over 50, there was no difference in DMFS between women who received adjuvant chemotherapy and those who did not, indicating that these patients could safely avoid chemotherapy and achieve the same outcome.
To the research community, the observations in women 50 years or younger, where there was a 5 percent benefit seen from chemotherapy at 8.7 years, are intriguing and should provoke investigation of the respective merits of chemotherapy or ovarian function suppression through an LHRH analogue in this specific young patient population with a high clinical risk and a Low genomic Risk.
As presented in 2016, the long -term MINDACT results were consistent for lymph node negative as well as 1-3 lymph node positive patients, showing that a MammaPrint Low Risk classification should be considered Low Risk regardless of other clinical factors, and that patients in this population may forgo chemotherapy.
"We are immensely proud of these results being published in The Lancet Oncology – the longer term follow up clearly shows the utility that MammaPrint provides to clinicians and their patients. In particular, it confirms that Low genomic Risk means Low Risk, and that we can safely de-escalate patients, especially those older than 50 years, who were traditionally treated aggressively, including those with lymph node positive disease," said Martine Piccart, MD, PhD, Honorary Professor of Oncology at the Université Libre de Bruxelles, Scientific Director at the Institut Jules Bordet, Member of the Breast Cancer Research Foundation’s Scientific Advisory Board, previous president of the EORTC, former president of ESMO (Free ESMO Whitepaper) and ECCO and the principal investigator of the MINDACT trial. "These findings reinforce that all early breast cancer patients should have access to risk of recurrence testing – it should be considered the standard of care at diagnosis for all women."

The findings at 8.7 years further demonstrate what was found at 5 years: a Low-Risk MammaPrint result identifies a subset of breast cancer patients with up to three positive lymph nodes who can successfully forgo adjuvant chemotherapy, regardless of their clinical risk. An "age effect" has now emerged and must be taken into account. These data reinforce the essential need to examine the biology of a tumor before jointly deciding on a treatment path, as the additional insight can be used to optimize treatment strategy for patients of any age.

"There has been growing interest from across the breast cancer community in understanding the chemotherapy benefit seen for pre-menopausal women," said Laura van’t Veer, PhD, Co-founder and Chief Research Officer at Agendia. "There is great value in exploring this trend and its connection to ovarian suppression, and in ensuring all women – no matter their age – have access to genomic testing, as it will ultimately allow doctors and their patients to consider all possible options based on their confirmatory genomic profile as part of an informed treatment plan."

By using MammaPrint and BluePrint to gain an understanding of the biology of a patient’s tumor, physicians are able to confidently determine the need for chemotherapy, endocrine therapy and the timing for surgery. These long-term follow up data confirm the clinical utility of MammaPrint in the post-operative treatment setting and underscore Agendia’s commitment to improving patient outcomes.

On March 12, 2021 Onco360, the nation’s largest independent Oncology Pharmacy, reported that it has been selected by AVEO Oncology to be a specialty pharmacy partner for FOTIVDA (tivozanib), a new oral treatment for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies (Press release, Onco360, MAR 12, 2021, View Source [SID1234576597]).

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"Onco360 is excited to be selected as a specialty pharmacy provider for FOTIVDA patients," said Benito Fernandez, Chief Commercial Officer, Onco360. "The recent approval of FOTIVDA unlocks a new therapy option for treatment-experienced patients with previously treated advanced RCC who have limited treatment options. As a provider of this key treatment, Onco360 can support the highly specialized needs of RCC patients and their physicians across the US."

Renal cell carcinoma (RCC) is the most common type of kidney cancer1, which is among the 10 most common cancers in both men and women.2 According to the American Cancer Society 2020 statistics, approximately 73,750 new cases of kidney cancer will be diagnosed and about 14,830 people will die from this disease.2 Local therapies are often used to treat RCC in earlier stages; however, RCC patients are typically asymptomatic until disease progression and require systemic and targeted treatments at diagnosis.3 Targeted drugs used to treat advanced kidney cancer or metastatic RCC work by blocking angiogenesis and/or important proteins in cancer cells that help them grow and survive.4 Agents that target the vascular endothelial growth factor (VEGF) pathway have shown significant antitumor activity in RCC but are associated with adverse events and side effects that commonly result in high rates of dose interruptions and reductions.5 A more potent, highly selective inhibitor of VEGF receptors may improve efficacy and tolerability, and thus meet an unmet need for efficacious agents with differentiated safety profiles for RCC patients.6

FOTIVDA is manufactured by AVEO Oncology, an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. The FDA’s approval of FOTIVDA, for the treatment of adult patients with relapsed or refractory advanced RCC following two or more prior systemic therapies, is based on AVEO’s pivotal Phase 3 study, TIVO-3, comparing FOTIVDA to sorafenib in relapsed or refractory advanced RCC following two or more prior systemic therapies. The study met its primary endpoint of progression free survival (PFS), demonstrating a reduction in the risk of progression or death on treatment by 27% and a 44% improvement in median PFS compared to sorafenib (PFS hazard ratio of 0.73, p=0.02). Median PFS was 5.6 months for FOTIVDA compared to 3.9 months for sorafenib. The application is also supported by three additional trials in RCC and includes safety data from over 1,000 clinical trial subjects. For full prescribing information, visit FOTIVDA.com.

On March 12, 2021 AVEO Oncology (Nasdaq: AVEO) reported that it has entered into a clinical trial collaboration and supply agreement with Bristol Myers Squibb to evaluate FOTIVDA (tivozanib) in combination with OPDIVO (nivolumab), Bristol Myers Squibb’s anti-PD-1 therapy, in the pivotal Phase 3 TiNivo-2 trial in patients with advanced relapsed or refractory renal cell carcinoma (RCC) following prior immunotherapy exposure (Press release, AVEO, MAR 12, 2021, View Source [SID1234576596]). FOTIVDA is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) approved for the treatment of adult patients with relapsed or refractory advanced RCC following two or more prior systemic therapies.

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The randomized, open-label, controlled TiNivo-2 Phase 3 trial is expected to enroll approximately 326 patients with advanced RCC who have progressed following prior immunotherapy treatment. The study plans to enroll across clinical sites in the United States, Europe, and Latin America. Patients will be randomized 1:1 to receive either FOTIVDA (1.34 mg/QD for 21 days followed by 7 days off treatment) in combination with OPDIVO (480 mg every 4 weeks) or FOTIVDA alone. The TiNivo-2 study’s primary endpoint will assess progression free survival (PFS), with key secondary endpoints to include overall survival, overall response rate and duration of response, and safety.

"With the recent U.S. FDA approval of FOTIVDA in the relapsed/refractory RCC setting, I look forward to further exploring FOTIVDA’s immunomodulatory effects and differentiated tolerability profile in combination with OPDIVO," said Toni Choueiri, M.D., Director, Lank Center for Genitourinary Oncology; Director, Kidney Cancer Center; Jerome and Nancy Kohlberg Chair and Professor of Medicine, Harvard Medical School, Dana-Farber Cancer Institute. "This combination was first explored in the Phase 1/2 TiNivo study, where it demonstrated favorable tolerability and prolonged PFS using the combination of FOTIVDA and OPDIVO in both treatment naïve and previously treated patients with advanced RCC. The TiNivo-2 Phase 3 study is expected to further our understanding of the activity and tolerability of this combination following prior immunotherapy."

"The advanced RCC treatment landscape has seen significant benefit from the introduction of immunotherapy-VEGF TKI combinations in earlier-line treatment, and we believe that this benefit could extend to the relapsed/refractory setting with an effective, well-tolerated combination," said Michael Bailey, president and chief executive officer of AVEO. "On the heels of the recent U.S. FDA approval of FOTIVDA as monotherapy for the treatment of adult patients with relapsed or refractory advanced RCC following two or more prior systemic therapies, we are keenly interested in exploring its full potential in the combination setting. Working with our clinical collaborators and Bristol Myers Squibb, our goal is to advance this trial as expeditiously as possible."

Bristol Myers Squibb will provide OPDIVO clinical drug supply for the study. AVEO will serve as the study sponsor and will be responsible for costs associated with the trial execution.

OPDIVO is a registered trademark of Bristol Myers Squibb.

About FOTIVDA (tivozanib)

FOTIVDA (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma (UK) Limited for the treatment of adult patients with advanced RCC. FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models1. FOTIVDA was discovered by Kyowa Kirin.

INDICATIONS

FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hypertension and Hypertensive Crisis: Control blood pressure prior to initiating FOTIVDA. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the FOTIVDA dose.

Cardiac Failure: Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA.

Cardiac Ischemia and Arterial Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe arterial thromboembolic events, such as myocardial infarction and stroke.

Venous Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe venous thromboembolic events.

Hemorrhagic Events: Closely monitor patients who are at risk for or who have a history of bleeding.

Proteinuria: Monitor throughout treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with FOTIVDA.

Thyroid Dysfunction: Monitor before initiation and throughout treatment with FOTIVDA.

Risk of Impaired Wound Healing: Withhold FOTIVDA for at least 24 days before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue FOTIVDA if signs or symptoms of RPLS occur.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

Allergic Reactions to Tartrazine: The 0.89 mg capsule of FOTIVDA contains FD&C Yellow No.5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

ADVERSE REACTIONS

The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis, and the most common Grade 3 or 4 laboratory abnormalities (≥5%) were sodium decreased, lipase increased, and phosphate decreased.

DRUG INTERACTIONS

Strong CYP3A4 Inducers: Avoid coadministration of FOTIVDA with strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed.

Females and Males of Reproductive Potential: Can impair fertility.

Hepatic Impairment: Adjust dosage in patients with moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.