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BERGENBIO COMPLETES ENROLMENT INTO LATEST COHORT OF PHASE II BEMCENTINIB COMBINATION STUDY IN REFRACTORY NSCLC

On March 12, 2021 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported that it has completed enrolment into Cohort C1 of its Phase II study (BGBC008) of bemcentinib in combination with anti-PD-1 therapy Keytruda (pembrolizumab) in refractory non-small cell lung cancer (NSCLC) patients (Press release, BerGenBio, MAR 12, 2021, https://www.bergenbio.com/bergenbio-completes-enrolment-into-latest-cohort-of-phase-ii-bemcentinib-combination-study-in-refractory-nsclc/ [SID1234578614]).

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The BGBC008 trial ClinicalTrials.gov Identifier: NCT03184571 is being conducted in three cohorts evaluating the safety and benefit of bemcentinib and pembrolizumab combination in refractory NSCLC patients. Cohort C is assessing second line patients refractory to first line treatment with checkpoint inhibitors in combination with chemotherapy. A total of 13 patients have been enrolled in Cohort C1 and the first efficacy data is expected within 24 weeks. If successful the trial will expand to Cohort C2, assessing a further 29 patients.

The study is being sponsored by BerGenBio in collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, New Jersey, USA, who continue to supply Keytruda (pembrolizumab) for use in the study, under a collaboration agreement signed in March 2017.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are pleased to have completed enrolment into the first stage of the third cohort planned for this study. We are excited by the potential patient benefit of
selective AXL inhibition with bemcentinib, to reverse acquired resistance to immune checkpoint inhibitors in cAXL-positive patients who have relapsed on immunotherapy and chemotherapy. There are currently limited treatment options for patients for whom first line therapies in NSCLC have been ineffective. If successful, this combination treatment could provide an important alternative to second line chemotherapy standard-of-care. I look forward to providing an update on the data from this cohort in due course."

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases.

In COVID-19, AXL has two synergistic mechanisms of action, it acts a co-receptor to ACE2, to which the spike protein of the Sars-Cov-2 virus attaches and enters the host cell, and AXL expression is upregulated that leads to suppression of the Type 1 Interferon immune response by host cells and in their environment. Research data confirms bemcentinib inhibits SARS-CoV-2 host cell entry and promotes the anti-viral Type I interferon response.

In cancer, increase in AXL expression has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers. AXL suppresses the body’s immune response to tumours and drives treatment failure across many cancers. High AXL expression defines a very poor prognosis subgroup in most cancers. AXL inhibitors, such as bemcentinib, therefore, have potential high value as monotherapy and as the cornerstone of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases including fibrosis.

About Bemcentinib

Bemcentinib (formerly known as BGB324), is a potential first-in-class, potent and highly selective AXL inhibitor, currently in a broad phase II clinical development programme. It is administered as an oral capsule and taken once per day. Ongoing clinical trials are investigating bemcentinib in COVID-19, and multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity.

Precision BioSciences to Report Fourth Quarter and Fiscal Year 2020 Financial Results on March 18, 2021

On March 12, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company, reported it will publish fourth quarter and fiscal year 2020 financial results and provide a business update on Thursday, March 18, 2021 (Press release, Precision Biosciences, MAR 12, 2021, View Source [SID1234576692]).

Cardinal Health signs definitive agreement to sell its Cordis business to Hellman & Friedman

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.

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.

Marker Therapeutics, Inc. Announces Pricing of Public Offering of Common Stock

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.

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.

Landmark Long-Term Data from EORTC’s MINDACT Study Published in The Lancet Oncology

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]).

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.