On February 2, 2021 EORTC reported 1945 OligoRARE trial in stereotactic body radiotherapy in addition to standard of care treatment in patients with oligometastatic rare cancers, receives significant financial contribution by the Anticancer Fund and the Rising Tide Foundation for Clinical Cancer Research (Press release, EORTC, FEB 2, 2021, View Source [SID1234574503]).

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Metastatic cancer can range from a single metastasis to widely disseminated metastases, making it the leading cause of cancer death. Today, the concept of oligometastases is generally considered an intermediate state between locoregional cancer and widespread metastases with a limited number of lesions and organs involved. By nature of its limited spread, it has been shown through mostly retrospective studies that aggressive metastasis-directed therapy (surgery or radiation) added to standard of care systemic therapy achieved long-term survival or even cure in about one quarter of the patients. Two thirds of these patients had lung, prostate, breast or colorectal cancer.

In a joint grant call, the Anticancer Fund and the Rising Tide Foundation for Clinical Cancer Research have selected to award the EORTC 1945 OligoRARE clinical trial, which aims at improving overall survival in patients with oligometastatic rare cancers, including all solid cancer types except lung, breast, colon, prostate cancer.

The total cost of the EORTC OligoRARE study amounts to approximately €1.9M, of which the Anticancer Fund and Rising Tide Foundation will jointly contribute €800,000 while the remaining €1.1M has been secured by the EORTC.

"We are very happy to count both the Anticancer Fund and Rising Tide Foundation as partners in tackling unmet patient-centred needs in cancer clinical research. Their funding will contribute to an important international randomised clinical trial, evaluating oligometastatic treatment in underrepresented cancer types", commented Dr Denis Lacombe, EORTC’s Director General.

"The Anticancer Fund believes in the power of partnerships to develop cancer treatments that are outside the scope of the pharma industry. Cancer care is multidisciplinary but clinical research in radiotherapy, and in surgery, is badly underserved, while contributing substantially to patients’ benefit", explained Lydie Meheus, Managing Director of the Anticancer Fund. ‘We are also delighted we can join hands with EORTC and Rising Tide Foundation to make this trial happen. This is the second time we support an EORTC led trial and we believe this partnership is meant to last. Because together, we can do so much more.’

The CEO of Rising Tide GmbH, Wendelin Zellmayer stated, "Oligometastatic rare cancers are an under-served area in research. In collaboration with the Anticancer Fund, the Rising Tide Foundation for Clinical Cancer Research has granted the European Organization for Research and Treatment of Cancer ("EORTC") a joint award to conduct a clinical trial in 6 countries with Matthias Guckenberger from University Hospital Zurich as the Study Coordinator, to change the standard of treatment and improve patient outcome."

The study

OligoRARE builds on the experience and network of the partnership between the EORTC and ESTRO (European Society for Therapeutic Radiology and Oncology). EORTC’s OligoRARE, a European based study (six countries) with a transatlantic collaboration with British Columbia Cancer Agency in Canada, will be the first to be done using an identical stereotactic body radiotherapy (SBRT) approach in cancers where the oligometastatic state is uncommon, thus where data is severely lacking. The study will target patients with oligometastatic cancer, including all solid cancer types except lung, breast, colon and prostate cancer.

The primary objective of this clinical trial is to assess if the addition of SBRT improves overall survival (OS) compared to standard of care treatment alone, in patients with ‘oligometastatic rare’ cancers. Patients with a maximum of 5 oligometastatic lesions will be treated as per standard of care with or without the addition of targeted radiation therapy to sites of known disease. Standard of care in both arms may include chemotherapy, targeted therapy, hormonal therapy, immunotherapy or observation. Patients will be followed every 3 months for the first 2 years then every 6 months for the next 3 years.

A total of 200 patients will be recruited over a period of 5.5 years. Additional follow-up of 28 months is expected to provide the targeted number of events for analysis. The study is coordinated by Dr Matthias Guckenberger (Zurich, Switzerland) and Dr Piet Ost (Gent, Belgium).

On the study’s importance, Dr Mattias Guckenberger commented: "Today, we have a strong rational that adding local treatment, mostly radiotherapy or surgery, to systemic therapy improves survival of oligometastatic patients, meaning patients with only limited metastatic disease. Evidence is mostly based on the common cancer sites: lung cancer, colorectal cancer and prostate cancer. There is consequently a strong need to test this hypothesis of a curative approach in oligometastatic disease also in patients with less common cancer sites. Such a trial in rare oligometastatic cancer patients does require a large and strong network to enroll sufficiently large numbers of patients, which is the rational for the OligoCare trial in the European EORTC network."

On February 2, 2021 McKesson Corporation (NYSE:MCK) reported results for the third quarter ended December 31, 2020 (Press release, McKesson, FEB 2, 2021, View Source [SID1234574502]).

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"McKesson continued to demonstrate its operational excellence and extensive healthcare supply chain expertise, as we began the distribution of COVID-19 vaccine doses to the entire U.S. in the third quarter," said Brian Tyler, chief executive officer. "McKesson’s long history of serving as the centralized distributor for the Vaccines for Children program for the Centers for Disease Control and Prevention, including during the H1N1 public health crisis, positions us well to distribute hundreds of millions of COVID-19 vaccines safely and efficiently to the right location, in the right quantity, and in the right condition. Our COVID-19 vaccine distribution has been highly successful, achieving all volume and timing requirements by the government, and I want to thank our 80,000 employees around the world for their tremendous efforts and dedication."

"While the overall environment remains challenging due to the sustained impact of the COVID-19 pandemic, we are pleased to report third-quarter adjusted earnings results ahead of our expectations. McKesson’s performance reflects strong execution and the benefits from our ongoing strategic investments in the growth areas of oncology and biopharma services. Based on our year-to-date progress and the successful execution of distributing COVID-19 vaccines and ancillary supplies in the U.S., we are raising and narrowing our guidance range for fiscal 2021 and now expect Adjusted Earnings per diluted share of $16.95 to $17.25."

Third-quarter revenues were $62.6 billion, up 6% from a year ago, driven by growth in the U.S. Pharmaceutical segment, largely due to market growth and higher specialty volumes, partially offset by branded to generic conversions.

Third-quarter Loss per diluted share of ($39.03) included a pre-tax $8.1 billion expense accrual related to opioid litigation and a pre-tax long-lived asset impairment charge of $115 million primarily related to McKesson’s retail pharmacy businesses in the International segment. Third-quarter Adjusted Earnings per diluted share does not include these charges.

Third-quarter Adjusted Earnings per diluted share was $4.60 compared to $3.81 a year ago, an increase of 21%, driven by a lower share count and growth in the Medical-Surgical Solutions segment, partially offset by a higher tax rate and the lapping of the prior year contribution from the company’s now separated investment in Change Healthcare LLC ("Change Healthcare"). Third-quarter Adjusted Earnings per diluted share also included pre-tax net gains of approximately $30 million, or $0.14 per diluted share, associated with McKesson Ventures’ equity investments.

For the first nine months of the fiscal year, McKesson returned $709 million of cash to shareholders via $500 million of common stock repurchases and $209 million of dividend payments. During the first nine months of the fiscal year, McKesson generated cash from operations of $1.2 billion, and invested $427 million internally, resulting in Free Cash Flow of $745 million.

Opioid-related charges

In the third quarter of fiscal 2021, McKesson recorded a GAAP-only pre-tax charge of $8.1 billion, $6.7 billion post-tax, related to the estimated liability for opioid-related claims of governmental entities. The Company is in ongoing, advanced discussions with state attorneys general and plaintiffs’ attorneys regarding a settlement framework under which the Company would pay its portion of a broad settlement over a period of 18 years. A loss in this amount has now been deemed probable and reasonably estimable.
U.S. Pharmaceutical Segment

Third-quarter revenues were $49.5 billion, up 7%, driven by market growth and higher specialty volumes, partially offset by branded to generic conversions.
Third-quarter Segment Operating Profit was $635 million and operating margin was 1.28%. Adjusted Segment Operating Profit was $656 million, up 2% from a year ago, driven by growth in specialty, partially offset by higher operating expenses in support of the company’s strategic growth initiatives. Adjusted operating margin was 1.33%, down 5 basis points.
International Segment

Third-quarter revenues were $9.3 billion, down 6% on a reported basis and down 10% on an FX-Adjusted basis, driven by the contribution of McKesson’s German wholesale business to a joint venture with Walgreens Boots Alliance.
Third-quarter Segment Operating Loss was ($71) million and operating margin was (0.77%), driven by a GAAP-only pre-tax long-lived asset impairment charge of $115 million primarily related to McKesson’s retail pharmacy businesses in Canada and Europe. Adjusted Segment Operating Profit was $158 million, up 9%. On an FX-Adjusted basis, Adjusted Segment Operating Profit was $150 million, up 3%. Adjusted operating margin was 1.70%, up 23 basis points. On an FX-Adjusted basis, adjusted operating margin was 1.69%, up 22 basis points.
Medical-Surgical Solutions Segment

Third-quarter revenues were $3.1 billion, up 43%, primarily driven by demand for COVID-19 tests in the Primary Care and Extended Care businesses.
Third-quarter Segment Operating Profit was $260 million and operating margin was 8.51%. Adjusted Segment Operating Profit was $279 million, up 52%, driven by demand for COVID-19 tests and the contribution from kitting and distribution of ancillary supplies for COVID-19 vaccines, partially offset by inventory charges. Adjusted operating margin was 9.14%, up 55 basis points.
Prescription Technology Solutions Segment

Third-quarter revenues were $777 million, up 9%, driven by new brand support programs and higher volumes of existing brand support programs.
Third-quarter Segment Operating Profit was $114 million and operating margin was 14.67%. Adjusted Segment Operating Profit was $131 million, up 27%, reflecting organic growth in the segment. Adjusted operating margin was 16.86%, up from 14.43% in the prior year.
Company Updates

McKesson launched Ontada, an oncology technology and insights business within the U.S. Pharmaceutical Segment, designed to support innovation, acceleration and evidence generation to drive better outcomes for cancer patients.
McKesson’s Board of Directors authorized an additional $2.0 billion share repurchase program, demonstrating confidence in McKesson’s diversified capital allocation strategy.
Recent Sustainability and ESG Highlights

Dr. Kelvin A. Baggett joined McKesson in the newly created role of chief impact officer effective November 30, 2020.
McKesson issued its FY20 Corporate Responsibility report highlighting its strategy and action towards better health for people and the planet and has joined the United Nations Global Compact initiative, a voluntary leadership platform for the development, implementation and disclosure of responsible business practices.
For the eighth consecutive year, McKesson was recognized as one of the "Best Places to Work for LGBTQ Equality" by the Human Rights Campaign (HRC) Foundation, achieving 100 percent on the HRC’s 2021 Corporate Equality Index.
Fiscal 2021 Outlook

McKesson raised and narrowed fiscal 2021 Adjusted Earnings per diluted share guidance to $16.95 to $17.25 from the previous range of $16.00 to $16.50 to primarily reflect improved growth in the business and the contribution from McKesson’s successful distribution of COVID-19 vaccines and ancillary supplies. Fiscal 2021 Adjusted Earnings per diluted share guidance assumes $0.25 to $0.35 related to COVID-19 vaccine distribution and $0.20 to $0.30 related to the kitting and distribution of ancillary supplies for COVID-19 vaccines.

Fiscal 2021 guidance continues to assume that a full recovery of pharmaceutical prescription volumes and patient visits will not occur this fiscal year.

Other remaining businesses

As a result of the segment realignment effective in the second quarter of fiscal 2021, Other reflects equity earnings and charges for retrospective periods for the company’s previous investment in Change Healthcare, which was separated from the company during the fourth quarter of fiscal 2020.

Conference Call Details

The company has scheduled a conference call for today, Tuesday, February 2nd at 8:00 AM ET to discuss the company’s financial results. A live audio webcast of the conference call will be available on McKesson’s Investor Relations website at View Source An archive of the conference call will also be available on the company’s Investor Relations website at View Source

Upcoming Investor Events

McKesson management will be participating in the following investor conferences:

Cowen 41st Annual Health Care Conference, March 1, 2021
Webcasts will be available live and archived on the company’s Investor Relations website at View Source A complete listing of upcoming events for the investment community, including details and updates, will be available on the company’s Investor Relations website

Non-GAAP Financial Measures

GAAP refers to the U.S. generally accepted accounting principles. This press release includes GAAP financial measures as well as Non-GAAP financial measures, including Adjusted Gross Profit, Adjusted Operating Expenses, Adjusted Other Income, Adjusted Equity Income from Change Healthcare, Adjusted Income Tax Expense, Adjusted Earnings, Adjusted Earnings per Diluted Share, Adjusted Segment Operating Profit, Adjusted Segment Operating Profit Margin, Adjusted Corporate Expenses, Adjusted Operating Profit, FX-Adjusted results and Free Cash Flow which are financial measures not calculated in accordance with GAAP. Refer to the "Supplemental Non-GAAP Financial Information" section of the accompanying financial statement tables for the definitions and usefulness of the Company’s Non-GAAP financial measures and the attached schedules for reconciliations of the differences between the Non-GAAP financial measures and their most directly comparable GAAP financial measures.

The Company does not provide forward-looking guidance on a GAAP basis as McKesson is unable to provide a quantitative reconciliation of this forward-looking Non-GAAP measure to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because McKesson cannot reliably forecast LIFO inventory-related adjustments, gains from antitrust legal settlements, restructuring, impairment and related charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially.

On February 2, 2021 Ribon Therapeutics, a clinical stage oncology company developing therapeutics targeting stress support pathways, reported it has entered into an exclusive license agreement with Ono Pharmaceutical Co., Ltd., for the development and commercialization of RBN-2397 in Japan, South Korea, Taiwan and ASEAN countries (the "Ono Territory") (Press release, Ribon Therapeutics, FEB 2, 2021, View Source [SID1234574501]). RBN-2397, Ribon’s novel, first-in-class PARP7 inhibitor, is currently in Phase 1 clinical development for the treatment of cancer.

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"This agreement enables us to strategically expand our program in support of Ribon’s mission to bring therapeutics targeting stress support pathways for the treatment of cancer to as many appropriate patients as possible," said Victoria Richon, Ph.D., President and Chief Executive Officer, Ribon Therapeutics. "We believe that RBN-2397 could serve as a meaningful intervention for the treatment of tumors with PARP7 expression, which has been shown to play a key role in cancer survival. We look forward to working with Ono, a global leader in immuno-oncology, to unlock the potential of RBN-2397 for patients in Japan, South Korea, Taiwan and ASEAN countries."

"We are pleased to be collaborating with Ribon, a pioneer in the development of novel precision oncology drugs targeting stress support pathways", said Gyo Sagara, President, Representative Director of Ono. "We believe that RBN-2397 could have a profound impact on patients with cancer, given the potential of the therapy’s dual mechanism to suppress tumor growth and enhance immune reaction to tumor cells. We look forward to developing RBN-2397 with Ribon by harnessing our experience and expertise in oncology."

Under the terms of the agreement, Ribon will receive a one-time upfront payment of approximately $16.3 million from Ono. In addition, Ribon is eligible to receive up to a potential of approximately $132 million at current exchange rates based on the achievement of certain regulatory and commercial milestones, as well as tiered royalties ranging from the high single digits to low teens on net sales of RBN-2397 in the Ono Territory. In exchange, Ono will have the exclusive rights to develop and commercialize RBN-2397 in the Ono Territory. Additionally, Ono will have the right to participate in global clinical studies of RBN-2397 by bearing the costs of such studies in the Ono Territory.

Ribon retains all rights to develop and commercialize RBN-2397 worldwide outside of the Ono Territory, including the United States, the European Union and China.

About RBN-2397

RBN-2397, is an orally available small molecule inhibitor of PARP7 that we are developing for the treatment of solid tumors. PARP7 is upregulated in response to cellular stress, including genomic instability in cancers, and acts as a brake on the cellular stress response by negatively regulating the Type I interferon response. By inhibiting PARP7 in tumor cells, RBN-2397 has been shown to directly inhibit cellular proliferation and restore interferon signaling to stimulate an innate and adaptive antitumor immune response. RBN-2397 is currently in a Phase 1 dose-escalation clinical trial as a monotherapy in patients with advanced solid tumors to primarily assess safety and tolerability. PARP7 is overexpressed in a number of tumors, including squamous cell carcinoma of the lung, or SCCL, which represents approximately 30% of all non-small cell lung cancers, or NSCLC.

On February 2, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported that its Board of Directors has decided to pay a dividend of $0.32 per share for the quarter ended December 31, 2020 (Press release, Bio-Techne, FEB 2, 2021, View Source [SID1234574500]). The quarterly dividend will be payable February 26, 2021 to all common shareholders of record on February 12, 2021. Future cash dividends will be considered by the Board of Directors on a quarterly basis.

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On February 2, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that it intends to offer and sell shares of common stock (or pre-funded warrants in lieu thereof) in an underwritten public offering (Press release, Moleculin, FEB 2, 2021, View Source [SID1234574499]). All shares of common stock (or pre-funded warrants in lieu thereof) in the offering will be sold by Moleculin. As part of this offering, Moleculin intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. The proposed offering is subject to market and other conditions. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

Oppenheimer & Co. Inc. is acting as the sole book-running manager for the proposed offering.

The Company intends to use the net proceeds of the offering to fund its planned clinical trials, preclinical programs, for other research and development activities and for general corporate purposes.

The securities described above are being offered by the Company pursuant to a shelf registration statement on Form S-3 (No. 333-235686) originally filed December 23, 2019 with the Securities and Exchange Commission (SEC) and declared effective by the SEC on April 9, 2020. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus may be obtained, when available, from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at (212) 667-8055, or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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