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Medivir presents MIV-818 data at ASCO Gastrointestinal Cancers Symposium

On January 12, 2021 Medivir AB (Nasdaq Stockholm: MVIR) reported that a presentation entitled "Phase I study of the novel pro-drug MIV-818 in patients with hepatocellular carcinoma, intra-hepatic cholangiocarcinoma or liver metastases" will be given by Professor Jeff Evans, Director of Institute of Cancer Sciences at University of Glasgow, at the virtual ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO-GI) (Press release, Medivir, JAN 12, 2021, View Source [SID1234573938]). The presentation will be given on January 15, 2021, at 2 pm CET during the Hepatobiliary Cancer session (presentation number 309).

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The results from the completed phase Ia intra-patient dose escalation part of the study show that MIV-818 has an acceptable safety and tolerability profile and a selective effect on liver cancer cells. The inter-patient dose escalation phase Ib part is currently ongoing at a dose of 40 mg for 5 days in 21-day cycles.

Details of all presentations for the 2021 ASCO (Free ASCO Whitepaper) GI Symposium are available at the conference website: LINK

For further information, please contact:
Yilmaz Mahshid, CEO, Medivir AB, phone: +46 (0)8 5468 3100.
[email protected]

About MIV-818
MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted, orally administered drug for patients with HCC and other forms of liver cancer.

About liver cancer
Liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. HCC is a very diverse disease with multiple cancer cell types and without specific mutations seen in other tumor types. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

Boston Scientific Announces Preliminary Unaudited Sales For The Fourth Quarter And Full Year 2020

On January 12, 2021 Boston Scientific Corporation (NYSE: BSX) reported that net sales, based upon preliminary unaudited financial information, of approximately $2.71 billion during the fourth quarter of 2020 (Press release, Boston Scientific, JAN 12, 2021, View Source [SID1234573937]). This represents a decline of approximately (6.8) percent on a reported basis, approximately (8.3) percent on an operational1 basis and approximately (8.0) percent on an organic2 basis, all compared to the prior year period. Included within organic results is a negative 370 basis point impact associated with the conversion of U.S. WATCHMAN customers to a consignment inventory model and transition to the next-generation WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device.

For the full year 2020, the company generated net sales, based upon preliminary unaudited financial information, of approximately $9.91 billion. This represents a decline of approximately (7.7) percent on a reported basis, approximately (7.8) percent on an operational basis and approximately (11.3) percent on an organic basis, all compared to the prior year period. Included within organic results is a negative 170 basis point impact from WATCHMAN discussed above.

Fourth quarter preliminary financial results and recent developments:

Delivered the following fourth quarter sales growth/(declines) in each reportable segment3 compared to the prior year period:
MedSurg: 1.5 percent reported, 0.1 percent operational and 1.1 percent organic
Rhythm and Neuro: (6.1) percent reported, (7.7) percent operational and organic
Cardiovascular: (12.0) percent reported, (13.5) percent operational and organic

Accelerated sequential organic growth in the Peripheral Interventions business (4.8 percent organic growth), including 12 percent growth within the Interventional Medicine3 portfolio.

Returned to growth in the MedSurg reportable segment3 (1.1 percent organic growth) in the fourth quarter, driven by recovering procedural trends and favorable site of service mix. This includes a broad-based recovery in the Endoscopy business (1.5 percent organic growth), and growth within the stone and benign prostatic hyperplasia (BPH) franchises in Urology and Pelvic Health (0.6 percent organic growth).

WATCHMAN and WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device portfolio experienced strong customer demand in the fourth quarter. Organic sales declined 56 percent, which includes a negative 74 percent impact due to the conversion to a consignment inventory model and transition discussed above, and surpassed 150,000 cumulative implants worldwide.

Achieved key milestones for the Neuromodulation business with the WaveWriter Alpha portfolio of Spinal Cord Stimulator (SCS) systems including recent U.S. Food and Drug Administration (FDA) approval and third quarter 2020 launch in Europe.
J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021
Also as previously announced, Boston Scientific will participate in the virtual J.P. Morgan Healthcare Conference today. Mike Mahoney, chairman and chief executive officer, will present at approximately 8:20 a.m. EST. At 8:40 a.m. EST, Mike will be joined by Dan Brennan, executive vice president and chief financial officer, Dr. Ian Meredith, executive vice president and global chief medical officer, and Susie Lisa, vice president, Investor Relations, in a question-and-answer session with the host analyst and audience members.

A live webcast of the presentation and question-and-answer session will be available on the Investor Relations section of the Boston Scientific website at investors.bostonscientific.com. A replay of the webcast will be accessible at investors.bostonscientific.com beginning approximately one hour following the completion of the event.

Conference Call on Wednesday, February 3, 2021
As previously announced, Boston Scientific will webcast its conference call discussing financial results and business highlights for the fourth quarter and full year 2020 on Wednesday, February 3, 2021 at 8:00 a.m. EST. A live webcast of the conference call will be available on the Investor Relations section of the website at investors.bostonscientific.com. A replay of the webcast will be archived and available at investors.bostonscientific.com beginning approximately one hour following the completion of the meeting.

Dragonfly Therapeutics Announces Inclusion of TriNKET ™ AbbVie Immunotherapy Candidate Drug

On January 12, 2021 Dragonfly Therapeutics ("Dragonfly"), a biotechnology company developing new immunotherapies that harness the innate immune system to treat disease, reported that AbbVie (NYSE: ABBV ) has licensed its first drug candidate TriNKET from Dragonfly, part of a multi-objective collaboration started in November 2019 designed to advance a series of new immunotherapies based on Dragonfly NK cell implicators for autoimmune and oncological indications (Press release, Dragonfly Therapeutics, JAN 12, 2021, View Source;876043116.html [SID1234573935]).

"AbbVie is committed to providing improved treatment options for our patients," said Tom Hudson , MD, senior vice president of R&D and chief science officer for AbbVie. "The collaboration with Dragonfly has been remarkable. Working together, the teams have made rapid progress to develop this first TriNKET in record time."

"AbbVie is a global leader in the treatment of immune diseases," said Bill Haney , co-founder and CEO of Dragonfly. "They are a terrifying partner and this membership, as soon as we launch our collaboration, is a huge vote of confidence. We look forward to continued success and rapid progress with the AbbVie team to advance new treatment options for patients."

The listing grants AbbVie exclusive global intellectual property rights to develop and commercialize products targeting this first specific goal, developed using Dragonfly’s TriNKET technology platform. Dragonfly will receive a membership payment, as well as potential future development milestone payments and royalties from the sales of marketed candidates.

Biond Biologics and Sanofi Enter into Global Licensing Agreement for BND-22, a Novel Immune Checkpoint Inhibitor Targeting the ILT2 Receptor

On January 12, 2021 Biond Biologics Ltd. ("Biond" or the "Company"), a privately-held biopharmaceutical company, developing novel immunotherapies for cancer and a platform enabling the intracellular delivery of biologics, reported that it has entered into an exclusive worldwide license agreement with Sanofi (EURONEXT: SAN) (NASDAQ: SNY), for the development and commercialization of BND-22 (Press release, Biond Biologics, JAN 12, 2021, View Source [SID1234573934]).

BND-22 is a humanized IgG4, antagonist antibody targeting the Ig-like transcript 2 (ILT2) receptor in development for the treatment of solid tumors. ILT2, a member of the ILT family of immuno-modulating receptors, is an inhibitory receptor expressed on both innate and adaptive immune cells that binds MHC class I molecules including HLA-G, an immunosuppressive protein expressed by multiple tumor types.

Under the terms of the agreement, Biond will receive a $125 million upfront payment in cash and will be entitled to receive more than $1 billion in development, regulatory, and sales milestones, as well as tiered double digit royalty payments. Biond will lead the first-in-human, phase 1a study of BND-22, evaluating its safety and tolerability as a single agent and in combination with approved cancer therapeutics as well as exploring potential associations between BND-22 anti-tumor activity and select tumor and blood-based biomarkers; Sanofi will assume clinical development and commercialization responsibilities thereafter.

BND-22 has been shown in preclinical studies to have a broad anti-tumor effect by targeting ILT2-mediated "do not eat me" signals in macrophages and by activating natural killer (NK) and CD8+ lymphocytes. The program is supported by a comprehensive biomarker strategy designed to guide patient enrollment in advanced clinical trials. An Investigational New Drug (IND) application for BND-22 has recently been submitted to FDA and a phase 1 study to evaluate the safety, tolerability, and preliminary anti-tumor activity of BND-22 in advanced cancer patients is planned to start by mid-2021.

"We are thrilled to partner with Sanofi, an organization with a global footprint and exceptional drug development and commercialization capabilities," said Ori Shilo, Co-Founder and Chief Financial Officer at Biond. "We believe this collaboration creates substantial value for our shareholders and validates Biond’s long term strategy to establish valuable partnerships with leading biopharmaceutical companies."

"The emphasis in the development of cancer immunotherapies has been placed so far mainly on drugs that stimulate the adaptive immune system to attack malignant cells, in particular T lymphocytes. Unfortunately, many advanced cancer patients do not derive a durable benefit from these drugs," said Tehila Ben-Moshe, Ph.D., Co-Founder and Chief Executive Officer at Biond. "Biond Biologics was founded with a unique model that enables focused development of breakthrough cancer therapies, reaching clinical trials more quickly. BND-22, the first clinical drug candidate to graduate Biond’s development model, is a novel immunotherapy that targets both adaptive and innate immune cells and takes advantage of the anti-tumor activity of not only T cells but also that of additional immune cells, such as NK cells and macrophages. We look forward to progressing BND-22 into the clinic together with our new partner Sanofi, using our in-depth knowledge of the ILT2 pathway and expertise in immuno-oncology."

RedHill Biopharma Increases Previously Announced Bought Deal to $25 Million

On January 12, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that due to demand, the underwriter has agreed to increase the size of the previously announced offering and purchase on a firm commitment basis 3,188,776 American Depositary Shares (ADSs) of the Company, at a price to the public of $7.84 per ADS, less underwriting discounts and commissions (Press release, RedHill Biopharma, JAN 12, 2021, View Source [SID1234573933]). Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. The closing of the offering is expected to occur on or about January 14, 2021, subject to satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company also has granted to the underwriter a 30-day option to purchase up to additional 478,316 ADSs at the public offering price, less underwriting discounts and commissions.

The gross proceeds to RedHill, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter’s option to purchase additional ADSs, are expected to be approximately $25 million. The Company intends to use the net proceeds from this offering to fund its clinical development programs, commercialization activities and for acquisitions and general corporate purposes.

The securities described above are being offered by RedHill pursuant to a "shelf" registration statement on Form F-3 (File No. 333-226278) previously filed with the Securities and Exchange Commission (the "SEC") on July 23, 2018 and declared effective by the SEC on July 31, 2018. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the securities being offered have been filed with the SEC and are available on the SEC’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A final prospectus supplement and the accompanying prospectus relating to the offering will be filed with the SEC and , upon filing, may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a 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.