On January 12, 2021 Scorpion, which focuses on "precision medicine" for cancer, reported it has completed a $162 million funding round, bringing the biotech’s total venture haul to about $270 million (Press release, Scorpion Therapeutics, JAN 12, 2021, View Source [SID1234573949]). It’s a large amount for a new company that so far has kept much of its work under wraps, and a sign that the region’s early-stage biotech industry is vibrant, despite the pandemic.

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"This will allow us to accelerate nearly all aspects of the business," said Gary Glick, Scorpion’s chief executive, who pointed out the oversubscribed round brought on 11 new investors.

Glick said the company would announce its first medicine candidate this year, with plans to begin clinical trials in 2022. While he declined to provide an update on how many other drugs the company has in development, Glick said the new funding could help Scorpion support multiple clinical trial programs.

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Scorpion is aiming to tackle cancer in three ways. It wants to make better medicines for known cancer mutations, which could spare healthy tissue and limit side effects, develop medicines for cancer targets previously dismissed as "undruggable," and discover new ones. Scorpion has plans to commercialize its own drugs, Glick said, instead of partnering with pharmaceutical giants.

On January 12, 2021 Medivir AB (publ) (Nasdaq Stockholm: MVIR) reported that it has entered into an exclusive licensing agreement, through which IGM Biosciences, Inc. (Nasdaq: IGMS), will receive global, exclusive development rights for birinapant, a clinical-stage SMAC mimetic that binds to and degrades Inhibitors of Apoptosis Proteins (IAPs), leading to cell death (apoptosis) in tumor cells (Press release, Medivir, JAN 12, 2021, View Source [SID1234573940]). The combination of IGM-8444, an IgM antibody targeting Death Receptor 5 (DR5) being developed by IGM, and birinapant has been shown to enhance anti-tumor activity preclinically. Medivir will receive an upfront payment of USD 1 million upon signing the agreement, followed by an additional USD 1.5 million when birinapant is included by IGM in clinical phase I studies. The terms of the agreement furthermore entitle Medivir, should birinapant be successfully developed and approved, to receive milestone payments up to a total of approximately USD 350 million, plus tiered royalties up to mid-teens on net sales.

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– "Agreements, such as the one announced today with IGM, continue to be a core component of Medivir’s corporate mission and business model," said Yilmaz Mahshid, Chief Executive Officer of Medivir. "Today’s announcement further exemplifies our focus and commitment to the development and commercialization of innovative treatments for cancer, and we look forward to IGM’s progress with birinapant in the clinic and beyond."

– "Based on our in vitro and in vivo models, which have shown remarkable synergy between IGM-8444 and birinapant, we are excited to explore this combination’s potential to deliver superior anti-tumor activity in patients with solid tumors," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "This agreement is part of a broader strategy to realize the full potential of our IgM drug candidates by maintaining control over the timing and development path of the more promising combinations to emerge from our preclinical and clinical work. We look forward to moving the IGM-8444-birinapant combination into clinical testing to begin validating the significance of targeting DR5 with an IgM antibody in certain combinations and to continuing to explore similar strategic options across our IgM platform."

In addition to its apoptotic activity, birinapant augments anti-tumor immune system activity. Through this double action, on both tumor cells and cells of the immune system, birinapant has the potential to improve the treatment of several types of cancer when used in combination with other drugs. IGM-8444 is currently being tested in a phase I dose escalation study in patients with solid and hematologic malignancies. DR5 is a member of the tumor necrosis factor receptor superfamily (TNFRSF) and is often expressed on the surface of cancer cells. Subject to regulatory review, IGM hopes to begin the clinical testing of birinapant in combination with IGM-8444 for the treatment of solid cancers later this year.

Medivir AB is obliged to make this information public pursuant to the EU Market Abuse Regulation.

The information was submitted for publication, through the agency of the contact person set out above, at 23.59 CET on January 11, 2021.

About birinapant

Birinapant is a SMAC mimetic that was acquired from TetraLogic Pharmaceuticals Corporation (TetraLogic) in 2016 and has since then been developed by Medivir. Medivir recently renegotiated the original agreement with TetraLogic so that the compensation Medivir is obliged to pay in connection with a licensing agreement is based on the distribution of actual future revenues to Medivir.

On January 12, 2021 Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported with Eli Lilly and Company ("Lilly",NYSE: LLY) that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for TYVYT (sintilimab injection) as second-line therapy for squamous non-small cell lung cancer (sqNSCLC) (Press release, Innovent Biologics, JAN 12, 2021, View Source [SID1234573939]). The application is the third sNDA for TYVYT (sintilimab injection) in NSCLC.

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This sNDA was based on a randomized, open-label, Phase 3 clinical trial (ORIENT-3)—evaluating TYVYT (sintilimab injection) as second-line therapy for patients with advanced or recurrent sqNSCLC whose cancer had progressed on first-line platinum-based chemotherapy. Based on the final analysis in the pre-specified full analysis set, TYVYT demonstrated a statistically significant improvement in overall survival (OS) compared with docetaxel, which met the pre-specified superiority criteria. The progression-free survival (PFS) and objective response rate (ORR) were also significantly improved. The safety profile is consistent with previously reported sintilimab studies, and no new safety signals were identified. Detailed data will be released in an upcoming international academic conference or journal.

The principal investigator of ORIENT-3, Professor Yuankai Shi, Associate Dean of Cancer Hospital, Chinese Academy of Medical Sciences, stated: "Lung cancer is the leading cause of cancer death globally, of which NSCLC accounts for 80% to 85%. In the past few decades, drug development of NSCLC has mainly focused on nonsquamous NSCLC, while drug development of squamous NSCLC has been slower due to its unique epidemiological, histopathological and molecular characteristics. In China, the options for second-line immunotherapy are even more limited. The ORIENT-3 study confirmed that the anti-PD-1 monoclonal antibody sintilimab significantly improved OS for the second-line treatment of squamous NSCLC patients, which is of great clinical value. We hope that the positive results of ORIENT-3 can potentially help more squamous NSCLC patients."

"TYVYT (sintilimab injection) is the first anti-PD-1 monoclonal antibody included in the New Catalogue of the National Reimbursement Drug List," said Dr. Hui Zhou, Vice President of Medical Science and Strategy Oncology of Innovent. "In August 2020, the NMPA accepted a new indication application for TYVYT (sintilimab injection) in combination with chemotherapy for first-line treatment of squamous NSCLC. In ORIENT-3 study, sintilimab as second-line monotherapy demonstrated a significantly improved survival benefit for patients with advanced squamous NSCLC, and we look forward to the approval of this indication, to potentially help more patients with this type of lung cancer."

"We are excited about these results, showing TYVYT (sintilimab injection) significantly improved overall survival in this patient population. This study underscores the joint commitment from Lilly and Innovent to provide innovative treatment options to patients with lung cancer," said Dr. Wang Li, Senior Vice President of Lilly China and Head of Lilly China Drug Development and Medical Affairs. "We would like to thank the patients, the investigators, the clinical trial centers and our colleagues from Innovent that are involved in the study. We look forward to working together to potentially bring this new treatment option to patients in China with squamous NSCLC."

About ORIENT-3 Trial

ORIENT-3 is a randomized, open-label, multi-center, Phase 3 clinical trial in China to evaluate the efficacy and safety of TYVYT (sintilimab injection) as second-line therapy for advanced or metastatic sqNSCLC (ClinicalTrials.gov, NCT 03150875). The primary endpoint is overall survival (OS). The secondary endpoints include progression-free survival (PFS) assessed by investigators based on RECIST v1.1, objective response rate (ORR) and safety profile.

A total of 290 patients were enrolled in ORIENT-3 and randomized in a 1:1 ratio to receive either TYVYT (sintilimab injection) 200mg or docetaxel every three weeks. The patients received treatment until radiographic disease progression, unacceptable toxicity or any other conditions that require treatment discontinuation.

About Squamous NSCLC

Lung cancer is a malignancy with the highest morbidity and mortality in China. NSCLC accounts for about 80 to 85 percent of lung cancer. Approximately 70 percent of people with NSCLC have locally advanced or metastatic NSCLC at initial diagnosis, rendering many of those patients with no chance of radical resection. Meanwhile, even after radical surgery, patients still have a high chance of recurrence and eventually die from disease progression. About 30 percent of people with NSCLC in China have tumors of the squamous subtype and there are limited second-line immunotherapies for these patients. In China, there remains a huge unmet medical need.

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection), an innovative drug with global quality standards jointly developed in China by Innovent and Eli Lilly and Company, has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy, and is included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT was included in the National Reimbursement Drug List (NRDL) in 2019 as the historically first PD-1 inhibitor entering in NRDL and the only PD-1 included in the list in that year.

In April 2020, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with ALIMTA (pemetrexed) and platinum chemotherapy as first-line therapy for the treatment of patients with non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT (sintilimab injection) monotherapy met the primary endpoint of overall survival in the Phase 2 ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma. In August 2020, the NMPA accepted the sNDA for TYVYT in combination with GEMZAR (gemcitabine for injection) and platinum chemotherapy as first-line therapy in squamous NSCLC. In September 2020, TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection) as a first-line treatment in advanced hepatocellular carcinoma met the predefined primary endpoints of overall survival and progression-free survival in an interim analysis of the Phase 3 ORIENT-32 study. In January 2021, the NMPA accepted the sNDA for TYVYT as second-line therapy for sqNSCLC.

TYVYT (sintilimab injection), is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, block the PD-1 / PD-Ligand 1 (PD-L1) pathway and reactivate T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. Meanwhile, Innovent is conducting clinical research studies on TYVYT (sintilimab injection) worldwide.

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.

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.

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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.