On January 11, 2021 Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) ("Takeda") reported that it will present virtually at the 39th Annual J.P. Morgan Healthcare Conference at 5:20 p.m. ET on Monday, January 11, 2021 / 7:20 a.m. JT on Tuesday, January 12, 2021 (Press release, Takeda, JAN 11, 2021, View Source [SID1234573842]). Investors and the general public are invited to listen to the live webcast with Christophe Weber, president and chief executive officer, here. A replay of the webcast will also be archived at the same location. A link to the webcast and slides for download will also be available on Takeda’s website at View Source

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On January 11, 2021 EQRx, a company committed to developing and delivering important new medicines at lower prices, reported that it has raised $500 million in Series B financing (Press release, EQRx, JAN 11, 2021, View Source [SID1234573841]). Since launching a year ago, EQRx has raised approximately $750 million to advance its mission of bringing new medicines to treat life-threatening and chronic diseases to patients and healthcare systems around the world at prices that are a fraction of the cost of today’s leading therapies.

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The Series B financing includes participation from all Series A investors, life science specialists, world-class mutual funds and private equity funds, sovereign wealth and family offices, and market-leading payers and health systems that cover more than 20% of insured lives in the United States.

"There is an urgent need for change in the industry’s approach to drug pricing, and although challenging, changing the model is not only possible, it is critical," said Alexis Borisy, founder, chairman and chief executive officer of EQRx. "The price of a drug should never be the rate-limiting factor to patient access. EQRx is confronting this issue head-on by employing a disruptive, market-based approach to create true, sustainable access to great medicines at fair prices and reestablish trust and transparency between drug developers and the people who need these medicines."

EQRx is building a highly competitive pipeline of important new drug candidates to address diseases like cancer and inflammatory conditions that combined are projected to represent nearly 40% of the drug spend among the highest cost diseases globally by 2025. By leveraging proven druggable targets and a relentless focus on efficiency, together with deep strategic partnerships with health systems and payers, EQRx anticipates a higher probability of regulatory success, a lower risk-adjusted cost of drug development and a more streamlined access model. The Company estimates that its broad pipeline of innovative therapies has the potential to save the U.S. healthcare system between 50-70% of its current drug spend across the respective therapeutic areas.

In oncology, EQRx has disclosed several late-stage drug candidates currently in development that show promise in the treatment of some of the most common and devastating types of cancers globally—lung cancer, breast cancer and other solid tumors—including:

sugemalimab, a PD-L1 antibody with compelling phase 3 clinical data in non-small cell lung cancer (NSCLC), as well as potential additional applications in gastric cancers, esophageal cancers, and lymphomas. Notably, sugemalimab has received Breakthrough Drug Designation and Orphan Drug Designation from the United States Food and Drug Administration (FDA) for the treatment of certain lymphomas;
almonertinib, an EGFR inhibitor, to treat certain types of NSCLC, which is already approved in China and is in late-stage clinical trials;
EQRx’s PD-1 antibody (formerly known as CS1003), which has received Orphan Drug Designation from the FDA for a type of primary liver cancer; and
lerociclib, a CDK4/6 inhibitor, which targets HR+/HER2- breast cancer, the most common type of the disease.
EQRx’s business model drives cost savings both through the potential use of these medicines as monotherapies, and by enabling biopharma companies to create high-quality, lower-cost combination regimens including EQRx’s drugs through partnerships.

The Company has also entered several strategic collaborations with national and regional health plans and large integrated delivery networks and health systems. "EQRx is the ultimate convener, bringing healthcare stakeholders together in meaningful strategic partnerships to modernize traditional drug manufacturer-to-patient access models globally," added Melanie Nallicheri, co-founder, president and chief operating officer of EQRx. "Our shared goal is to enable effortless prescribing for providers and equal access to important new medicines for people by eliminating barriers, especially high drug costs. With this Series B financing, EQRx is well-poised to make sustainable drug pricing a reality for people, payers and health systems."

On January 11, 2021 -bluebird bio, Inc. (Nasdaq: BLUE) reported its intent to separate its severe genetic disease and oncology businesses into differentiated and independent publicly traded companies (Press release, bluebird bio, JAN 11, 2021, View Source [SID1234573840]). bluebird bio, Inc. will retain focus on severe genetic disease (SGD) and will launch its oncology business ("Oncology Newco") as a new entity. bluebird bio’s Board of Directors approved the intent to separate into two companies and it is anticipated that the spin out of Oncology Newco is to be tax-free to shareholders, subject to receipt of a favorable Internal Revenue Service (IRS) ruling.

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Upon completion of the separation, current chief bluebird, Nick Leschly, will lead Oncology Newco as Chief Executive Officer and will take on the role of Executive Chair for bluebird bio, Inc. Current President of the SGD business, Andrew Obenshain will continue his leadership as Chief Executive Officer of bluebird bio, Inc. Further, current Chair of bluebird’s Board of Directors, Daniel Lynch, will become Chair of the Board for Oncology Newco.

"We are excited and energized to begin this new year with so much opportunity ahead. Over the last decade, bluebird bio has pioneered development of gene and cell therapies for severe genetic diseases and oncology – delivering transformative outcomes for patients. Through the tenacity and incredible work of our bluebirds, our first commercial product is now approved in Europe and we are now on the cusp of several potential product approvals with a strong pipeline of earlier oncology research candidates on the horizon. This is a position few biotech companies have been able to attain," said Nick Leschly, chief bluebird. "After careful strategic review, it is clear to us that the two businesses are best served by independent leadership and teams to drive distinct strategic and operational objectives. Specifically, we believe it is the right time to double down on the respective businesses to fully enable and optimize the continued innovation, development and deployment of transformative gene and cell therapies for the patients we serve."

"In close collaboration with the Board of Directors, bluebird bio leadership has conducted a thorough assessment of the business overall and examined a range of options for the future," said Daniel Lynch, Chair of bluebird bio’s Board of Directors. "Based on this review, we collectively believe this strategic decision is in the best interest of patients, employees, investors and other stakeholders. We are committed to working together through this transformative process to ensure each company is optimized with the right teams in place for progressing these therapies through the regulatory process into commercialization, harnessing the power of the pipeline to continue creation of innovative medicines, establishing and rapidly growing product revenue, and creating value for shareholders."

Launching Severe Genetic Disease and Oncology for Bold Futures

bluebird bio intends to ensure both SGD and Oncology Newco are established as independent organizations with enhanced therapeutic focus and strong financial foundations. The company believes this approach will provide both entities with the ability to achieve the following:

Enhanced resource allocation and capital considerations for each company
Therapeutic expertise and focus to more effectively execute and deliver on milestones
Streamlined and simplified operations
Tailored investment theses to attract an appropriately suited shareholder base
Sustained patients first culture and innovation mindset
Increased strategic flexibility
By establishing this foundation in two new environments, the company believes each entity will be in a stronger position to deliver on their goals:

Severe Genetic Disease

Focus on delivery of Core 3 therapies in β-thalassemia, cerebral adrenoleukodystrophy and sickle cell disease in the United States and Europe
Expand access and reimbursement for our commercial product, ZYNTEGLO (betibeglogene autotemcel), in Europe
Increase addressable patient populations through geographic expansion, label expansions, and product profile enhancement
Build on our expertise in gene therapy manufacturing through commercialization, significant process enhancements, and next generation technologies
Continue to explore innovative tools and technologies to ultimately bring these transformative medicines to more patients
Oncology Newco

Support commercial success of investigational B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR) T cell therapy, idecabtagene vicleucel (ide-cel), in multiple myeloma and continued development of investigational bb21217 product candidate; advancing into earlier lines and continuing to innovate
Deliver on the oncology pipeline of cellular therapies with a focus on non-Hodgkin’s lymphoma, acute myeloid leukemia, next-generation multiple myeloma and solid tumors
Advance next generation product cycling engine designed to rapidly build, test, learn and improve with an overarching goal of 1-2 investigational new drugs (INDs) in each of 2021 and 2022
bluebird bio Adds Additional Oncology Expertise to Board of Directors

As bluebird bio continues to build out therapeutic expertise within its Board of Directors, the company has appointed Ramy Ibrahim, M.D. to its Board of Directors. Dr. Ibrahim is a recognized leader in clinical development in immunotherapy and cell therapy. He is currently serving as a consultant for the Parker Institute for Cancer Immunotherapy (PICI) where he was recently the Chief Medical Officer and built the clinical capabilities within the institute as well as worked with renowned cell therapy experts to support building world class cell therapy startups. Before joining PICI, Dr. Ibrahim was the vice president and Global Therapeutic area head for Immuno-Oncology clinical development for AstraZeneca/MedImmune, leading the global clinical team developing multiple immunotherapies. In addition, as a member of the Bristol-Myers Squibb Immuno-oncology program, he served on the Yervoy (ipilimumab) clinical team supporting the program from early phase II through multiple global launches of the first FDA-approved immune checkpoint inhibitor. In addition to his engagement with investment firms, Dr. Ibrahim also serves on the Scientific Advisory Board of Harpoon and on the Board of Directors for Surface Oncology.

bluebird bio also acknowledges the significant and impactful contributions of Dr. David Schenkein, who after eight years, is stepping down from the bluebird bio Board of Directors.

Financial Summary

bluebird bio preliminary and unaudited cash, cash equivalents and marketable securities balance as of December 31, 2020 was approximately $1.3B. At the time of separation, bluebird bio plans to capitalize each business with sufficient cash runway to achieve value creating milestones. In preparation for the separation, bluebird bio will continue to prudently and carefully manage the cost structure of each business while evaluating dedicated financial and strategic funding sources. bluebird bio expects to incur increased transactional and separation expenses through the completion of the transaction as it works to separate and transition the two businesses. bluebird bio will provide additional financial details closer to the date of separation.

Transition and Timing

Specific details regarding the companies including financial statements, the name of Oncology Newco as well as executive management teams and the respective Board of Directors (BOD) for each company will be provided at a later date. Expected executive team, employee and BOD transitions will be effective as of the closing of the separation anticipated to be in the Q4 2021 timeframe. bluebird bio anticipates both companies will be headquartered in Cambridge, Mass. European operations will remain with bluebird bio and the SGD business. Facilities, research and manufacturing operations in Seattle, Wash. and Durham, N.C. will migrate with the Oncology Newco. The separation is subject to customary closing conditions, including the effectiveness of a Form 10 registration statement with the U.S. Securities and Exchange Commission, receipt of a private letter ruling from the IRS and tax opinion from counsel, and final approval by bluebird bio’s Board of Directors. There can be no assurance regarding the ultimate timing of the separation or that the separation will ultimately occur.

Goldman Sachs & Co. LLC is serving as exclusive financial adviser to bluebird bio and Goodwin Procter LLP is serving as its legal counsel.

Webcast Information

bluebird bio will hold a conference call to discuss the news on Monday, January 11 at 8:00 a.m. ET. Investors may listen to the call by dialing (844) 825-4408 from locations in the United States or +1 (315) 625-3227 from outside the United States. Please refer to conference ID number 225-6277.

In addition, members of the management team will participate in the 39th Annual J.P. Morgan Healthcare Conference, Monday, January 11 at 2:50 p.m. ET.

To access the live webcast of bluebird bio’s presentations, please visit the "Events & Presentations" page within the Investors & Media section of the bluebird bio website at View Source Replays of the webcast will be available on the bluebird bio website for 90 days following the event.

On January 11, 2021 Novocure (NASDAQ: NVCR) reported operating statistics and preliminary, unaudited net revenues and cash balances for the fourth quarter and full year 2020 (Press release, NovoCure, JAN 11, 2021, View Source [SID1234573839]). Novocure plans to discuss these results with investors at the 39th Annual J.P. Morgan Virtual Healthcare Conference. Novocure also plans to highlight key clinical and product development programs.

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(1) The preliminary, unaudited results described in this press release are estimates only and are subject to revision until the company reports its full, audited financial results for the fourth quarter and full year 2020 on or about Feb. 25, 2021.

(2) An "active patient" is a patient who is receiving treatment under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.

(3) A "prescription received" is a commercial order for Optune or Optune Lua that is received from a physician certified to treat patients for a patient not previously on Optune or Optune Lua. Orders to renew or extend treatment are not included in this total.

"Our track record of execution extended throughout 2020 with significant achievements furthering our three overarching priorities," said William Doyle, Novocure’s Executive Chairman. "We sustained our commercial momentum with $494 million in net revenues, representing 41% annual revenue growth; launched three new clinical trials, expanding our development pipeline to include eight ongoing global studies involving nearly 3,000 patients across seven solid tumor cancers; and, increased our investments in product development."

"We continue to build on twenty years of innovation and execution to pioneer an emerging modality in cancer care," said Asaf Danziger, Novocure’s CEO. "Through our clinical and product development efforts, we believe we are just beginning to unlock the potential of the Tumor Treating Fields platform to extend survival in some of the most aggressive forms of cancer. We look forward to providing a full company update and discussing our 2020 financial results on our February conference call."

Fourth quarter 2020 operating statistics and preliminary financial highlights

On a preliminary, unaudited basis, for the quarter ended December 31, 2020, net revenues were $144.0 million, representing 45% growth compared to the fourth quarter 2019, and full year 2020 net revenues were $494.4 million, representing 41% growth compared to full year 2019.

In the United States, net revenues totaled $97.7 million in the quarter ended December 31, 2020, representing 48% growth compared to the same period in 2019.
In Germany and other EMEA markets, net revenues totaled $33.8 million in the quarter ended December 31, 2020, representing 31% growth compared to the same period in 2019.
In Japan, net revenues totaled $7.9 million in the quarter ended December 31, 2020, representing 42% growth compared to the same period in 2019
In Greater China, net revenues totaled $4.5 million in the quarter ended December 31, 2020, representing 132% growth compared to the same period in 2019.
We recorded $9 million and $36 million in revenues from Medicare fee-for-service beneficiaries billed under the coverage policy effective on September 1, 2019 for the three and twelve month periods ended December 31, 2020, respectively. We have gained a good understanding of how to ensure timely processing of Medicare claims and have sufficient experience to recognize approximately two-thirds of the expected contribution from Medicare beneficiaries. In the fourth quarter of 2020, we also recognized approximately $11 million in incremental net revenues compared to the first half of 2020 resulting from the successful appeal of previously denied claims for Medicare fee-for-service beneficiaries billed prior to established coverage.

There were 3,411 active patients at December 31, 2020, representing 17% growth compared to December 31, 2019, and one percent growth compared to September 30, 2020.

In the United States, there were 2,193 active patients at December 31, 2020, representing 12% growth compared to December 31, 2019.
In Germany and other EMEA markets, there were 953 active patients at December 31, 2020, representing 25% growth compared to December 31, 2019.
In Japan, there were 265 active patients at December 31, 2020, representing 38% growth compared to December 31, 2019.
Additionally, 1,411 prescriptions were received in the quarter ended December 31, 2020, representing two percent growth compared to the same period in 2019, and three percent growth compared to the quarter ended September 30, 2020. In the quarter ended December 31, 2020, 1,160 Optune prescriptions were written for patients with newly diagnosed glioblastoma.

In the United States, 962 prescriptions were received in the quarter ended December 31, 2020, representing a four percent decrease compared to the same period in 2019.
In Germany and other EMEA markets, 349 prescriptions were received in the quarter ended December 31, 2020, representing 22% growth compared to the same period in 2019.
In Japan, 100 prescriptions were received in the quarter ended December 31, 2020, representing eight percent growth compared to the same period in 2019.
At December 31, 2020, on a preliminary, unaudited basis, Novocure had $235 million in cash and cash equivalents and $608 million in short-term investments, for a total balance of $843 million in cash, cash equivalents and short-term investments. This represents an increase of $608 million in cash and investments since September 30, 2020.

Anticipated clinical milestones

Data from phase 2 pilot HEPANOVA trial in advanced liver cancer (Q1 2021)
Data from phase 2 pilot EF-31 trial in gastric cancer (2021)
Interim analysis of phase 3 pivotal LUNAR trial in non-small cell lung cancer (2021)
Interim analysis of phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2021)
Interim analysis of phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2021)
Data from phase 3 pivotal METIS trial in brain metastases (2022)
Data from phase 2 pilot EF-33 trial with high-intensity arrays in recurrent glioblastoma (2022)
Final data from phase 3 pivotal LUNAR trial in non-small cell lung cancer (2023)
Final data from phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2023)
Final data from phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2023)
Fourth quarter and full year 2020 financial results conference call

Novocure will host a conference call and webcast to discuss fourth quarter and full year 2020 financial results at 8 a.m. EST on Thursday, February 25, 2021. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 3965899.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On January 11, 2021 Ultimovacs ASA ("Ultimovacs", ticker ULTI), reported its participation in the Phase II DOVACC collaboration study with the Nordic Society of Gynaecological Oncology – Clinical Trial Unit (NSGO-CTU), the European Network of Gynaecological Oncological Trial Groups (ENGOT) and AstraZeneca, to conduct a randomized Phase II clinical trial to evaluate Ultimovacs’ proprietary universal cancer vaccine, UV1, in combination with AstraZeneca’s durvalumab and olaparib in patients with relapsed ovarian cancer (Press release, Ultimovacs, JAN 11, 2021, View Source [SID1234573838]).

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Carlos de Sousa, Chief Executive Officer at Ultimovacs stated: "Now that the formal collaboration with NSGO-CTU/ENGOT and AstraZeneca is in place and preparations for the study are well underway, I am happy to provide further details on the DOVACC Phase II clinical trial, which was first announced in May of 2020. A key benefit of UV1 is its safety profile, which enables a triple combination study with a PD-L1 inhibitor and now for the first time also with a PARP inhibitor, in an indication in desperate need of new treatment options. Ultimovacs has four Phase II trials evaluating UV1, including more than 500 patients in total, supporting its universal potential across many cancer indications and as part of various treatment combinations."

"The NSGO-CTU is a highly regarded oncology society that has strong connections with similar organizations across Europe through the ENGOT collaboration," commented Jens Bjørheim, Chief Medical Officer at Ultimovacs. "The collaboration with the NSGO-CTU and ENGOT is exciting for us as they are very experienced with conducting clinical trials in the field of gynaecological oncology. Their expertise and network will support the recruitment of patients at multiple participating study sites across Europe."

"Our purpose at the NSGO-CTU and ENGOT is to improve treatment options in gynaecological cancer indications by coordinating clinical trial efforts across countries," added Dr. Mansoor Raza Mirza, Medical Director of the NSGO-CTU and Chair of the ENGOT. "The evaluation of UV1, durvalumab and olaparib in this Phase II triple combination study is an important next step in changing the standard of care for patients with ovarian cancer. We look forward to working with Ultimovacs to reach our mutual goal."

DOVACC is a multi-center, multinational, randomized Phase II clinical trial sponsored by the NSGO, the leading gynaecological oncology research society in the Nordic and Baltic regions. The trial is designed to evaluate Ultimovacs’ proprietary UV1 cancer vaccine in combination with AstraZeneca’s durvalumab, a PD-L1 checkpoint inhibitor and its PARP inhibitor, olaparib, the maintenance therapy for BRCA-mutated advanced ovarian cancer. The trial will be conducted at more than 30 hospitals in around 10 European countries. The Company expects to treat the first patient in the first half of 2021. Topline data on the primary endpoint is expected in 2023.

The second-line maintenance study will enroll patients with high-grade BRCA negative ovarian cancer after partial or complete response following the second round of chemotherapy. The study includes three arms treating a total of 184 patients. The first arm will enroll 46 patients receiving the PARP inhibitor olaparib. The 46 patients enrolled in the second arm will receive olaparib and the checkpoint inhibitor durvalumab. The third arm will include 92 patients that will receive Ultimovacs’ UV1 vaccine in combination with both AstraZeneca drugs. The primary endpoint is progression-free survival (PFS) in the treatment arm with solely the PARP inhibitor olaparib, versus PFS in the triple combination treatment arm. Under the terms of the collaboration, Ultimovacs will provide its UV1 vaccine and AstraZeneca will provide the PD-L1 and PARP inhibitors for the study.

Innovation Norway has granted Ultimovacs NOK 10 million, approximately EUR 1 million, to support the execution of the Phase II DOVACC study. In addition, the successful private placement in May of this year raised NOK 160 million, approximately EUR 16 million, allowing Ultimovacs to continue to implement the Company’s clinical development plan and fund its operations through the expected readout of the primary endpoint in the DOVACC study in 2023.

Ultimovacs management will host a webcast on Monday, January 11, 2021, at 11:00 a.m. CET to discuss the DOVACC clinical trial in more detail. The webcast will also feature a short video statement from lead investigator Dr. Mirza. The live webcast can be accessed through the investor section of Ultimovacs’ corporate website at www.ultimovacs.com. The webcast replay will be available for at least 72 hours following the call.

About UV1

UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. UV1 is being developed as an "off-the-shelf" therapeutic cancer vaccine which may serve as a platform for use in combination with other immunotherapy which requires an ongoing T cell response for their mode of action. To date, UV1 has been tested in four phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.

About UV1 Clinical Programs

As a universal cancer vaccine, UV1’s unique mechanism of action has the potential to be applicable across most cancer types. The clinical development of the UV1 vaccine includes four randomized, multinational, Phase II combination trials: INITIUM, NIPU, DOVACC and FOCUS, recruiting over 500 patients in total. The INITIUM trial is an Ultimovacs-sponsored clinical trial recruiting 154 patients with metastatic malignant melanoma to evaluate UV1 in combination with ipilimumab and nivolumab as first-line treatment. The NIPU study is testing UV1 in combination with checkpoint inhibitors ipilimumab and nivolumab as second-line treatment in 118 patients with advanced malignant pleural mesothelioma, a rare lung cancer. The study is sponsored by Oslo University Hospital and Bristol-Myers Squibb is providing the checkpoint inhibitors for this study. The DOVACC study is sponsored by the Nordic Society of Gynaecological Oncology. In total, 184 patients with high-grade ovarian cancer will be enrolled to evaluate UV1 in combination with durvalumab and olaparib, both provided by AstraZeneca. FOCUS is an investigator-sponsored, randomized clinical trial enrolling 75 patients with metastatic head and neck cancer receiving pembrolizumab as standard of care, and will evaluate the impact of adding UV1 to this regimen. Ultimovacs anticipates announcing data on the primary endpoints for the NIPU and INITIUM studies in 2022 and for the DOVACC and FOCUS studies in 2023. (Press release, Ultimovacs, JAN 11, 2021, View Source [SID1234573838])