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Sierra Oncology to Host KOL Panel Event to Discuss Updated Phase 3 Myelofibrosis Data Presented at ASH

On December 1, 2020 Sierra Oncology, Inc. (SRRA), a late-stage biopharmaceutical company on a quest to deliver targeted therapies that treat rare forms of cancer, reported it will host an analyst and investor event on Wednesday, December 16, 2020 at 10:00 am ET (Press release, Sierra Oncology, DEC 1, 2020, View Source [SID1234572014]). The event will feature three leading myelofibrosis experts:

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Jean-Jacques Kiladjian, MD, PhD, Saint-Louis Hospital; Paris Diderot University
Ruben Mesa, MD, Director of the Mays Cancer Center, home to UT Health San Antonio, MD Anderson Cancer Center
Srdan Verstovsek, MD, PhD, University of Texas; MD Anderson Cancer Center
The call will include an overview of momelotinib data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, a panel discussion moderated by Barbara Klencke, MD, Chief Development Officer of Sierra Oncology, and an open question & answer session with attendees.

Analyst & Investor Event and Webcast Information

Date and Time: Wednesday, December 16, 2020, 10:00 am ET

To register, please click here.

The presentation will be webcast live, and an archive of the presentation will be accessible after the event through the Sierra Oncology website: www.SierraOncology.com.

About Momelotinib

Momelotinib is a selective and orally bioavailable JAK1, JAK2 and ACVR1 inhibitor currently under investigation for the treatment of myelofibrosis. Myelofibrosis results from dysregulated JAK-STAT signaling and is driven by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia.

Momelotinib is currently under investigation in the MOMENTUM clinical trial, a global, randomized, double-blind Phase 3 study for symptomatic and anemic myelofibrosis patients. Top-line data are anticipated in H1 2022. The U.S. Food & Drug Administration has granted Fast Track designation for momelotinib.

Ipsen highlights new strategic priorities and provides mid-term financial outlook

On December 1, 2020 Ipsen (Euronext: IPN; ADR: IPSEY), a specialty-care focused biopharmaceutical group, reported that it will host a virtual Capital Markets Day to highlight the Group’s new strategic priorities with the aim of driving continued growth and bringing transformative medicines to patients (Press release, Ipsen, DEC 1, 2020, View Source [SID1234572012]).

David Loew, Chief Executive Officer of Ipsen stated: "Our new Group strategy positions Ipsen for long-term success by focusing together for patients and society. We will reinforce our commitment to Oncology, Rare Disease and Neuroscience by strengthening and accelerating our external innovation efforts and pipeline in clearly-defined segments. Through prioritization and collaboration, we will drive efficiencies to support investment in our pipeline. We are building on a strong foundation of engaged employees, agile development capabilities and global commercial footprint. I am energized to execute on our key strategic priorities to create long-term value for all stakeholders."

Bring the full potential of innovative medicines to patients

Ipsen is focused on maximizing the value of its current Specialty Care product portfolio through commercial excellence and geographic expansion. The Group aims to maximize its core brands Somatuline (lanreotide), Decapeptyl (triptoreline) and Dysport (botulinum toxin type A) and capture the full potential of its innovative oncology products Cabometyx (cabozantinib) and Onivyde (irinotecan liposome injection). If approved, the launch of palovarotene will be a key milestone to bring this medicine to patients with FOP and strengthen Ipsen’s presence in Rare Disease.

A strategic review of the Consumer Healthcare business is proceeding.

Build a high-value sustainable pipeline

Ipsen’s priority is to build a sustainable pipeline to drive long-term growth. Recent initiatives have prioritized the pipeline on the highest potential opportunities and progressed the transformation of the R&D organization. Ipsen is strengthening its external innovation efforts by targeting differentiated medicines in its three core therapeutics areas of Oncology, Rare Disease and Neuroscience, with a broader disease and modality scope than previously defined, and across all stages of clinical development.

Deliver efficiencies to enable targeted investment & growth

Ipsen is committed to generating efficiencies through a focused and agile operating model. Leveraging smart spending, streamlined operations, manufacturing efficiencies and optimizing digitalization, the Group will be able to reinvest in R&D and external innovation to fuel future growth.

Boost culture of collaboration & excellence

Patients and society are at the core of Ipsen’s mission, starting with fully engaged employees and a culture of accountability to perform and compete in the long-term. Ipsen is highly committed to its corporate social responsibility (CSR) initiatives which are centered around employees, community and the environment, as reflected throughout the organization and in the inclusion of responsibility metrics in management compensation.

Mid-term financial outlook and capital allocation strategy

Ipsen provides its financial outlook for the period 2020-20241:

Group Net Sales CAGR2 between +2% and +5%3,assuming potential additional indications
Commitment to invest in R&D supported by SG&A efficiencies
Lower SG&A as a percentage of net sales driven by further focus and optimization
Higher R&D as a percentage of net sales driven by external innovation strategy
External innovation is Ipsen’s number one priority for capital allocation. In support of its external innovation strategy, Ipsen expects to generate by 2024 a cumulative €3bn4 of firepower for pipeline expansion, excluding the sale of any assets.

Webcast

Ipsen will host a video webcast of the Capital Markets Day on Tuesday, 1 December 2020 from 2:00 p.m. to 5:00 p.m. CET (GMT+1) available at www.ipsen.com. Participants should log in to the webcast approximately 5 to 10 minutes prior to its start. No reservation is required to participate in the conference call.

Webcast link: View Source

Please note this event will be streamed live. No dial-in number available.

A recording will be available for 14 days on Ipsen’s website.

1 Ipsen is on track to deliver its previous 2022 financial targets and is committed now to a new 2024 financial outlook

2 Compound Annual Growth Rate

3 At constant exchange rates and scope

4 Based on Net Debt remaining below 2.0x EBITDA

Nordic Nanovector completes patient enrolment into Phase 1 trial of Betalutin® in Diffuse Large B Cell Lymphoma

On December 1, 2020 Nordic Nanovector ASA (OSE: NANO) reported that it has completed enrolment into the LYMRIT 37-05 Phase 1 clinical trial of Betalutin (177Lu lilotomab satetraxetan) in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) not eligible for autologous stem cell transplantation (ASCT) (Press release, Nordic Nanovector, DEC 1, 2020, View Source [SID1234571999]).

Eighteen DLBCL patients were enrolled into the trial at clinical trial sites in the US and Europe and were dosed with three escalating treatment doses of Betalutin (10MBq/kg, 15MBq/kg and 20MBq/kg). A preliminary data readout is expected in H1’2021.

As announced in April 2020, LYMRIT 37-05 will be paused pending analysis of these data, which is expected to inform plans for the further development of Betalutin in R/R DLBCL.

Nordic Nanovector’s primary focus is the timely completion of the pivotal Phase 2b PARADIGME trial of Betalutin in 3rd-line follicular lymphoma (3L FL).

Christine Wilkinson Blanc, Chief Medical Officer of Nordic Nanovector, said: "The completion of recruitment into this dose-finding study in patients with DLBCL is an important milestone. DLBCL remains a significant indication with a large unmet medical need. The data analysis from this trial will form the basis of our considerations for the further development of Betalutin in DLBCL and more broadly across non-Hodgkin’s lymphoma."

The LYMRIT 37-05 study is a Phase 1 open-label, single-arm, dose-escalation study in DLBCL designed to determine the dose to be recommended for further studies in DLBCL and assess the safety, tolerability, pharmacokinetic profile and preliminary anti-tumour activity of a single administration of Betalutin. More information on this study can be found at www.clinicaltrials.gov (NCT02658968).

DLBCL is an aggressive form of non-Hodgkin’s Lymphoma (NHL) that accounts for 30% of all NHL cases1,2. The number of diagnosed incident cases of DLBCL in the seven major markets (US, key five European markets and Japan) was 64,172 in 2018 and is expected to grow to 74,927 in 20283.

Approximately 40% of DLBCL patients relapse after first-line combination treatment with rituximab and chemotherapy. These patients have few therapeutic options, with high-dose chemotherapy and autologous stem cell transplant (ASCT) achieving long-term remissions in only a minority of patients4. Relapsed DLBCL therefore remains a serious unmet medical need.

References

Siegel R, Miller K and Jemal A. Cancer Statistics, 2019. CA Cancer J. Clin. 2019;69(1):7-34
View Source
Non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL), 2020, Decision Resources Group, Clarivate
Liu Y, Barta SK. Diffuse large B-cell lymphoma: 2019 update on diagnosis, risk stratification, and treatment. Am J Hematol. 2019 May;94(5):604-616.

Transition Bio, Inc. Closes Seed Financing and Launches Company

On November 30, 2020 Transition Bio, Inc. ("Transition Bio" or the "Company") reported forming, funding, and launching with the focused objective to build the best and first-in-class technological capabilities required to evaluate and advance the novel area of cell biology known as condensates (Press release, Transition Bio, NOV 30, 2020, View Source [SID1234648797]).

The initial closing of the Company’s Series Seed financing occurred at the end of September and was led by Lifeforce Capital.

Transition Bio brings together the unique fundamental knowledge and experience of Professor David Weitz of Harvard University’s John A. Paulson School of Engineering and Applied Sciences and Department of Physics, and Professor Tuomas Knowles of the University of Cambridge’s Departments of Chemistry and Physics.

"After nearly 15 years of supporting each other’s work from an academic point of view, it is extremely exciting to combine the distinctive capabilities of our respective labs," commented Professor Weitz. "It is our strong belief that this area of liquid-liquid phase separation offers an amazing opportunity in human health care advancement."

Professor Knowles added, "David and I have long discussed how we could merge our knowledge and technologies to create something substantial that could genuinely change the world." Knowles continued, "The combination of unique physical science methods with microfluidics and "big data" allows for disruptive advances in the world of drug discovery and diagnostics."

Professors Weitz and Knowles branded the analysis of condensates cell biology based on the Company’s proprietary technology as Condensomics. Transition Bio aims to make the Company the world leader in the field. When fully built, Transition Bio’s condensomics approach will replace the industry’s current reliance on inadequate conventional technologies to study biomolecular condensates.

Leading the Company’s research efforts is Assaf Rotem, Ph.D., who joined as Head of Research and Development based in Cambridge, MA. Assaf was most recently Director and Group Leader of Platform Technology at Repertoire Immune Medicine and was a Postdoctoral Research Fellow in Biomicrofluidics at Harvard University under the direction of Professor Weitz. Assaf will lead a team of scientists based in Cambridge, MA, the Company’s headquarters, and Cambridge, UK, together with William Arter, Ph.D., and Georg Krainer, Ph.D., members of the Knowles Lab who are responsible for the Company’s UK-based scientific operations.

Transition Bio further announced that its Board of Directors will include Professor Weitz, Professor Knowles, Dr. Samuel Cohen (UK), David Zimble, Esq. (Israel), and Executive Chairman, Kelly Martin (U.S.). Owen Hughes (U.S.) will serve as an advisor to the Company.

Baudax Bio to Participate in the Piper Sandler 32nd Annual Healthcare Conference

On November 30, 2020 Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, reported that Gerri Henwood, the Company’s President and Chief Executive Officer, will participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference, being held virtually December 1-3, 2020 (Press release, Baudax Bio, NOV 30, 2020, View Source [SID1234572279]). The company will conduct institutional investor meetings on December 2, 2020; meetings may be requested through Piper Sandler.

A pre-recorded fireside chat with Ms. Henwood is now available on the Piper Sandler conference site and on the "Events" page within the Investors section of the Baudax Bio website at View Source The recording will be available for a period of 30 days following the event.