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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]).

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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.

Taiwan-based Enterprises AP Biosciences and LuminX Novel Cancer Treatments

On November 30, 2020 AP Biosciences reported In recent years, an increasing number of drugs have been granted breakthrough therapy designation in the United States, encouraging more companies to propose novel cancer treatment solutions (Press release, AP Biosciences, NOV 30, 2020, View Source [SID1234572009]). Currently, there are two companies in Taiwan that are accelerating the development of these therapies and provide innovative treatments.

AP Biosciences’ target-dependent T-cell activating bi-specific antibodies

AP Biosciences (APBio) is a discovery-stage immunotherapeutic company developing mono- and bi-specific antibodies for various forms of treatment. One of the company’s major products, T-Cube bsAbs, involves bi-specific antibodies that lead T cells to cancer cells. They do so by bridging the T cells to unique antigens found on the surface of cancer cells, resulting in T cell activation which kills the cancer cells.

Unlike many current immune-therapeutic drugs (which activate the immune system to combat cancer cells while inducing a cytokine storm accompanied by strong side effects), APBio’s antibody drugs would benefit patients via improved specificity, leading to higher efficacy and a more favourable safety profile.

"T-Cube bi-specific antibodies activate cytotoxic and memory T cells upon binding to targeted cancer cells. In short, we’re creating better antibodies for better cures," explained Dr. Jeng Her, CEO of APBio. "In the near term, we see these treatments benefiting patients with liver, kidney, and lung cancers. Superiority in efficacy, safety, and cost is what makes our solutions unique and exciting to the medical community."

The strategy employed by APBio has attracted companies such as Innovent Biologics and Tasly Biopharmaceuticals to become development partners for several bi-specific antibodies. IBI302, a bi-specific antibody licensed to Innovent for the wet form of age-related macular degeneration (wet AMD), entered Phase I of clinical trials in April 2019. Further, APBio recently raised US$19.5 million in its series B funding round for the development of three in-house T-Cube antibodies, targeting human trials as early as Q4 2021.

LuminX provides cell GPS positioning in vivo

Most breakthrough therapy designations are granted to cell therapies. These therapies face great challenges in pre-market certification, owing to the difficulty of pre-clinical PK/PD data collection.

LuminX aims to accelerate and fine-tune cell therapies through better understanding of processes in the preclinical stage. With the help of an innovative cell-tracking method, live cells can be detected through fluorescence, thus making them easier to track for an extended period of time. This visibility helps scientists and researchers understand how therapeutic cells are distributed either in vivo or in vitro, how long they survive, and recognize what the cells’ eventual biological fate might be in a research or hospital setting.

According to Dr. Long-Jyun Su, CEO of LuminX, the company’s solution involves labelling cells with LuminX-tracking reagents that are non-toxic and non-genotoxic. The outcome sees labelled cells glow red for easy visual identification and remain potent long thereafter. The executive said that other techniques require 100, 1,000, or even 10,000 cells to elicit detection, whereas LuminX’s method only requires 10.

Dr. Su explained, "LuminX’s cell-tracking service is able to quantify the number of therapeutic cells in an individual organ, allowing us to obtain data on cell biodistribution and PK/PD. This means we’re able to study the movement of drugs through the animal model in the preclinical stage. Additionally for researchers and cell therapy companies, our tech will be a game-changer as it drastically cuts down the time and money otherwise needed for research and development."