On February 11, 2022 Bio-Techne Corporation (NASDAQ: TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at the 11th Annual SVB Leerink Global Healthcare Conference on Thursday, February 17, 2022, at 9:20 a.m. EST (Press release, Bio-Techne, FEB 11, 2022, View Source [SID1234608009]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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On February 11, 2022 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, reported its financial results for FY 2021 and provides an update on the strategic review of its CHC business (Press release, Ipsen, FEB 11, 2022, View Source [SID1234608007]).

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David Loew, Chief Executive Officer, commented:

"The strong results in 2021 are aligned with our strategic intent, with improving levels of commercial execution reflecting in excellent performances from every major brand. As the replenishment of our pipeline gathered pace, it was an exciting year for business development and our key clinical programs. Furthermore, sharpening our focus on Specialty Care, I am pleased that we have entered into exclusive negotiations to divest our Consumer Healthcare business.

We will continue to grow our business in 2022, and beyond, through our core and innovative brands as we manage the gradual erosion of Somatuline while in addition, supporting growth through external innovation. Based on our strategy and our improved execution, we are pleased to update our mid-term outlook, underpinning the strength of Ipsen’s growth story built on our culture and an unrelenting focus on patients."

Exclusive negotiations to divest the Consumer Healthcare business
Following the decision of its Board of Directors held on 10 February 2022, Ipsen has entered into exclusive negotiations with Mayoly Spindler for the divestment of its global CHC business. This is a major step forward in the Company’s execution of its strategic roadmap presented in December 2020 towards building a more-focused Ipsen, centring on Specialty Care.

The combination of Ipsen’s and Mayoly Spindler’s respective CHC businesses will create a global consumerhealthcare platform with a critical size and the capacity to support its growth. The consideration for Ipsen’s CHC business represents an enterprise value of €350m, including an earnout contingent payment of €50m.

The proposed transaction will be submitted to the relevant employee-representation bodies and is expected to close before the end of Q3 2022, subject to regulatory approvals and customary closing conditions.

Delivering on strategy
Ipsen delivered successfully on its first year of the implementation of its strategy: Focus. Together. For patients and society. The key Specialty Care brands grew across all geographies, and alongside its expanding footprint in 2021, Ipsen began to invest in, and prepare for, a number of future launches.

It was a strong year of advancement of key R&D programs in Oncology, Rare Disease and Neuroscience, enhanced by the completion of seven external-innovation agreements. Ipsen also initiated a global program to drive efficiencies across the entire cost base, which started to deliver savings in 2021.

Further accomplishments were made in the Company Social Responsibility agenda, across the pillars of Employees, Communities and Environment. Ipsen increased the proportion of female leaders, now representing 42% of the full Global Leadership Team. Ipsen also announced the halving of absolute greenhouse-gas emissions of facilities and fleet (Scopes 1 and 2) by 2030, and will work closely with partners to deliver science-based Scope 3 emissions reductions by 2030.

Those achievements were the result of Ipsen’s evolving culture, underpinned by the strengthening of the Executive Leadership Team and the establishment of an asset-centric model. These successes provide excellent platforms for a culture of high performance, improved execution and a better and faster decision-making process.

Comparison of 2021 performance to guidance
Ipsen exceeded its full-year 2021 guidance, upgraded in October 2021:

FY 2021 guidance FY 2021 actuals
Total-sales growth Greater than 11.0%3 12.3%6
Core operating margin Around 34% 35.2%

Full-year 2022 guidance
Ipsen has set its financial guidance for FY 2022, excluding any contribution from the CHC business4:

Total-sales growth greater than 2.0%, at constant currency. Based on the level of exchange rates in January 2022, Ipsen anticipates an additional favorable impact of 2% from currencies
Core operating margin greater than 35.0% of total sales, excluding any potential impact of incremental investments from future external-innovation transaction
This guidance incorporates expectations for Somatuline of further launches of generic lanreotide in other countries in the E.U., as well as increased competition in the U.S.

Update of mid-term 2020-24 outlook
Ipsen today updates its outlook for 2020-24 to exclude any contribution from the CHC business5 and based on the strong performance delivered in 2021:

Total-sales 2020-24 compound annual growth rate between +4% and +6%6 at constant currency and assuming risk-adjusted potential additional indications
Continued commitment to invest in R&D supported by SG&A efficiencies:
Reduced SG&A expenses as a percentage of total sales, driven by further focus and optimization
Higher R&D expenses as a percentage of total sales, driven by the external-innovation strategy
To support the external-innovation strategy, Ipsen anticipates cumulative remaining firepower of €3.5bn by 2024, including the divestment of the CHC business. The calculation is based on net debt at 2.0 x EBITDA.

Palovarotene
In January 2022, Ipsen announced the first regulatory approval for palovarotene worldwide with Health Canada approving SohonosTM (palovarotene capsules). Ipsen plans to make a resubmission for palovarotene in fibrodysplasia ossificans progressiva to the U.S. FDA in H1 2022 and to continue the review process with the European Medicines Agency after the ‘clock-stop’ period. Discussions are progressing with other regulatory authorities around the world.

Basis of preparation for reported Financial Statements including the CHC business as continuing operations. 5 Earnings per share.
At constant exchange rates (CER), which exclude any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.
At CER, which exclude any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.
Assuming presentation of the CHC business as discontinued operations starting in 2022 and comparing to the FY 2021 operating performance excluding the contribution of the CHC business (as presented in the section ‘Core Measures excluding contribution from CHC’ thereafter).
Assuming presentation of the CHC business as discontinued operations starting in 2022 and comparing to the FY 2020 operating performance, excluding the contribution from the CHC business (as presented in the section ‘Core Measures excluding contribution from the CHC business’ thereafter).
Prior outlook, outlined in December 2020, included a total-sales 2020-24 compound annual growth rate of 2% to 5% at CER.

On February 11, 2022 Ichnos Sciences reported that innovation in medicine by developing potentially transformative biologic treatments in immuno-oncology (Press release, Ichnos Sciences, FEB 11, 2022, View Source [SID1234608006]). The company, currently a subsidiary of Glenmark Holding, SA, plans to pursue external financing following achievement of clinical proof of concept for its lead assets.

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Headquartered in New York City, Ichnos has discovery and manufacturing operations at two sites in Switzerland. As a fully integrated biotechnology company with approximately 225 employees, Ichnos has strong capabilities in research, antibody engineering, CMC and clinical development of biotechnologies.

Ichnos is guided by an accomplished management team with experience developing immune cell engagers within the biopharmaceuticals industry, and is led by Cyril Konto, M.D., President and Chief Executive Officer.

The proprietary BEAT technology platform1 is the basis for Ichnos’ clinical-stage oncology pipeline. Using this technology coupled with the proprietary common light chain library, the company is developing novel multispecific immune cell engagers and modulators, with the goal of realizing its mission to provide breakthrough, potentially curative therapies that may extend and improve lives, writing a new chapter in healthcare.

ONCOLOGY PIPELINE
The first wave of Ichnos’ multispecific antibody pipeline consists of five programs targeting a range of hematologic malignancies and solid tumor indications through engagement of a broad spectrum of immune cells. The most advanced program is ISB 1342, a clinical-stage, potentially first-in-class bispecific antibody targeting CD38 and CD3, which is in Phase 1 for the treatment of relapsed/refractory multiple myeloma. OVERVIEW OF SELECT ONCOLOGY DRUG PRODUCT CANDIDATES ISB 1342 (CD38 X CD3 BISPECIFIC ANTIBODY)

• A Phase 1, open-label, dose-escalation, first-in-human study of ISB 1342 in patients with relapsed/refractory multiple myeloma is ongoing. + Enrollment of patients receiving a weekly dosing regimen is ongoing. + Number of sites participating in the study was expanded in the end of 2021 to enhance enrollment. New locations in the U.S. were added and 11 sites have opened for enrollment in France and are now recruiting subjects. + Clinical proof of concept in the ongoing study is anticipated in the middle of calendar year 2022.
• The primary objectives of the study are to: + Determine maximum tolerated dose and/or recommended Phase 2 dose of ISB 1342 (Part 1 dose escalation). Assess anti-myeloma activity of ISB 1342 according to the International Myeloma Working Group response criteria (Part 2 dose expansion).
• Preclinical data on ISB 1342 were presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting and EHA (Free EHA Whitepaper) 2021 Virtual Congress.
• ISB 1342 was granted Orphan Drug Designation for multiple myeloma by the FDA.
• The bulk drug substance is manufactured at the Ichnos site in La Chaux-de-Fonds, Switzerland. ISB 1442 (CD38 X CD47 BISPECIFIC ANTIBODY)
• This first-in-class 2+1 biparatopic bispecific antibody targeting CD38 x CD47 was generated using the BEAT 2.0 technology developed by scientists in Ichnos’ laboratories in Lausanne at the Biopole life sciences campus.
• ISB 1442 is designed to kill CD38-expressing tumor cells through inhibition of the CD47-SIRPα axis to increase antibody-dependent cellular phagocytosis (ADCP) and enhance antibody-dependent cellular cytotoxicity through complement dependent cytotoxicity (CDC) and antibody-dependent cell cytotoxicity (ADCC), enabled by the architecture and engineered Fc of the molecules.
• IND-enabling studies are proceeding, and IND filing is planned for second quarter of calendar year 2022. A Phase 1/2 first-in-human dose-finding study of ISB 1442 in relapsed/refractory multiple myeloma and other select hematologic malignancies is currently planned to start in the middle of 2022.
• Preclinical data on ISB 1442 were shared in an oral presentation at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting on December 11, 2021. These data, which may be viewed at this link, show: + Higher potency in vitro for ISB 1442 relative to daratumumab in CD38 high/low tumor models as measured by a multiple antibody-dependent mechanisms of action killing assay + Higher tumor growth inhibition for ISB 1442 than daratumumab in CD38 high preclinical in vivo models + Low on-target off-tumor binding with ISB 1442 compared to anti-CD47 mAb (5F9), resulting in lower red blood cell depletion and potentially a better therapeutic index than anti-CD47 bivalent monoclonal antibodies
• The first bulk drug substance batches to support IND filing and early clinical studies were manufactured at the Ichnos site in La Chaux-de-Fonds, Switzerland in 2021.Based on BEAT 2.0 technology, ISB 2001 trispecific antibody (TREATTM) represents a first-in-class potential treatment for hematologic malignancies and is designed to extend therapeutic durability.
• Identification and amino acid sequence lock of the top two candidates was achieved in 2021. Preclinical evaluation of in vivo efficacy, PK/PD correlation, additional biophysical properties description, late pharmacology studies and other attribute-defining studies are ongoing this quarter, and the results will inform the selection of the drug product candidate in the first half of calendar year 2022.
• Process development is ongoing at the Ichnos site in La Chaux-de-Fonds, Switzerland. AUTOIMMUNE DISEASES Ichnos has two monoclonal antibody drug product candidates addressing autoimmune diseases in the pipeline. The first, ISB 880, an anti-IL-1RAP antagonist, was licensed to Almirall, S.A. in December 2021, and the second, ISB 830 (telazorlimab), an OX40 antagonist that completed a Phase 2b study in moderate to severe atopic dermatitis in calendar year 2021, is in out-licensing discussions.

Both compounds have potential across a range of autoimmune diseases and are being out-licensed to enable a greater focus on oncology. Ichnos entered an exclusive global licensing agreement for ISB 880 in autoimmune diseases with Almirall in December 2021. Within the terms of the agreement, Almirall will assume full cost and responsibility for the global development and commercialization of the compound. Ichnos received an upfront payment of €20.8 million and the deal also includes development and commercial milestone payments and tiered royalties based upon future global sales.

• ISB 880, a fully human, high-affinity, monoclonal antibody blocking IL-1RAP signaling, has completed IND-enabling studies for patients with autoimmune diseases. The optimal antibody profile, the strong in vitro and in vivo data package, as well as toxicology, CMC, and clinical pharmacology plans will enable U.S. IND filing by Almirall in the first half of calendar year 2022.
• Blockade of IL-1RAP simultaneously abrogates multiple disease drivers among the IL-1 family of proinflammatory cytokine receptors, including IL-1R, IL-33R, and IL-36R, differentiating ISB 880 from single cytokine blockade therapies. These cytokines have been implicated in numerous autoimmune conditions, opening opportunities for ISB 880 to be positioned across broad disease indications.
• To date there is no IL-1RAP antagonist approved or under clinical development for autoimmune disease, positioning ISB 880 as a potential first-in-class therapeutic.
• Ichnos will retain rights for antibodies acting on the IL-1RAP pathway for oncology indications.The database for the ISB 830-204 Phase 2b clinical study in atopic dermatitis was locked in October 2021. This study, which was conducted in the U.S., Canada, Germany, Czech Republic, and Poland, had a randomized, controlled, multicenter design and assessed three doses and two dosing schedules of telazorlimab versus placebo in adults with moderate-to-severe atopic dermatitis (AD).
• Results from the double-blind portion of the study are summarized below. + Efficacy: The primary endpoint of EASI score, % change from baseline to Week 16, was achieved for the two highest doses of telazorlimab tested (300 mg and 600 mg q 2 weeks) versus placebo. Numerical improvements were also seen for the two higher dose arms of telazorlimab compared to placebo in the secondary endpoints of EASI75 and Investigator Global Assessment, but most of the differences were not statistically significantSafety: Telazorlimab was well tolerated.

The most commonly reported adverse events (>5%) were atopic dermatitis, nasopharyngitis, upper respiratory tract infection, and headache. One patient with pre-existing hypertension in the telazorlimab group died due to a presumed cardiovascular event during the treatment period. The investigator considered the death to be unrelated to the study drug.
• In addition to data from the 16-week primary analysis period, preliminary results from the open-label extension and follow-up period of this study, which was ongoing at the time, were presented at the 2021 Society for Investigative Dermatology Virtual Meeting and are accessible here. Of note: Clinical efficacy continued to improve after Week 16, with maximal impact achieved several weeks later + Reduction in AD disease activity was maintained after discontinuation of telazorlimab, through three months of follow-up
• A U.S. IND to conduct studies of telazorlimab in autoimmune diseases, including Rheumatoid Arthritis (RA), is active. • Licensing discussions are ongoing.

On February 11, 2022 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology platform company Drugging the Genome to address disease at the base level using a new class of precision genetic medicines, reported its financial results for the three-month period ended December 31, 2021, and other recent developments (Press release, NeuBase Therapeutics, FEB 11, 2022, View Source [SID1234607987]).

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"We are making significant progress in advancing the IND-enabling studies for the development candidate for our myotonic dystrophy type 1 (DM1) program, and we expect to file an IND with the FDA in Q4 CY2022," said Dietrich A. Stephan, Ph.D., Founder, Chief Executive Officer, and Chairman of NeuBase. "These studies are on track for data readouts to occur throughout CY2022, with the first presentation of rodent pharmacokinetic and bioavailability data to occur at an upcoming scientific meeting. We expect these data to illustrate the differentiated potential for our candidate to be a whole-body solution to treat DM1 and the unique ability of our delivery shuttle for distribution into the brain. The ability to cross the blood brain barrier and reach the deep brain is also especially relevant for our Huntington’s disease program, where we are planning to initiate scale-up and toxicology activities this year."

Dr. Stephan added, "In addition, I’m especially excited to have welcomed Todd to the executive team as Chief Financial Officer. The team and science are strong, and I believe we are at a pivotal moment for NeuBase as we are building a robust data package that is expected to support bringing our first candidate into the clinic for DM1, validate our genetic medicine technology platform to efficiently deliver genetic medicines with broad tissue distribution, including into the deep brain, and to precisely engage genetic mutations in a manner that is well-tolerated with the potential for sustained efficacy."

First Quarter of Fiscal Year 2022 and Recent Operating Highlights

Myotonic Dystrophy Type 1 (DM1) Program: NeuBase is making steady progress advancing IND-enabling studies for its development candidate in the DM1 program, which includes PK, absorption, distribution, metabolism, and excretion (ADME), and bioavailability via intravenous (IV) and subcutaneous (SQ) routes of administration, exploratory and IND-enabling Good Laboratory Practice (GLP) toxicology, and mechanism of action studies. In addition, GMP manufacturing of NeuBase’s development candidate to support Phase 1/2 clinical trials has been successfully implemented via contract manufacturing organizations. The Company plans to announce a robust data package through posters and presentations at scientific meetings and peer-reviewed publications throughout CY2022. NeuBase expects these data to support the submission of an IND filing to the FDA in the Q4 CY2022.
Huntington’s Disease (HD) Program: The HD program is currently in preclinical development. In CY2022, NeuBase expects to nominate a development candidate and initiate scale-up and toxicology activities to support an IND filing to the FDA in CY2023.
KRAS Oncology Program: The Company is conducting in vitro mechanistic studies and in vivo pharmacology studies for the KRAS program (KRAS G12V and G12D mutations).
Appointed New Chief Financial Officer: The Company appointed Todd P. Branning as CFO. Mr. Branning brings more than 25 years of experience leading corporate finance and accounting, tax, financial planning and analysis, and investor relations for several publicly traded pharmaceutical companies.
Financial Results for the Fiscal Quarter Ended December 31, 2021

As of December 31, 2021, the Company had cash and cash equivalents of approximately $47.3 million, compared with approximately $52.9 million as of September 30, 2021.
NeuBase estimates its current cash and cash equivalents are sufficient to fund currently planned operating and capital expenditures into the first quarter of CY2023.
For the fiscal quarter ended December 31, 2021, the Company reported a net loss of approximately $7.7 million, or a net loss of $0.24 per share, compared with a net loss of approximately $4.1 million, or a net loss of $0.18 per share, for the same period last year.
For the fiscal quarter ended December 31, 2021, total operating expenses were approximately $7.3 million, consisting of approximately $2.9 million in general and administrative expenses and $4.4 million of research and development expenses. This compares with total operating expenses of approximately $4.7 million for the same period last year, consisting of approximately $2.7 million in general and administrative expenses and $2.0 million in research and development expenses.

On February 10, 2022 LinKinVax, a clinical-stage biotechnology company, reported completion of a €4.350 million seed capital funding round (Press release, LinKinVax, FEB 10, 2022, View Source [SID1234648589]). It was led by LinKinVax’s core shareholders and business angels and will enable LinKinVax to accelerate the clinical development of its innovative protein-based vaccine platform, which can be tweaked to changes and mutations in target pathogens.
LinKinVax has already risen to prominence in the French sector, with Bpifrance granting it €31 million under a Covid-related PIA PSCP program and Government "Plan Relance", in May 2021.
LinKinVax’s innovative technology directly targets dendritic cells ("DC"), which play a crucial role in the immune system, stimulating and regulating immune responses. It is predicated on work by the U955 research team at the Vaccine Research Institute/Inserm (VRI) in which Inserm, University of Paris Est Créteil (UPEC), and the Mondor Institute of Biomedical Research (IMRB) participate. Thanks to the potential of its technology platform and the advances in its portfolio, LinKinVax aims to make a decisive contribution to the global public health challenges of infectious diseases and cancer.

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André-Jacques Auberton-Hervé, Chairman co-founder and CEO of LinKinVax commented:

"We are thrilled that our breakthrough vaccine technology has generated so much interest among new investors, and with the renewed trust our longstanding partners, we can push ahead confidently with the next stages of our ambitious clinical program. Our objective is to provide effective vaccines as rapidly as possible to help address the public health challenges linked to the various pathogens we are targeting—HIV, SarsCov2, HPV, papillomavirus-related cancers, chlamydia."

The investors who contributed to the round are: André-Jacques Auberton-Hervé (co-founder and CEO of LinKinVax), Jean-Paul Kress (CEO of Morphosys), Geoffrey Duyk (US biotechnology entrepreneur and investor), Giorgio Anania, Rémi Gaston-Dreyfus and Alain Tingaud (recognized entrepreneurs in the high-tech sector).