On April 27, 2022 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported its sales performance for the first quarter of 2022 (Press release, Ipsen, APR 27, 2022, View Source [SID1234613008]).

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Highlights

A strong first-quarter total-sales performance, with growth of 9.6% at CER [1] (12.5% as reported) to €687.9m, driven by Decapeptyl (triptorelin), Dysport (botulinum toxin type A), Cabometyx (cabozantinib) and Onivyde (irinotecan liposome injection) double-digit growth and flat sales of Somatuline (lanreotide)
Confirmation of full-year guidance for 2022, with total-sales growth greater than 2.0% at CER1 and a core operating margin greater than 35.0% of total sales
Transaction announced in February 2022 for the divestment of the Consumer HealthCare (CHC) business anticipated to be completed by end of Q3 2022

Q1 2022 total sales

Total sales in this announcement are unaudited IFRS consolidated sales and reflect Specialty Care sales only, in accordance with IFRS 5.

David Loew, Chief Executive Officer, commented:

"The execution of our strategy was reflected in our first-quarter performance across the business. The strong sales were in line with our expectations, with Decapeptyl, Dysport, Cabometyx and Onivyde all delivering double-digit growth. Our guidance for the year, which assumes increasing levels of competition for Somatuline, is underpinned by our strong platform of growth across these core and innovative medicines.

Alongside the anticipated U.S. regulatory resubmission for palovarotene in the first half of the year, we look forward to a number of important data readouts in the second half, while our pipeline will continue to be replenished through the external-innovation strategy. It is an exciting time for Ipsen as we deliver on our strategy, produce strong results, expand our pipeline and focus together, for patients and society."

Full-year 2022 guidance

Ipsen today confirms its financial guidance for FY 2022, which excludes any contribution from CHC:

Total-sales growth greater than 2.0%, at CER [2]. Based on the level of exchange rates in Q1 2022, Ipsen anticipates an additional favorable impact of 2% from currencies in the year
Core operating margin greater than 35.0% of total sales, excluding any potential impact of incremental investments from future external-innovation transactions
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.

Ongoing conflict in Ukraine

Ipsen is firmly committed to the safety and care of its employees and to providing essential support and access to its treatments and medicines for patients.

Since the beginning of the conflict in Ukraine, Ipsen’s immediate actions have been to ensure that all colleagues are safe and to limit any impact on the supply of medicines. The Company has also provided humanitarian relief via a donation of €1.5m in favor of two highly reputed humanitarian organizations: Tulipe, a pharmaceutical distributor managing donations from health companies to meet the emergency needs of populations in distress, and The Red Cross.

Ipsen’s position is to continue to serve patients with their healthcare needs, regardless of their country origin and in compliance with applicable laws. In Russia, the Company has, however, suspended several promotional activities, including advertising. No new clinical trials will be initiated in Russia.

In 2021, Ipsen’s Specialty Care sales in Russia and Ukraine were less than 3.0% of total Specialty Care sales.

Consumer HealthCare

In February 2022, Ipsen announced that it had entered into exclusive negotiations with Mayoly Spindler for the divestment of its global CHC business, a major step forward in the Company’s execution of its strategic roadmap towards building a more-focused Ipsen, centering on Specialty Care. Ipsen confirms that the transaction is anticipated to close by the end of Q3 2022, subject to regulatory approvals and customary closing conditions.

[1] 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.

[2] At CER, which excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.

On April 27, 2022 Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, reported that it will present a poster featuring data on AL101 in adenoid cystic carcinoma (ACC) at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to take place June 3-7, 2022 in Chicago, Illinois (Press release, Ayala Pharmaceuticals, APR 27, 2022, View Source [SID1234613027]).

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Details of the poster presentation are as follows:

Abstract Title: Results of ACCURACY: A phase 2 trial of AL101, a selective gamma
secretase inhibitor, in subjects with recurrent/metastatic (R/M) adenoid
cystic carcinoma (ACC) harboring Notch activating mutations (Notchmut)
Abstract Number: 6046
Session Title: Head and Neck Cancer
Session Date and Time: Monday, June 6, 2022, 1:15 PM-4:15 PM CDT
The ongoing Phase 2 ACCURACY clinical trial is an open-label, single-arm, multi-center study to assess the clinical activity of AL101 using radiographic assessments of patients with R/M ACC demonstrating disease progression within 6 months prior to dosing. The company will present safety, efficacy, PK and PD data from the 4mg and 6mg AL101 cohorts in the trial.

About Adenoid Cystic Carcinoma (ACC)

ACC is a rare malignancy of the secretory glands including salivary glands, accounting for about 10% of all salivary gland tumors with an annual incidence of 3,400 in the U.S. There is currently no approved standard of care for patients with recurrent/metastatic ACC. Patients with locoregional disease undergo surgery and radiation therapy, with recurring disease treated by chemotherapy. ACC is an immunologically "cold" tumor that is refractory to chemotherapy, with a recurrence rate of about 60% after initial surgery. The Notch pathway has been determined to be an oncogenic driver of ACC and its dysregulation plays a key role in tumorigenesis and correlates with a distinct pattern of metastasis and a poor prognosis.

About AL101

AL101 is an investigational small molecule Gamma Secretase Inhibitor (GSI) that is designed to potently and selectively inhibit Notch 1, 2, 3 and 4, and is currently being evaluated in the Phase 2 ACCURACY clinical studies in patients with adenoid cystic carcinoma (ACC). AL101 is designed to inhibit the expression of Notch gene targets by blocking the final cleavage step by the gamma secretase required for Notch activation. Ayala obtained an exclusive, worldwide license to develop and commercialize AL101 from Bristol-Myers Squibb Company in November 2017. AL101 was granted U.S. FDA Fast Track Designation and Orphan Drug Designation for the treatment of ACC.

On April 27, 2022 Ashvattha Therapeutics ("Ashvattha"), a clinical stage company developing novel hydroxyl dendrimer therapeutics, reported it has secured $69 million in a Series B financing and in a separate agreement entered an exclusive licensing deal with Huadong Medicine (Press release, Ashvattha Therapeutics, APR 27, 2022, View Source [SID1234613043]). Proceeds will support the advancement of Ashvattha’s pipeline of hydroxyl dendrimer therapeutics (HDTs), including multiple clinical stage programs. Ashvattha launched a Phase 2 study in severe COVID-19 earlier this year and in 2022 plans to launch a Phase 2 study in wet AMD/DME and Phase 1/2 study in ALS.

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The Series B financing was led by Huadong Medicine Investment Holding Co., Ltd, with participation from existing investors, including Natural Capital, Plum Alley, Tribe Capital and several prominent technology and biotech angel investors bringing Ashvattha’s total funding to $69 million.

The exclusive licensing agreement with Huadong which includes up to $45 million advanced payments for product development, grants Huadong development and commercialization rights to its pipeline assets in China and parts of southeast Asia. Under the terms of the exclusive licensing agreement:

Huadong will advance up to $30 million to cover research and development costs for Ashvattha’s hydroxyl dendrimer clinical candidates, OP-101, D-4517.2 and OP-801, and $15 million for additional preclinical candidates
Huadong will gain exclusive licensing rights to develop, manufacture and commercialize these candidates in China, and southeast Asian countries such as Singapore and Malaysia.
Huadong will pay Ashvattha a royalty of 10% of net sales of licensed products
HDTs have been shown to selectively target reactive inflammatory cells in diseased tissue, with the ability to cross the blood-brain barrier and blood-retinal barrier to treat neurology, ophthalmology, and inflammatory diseases. Interim data from ongoing Phase 2 PRANA clinical study in severe COVID-19 patients demonstrated the ability of OP-101, an HDT, to cross the blood-brain barrier and reduce neuronal injury and systemic hyperinflammation, reinforcing the potential of the HD platform.

"We believe that hydroxyl dendrimer therapeutics are the future of precision medicine and look forward to demonstrating this with multiple clinical data catalysts in our ophthalmology, neurology and inflammatory programs this year," said Jeffrey Cleland, Ph.D., Chairman & CEO of Ashvattha Therapeutics. "This investment and partnership confirm confidence in our approach to precision medicine with disease-cell selective HDTs, as well as the broad potential of our platform, and the potential to dramatically increase the therapeutic index of drugs."

Mr. Lv Liang, Chairman of Huadong Medicine, added, "We believe Ashvattha’s hydroxyl dendrimer platform has the potential to produce highly selective drugs. This collaboration will enable us to build an R&D ecosystem, further enriching our pipeline in the fields of tumor, immunity and endocrinology. This allows us to accelerate scientific research innovation and internationalization. We look forward to working with Ashvattha to advance a new class of therapeutics that may hold the potential to enhance the treatment landscape for a broad range of patient populations."

About OP-101
OP-101 is an HDT with N-acetyl cysteine (NAC) that selectively targets reactive macrophages and microglia, which are responsible for hyperinflammation, lung injury and multi-organ failure caused by viral or bacterial infections, including COVID-19.

About D-4517.2
D-4517.2 is an HDT with potent anti-angiogenic activity inhibiting VEGFR/PDGFR that selectively targets reactive inflammatory cells and crosses the blood-retinal barrier.

About OP-801
OP-801 is an HD imaging agent that provides information on uptake of HDs across tissue barriers including the blood brain barrier. 18F-OP-801 selectively targets reactive microglia in regions of neuroinflammation in neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease.

On April 27, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that it will release financial results for the first quarter ended March 31, 2022 before the open of trading on Wednesday, May 11 (Press release, Biodesix, APR 27, 2022, View Source [SID1234613060]). Biodesix’s management will host a conference call and webcast to discuss its financial results and provide a general business update at 8:00 a.m. Eastern Time on the same day. Dial-in and call details are as follows:

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On April 27, 2022 Mirati Therapeutics, Inc. (Nasdaq: MRTX), a clinical-stage targeted oncology company reported the presentation of new clinical research showcasing the potential of its investigational KRASG12C inhibitor, adagrasib, in a study of patients with KRASG12C-mutated non-small cell lung cancer (NSCLC) at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3 to 7, 2022 in Chicago, IL (Press release, Mirati, APR 27, 2022, View Source [SID1234613076]).

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"Mirati continues to develop adagrasib with the goal of having a meaningful impact on patients with lung cancer," said Charles Baum, M.D., Ph.D., president, founder and head of research and development, Mirati Therapeutics, Inc. "Our data at this year’s ASCO (Free ASCO Whitepaper) congress includes important insights into adagrasib’s clinical profile in patients with NSCLC who harbor a KRASG12C mutation, including those with active and untreated CNS metastases, which is a serious and potentially fatal complication for these patients. We believe adagrasib has the potential to transform the lives of those with KRAS-mutated cancers including lung, colorectal, pancreatic and other tumors that carry the KRASG12C mutation."

The adagrasib New Drug Application (NDA) is currently being reviewed by the U.S. Food and Drug Administration (FDA) for Accelerated Approval (Subpart H) as a treatment for patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy. The application is being reviewed under the FDA Real Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Adagrasib has also achieved Breakthrough Therapy Designation in the U.S. as a potential treatment for patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy.

Mirati presentations at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting include:

Presentation Title: KRYSTAL-1: Activity and Safety of Adagrasib (MRTX849) in Patients with Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring a KRASG12C Mutation
Author: Alexander I. Spira
Abstract Number: 9002
Session: Lung Cancer—Non-Small Cell Metastatic
Presentation Date/Time: Friday, June 3, 2022 at 2:24 to 2:36 PM ET/1:24 to 1:36 PM CT

Presentation Title: Activity of Adagrasib (MRTX849) in Patients with KRASG12C-Mutated NSCLC and Active, Untreated CNS Metastases in the KRYSTAL-1 Trial
Author: Joshua K Sabari
Abstract Number: LBA9009
Session: Clinical Science Symposium/Including the Excluded: Advancing Care for All Patients With Lung Cancer
Presentation Date/Time: June 6, 2022 at 5:30 to 5:42 PM ET/4:30 to 4:42 PM CT

Mirati will also host an exhibit at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting at booth number 2097.

Virtual Investor Event

Mirati Therapeutics will host an Investor Event on Monday, June 6, 2022 at 8:00 PM ET / 7:00 PM CT.

Investors and the general public are invited to register and listen to a live webcast of the event through the "Investors and Media" section on Mirati.com. A replay of the event will be available shortly after the conclusion of the event.

About Adagrasib (MRTX849)

Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24-48 hours. Adagrasib is a being evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer and pancreatic cancer. For more information visit Mirati.com/science.

Mirati has an Expanded Access Program (EAP) for investigational adagrasib for the treatment of eligible patients with KRASG12C-mutated cancers, regardless of tumor type, in the U.S. Learn more about the EAP at Mirati.com/expanded-access-policy.