1stOncology™: Cancer Intelligence Service – Page 6479 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Philogen receives authorisation to initiate new study in France to evaluate Nidlegy™ in several non-melanoma skin cancers

On February 17, 2022 Philogen S.p.A. ("Philogen" or "the Company"), a clinical-stage biotechnology company focused on antibody and small molecule-based targeted therapeutics, reported that France’s National Agency for the Safety of Medicines and Health Products (ANSM) has authorized the Company to run a Phase II study of Nidlegy in patients affected by different nonmelanoma skin cancer indications (Press release, Philogen, FEB 17, 2022, View Source [SID1234608209]). A favourable opinion about the study had already been obtained by one of the country’s ethic committees (Comité de Protection des Personnes Sud-Est III) in January 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Patients affected by Basal Cell Carcinoma (BCC), cutaneous Squamous Cell Carcinoma (cSCC), Merkel Cell Carcinoma, Keratoacanthoma, tumoral cutaneous T-Cell Lymphoma, Kaposi’s Sarcoma or Adnexal Tumors of the Skin, for whom available alternatives have already been exhausted or who are no candidates to such alternative approaches will be eligible for the clinical study.

Nidlegy, the combination of the two active principles bifikafusp alfa (L19IL2) and onfekafusp alfa (L19TNF), has already shown promising results in the intralesional treatment of patients with advanced melanoma and in BCC and cSCC in an ongoing Phase II study. The durable responses, excellent safety profile and favourable cosmetic outcome of injected lesions have encouraged the investigation of efficacy and safety of Nidlegy in injectable lesions of numerous non-melanoma skin cancer indications, which are underserved by alternatives presently available.

Prof. Dario Neri, co-founder and President of the Scientific Advisory Board of Philogen said: "We are delighted to start this clinical Phase II study in non-melanoma skin cancers in France under the leadership of Prof. Jean-Jacques Grob, a world-class expert in this group of tumors and to explore the potential of Nidlegy in patients for whom existing therapeutic alternatives are not or no longer practicable."

Targovax ASA: Fourth quarter 2021 results

On February 17, 2022 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported its fourth quarter 2021 results (Press release, Targovax, FEB 17, 2022, View Source [SID1234608204]). Targovax’s CEO will give an online presentation and update on the clinical program to investors, analysts and the press at 10:00 CET today (details below).

2021 HIGHLIGHTS
ONCOS-102
Reported class-leading ORR of 35% for ONCOS-102 in PD1-refractory melanoma, associated with broad and powerful immune activation in responding tumors
Reported 25.0 months median Overall Survival (mOS) for ONCOS-102 combined with chemotherapy in first line mesothelioma
Granted two Fast-Track designations for ONCOS-102 by the US FDA, for both PD1-refractory melanoma and malignant pleural mesothelioma
NextGen circRNA ONCOS vectors
Expanded the pipeline programs into circular RNA delivery
Appointed Dr. Erik Digman Wiklund as CEO, previous Targovax CBO and CFO and circRNA co-discoverer
Appointed circRNA co-discoverer Dr. Thomas B Hansen as VP of Research to lead the NextGen circRNA ONCOS pipeline program
Announced a research collaboration with Prof. Michael Uhlin at Karolinska Institutet in Stockholm for development and characterization of NextGen ONCOS viruses
Mutant KRAS
Awarded two prestigious research grants towards the TG mut KRAS vaccine program totaling NOK 18m over four years; NOK 9.8m from the Research Council of Norway and NOK 8.2m from Innovation Norway
Corporate
Completed a rights issue raising gross proceeds of NOK 175m
Erik Digman Wiklund, CEO commented: "During 2021, adenoviruses clearly pulled ahead as the most promising class for oncolytic immunotherapy, as demonstrated by convincing clinical data from both Targovax (ONCOS-102) and several of our peers. When it comes to the breadth, depth, and consistency of the translational analyses from our phase 1/2 clinical program, the totality of the ONCOS-102 data package is second to none. As such, Targovax can now soundly be considered one of the front-runners in the oncolytic virotherapy space. We are planning to leverage this position by building an innovative pipeline of NextGen ONCOS viruses, including a move into the emerging circular RNA field."

Scandion Oncology announces its results for the fourth quarter and year-end 2021

On February 17, 2022 Scandion Oncology (Scandion) reported its fourth quarter and year-end report for 2021 (Press release, Scandion Oncology, FEB 17, 2022, View Source,c3508355 [SID1234608203]). The following is taken from the report.

Bo Rode Hansen, President and CEO, comments

"The fourth quarter completed a busy and successful 2021 for Scandion in which we transformed the company on substantially all accounts, increasing its fundamental value. We have prepared for the future with continued focus on fundamental value creation and are poised to enter the right partnerships for Scandion when the data are ready."

Highlights during Q4 2021

On November 8, Scandion Oncology announced that the timeline for read-out of the dose-finding clinical Phase Ib study PANTAX will be extended, and read-out is expected in Q2-Q3 2022. The reasons are challenging patient recruitment and a staggered study design, as requested by the German authorities. Disregarding this postponement, the study is performing as well as the Company could have hoped for.
Highlights after the end of the period

On January 12, Scandion Oncology announced that Mads Kronborg, bringing more than a decade of corporate communication and investor relations experience in the global life-science industry, will now help plan and drive its external communication as Head of External Communication.
On January 18, Scandion Oncology announced that data with the Company’s lead compound SCO-101 as combination therapy in patients with metastatic colorectal cancer was accepted for poster presentation at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium.
On February 2, Scandion Oncology announced approval from the German and Spanish regulatory authorities to expand part 2 of the CORIST Phase II study to Germany and Spain.
The Q4 and year-end report 2021 is available on the Company’s website: www.scandiononcology.com.

Audiocast today, February 17 at 08:30 am CET

Today at 08:30, Scandion Oncology’s executive management will host a webcast and conference call presenting the results and a company update.

At the end of the presentation there will be a Q&A session.

Access to the event can be obtained as follows:

View Source

REPLAY access:

Webcast replay will be available at www.scandiononcology.com in the Investors section and at www.financialhearings.com

The information was provided by the contact person above for publication on February 17, 2022, at 07.30 CET.

Cambrian BioPharma Announces Licensing Agreement to Develop Selective mTOR Inhibitors

On February 16, 2022 Cambrian BioPharma, a multi-asset longevity biotech, reported a licensing agreement with Novartis to advance novel, selective compounds designed and characterized by Novartis to target the mechanistic target of rapamycin (mTOR) pathway (Press release, Cambrian Biopharma, FEB 16, 2022, View Source [SID1234649843]). The licensed assets are structural analogs of the FDA-approved drug rapamycin, which has been shown to prevent or reverse multiple age-related health deficits in mice1 and extend their average lifespan by up to 31%2.

The assets will be developed by new Cambrian subsidiary Tornado Therapeutics led by industry and Novartis veteran Joan Mannick, M.D., as CEO. The most advanced asset is now moving into IND-enabling studies, while a second asset is undergoing preclinical efficacy testing.

Under the terms of the agreement, Cambrian acquired exclusive, worldwide rights to the assets, while Novartis received an upfront payment and is entitled to royalties and milestone payments for successfully commercialized medicines. Financial terms of the agreement were not disclosed.

"Pioneers in longevity therapeutics have seen the potential of next-generation mTOR inhibitors for years," said James Peyer, CEO of Cambrian BioPharma. "This partnership, led by Dr. Mannick and combining Cambrian’s development capabilities with the foundational work done at Novartis, creates a fantastic opportunity to bring a new class of potentially safer, more effective mTOR inhibitors to patients."

"Although mTOR inhibitors are the best validated therapeutic targeting aging biology, their potential benefits for human aging are just beginning to be explored," said Dr. Mannick, CEO of Tornado Therapeutics. "The assets we have in-licensed from Novartis will allow us to do a thorough assessment of the safety and efficacy of mTOR inhibitors in aging-related conditions in humans with the ultimate goal of extending healthy lifespan."

Dr. Mannick joins Tornado Therapeutics from Life Biosciences, where she served as Head of Research and Development. Prior to joining Life Biosciences, she was the Co-Founder and Chief Medical Officer of resTORbio, now Adicet Bio. Previously, she served as Executive Director of the New Indications Discovery Unit at the Novartis Institutes for BioMedical Research, where she led clinical studies of mTOR inhibitors to improve immune function in older adults. Prior to Novartis, Dr. Mannick served as Medical Director at Genzyme working in multiple therapeutic areas and was faculty member at Harvard Medical School and University of Massachusetts Medical School. She received an A.B. from Harvard College and an M.D. from Harvard Medical School and completed her residency at Brigham and Women’s Hospital, followed by an infectious diseases fellowship as part of the Harvard Combined Infectious Diseases Program.

About mTOR Inhibitors

The FDA-approved drug rapamycin and its analogues (rapalogs) are inhibitors of the mechanistic target of rapamycin (mTOR). mTOR inhibitors are an exceptionally well-explored therapeutic class, encompassing three FDA-approved medications evaluated in more than 3,000 clinical trials. Recent studies have demonstrated that mTOR inhibitors extend health and lifespan in multiple organisms, including yeast, worms, flies and mice, establishing them as the best validated class of longevity therapeutics1. The next generation mTOR inhibitors in-licensed by Cambrian are predicted to have improved safety and efficacy as compared to currently approved rapalogs.

DEFENCE RETAINS CATO SMS TO ADVISE ON ITS PHASE I CLINICAL TRIAL ON ACCUTOXTM FOR BREAST CANCER

On February 16, 2022 Defence Therapeutics Inc. ("Defence" or the "Company"), a pre-clinical biotechnology company developing various products for the immuneoncology space, is pleased to reported the establishment of an agreement with Cato SMS, to advise on the submission of its clinical application to Health Canada in order to initiate a Phase I trial using AccuTOXTM against breast cancer (Press release, Defence Therapeutics, FEB 16, 2022, View Source [SID1234626247]).

CATO SMS is a consulting firm with more than 30 years of global experience to guide clinical development of biopharma pipelines. With offices across North America, Europe, and the Middle East, CATO SMS has experience conducting trial designs in more than 25 countries. Their specialists deliver innovative regulatory consulting solutions to guide complex challenges with a proven center of excellence in oncology.

"We are very pleased to work with Cato SMS on our AccuTOXTM program. This step is central to Defence as it ensures the achievement of important milestones for our clinical program. Cato SMS will be designing the clinical protocol, pre-CTA meeting package, CTA Compilation and Submission as well as regulatory affairs for our AccuTOXTM Phase I trial" says Mr. Plouffe, the CEO of Defence.

The AccuTOXTM program consists of using a lead variant of the AccumTM molecule to trigger cell death in cancer cells. When combined with the immune-checkpoint inhibitor CTLA-4, this lead AccumTM triggered potent anti-tumoral response in several cancer models including, T-cell lymphoma, melanoma, colon and breast cancer. As such, Defence plans to use AccuTOXTM in its Phase I to treat breast cancer patients in Q4 of 2022.

According to Fortune Business InsightsTM, the Global Breast Cancer Therapeutics Market to exhibit 13.1% CAGR and hit USD 55.27 Billion till 2027.