1stOncology™: Cancer Intelligence Service – Page 10779 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

BioInvent receives €2 million milestone from Daiichi Sankyo

On October 22, 2020 BioInvent International AB ("BioInvent" or the "Company") (OMXS: BINV) reported that it will receive a €2 million milestone payment under its collaboration with Daiichi Sankyo related to the initiation of a global Phase I clinical trial with an anti-glycoprotein A repetitions predominant (GARP) directed antibody (Press release, BioInvent, OCT 22, 2020, https://www.prnewswire.com/news-releases/bioinvent-receives-2-million-milestone-from-daiichi-sankyo-301157650.html [SID1234568754]).

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!

The first-in-human, global, multi-center, open-label phase l dose escalation study, being conducted by Daiichi Sankyo, will evaluate the safety and tolerability of DS-1055 in adult patients with advanced or metastatic solid tumors.

The antibody DS-1055 was discovered by Daiichi Sankyo and targets GARP, a transmembrane protein expressed on the surface of regulatory T cells (Tregs), which are involved in immune tolerance and have strong immunosuppressive activity.i

The discovery of DS-1055 was supported by access to BioInvent’s proprietary n-CoDeR antibody library through a collaboration agreement. Under the terms of the agreement, payments are due to BioInvent when certain clinical milestones are achieved, and royalty payments are due on net sales when a product is commercialized.

Martin Welschof, CEO of BioInvent, said: "We are very pleased with the initiation of this Phase I clinical trial with DS-1055 and look forward to further collaboration with Daiichi Sankyo. We continue to apply our versatile n-CoDeR/F.I.R.S.T technology platform to our in-house clinical development program, and to our partnering model which gives us many shots on goal."

Alligator Bioscience focuses on ATOR-1017 and mitazalimab

On October 22, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the decision to focus its resources on the two proprietary candidate drugs, ATOR-1017 and mitazalimab (Press release, Alligator Bioscience, OCT 22, 2020, View Source [SID1234568753]). Positive safety and strong Proof of Mechanism data support moving both into clinical efficacy (Phase Ib/II) studies in 2021. Due to this prioritization, Alligator will complete the ongoing dose-escalation study with the bispecific ATOR-1015 as planned during Q4 2020, after which it will be partnered for further development.

"ATOR-1017 and mitazalimab are frontrunners worldwide and Alligator must prioritize and focus investments on these assets to maximize their value. They both have potential in large cancer indications with high medical need and billion-dollar markets. They also target important immune mechanisms where clinical validation is now emerging and has attracted significant interest already. Under the revised plan, resources will be concentrated to the upcoming phase Ib/II efficacy studies for ATOR-1017 and mitazalimab", said Per Norlén, CEO at Alligator Bioscience.

The decision to focus the clinical resources to ATOR-1017 and mitazalimab is further explored in the Q3 interim report, published today October 22 at 8:00 a.m.

Alligator will host a conference call today at 2:00 p.m. CEST for investors, analysts and media, where CEO Per Norlén will present and comment on the Q3 interim report and the focus of the clinical operations. The conference will be held in English. All necessary information to listen-in and ask questions are available on the following link: View Source

Ipsen Delivers Sales Growth in the First Nine Months of 2020 Despite the Impact of COVID-19 and Confirms Its 2020 Full Year Guidance

On October 22, 2020 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported sales for the third quarter of 2020 (Press release, Ipsen, OCT 22, 2020, View Source [SID1234568750]).

Q3 2020 Group sales growth of +2.2%1 at constant exchange rates and decrease of -1.8% as reported, driven by Specialty Care sales growth of 5.1%1 despite the continuing negative COVID-19 impact. Positive Q3 performance results in YTD sales growth of +2.8%1 at constant exchange rates and +1.5% as reported.
Confirmation of 2020 full year guidance, with Group sales growth greater than +2.0% at constant currency and Core Operating margin greater than 30.0% of net sales.
Key Q3 pipeline progress:
Cabometyx (cabozantinib): Presentation at the ESMO (Free ESMO Whitepaper) 2020 Virtual Congress of the Phase III CheckMate -9ER trial in patients with previously untreated advanced renal cell carcinoma, in which Cabometyx in combination with nivolumab met all key efficacy endpoints of overall survival, progression-free survival and objective response rate. The results were consistent across the pre-specified International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk and PD-L1 expression subgroups.
Palovarotene: Presentation at the American Society for Bone and Mineral Research (ASBMR) 2020 Annual Meeting of post hoc analyses from the Phase III MOVE trial investigating palovarotene as a chronic and episodic treatment for patients with fibrodysplasia ossificans progressiva (FOP).
Appointment of Philippe Lopes-Fernandes as Executive Vice President, Chief Business Officer, effective 1 October 2020, with responsibility for business development and alliance management.
David Loew, Chief Executive Officer of Ipsen stated: "The Group delivered a resilient performance in the third quarter, despite the continued impact of the pandemic, and I am pleased to confirm our 2020 full year financial objectives. Our pipeline achieved notable progress with incremental positive data on Cabometyx and palovarotene, supporting our intention to bring these important therapies to patients. I look forward to sharing my long-term vision for Ipsen and the outcomes of a comprehensive strategic review at our Capital Markets Day on December 1st."

COVID-19 impact

In the third quarter of 2020, the business recovered gradually from the impact of COVID-19. While the Specialty Care portfolio comprised of differentiated products for critical conditions remained relatively resilient, Somatuline, Decapeptyl and Onivyde sales were negatively impacted by lower patient diagnoses and missed treatments due to the ongoing impact of the pandemic and the challenging hospital environment. In neuroscience, the aesthetics market showed a stronger recovery, while the therapeutics market rebounded more slowly with the gradual re-opening of injection centers. Consumer Healthcare sales, notably Smecta, continued to be negatively impacted across geographies.

The Group continued to realize cost savings in the third quarter, resulting from digital sales detailing, lower travel throughout the Group and the conversion to virtual conference and medical meetings.

2020 Guidance confirmed

The Group confirms the following financial targets for the current year:

Group sales growth greater than +2.0% at constant currency, with an expected negative impact of 1.5% from currencies based on the level of exchange rates at the end of September.
Core Operating margin greater than 30.0% of net sales
Recent pipeline highlights

Positive results of the Phase III CheckMate -9ER trial presented at the ESMO (Free ESMO Whitepaper) Congress, in which Cabometyx in combination with Bristol Myers Squibb’s Opdivo (nivolumab) demonstrated significant improvements across all efficacy endpoints, including superior overall survival (OS), a doubling of median progression-free survival (PFS) and superior objective response rate (ORR) versus sunitinib, with a favorable safety profile in previously untreated advanced renal cell carcinoma (RCC). Key efficacy results were consistent across the pre-specified International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk and PD-L1 expression subgroups. The regulatory filing has been submitted and validated by the EMA, thus beginning the centralized review process.
At the American Society for Bone and Mineral Research (ASBMR) 2020 Annual Meeting, Ipsen presented post hoc analyses from the Phase III MOVE trial investigating palovarotene as a chronic and episodic treatment for fibrodysplasia ossificans progressiva (FOP) in both pediatric and adult patients, with palovarotene demonstrating a 62% reduction in mean annualized new heterotopic ossification (HO) volume relative to untreated patients from a longitudinal Natural History Study (NHS).
The Phase II CLARINET FORTE study results showed that increasing the dose frequency of Somatuline from monthly to bi-monthly achieved a progression-free survival of 8.3 months in patients with progressive midgut neuroendocrine tumors (NETs) and 5.6 months in patients with progressive pancreatic NETs. These results showed no new safety signals associated with this increased dose regimen, potentially delaying the need for additional, more toxic second-line therapies.
Third quarter 2020 sales highlights

Note: Unless stated otherwise, all variations in sales are stated excluding foreign exchange impacts (currency effects established by recalculating net sales for the relevant period at the exchange rates from the previous period)Q3 2020 Group sales grew 2.2%1 to €633.3 million.

Sales of Specialty Care products reached €580.5 million, up 5.1% year-on-year.

Somatuline sales reached €272.9 million, up 7.1% year-on-year, driven by volume growth in North America, the U.K. and Germany and despite delays in patient diagnoses and treatment due to COVID-19. In the U.S., the performance of Somatuline in Q3 was also negatively impacted by end-user buying patterns.

Decapeptyl sales reached €94.5 million, down 2.8% year-on-year, mainly due to lower sales in China and in some European countries as a result of the impact of COVID-19.

Cabometyx sales reached €76.8 million, growing 20.9% year-on-year, driven by good performance in Major Western European countries, Russia and Brazil.

Onivyde sales reached €27.5 million, up 11% year-on-year, driven by volume growth in the U.S.

Dysport sales reached €87.4 million, down 1.4% year-on-year, impacted by COVID-19 despite a gradual recovery of the therapeutics market and better dynamics in the aesthetics market.

Consumer Healthcare product sales reached €52.8 million, down 21.9%1, with a decrease in Smecta sales of 38% impacted by COVID-19, implementation of hospital central procurement in China and lower performance in France.

Conference call

Ipsen will hold a conference call Thursday, 22 October 2020 at 2:30 p.m. (Paris time, GMT+1). Participants should dial in to the call approximately 15 minutes prior to its start.

Participants can register for the call on the link below:
View Source

Conference ID: 3185126

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

salk institute and bridgebio pharma collaborate to advance therapies for genetically driven disease

On October 21, 2020 The Salk Institute and BridgeBio Pharma, Inc. (Nasdaq: BBIO) reported a three-year collaboration agreement formed to advance cutting-edge academic discoveries in genetically driven diseases toward therapeutic applications (Press release, BridgeBio, OCT 21, 2020, View Source [SID1234576223]). Under the partnership, BridgeBio will help fund research programs from Salk’s world-renowned innovative cancer research, with the eventual goal of developing new therapeutics for patients in need.

"Salk is known for its outstanding research, in particular in the field of oncology, so we are excited to enter into this partnership with BridgeBio to advance our discoveries and help develop next-generation therapies," says Salk Vice President and Chief Science Officer Martin Hetzer, Ph.D. "The partnership represents an excellent opportunity for academic research to reach new potential in the clinical setting."

"BridgeBio is focused on partnering with leading academic institutions to accelerate promising research into clinical studies, with a range of therapeutic modalities such as biologics, gene therapies and small molecules," said BridgeBio CEO and founder Neil Kumar, Ph.D. "The Salk Institute is known as a place where great science is occurring—and has occurred for decades—and we feel privileged to have the opportunity to partner with them. Through this partnership, we look forward to translating exciting academic findings into potential treatments and understanding the impact they may bring to patients."

The Salk Cancer Center is one of seven National Cancer Institute (NCI)-designated basic research cancer centers in the United States. Here, researchers are using game-changing technologies to expose the molecular mechanisms underlying tumors in order to develop targeted cancer therapies. Salk is also home to the Conquering Cancer Initiative, which is a scientific and philanthropic endeavor to bring together collaborative cancer researchers to harness new strategies against five deadly cancers: pancreatic, ovarian, lung, brain (glioblastoma) and triple-negative breast. Salk’s scientists aim to identify cancer’s vulnerabilities in order to develop new methods that can attack the tumors while leaving the healthy tissues alone.

BridgeBio partners with academic institutions, like the Salk Institute, to support early-stage research around genetically validated targets. Through close collaboration, BridgeBio aims to rapidly translate novel discoveries into potentially life-saving treatments. The company works across multiple genetically driven diseases and therapeutic areas, helping provide the insights and support needed to rapidly bring the latest scientific advancements from the lab bench to the patient bedside. Its academia-industry collaborations focus on creating partnerships with biomedical research institutes that are built on trust, engagement, science and respect.

bridgebio pharma, inc. and the university of colorado anschutz medical campus collaborate to advance medicines for genetically driven diseases

On October 21, 2020 BridgeBio Pharma, Inc. (Nasdaq: BBIO) and the University of Colorado Anschutz Medical Campus reported a collaboration to advance novel research on genetically driven diseases into therapeutic applications for patients (Press release, BridgeBio, OCT 21, 2020, View Source [SID1234576222]).

"We are grateful to be collaborating with the University of Colorado Anschutz Medical Campus, which is the largest academic health center in the Rocky Mountain region, a world-class medical destination, and home to one of the leading Personalized Medicine Centers in the country. We are excited to work together to translate life-changing discoveries from the lab into potential medicines for patients," said BridgeBio CEO and founder Neil Kumar, Ph.D.

This collaboration comes on the heels of an eight-month pilot collaboration. Under the new, expanded collaboration, BridgeBio will support early-discovery research already underway in CU Anschutz labs and will accelerate promising therapies into the clinic in order to develop and ultimately commercialize therapies for patients. The collaboration’s structure focuses on close partnership, actionable feedback and joint touchpoints between the BridgeBio and the CU Anschutz research teams.

"This collaboration represents a new model between academia and the pharmaceutical industry. It provides all CU Anschutz faculty with the opportunity to translate cutting edge research in genetic science to patients with unmet needs," said Kimberly Muller, Executive Director of CU Innovations. "BridgeBio is uniquely suited as a collaborator as they combine a novel drug discovery platform, with the processes needed to advance multiple individual therapies simultaneously. Together, we will find, develop and deliver breakthrough medicines for genetic diseases to patients as quickly and safely as possible."

BridgeBio is determined to move away from traditional one-off interactions between drug development companies and research institutions and formalize collaborations that are built on trust, engagement, science and respect. The BridgeBio team is committed to acting responsibly with academic researchers who work around the clock to understand the mechanisms of genetically driven conditions and how we can best treat patients by targeting the disease source.