1stOncology™: Cancer Intelligence Service – Page 8214 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

ISA Pharmaceuticals Commences Patient Treatment in Third Phase 2 Clinical Trial with the Combination of ISA101b and Libtayo® (cemiplimab)

On September 8, 2021 ISA reported the start of patient dosing in a pivotal clinical trial investigating the combination of ISA101b and Libtayo (cemiplimab) in advanced HPV16 positive oropharyngeal cancer (Press release, ISA Pharmaceuticals, SEP 8, 2021, View Source [SID1234587393]). This new study is the third with active recruitment under ISA Pharmaceuticals’ strategic immuno-oncology collaboration with Regeneron.

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 oropharyngeal cancer phase 2 study (NCT04398524) will include 86 patients with recurrent/metastatic HPV16 positive oropharyngeal cancer that progressed with prior anti-PD-1 therapy, a cancer with a high unmet medical need. The primary efficacy outcome parameter is Overall Response Rate (ORR) and the study expects top line data in the second half of 2023.

The other studies testing the combination of ISA101b and Libtayo are:
A cervical cancer phase 2 study (NCT04646005) that is being conducted by Regeneron. It will enrol 103 adult patients with recurrent/metastatic HPV16 positive cervical cancer who have experienced disease progression after first line chemotherapy. Primary endpoint of this study will be ORR.
A randomised, placebo controlled phase 2 study in first and second line HPV16 positive head-and-neck cancer (NCT03669718) that will include 194 patients also with ORR as primary endpoint. ISA Pharmaceuticals runs this study. Top line results for this study are expected in the second half of 2022.

ISA101b immunotherapy targets HPV16 positive cancers. It induces strong and specific immune responses to the HPV16 virus, and (re-)establishes a powerful and targeted T-cell immune response against infected and/or cancerous cells and tissues. ISA101b is using ISA’s proprietary Synthetic Long Peptide (SLP) technology. Libtayo is an anti-PD-1 antibody that is being jointly developed by Regeneron and Sanofi.

Gerben Moolhuizen, Chief Executive Officer of ISA Pharmaceuticals, said: "We are pleased to announce that the first patient has been treated in this new study. It highlights the productive collaboration we have with Regeneron, with active operational involvement from both companies. This additional trial offers a potentially shortened path to first approval in a HPV16 positive cancer indication."

Head-and-neck and cervical cancers can be severe and life-threatening, often diagnosed in young to middle aged adults, with low overall survival rates once these cancers progress to advanced stages. HPV16 is a major cause of head & neck cancer with over 25,000 new cases and 11,000 deaths in Europe(1) and 46,000 new cases and 9,000 deaths in the US(2).

Scandion Oncology provides a clear path to market for SCO-101 at today’s Capital Markets Day

On September 8, 2021 Scandion Oncology A/S, the Cancer Drug Resistance Company, reported it will provide novel information on its lead candidate drug SCO-101 and a focused clinical strategy with a clear path to registration at today’s Capital Markets Day (Press release, Scandion Oncology, SEP 8, 2021, View Source,c3411474 [SID1234587392]). The company will also communicate about its pipeline, future business opportunities and give an update from part 1 of the CORIST Phase II study.

Data from the CORIST study have triggered an updated focused clinical strategy. Scandion has documented a unique Mode of Action (MoA) for SCO-101 in the CORIST study, where the company shows a significant potentiation of Irinotecan by combining SCO-101 with FOLFIRI in patients. The combination resulted in a dramatically increased exposure and half-life of SN-38 (the active metabolite of Irinotecan). The molecular mechanism of action driving the increased exposure has been identified. The Company has filed a patent application on this unique mode of action.

Scandion Oncology will become a Phase III company
"Our path forward is built on a unique Mode of Action (MoA) and we have focused our clinical strategy to provide a clear route to registration and return on investments in RAS wild-type metastatic colorectal cancer. The ultimate outcome is to become a Phase III company as early as in 2023. We further see a huge opportunity for building on this platform knowledge, to broaden the clinical opportunities for SCO-101 in combination with Irinotecan and maximize business value," said Bo Rode Hansen, President & CEO.

Refocusing from last line mCRC to 2nd line
This also means, that Scandion will refocus from last line metastatic colorectal cancer (mCRC) to second line of treatment to add significantly more value. To maximize the market potential in second line mCRC, the Company aims to position SCO-101 in combination with VEGF monoclonal antibodies (mAbs) and/ or EGFR monoclonal antibodies (mAbs) which are used as backbone in 1st and 2nd line of treatment of RAS wild-type mCRC.

In preparation for the pivotal study, the company will redesign part 3 of CORIST, which is funded, to include 10 patients as a separate arm that will run in parallel to the 25 patients in CORIST part 2. CORIST part 3 will evaluate safety of combining SCO-101 and FOLFIRI with mAbs (VEGF and/or EGFR), pharmacokinetics and be included in the overall efficacy assessment in CORIST Phase II. The company is further planning to open an Investigational New Drug (IND), to allow for inclusion of patients from US clinical sites.

Focusing our pipeline on value creation and highest probability of success
"We are prioritizing SCO-101 in combination with Irinotecan over other projects in our pipeline, as we see the most value creation potential for this combination. We will therefore cease investing in less documented MoAs including SCO-101 in combination with anti-oestrogens and in indications outside of cancer (antibiotics). The implications are that we de-prioritize two of our preclinical projects: EndoRIST and SOM-001. In terms of pipeline, we will focus on maximum value creation and highest probability of success. We have defined a clear roadmap for our coming years," said Bo Rode Hansen.

The Capital Markets Day will take place between 9am and 11.30am CET today and will be webcasted live and is accessible at: View Source

This information is information that Scandion Oncology A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on September 8, 2021 at 8:30 CET.

Biofrontera reports preliminary revenue for the month of August 2021

On September 8, 2021 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported preliminary, unaudited revenue for the month of August 2021 (Press release, Biofrontera, SEP 8, 2021, View Source [SID1234587391]).

The Company’s preliminary, unaudited revenue from product sales in August 2021 amounted to approximately EUR 1,485 thousand, compared to EUR 1,341 thousand in August 2020, an increase of 11%.

Preliminary revenues from product sales in the US were around EUR 1,027 thousand compared to EUR 917 thousand in August 2020, an increase of 12%. In Germany, revenues from product sales amounted to approximately EUR 349 thousand, compared to EUR 345 thousand in August 2020, a slight increase of 1%. In the rest of Europe, the Company generated product sales of around EUR 109 thousand, compared to EUR 79 thousand in August 2020, a plus of 38%.

Due to the pandemic, the monthly and year-to-date sales development is compared with sales in 2019 for increased transparency. As such, an increase of 11% in August 2021 total product sales was achieved in all markets compared to August 2019. In the USA, product sales increased by about 4% compared to August 2019. In August 2021, product sales were up by around 36% in Germany and product sales in the remaining European markets increased by approximately 7% compared to August 2019.

Compared to 2019, product sales in all markets were down by around 2% compared to sales in the period January to August 2021. Year-to-date product sales in 2021 increased by around 25% in Germany and by 21% in the rest of the European market compared to the same period in 2019. Product revenue in the US market was down 12%, mainly due to the weak sales months of January and February this year due to the pandemic as well as the lack of or lower sales of Aktipak and Xepi compared to the period January to August 2019.

GT Biopharma to Present at Upcoming September Investor Conferences

On September 8, 2021 GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE protein biologic technology platform, reported that Anthony Cataldo, Chairman & CEO, Dr. Greg Berk, President of R&D and Chief Medical Officer, and Dr. Jeff Miller, Consulting Chief Scientific Officer will be presenting and hosting one-on-one meetings at the upcoming H.C. Wainwright 23rd Annual Global Healthcare Conference and the Baird Global Healthcare Conference (Press release, GT Biopharma, SEP 8, 2021, View Source [SID1234587390]).

Details for the presentations are as follows:

H.C. Wainwright 23rd Annual Global Healthcare Conference

Date: September 13, 2021
Pre-recorded Corporate Presentation Release Time: 7:00 A.M. ET
Webcast Participation: View Source

Additionally, the management team will participate in the following live panel presentation: "Novel Therapeutic Approaches to NK Therapy in Cancer" at 1:00P.M. ET

Baird Global Healthcare Conference

Date: September 15, 2021
Time: 8:30 A.M. ET
Registration: By invitation only

If you are interested in participating in either of the conferences or to schedule a one-on-one meeting with the management team, please contact your respective representative with each conference organizer.

Cernostics Contracts with Geisinger Health Plan to Become an In-network Provider for TissueCypher® Barrett’s Esophagus Assay

On September 8, 2021 Cernostics, pioneer of the worlds’ first precision medicine test to predict future development risk of esophageal cancer from Barrett’s esophagus (BE), TissueCypher Barrett’s Esophagus Assay, reported that it has become a participating ("in- network") provider for Geisinger Health Plan (GHP)’s more than 550,000 plan members in Central, North Central and East Central Pennsylvania (Press release, Cernostics, SEP 8, 2021, View Source;utm_medium=rss&utm_campaign=cernostics-contracts-with-geisinger-health-plan-to-become-an-in-network-provider-for-tissuecypher-barretts-esophagus-assay [SID1234587389]). The TissueCypher Barrett’s Esophagus Assay has been a covered service for GHP members since a January 2021 decision determined that it was "medically necessary" for the evaluation of biopsies from certain BE patients, becoming the first commercial health care plan to have a coverage policy for TissueCypher.

This decision by GHP comes in response to multiple recent peer-reviewed publications that independently validated the clinical validity and clinical utility of the TissueCypher Barrett’s Esophagus Assay.

Objectively and accurately predicting progression from BE to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) is critical as the incidence of esophageal cancer is growing in the US at one of the fastest rates of all cancers. Once diagnosed, EAC is highly lethal, so early detection and advanced warning in patients with BE by TissueCypher provides valuable clinical decision support to physicians managing these patients.

"We’ve collaborated with Cernostics in the development of the clinical evidence demonstrating the value of TissueCypher for risk-stratification of patients with BE. TissueCypher uses biomarker information not available by any other technology and has allowed us to determine optimal treatment and follow-up strategies in an informed and intelligent way. Importantly, the test can be run on previously obtained biopsies. It’s exciting to see that our patients and gastroenterologists now have access to this important technology as a covered benefit and in-network lab service," said Dr. David Diehl, Director of Interventional Endoscopy at Geisinger Medical Center.

Mike Hoerres, Chief Executive Officer of Cernostics, added, "We are proud to work with Geisinger, one of the leading integrated healthcare delivery systems in the US, to bring TissueCypher testing to our neighbors throughout Pennsylvania. We see this as a great way to support the legacy and vision of Abigail Geisinger, delivering state-of-the-art medicine to the communities we serve right here in Pennsylvania."