On September 30, 2020 Isofol Medical AB (publ), (Nasdaq First North Premier Growth Market: ISOFOL), reported an update on the extension study portion of the ISO-CC-005 Phase I/IIa study (Press release, Isofol Medical, SEP 30, 2020, View Source [SID1234567782]). New data following 16-weeks of treatment and beyond shows best Overall Response Rate (ORR) of 55% in 31 patients. The results are in line with the targeted readout in the ongoing global Phase III study, AGENT.

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The new data comes from the two safety extension cohorts of 31 evaluable patients who have been followed and evaluated with CT-scans after 16 weeks or longer, to analyze the exploratory endpoint best ORR – defined as percentage of patients whose disease decreased more than 30% and/or disappears after treatment – which is the primary endpoint in the AGENT-study. Out of the 31 patients, 17 were treated with an ARFOX regimen*, which is the experimental regimen in the ongoing AGENT-study. A best ORR of 59% was observed in the ARFOX regimen group versus 50% in the ARFIRI regimen** group, despite a high frequency of right-sided tumor location and BRAF mutation, both being poor prognostic factors for response. In total, the data resulted in a best ORR of 55 %.

Roger Tell, M.D., Ph.D., Chief Medical Officer at Isofol commented, "We are excited to see continued signals of safety and efficacy on the extension cohorts of the Phase I/IIa study of arfolitixorin in mCRC. An improvement of approximately 10-15% over standard of care chemotherapy, which is typically in the 40-45% range in a non-selected population (all-comers), provides strong validation for the ongoing AGENT-study. We are confident that the data generated with arfolitixorin support its potential as a new treatment option for people with mCRC, an indication with a great unmet need."The ISO-CC-005 Phase I/IIa study was completed in January 2020 and included totally 105 patients between dose finding cohorts (62 patients) and two safety extension cohorts (43 patients). The extension phases include a similar target population, as in the AGENT-study in the first-line setting, to evaluate safety and efficacy at eight weeks on the selected dose regimen of arfolitixorin (120 mg/m2). After the eight weeks of the main study the investigators could decide to either terminate the patient’s participation or continue treatment and evaluate patients beyond eight weeks (not mandated).

On September 29, 2020 MONTIS BIOSCIENCES, a discovery stage biotech company focused on novel immuno-oncology therapeutics targeting the interactions between perivascular macrophages and the tumor vasculature, reported that has named Karen Zinkewich-Péotti, Ph.D., as its Chief Executive Officer (Press release, Montis Biosciences, SEP 29, 2020, View Source [SID1234578966]). Dr. Zinkewich-Péotti brings strong R&D leadership experience from both international biopharmaceutical companies and smaller biotech. Over the course of her career she has developed extensive expertise in different therapeutic modalities, including antibodies, antibody-drug conjugates and small molecules.

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"We are very pleased that Karen is joining the Montis team. She brings a wealth of experience in Oncology, from target discovery to the clinic, as well as in different types of collaborations and partnerships", said Montis Biosciences Chair Luc Dochez, Managing Partner, Genetic Diseases, Droia Ventures. "Karen’s experience and expertise will help us to accelerate development of our lead programs and to build out the discovery platform which addresses different approaches to target the tumor micro-environment."

Dr. Zinkewich-Péotti, a cell biologist by training, was most recently at Ipsen, as Senior VP at the interface between R&D and BD to in-license new pipeline and commercial therapeutics. She previously led Global Drug Discovery at Ipsen. Prior to Ipsen, she had roles of increasing responsibility at Celltech, Aventis and UCB, ultimately heading up Oncology Research in the 3 companies. She and her teams have successfully advanced numerous compounds into the clinic, including CDP791 and CDP860, respectively VEGFR2 and PDGFR-beta blocking antibodies as well as providing scientific support for commercial products.

"I am delighted to be joining Montis Biosciences", said Dr. Zinkewich-Péotti. "With this extraordinary team and mechanistic insights into the relationship between vascular dysfunction and immune suppression, we are poised to discover new therapeutics and importantly, to identify the patients who can most benefit from this novel approach."

Montis Biosciences launched earlier this year, with €8,4 million seed financing and a novel approach to immuno-oncology. Montis was founded by Droia Ventures, VIB and KU Leuven based on the foundational science discovered by the labs of Peter Carmeliet (VIB-KU Leuven) and Massimiliano Mazzone (VIB-KU Leuven). The founders were joined by investors Polaris Partners, ALSA Ventures and Pfizer Ventures, the venture capital arm of Pfizer.

On September 29, 2020 Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH), "Mereo" or "the Company", a clinical stage biopharmaceutical company focused on oncology and rare diseases, reported unaudited interim financial results for the six months ended June 30, 2020 and provides a corporate update (Press release, Mereo BioPharma, SEP 29, 2020, View Source [SID1234568616]).

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Denise Scots-Knight, Chief Executive of Mereo, said: "Following the closing of our $70 million financing in the first half of 2020 we have focussed on executing our strategy, advancing etigilimab ("Anti-TIGIT") for the treatment of solid tumors alongside developing our rare disease portfolio. We remain on track to initiate a Phase 1b/2 study of etigilimab (Anti-TIGIT) in combination with an anti-PD-1 in a range of solid tumor types in Q4 2020. Our rare disease portfolio includes setrusumab for osteogenesis imperfecta which we plan to partner prior to the initiation of a pivotal Phase 3 study, and alvelestat which is being investigated in an ongoing Phase 2 proof-of-concept study for alpha-1 anti-trypsin deficiency. We were also pleased to have recently announced the initiation of a Phase 1b/2 placebo-controlled study of alvelestat in COVID-19 infected patients following the scientific publications demonstrating the involvement of neutrophil elastase in COVID-19 infection pathways. We also continue to advance other discussions with potential partners to optimize the value of our broader product portfolio."

Recent Highlights and Upcoming Milestones

Etigilimab (Anti-TIGIT) for Solid Tumors

On track to initiate a Phase 1b/2 study of etigilimab in combination with an anti-PD-1 in a range of solid tumor types in Q4 2020.

Setrusumab for Osteogenesis Imperfecta (OI)

Receipt of FDA Rare Pediatric Disease Designation on September 23, 2020.
Following regulatory discussions in 1H 2020, both the FDA and EMA have agreed on the principles of a design of a single Phase 3 pediatric pivotal study in OI.
Intend to partner setrusumab prior to conducting a pivotal trial of setrusumab in children with severe OI. Partnering discussions are well underway with a range of potential structures including options for Mereo to retain commercial rights in certain regions.

Alvelestat for Severe Alpha-1 Antitrypsin Deficiency (AATD)

Topline data from an ongoing Phase 2 proof of concept study remains on track for 2H 2021.
Announced the initiation of a Phase 1b/2 placebo-controlled clinical trial to evaluate the safety and efficacy of alvelestat in hospitalized, adult patients with moderate to severe COVID-19 respiratory disease.
Investigator-sponsored studies underway in AATD and in the orphan disease, bronchiolitis obliterans syndrome (BOS).

Partnering Discussions Continue for Portfolio of Other Clinical-Stage Programs

Leflutrozole for hypogonadotropic hypogonadism (HH)
º Partnering discussions continuing based on development in male infertility.
Acumapimod for Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
º Discussions continuing on separate financing for the Phase 3 study agreed with the FDA and EMA.
Corporate

Appointment of Dr. Brian Schwartz and Dr. Jeremy Bender as Non-Executive Directors and departure of Mr Paul Blackburn as Non-Executive Director effective October 1, 2020
Dr. John Lewicki appointed as Chief Scientific Officer and Dr. Ann Kapoun appointed as Head Translational R&D in July 2020.
Financial Highlights

Cash resources of £56.8 million as at June 30, 2020 (June 30, 2019 £36.1 million).
£11.8 million raised in equity and debt in Q1 2020.
Additional $70 million (£56 million) raised in PIPE in Q2 2020.
Cash runway to early 2022.

Conference Call Information
Mereo will host a live conference call and webcast today at 8:00 a.m. EDT / 1:00 p.m. BST to discuss the Company’s financial results and provide a corporate update.

Dial-in numbers: (866) 688-2942 (U.S.) or +1 (561) 569-9224 (U.K./International)

Conference ID number: 9572439

A live and archived webcast may be accessed by visiting the Investors sections of the Company’s website at View Source The archived webcast will remain available on the Company’s website following the live call.

On September 29, 2020 Cellaria Inc (Wakefield, MA, USA), a scientific innovator with breakthrough tools for cancer research, reported that it has introduced three next generation Pancreatic Cancer cell lines, substantially boosting the value of ​in vitro​ methods in the development of more effective therapies (Press release, Cellaria, SEP 29, 2020, View Source [SID1234568099]). Difficult to detect and with a poor survival rate, Pancreatic Cancer remains a primary and illusive therapeutic target for researchers. The new cell models are scalable and stable, securely linked to specific patient tumor samples and supported by Cellaria quality control certifications, which include full cell line authentication. They directly facilitate more clinically relevant, translatable research and represent a major step forward for academic and industrial researchers working to advance more effective, personalized medicine and lead drug candidates.

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‘Legacy cell lines are a crucial tool for cost-effective ​in vitro​ studies, but most do not securely represent the heterogeneity of the original patient tumor,’ said David Deems, CEO, Cellaria Inc. "Genetic drift, selective overgrowth and/or contamination are recognized issues that erode the relevance of commercial lines, thereby compromising progress. In contrast, our novel cell models are extremely stable and have a strong, robustly authenticated connection to specific patient tumors. They offer breakthrough reproducibility, rigor and relevance in both clinical studies and drug discovery."

Pancreatic cancer tumors are elusive in conforming to standard definitions and tend to morph and metastasize into different cancers following treatment. Cellaria’s three new cell models – "Stew", "Chocolate", and "Basket" – are derived from patients diagnosed with pancreatic adenocarcinoma (the most common form of Pancreatic Cancer), and vary with respect to factors such as gender, ethnicity, age, treatment history, and diagnosis.​ ​As a result, they enable

researchers to closely align their studies with a specific patient cohort, with defined molecular targets and biomarkers. All are provided with protocols for preserved biomarker expression and a Certificate of Analysis (COA) attesting their growth characteristics. Beyond supporting optimal application of the cell line, the COA meets growing requirements within the research community for demonstrable cell line authentication.

‘In-depth scientific know-how is a hallmark of the Cellaria approach,’ said David Deems. ‘All our cell models are subject to extensive characterization assays including genomic and biomarker analysis, gene expression and protein profiling. Furthermore, we have data showing response to at least three approved drug therapies for each line. This information is a powerful aid to gathering useful, actionable data from the outset for new or established research groups. We’re delighted to add these new products to our established portfolio for breast, lung, colon, and ovarian cancers, to accelerate the progress of therapeutic and basic science towards a treatment for this challenging condition.’

Cellaria cell models for a range of cancers have already demonstrated proven value in ​in vitro studies. Find out more about the potential impact of the Stew, Chocolate and Basket at: www.cellariabio.com​ or call 978-720-8051.
About Cellaria Inc.

Cellaria Inc’s mission is to develop and build more informative disease cell models to revolutionize and accelerate the search for a cure. The company provides a suite of products and services that are actionable, replicable and that originate from a patient’s unique specimens. ​With 7 years of research and development, Cellaria’s solutions better enable disease researchers to select promising compounds and ultimately identify the most effective treatment for each patient’s needs. This helps lead the research community to more personalized therapeutics, revolutionizing and accelerating the search for a cure and/or personalized treatments.

On September 29, 2020 Polyphor AG (SIX: POLN) reported the closing of the previously announced exclusive licensing agreement with Fosun Pharma for balixafortide in China (Press release, Polyphor, SEP 29, 2020, View Source [SID1234567844]). As a result of closing the transaction, Polyphor received the agreed upfront payment of $15 million.

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Under the terms of the agreement, Polyphor and Fosun Pharma will develop and commercialize balixafortide for the Chinese market with an initial focus on metastatic breast cancer. China is projected to be the second largest market globally for breast cancer treatments. Additional cancer indications and combination therapies will be evaluated jointly by the companies. Polyphor retains all rights to balixafortide outside of China.

In addition to the upfront payment, Polyphor is eligible for additional development milestone payments of up to $19 million, sales milestone payments of up to $148 million plus up to mid-teen royalties on net sales achieved in the territory.

Fosun Pharmaceutical AG is a wholly-owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co. Ltd ("Fosun Pharma", stock code: 600196.SH; 02196.HK), a leading healthcare company in China. It is listed on both the Shanghai Stock Exchange and the Hong Kong Stock Exchange.