On September 30, 2020 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that the first patient has been dosed in its Phase 1 clinical trial evaluating IGM-8444, an IgM antibody targeting the Death Receptor 5 (DR5) protein, in patients with solid cancers and non-Hodgkin’s lymphoma (Press release, IGM Biosciences, SEP 30, 2020, View Source [SID1234567810]).

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The multicenter, open-label Phase 1 clinical trial will evaluate IGM-8444 intravenously administered as a monotherapy and in combination with chemotherapy in patients with relapsed and/or refractory solid cancers and non-Hodgkin’s lymphoma. The key objectives of this trial are to provide an initial assessment of the pharmacokinetics, safety, biomarkers and preliminary efficacy of IGM-8444 both as a single agent and in combination with standard of care chemotherapy. IGM expects to report initial data from this Phase 1 trial in 2021.

"The initiation of this clinical trial is another significant milestone in IGM’s development, as it marks the second program from our proprietary IgM antibody platform to begin clinical development," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We believe that IgM antibodies have the potential to overcome some of the limitations of current IgG-based medicines and deliver new therapeutic options to patients with cancer and other serious diseases, and we hope to pursue a broad clinical development strategy for IGM-8444, including in combination with other targeted oncology drugs."

"DR5 IgM antibodies have the capacity for multivalent binding of DR5 and are designed to more efficiently send an apoptotic signal to the cancer cell and enhance in vitro potency in killing cancer cells compared to IgG antibodies with the same binding units," said Johanna Bendell, M.D., Chief Development Officer, Director, Drug Development Program, Sarah Cannon Research Institute at Tennessee Oncology. "I look forward to working with the IGM team in their pursuit to fully elucidate the potential of this novel therapy."

On September 30, 2020 Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, reported that it has completed the sale of Verastem’s COPIKTRA (duvelisib), a marketed oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first FDA-approved dual inhibitor of PI3K-delta and PI3K-gamma, to Secura Bio, Inc (Press release, Verastem, SEP 30, 2020, View Source [SID1234567809]).

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In consideration for the COPIKTRA assets, Verastem received from Secura Bio $70 million in cash. Additionally, Verastem is eligible to receive up to a total deal value of $311 million if certain regulatory and sales-based milestones are successfully met by Secura Bio and COPIKTRA’s other rest-of-world partners. Verastem will also receive low double-digit royalties on net sales over $100 million in the U.S., Europe and the United Kingdom. Secura Bio has assumed all operational and financial responsibility for COPIKTRA program activities, including commercialization efforts in the United States and Europe, ongoing clinical trials, development and commercialization partnerships with Yakult, CSPC and Sanofi and existing royalty obligations.

Verastem’s sale of COPIKTRA to Secura Bio follows Verastem’s previously announced new strategic direction focused on development of its RAF/MEK inhibitor (VS-6766) and FAK inhibitor (defactinib) program in KRAS mutant (KRASmt) solid tumors. Verastem’s first potential indications for the VS-6766 and defactinib combination will be in low-grade serous ovarian cancer (LGSOC) and KRASmt non-small cell lung cancer (NSCLC).

"This transaction delivers clear benefits for both Verastem Oncology and Secura Bio. At Verastem, we will now focus all of our efforts and resources on development of the VS-6766 and defactinib combination in LGSOC and KRASmt NSCLC," said Brian Stuglik, Chief Executive Officer of Verastem Oncology. "The ongoing Phase 1/2 FRAME study continues to provide encouraging data and we plan to commence registration-directed clinical trials in LGSOC and KRASmt NSCLC by the end of 2020."

MTS Health Partners, L.P and Ropes & Gray LLP acted as advisors to Verastem Oncology on this transaction.

About VS-6766

VS-6766 (formerly known as CH5126766, CKI27 and RO5126766) is a unique inhibitor of the RAF/MEK signaling pathway. In contrast to other MEK inhibitors in development, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors.

About Defactinib

Defactinib (VS-6063) is an oral small molecule inhibitor of FAK and PYK2 that is currently being evaluated as a potential combination therapy for various solid tumors. The Company has received Orphan Drug designation for defactinib in ovarian cancer and mesothelioma in the US, EU and Australia. Preclinical research by Verastem Oncology scientists and collaborators at world-renowned research institutions has described the effect of FAK inhibition to enhance immune response by decreasing immuno-suppressive cells, increasing cytotoxic T cells, and reducing stromal density, which allows tumor-killing immune cells to enter the tumor.1,2

About the VS-6766/Defactinib Combination

RAS mutant tumors are present in ~30% of all human cancers, have historically presented a difficult treatment challenge and are often associated with significantly worse prognosis. Challenges associated with identifying new treatment options for these types of cancers include resistance to single agents, identifying tolerable combination regimens with MEK inhibitors and new RAS inhibitors in development addressing only a minority of all RAS mutated cancers.

The combination of VS-6766 and defactinib has been found to be clinically active in patients with KRAS mt tumors. In an ongoing investigator-initiated Phase 1/2 FRAME study, the combination of VS-6766 and defactinib is being evaluated in patients with LGSOC, KRASmt NSCLC and colorectal cancer (CRC). Updated interim data from this study presented at the 2nd Annual RAS-Targeted Drug Development Summit in September 2020 demonstrated a 56% overall response rate and long duration of therapy among patients with KRAS-G12 mt LGSOC. Based on an observation of higher response rates seen in NSCLC patients with KRAS-G12V mutations in the study, Verastem will also be further exploring the role of VS-6766 and defactinib in KRAS-G12V NSCLC. The FRAME study was expanded in August 2020 to include new cohorts in pancreatic cancer, KRASmt endometrial cancer and KRAS-G12V NSCLC.

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.