On September 30, 2020 ImmuPharma PLC (LSE:IMM), (Euronext Growth Brussels: ALIMM) ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, reported its interim results for the six months ended 30 June 2020 (the "Period") (Press release, ImmuPharma, SEP 30, 2020, View Source [SID1234567811]).

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Key Highlights (including post Period review)

Financials

Stable financial performance over the Period
– Cash balance of £2.7m as at 30 June 2020 (31 December 2019: £1.4m)
– Derivative financial asset of £2.5m as at 30 June 2020 (31 December 2019: £2.3m)
– Incanthera financial asset of £1.2 million (£0.7 million at 31 December 2019) and warrants financial asset of £0.5 million (£Nil at 31 December 2019)
– Convertible loan notes of £2.4 million (face value) (£Nil at 31 December 2019)
– Loss for the period of £3m (30 June 2019: £3.9m)
– Share based expense of £1m (30 June 2019: £1m)
– Research and development expenses of £0.9m (30 June 2019: £1.4m)
– Administrative expenses of £1m (30 June 2019: £0.9m)
– Basic and diluted loss per share of 1.69p (30 June 2019: 2.80p)
– £1.5m subscription agreement through the issue of 15,000,000 new ordinary shares – March 2020
– Agreements with 2 specialist US healthcare investors for a total investment of up to $6.3m (£4.94m) – June 2020
– Placing of new ordinary shares of £6.5m (gross) – September 2020
‘Autoimmunity’: LupuzorTM

License and development agreement with Avion Pharmaceuticals progress
– Avion strengthened advisory team for Lupuzor Phase III trial, including collaboration with leading Lupus patient group and formation of Key Opinion Leaders ("KOLs")
– Submission to the Food and Drug Administration (FDA) for a Special Protocol Assessment (SPA) for forthcoming international Phase III trial of Lupuzor

Other program developments

Elro and Ureka combined to form Ureka Pharma SAS
Three therapy areas: Cancer, Metabolism and (new) Anti-Infectives (Anti-Viral, Anti-Bacterial, Anti-Fungal) – these programs include:
– Anti-Infective: BioAMP-B (Anti-Fungal) product for lung infections
– Metabolism: BioGlucagon product – rescue therapy for low sugar events in diabetes
– All programs provide future partnering opportunities
Incanthera plc oncology specialist where ImmuPharma held 11.9% shareholding at 30 June 2020, listed on Aquis Stock Exchange ("AQSE", formerly NEX Exchange) in February 2020 – 2 recent progress updates:
– Successful study results for its skin cancer technology, Sol
– Positive data from Sensitisation study
Commenting on the statement and outlook Tim McCarthy, Chairman, said: "Despite the disruptions of Covid -19 pandemic, we have been focused, in collaboration with our partner Avion, on expediting Lupuzor into a new optimised, international Phase III study in Lupus patients. With the SPA now submitted to the FDA, we await final guidance on the protocol of the trial from the FDA, prior to commencing patient recruitment. "We continue to progress our other R&D programs which includes our anti-fungal Bio-AMP-B therapy, which has the potential of progressing quickly through initial bio-equivalence trials. Discussions for potential partnering opportunities continue. These initiatives create further opportunities in the medium to long term.

"In response to strong investor interest this year, we are delighted to welcome new and returning institutional and private investors as part of three successful capital raisings. This has created a robust financial position with an anticipated cash runway until the end of 2023.

"As we move our key asset, Lupuzor into a new international optimised Phase III trial and continue to progress our development pipeline, the investment thesis of ImmuPharma continues to strengthen and we look forward to providing further value enhancing progress updates over the next period to create long term shareholder value for our shareholders.

"In closing, the Board would like to take this opportunity to thank its shareholders, new and longstanding, for their continued support as well as its staff, corporate and scientific advisers and our partners including, CNRS and Avion."

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014. ("MAR")

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.