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Carina Biotech completes its first commercial agreement

On September 1, 2020 Carina Biotech and biopharmaceutical company Biosceptre reported that they have signed an agreement that will see the advancement of a promising cancer immunotherapy (Press release, Carina Biotech, SEP 1, 2020, http://carinabiotech.com/carina-biotech-completes-its-first-commercial-agreement/ [SID1234564185]).

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Biosceptre, developing targeted therapeutics and immune-oncology products, have acquired the exclusive rights to Carina Biotech’s nfP2X7-targeted CAR-T cells and associated intellectual property, which have shown encouraging cancer-killing capacity against a number of cancers in pre-clinical testing. Biosceptre and Carina will collaborate to further develop the nfP2X7 CAR-T program, with the aim of advancing towards clinical trials in the near future. Under the terms of the deal, Carina received an upfront cash payment and equity in Biosceptre.

Deborah Rathjen, PhD, CEO of Carina Biotech, said: "This agreement with Biosceptre represents a significant milestone for Carina as the first commercial agreement involving our proprietary CAR-T technology. We believe that nfP2X7-targeting CAR-T cells hold significant promise as a potential treatment for a range of solid cancers, and we are pleased to be working with Biosceptre to further bolster their pipeline of therapies exploiting the novel nfP2X7 target."

"I would like to pay particular tribute to the Carina Board of Directors, led by our Chair Dr Leanna Read, for their role in bringing this deal to fruition," Dr Rathjen added.

Gavin Currie, CEO of Biosceptre said: "With this deal we are building on our commitment to therapies focussed on non-functional P2X7, a cancer target that has been shown to be present on the majority of cancers. Our goal is to bring novel therapeutics to patients suffering from a wide range range of malignancies, and CAR-T therapy is an important part of our immune-oncology approach."

ABOUT nfP2X7
P2X7 is an ATP-gated cation channel on the surface of some normal cells. In response to certain extracellular conditions, P2X7 forms a pore in the cell that is associated with the induction of cell death. It was demonstrated by Biosceptre that a dysfunctional variant of P2X7 (nfP2X7) is expressed by cancer cells and is unable to open the large pore that drives normal cell death. Biosceptre has shown that nfP2X7 is widely distributed on over 20 types of cancer yet substantially absent in healthy cell types – making it an ideal target to treat cancer.

In 2015, Carina founding CEO Dr Justin Coombs, together with Professor Simon Barry and his laboratory at the Women’s & Children’s Hospital, created the first CAR-T cells targeted against nfP2X7. Carina Biotech has since demonstrated pre-clinical anti-cancer activity against a broad range of cancer types including prostate, breast and ovarian cancers.

Xspray announces positive stability data on HyNap-Dasa tablets

On August 31, 2020 Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) reported six months data from its stability study with HyNap-Dasa tablets manufactured in commercial scale (Press release, Xspray, AUG 31, 2020, View Source [SID1234650108]). Six months stability data on commercially manufactured HyNap-Dasa demonstrates that the tablets complies with specifications and that they can be used in an upcoming ANDA filing.

In February 2020 stability studies were initiated with HyNap-Dasa tablets manufactured in commercial scale according to GMP-standard. In accordance with regulatory requirements three batches were put on stability at accelerated conditions (40oC and 75% relative humidity) and normal conditions (25oC and 60% relative humidity). Xspray now announces that the six months data have been analyzed and show compliance with the specification.

"As expected, the stability study showed good results, which is necessary for the filing for market approval in the US. We continue to work intensively on the preparations to be able to file an application for market approval for HyNap-Dasa as soon as possible. In late September we are awaiting the results from the second bioequivalence study with HyNap-Dasa, thereafter we will decide on the best strategy for our upcoming ANDA filing," comments Per Andersson.

Cue Biopharma Reports Second Quarter 2020 Results and CUE-101 Phase 1 Dose Escalation Trial Updates

On August 31, 2020 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, provided a business update for the second quarter of 2020 (Press release, Cue Biopharma, AUG 31, 2020, View Source [SID1234608297]).

"We are very pleased with the progress we continue to make advancing CUE-101 through the ongoing Phase 1 monotherapy dose-escalation trial," said Daniel Passeri, chief executive officer of Cue Biopharma. "We are highly encouraged with the emerging data sets from this ongoing study, have completed dosing cohorts 4 and 5 in July and August, and recently were cleared by the Safety Review Committee to begin dosing cohort 6, at 4mg/kg."

"We remain well positioned for continued execution of our development plans for our lead asset CUE-101 which is representative of our IL-2 based CUE-100 series and the continued build out of our pipeline via our proprietary protein engineering approach," said Anish Suri, chief scientific officer and president of Cue Biopharma.

Second-Quarter 2020 Financial Results

The Company had steady collaboration revenue of approximately $1.1 million for the three months ended June 30, 2020 and 2019.

Research and development expenses were $8.1 million and $6.9 million for the three months ended June 30, 2020 and 2019, respectively. This increase of approximately $1.3 million was due primarily to the increase in laboratory and drug manufacturing costs, stock-based compensation and clinical expenses, offset by a decrease in travel expenses as the COVID-19 pandemic hampered business travel throughout the second quarter.

General and administrative expenses were $3.9 million and $3.4 million for the three months ended June 30, 2020 and 2019, respectively. This increase of approximately $0.5 million was due primarily to stock-based compensation and legal fees offset by a decrease in travel expenses for the second quarter.

"As of June 30, 2020, we had approximately $85 million in cash and marketable securities which will allow us to support the continued development of our Immuno-STAT platform, including the clinical development of CUE-101, into 2022," said Kerri-Ann Millar, chief financial officer of Cue Biopharma, Inc.

iCo Therapeutics Announces Second Quarter 2020 Financial Results

On August 31, 2020 iCo Therapeutics Inc. (TSXV: ICO) (OTCQB: ICOTF) ("iCo" or "the Company")reported financial results for the quarter ended June 30, 2020 (Press release, iCo Therapeutics, AUG 31, 2020, View Source [SID1234565218]). Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards ("IFRS").

Stated William Jarosz, CEO of iCo Therapeutics Inc., "Our Q2 results show a marked quarter over quarter decline in our operating expenses compared to Q1, having substantially completed our Australian Phase 1b trial in Q1. During the quarter, we continued to work closely with our partner Alexion in advancing our iCo-008 program despite the global Covid 19 pandemic."

Q2 2020 Operational and Financial Highlights

On April 15, 2020, the iCo announced pharmacokinetic results from the Phase 1b study. The oral Amphotericin B at the 100 mg dose achieved a median plasma Cmax of 25 ng AmB/mL and AUC (0-inf) 990 hr* ng/mL after day 1 of dosing and a median plasma Cmax of 44 ng AmB/mL and AUC (0-inf) 1998 hr*ng/mL after 10 day of dosing. This approximate doubling of the AUC (0-inf) measure between day 1 and day 10 was observed not only at the 100 mg dose but at the 400 mg dose as well.

On July 30, 2020, iCo announced the publication of results of their Oral Amphotericin B (iCo 019) Phase 1a Study in one of the leading infectious diseases journals, Antimicrobial Agents and Chemotherapy entitled "Phase I Clinical Study to evaluate the safety, tolerability, and pharmacokinetics of a novel oral amphotericin B formulation (ICO-019) in healthy human subjects". In January 2020, the assignment of the IMMUNE sublicense to Alexion was completed. Under the terms of the assignment, Alexion was required to pay US$6 million into the Court in the settlement of IMMUNE’s creditor claims in exchange for IMMUNE’s rights under the IMMUNE License Agreement.

Financial results for Quarter ended June 30, 2020

We incurred a total comprehensive loss of $336,468 for the quarter ended June 30, 2020 compared to a total comprehensive loss of $386,359 for the quarter ended June 30, 2019, representing a decreased loss of $49,891. The decrease in the loss is primarily the result of lower research and development expenses and lower general and administrative expenses recognized in the quarter ended June 30,2020.

Research and development expenses were $76,886 for the quarter ended June 30, 2020 compared to $156,333 for the quarter ended June 30, 2019, representing a decrease of $79,447. The decrease is related to lower intellectual property costs in the quarter ended June 30, 2020.

The Phase 1b trial was substantially completed in the prior quarter with minimal Phase1b expenses recognized in the current quarter. The Phase 1b trial was conducted in Australia, which provides refundable tax credits for qualifying research and development activities conducted there. The refundable tax credit is calculated at 43.5% of the qualifying expenditures and the Company recognized $161,867 in other income as its estimate of the tax refund related to qualifying expenditures for the six month period ended June 30, 2020.

For the quarter ended June 30, 2020 general and administrative expenses were $169,765 compared to $241,512 for the quarter ended June 30, 2019, representing a decrease of $71,747. The decrease reflects lower consulting and professional fees during the period. The Company’s participation in the IMMUNE bankruptcy process last year caused an increase in consulting and professional fees in the prior year.

Liquidity and Outstanding Share Capital

As at June 30, 2020, we had cash and cash equivalents of $365,824 compared to $989,937 as at December 31, 2019.

As at August 31, 2020, we had an unlimited number of authorized common shares with 153,747,713 common shares issued and outstanding.

Immutep and Monash University Receive Grant Funding for LAG-3 Project

On August 31, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) reported that the Australian Research Council (ARC) has awarded Immutep and research partner Monash University a A$671,427 grant under the ARC‘s Linkage Project scheme to support their research collaboration into Lymphocyte Activation Gene-3 (LAG-3) for a further three years (Press release, Immutep, AUG 31, 2020, View Source [SID1234564240]).

The collaboration between Immutep and Monash University’s Biomedicine Discovery Institute (BDI) commenced in 2017 and the parties have been investigating the structure of LAG-3 and how it binds to its main ligand, MHC Class II. This new funding will allow further investigation and provide insights into the way LAG-3 controls T cell function, and may ultimately lead to the development of a new generation of innovative medicines for the treatment of cancer, autoimmune diseases or infectious diseases.

ARC Laureate Fellow at the Monash BDI, Professor Jamie Rossjohn, said: "We thank the ARC for the continued funding to support our collaboration with Immutep. Through the partnership, we are able to combine the state-of-the-art structural biology facilities we have here at the BDI with the expertise of Dr Triebel, who is the pioneer of the LAG-3 immune checkpoint. This is important work and we look foward to furthering our understanding of LAG-3 structure and function."

Immutep‘s CSO and CMO, Dr Frederic Triebel, also welcomed the grant and said: "We have been very pleased to collaborate on this project alongside one of the leading international groups in structural immunology led by Professor Rossjohn. We look foward to continuing our studies into LAG-3 and are most grateful, of course, for the support of the ARC."

The title of the new grant is "Investigating the atomic structure of an immune cell inhibitory receptor" and will be conducted over a three year period. Professor Rossjohn will have overall oversight of the project and will be responsible for resources management of the grant. As the leading global authority on LAG-3, Dr Triebel will provide his expertise and facilitate access to relevant LAG-3 specific constructs, reagents and antibodies directed against LAG-3. Immutep will also make a financial contribution towards the study.