On August 25, 2021 Pierre Fabre reported 2021 Annual Report (Presentation, Pierre Fabre, AUG 25, 2021, View Source [SID1234639493]).

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On August 25, 2021 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focused on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, reported the initiation of Dose Escalation within the Phase I Investigator Initiated Trial (IIT) of Pidnarulex for the treatment of advanced hematological malignancies (Press release, Senhwa Biosciences, AUG 25, 2021, View Source [SID1234586897]). After evidence of human efficacy was observed in patients with specific biomarkers and resistant to standard treatments, including chemotherapeutics, the Phase I study was redesigned to further determine the Recommended Phase II Dose.

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This open-label dose escalation Phase I IIT study of Pidnarulex is sponsored by the Peter MacCallum Cancer Center (PMCC), in Australia, focusing on various haem cancers, including multiple myeloma, T-cell non-Hodgkin lymphoma, acute myeloid leukaemia and myelodysplastic syndrome. Senhwa is providing the study supplies and the Investigational Product, Pidnarulex, which is intravenously administered on 4-week cycles.

The preliminary results from the preceding portion of the Phase I study, completed in 2017, demonstrated that among the 16 evaluable patients, one patient experienced a partial response after the Pidnarulex treatment, while five patients had stable disease. The PMCC was invited to the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting on 11th December, 2017, and presented a poster on these findings.

"The multiple myeloma patients enrolled in the initial portion of the Phase I study were resistant to other therapies; however, fifty percent of the multiple myeloma patients treated with Pidnarulex were able to stabilize their conditions. We here at Senhwa will continue to work at providing alternative therapeutics for treatment resistant cancers," said Dr. John Soong, Chief Medical Officer of Senhwa Biosciences.

"We look forward to the outcome of this study and we hope that the findings may inspire more collaborative opportunities to determine if Pidnarulex is effective in treating various forms of haem cancers," said Tai-Sen Soong, the Chief Executive Officer of Senhwa Biosciences.

Hematological cancers affect populations worldwide, notably, there are more than 160,000 new cases of multiple myeloma worldwide per year. The global drug market for multiple myeloma is expected to reach USD 37.5 billion by 2024, according to the forecast of Grand View Research, a leading market research firm.

About Pidanrulex (CX-5461)

Specific mutations within the Homologous Recombination (HR) pathway may be exploited by Pidnarulex through a synthetic lethality approach by targeting the DNA repair defects in Homologous Recombination Deficiency (HRD) tumors. Specifically, Pidnarulex is designed to stabilize DNA G-quadruplexes of cancer cells which leads to disruption of the cell’s replication fork. While acting in concert with HR pathway deficiencies, such as BRCA1/2 mutations, replication forks stall and cause DNA breaks, ultimately resulting in cancer cell death. On the other hand, PMCC postulates a different mechanism of action. Specifically, it is thought that Pidanrulex acts as a RNA Pol I Inhibitor.

On August 25, 2021 InDex Pharmaceuticals Holding AB (publ) reported that interim report January – June 2021 (Press release, InDex Pharmaceuticals, AUG 25, 2021, View Source [SID1234586866])

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Period April – June 2021
Net sales amounted to SEK 0.0 (0.0) million
Operating loss amounted to SEK –42.6 (–15.6) million
Result after tax amounted to SEK –42.6 (–15.6) million, corresponding to SEK –0.08 per share (–0.07) before and after dilution
Cash flow from operating activities amounted to SEK –53.4 (–32.8) million
Period January – June 2021
Net sales amounted to SEK 0.0 (0.0) million
Operating loss amounted to SEK –51.9 (–39.6) million
Result after tax amounted to SEK –52.0 (–39.6) million, corresponding to SEK –0.11 per share (–0.17) before and after dilution
Cash flow from operating activities amounted to SEK –62.0 (–54.7) million
Cash and cash equivalents at the end of the period amounted to SEK 478.8 (70.6) million
Number of employees at the end of the period was 7 (7)
Number of shares at the end of the period was 532,687,650
All comparative amounts in brackets refer to the outcome during the corresponding period 2020.

Significant events during the quarter
InDex announced that patient recruitment for the phase III study CONCLUDE is planned to initiate after the summer
Significant events after the quarter
InDex received first regulatory approval from the Swedish MPA to start the phase III study CONCLUDE with cobitolimod
InDex received FDA clearance to start the phase III study CONCLUDE
Other events
InDex got patent for additional DIMS compounds granted in Europe
The annual general meeting in InDex Pharmaceuticals Holding AB was held on June 3, 2021. Board members Wenche Rolfsen (also chairman), Marlene Forsell, Uli Hacksell and Lennart Hansson were re-elected. Yilmaz Mahshid and Stig Løkke Pedersen had ahead of the annual general meeting declined re-election
CEO statement
We are now close to the start of the phase III study CONCLUDE to evaluate cobitolimod as a new treatment for patients with moderate to severe left-sided ulcerative colitis. It is a global clinical study which will include 440 participants and be conducted at several hundred clinics in over 30 countries. The process of applying for and obtaining approval from the relevant authorities in the participating countries is ongoing, and in July we received the first regulatory approval to start the study from the Swedish MPA and yesterday from the US FDA.

We will initiate patient recruitment when the clinics are up and running again after the summer as the healthcare situation has started to normalise. Together with our CRO we are finalising the practical preparations.

To strengthen our clinical development organisation, we have hired two new employees, Anders Bröijersén as Senior Medical Director Clinical Operations and Johan Levin as Project Manager Clinical Operations. Both have long and broad experience of clinical development and conducting clinical studies. I am pleased that we have been able to attract two such qualified employees and welcome Anders and Johan to the team. Much of their time will be devoted to support the clinics in the study as ambassadors for InDex and the CONCLUDE study, which was a successful model for patient recruitment in our previous study CONDUCT.

In parallel with the phase III study, we will conduct a smaller clinical pharmacokinetic study (PK study) with cobitolimod in Sweden. We have received approval from the Swedish MPA to start also this study. The purpose of the study is to evaluate the systemic uptake of cobitolimod, and the data will support future regulatory applications for market approval of cobitolimod. Previous preclinical and clinical studies have shown that the systemic uptake of cobitolimod is very limited, which likely contributes to the excellent safety profile. This is a significant advantage compared to the current systemically administered drugs for ulcerative colitis that can cause severe off-target effects.

Besides cobitolimod for ulcerative colitis, InDex has a preclinical portfolio of more than 150 DNA-based ImmunoModulatory Sequences (DIMS), of which we are testing a selected number of candidates in models of other inflammatory diseases. In April, a new European patent was granted that provides protection for 19 different DIMS substances. This patent has previously been granted in the US and Canada, and we are very pleased that also the European Patent Office confirms the novelty of our DIMS platform.

In June, we had the Annual General Meeting and although we had postponed it as much as possible, we were unfortunately not able to welcome the shareholders to a physical meeting this year either. On September 2, I will present the company at the Pareto Securities Healthcare Conference, which will be held virtually also this year.

Soon I hope we can start meeting each other in person again and I look forward to welcoming the first patient in the phase III study CONCLUDE.

Publication

This information is information that InDex Pharmaceuticals Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (MAR). The information was submitted for publication through the agency of the contact person set out above at 8:00 CET on August 25, 2021.

On August 25, 2021 Patrys reported its Annual Report for the 2020-2021 Financial Year (FY21) (Press release, Patrys, AUG 25, 2021, View Source [SID1234586882]).

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Highlights include:

2020

Expansion of deoxymab portfolio with the addition of full sized IgG antibody, PAT-DX3
First patent granted for deoxymab-nanoparticles
Capital raising of $7.3m via a Placement and Rights Issue
2021

Successful development and selection of an optimised stable cell-line for commercial scale production of clinical grade PAT-DX1
New United States patent granted for Patrys’ deoxymab assets
Completion of animal pharmacokinetic studies for both PAT-DX1 antibody fragment and full-sized PAT-DX3 IgG antibody
Announcement of a collaborative research program with Imagion Biosystems Limited to improve brain tumor imaging and diagnosis
Publication of preclinical data, from collaboration with Yale School of Medicine demonstrating the ability of PAT-DX1 to cross the blood-brain barrier (BBB) and significantly inhibit the growth of both primary and secondary cancers in the brain in animal models

On August 25, 2021 Iotron Medical Inc. (Iotron) and Canadian Isotope Innovations Corp. (CIIC) reported a collaboration to produce the radioisotope copper-67 (Cu-67) for new cancer therapies (Press release, Iotron Medical, AUG 25, 2021, View Source;a-new-collaboration-to-produce-copper-67-301362227.html [SID1234586898]). This investment will increase the production capacity of the CIIC-operated facilities in Saskatoon, making Cu-67 more widely available to international cancer researchers.

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Iotron Medical, a spin-out business of Iotron Industries, has been providing innovative solutions using electron beam technology for more than 25 years. CIIC is a startup company, producing medical radioisotopes using a novel linear accelerator-based method initially developed at the Canadian Light Source.

Cu-67 has long been known for its excellent properties for personalized cancer therapy but has been extremely difficult to produce with sufficient quantity and purity using nuclear reactors or cyclotrons. Lack of an adequate and reliable supply of this radioisotope has prevented medical researchers from exploring the potential of Cu-67 in new targeted cancer therapies.

"Iotron is excited about the future for Cu-67 and the opportunity to work with CIIC to make the benefits of this radioisotope available to the wider market, and positively impact the lives of so many people," said Mike Scott, Iotron Board Chair.

CIIC and Iotron are proud to establish the world’s first private sector producer and supplier of this valuable radioisotope, building on the application innovations and accelerator expertise of both parties. This novel production method for high purity Cu-67 is needed by researchers and pharmaceutical companies developing new drugs for a variety of cancers including neuroendocrine tumors, prostate and neuroblastoma. When linked to a suitable targeting agent, Cu-67 delivers highly localized radiation to tumor cells.

"CIIC looks forward to working with our partner Iotron to bring this important radioisotope to market and to produce it in the volume needed for researchers and the broader pharmaceutical community," said Dr. Mark de Jong, Chief Technical Officer of CIIC.

Iotron and CIIC have committed to a five-year agreement that will establish a stable and reliable source of Cu-67, with plans to expand production further as market demand grows. The first shipments of Cu-67 have been made to a US research group in July demonstrating the ability of Iotron-CIIC to make and supply this critical isotope. Batches of Cu-67 are being produced biweekly for researchers, and by the end of 2021, more will be available to support clinical trials in North America and around the world.

For more information about the CIIC-Iotron collaboration or to order Cu-67 radioisotope please refer to the website at www.copper67.com.