On August 26, 2020 InDex Pharmaceuticals Holding AB (publ) reported that interim report January – June 2020 (Press release, InDex Pharmaceuticals, AUG 26, 2020, View Source [SID1234564029])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Focus on phase III preparations

"The commercial preparations have confirmed our belief in the potential of cobitolimod, where we estimate that the annual sales at a successful commercialisation can reach more than USD 1 billion," says Peter Zerhouni, CEO of InDex Pharmaceuticals.

Period April – June 2020

Net sales amounted to SEK 0.0 (0.0) million
Operating loss amounted to SEK –15.6 (–17.7) million
Result after tax amounted to SEK –15.6 (–17.7) million, corresponding to SEK –0.17 per share (–0.26) before and after dilution
Cash flow from operating activities amounted to SEK –32.8 (–13.6) million
Period January – June 2020

Revenues amounted to SEK 0.0 (0.0) million
Operating result amounted to SEK –39.6 (–34.9) million
Result after tax amounted to SEK –39.6 (–34.9) million, corresponding to SEK –0.45 per share (–0.51) before and after dilution
Cash flow from operating activities amounted to SEK –54.7 (–32.0) million
Cash and cash equivalents at the end of the period amounted to SEK 70.6 (50.5) million
Number of employees at the end of the period was 7 (7)
Number of shares at the end of the period was 88,781,275
All comparative amounts in brackets refer to the outcome during the corresponding period 2019.

Significant events during April – June 2020

InDex received positive responses from FDA and EMA regarding phase III development of cobitolimod for the treatment of moderate to severe ulcerative colitis
The annual general meeting in InDex Pharmaceuticals Holding AB was held on Monday April 20, 2020. Board members Wenche Rolfsen (also chairman), Uli Hacksell, Lennart Hansson and Stig Lökke Pedersen were re-elected, and Marlene Forsell and Yilmaz Mahshid were elected as new ordinary board members
Significant events after the reporting period

No significant events have occurred after the end of the reporting period
Other events

InDex announced that the successful results of the CONDUCT study will be presented orally at two leading medical conferences
CEO statement
Our focus remains on the phase III preparations with cobitolimod in ulcerative colitis. To assist, we have expanded our circle of medical advisors by setting up a North American advisory board. It is fantastic that we have succeeded to attract six of the top clinical experts in inflammatory bowel disease to support the continued development and positioning of cobitolimod with a focus on the US market. The group’s first meeting in June clearly showed that they see a potential prominent role for cobitolimod in the future treatment of ulcerative colitis. We continue the work to finalize the phase III design and the associated financing. Contingent on how the Covid-19 pandemic evolves, we plan to start the study in the second quarter of 2021.

We have also had a US consultancy firm to detail the positioning as a complement to the market research we conducted during the first quarter of this year, which has provided us with a deeper understanding of the future market. The commercial preparations have confirmed our belief in the potential of cobitolimod, where we estimate that the annual sales at a successful commercialisation can reach more than USD 1 billion. More than 2 million people have ulcerative colitis in the US, Europe and Japan, and of these about 60 percent are estimated to suffer from moderate to severe ulcerative colitis. Approximately 55 percent of this group are considered to have left-sided colitis and more than half do not respond to conventional treatment and need other alternatives. With an assumed price in the US, Europe and Japan in line with the most recently launched products, it corresponds to an addressable market for moderate to severe left-sided ulcerative colitis of over USD 9 billion annually.

Since May, there have been several important news regarding competing development projects in phase III in ulcerative colitis. One project has been discontinued and others have reported less promising clinical results. Several of these drug candidates will probably not reach the market in the end. Cobitolimod has a completely different mechanism of action and safety profile than these substances, and for InDex the news mainly mean reduced future competition. It will also be very interesting to get more data from these studies that we can learn from for our own development.

Our phase IIb results from the CONDUCT study will be presented orally in October at two leading gastroenterology conferences; the UEGW in Europe and the ACG in the US. These events are great opportunities for us to further reach the international scientific community with the successful results, as well as potential partners and specialist investors.

It is very inspiring with the support from all our medical advisors. They point out cobitolimod’s unique combination of efficacy and safety as well as the novel mechanism of action. I look forward to an eventful autumn for InDex with the continued phase III preparations.

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

On August 26, 2020 Oncopeptides reported interim result Q2 2020 (Press release, Oncopeptides, AUG 26, 2020, View Source [SID1234564028])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Financial overview April 1 – June 30, 2020
Net sales amounted to SEK 0.0 M (0.0)
Loss for the period was SEK 401.0 M (loss: 171.9)
Loss per share, before and after dilution, was SEK 6.79 (loss: 3.52)
On June 30 cash and cash equivalents amounted to SEK 937.8 M (626.8)
Significant events during the period April 1 – June 30, 2020
Marty J Duvall was appointed CEO from July 1, and Jakob Lindberg assumed the role as
Chief Scientific Officer
NDA for accelerated approval of melflufen in the U.S was submitted
A laboratory for preclinical development was taken over to strengthen the technology platform and build the company’s pipeline
A directed share issue of SEK 1,414 M (USD 144 M) (before issue costs) to well-known life science investors, out of which SEK 716.4 M (before issue costs) was paid in after the end of the reporting period was completed
Enrollment in the OCEAN phase 3 study continues after the initial recruitment goal of 450 patients was reached in May
Final data from the pivotal HORIZON study were presented at EHA (Free EHA Whitepaper)
Patient enrollment to the company’s exploratory clinical studies was resumed in May after a temporary pause due to the COVID-19 pandemic
Significant events after the reporting period
The first patient was enrolled in the phase 1/2 AL-Amyloidosis study. This is the first study with melflufen in an indication outside multiple myeloma
Oncopeptides started a phase 2 study called PORT to evaluate an alternative administration of melflufen
Financial overview of the group

Conference call for investors, analysts and the media
The Interim Report Q2 2020 and an operational update will be presented by CEO Marty J Duvall and members of Oncopeptides management team, Wednesday August 26, 2020 at 14:00 (CET). The conference call will also be streamed via a link on the website: www. oncopeptides.com.

Financial calendar
Interim Report Q3, 2020: November 19, 2020
Year-end Report 2020: February 18, 2021
Interim Report Q1 2021: May 26, 2021
Annual General Meeting 2021: May 26, 2021

This information is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 08:00 CET on August 26, 2020.

On August 26, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the results of non-clinical research on STA551, a Switch Antibody created by Chugai and currently in phase I clinical trial for solid tumors, have been published in Cancer Discovery Online (Press release, Chugai, AUG 26, 2020, View Source [SID1234564027]). Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), is recognized as the world’s leading journal for reporting novel non-clinical and clinical research in the oncology field.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Antibody to CD137 activated by extracellular adenosine triphosphate is tumor selective and broadly effective in vivo without systemic immune activation"
(View Source)

The following points were demonstrated in this research:

Creation of STA551, an anti-CD137 agonist antibody that binds to CD137 in an adenosine triphosphate (ATP)-dependent manner and exerts agonistic activity, which is known to be present at high concentrations in solid tumor tissues.
STA551 binds to CD137 and activates T cells in the presence of ATP, but not in the absence of ATP (in vitro)
STA551 showed antitumor efficacy in all eight mouse models transplanted with multiple cancer cell lines (mouse)
Conventional anti-CD137 agonist antibody induces systemic immune reactions, but not with STA551 (mouse)
STA551 was well tolerated in animal toxicity studies
"We are very pleased that the results of our basic research on STA551, the first clinical development project to apply our Switch-Ig technology, were published in Cancer Discovery. We believe that the publication of the article was highly regarded not only for the non-clinical results of STA551 but also for the concept of Switch Antibody, which "binds to antigens only in the presence of a molecule (switch molecule) that are specifically present in pathological tissues," said Dr. Hisafumi Okabe, Executive Vice President, Supervisory responsibility for Research and Translational Research. "We are confident that Chugai’s strength in antibody engineering technology will not only solve the challenges of conventional antibody drugs but also further expand the potential of antibody drugs as a modality. We are very much looking forward to the ongoing phase I clinical trial of STA551 to show a high safety profile and anti-tumor efficacy and become a drug that can contribute to the treatment of patients."

Aiming to become a top innovator in the healthcare industry, Chugai strives to contribute to patients around the world by providing innovative medicines and services through the pursuit of science and unique technological capabilities.

About STA551
STA551 is a Switch Antibody using Switch-Ig developed by Chugai. It activates by recognizing adenosine triphosphate (ATP) as a switch molecule, which is believed to exist in high concentration in tumor tissues, and binds to the target antigen, CD137. A phase I clinical trial for solid tumors is ongoing.

About Switch-Ig
Switch-Ig is a technology that enhances the disease site specificity of antibodies. Conventional antibodies may bind to the target antigen not only in the disease site but also in normal tissues, causing problems such as side effects. Switch-Ig is an antibody designed to bind to a target antigen only in the presence of a molecule (switch molecule) that becomes highly concentrated at the disease site. It is less likely to react with the target antigen in normal tissues with low switch molecule concentrations. By utilizing this technology, it is expected that the antibody can react specifically to the disease site and avoid the safety problems and deterioration of plasma kinetics caused by binding to normal tissues.

On August 26, 2020 Sprint Bioscience AB (Nasdaq First North Premier Growth Market: SPRINT) reported its interim report for the period January – June 2020 (Press release, Sprint Bioscience, AUG 26, 2020, View Source [SID1234564026]). The full report is available on the company’s website.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

January – June – Financial summary

Net sales during the period amounted to SEK 11.3 (23.9) million
Operating profit for the period amounted to SEK -19.6 (-1.8) million
Profit after tax for the period amounted to SEK -22.3 (-3.3) million
Earnings per share before and after dilution for the period amounted to SEK -1.81 (-0.35)
Second quarter – Financial summary

Net sales during the quarter amounted to SEK 5.8 (19.3) million
Operating profit for the quarter amounted to SEK -10.1 (4.9) million
Profit after tax for the quarter amounted to SEK -12.5 (4.5) million
Earnings per share before and after dilution for the quarter amounted to SEK -1.01 (0.47)
Significant events during the period

On April 30, the company announced that a study published in the scientific journal Science Advances presents preclinical results showing that Vps34 inhibitor SB02024 strongly activates the immune system in tumors of malignant melanoma and colorectal cancer with reduced tumor growth as a result. The results support the continued development of SB02024 both as a single drug and in combination with other immunooncological drugs.
On May 13, the Annual General Meeting authorized the Board and on May 22, the Board decided to carry out a new issue of units with preferential rights of approximately SEK 48.5 million and a directed issue of warrants to issue guarantors in the rights issue. At the same time, the company announced that the company was raising a loan financing of SEK 10 million. On May 29, the prospectus for the issue was published.
On May 11, the company announced that they had decided to apply for short-term work for the Company’s employees. Working hours will be reduced to 40 percent from 1 June 2020 and six months onwards. The measure is taken to strengthen the Company’s financial sustainability as the ongoing covid-19 pandemic has affected the possibilities of entering into new, revenue-generating partner agreements in the near future.
On May 13, the company announced that after a series of preclinical research advances in the VADA project, it has chosen to publish the project’s target protein. The aim is to develop drug substances that inhibit the protein vaccinia-related kinase 1 (VRK1) in order to enhance the effect of immuno-oncological therapy, radiation therapy and cytotoxic drugs. The company believes that this approach provides a unique position in the market for innovative pharmaceutical projects and will now initiate contacts with potential partners.
On May 14, the exercise period for subscription of shares in the company began with the support of warrants of series TO2 2019. A warrant of series TO2 2019 entitled to subscribe for a new share and a total of 47,031 shares were subscribed, corresponding to a utilization rate of 4.38 percent. The final outcome after recalculation of the subscription price and the number of shares due to the company’s rights issue of units meant that each warrant entitles the holder to subscribe for 1.09 shares at a subscription price per share of SEK 7.54. Registration of shares with the Swedish Companies Registration Office took place in July.
On 22 June, the company announced that the new share issue of units decided by the Board on 22 May 2020 had been completed. The outcome shows that the issue was subscribed for at 126% and a total of 2,939,400 units were issued. Issue proceeds before issue costs amounted to SEK 48.5 million. The Board has also decided on a directed issue of 2,016,667 warrants of series TO4 2020/2021 to the issue guarantors in the rights issue as compensation for their guarantee commitments. Upon full exercise of the warrants in the issue and to the guarantors, the Company will receive an additional maximum of SEK 40.9 million before issue costs during Q1 2021.
EVENTS AFTER THE END OF THE REPORTING PERIOD
On July 15, it was announced that Karin Almqvist has decided to leave her position as CFO, but will remain in the company until October 15, 2020.
The company announced on July 1 that Petra Pharma, in accordance with the possibilities provided in the parties’ license agreement, has transferred the license agreement and the subsequent collaborative project PIP4K2 to the newly formed company Ravenna Pharmaceuticals, Inc. Ravenna Pharmaceuticals thus takes over responsibility for further development and financial commitments to Sprint Bioscience. The project aims to develop a new type of drug for leukemia.
On August 25, the company announced that from September 1, it will return to full capacity by completing the short-term work that began on June 1.

On August 25, 2020 QIMR Berghofer-led reported that it has discovered the pivotal role played by an important immune system protein that, if harnessed through immunotherapy, has the potential to treat a wide range of cancers and inflammatory diseases (Press release, QIMR Berghofer Medical Research Institute, AUG 25, 2020, View Source [SID1234565399]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The researchers had been working on the tropical parasitic diseases malaria and leishmaniasis when they discovered that the Natural Killer Cell Granule Protein (NKG7) played an important role in a range of diseases.

Professor Christian Engwerda, who is the Acting Head of QIMR Berghofer’s Infectious Diseases program, said his team found that when the NKG7 protein was turned off it reduced inflammation in mice, but if it was stimulated it enhanced the immune response.

"NKG7 is a key promoter of inflammation, which is the basis of many of the diseases we encounter including cancers, autoimmune diseases, neurological diseases and infectious diseases," Professor Engwerda said.

"The protein was first identified a few decades ago, but no one had worked out that it was a key weapon of the immune system that’s really important for controlling tumours and infections and for helping current medicines work well.

"It does this by delivering the toxic agents from immune cells to targeted disease cells. Our research shows that in cancer, the protein is activated when patients are treated with drugs that switch on the immune system to deliver cancer-killing agents to tumours.

"In autoimmune and other inflammatory diseases where the immune system is overactive, the NKG7 protein is too active, and we found by blocking it in mice, inflammatory damage was reduced."

The research was conducted in mice and human blood samples collected from leishmaniasis patients in India. The researchers found leishmaniasis patients expressed high levels of the molecule in their blood.

Co-lead author, QIMR Berghofer Senior Scientist and Immunology Department Coordinator, Professor Mark Smyth, said the findings opened the way for new immunotherapies.

"NKG7 is expressed on different immune cells at different stages of disease and our study showed that targeting the protein by blocking its function would be a new way to dampen inflammation in diseases," he said.

"Activating it on the other hand would enhance the immune response during some infectious diseases and cancer.

"Our research showed some cancer patients who responded well to certain immunotherapies expressed high levels of this molecule in the immune cells attacking their tumours, indicating it can play a role in preventing cancer metastasis.

"The challenge now is to explore what drugs can be used to manipulate the protein in the immune system, so doctors can either turn it on or off, depending on the disease or condition."

Professor Engwerda said the research demonstrated the value of studying a broad range of diseases, including those that don’t directly affect Australians.

"Apart from it being important for us to play our part as global citizens by trying to find cures for diseases impacting the developing world, this study shows research into any illness can expand our understanding of the immune system and the biology of disease," he said.

The research was led in collaboration with the Institute of Medical Sciences at Banaras Hindu University in Varanasi, India, as part of a long-standing India-Australia relationship.

The study has been published in the journal Nature Immunology.

The research was partly funded by the National Health and Medical Research Council of Australia, the National Institutes of Health (USA), QIMR Berghofer and the Queensland Government.