On June 1, 2022 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing IgM antibodies, reported that Fred Schwarzer, Chief Executive Officer, will participate in a fireside chat at the 2022 Jefferies Healthcare Conference on Wednesday, June 8, 2022 at 3:00 p.m. EST in New York (Press release, IGM Biosciences, JUN 1, 2022, View Source [SID1234615316]).

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!

A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On June 1, 2022 The Cancer Research Institute (CRI), a nonprofit organization dedicated to the discovery and development of powerful immunotherapies for all types of cancer, reported the publication of its newest analysis of the global landscape of cellular immunotherapies, including R&D trends and real-world usage data (Press release, Cancer Research Institute, JUN 1, 2022, View Source [SID1234615332]). The report, published today in Nature Reviews Drug Discovery, highlights trends in cellular immunotherapy for cancer including top modalities, targets, clinical development, and data from patients receiving CAR-T therapies in clinical practice. This report is an update to CRI’s prior cellular immunotherapy landscape analysis published in July 2021.

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!

In this analysis, author Samik Upadhaya, Ph.D., assistant director of scientific affairs and member of the Anna-Maria Kellen Clinical Accelerator team at CRI, and colleagues provide an update on the overall status of the cellular cancer immunotherapy landscape as well as observations on key changes within the field including clinical practice. Findings include:

As of April 15, 2022, there were 2,756 active cell therapy agents in the global immuno-oncology pipeline, an increase of 36% over the 2021 landscape analysis that identified 2,031 such agents, but also a modest deceleration compared to 43% growth in the prior year
CAR-T therapeutics continue to dominate the cell therapy pipeline with growth of 24% since 2021
Development continues for non-T cell therapies including NK cell, dendritic cell, stem cell, and other myeloid-derived cell therapies, with the greatest growth in NK cell therapy, up 55% over the prior year
Clinical usage of cell therapy for cancer treatment is not keeping pace with regulatory approvals, with clinicians citing cost, travel, and supply limitations as key barriers to patient access
This latest report from the Cancer Research Institute, titled, "Landscape of cancer cell therapies: trends and real-world data," was generated in collaboration with IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, which provided the authors with access to IQVIA’s proprietary clinical trials database. The report is part of a suite of CRI-owned immuno-oncology landscape analyses that includes reports on cell therapy drug development and the broader IO landscape including clinical development of checkpoint inhibitors, cancer vaccines, and oncolytic viruses in addition to bispecific antibodies and other immunomodulators.

To access an interactive dashboard of the Cancer Research Institute’s cancer cell immunotherapy report, visit the CRI website at cancerresearch.org/cell-therapy.

On June 1, 2022 The Board of Directors of Scandion Oncology ("Scandion"), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, has, based on the authorization granted by the Extraordinary General Meeting (EGM) on 13 November 2020, reported that resolved on an issue of shares with preferential rights for existing shareholders ("Rights Issue") (Press release, Scandion Oncology, JUN 1, 2022, View Source,c3578213 [SID1234615350]).

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!

In the event of full subscription, the Rights Issue will provide Scandion with approximately SEK 93.7 million before deduction of issue costs. The Rights Issue is covered by subscription and guarantee commitments from principal owners and new investors corresponding to approximately 80% of the issue proceeds.

Scandion will use the proceeds from the Rights Issue to approximately double the commercial potential of its lead asset, SCO-101, in metastatic colorectal cancer (mCRC) by expanding the clinical development in this indication to also explore RAS mutated patients.

Additionally, proceeds will be used to conduct pre-clinical development to explore and position the use of SCO-101 and other candidates in combination with e.g. immunotherapy and chemotherapy, and to finance the overall development of Scandion as a listed clinical stage biotech company and attractive investment case also for institutional investors. This includes up-listing to the Nasdaq main market.

"We are delighted to being able to raise additional capital to fund our long-term planning and execution of our strategy. In this way we can create the most value from our compounds, first and foremost by approximately doubling the commercial potential for SCO-101. This will be a very important element in our long-term value creation", says Bo Rode Hansen, President & CEO of Scandion.

The Rights Issue in brief
The Board of Directors has, based on the authorization granted by the EGM on 13 November 2020, resolved on an issue of shares with preferential rights for existing shareholders. It will also be possible to subscribe for shares without preferential rights.

In the event all shares are not subscribed for with subscription rights, the board of directors shall resolve on the allotment of shares subscribed for without subscription rights. In such case shares shall firstly be allotted to persons who have also subscribed for shares by exercising subscription rights, secondly to other persons who have subscribed for shares without exercising subscription rights, and thirdly to guarantors.

Issue size: In the event of full subscription, Scandion will receive approximately SEK 93.7 million before deduction of transaction related costs. Preliminary transaction related costs are approximately SEK 17 million.
Record date: Holders of Scandion shares on the record date of 13 June 2022 are entitled to subscribe for shares in the Rights Issue in relation to their holding of shares on the record date. Last day for trading including the right to subscribe for shares is 9 June 2022. The first day of trading excluding the right to subscribe shares is 10 June 2022.
Preferential rights: For one (1) existing share on the record date of 13 June 2022, shareholders will receive one (1) subscription right. Three (3) subscription rights entitle to subscription of one (1) share.
Subscription price: SEK 8.75 per share. No commission is payable.
Subscription and guarantee commitments: Subscription and guarantee commitments have been received from principal owners and new investors amounting to approximately SEK 75 million, corresponding to approximately 80% of the issue proceeds.
Terms of the Rights Issue

Those who are registered as shareholders on the record date, 13 June 2022, have the preferential right to subscribe for new shares in the Rights Issue in relation to the number of shares held on the record date. One (1) existing share in Scandion entitles to one (1) subscription right. Three (3) subscription rights entitle to subscription of one (1) new share, i.e., a subscription ratio of 1:3. In addition, investors are offered the possibility to subscribe for shares without subscription rights.

In the event that all shares are not subscribed for with subscription rights before the expiry of the subscription period, the remaining shares will, without compensation to the holders of unexercised subscription rights, be allotted to such existing shareholders and qualified investors having made binding undertakings to subscribe for remaining shares without subscription rights. In case of oversubscription of the remaining shares, the remaining shares will be allocated according to apportionment keys determined by the board of directors.

The subscription price is SEK 8.75 per new share. Provided that the Rights Issue is fully subscribed, the share capital will increase by a maximum of DKK 787,320.8280 by a new issue of a maximum of 10,711,848 new shares. In the event of full subscription, the Rights Issue will provide Scandion with approximately SEK 93.7 million before deduction of issue costs. Shareholders who choose not to participate in the Rights Issue will, provided that the Rights Issue is fully subscribed, have their ownership diluted by approximately 25%, but have the opportunity to financially compensate for this dilution by selling their subscription rights.

Subscription of shares shall take place during the period from and including 16 June 2022 to and including 1 July 2022. The board of directors has the right to extend the subscription and payment period. A possible extension of the subscription period shall be announced by press release no later than the last subscription day in the Rights Issue, i.e. 1 July 2022. Trading in subscription rights takes place on Nasdaq First North Growth Market during the period from and including 16 June 2022 to and including 28 June 2022 and trading in paid subscribed shares (Sw. Betalda tecknade aktier) during the period from and including 16 June 2022 until the Rights Issue has been registered with the Danish Business Authority (Dk. Erhvervsstyrelsen).

The subscription period and the Rights Issue is conditional on the Danish Financial Supervisory Authority having approved the prospectus and the prospectus having been passported to Sweden prior to the first day of the subscription period.

Subscription and guarantee commitments

Scandion has received subscription and guarantee commitments from principal investors and a guarantee consortium totaling approximately SEK 75 million, corresponding to approximately 80% of the Rights Issue.

Preliminary time plan

9 June 2022 Last day of trading incl. preferential rights
10 June 2022 First day of trading excl. preferential rights
13 June 2022 Record date
15 June 2022 The prospectus is made public
16 June – 28 June 2022 Trading in subscription rights
16 June – 1 July 2022 Subscription period
16 June – until registration with the Danish Business Authority Trading in paid subscription shares (Sw. "BTA")
5 July 2022 Announcement of outcome in the Rights Issue
Lock-up agreements

In connection with the Rights Issue, Scandion’s board members and executive management who own shares in Scandion, have undertaken, subject to customary exceptions, towards Redeye AB, not to transfer or otherwise sell their shares for a period of 180 days after the end of the subscription period.

Investor meetings

Invitation to investor meetings will be sent out separately and will also be presented on Scandion’s and Redeye AB’s respective websites (www.scandiononcology.com, www.redeye.se).

Prospectus

The prospectus is expected to be made public around 15 June 2022. Full terms and conditions as well as information about subscription and guarantee commitments will be available in Scandion’s prospectus which, together with an information folder, will be published on Scandion’s and Redeye AB’s respective websites (www.scandiononcology.com, www.redeye.se).

Advisers
Redeye AB acts as financial adviser and Horten Advokatpartnerselskab (as to Danish law) and Advokatfirman Schjødt (as to Swedish law) act as legal advisers in connection with the Rights Issue. Hagberg & Aneborn Fondkommission AB acts as the issuing agent in the Rights Issue.

Certified Adviser

This information is such information as Scandion is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 13:00 CET on 1 June 2022.

On June 1, 2022 Accutar Biotechnology, Inc., a clinical stage biotechnology company focusing on artificial intelligence (AI)-enabled drug discovery, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AC0176 for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC) with disease progression on or after treatment with androgen receptor signaling inhibitors (Press release, Accutar Biotechnology, JUN 1, 2022, View Source [SID1234615369]). AC0176 is an orally bioavailable, chimeric degrader molecule targeting the androgen receptor (AR). AC0176 is currently being evaluated in a Phase 1 clinical trial to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in patients with mCRPC.

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!

"mCRPC is a devastating cancer for men marked by high recurrence rate and poor survival. Receiving Fast Track designation from the FDA highlights the high unmet medical need for mCRPC and acknowledges the potential of AC0176 as a novel treatment for this patient population," said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. "AC0176 was designed to potently degrade both AR wildtype and prevalent AR mutations which confer drug resistance to current AR signaling inhibitors. We look forward to continued interaction with FDA as we quickly advance the development of this potentially promising treatment option for patients in need."

About Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Prostate cancer (PC) is the second most commonly diagnosed cancer among men worldwide, and the first among men in the United States. mCRPC is a lethal diagnosis, and more effective therapeutic approaches are urgently needed for patients, particularly those who progressed on AR signaling inhibitors. AR-reactivating mechanisms conferring resistance to AR signaling inhibitors include, AR amplification and overexpression, AR point mutations, AR splicing variants, intra-tumoral androgen synthesis, promiscuous AR activation by other factors, etc.

About AC0176

AC0176 is an investigational orally bioavailable, chimeric degrader of AR for the potential treatment of prostate cancers. In preclinical studies, AC0176 demonstrated potent and selective AR protein degradation, favorable pharmacological properties, as well as promising anti-tumor activity in animal models. AC0176 was designed to have broad coverage of AR wildtype and prevalent AR mutations, including but not limited to L702H, T878A, H875Y, W742C. AC0176 is being evaluated in a Phase 1 clinical trial, and information on the study can be found on www.clinicaltrials.gov (NCT05241613).

On June 1, 2022 Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported that clinical data for the dose-escalation part of the Phase I study of TST001 in combination with CAPOX as the first line treatment of advanced and metastatic G/GEJ cancer has been published on the ASCO (Free ASCO Whitepaper)’s website: View Source (Press release, Transcenta, JUN 1, 2022, View Source [SID1234615386]).

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 data showed that TST001 in combination with CAPOX as the first line treatment of patients with advanced and metastatic G/GEJ cancer is well tolerated and encouraging preliminary anti-tumor activities have been observed. The recruitment for the current cohort is ongoing, and the safety and efficacy of the combination of TST001+CAPOX as first line treatment for patients with advanced and metastatic G/GEJ cancer will be further evaluated.

TST001（Claudin18.2）
Abstract Number: 4062
Session Date and Time: June 4, 2022, 8:00 AM-11:00 AM CDT
Title: A Phase I Study of TST001, a High Affinity Humanized Anti-Claudin18.2 Monoclonal Antibody, in Combination with Capecitabine and Oxaliplatin (CAPOX) as a First Line Treatment of Advanced G/GEJ Cancer
First author: Professor Jifang Gong, Peking University Cancer Hospital and Research Institute
Presentation Format: Poster

The study aimed to evaluate the safety, tolerability and preliminary efficacy of TST001 in combination with CAPOX as the first line treatment of patients with advanced G/GEJ cancer. (ClinicalTrials.gov Identifier: NCT04495296). Chinese patients with advanced G/GEJ cancer who had not received prior systemic treatment were enrolled regardless of Claudin18.2 expression in the dose escalation phase following 3+3 design; the safety and efficacy profile was being further evaluated in the dose expansion phase.

As of April 5, 2022, 14 patients had been dosed with TST001 at 1, 3, 6 or 8 mg/kg plus CAPOX Q3W in the dose escalation phase, and 12 patients at 6 mg/kg Q3W in the expansion phase. No subject experienced dose-limiting toxicity. Treatment-emergent adverse events (TEAEs) were mostly grade 1-2, including nausea, hypoalbuminemia, anemia, vomiting, and AST increased. Among the 9 subjects in the dose-escalation phase without Claudin18.2 selection who had measurable lesions and had received at least one posttreatment tumor assessments, 5 achieved partial response and 3 achieved stable disease as the best overall response per RECIST1.1.

"Claudin18.2 has been validated as a novel target and promising anti-tumor activity has been observed in the phase II FAST clinical trial of IMAB362." said Professor Lin Shen from Beijing Cancer Hospital. "According to efficacy and safety results from trials thus far, TST001 showed manageable safety profile and encouraging anti-tumor activities in Claudin18.2 expressing treatment naïve gastric cancer patients. I am looking forward to further evaluating this combo therapy in a randomized global multi-center phase III registration trial in Claudin18.2 positive gastric cancer patients."

"From the dose-escalation phase, we are very pleased to show that TST001 is well tolerated and displayed encouraging clinical response in combination with chemotherapy in Claudin18.2 unselected first line gastric cancer patients." said Dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta. "We will continue to evaluate the safety and efficacy of this combination and plan to initiate a multi-center global registration enabling trial in Claudin18.2 positive first line gastric cancer patients. The development will be supported by our proprietary Claudin18.2 companion diagnostic kit being developed in parallel and strong in-house CMC capabilities. We believe that TST001 in combination with chemotherapy could provide a novel option for the treatment of Claudin18.2 positive gastric cancer patients globally."

About TST001

TST001 is a high affinity humanized anti-Claudin18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activities and potent anti-tumor activities in tumor xenograft models. TST001 is the second Claudin18.2 targeting antibody therapeutic candidate being developed globally. TST001 is generated using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. TST001 kills Claudin18.2 expressing tumor cells by mechanisms of antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Leveraging advanced bioprocessing technology, the fucose content of TST001 was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of TST001. Clinical trials for TST001 are ongoing in China and US (NCT04396821, NCT04495296/CTR20201281). TST001 was granted Orphan Drug Designation in the US by FDA for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ).