On April 4, 2023 Beactica Therapeutics AB, the Swedish precision oncology company, and Oscotec Inc. (039200: KOSDAQ), the Korean drug development company, reported that they have mutually agreed to terminate their collaboration and licensing agreement (Press release, Beactica, APR 4, 2023, View Source [SID1234629821]). The collaboration focused on research and development of novel anti-cancer drug candidates arising out of Beactica’s LSD1 programme.

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The LSD1 programme includes BEA-17, a first-in-class small molecule targeted degrader of the epigenetic enzyme LSD1 and its co-factor CoREST. The current lead indication for BEA-17 is glioblastoma, an indication that falls outside the scope of Oscotec’s strategic priorities.

As part of the agreement, Beactica Therapeutics will retain full exclusive global rights for further development and commercialization of the LSD1 programme, and gain ownership of all results from the collaboration. No obligations will remain between the companies.

BEA-17 was recently granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of glioblastoma (GBM).

"We have valued the opportunity to collaborate with Beactica Therapeutics and congratulate them on FDA’s Orphan Drug Designation to BEA-17 for the treatment of glioblastoma," said Dr Taeyoung Yoon, CEO/CSO of Oscotec. "For portfolio reasons, we have now decided to focus on internal assets that are more closely aligned with our strategic objectives."

"We have appreciated the collaboration with Oscotec and are pleased by what we have achieved together. Retaining global rights to the LSD1 programme increases the potential in Beactica and is well aligned with the Company’s ambition to itself become a clinical-stage company," said Dr Per Källblad, CEO of Beactica Therapeutics.

On April 4, 2023 Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) reported it will host an R&D Day focusing on new clinical results and biomarker data for its lead asset, the IL1RAP-binding antibody nadunolimab (CAN04), in pancreatic cancer (PDAC) patients, following presentation of these results at the AACR (Free AACR Whitepaper) Annual Meeting 2023 (AACR 2023) (Press release, Cantargia, APR 4, 2023, View Source [SID1234629820]). The R&D Day will be hosted by Cantargia management and Prof. Eric Van Cutsem, principal investigator in the CANFOUR trial.

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Cantargia recently announced new results from the phase I/IIa clinical trial CANFOUR, evaluating nadunolimab in combination with chemotherapy for treatment of PDAC, to be presented at AACR (Free AACR Whitepaper) 2023 on April 17, 2023. A key finding is that patients with high tumor levels of IL1RAP, the target of nadunolimab, benefit most from the treatment.

During the R&D Day, Prof. Van Cutsem, Division Head of Digestive Oncology at University of Leuven and University Hospitals Gasthuisberg in Leuven, Belgium, and renowned expert in PDAC, will discuss the current treatment landscape in PDAC and the relevance of the new nadunolimab data. He will be joined by Dr. Dominique Tersago and Dr. David Liberg from Cantargia’s management team.

Event details and registration information

Date and time: April 24, 2023 2:00-3:30 PM CET (8:00-9:30 AM EST).
Venue: Redeye, Mäster Samuelsgatan 42, 10 tr, Stockholm
The event will be conducted in English and a simultaneous live webcast will be available for those unable to attend in person at the following link. The webcast will also be accessible on-demand, shortly after the event, at Cantargia’s website www.cantargia.com. A live question and answer session will follow the formal presentations. Participation in the event on-site requires registration at the following link.

Program

Welcome and introduction to Cantargia – Göran Forsberg, CEO
Nadunolimab mechanism of action – David Liberg, VP Research
Clinical results including new biomarker data of nadunolimab – Dominique Tersago, CMO
Pancreatic cancer and relevance of nadunolimab results – Prof. Eric Van Cutsem
Cantargia’s ongoing clinical trials – Dominique Tersago
Upcoming milestones and concluding remarks – Göran Forsberg
For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
E-mail: [email protected]

The information was submitted for publication, through the agency of the contact person set out above, at 12.30 CET on 4 April 2023.

On April 4, 2023 Scorpion Therapeutics, Inc. ("Scorpion"), a pioneering oncology company redefining the frontier of precision medicine through its Precision Oncology 2.0 strategy, and Pierre Fabre, a French pharmaceutical and dermo-cosmetic group present in 120 countries, reported an exclusive collaboration and license agreement for the co-development of STX-721 and STX-241, two candidates in Scorpion’s franchise of highly-selective, next-generation mutant epidermal growth factor receptor ("EGFR") inhibitors (Press release, Scorpion Therapeutics, APR 4, 2023, View Source [SID1234629819]). Discovered by Scorpion, STX-721 and STX-241 are potentially best-in-class inhibitors of EGFR mutations and potent treatment options for emergent and unmet medical needs in non-small cell lung cancer ("NSCLC"). Under the agreement, Scorpion will lead clinical development of STX-721 and Pierre Fabre will lead clinical development of STX-241. Scorpion will retain commercialization rights to STX-721 and STX-241 in the United States, Canada and Japan, and Pierre Fabre will be responsible for commercialization activities in all other territories, with a focus on Europe and China.

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"Our mission is to develop the next generation of transformational therapies and to deliver them to patients worldwide," said Axel Hoos, M.D., Ph.D., Chief Executive Officer of Scorpion. "Pierre Fabre is the ideal partner to accelerate this vision; a global pharmaceutical company with a robust clinical and commercial footprint in Europe and Asia, and a track record of successfully partnering with biotechnology companies to develop and provide access to innovative cancer medicines. This partnership should help to expand the reach of our EGFR targeting programs, allowing us to help patients who urgently need these treatments, including in markets such as China, where nearly 50% percent of all cases of NSCLC are expected to be EGFR-mutant by 2030.1

"We are excited to engage into this co-development collaboration with Scorpion and eager to add STX-721 and STX-241 to our portfolio in oncology. Pierre Fabre has a track-record in developing and commercializing cancer therapies for nearly four decades. We recently focused our R&D efforts on targeted therapies and this partnership with Scorpion embodies this strategic move," said Eric Ducournau, Chief Executive Officer of Pierre Fabre.

NSCLC is the most common sub-type of lung cancer and various EGFR mutations are the most frequent drivers of NSCLC, occurring in approximately 14-38 percent of tumors, depending on geography.2, 3, 4 Scorpion’s franchise of highly selective, next-generation mutant EGFR inhibitors is designed to address several of these activating mutations, with STX-721 targeting EGFR Exon 20 insertion mutants, and STX-241 targeting Exon 19 or 21 mutations with the co-occurring C797S mutation, a known resistance mechanism to 3rd generation EGFR inhibitors.

For NSCLC driven by EGFR Exon 20 insertion mutations, toxicities associated with the inhibition of wild-type EGFR in healthy tissues, such as the skin and gastrointestinal tract, often occur during treatment. These toxicities can lead to dose reductions or interruptions which, in turn, may reduce the overall efficacy of the treatment. STX-721 and STX-241 have been designed to maximize selectivity for the mutant form of the enzyme and to avoid the inhibition of wild-type EGFR in healthy tissues to minimize the occurrence of these toxicities.

Up to 12.5 percent of patients with NSCLC driven by mutations in Exon 19 or 21 who are treated with covalent inhibitors of EGFR in a front-line setting develop secondary resistance mutations at C797S.5 There are currently no approved therapeutic options for the significant number of patients that develop "double mutant" EGFR NSCLC, creating a significant and growing unmet need.

Together, Scorpion’s next-generation EGFR inhibitors may have the potential to address over 90 percent of activating mutations in EGFR-mutant NSCLC, potentially providing improved clinical outcomes to thousands of patients globally.

"Based on their preclinical data, we’ve concluded that STX-721 and STX-241 may present best-in-class product profiles. Further, this partnership will significantly expand our efforts in precision oncology, allowing us to better support the care and treatment of thousands of people globally," added Francesco Hofmann, Head of Research and Development for Medical Care at Pierre Fabre.

Subject to the terms of the agreement, Scorpion will receive a combined $65 million from an upfront payment and the achievement of near-term milestones, and will be eligible to receive up to a total of $553 million in potential milestone payments. In addition, Pierre Fabre will pay Scorpion tiered percentage royalties on a licensed product-by-licensed product basis, ranging from mid-single to mid-teens based on annual net sales of each licensed product in territories excluding the United States, Canada, and Japan. Scorpion will pay Pierre Fabre tiered percentage royalties based on a licensed product-by-licensed product basis, ranging from low-single to low-double digits on annual net sales of each licensed product in the United States. The companies will share global development expenses based on a pre-specified cost-sharing arrangement.

About STX-721
STX-721 is a next-generation, orally delivered small molecule designed with potentially best-in-class selectivity to target Exon 20 insertion mutations in EGFR. Scorpion estimates that NSCLC tumors that express EGFR with Exon 20 insertion mutations have an incidence of approximately 3,400 patients per year in the United States. STX-721 is currently advancing through preclinical studies and Scorpion expects to submit an investigational new drug ("IND") application to the U.S. Food and Drug Administration ("FDA") in the middle of 2023.

About STX-241
STX-241 is a fourth generation, orally delivered, central nervous system ("CNS")-penetrant small molecule designed with potentially best-in-class selectivity to target resistance mutations at C797S. Scorpion estimates that up to 3,000 patients per year in the United States, or up to 12.5 percent of NSCLC patients with Exon 19 or 21 mutations, develop resistance mutations at C797S. STX-241 is currently advancing through preclinical studies, and Scorpion expects to submit an IND to the U.S. FDA in the first half of 2024.

On April 4, 2023 After twenty years as one of the first personalized oncology companies, Indivumed reported its evolution into Indivumed Therapeutics after the acquisition of Indivumed Services GmbH and its CRO service offerings by Crown Bioscience (Press release, Indivumed, APR 4, 2023, View Source [SID1234629818]). Indivumed Therapeutics emerges as an oncology biotech company focused fully on biomarker and therapeutic target discovery and validation, drug development, and clinical trial performance. Indivumed Therapeutics will continue utilizing its global clinical network for biospecimen and clinical data collection to grow its unique multi-omics database using its AI-driven discovery and development platform for novel therapies in oncology.

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"Indivumed’s success over the last twenty years has been possible due to our constant focus on highly standardized sample and clinical data collection through a global clinical network. It is amazing to see how our clinically anchored quality approach, combined with AI-empowered data analytics, pays off and drives reliable target discovery with incredible speed. Now, we partner with biotech, pharma and diagnostic companies providing for their development programs a broad range of novel therapeutic targets with a high probability of clinical success. We ourselves will focus on distinct targets for lead compound and diagnostic signature development to directly impact cancer therapy." said Prof. Dr. Hartmut Juhl, CEO and Founder of Indivumed.

Indivumed Therapeutics will accelerate cancer drug development through its AI-driven analysis platform, nRavel, by linking in-silico target discovery and development with matched patient-derived tumor models for downstream target and lead compound validation. The company will drive multi-omics oncology R&D by leveraging its partnerships with leading cancer clinics in Europe, The Americas, and Asia to further expand its database and drive preclinical and clinical development programs.

Indivumed Therapeutics has already identified numerous potential predictive and diagnostic targets and biomarkers of which several have been selected for biological validation and lead compound development. Several patents have already been filed and Indivumed Therapeutics proceeds with the identification process for additional targets and biomarkers. The business focus will be out-licensing of validated targets, lead compounds, and biomarkers at different development stages. All this in close partnerships with academia, biotech, and pharma companies to increase the probability of achieving the ultimate goal of advancing Precision Oncology for the cure of cancer.

On April 4, 2023 Carisma Therapeutics Inc. (Nasdaq: CARM), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported financial results for the year ended December 31, 2022 and highlighted recent business updates (Press release, Carisma Therapeutics, APR 4, 2023, View Source [SID1234629817]).

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"2022 was a transformational year for Carisma as we made meaningful progress across all areas of our business, including entering a development collaboration with Moderna, advancing our lead program CT-0508 in HER2+ solid tumors, and announcing our merger with Sesen Bio," said Steven Kelly, President and Chief Executive Officer of Carisma. "The successful close of the merger and concurrent financing has further strengthened our foundation, enabling us to continue to advance our pipeline of important therapies. We look forward to the multiple potential value inflection points over the next 18 months, including the completion of our Phase 1 study of CT-0508, as well as data from clinical trial sub-study of CT-0508 in combination with pembrolizumab."

Recent Business Highlights

Completed merger transaction with Sesen Bio in March 2023. Carisma Therapeutics and Sesen Bio closed the previously announced merger, pursuant to which the combined company changed its name to "Carisma Therapeutics Inc." and commenced trading on The Nasdaq Global Market under the symbol "CARM." The combined company will focus on the development of Carisma’s chimeric antigen receptor macrophage (CAR-M) therapies, which are believed to be the only therapies of their kind with demonstrated proof of mechanism and safety data in clinical trials. At the closing of the merger, taking into account the reverse stock split of shares of common stock of Sesen Bio prior to the closing, the combined company had approximately 40.3 million outstanding shares of common stock.
Received $105.3 million of proceeds as a result of completing the merger transaction, which includes $74.7 million from Sesen Bio and $30.6 million from a concurrent financing. The $30.6 million financing was from a syndicate of investors, including HealthCap, AbbVie, Wellington Partners, SymBiosis, Penn Medicine, TPG Biotech, MRL Ventures Fund, the therapeutics-focused corporate venture arm of Merck & Co., Agent Capital, Solasta, Livzon, Pictet Alternative Advisors and 4Bio.

Expanded Scientific Advisory Board (SAB) with additional expertise in solid tumor immunotherapy development capabilities. The Company appointed leading solid tumor immunotherapy expert Padmanee Sharma, MD, PhD to Carisma’s SAB in January 2023. Dr. Sharma is a nationally regarded cancer immunologist and professor in the departments of Genitourinary Medical Oncology and Immunology, Associate VP of Immunobiology and the T.C. and Jeanette D. Hsu Endowed Chair in Cell Biology at The University of Texas MD Anderson Cancer Center. Additionally, the Company appointed Moderna CSO of External Research Ventures, Lin Guey, PhD to Carisma’s SAB in February 2023. Dr. Guey is a leading expert in mRNA therapeutics and oversees Moderna’s partnership with Carisma to develop in vivo CAR-M therapies.

Presented new data from Phase 1 clinical trial of CT-0508 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2022. Additional findings from the CT-0508 CAR-M clinical trial for patients with advanced metastatic human epidermal growth factor receptor 2 (HER2) overexpressing solid tumors, supported a favorable safety profile and demonstrate that CT-0508 has been successfully manufactured using macrophages obtained from heavily pre-treated, advanced solid tumor patients and has shown high CAR expression, viability, and purity.
Anticipated Upcoming Milestones

Additional data from Group 2 of Carisma’s Phase 1 CT-0508 study expected in the second half of 2023
Initial data from clinical trial sub-study of CT-0508 in combination with KEYTRUDA (pembrolizumab) expected in the second half of 2023
Submission of IND application to the FDA for CT-0525, Carisma’s first anti-HER2 CAR-Mono product candidate, expected in the second half of 2023
Nomination of additional targets(s) under the Moderna development collaboration expected in 2023
Fiscal 2022 Financial Results

Cash, cash equivalents and marketable securities as of December 31, 2022 were $52.0 million, compared to $28.6 million as of December 31, 2021, and is not inclusive of proceeds from the merger transaction with Sesen Bio and concurrent financing, which were completed in March of 2023.
Moderna collaboration revenues were $9.8 million for the year ended December 31, 2022. The Company began its collaboration with Moderna in January 2022 and deferred $47.5 million in revenue from the Moderna collaboration agreement, which will be recognized in future periods.
Research & development expenses were $56.6 million for the year ended December 31, 2022, compared to $34.4 million in 2021. The increase was primarily due to costs associated with growth and expansion of Carisma’s clinical and pre-clinical activities to support advancing CT-0508 in clinical development and expand research for the Company’s Moderna in vivo research.
General & administrative expenses were $9.4 million for the year ended December 31, 2022, compared to $6.4 million in 2021, primarily due to costs associated with the expanded patent portfolio and preparing to operate as a public company.
Net loss was $61.2 million for the year ended December 31, 2022, compared to net loss of $40.8 million in 2021, primarily due to increased research and development expenses, which was partially offset by Moderna collaboration revenue.
Outlook

Carisma believes that its cash, cash equivalents and marketable securities of $52.0 million as of December 31, 2022, in combination with the net proceeds of $105.3 million from the completion of the merger with Sesen Bio and concurrent financing, are sufficient to sustain Carisma’s planned operations through the end of 2024.

About CT-0508

CT-0508 is a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M). It is being evaluated in a landmark Phase 1 multi-center clinical trial that focuses on patients with recurrent or metastatic HER2-overexpressing solid tumors whose cancers do not have approved HER2-targeted therapies or who do not respond to treatment. We are selecting participants who have tumors of any anatomical origin, but with the commonality of overexpressing the HER2 receptor on the cell surface, which is the target for our CAR-M. The Phase 1 clinical trial is first-of-its-kind, marking the first time that engineered macrophages are being studied in humans. The trial continues to enroll patients at seven clinical sites in the U.S., including (i) the University of Pennsylvania Abramson Cancer Center, (ii) the University of North Carolina Lineberger Comprehensive Cancer Center, (iii) the City of Hope National Medical Center, (iv) the MD Anderson Cancer Center, (v) the Sarah Cannon Cancer Research Institute, (vi) Oregon Health & Science University and (vii) Fred Hutchinson Cancer Center.