PR: Heidelberg Pharma Secures Patent for the Use of its ADC Technology Platform

On November 15, 2023 Heidelberg Pharma AG (FSE: HPHA) reported that its subsidiary Heidelberg Pharma Research GmbH has been granted a patent covering site-specific ATAC conjugates by the European Patent Office (EPO) (Press release, Heidelberg Pharma, NOV 15, 2023, View Source [SID1234637704]). Site-specific ATAC conjugates comprise a genetically engineered antibody to which Heidelberg Pharma’s proprietary amatoxin payloads can be coupled via specific linkers. The European patent also covers a method for the synthesis of such conjugates as well as their use in the treatment of diseases. It has a term until 2036. ATAC conjugates are antibody drug conjugates (ADCs) based on the toxin Amanitin.

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The patent protects the use of Amanitin-based ADCs for research and development, as well as for the use in clinical studies and the commercialization of resulting product candidates.

Professor Andreas Pahl, Chief Scientific Officer of Heidelberg Pharma, comments: "We are very pleased that this patent has been granted, as it protects essential aspects of our ATAC technology, as e.g. improved safety and tolerability of our product candidates."

About Heidelberg Pharma’s proprietary ATAC technology

Antibody drug conjugates (ADCs) combine the high affinity and specificity of antibodies with the potency of cytotoxic small molecules for the treatment of cancer. ATACs are ADCs whose active ingredient is the mushroom toxin Amanitin. Amanitin inhibits mRNA transcription by binding to RNA polymerase II, a mechanism that is crucial for the survival of eukaryotic cells. In preclinical testing, ATACs have been shown to be highly efficacious, overcoming frequently encountered resistance mechanisms and combating even quiescent tumor cells.

Evogene Reports Third Quarter 2023 Financial Results

On November 15, 2023 Evogene Ltd. (Nasdaq: EVGN, TASE: EVGN), a leading computational biology company aiming to revolutionize the development of life-science-based products utilizing cutting-edge computational biology technologies across multiple market segments, reported its financial results for the third quarter period ended September 30, 2023 (Press release, Evogene, NOV 15, 2023, View Source [SID1234637703]).

Mr. Ofer Haviv, Evogene’s President and Chief Executive Officer, stated: "The events in Israel since October 7, 2023, have brought about significant changes to our nation; we find ourselves at a time of profound reflection. Our hearts go out to all those directly and indirectly impacted by these evil acts. I want to emphasize that these hardships only deepen our resolve to succeed and thrive. Despite these challenges, Evogene and our subsidiaries continue to operate, unwavering in our commitment to innovation and progress. Our strategic focus remains steady, and our dedicated team works tirelessly to achieve our objectives for 2023 and set the course for 2024.

In these uncertain times, it’s crucial to underscore the financial stability of the Evogene Group. As of the end of the third quarter, the group had a consolidated cash position of approximately $37.2 million, with contributions from Lavie Bio – $7.1 million, Biomica – $14.6 million, and Evogene (together with Casterra, AgPlenus, and Canonic) – $15.5 million. It’s important to note that this figure doesn’t include any amount due to the purchase orders received by Casterra in the last few months and that Lavie Bio’s cash balance is set to increase by an additional $2.5 million in January 2024 as part of a commercial agreement with Corteva.

Furthermore, we anticipate additional orders for Casterra’s castor seeds and new collaborations to generate cash flow for the group, further enhancing our financial stability."

Mr. Haviv continued: "As previously stated, this year we invested in establishing collaborations directly between Evogene and industry leaders, aiming to leverage our AI tech-engines for product development. We are very excited with the initial fruits of these efforts, as demonstrated by the recently reported collaboration with Colors Farm and Ben Gurion University – to pioneer crustacean gene editing technology aiming to enhance crustacean traits. The collaboration is powered by a grant from the Israel Innovation Authority and will utilize Evogene’s GeneRator AI tech-engine."

Mr. Haviv added: "We are very proud of the achievements of our subsidiaries in the last few months. I want to emphasize that as part of their competitive advantage, all the subsidiaries use Evogene’s AI tech-engines, under exclusive license, to direct and accelerate their product development."

Biomica Ltd. – develops microbiome-based therapeutics, leveraging Evogene’s MicroBoost AI tech-engine.

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– Biomica’s leading product candidate, BMC128, for treating cancer patients, is now in a phase 1 clinical trial. The trial is conducted in Israel and started at the Rambam Health Care Campus. It aims to evaluate BMC128’s safety and tolerability alongside Bristol Myers Squibb’s Opdivo immunotherapy. In August, Biomica opened a second site at The Davidoff Cancer Center to allow the recruitment of additional potential patients. The trial is planned to include 10-12 patients; currently, 7 have enrolled.

– Biomica is advancing in preparing for a pre-IND meeting for BMC128, expected to occur in the first quarter of 2024.

Lavie Bio Ltd. – develops and commercializes microbiome-based ag-biological products, utilizing Evogene’s MicroBoost AI tech-engine.

– In July, Lavie Bio announced a licensing agreement with Corteva. The agreement grants Corteva exclusive rights to develop further and commercialize two of Lavie Bio’s lead bio-fungicide product candidates – LAV311 and LAV312 – targeting fruit-rots. Lavie Bio is entitled to an initial payment of approximately $5 million in 2 installments: the first payment of $2.5 million was received in September 2023, and the second payment is expected in the first quarter of 2024. It will also be eligible for additional future milestone payments and royalties from Corteva’s sales of these future products.

– Last week, Lavie Bio announced a significant progress in its bio-fungicide program with LAV321, designed to combat downy mildew and late blight diseases. Field trials conducted in 2023 across Europe and the United States have yielded impressive results, establishing LAV321 as a potent solution against fungal diseases. Next year, LAV321 is expected to be tested in field trials by several multinational companies, for some of which it will be the second year of validation.

AgPlenus Ltd. – aims to develop and commercialize next-generation crop protection products, utilizing Evogene’s ChemPass AI tech-engine.

– As previously disclosed, there is a growing interest in AgPlenus’ lead target protein APTH1 and the small molecules that bind to this protein as candidates for a novel herbicide with a broad weed control spectrum. AgPlenus expects this interest to lead to a collaboration with a leading industry player.

Casterra Ag Ltd. – provides an integrated end-to-end solution for large-scale castor bean cultivation, utilizing Evogene’s GeneRator AI tech-engine.

– In September, Casterra delivered its first shipment of high-yield, high-oil castor seeds from Brazil and Zambia to an African region, generating recognized revenue of approximately $0.9 million in this quarter.

– In recent months, Casterra made substantial steps in expanding its overseas seed production capabilities through subcontractors. As the complexity of this operation is high, it requires additional resources and extensive physical attendance of Casterra’s professionals at the production sites overseas. Casterra is currently investing efforts in expanding its workforce to support this operation and, in parallel, looking for additional seed production subcontractors to manage risks.

Canonic Ltd. – provides tailored medical cannabis products to optimize consumer well-being, utilizing Evogene’s GeneRator AI tech-engine.

– The Israeli medical cannabis market is characterized by a vast spectrum of products, either grown locally or imported. Capturing the patients’ attention is challenging, leading to prices dropping even for premium products. To address this challenge, Canonic is focusing its marketing efforts on the frequent launching of new products in limited batches. During the third quarter, Canonic launched two new products, Tango and Two Aces, and this week, an additional product, SouthSide, was launched.

– During the last quarter, Canonic engaged with a new Israeli cultivator, EverGreen; four elite strains are currently being cultivated.

Mr. Haviv concluded: "All the subsidiaries are advancing their business targets, and as a shareholder, Evogene is very proud of this progress. Looking forward, when evaluating the needs of our wholly owned subsidiaries and their commercial potential, we intend to invest more efforts and resources in Casterra – since we see significant potential in the bio-diesel market, which castor oil can support, while reducing our investment in Canonic – due to the challenging market conditions of the medical cannabis sector."

Key Financial Highlights:

As of September 30, 2023, Evogene had consolidated cash, cash equivalents, and short-term bank deposits amounted to approximately $37.2 million. This included $14.6 million for Biomica, $7.1 million for Lavie Bio, and $15.5 million collectively for Evogene, Casterra, Canonic, and AgPlenus. The injection of funds from the last round of investment in July strengthens Evogene’s financial position and provides it with the resources needed to execute future plans effectively.

The $15.5 million reflected in the cash balance of Evogene, together with Casterra, Canonic, and AgPlenus, does not include any amount due to the purchase orders received by Casterra in the last few months, which were partially supplied during the third quarter of 2023, and the $7.1 million reflected in the cash balance of Lavie Bio does not include the $2.5 million, which represents the second half of the upfront payment from the licensing agreement with Corteva, that is expected to be received at the beginning of 2024.

During the third quarter, the consolidated cash usage was approximately $4.8 million or approximately $3.2 million, excluding Lavie Bio, Biomica, and $1.2 million of advanced payments to Casterra’s subcontractors for castor seed production.

Financial Performance:

Revenues for the third quarter of 2023 were approximately $3.8 million compared to approximately $0.5 million in the same period the previous year. The revenue increase was primarily due to revenues recognized by Lavie Bio per the licensing agreement with Corteva and due to revenues recognized by Casterra for the supply of castor seeds during the third quarter of 2023.

R&D expenses for the third quarter of 2023, which are reported net of non-refundable grants received, were approximately $5.1 million and remained stable compared to approximately $5.0 million in the same period in the previous year.

Sales and marketing expenses were approximately $850 thousand for the third quarter of 2023 and slightly decreased as compared to approximately $895 thousand in the same period the previous year. The main contributor to this expense decrease was a reduction in personnel expenses at Canonic.

General and administrative expenses were approximately $1.5 million in the third quarter of 2023 and remained stable compared to approximately $1.6 million in the same period in the previous year.

Operating loss for the third quarter of 2023 was approximately $4.2 million compared to an operating loss of approximately $7.1 million in the same period in the previous year. The decrease in operating loss is mainly due to the increased revenues mentioned above.

Financing income net for the third quarter of 2023 was approximately $320 thousand compared to the financing expenses net of approximately $61 thousand in the same period in the previous year. This difference was mainly due to an increase in interest income during the third quarter of 2023 compared to the same period in the previous year.

Net loss for the third quarter of 2023 was approximately $3.9 million compared to a net loss of approximately $7.2 million in the same period in the previous year. The decrease in the net loss is mainly due to the increased revenues recognized in the third quarter of 2023.

Evaxion Presents Proof-of-Principle for Its Unique AI Model Predicting Responses to Cancer Immunotherapy

On November 15, 2023 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported for the first time its AI model designed to predict patient responses to cancer immunotherapy at the Biomarkers & Precision Oncology Europe conference in Berlin, Germany (Press release, Evaxion Biotech, NOV 15, 2023, View Source [SID1234637702]).

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The broad use of immunotherapy drugs called checkpoint inhibitors has significantly advanced cancer treatment. However, their effectiveness is limited, with success rates at approximately 15% for most cancers. This inherent challenge emphasizes the critical need for a reliable approach to identify the patients who will benefit from standard-of-care cancer immunotherapy. This can improve patient outcomes and reduce healthcare costs.

"When I joined Evaxion, I was inspired by the wealth of opportunities to improve the lives of patients facing life-threatening diseases. Building upon Evaxion’s core competencies, we have developed an AI model that shows promising results in predicting patients at risk of advancing into progressive disease while undergoing checkpoint inhibitor therapy, enabling earlier intervention with alternative treatments," commented Christian Kanstrup, Evaxion’s Chief Executive Officer.

Christian continued, "We set out to improve patient outcomes and address the growing healthcare burden by developing our first checkpoint inhibitor response predictor model. The model relies on our unique AI-Immunology platform, builds upon our existing core competencies and is part of the "Responder" leg of our corporate strategy. Today’s presentation marks our first step on our journey towards this goal, and we will develop a commercial offering where collaboration and partnerships will be instrumental in achieving our vision for a more cost-effective and efficient healthcare system as well as improving patient outcomes."

CNS Pharmaceuticals Reports Third Quarter 2023 Financial Results and Reiterates Company is on Track to Achieve Milestones for Berubicin Potentially Pivotal Study Before Year End

On November 15, 2023 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported its financial results for the quarter ended September 30, 2023 and reiterated upcoming milestones (Press release, CNS Pharmaceuticals, NOV 15, 2023, View Source [SID1234637701]).

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"Over the course of 2023, we have demonstrated solid execution and rapid progression of enrollment in our ongoing potentially pivotal study of Berubicin. We are preparing for the most significant milestones for patients, the Company and our stockholders in just a few short weeks, with interm data expected in December 2023," commented John Climaco, CEO of CNS Pharmaceuticals. "With topline data from our interim analysis expected in the coming weeks, we are poised to determine whether or not the independent Data Safety Monitoring Board recommends continuing the study. We are hopeful that by the end of this study Berubicin will ultimately demonstrate life-saving value as a second-line treatment for patients with recurrent glioblastoma. We look forward to an exciting remainder of the year and building value for all stakeholders in the near and long-term."

Recent Clinical Achievements

• Achieved enrollment of 239 patients; The Company has opened 45 clinical trial sites of the 60 sites selected across the U.S., Italy, France, Spain, and Switzerland.

• Presented updated results from ongoing potentially pivotal study of Berubicin in adult patients with recurrent GBM after failure of standard first line therapy at the 2023 SNO/ASCO CNS Cancer Conference.

Upcoming Expected Milestones

• Report topline results of interim analysis expected in December 2023. Enrollment will continue during the interim analysis.

• Complete enrollment in December 2023.

For more information about this trial, visit clinicaltrials.gov and reference identifier NCT04762069.

The FDA has granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the agency for guidance on expediting the development and review process. Additionally, the Company has received Orphan Drug Designation from the FDA, which may provide seven years of marketing exclusivity upon approval of an NDA.

Summary of Financial Results for the Third Quarter 2023

The net loss for the three months ended September 30, 2023 was approximately $4.5 million compared to approximately $3.4 million for the comparable period in 2022. The change in net loss is attributable to an increase in research organization (CRO) expenses and patient treatment costs related to continued progress with the Company’s clinical trial for Berubicin, a credit to research and development expense in the prior year period for the funds collected from WPD Pharmaceuticals related to their purchase of Berubicin drug product for their clinical trials, as well as increases in legal and professional fees and other expenses.

The Company reported research and development expenses of $3.4 million for the three months ended September 30, 2023 compared to approximately $2.2 million for the comparable period in 2022. The increase in research and development expenses during the period was mainly attributed to increasing enrollment and the timing of CRO expenses related to continued progress with the Company’s clinical trial for Berubicin.

General and administrative expense was approximately $1.1 million for the three months ended September 30, 2023 compared to approximately $1.2 million for the comparable period in 2022.

As of September 30, 2023, the Company had cash of approximately $0.9 million. In addition, in October 2023, the Company raised an additional $2.6 million in a warrant inducement transaction and placements on the ATM facility. The Company’s current expectation is that the cash on hand and cash raised in October is sufficient to fund our operations through the end of the fourth quarter of 2023. The timing and costs of clinical trials are difficult to predict and trial plans may change in response to evolving circumstances and as such the foregoing estimates may prove to be inaccurate.

Cellectis Announces the execution of the Subsequent Investment Agreement with AstraZeneca

On November 15, 2023 Cellectis (Euronext Growth: ALCLS – NASDAQ: CLLS) reported that, following the consultation of its works council, it has now signed a binding Subsequent Investment Agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) regarding the contemplated additional equity investment of $140M by AstraZeneca, which was previously announced on November 1, 2023 (Press release, Cellectis, NOV 15, 2023, View Source [SID1234637700]). The additional investment will be made by way of subscription of 10,000,000 "class A" convertible preferred shares and 18,000,000 "class B" convertible preferred shares, in each case at a price of $5.00 per share (the "Additional Investment").

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The closing of the Additional Investment remains subject to (i) the approval of the extraordinary general meeting of the shareholders of Cellectis to be called in the coming days and expected to be held on or around December 22, 2023, (ii) clearance of such investment from the French Ministry of Economy according to the foreign direct investment French regulations, and (iii) other customary closing conditions. Immediately following the Additional Investment, it is anticipated that AstraZeneca would own approximately 44% of the share capital of the Company and 30% of the voting rights of the Company (based on the number of voting rights currently outstanding).

In the absence of a public offering, no prospectus will be established in France or outside of France in connection with the Additional Investment.