Regeneron Announces Investor Conference Presentation

On November 15, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast management participation as follows (Press release, Regeneron, NOV 15, 2023, View Source [SID1234637707]):

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Piper Sandler 35th Annual Healthcare Conference at 8:30 a.m. ET on Tuesday, November 28, 2023

The session may be accessed from the "Investors & Media" page of Regeneron’s website at View Source A replay and transcript of the webcast will be archived on the Company’s website for at least 30 days.

Orionis Biosciences Announces First Patient Dosed in Phase 1 Clinical Trial of ORB-011 in Patients with Advanced Solid Tumors

On November 15, 2023 Orionis Biosciences, a life sciences company pioneering the creation of highly selective and tunable therapeutics for cancer and other diseases, reported that the first patient has been dosed in a Phase 1 clinical trial of ORB-011, an attenuated, cis-targeted interferon immunotherapy based on the company’s A-Kine platform (Press release, Orionis Biosciences, NOV 15, 2023, View Source [SID1234637706]). ORB-011 is the first clinical candidate to emerge from the platform, which engineers cytokines to be highly selective for specific cellular targets while avoiding the broad systemic activity and associated toxicities observed with traditional cytokine therapies. The company is also announcing the appointment of Tony Fadell to its Board of Directors.

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ORB-011 is a first-in-class modified interferon designed to act with a high level of precision on cDC1 dendritic immune cells, potent activators of tumor cell killing CD8+ T cells. Preclinical research has shown that selective activation of cDC1s with such conditionally active interferon molecules translates into effective antitumor activity. Targeted activation of cDC1 was also well tolerated in non-human primate studies.

"The beginning of this clinical study represents a major milestone for Orionis and our A-Kine protein engineering platform, which combines a range of redesigned immune-modulatory cytokines with targeting modules aimed at cell types of therapeutic relevance. ORB-011 has the potential to harness the therapeutic activity of interferon in a new way," said Nikolai Kley, Ph.D., Founder, President, and Chief Executive Officer of Orionis Biosciences. "Interferons and other cytokines in our pipeline are powerful immune-activating agents. By localizing their activity to specific target cells, and exploiting communication networks across immune cells, we are evolving immunotherapies with unique translational potential."

Tony Fadell, Principal at Build Collective has joined the Orionis Board of Directors. He is the founder and former CEO of Nest, the company that pioneered the "Internet of Things." Tony was the SVP of Apple’s iPod Division and led the team that created the first 18 generations of the iPod and the first three generations of the iPhone. Tony holds more than 300 patents and is the author of the New York Times Best-Seller "BUILD – An Unorthodox Guide to Making Things Worth Making."

"Tony is a tremendously supportive and collaborative investor, bringing a broad range of expertise and insights to countless topics important to the strategic growth and vision of our business," said Dr. Kley. "His increased involvement will help us take Orionis to the next level and execute on our mission to bring new breakthrough medicines to patients in need."

"Orionis deploys the most powerful new foundational technologies available: Robotics plus Assay-on-Chip for high-throughput screening, generative AI for structure-based drug design…to name only a few," said Fadell. "This is what’s needed to combat the toughest, currently undruggable diseases. I’m excited about Orionis’s focus on immunotherapies: activating and directing our natural immune system to go after cancer. I can’t think of a more worthwhile endeavor."

About ORB-011
ORB-011 is a clinical-stage, targeted interferon that is designed to specifically activate cDC1 dendritic cells, immune cells that are specialized in presenting tumor antigens to, and activating, tumor cytotoxic CD8 T cells. It achieves localized activity by a unique mechanism of induced proximity on the cell surface of cDC1s. Orionis is evaluating ORB-011 in a Phase 1 open-label dose-escalation study (NCT05947474) for patients with recurrent or refractory solid tumors amenable to medically safe serial biopsies, including, but not limited to, colorectal cancer, HR+ or triple-negative breast cancer, non-small cell lung cancer, pancreatic cancer, head and neck squamous cell carcinoma, metastatic melanoma, bladder/urothelial, gastric cancers, esophageal, renal cell, hepatic and ovarian cancers. The Phase 1 clinical trial will provide initial safety, pharmacokinetic and pharmacodynamic readouts, and identify a dose of ORB-011 for use in future studies. It is being conducted at this time at the M.D. Anderson Cancer Center in Houston, Texas and at Honor Health Research Institute in Scottsdale, Arizona.

About the A-Kine Platform
Orionis’s A-Kine platform is designed to harness the intrinsic function and therapeutic potential of cytokines as key immune system regulators and natural defenders against cancer and infections. A-Kines are designed to be highly selective for intended cell targets, such as immune cells, and to avoid broad systemic activity and associated toxicities observed with traditional cytokine therapies. The platform covers multiple cytokine classes, including interferons, interleukins, and tumor necrosis factors, to generate a diversified pipeline of targeted immunotherapy candidates. These redesigned cytokines are leveraged to restart a stalled Cancer Immunity Cycle at multiple different positions to elicit natural mechanisms of immune attack against a variety of cancers.

Corporate presentation

On November 15, 2023 Immunome presented its corporate presentation (Presentation, Immunome, NOV 15, 2023, View Source [SID1234637705]).

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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.