On December 3, 2024 Orakl Oncology ("Orakl"), a pioneering precision oncology company, reported an €11 million seed funding round, led by Singular, with support from Bpifrance including the Grand Prix i-Lab, and participation from existing investors (Press release, Orakl Oncology, DEC 3, 2024, View Source [SID1234656620]). This new funding will be used to accelerate the company’s growth and support the launch of two new commercial products, O-Predict and O-Validate designed to transform the landscape of oncology drug development.

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Founded in 2023 by Fanny Jaulin, PhD, Diane-Laure Pagès, PhD, and Gustave Ronteix, PhD, Orakl is a spin-off from the Gustave Roussy Institute – the leading European cancer research institute. The company is addressing a critical challenge in oncology, where only 4% of drug candidates will reach cancer patients. The majority of drugs fail in clinical trials due to inaccurate and disjointed decisions made from heterogeneous data and models that do not translate well in humans. To solve this challenge, Orakl has developed a first-in-class, AI-powered techbio platform that combines real-world patient data with cutting-edge biology into a unique and integrated decision-making engine for the entire drug development process. Orakl’s technology delivers best-in-class predictions to significantly improve the recruitment of responding patients and clinical trial probability of success. This fulfills Orakl’s mission: transforming the oncology drug development landscape and providing more drugs to patients, faster.

Dr. Fanny Jaulin, Orakl Oncology CEO & Co-Founder, commented: "Our mission at Orakl is to revolutionize drug development by offering an unparalleled decision-making platform that empowers drug developers to de-risk clinical trials and expedite the availability of new transformative medicines. By addressing the urgent unmet needs in digestive cancers, we aim to redefine the future of precision medicine and deliver breakthroughs that patients desperately need."

Leveraging machine learning, advanced cell biology and engineering, Orakl’s platform is powered by hundreds of individualized patient avatars that combine rich, longitudinal real-world data and sustainable tissues from the same patient to simulate real-life drug responses. Initially focusing on colorectal and pancreatic cancers – two major unmet medical needs – the company’s growing collection of patient avatars helps pharmaceutical and biotech companies predict and optimize clinical trial outcomes, discover and validate new therapeutic targets, and identify optimal drug combinations or competitive threats*. Orakl also plans to use the platform to inform in-licensing decisions and build its own internal pipeline.

Prof. Fabrice Barlesi, General Director of Gustave Roussy, commented: "As Europe’s leading cancer center and a pioneer in precision medicine, we are proud to innovate through our spin-off, Orakl, which develops ex vivo patient avatars for therapeutic decision-making and accelerates the discovery of next-generation cancer therapies."

Building on this foundation, Orakl is now marketing its two first AI-powered commercial solutions to reinvent oncology drug development. The first solution, O-Predict, forecasts patient responses to new drug candidates, predicting key clinical outcomes such as the number of responders and progression-free survival. It also evaluates the efficacy of these new treatments against standard or competitor therapies, designs combinatorial treatments, and identifies multimodal predictive biomarkers. Orakl’s second product, O-Validate, provides biological evidence of causality, supporting target and biomarker validation and enabling data-based strategic decision-making across drug development stages.

Jeremy Uzan, General Partner at Singular, commented: "A key strength of Orakl lies in its team – a mix of deep expertise in cancer research, cell biology, and computational biology. With the recent addition of Jessica Atkinson as Business Advisor, the company is better positioned than ever to forge strategic partnerships in the pharmaceutical sector. Backed by a solid scientific foundation and a clear business focus, Orakl is set to drive meaningful progress in oncology—and we are proud to support the team on this journey."

The new investment will enable Orakl to build its business unit and position the company for strategic partnerships within the pharmaceutical sector. To lead this initiative, Orakl has appointed Jessica Atkinson as Business Advisor. As a business expert with extensive experience at Merck and Foundation Medicine, she will develop and execute a strategic approach to drive Orakl’s entry into the clinical oncology market. In addition, Orakl is building a dedicated business team to support its new commercial offerings expecting to transform drug development in the era of precision oncology.

This investment follows a €3M pre-seed round in October 2023 led by Speedinvest with participation from HCVC and Verve Ventures. Together with the award from the Fondation Jean-Jacques et Felicia Lopez Loreta pour l’Excellence Scientifique, this brings Orakl’s total capital raised to date to nearly €15 million.

On December 3, 2024 Epsilogen, the global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, reported that it has commenced a Phase Ib study evaluating MOv18 IgE in patients with platinum-resistant ovarian cancer (PROC) (Press release, Epsilogen, DEC 3, 2024, View Source [SID1234648748]).

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The Phase Ib, open-label, dose escalation and expansion trial (NCT06547840) will enrol 45 patients with PROC whose disease has progressed after no more than four lines of prior therapy. The trial will assess the safety, tolerability and efficacy of MOv18 IgE in ascending dose cohorts.

MOv18 IgE is an IgE antibody targeting the folate receptor alpha (FR alpha) antigen which is selectively expressed by a variety of cancers including ovarian, non-small cell lung, endometrial and triple negative breast cancer. It is the first ever IgE antibody therapeutic to enter clinical testing and the Phase Ib trial will generate extensive translational data to allow further understanding of IgE’s unique mechanism of action in man. A previous Phase I safety study of MOv18 IgE found it to be safe and well tolerated, with evidence of anti-tumour activity observed, as reported in Nature Communications (View Source).

Dr Tim Wilson, CEO of Epsilogen, said: "We are pleased to have initiated the Phase Ib study of MOv18 IgE, following the encouraging Phase I data. This is a key step in our goal of bringing this exciting new therapeutic modality to cancer patients".

On December 3, 2024 Gilead Sciences, Inc. (Nasdaq: GILD) and Tubulis reported that they have entered into an exclusive option and license agreement to discover and develop an antibody-drug conjugate (ADC) against a solid tumor target (Press release, Gilead Sciences, DEC 3, 2024, View Source [SID1234648765]).

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Through this agreement, Gilead will gain access to Tubulis’ proprietary Tubutecan and Alco5 platforms. The companies will collaborate to select the best technology to utilize, with Tubulis leading discovery and development efforts to design a topoisomerase I inhibitor-based ADC candidate with superior biophysical properties and stability to address current treatment challenges such as durability and off-target toxicity.

"As we expand our oncology portfolio to address the greatest gaps in care, accessing novel technologies is critical to advancing our pipeline," said Flavius Martin, MD, Executive Vice President, Research, Gilead Sciences. "With Gilead’s ongoing focus on innovating with next-generation therapies and combinations, we are excited to partner with Tubulis to explore a range of solutions that may help increase the therapeutic value of the ADC modality."

"Gilead has established a long track record of developing drugs that provide a significant step-up in therapeutic value, making them a great collaborator for leveraging our technology platforms, in line with our vision of fundamentally changing the ADC landscape," said Dominik Schumacher, PhD, CEO and co-founder of Tubulis. "Tubulis remains primarily focused on driving value through our own clinical development programs while selectively building partnerships with leaders in the industry."

Terms of the Agreement

Under the terms of the agreement, Tubulis will receive an upfront payment of $20 million and, if Gilead exercises its option, a separate option exercise fee of $30 million. In addition, Tubulis will be eligible for development and commercialization milestone payments totaling up to $415 million, plus mid-single to low double-digit tiered royalties on sales of marketed products resulting from the collaboration. Tubulis will lead early-stage research and development activities for the ADC program. If Gilead exercises its option to exclusively license the program, Gilead will be responsible for further development and commercialization activities for all products resulting from the collaboration.

Gilead does not exclude acquired IPR&D expenses from its non-GAAP financial measures. This transaction with Tubulis is expected to reduce Gilead’s GAAP and non-GAAP 2024 EPS by approximately $0.01.

On December 3, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that abstracts related to lacutamab health-related quality of life and translational data from the TELLOMAK trial and SAR443579, Sanofi-partnered ANKET asset, have been selected for the American Society of hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Innate Pharma, DEC 3, 2024, View Source [SID1234648749]).

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"We are proud of the progress being made across our multiple programs, including our lead proprietary asset lacutamab and the multi-specific NK cell engagers from our ANKET platform," commented Dr. Sonia Quaratino, Chief Medical Officer of Innate Pharma. "We look forward to presenting data supporting the advancement of our programs at the upcoming ASH (Free ASH Whitepaper) 2024 as we move closer to our goal of delivering new treatment options for patients with high unmet medical needs."

Details of the presentations

•Lacutamab in Patients with Relapsed and/or Refractory Sézary Syndrome: Translational Analysis from the TELLOMAK Phase 2 Trial
Abstract Number: 1609
Presentation Type: Poster Presentation
Session: 622. Lymphomas: Translational – Non-Genetic: Poster I
Date and Time: Saturday, Dec. 7, 2024, 5:30 PM – 7:30 PM PT

•Health-Related Quality of Life in Patients with Relapsed/Refractory Cutaneous T-Cell Lymphoma Treated By Lacutamab: Patient-Reported Outcomes from the Phase 2 TELLOMAK Trial
Abstract: 466
Presentation Type: Oral Presentation
Session Name: 625. T Cell, NK Cell, or NK/T Cell Lymphomas: Clinical and Epidemiological: When Old Meets New in T Cell Lymphomas
Presentation Date and Time: Sunday, Dec. 8, 2024, 10:15 AM PT

•Phase 1/2, Open-Label, Multi-Center Study Assessing the Safety, Tolerability and Preliminary Efficacy of CD123 Natural Killer Cell Engager (NKCE), SAR443579, in Combination With Venetoclax and Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy (Sanofi)
Abstract: 2883.3
Presentation Type: Poster Presentation
Session Name: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster II
Date and Time: Sunday, Dec. 8, 2024, 6:00 PM – 8:00 PM PT

About Lacutamab

Lacutamab is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease, and peripheral T cell lymphoma (PTCL). Rare cutaneous lymphomas of T lymphocytes have a poor prognosis with few efficacious and safe therapeutic options at advanced stages.

KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up 90% of patients with certain aggressive CTCL subtypes, in particular, Sézary syndrome. It is expressed by up to 50% of patients with mycosis fungoides and peripheral T-cell lymphoma (PTCL). It has a restricted expression on normal tissues.

Lacutamab is granted European Medicines Agency (EMA) PRIME designation and US Food and Drug Administration (FDA) granted Fast Track designation for the treatment of patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies. Lacutamab is granted orphan drug status in the European Union and in the United States for the treatment of CTCL.

On December 3, 2024 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, reported a USD $1 million milestonepayment from Regeneron Pharmaceuticals, Inc. was triggered (Press release, MediGene, DEC 3, 2024, View Source [SID1234648766]). Regeneron purchased the MAGE-A4-TCR program as part of its acquisition of2seventy bio Inc.’s pre-clinical and clinical oncology and autoimmune cell therapy pipeline, which closed in April 2024. The payment was triggered by a development milestone for a trial in China led by JW Therapeutics (also a prior collaborator of 2seventy bio, Inc.) of Regeneron’s MAGE-A4 cell therapy, which contains a Medigene generated T cell receptor (TCR) targeting MAGE-A4.

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"We are excited that this program is moving forward, incorporating our TCR directed at MAGE-A4 into the clinic and potentially providing the first clinical validation of our unique TCR discovery and generation capabilities and our End-to-End Platform technologies," said Dr. Selwyn Ho, Chief Executive Officer of Medigene. "We look forward to the results of this trial and remain committed to delivering best-in-class, differentiated T cell receptors for use in multiple TCR-guided therapies for patients with solid tumors."

This payment has been included in the current financial guidance provided by the Company, and therefore confirmation of this milestone does not change 2024 guidance.