On December 4, 2024 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the Company was notified that the first patient has been dosed in a Phase 3 clinical trial with Shanghai Henlius Biotech, Inc. Alligator out-licensed HLX22/AC101 to AbClon, Inc. in October 2016 (Press release, Alligator Bioscience, DEC 4, 2024, View Source [SID1234648783]). Abclon, Inc. subsequently sub-licensed AC101 for clinical development by Shanghai Henlius Biotech Inc.

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"We are pleased to announce that Henlius Biotech has dosed the first patient in its Phase 3 international multi-centre clinical trial of HLX22/AC101, aiming to provide a new first-line treatment for HER2-positive advanced gastric/gastroesophageal junction cancer. This progress demonstrates Henlius’ commitment to the HLX22/AC101 program. Also, this bodes well for Henlius’ completion of the ongoing Phase 2 trial, which will trigger a milestone payment to Alligator," said Søren Bregenholt, CEO of Alligator Bioscience.

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 Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company focused on developing innovative radiotherapeutics, reported the renewal of its Master Services Agreement (MSA) with Telix IsoTherapeutics Group Inc. (‘IsoTherapeutics’, a Telix Group company) (Press release, Plus Therapeutics, DEC 3, 2024, View Source [SID1234648800]). This MSA secures a reliable supply of cGMP Re-186, the radioisotope used in Plus Therapeutics’ lead radiotherapeutic candidate Rhenium (186Re) Obisbemeda.

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"This continuing agreement with Telix IsoTherapeutics Group builds on our recently announced partnership with SpectronRx and reflects our comprehensive supply chain strategy," said Marc H. Hedrick, M.D., Plus Therapeutics’ President and Chief Executive Officer. "By securing supply of Re-186 through IsoTherapeutics and leveraging SpectronRx for final drug manufacturing of Rhenium (186Re) Obisbemeda, we are establishing a scalable, end-to-end supply chain that positions us to meet the demands of late-stage clinical trials and future commercial needs."

Key highlights of the agreement:

Focus on the production of key radionuclide intermediate aluminum perrhenate and the final processing of cGMP Re-186
Enables expanded, scalable, just-in-time manufacturing to support overall supply chain
About Rhenium (186Re) Obisbemeda

Rhenium (186Re) Obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high-dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) Obisbemeda has the potential to reduce off-target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) Obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).

On December 3, 2024 TRIO Pharmaceuticals, Inc., a biotechnology company pioneering bispecific antibodies for the treatment of cancer with unprecedented potency and selectivity, reported the successful completion of a $3.1 million financing round (Press release, Trio Pharmaceuticals, DEC 3, 2024, View Source [SID1234648780]). TRIO’s pre-Series A financing was led by San Diego based Friedman Bioventure Fund (FBVF). "The TRIO team has demonstrated impressive bioactivity for both their TRAILBody and TIE-ADC bispecific antibody architectures, and we believe these potential medicines warrant accelerated development," said Dr. Jeff Friedman of FBVF.

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Additional significant support came from the Multiple Myeloma Research Foundation (MMRF), through its venture philanthropy arm, the Myeloma Investment Fund (MIF), underscoring the potential of TRIO’s work to impact cancers with high unmet needs. Further investors included NuFund Venture Group, Life Science Angels and others.

Friedman Bioventure brings expertise in supporting innovative biotech startups, aiming to accelerate breakthrough therapies to market. The Myeloma Investment Fund focuses on advancing treatments for cancers affecting blood and bone marrow, notably multiple myeloma. The Multiple Myeloma Research Foundation (MMRF) is the largest nonprofit in the world solely focused on accelerating a cure for each and every multiple myeloma patient. MMRF has raised over $600 million for research, opened nearly 100 clinical trials, and helped bring 15+ FDA-approved therapies to market.

"TRIO’s innovative approach aligns with our mission to drive breakthrough treatments for the myeloma community," said Dr. Stephanie Oestreich, Managing Director, Myeloma Investment Fund. "This investment underscores our commitment to accelerating therapeutic options for myeloma patients."

TRIO Pharmaceuticals’ proprietary platforms, TRAILBody and TIE-ADC, are advancing next-generation immunotherapies for cancers with high mortality rates, such as Multiple Myeloma, Acute Myeloid Leukemia, ovarian, endometrial, and triple-negative breast cancers. These therapies combine targeted tumor growth inhibition with immune system modulation to offer potent, less toxic options compared to conventional treatments.

"This financing round empowers us to expand our preclinical activities and advance our programs towards clinical development," said Dr. Reiner Laus, CEO of TRIO Pharmaceuticals. "The support from organizations like Friedman Bioventure and the Myeloma Investment Fund is invaluable as we work to bring our transformative therapies closer to patients in need."

TRIO Pharmaceuticals is dedicated to reimagining cancer care through the application of novel antibody therapeutics. This funding will accelerate TRIO’s journey towards clinical trials, offering new hope for patients facing cancers that resist standard therapies.

On December 3, 2024 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company dedicated to developing cancer therapies and transforming the cost, pace, and timeline of oncology drug discovery and development, reported that the FDA has granted Fast Track Designation for investigational drug candidate, LP-184, for treatment of Triple Negative Breast Cancer (TNBC) (Press release, Lantern Pharma, DEC 3, 2024, View Source [SID1234648779]). This marks the second Fast Track Designation received for LP-184 in 2024, following its designation for Glioblastoma in October.

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LP-184 is currently in a Phase 1A clinical trial designed to evaluate the safety and tolerability of this synthetically lethal investigational drug candidate in a broad range of solid tumors, including TNBC. LP-184 was optimized and advanced in part with Lantern’s AI platform, RADR, which helped validate mechanisms that could be exploited in the clinical setting to eradicate challenging cancers and uncover insights in targeted patient populations.

"Receiving a second FDA Fast Track Designation for LP-184 reinforces the significant potential of this drug candidate to address critical unmet needs in aggressive cancers, especially those like TNBC where patients have limited therapeutics options," stated Panna Sharma, President and CEO of Lantern Pharma. "Recent data presented at the Immuno-Oncology Summit demonstrated LP-184’s ability to sensitize TNBC tumors that are non-responsive to checkpoint inhibitors, potentially expanding treatment options for patients with limited therapeutic choices."

About TNBC and the Need for Novel Therapies

TNBC represents approximately 20% of all breast cancers, affecting nearly 29,000 patients annually in the US. The prognosis for TNBC patients is considerably worse than hormone receptor-positive breast cancers, with over 50% of patients relapsing in the first 3-5 years and metastatic TNBC patients having a median overall survival of less than one year. Currently available treatment options are limited, particularly for patients who develop resistance to existing therapies.

Compelling Preclinical Data Demonstrates LP-184’s Potential in TNBC

The graph above demonstrates LP-184’s remarkable anti-tumor activity across a panel of 10 TNBC patient-derived xenograft (PDX) models. Notably, LP-184 showed consistent efficacy in both PARPi (PARP inhibitor) resistant and PARPi sensitive tumors, with treatment resulting in complete tumor regression (107-141% tumor growth inhibition) across all models tested. This data is particularly significant as it suggests LP-184’s potential as a novel therapeutic option for TNBC patients, including those who have developed resistance to existing PARP inhibitor treatments – a growing clinical challenge in TNBC therapy. This TNBC data was initially presented at the San Antonio Breast Cancer Symposium in 2022.

LP-184’s unique mechanism of action is driven by the enzymatic activation of the drug by Prostaglandin Reductase 1 (PTGR1), which converts LP-184 into its highly potent cytotoxic form specifically within cancer cells. RADR platform analysis and subsequent in-vivo validation studies have shown that PTGR1 is frequently elevated in TNBC tumors compared to normal tissue, making these cancers particularly susceptible to LP-184 treatment. This biomarker-driven approach allows for the potential identification of patients most likely to respond to LP-184 therapy, aligning with current and emerging precision medicine approaches in TNBC treatment.

About LP-184

LP-184 is a small molecule drug candidate and next-generation acylfulvene that preferentially damages DNA in cancer cells that overexpress specific biomarkers or harbor mutations in DNA damage repair pathways. LP-184 was developed using Lantern’s proprietary RADR AI platform to identify patient populations and cancer subtypes that have the potential to respond to treatment. The compound is being evaluated in multiple solid tumors where it has shown nanomolar potency and activity in drug-resistant cancers. LP-184 has received Orphan Drug Designations from the FDA for the treatment of pancreatic cancer, glioblastoma (GBM), and ATRT, and has also been granted a Rare Pediatric Disease Designation for ATRT.