On December 4, 2024 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, reported that a patient currently treated with Namodenoson in a compassionate use program in Can-Fite’s Phase II Liver Cancer Study has an overall survival time of 8 years with a complete response (Press release, Can-Fite BioPharma, DEC 4, 2024, View Source [SID1234648786]).

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The patient, who suffered from advanced liver cancer was enrolled in the former Can-Fite Phase II study, continue to be treated with Namodenoson, and has now an overall survival of 8 years, with disappearance of ascites, normal liver function, good quality of life and is defined as a long term complete response.

Can-Fite is currently enrolling patients in Israel, Europe and the US for a pivotal Phase III clinical study for patients with advanced HCC as a 2nd or 3rd line treatment and Namodenoson is administered twice daily orally. The study protocol has been agreed upon with U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel and Romania.

"With a very favorable safety profile and anti-cancer effect of Namodenoson, we are now enrolling patients for the pivotal Phase III clinical study where we expect to prolong patients’ overall survival, and see a response similar to that of the patient who has now been treated with Namodenoson for 8 years. The uniqueness of Namodenoson which specifically acts against the tumor cells and protects the normal liver cells, is the rationale for the conductance of the current trial," stated Prof. Salomon Stemmer, a leading key opinion leader, at the Institute of Oncology, Rabin Medical Center, Israel.

According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. As new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $6.1 billion by 2027 for the G8 countries.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On December 4, 2024 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the compensation committee of BioCryst’s board of directors granted five newly-hired employees stock options to purchase an aggregate of 17,400 shares, and restricted stock units (RSUs) covering an aggregate of 12,150 shares, of BioCryst common stock (Press release, BioCryst Pharmaceuticals, DEC 4, 2024, View Source [SID1234648785]). The options and RSUs were granted as of November 29, 2024, as inducements material to each employee entering into employment with BioCryst. The options and RSUs were granted in accordance with Nasdaq Listing Rule 5635(c)(4).

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The options have an exercise price of $7.50 per share, which is equal to the closing price of BioCryst common stock on the grant date. The options and RSUs vest in four equal annual installments beginning on the one-year anniversary of the grant date, in each case subject to the new employee’s continued service with the company. Each stock option has a 10-year term. The options and RSUs are subject to the terms and conditions of BioCryst’s Inducement Equity Incentive Plan and a stock option agreement or restricted stock unit agreement, as applicable, covering the grant.

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).