On February 16, 2021 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that it has successfully completed the assignment of its key patent portfolio from the University of Melbourne (Press release, Clarity Pharmaceuticals, FEB 16, 2021, View Source [SID1234575072]). The assignment from the University of Melbourne to Clarity provides Clarity with the full rights and ownership of the patents moving forward.

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Clarity previously held exclusive licenses on several granted patents and patent applications from the University of Melbourne. With the assignment of the entire patent portfolio from the University of Melbourne to Clarity, the Company bolsters its strong IP position as it prepares for the next stage of its corporate and commercial development activities.

"The University of Melbourne has been one of the main collaborating institutions with Clarity on many levels, including basic research, early pre-clinical development, intellectual property, grant funding and direct investment," commented Clarity’s Executive Chairman, Dr Alan Taylor. "The research of Professor Paul Donnelly and his team at the School of Chemistry and Bio21 Institute of Molecular Science and Biotechnology, University of Melbourne, has been critical to the successful development and commercialisation of Clarity’s platform SAR Technology."

Clarity has aggressively pursued the patent protection of the SAR Technology, as well as the radio-imaging and radio-therapeutic agents associated with it in all major international jurisdictions. Broad patent coverage provides strong protection for Clarity’s platform around the world, and the nature of the SAR Technology and the patent strategy allows Clarity to file additional patents with new disease targeting agents in the development pipeline. Clarity’s lead products in development, SARTATE, SAR-bisPSMA and SAR-Bombesin, are examples of this strategy. With this broad and deep patenting strategy, the Company aims to safeguard its existing products as well as expand the pipeline and sustain its competitive advantage in the area of radiopharmaceuticals.

Professor Moira O’Bryan, Dean of Science at the University of Melbourne commented, "The University of Melbourne is continually focused on its aims of making distinctive contributions to society in research, teaching and learning, and engagement. Our collaboration with Clarity has seen significant benefits already to both organisations, and we look forward to our continued relationship with the Company as it progresses its very exciting ambitions of treating childhood cancer as well as other large cancer indications such as prostate and breast cancers".

Dr Taylor commented, "The strong relationship between our organisations remains an important part of Clarity as we continue to work together to make Clarity’s story of commercialising great Australian science a success through our pursuit to improve treatment outcomes for children and adults with cancer."

On February 15, 2021 OSE Immunotherapeutics reported that the Company has signed a loan agreement of up to €25 million with the European Investment Bank (EIB) (Press release, OSE Immunotherapeutics, FEB 15, 2021, View Source [SID1234646986]).

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The loan facility of up to €25 million is divided into three tranchesincluding two tranches of €10 million each and a third tranche of €5 million.

The first €10 million tranche, unconditional and which OSE will request payment before the end of May 2021, will help expand the clinical development of Tedopi in combination with a checkpoint inhibitor in additional cancer indications. This first tranche will also support the entry into Phase 1/2 of OSE279, OSE’s proprietary anti-PD-1 antibody, in a niche oncology indication. This development of OSE279 will allow OSE Immunotherapeutics to have its own proprietary anti-PD-1 antibody and leverage it across OSE’s product portfolio in combination with other drug candidates. Moreover, OSE-279 is the key anti-PD-1 backbone component of the bifunctional checkpoint inhibitor BiCKI platform, targeting PD-1 and other innovative targets, paired with novel immunotherapy targets.

The remaining two tranches of €10 and €5 million, available upon achievement of specific clinical milestones, are planned to be used to accelerate the clinical development of the Company’s other programs, in particular CD28 antagonist FR104 and new anti-ChemR23 agonist OSE-230.

Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, comments: "We are very grateful for EIB’s support, a major financial European institution, as the Company is at an inflection point of its growth. The first €10 million tranche allows OSE to extend its financial visibility to Q2 2022. This new flexible funding tool will help expand and accelerate the development of our clinical stage portfolio and explore new therapeutic indications with strong medical need, reinforcing OSE’s status as a key global player in immunotherapy."

Ambroise Fayolle, Vice-President of the EIB, explains: "The EIB is pleased to announce its support of OSE, a biotech combining a high level of research and innovation, highly qualified collaborators and cutting-edge expertise in the field of monoclonal and bispecific antibodies. The portfolio of products under development in various therapeutic areas such as immuno-oncology, autoimmune diseases and a vaccine project against SARS-CoV-2, means that OSE Immunotherapeutics is a potential major player in the health sector. This project is fully in line with the mandate set for the EIB by its shareholders – the EU Member States – to support innovation across Europe".

This loan will carry a fixed interest of 5% per year paid annually, with a maturity of five years (each drawdown is treated separately in terms of maturity). The repayment of each tranche will therefore be made at the end of a period of five years after the date of disbursement of the said tranche.

The loan agreement is supplemented by an agreement to issue warrants to the EIB for the first two tranches of the financing, in particular 850,000 warrants for the first tranche to be issued when drawn. 550,000 additional warrants could be issued if the second tranche of €10 million is drawn by OSE Immunotherapeutics.

Each warrant will give the right to subscribe to one ordinary share of OSE Immunotherapeutics at the subscription price of €0.01 and at the exercise price calculated on the basis of the volume-weighted average of the 3 trading days preceding the pricing (which will take place at the end of May 2021), with a discount of 2.5%.

The warrants will be exercisable for a period of 12 years.
Subject to certain customary exceptions, the warrants will only be exercisable after a five-year period starting from the drawdown of the relevant tranche, thus limiting the impact in terms of dilution and volatility in the coming years.

The warrant agreement includes an exercise parity adjustment clause which could apply, under certain conditions, in case of capital increase. The EIB will be granted with the possibility, under certain conditions, to request OSE Immunotherapeutics to buy back its warrants for a maximum amount of €15 million and, beyond that amount, to find a buyer and pay interests on the price of the remaining warrants

On February 15, 2021 , Eli Lilly reported The UK’s National Institute for Health and Care Excellence (NICE) has not recommended Eli Lilly’s Verzenios (abemaciclib) with fulvestrant for the treatment of advanced breast cancer patients (Press release, Eli Lilly, FEB 15, 2021, View Source [SID1234575342]).

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Lilly had been seeking a recommendation within Verzenios’ marketing authorisation, for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in adults who have had endocrine therapy.

NICE has reviewed additional evidence, collected as part of the Cancer Drugs Fund (CDF) managed access agreement for Verzenios plus fulvestrant in these breast cancer patients, to make this appraisal.

Typically, people with hormone receptor-positive, HER2-negative advanced breast cancer receive exemestane plus everolimus after endocrine therapy.

NICE said that there is uncertainty around Verzenios plus fulvestrant treatment because there is no evidence directly comparing this therapy to exemestane plus everolimus.

However, an indirect comparison suggests that people receiving Verzenios plus fulvestrant have longer before their disease progresses and live longer compared to people having exemestane plus everolimus.

NICE added that it is unclear how long people would have treatment for and therefore how much the treatment would cost.

On the cost-effectiveness front, NICE said that because of these uncertainties, estimates vary.

The ‘most likely’ estimates are higher than what NICE usually considers a cost-effective use of NHS resources.

"[The] news that NICE has been provisionally unable to approve Verzenios with fulvestrant for routine use on the NHS following its time on the Cancer Drugs Fund is a devastating blow for thousands of women with incurable secondary breast cancer who could benefit from this innovative treatment in future," said Delyth Morgan, chief executive at Breast Cancer Now.

"Verzenios with fulvestrant is an example of continued advances in treatment and care for secondary breast cancer and it’s deeply concerning that new patients could be denied the chance to benefit from this progress.

"While treatment will continue for women currently receiving it, NICE, NHS England and Lilly UK must work swiftly together to explore all possible solutions to see this provisional decision reversed, including considering additional discounts. Unless this happens, patients in the future will pay the price of being denied the precious chance this treatment brings to live well for longer," she added.

The draft recommendation will not affect treatment for those who have already been receiving Verzenios plus fulvestrant via the CDF.

The combination treatment will no longer be available in the CDF for this indication if the final guidance does not recommend Verzenios plus fulvestrant therapy.

On February 15, 2021 BioTheryX, Inc., a clinical-stage company focused on degrading proteins to create life-saving medicines, reported that the company will participate virtually in the following scientific and investor events (Press release, BioTheryX, FEB 15, 2021, View Source [SID1234575080]):

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Targeted Protein Degradation & PROTAC Symposium
Tuesday, February 16, 2021, 16:30 GMT
Aparajita Hoskote Chourasia, Ph.D., Senior Director of Biology, will give a presentation entitled, "Developing Novel Cereblon-Directed PHMs as First-in-Class Targeted Protein Degradation Therapies".
North American Protein Degradation Congress
Tuesday, February 23, 2021, 3:00 pm ET
Leah Fung, VP, Medicinal Chemistry, will give a presentation entitled, "BioTheryX is Leveraging Novel Cereblon-Directed Molecular Glues to Discover First-in-Class TPD Therapies for Oncology".
LifeSci Partners Precision Oncology Day
Wednesday, February 17, 2021, 1:00 PM ET
Rob Williamson, President and CEO, will present an overview on the company’s targeted protein degradation platform and the management team will participate in 1x1s with investors.
BMO BioPharma Spotlight Series: Targeted Protein Degradation and Other Next Gen Protein Technologies
Thursday, February 18, 2021, 10:30 AM ET
Rob Williamson, President and CEO, will participate in a panel entitled "Ligating Competitors for Collaboration in the Protein Degradation Space", moderated by BMO analysts Matt Luchini and Nick Lenard.
Additional panel participants include Ian Taylor, CSO, Arvinas; Stew Fisher, CSO, C4 Therapeutics; and Jared Gollob, CMO, Kymera. In addition to the panel, the BioTheryX management team will also participate in 1x1s with investors during the event.
2021 SVB Leerink Global Healthcare Conference
Tuesday, February 23, 2021
The BioTheryX management team will participate in 1x1s with investors.

On February 15, 2021 SHEPHERD Therapeutics, a company dedicated to catalyzing lifesaving treatments for rare cancer patients, and Oncoheroes Biosciences, a biotech company focused on advancing new therapies for childhood cancer, reported they have entered into a partnership to collaborate in the discovery, development and commercialization of innovative drug products for rare oncology indications (Press release, Oncoheroes Biosciences, FEB 15, 2021, View Source [SID1234575079]).

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Out of 400 known distinct cancers, 380 are considered rare according to the American Cancer Society’s metric of an incidence of less than 6 per 100,000. Rare cancers affect almost one in three new patients, or over half a million Americans each year. Despite the prevalence of rare cancers, 2012-2016 data shows that 75% of all clinical trials did not specifically include even one rare cancer by name.

Childhood cancer is considered a rare disease that accounts for about 1% of all U.S. cancer diagnoses. Every year, cancer takes the lives of 90,000 children and adolescents worldwide, despite treatment advances in recent decades. Although cancer is the leading cause of death by disease among children in the United States, pediatric oncology treatments are lacking: Only five pediatric-specific drugs have been granted U.S. Food and Drug Administration (FDA) approval in the last 20 years versus more than 200 for adults.

Oncoheroes and SHEPHERD’s collaboration advances a paradigm change in drug development for rare cancers. The companies will use DELVE, SHEPHERD’s next-generation, precision-oncology platform that integrates bioinformatics, machine learning and mathematics, to unveil unprecedented insights into rare cancers, including childhood cancer. DELVE enables the companies to move beyond a single target-based approach to identify all of the primary mechanisms of action responsible for drug response and resistance within the human transcriptome.

The companies’ first project of the collaboration will identify additional pediatric and rare adult indications for Oncoheroes’ lead asset, volasertib. Volasertib is an inhibitor of Polo-like-kinase 1 (PLK1), an enzyme known to be involved in disease progression in a number of cancers. Volasertib has recently been granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) by the FDA for the treatment of rhabdomyosarcoma, the most common soft tissue sarcoma in children and young adults, representing 3-4% of all childhood cancers.

"Getting a diagnosis of cancer as a child should not be a death sentence, yet too many lives are being lost or diminished because of a dearth of pediatric cancer research and treatments," said David Hysong, CEO of SHEPHERD. "SHEPHERD and Oncoheroes are coming together in hope and in action, leveraging the full extent of our combined technology, experience and expertise to help save lives."

"We are excited about this partnership between two mission-driven companies determined to address high unmet medical needs in the rare oncology space. We are confident that SHEPHERD’s technology, combined with Oncoheroes’ expertise in the pediatric oncology space, will deliver new therapeutics options to children and adolescents with cancer," stated Ricardo Garcia, CEO of Oncoheroes.