On October 6, 2020, Advaxis, Inc. (the "Company") reported that received a notice (the "Notice") from Aratana Therapeutics, Inc. ("Aratana"), dated September 17, 2020, indicating that Aratana is terminating the Exclusive License Agreement, dated March 19, 2014, by and between Aratana and the Company (the "Agreement") and that such termination of the Agreement will be effective on December 21, 2020 (Filing, 8-K, Advaxis, OCT 6, 2020, View Source [SID1234568218]). Other than in respect of the Agreement, there is no material relationship between the Company and Aratana.

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Under the Agreement, the Company granted Aratana an exclusive, worldwide, royalty-bearing license, with the right to sublicense, certain of the Company’s proprietary technology to enable Aratana to develop and commercialize animal health products targeted for treatment of osteosarcoma and other cancer indications in animals. Aratana paid an upfront payment to the Company in the amount of $1 million upon signing of the Aratana Agreement. The Agreement also required Aratana to pay the Company (a) up to $36.5 million based on the achievement of milestones relating to the advancement of products through the approval process with the United States Department of Agriculture in the United States and the relevant regulatory authorities in the European Union, and up to an additional $15 million in cumulative sales milestones based on achievement of gross sales revenue targets for sales of any and all products for use in non-human animal health applications, or the Aratana Field (regardless of therapeutic area), and (b) tiered royalties starting at 5% and going up to 10%, paid based on net sales of any and all products (regardless of therapeutic area) in the Aratana Field in the United States. The Agreement required royalties for sales of products outside of the United States to be paid at a rate equal to half of the royalty rate payable by Aratana on net sales of products in the United States (starting at 2.5% and going up to 5%). The Agreement also required Aratana to pay the Company 50% of all sublicense royalties received by Aratana and its affiliates. In fiscal year 2019, the Company received approximately $8,000 in royalty revenue from Aratana.

The Notice of termination follows Aratana’s acquisition by Elanco Animal Health Incorporated, effective July 18, 2019.

The Company will not incur any early termination penalties as a result of the termination. Aratana will be required to make all payments to the Company that would have otherwise been payable under the Agreement through the effective date of the termination.

On October 5, 2020 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to improve drug discovery and development, and identify patients who will benefit from its portfolio of targeted oncology therapeutics, reported the advancement of its collaboration with Georgetown University for LP-184, a small molecule drug candidate currently in preclinical development for certain genomically defined solid tumors, including prostate and pancreatic cancers (Press release, Lantern Pharma, OCT 5, 2020, View Source [SID1234568098]).

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The first phase of the joint research activities with Georgetown which began in the 4th quarter of 2019 generated strong evidence of the efficacy of LP-184 in certain solid tumors and linked the anti-tumor activity to the presence of specific biomarkers. Phase one of the collaboration was a proof of concept study that demonstrated LP-184 had nanomolar potency across a wide variety of cell lines specifically engineered to study prostate cancer. LP-184 demonstrated increased efficacy in killing prostate cancer cells that overexpress PTGR1, a gene that is often upregulated in aggressive cancer tumors as well as higher anti-cancer activity in cells lines that had targeted DNA damage repair gene mutations. LP-184 was further tested in 3D organoid cultures, which are derived from patient tumor samples and more closely represent the actual biology of human tumors than cell lines, resulting in dose-dependent cell death in multiple patient-derived xenograft (PDX) prostate cancer models. Additional genomic, transcriptomic and drug sensitivity data from the cell lines and 3D organoids was also obtained, which is helping to refine the response signature, and is providing insights into which DNA repair deficiencies are more likely to be highly sensitive to LP-184. Since aggressive cancers can frequently over express PTGR1, this important insight regarding the observed efficacy of LP-184 in such tumors will be further validated in the next phase of the collaboration.

Mr. Sharma added: "I am very excited about the results of the first phase of our collaboration with Georgetown University as it validates that LP-184 is a highly potent agent in cancers that exhibit certain molecular features. This fact is highly significant as it suggests LP-184 could develop into a first-in-class compound for the treatment of certain prostate and pancreatic cancers and potentially other solid tumors. Moreover, LP-184 seems to work specifically by damaging and blocking a pathway critical for cancer cell proliferation; it could potentially be a perfect drug for use in combination with existing therapies for these prostate and pancreatic cancers as well as other solid tumors where we can exploit this molecular feature. We will be working alongside Dr. Banerjee to further elucidate this mechanism and generate a signature that we can use for future patient selection in trials and patient treatment."

The next phase of the collaboration and research program with Georgetown will focus on a larger set of PDX models and help pinpoint the specific mechanism of action, and seek confirmatory validation of the role of PTGR1 and the genetic mutations driving the DNA damage repair pathways that make the drug highly potent in these cancers. Research will also focus on completing the acquisition of detailed genomic information in prostate cancers, which will involve work in animal models and cell lines that have been edited to under and over express key driver genes.

Dr. Partha Banerjee, a world-renowned expert in molecular oncology and prostate cancer, and lead investigator for LP-184 at Georgetown University, commented: "There is currently a lack of approved therapeutic options for metastatic castration resistant prostate cancer (mCRPC), which affects ~33,000 men per year in the U.S. alone. It is a highly lethal disorder with increasing incidence in the US and a 5-year survival rate of 26%, as compared to 91% for localized prostate disease. LP-184 has the potential to preferentially target DNA damage repair pathway in cancer cells that express certain biomarkers, like PTGR1. Thus, if LP-184 is able to demonstrate efficacy in future human clinical trials and meaningfully increase the survival rate, this would be extremely important for patients." In addition to Dr. Partha Banerjee, Dr. Shiv Shrivastava, who previously served as the Co-Director of the Center for Prostate Disease Research at Walter Reed National Military Medical Center is also advising Lantern Pharma in the development strategy in this precision oncology approach for LP-184.

LP 184 has been advanced using Lantern’s proprietary RADR A.I. platform that uses machine learning, genomics, and computational biology to accelerate the discovery of potential mechanisms of action and genomic and biomarker signatures that correlate to drug response in cancer patients.

The goal of phase two of the collaboration is to create a more biologically relevant and robust gene signature in preparation for clinical trials, with the objective of allowing future prostate cancer patients to experience the benefit of a more personalized cancer treatment approach. Ultimately, Lantern’s A.I. driven approach could save millions of dollars in drug development costs while significantly accelerating the path to commercialization.

Panna Sharma, CEO of Lantern Pharma, said: "I am excited about the potential of LP-184, particularly as it relates to a more targeted therapy for patients with prostate cancer. If we can further develop this potent compound as a novel therapeutic agent, it would constitute an important breakthrough in the treatment of this deadly form of prostate cancer. I look forward to our continued collaboration with Dr. Banerjee and Georgetown University."

On October 5, 2020 The Pershing Square Sohn Cancer Research Alliance (PSSCRA) reported the opening of applications for its 2021 Prize for Young Investigators in Cancer Research (Press release, The Pershing Square Sohn Cancer Research Alliance, OCT 5, 2020, View Source [SID1234568114]). The prize of $200,000 per year for up to three years is awarded annually to at least six New York City area-based scientists. The prize empowers researchers to pursue innovative, high-risk/high-reward cancer research at a stage when traditional funding is lacking.

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"Science, social justice and the collective environmental conscience have never been as intertwined. Symbolizing the notion of infinity, our eighth year promises to reveal new insights and innovation in cancer research at a scale that is as broad as it is entangled: spanning the micro and the macro, the individual and the societal; the biologic and the synthetic," said Pershing Square Foundation Trustee Neri Oxman. "We look forward to reviewing radically innovative applications as we continue to grow our PSSCRA community."

Applicants must have between two and eight years of experience running their own laboratories by the award start date (July 2021), hold a PhD, MD or MD-PhD (or degree equivalent), and be affiliated with a research institution in the greater New York City area. The greater New York City area includes New York City’s five boroughs, Long Island, Westchester County, New Jersey, and Western Connecticut (Fairfield and New Haven Counties). The deadline to submit a Letter of Intent is November 9, 2020. For more details on PSSCRA and the application process, including the full eligibility criteria, please visit: View Source

Now providing funding and support for 46 investigators at eleven academic research institutions, the highly competitive Prize underwrites the bold research of cancer scientists at a formative stage in their careers. In order to facilitate collaboration and innovation, each Prize winner is given access to leaders in the pharmaceutical and biotech industries and the opportunity to present his or her work to scientific, business, and philanthropic audiences.

"As we embark on the eighth year of the Prize, we remain extremely impressed by the remarkable scientific talent in the NYC area. It is our goal to build a community of innovative and skilled individuals and to support their exploration of the most exciting and revolutionary ideas, especially during a time when scientific research is more pressing and vital than ever," said Olivia Tournay Flatto, PhD, President of The Pershing Square Foundation and Co-Founder and Executive Director of the Pershing Square Sohn Cancer Research Alliance. "The future of the New York area’s life science research and industry relies on our ability to discover and support such new talent."

"The Pershing Square Sohn Prize is an immense honor for me and my team," said Britta Will, PhD, a 2020 Prize winner who is an Assistant Professor of Medicine at Albert Einstein College of Medicine. "It provides us with a truly unique opportunity to comprehensively explore a wholly new research direction which would have otherwise taken years to realize."

"The Pershing Square Sohn Prize will open the gateway for my laboratory to tackle high-risk and bold questions. This award will also provide the means to establish communication and collaboration with other outstanding scientists by virtue of participation in networking events. It will, therefore, undoubtedly support the development of my scientific career," said Camila dos Santos, PhD, a recipient of the 2018 Prize and Assistant Professor at Cold Spring Harbor Laboratory. "I am incredibly honored to be a recipient of this prestigious award and become a part of such an extraordinary effort and community."

"This is a highly impactful and prestigious award which has made a major impact on my career," remarked 2014 Prize winner Ross Levine, MD, the Laurence Joseph Dineen Chair in Leukemia Research and Director of the MSK Center for Hematologic Malignancies at Memorial Sloan Kettering Cancer Center. Dr. Levine concluded his project in 2017 and has participated in PSSCRA’s application process as a guest reviewer for the past three years.

On October 5, 2020 Medivir AB (Nasdaq Stockholm: MVIR) reported it has appointed Dr. Tom Morris as interim Chief Medical Officer effective October 5, 2020 (Press release, Medivir, OCT 5, 2020, View Source [SID1234568130]). Dr. Morris will report to CEO Yilmaz Mahshid and join the Medivir Executive Team.

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Tom Morris has more than 20 years of experience within drug development, mostly in oncology. Previously employed at Medeval Ltd and more recently at AstraZeneca. He has overseen the clinical development of several global drug programs, interacting with regulatory agencies, external clinical experts and academic groups worldwide.

Dr. Morris holds a BSc in Physiology from the University of Wales, medical degrees from the University of Wales College of Medicine and Master of Laws degree from Cardiff Law School. Currently a fellow and Board member of The Faculty of Pharmaceutical Medicine, a former chair of its Ethical Issues committee and a member of its Professional Standards Committee.

On October 5, 2020 Diaceutics PLC, (AIM: DXRX) reported new research which predicts that the Non-Small Cell Lung Cancer (NSCLC) testing market will expand to $3.6 billion in the United States by 2025 – up considerably from just $125 million today (Press release, Diaceutics, OCT 5, 2020, View Source [SID1234568115]). The findings are published in the 2020 Diaceutics PM Readiness Report.

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Driven by the increased utility of NSCLC testing and testing services, as well as new single and combination treatments – Diaceutics’ research found that currently, there are 714 new precision medicine treatments focused on NSCLC in late-stage clinical trials – this exponential growth represents 40% of the total value for the NSCLC treatment market. The growing market demonstrates the mounting dependence on precision medicine therapies for cancer treatment; and the pharmaceutical sector’s increasing investment in testing to ensure that their new treatments reach the eligible patient population. In doing so, they are closing the gap on the $2-3 billion in potential NSCLC revenues that is currently lost every year due to inefficient testing.

Currently, only half of patients with advanced NSCLC are receiving the right drug
As pharma revenues continue to be lost due to hurdles inherent with current NSCLC testing pathways, analysis in Diaceutics’ PM Readiness Report shows that this has a significant impact on patient treatment. Currently, only half of NSCLC patients who are eligible for precision medicine therapies receive them, with not enough emphasis being placed on the economic value of diagnostic testing. Pharma investment therefore often does not reflect the true value of efficient testing, or the investment is spread too thinly across multiple players. This disincentivises stakeholders within the testing ecosystem from addressing the entire patient journey from cough to precision treatment, leading to a fragmented approach to testing.

Diaceutics’ research found that by investing heavily in the PD-L1 22C3 antibody, Merck has shown how education and investment drives biomarker adoption, with 83% of all PD-L1 testing today using Merck’s associated antibody.

Furthermore, 10% of patients receive NSCLC treatment without relevant testing
Diaceutics’ research shows that even when patients do receive a precision medicine drug, one-in-10 will receive the wrong one. The PM Readiness Report found that 10% of NSCLC patients are receiving precision medicine treatments without having had the relevant biomarker tests, signifying a knowledge gap amongst oncologists around biomarkers and their associated treatments.

Progress is being made with PD-L1
Recent guidance from the FDA states that it is continually approving multiple drugs that are dependent on the same biomarkers, and pharmaceutical companies should therefore focus on promoting multiple tests that lead patients to their specific therapies, rather than focusing on one proprietary test.

Diaceutics analysed the value in multiple pharma competitors simultaneously promoting companion diagnostic tests for specific groups of therapies and found significant revenue benefits for pharma. In the case of PD-L1 testing, this approach has reduced the post-launch time it takes for a new biomarker test to reach 80% of the eligible patient population from seven years to three. In the case of EGFR and ALK, however, the average delay remains high at six years due to poor pre-launch preparation.

The impact of COVID-19
The fragility of the testing ecosystem has been highlighted by the emergence of COVID-19 and Diaceutics has observed the pandemic’s highly disruptive impact on cancer testing. It found that cancer testing in China decreased by as much as 50% in Q2 2020 versus the Q2 2019. The company’s tracker in the US also revealed that there was a 31% drop in newly diagnosed cases of lung cancer between February and March 2020. The research revealed that while patients already diagnosed with cancer and receiving treatment were continuing to be supported, the decrease in testing over this period will result in a backlog of undiagnosed patients. The ramifications of this backlog will be felt in 2021 and beyond. Furthermore, the increased pressure on testing laboratories caused by the demand for COVID testing has seen a decentralisation of cancer testing observed across China with regional laboratories having to manage the fallout. As a result, Diaceutics observed that enhanced planning and investment will be critical to absorb what will be a significant increase in testing needs following COVID-19.

Speaking about the findings of the report, Peter Keeling, CEO and Founder of Diaceutics, said: "Patients simply cannot get the right treatment without efficient testing – COVID-19 has unequivocally proven that model to be true and has presented us with an opportunity to get out in front of a global testing crisis which has this year, been put in the spotlight.

"The era of launching a therapy with a single companion diagnostic partner is definitely behind us. We need to consider the global needs of our patients and the regional restrictions which have been further exacerbated by the pandemic. This calls for pharma to think beyond a one-size-fits-all approach and to embrace the democratisation of testing.

"The time has come to eradicate the hurdles that stand in the way of getting patients the treatment they deserve. Our evidence, our partners and our experience tell us that there is a better way and that the time for that better way is now. We believe that a global platform will enable the collaboration required between stakeholders to overcome the hurdles in today’s testing ecosystem.

"Research from the Report shows that a platform like DXRX has the potential to reduce the time to achieve 50% test adoption in NSCLC from the current average of 4.5 years to just months. That would be transformative for patients and could make the promise of precision medicine a reality for more people."