On October 18, 2022 GSK plc (LSE/NYSE: GSK) and Tempus, a US-based precision medicine company, reported that have entered into a three-year collaboration agreement that provides GSK with access to Tempus’ AI-enabled platform, including its library of de-identified patient data (Press release, GlaxoSmithKline, OCT 18, 2022, View Source [SID1234622092]). Through its leading Artificial Intelligence and Machine Learning (AI/ML) capability, GSK will work together with Tempus to improve clinical trial design, speed up enrolment and identify drug targets. This will contribute to GSK’s R&D success rate and provide patients with more personalised treatment faster.

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The new collaboration builds from the existing relationship between the companies that began in 2020 on clinical trial enrolment of patients with certain types of cancer. It will now expand GSK’s access to de-identified patient data bringing greater scale and detail. Tempus’ dataset draws from its work with over 40% of oncologists in the U.S. at academic medical centres and community hospitals.

Tony Wood, Chief Scientific Officer, GSK, said: "This collaboration will provide GSK with unique insights to discover better medicines and transform drug discovery. Tempus complements the work our team is already doing at the intersection of genomics and machine learning across both early discovery and clinical trials."

GSK’s investments in human genetics, functional genomics and AI/ML have enabled the company to more than double the number of targets in the early portfolio since 2017 and have increased the proportion of those with genetic support beyond 70%. Medicines with genetic validation are twice as likely to become registered medicines. As a leader in AI-enabled precision medicine, Tempus has developed a platform that provides a rapid way of testing complex biomarker hypotheses. Powered by machine learning, this is an important component of selecting patients who could benefit from candidate medicines in GSK’s portfolio in the future.

Eric Lefkofsky, Founder and CEO, Tempus, said: "GSK’s data-first approach to therapeutic research aligns with our own, and we believe that Tempus has the resources and capabilities to complement GSK’s dedication to data science, in a way others can’t given the breadth and depth of our platform. We both share a commitment to providing patients with more personalised therapeutic options to help them live longer and healthier lives."

GSK and Tempus currently collaborate on an open label phase II study, which applies an innovative, data-driven approach designed to accelerate and streamline study timelines. This includes expediting the protocol development and intelligent site selection in under 60 days and enrolling its initial patients within three months of the study launch.

The expanded collaboration has a minimum financial commitment over three years, for which GSK made a $70 million initial payment. GSK then has an option to extend for two additional years.

On October 17, 2022 Xspray Pharma AB reported the company has based on the authorisation granted by the annual general meeting of Xspray on 19 May 2022, and in accordance with what the Company indicated in the interim report for the second quarter of 2022, successfully carried out a fully subscribed directed share issue at a subscription price of SEK 50 per share (the "Issue") (Press release, Xspray, OCT 17, 2022, View Source [SID1234650114]). The subscription price has been negotiated at arm’s length with investors and is based on the Board’s assessment, following discussions with the Company’s financial advisor, at market conditions.

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A number of Swedish institutional investors, including Third Swedish National Pension Fund (AP3), Flerie Invest AB and Östersjöstiftelsen have subscribed for shares in the Issue. The Board has carefully considered alternative financing solutions, including the prospects to carry out a rights issue. The Board has concluded that a rights issue would take a significantly longer time to complete and entail a higher risk for a materially adverse effect on the share price, particularly in light of the market volatility and the challenging market conditions. Another important reason for deviating from the shareholders’ preferential rights is to further enhance the shareholder base with an institutional investor in the form of the Third Swedish National Pension Fund (AP3). In light of the above, the Board has made the assessment that a directed share issue with deviation from the shareholders’ preferential rights creates the best conditions to secure the Company’s continued financial stability in the current market climate and to enable market preparing activities before the upcoming launch on the American market. Overall, the Board considers that the Issue contributes to creating value for all the Company’s shareholders and is beneficial for the Company.

The Company intends to use the net proceeds from the Issue primarily to:

Market preparing activities before the upcoming launch on the American market
Continued development of the Company’s product portfolio with an initial focus on the product candidate XS003, which is the next product to be launched on the American market
To enhance the Company’s financial stability
The Issue is expected to raise proceeds for the Company of SEK 100 million, before transaction costs. The Issue will result in an increase in the number of shares in Xspray of 2,000,000, from 20,680,408 to 22,680,408, and an increase in the share capital by SEK 2,000,000 from SEK 20,680,408 to SEK 22,680,408 resulting in a dilution of approximately 8.8 percent.

Zonda Partners has acted as Bookrunner in connection with the Issue. Advokatfirman Vinge has acted as legal advisor to Xspray Pharma.

On October 17, 2022 Nexi reported that it had attracted Series A investment worth 22 billion won (Press release, NEX-I, OCT 17, 2022, View Source;mode=VIEW&num=31&category=&findType=&findWord=&sort1=&sort2=&page=2 [SID1234643439]). In addition to existing investors such as DSC Investment, Schmidt, Atinum Investment, and Hana Ventures, six institutions including Stone Bridge Ventures, TS Investment, CJ Investment, Wonik Investment Partners, Medytox Venture Investment, and GC Green Cross participated as new investors in this investment. Nexi’s cumulative investment has increased to 27 billion won, including this round.

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NexI plans to use this investment for research and development and preclinical testing of the company’s leading candidate substances, ‘NXI-101’ and ‘NXI-201’. Kyung-wan Yoon, CEO of Nexi, said, "Our goal is for NXI-101 to enter clinical trials in 2024."

Nexi, established in 2021, has a platform technology to discover factors that cause refractoriness to existing immunotherapy drugs. The company explains that it is a platform technology that discovers the cause of anti-cancer immunotherapy drugs not working well and then develops a drug that targets and eliminates or suppresses the cause.

GC Green Cross, which participated in this investment, plans to seek mid- to long-term cooperation with NexI as a strategic investor (SI).

On October 17, 2022 Race Oncology Limited (ASX:RAC) is an Australian pharmaceutical company reported that focused on the development of its key drug, Zantrene, which is currently being studied for pre-clinical and clinical efficacy in several cancer indications (Press release, Race Oncology, OCT 17, 2022, View Source [SID1234622381]).

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Zantrene is a highly targeted precision oncology agent as well as a chemotherapy cardioprotective. The drug is the most potent small molecule inhibitor of the key epitransgenomic Fatso/Fat mass and obesity-associated (FTO) protein.

Zantrene’s dual blockbuster potential

The market opportunity for Zantrene is large with the global FTO addressable cancer market estimated to be more than US$120bn in 2020. RAC expects to generate oncology revenues from: (a) FTO-driven cancers including acute myeloid leukaemia (AML), melanoma, renal cancer, breast and pancreatic, and colorectal cancers; and (b) Protection from anthracycline and proteasome inhibitor cardiac damage which is an independent multi-billion dollar opportunity.

Notably, in pre-clinical models Zantrene protects the heart from anthracycline and proteasome inhibitor induced damage while providing improved anti-cancer treatments. We believe this is an unmatched differentiator for the company.

Success in AML is likely to drive growth in near term

RAC has completed a Phase II single agent clinical trial pertaining to the use of Zantrene in treating relapsed/refractory AML and is currently in another two Phase I/II trials exploring combination treatment in AML as well as treatment of extra-medullary AML. Furthermore, it is in the process of preparing to file an Investigational New Drug application in the US (US IND) for extramedullary AML, besides owning an orphan drug designation for the treatment of AML in the US.

We think that success in the AML field will be a springboard for the company to support its other growth pillars, viz., cardioprotection (breast and other cancers), melanoma and renal cancer programmes.

Valuation range of A$6.61-A$11.91 per share

We value RAC at A$3.4bn base case and A$6.1bn bull case. Adjusting for probability and accounting for future capital raises, this equates to A$6.61 per share base case and A$11.91 per share bull case. We have used a DCF approach assuming Zantrene is commercialised according to forecasted timelines. Commercialisation could occur either by RAC or a potential partner that would acquire Zantrene and/or RAC. Key risks to our model include clinical, regulatory, commercial and competition risks.

On October 18, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported the launch of the first commercial version of its PanOmics data analysis platform PanHunter at Bio-IT World (18-19 October in Berlin, Germany) (Press release, Evotec, OCT 17, 2022, View Source [SID1234622120]). PanHunter is Evotec’s PanOmics data access and analytics platform and was developed and used successfully internally and in industry-shaping drug discovery partnerships over many years. Evotec now makes PanHunter available to collaborators and partners as a software-as-a-service ("SaaS") product.

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PanHunter originates from Evotec’s commitment towards patient-centric, PanOmics-driven drug discovery. The amount of available PanOmics data is growing at exponential rates in the public domain and in the pharmaceutical industry. More PanOmics data has been generated in the last two years than in all previous years combined. These PanOmics data hold an overwhelming amount of information about the condition of the respective patients, the molecular biological context, and causes of diseases. To extract such insights and new knowledge from data, it is paramount to use the smartest and easiest-to-use analytical tools and make them available to all scientists across disciplines.

PanHunter is unique in its ability to integrate the analysis of PanOmics data, designed as an easy-to-use yet fully comprehensive PanOmics data analysis platform. It thereby supports, for instance, the stratification of patient populations via molecular mechanisms and the prediction of efficacy and toxicity profiles of drug candidates given appropriate data inputs. With the launch of the first commercial version of the software at Bio-IT World Europe, Evotec makes PanHunter available to interested partners to accelerate their data-driven research.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "In the ever-accelerating world of Omics driven drug discovery we are excited to release PanHunter. PanHunter is our contribution to enable scientists to handle huge high-dimensional data sets to better understand diseases on a molecular level. Improved molecular understanding of disease as well as drug candidates accelerates the drug discovery process and improves probabilities of success in the pre-clinic and clinic."

Dr Matthias Evers, Chief Business Officer of Evotec, said: "With our first commercial release, we are making a bold claim that the future of successful drug discovery lies in convergence between science and tech. With PanHunter we enable scientists across disciplines to explore this potential and engage in patient-driven, PanOmics-informed drug discovery towards deep disease understanding and achieving tractable insights. It is another step to overcome the limitations of a reductionist R&D approach and use AI to unleash disease understanding and improve success rates ("POS")."