On September 12, 2022 Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that translates the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported it has entered into a non-dilutive royalty financing agreement with OrbiMed for up to $250 million (Press release, Adaptive Biotechnologies, SEP 12, 2022, View Source [SID1234619403]). Proceeds from the agreement will strengthen Adaptive’s balance sheet, which stood at over $450 million in cash and marketable securities at the end of the second quarter of 2022, and provide the Company with additional capital to support its growth trajectory and path to profitability.

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"We are excited to work with OrbiMed on this creative royalty structure to continue unlocking the full potential of our immune medicine platform," said Chad Robins, Chief Executive Officer and Co-Founder of Adaptive Biotechnologies. "The agreement will extend our cash runway while providing flexibility to invest in growth initiatives in both our MRD and Immune Medicine business areas."

Under the agreement, Adaptive will receive an initial tranche of $125 million with the option to receive an additional $75 million, both for general corporate purposes. Adaptive can also access a third tranche of $50 million for potential M&A. OrbiMed will be entitled to receive 5% of the Company’s GAAP revenues, increasing to 8% and 10% if the second and third tranches are drawn, respectively.

"This investment reflects our confidence in Adaptive Biotechnologies and the potential to accelerate its significant contributions to the field of immune medicine," said Matthew Rizzo, General Partner of OrbiMed. "The company is well-positioned to deliver revenue growth while continuing to innovate and expand the applications of its platform in clinical diagnostics and drug discovery."

DLA Piper LLP (US) acted as the Company’s legal advisor, and Covington & Burling LLP acted as OrbiMed’s legal advisor.

On September 12, 2022 Targovax ASA reported that members of its executive management team are invited to present at upcoming conferences (Press release, Targovax, SEP 12, 2022, View Source [SID1234619401]):

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H.C. Wainwright 24th Annual Global Investment Conference, virtual
Date: 12 September 2022
Presenter: Erik Digman Wiklund, CEO
Time: Presentation available online from 07:00 EDT / 13:00 CEST

RAS Targeted Drug development summit, Boston
Date: 28 September 2022
Presenter: Lone Ottesen, CMO
Time: 12:30 EDT / 18:30 CEST

Immuno-Oncology Summit, Boston
Date: 14 October 2022
Presenter: Erik Digman Wiklund, CEO
Time: 11:45 EDT / 17:45 CEST

World Vaccine Congress Europe, Barcelona
Date: 11-14 October 2022
Presenter: Lubor Gaal, CFO
Time: TBD

On September 12, 2022 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies for autoimmune diseases, enhance gene therapies and mitigate unwanted immune responses to biologics, reported that Company’s Management will participate in upcoming investor conferences in September (Press release, Selecta Biosciences, SEP 12, 2022, View Source [SID1234619400]).

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Details on the conferences can be found below.

Cantor Fitzgerald’s Cell and Genetic Medicines Conference
Format: Panel presentation and one-on-one investor meetings, attending in-person
Panel Title: Ring Ring: Is That Large-Cap Pharma Calling? Importance of Established Partnerships in Place
Date: Thursday, September 15, 2022
Time: 8:00 a.m. ET
Location: New York, NY

To schedule a meeting with the Company, please contact your Cantor Fitzgerald representative.

Jefferies Cell and Genetic Medicine Summit
Format: Fireside chat and one-on-one investor meetings, attending in-person
Date: Friday, September 30, 2022
Time: 2:30 p.m. ET
Location: New York, NY

To schedule a meeting with the Company, please contact your Jefferies representative. The webcast of the fireside chat will be accessible in the Investors & Media section of the company’s website at www.selectabio.com.

On September 12, 2022 OncXerna Therapeutics, Inc. ("OncXerna"), a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, reported new biomarker data suggesting the Xerna TME Panel has predictive and prognostic potential in esophagogastric adenocarcinoma (Press release, OncXerna Therapeutics, SEP 12, 2022, View Source [SID1234619399]). The data are featured in a poster being presented today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022.

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The data featured in the ESMO (Free ESMO Whitepaper) poster are from retrospective analyses of results from PLATFORM, a randomized Phase 2 trial that evaluated maintenance therapies such as the anti-PD-1 antibody durvalumab in esophagogastric adenocarcinoma patients treated with first-line chemotherapy. Analyses were performed using the Xerna TME Panel, a novel RNA gene expression-based diagnostic panel that uses a machine learning-based algorithm to classify patients based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME).

Using the Xerna TME Panel, researchers analyzed pre-treatment tumor biopsies to classify patients who went on to receive durvalumab maintenance therapy or active surveillance only as immune score "high" or immune score "low." These classifications were compared against clinical outcomes recorded in the trial. Results showed that immune score high patients had a poorer prognosis with active surveillance compared to immune score low patients. However, despite this poorer prognosis, immune score high patients had improved 6- and 12-month progression free survival and 24-month overall survival with durvalumab maintenance therapy compared to the immune score high patients that received active surveillance. Analyses in the poster also compared the predictive potential of Xerna TME Panel classifications in esophagogastric adenocarcinoma to that of classifications based on PD-L1 combined positive score (CPS) status.

"Though specifically tailoring therapeutic regimens for individual patients can be an effective technique in the treatment of GI cancers, its application is limited by a lack of predictive biomarkers," said Professor Ian Chau, M.D., FRCP, co-author on the poster and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust and Professor at the Institute of Cancer Research, London & Surrey. "Data being presented at ESMO (Free ESMO Whitepaper) suggest the Xerna TME Panel can expand the applicability of personalized medicine in esophagogastric adenocarcinoma by predicting the patients who may benefit from anti-PD-1 maintenance therapy more accurately than PD-L1 CPS status. Moreover, classifications incorporating both PD-L1 CPS status and the Xerna TME Panel appear to further distinguish the subset of patients that will derive the most durable clinical benefit from checkpoint inhibitors. Taken together, these encouraging findings support the Xerna TME Panel’s potential as a diagnostic that can help us understand which patients are more likely to benefit from treatment and those that will not. This will hopefully lead to better treatment decisions and improved clinical outcomes for patients."

Key data featured in the ESMO (Free ESMO Whitepaper) poster are summarized in Tables 1A (patients randomized to active surveillance) and 1B (patients randomized to durvalumab maintenance therapy) below.

Table 1A: Survival function estimates for patients enrolled in the active surveillance arm according to Xerna TME Panel and PD-L1 CPS status. Data presented as: rate (97.5% confidence interval)

PFS: Progression-free survival; OS: Overall survival

Additionally, in PD-L1 CPS ≥5 patients who received durvalumab, 24-month OS rates were 38% and 0% in Xerna TME Panel immune score high (n=17) and low (n=9) subgroups, respectively. Twelve-month OS rates in the same subgroups were 44% and 33%, respectively.

Laura Benjamin, Ph.D., Chief Executive Officer of OncXerna Therapeutics and co-author on the ESMO (Free ESMO Whitepaper) poster, commented, "These results add to an emerging dataset suggesting the Xerna TME Panel can improve the probability of success in clinical trials of not only our internally developed product candidates, navicixizumab and bavituximab, but in trials of a wide range of precision therapies. We are fortunate to be collaborating with leading experts from industry and academia on these efforts, including my co-authors from QIAGEN GmbH, Genialis, and The Royal Marsden. I look forward to continuing our work together as we strive to leverage the XERNA TME Panel to increase the number of cancer patients that can benefit from a precision medicine approach."

A copy of the ESMO (Free ESMO Whitepaper) poster, entitled: "Predicting benefit from maintenance durvalumab after first-line chemotherapy (1L CTx) in oesophagogastric adenocarcinoma (OGA) using a novel tumour microenvironment (TME) RNA assay," will be available on the OncXerna website following the conclusion of the ESMO (Free ESMO Whitepaper) Congress.

About PLATFORM
PLATFORM was a Phase 2, randomized, multicenter, adaptive study sponsored by The Royal Marsden NHS Foundation Trust that assessed various maintenance therapies in locally advanced or metastatic esophagogastric adenocarcinoma patients. Patients initially received standard chemotherapy according to local practice based upon their HER2 status. HER2-negative patients who completed at least six cycles of standard chemotherapy, achieved stable disease or better on the end-of-treatment CT scan, and met additional eligibility criteria were then randomized to receive active surveillance only or a selected maintenance therapy, one of which was durvalumab. Results showed durvalumab maintenance therapy did not prolong PFS or OS compared to active surveillance in HER2-negative patients unselected for PD-L1 status. For more information on the trial, see Clinicaltrials.gov Identifier: NCT02678182.

About the Xerna TME Panel
The Xerna TME Panel uses proprietary RNA-based gene expression data and a machine learning-based algorithm to classify patients based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME). The Xerna TME Panel is an investigational assay that has not been approved and has not been demonstrated to be safe or effective for any use.

On September 12, 2022 NuCana plc (NASDAQ: NCNA) reported that data from the ongoing NuTide:302 study of NUC-3373 in combination with other agents at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting being held from September 9 to 13, 2022 (Press release, Nucana BioPharmaceuticals, SEP 12, 2022, View Source [SID1234619398]).

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Poster 345P: NUC-3373, a ProTide transformation of 5-FU, in combination with oxaliplatin (NUFOX) or irinotecan (NUFIRI) in patients with advanced colorectal cancer (NuTide:302)

NUC-3373, a phosphoramidate transformation of 5-FU, that was designed to overcome the key limitations and challenges associated with 5-FU has previously demonstrated promising anti-tumor activity and a favorable safety and pharmacokinetic profile as a single agent and in combination with leucovorin in heavily pre-treated patients with advanced colorectal cancer (CRC). Data presented at ESMO (Free ESMO Whitepaper) describe NUC-3373 plus leucovorin in combination with either oxaliplatin (NUFOX) or irinotecan (NUFIRI) in the dose-finding part of the study.

Both NUFOX and NUFIRI demonstrated encouraging anti-tumor activity in heavily pre-treated CRC patients with progressive disease who had all previously received regimens containing 5-FU, oxaliplatin and irinotecan. Of the 46 patients who received either NUFOX or NUFIRI, twelve (six from each cohort) achieved progression-free survival (PFS) of greater than three months, including three patients who achieved PFS of six months or longer. The disease control rates for the NUFOX and NUFIRI regimens were 80% and 55%, respectively. Data presented also indicate that NUFOX and NUFIRI have favorable safety profiles when compared to historical data for the 5-FU-containing regimens FOLFOX and FOLFIRI, with lower rates of toxicities such as neutropenia and gastrointestinal disturbances that limit their clinical utility. With these data, NuCana has established the recommended Phase 2 dose for NUC-3373 as part of NUFOX and NUFIRI regimens.

Andrew Coveler, Associate Professor, Medical Oncology at the University of Washington School of Medicine, Associate Professor, Clinical Research Division at the Fred Hutchinson Cancer Center, and lead author of the ESMO (Free ESMO Whitepaper) presentation said: "I am excited by the results of the NuTide:302 study in light of the heavily pre-treated nature of these patients. It is noteworthy to observe a high disease control rate and extended periods of progression-free survival in patients who had previously been treated with multiple lines of therapy that included oxaliplatin and irinotecan with 5-FU. There is a significant unmet need for new medicines to treat patients with colorectal cancer and I look forward to continuing the investigation of NUFIRI and NUFOX in combination with bevacizumab in earlier-line CRC patients."

"These data are highly supportive of our strategy to develop NUC-3373 as a replacement for 5-FU, one of the most widely used medicines for the treatment of patients with cancer," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "Based on the data from NuTide:302, we have initiated a randomized study in second-line CRC patients called NuTide:323 comparing NUFIRI plus bevacizumab to FOLFIRI plus bevacizumab, the global standard of care. Due to NUC-3373’s compelling biological rationale and strong clinical potential, we have also initiated the NuTide:303 study, investigating NUC-3373 in combination with either pembrolizumab in patients with various solid tumors or in combination with docetaxel in patients with non-small cell lung cancer."

About NUC-3373
NUC-3373 is a phosphoramidate transformation of 5-fluorouracil, or 5-FU, which is designed to overcome the key limitations and pharmacologic challenges that hinder the clinical utility of 5-FU, with the aim of improving 5-FU’s efficacy, safety and administration challenges.

5-FU (and its other forms including capecitabine) is an inactive prodrug and its anti-cancer activity is dependent on its conversion to the active anti-cancer metabolite (FUDR-MP), which binds to and inhibits thymidylate synthase (TS), a critical enzyme in de novo nucleotide synthesis and cell survival. TS is required to convert uridine (specifically dUMP) to thymidine (specifically dTMP), one of the four nucleotides that comprise DNA. The inhibition of TS results in an imbalance in the ratio of dUMP and dTMP, thereby disrupting DNA synthesis and repair, ultimately leading to cancer cell death. However, due to multiple limitations, 5-FU is not efficiently converted to FUDR-MP.

NUC-3373 generates much higher concentrations of FUDR-MP in patients’ cells. It also has a more convenient administration schedule and does not produce toxic levels of metabolites such as FBAL or FUTP (which are associated with hand-foot syndrome, neutropenia, mucositis and diarrhea) resulting in an improved safety profile.

In addition to preventing the synthesis of thymidine via TS inhibition, NUC-3373 treatment also results in the release of Damage Associate Molecular Patterns (DAMPs) and pro-inflammatory cytokines by cancer cells. These act as molecular signals to the immune system, encouraging them to kill cancer cells. Furthermore, NUC-3373 has been shown to induce the expression of PD-L1 on treated cells. In vitro experiments using NUC-3373 treated CRC cells co-cultured with immune cells have shown that NUC-3373 is able to potentiate the effects of PD-1 inhibitors, thus providing a strong scientific rationale for combining NUC-3373 and PD-1/PD-L1 inhibitors in patients.