On October 22, 2021 Chugai Pharmaceutical Co., Ltd. reported that the Company resolved at the meeting of its Board of Directors held on October 22, 2021 to revise the dividend forecast per share as described below (Press release, Chugai, OCT 22, 2021, View Source [SID1234591775]).

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1. Reasons for the revision
Reflecting the significant changes in the business environment, year-end dividend forecast has been revised to undecided. The year-end dividends will be decided after the fiscal year end based on basic profit distribution principles*.

*Regarding income distribution, taking into account the strategic funding needs and earning prospects, Chugai aims for a consolidated dividend payout ratio of 45% on average in comparison with Core EPS to provide a stable allocation of profit to all shareholders.

2. Contents of the revision

**Effective July 1, 2020, Chugai implemented a three-for-one stock split of its common stock. The dividends are calculated based on the assumption that the stock split was implemented at the beginning of the fiscal year 2020.

On October 22, 2021 Privo Technologies, Inc. ("Privo"), reported the positive results of their Phase 1/2 clinical trial examining their lead asset PRV111 in subjects with early-stage Head and Neck Squamous Cell Carcinoma (HNSCC). PRV111 is an innovative transmucosal delivery system capable of delivering cisplatin topically and directly to the tumor site (Press release, Privo Technologies, OCT 22, 2021, View Source;utm_medium=rss&utm_campaign=privo-technologies-inc-announces-positive-results-from-phase-1-2-clinical-trial-for-prv111-in-head-and-neck-squamous-cell-carcinoma [SID1234591884]). The data from the trial supports the Company’s intended mission since its inception of optimizing state-of-the-art chemotherapeutic drugs to be "Tough on cancer, Easy on patients".

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The primary endpoint of the study, which was to determine a safe and efficacious dose of PRV111 based on the incidence of dose-limiting toxicities (DLTs) and tumor volume changes from baseline, was met. PRV111 was associated with an observable tumor volume reduction of 35-100% (mean 69%). The secondary endpoints were to evaluate tumor responses and evaluate systemic, tumor and lymph node platinum levels following administration of PRV111. The overall tumor response rate in evaluable subjects was 87.5% with an average time to response of 5.5 days. No loco-regional recurrence was observed in 100% of subjects who completed a six-month follow-up. An increase in tumor-infiltrating lymphocytes was present post-treatment.

PRV111 showed a favorable safety profile with no severe adverse events (SAEs). Reported treatment emergent adverse events (TEAEs) were mild or moderate in severity, and no dose-limiting toxicities (DLTs) were observed. PRV111 treatment resulted in cisplatin levels that were found to be >350 times higher in the tumor, >110 times higher in lymph nodes, and >700 times lower in the blood than standard of care cisplatin IV treatments. No reported cases of systemic toxicity were observed.

The clinical trial design was Open-Label, Single-Arm Safety, Tolerability, Anti-Tumor Effects, Systemic Exposure, and Device Technical Effects of PRV111 in subjects with Head and Neck Squamous Cell Carcinoma. This was a two-stage, adaptive, first-in-human pharmacokinetic (PK), safety, and efficacy study. In Stage 1 and Stage 2, a total of 10 enrolled subjects were analyzed for safety and PK; eight of the 10 enrolled subjects were analyzed for efficacy.

Following an End-of-Phase 2 Meeting with the U.S. Food & Drug Administration (FDA), Privo is working on establishing the key elements of a Phase 3 program to support a New Drug Application (NDA) for the treatment of early-stage head and neck squamous cell carcinoma (HNSCC) of the oral cavity.

These clinical trial results have clinically validated the Privo’s transmucosal delivery system, and Privo is now also working to further develop PRV111 platform in a range of mucosal cancers including anal, colorectal, genitourinary, nasal and skin cancers and to explore the use of PRV111 for the treatment of precancerous oral cavity lesions.

About SCC

Squamous cell carcinoma (SCC) is cancer of the squamous cells – thin and flat cells that line the epithelia. SCC is found for the most part as a part of skin cancer, but SCC also accounts for the majority of oral, cervical, vaginal/vulval, and colorectal cancers. SCC in body cavities historically is associated with low survival rates and disfiguring surgeries, demonstrating a clear need for a better treatment. Privo focuses on SCC of the oral cavity as it is on the rise globally and lacks a clear treatment option for such a rare disease. Privo was granted Orphan Drug Designation for Treatment of anatomically accessible oral cancers (lip, tongue, gum, floor of mouth, salivary gland, and other oral cavity) by the U.S. FDA.

On October 22, 2021 Egle Therapeutics SAS (Egle), an emerging biotechnology company focused on developing First-In-Class immunotherapies targeting immune suppressor regulatory T-cells (Tregs) for oncology and autoimmune diseases, reported that it has completed a €40M ($46.4M) Series A financing (Press release, Egle Therapeutics, OCT 22, 2021, View Source [SID1234591777]). The Series A was co-led by LSP and Bpifrance through their InnoBio 2 fund. Fund+, Bioqube Ventures and Takeda Ventures, Inc. also participated in this round.

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Egle Therapeutics was founded in early 2020 with a vision to become a game changer in the field of Tregs immunomodulation through the unique concept of Tregs starving and specifically targeting the most immunosuppressive ones. Spun out of Institut Curie, Egle’s scientific foundation leverages unprecedented, computational-based, IL-2 modified variants and newly tumor-associated Treg targets to build a furnished pipeline of First-In-Class immunocytokines against Tregs. The new capital will be used primarily to advance 2 leads assets into the clinic and further strengthen its internal drug pipeline.

"Closing a substantial Series A of €40M from a high-quality syndicate of renowned investors, as well as a partnership with a top big pharma like the one we have announced with Takeda in June 2020, all in less than 18 months, puts Egle on a trajectory to execute its vision of tackling regulatory T cells to restore immunity in patients suffering from cancer and autoimmune diseases" commented Luc Boblet, co-founder and CEO of Egle. "The funding will give us appropriate resources to push the first Treg starvers into the clinic and we feel very privileged to undertake such responsibility for the benefit of the whole patient community".

The investor syndicate will join the Egle Therapeutics Board which will consist of Felice Verduyn-van Weegen (LSP), Vincent Brichard (LSP), Jean-Francois Morin (Bpifrance – InnoBio 2) and Sacha Mann (Takeda Ventures). Philippe Monteyne (Fund+), Jacques Mizrahi (Bioqube Ventures) and Elisa El Nouchi (Bpifrance InnoBio 2) will join as observers.

"Egle represents a strategic investment in a First-In-Class technology platform based on innovative research with novel T regulatory modulations and potential in the oncology and auto-immunity fields", commented Vincent Brichard, Venture Partner at LSP. "We feel privileged to be part of such an exciting company, with world class science and look forward to build it out together with the team" adds Felice Verduyn-van Weegen, partner at LSP.

"InnoBio 2 strives to invest in breakthrough ideas and to promote First-In-Class drugs candidates. We are delighted to have co-led a financing round that will enable Egle Therapeutics to broadly invest in its platform technologies, development programs, people and ultimately, towards delivering a pioneering new generation of immunotherapies to patients in need," said Jean-François Morin, Investment Director at Bpifrance.

On October 22, 2021 The Board of Directors of Alligator Bioscience AB (publ) ("Alligator" or "the Company") reported that it has previously, subject to approval by the Extraordinary General Meeting on 8 November 2021, resolved to carry out a rights issue of shares with preferential rights for the Company’s existing shareholders of approximately SEK 257 million (the "Rights Issue") (Press release, Alligator Bioscience, OCT 22, 2021, View Source [SID1234591762]). Through the press release issued on 7 October 2021 regarding the board’s decision to carry out the Rights Issue, Alligator announced that all members of the Company’s board and management with shareholdings in the Company had expressed their intention to subscribe for their respective pro rata share in the Rights Issue, in addition to the other subscription- and guarantee commitments already entered into, which secure the Rights Issue to 100 percent. Alligator hereby announces that all members of the Company’s board and management with shareholdings in the Company now have, via subscription commitments, formally undertaken to subscribe for their respective pro rata share in Rights Issue.

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Through the press release issued on 7 October 2021 regarding the board’s decision to carry out the Rights Issue, Alligator announced that the Company had received subscription commitments from a selection of the Company’s larger existing shareholders, including AP4, Roxette Photo NV and Omentum S.A. In the press release it was also announced that all members of the Company’s board and management with shareholdings in the Company had expressed their intention to subscribe for their respective pro rata share in the Rights Issue. Since the announcement, the Company has now received subscription commitments from all members of the Company’s board and management with shareholdings in the Company, including Søren Bregenholt (CEO), Anders Ekblom (Chairman of the board), Marie Svensson (CFO), Peter Ellmark (CSO), Veronica Wallin (board member) and Hans-Peter Ostler (board member), to subscribe for their respective pro rata share in the Rights Issue, amounting to a total of approximately SEK 0.7 million, which means that the Company has received subscription commitments amounting to a total of approximately SEK 44 million in connection to the Rights Issue, corresponding to approximately 17 percent of the Rights Issue. No compensation is paid for received subscriptions commitments.

For more information regarding the Rights Issue, see the Company’s press release issued on 7 October 2021 and the prospectus (the "Prospectus") that the Company is expected to publish around 9 November 2021.

Advisers

DNB Markets, a part of DNB Bank ASA, Sweden Branch and Redeye AB act as Joint Global Coordinators in connection with the Rights Issue. Setterwalls Advokatbyrå AB acts as legal adviser to Alligator and Baker & McKenzie Advokatbyrå KB acts as legal adviser to the Joint Global Coordinators in connection with the Rights Issue. Aktieinvest FK AB acts as the issuing agent in the Rights Issue.

On October 22, 2021 Invitae (NYSE: NVTA), University College London (UCL), and the Francis Crick Institute reported new data from their TRACERx lung cancer research collaboration funded by Cancer Research UK and sponsored by UCL (Press release, Invitae, OCT 22, 2021, View Source [SID1234591778]). The data, presented by Professor Charles Swanton of UCL and the Francis Crick Institute at the International Society of Liquid Biopsy (ISLB) Congress, further validate the value of liquid biopsy as a less invasive and more comprehensive approach to guiding personalized cancer treatment in the absence of detectable disease by clinical imaging. Previously reported findings from the TRACERx cohort found that monitoring for cancer circulating tumor DNA (ctDNA) based minimal residual disease (MRD) detected relapse of non-small cell lung cancer (NSCLC) up to three years earlier than standard of care imaging surveillance in some instances.1

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

The study used a new blood-based informatic tool called ECLIPSE (Extraction of CLonality from LIquid bioPSiEs) with an earlier iteration of the Invitae Personalized Cancer Monitoring (PCM) liquid biopsy assay to analyze plasma samples of patients in the TRACERx study. With this approach, data demonstrated multiplex-anchored PCR sequencing of the plasma samples enhanced MRD lead times relative to standard of care surveillance scanning and allowed holistic sampling of clonal dynamics, or tumor heterogeneity, with prognostic implications for disease progression.

"Tumours are highly heterogeneous and standard biopsies can miss important tumor traits. Our findings from applying our novel ECLIPSE software with Invitae’s multiplex-anchored PCR technology, which powers the Invitae PCM assay, are promising. They underscore the tremendous potential of PCM for providing representative tumor sampling throughout the disease course, and most importantly at an early stage or at early recurrence in the absence of disease on standard imaging, which may in the future inform clinical trial stratification and the best treatment plans for patients," said Professor Charles Swanton, Cancer Research UK’s Chief Clinician and a 2021 ISLB award recipient for outstanding scientific contribution in liquid biopsy. "Better understanding the true pathology of a patient’s tumor, including driver and passenger clonal mutations, and identifying MRD earlier, are key to unlocking personalized cancer care and changing the paradigm of cancer drug development towards earlier intervention in the adjuvant setting where cures are more readily achievable."

Invitae’s PCM is a pan-cancer, tumor-informed liquid biopsy assay that uses next-generation sequencing powered by Anchored Multiplex PCR (AMP) to monitor MRD with high sensitivity at low variant allele fractions. The service employs a combination of a tumor profile, blood tests and personalized assays based on a patient’s tumor with the goal of earlier detection of cancer recurrence through ctDNA before it is detectable by imaging or other conventional methods. ECLIPSE, developed by the Cancer Research UK TRACERx team at UCL and the Francis Crick Institute, uses a standardized algorithm that helps resolve tumor tissue-based sample bias. Coupling Invitae’s PCM assay with ECLIPSE, the researchers analyzed 972 longitudinal plasma samples from 136 TNM I-III NSCLC patients in TRACERx who had undergone multiregion whole exome sequencing of primary tumor and relapse tissue and had 364 surveillance scans. Seventy-five of these patients experienced a recurrence of their surgically resected disease.

The researchers concluded that multiplex-anchored PCR with trinucleotide specific background models improves NSCLC relapse detection compared to standard of care clinical follow up. Using ECLIPSE, plasma samples of less than 1% purity can be used to accurately profile the clonal structure of tumors at diagnosis, during treatment and at relapse, which impacts patient outcome and has the potential to guide personalized medicine.

"Determining the best treatment plan for a cancer patient depends on several factors, including the results of current disease monitoring. Unfortunately, traditional monitoring methods such as imaging and tissue biopsy are insensitive when it comes to adequately representing a tumor or detecting relapse early in a patient’s treatment cycle," said Robert Nussbaum, M.D., chief medical officer of Invitae. "These findings further validate the role of PCM in determining a therapy’s effectiveness and identifying relapses more quickly, both of which are essential to optimizing personalized treatment plans."

PCM and other liquid biopsy approaches for monitoring MRD have the potential to become a mainstay in personalized oncology. PCM could be applied in a variety of ways to help improve patient care and prolong survival outcomes, including monitoring for recurrence, monitoring a patient’s response to therapy to inform treatment decisions, and improving clinical trial designs to help get new therapies to market sooner.

About TRACERx Study

TRACERx (Tracking Cancer Evolution through therapy (Rx)) lung study is the single biggest investment in lung cancer research by Cancer Research UK. Taking place over nine years, we believe the translational research programme is the first study to look at the evolution of cancer in real time and immense detail. Researchers follow patients with lung cancer all the way from diagnosis through to either disease relapse or cure after surgery, tracking and analysing how their cancer develops. TRACERx is led by UCL (University College London) via the Cancer Research UK Lung Cancer Centre of Excellence and also supported by the National Institute for Health Research, University College London Hospitals Biomedical Research Centre, Francis Crick Institute and the Rosetrees Trust.