On February 4, 2021 Onxeo S.A. (Euronext Growth: ALONX, Nasdaq First North: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR), in particular against rare or resistant cancers, reported that the Company has entered into a clinical research agreement with Institut Curie, the French leading cancer center, to conduct a phase 1b/2 study designed to evaluate the effect of AsiDNA, Onxeo’s first-in-class DDR inhibitor, in combination with radiotherapy in children with High-Grade Glioma (HGG) relapse and eligible to re-irradiation (Press release, Onxeo, FEB 4, 2021, View Source [SID1234575014]).

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High Grade Gliomas, representing about 20% of all pediatric central nervous system (CNS) tumors, still have a dismal outcome with a 5-year survival of less than 20%. Their standard treatment consists of surgical excision, in those locations where it is feasible, followed by radiotherapy (RT). In the absence of feasibility of surgical removal, a surgical biopsy is carried out to enable diagnosis. Radiotherapy is then performed alone or in association with chemotherapy and/or other medical treatments.

"This collaboration represents another clinical milestone for Onxeo and reflects the Company’s commitment to evaluate its drug candidate in indications with very high medical need, which is the case for this indication with a poor prognosis. The aim is to evaluate the synergy of the combination of AsiDNA with radiotherapy in order to improve treatment outcomes for these children suffering from relapsing High-Grade Glioma," said Olivier de Beaumont, Chief Medical Officer of Onxeo. "We are excited and honored to be collaborating with the teams at Institut Curie, a world-renowned academic institution that we would like to thank, as well as the teams of Fight Kids Cancer for their support in this research aimed at improving the care of these children."

"We look forward to start this original proof-of-concept study of the systemic administration of AsiDNA in combination with radiotherapy in this disease with a poor prognosis: the development of new treatments meets a major need. This first study is supported by a grant from the European Fight Kids Cancer program, which we thank for their support, and is being conducted within the framework of the European ITCC[2] consortium. High-grade gliomas in children are a particularly severe disease and the treatments available are limited in terms of their efficacy but also in terms of their potential toxicity on the brain. Combined with radiotherapy, AsiDNA could represent a real therapeutic breakthrough, bringing together greater efficacy with a very reassuring tolerance profile", said François Doz, MD, PhD, pediatrician oncologist, deputy director of clinical research, innovation and teaching at the SIREDO (Care, Innovation, Research, in oncology of children, adolescents and young adults) of Institut Curie and principal investigator of the study.

He concludes: "We are delighted with this clinical development in pediatric oncology of AsiDNA, an innovative therapy resulting from the work of Marie Dutreix’s research laboratory at Institut Curie. If this study is positive, it could pave the way for further studies in association with radiotherapy, in children with brain tumors".

Surgery, when possible, and radiotherapy, sometimes combined with chemotherapy, often allow control of the disease in high-grade gliomas in children, but this control is inconsistent and most usually transient because the tumors evolve secondarily due to the development of resistant tumor cells. In preclinical and clinical studies[3], the synergistic effect of AsiDNA in combination with "DNA breakers" such as radiotherapy has been demonstrated. Institut Curie and Onxeo collaborated on this multi-center phase 1b/2 trial design. Institut Curie, as study sponsor, will submit the application for authorization of this trial to the health authorities and ethics committees in the coming weeks, with the aim of initiating the study as early as 2021.

[1] Fight Kids Cancer is a European call for projects, a joint initiative of the French association Imagine for Margo, the Belgian KickCancer Foundation and the Luxembourg Kriibskrank Kanner Foundation.

[2] Innovative Therapies for Children with Cancer (ITCC) Consortium : www.itcc-consortium.org

[3] First-in-human phase I study of the DNA repair inhibitor DT01 in combination with radiotherapy in patients with skin metastases from melanoma. Le Tourneau C et al. Br J Cancer. 2016 May 24;114(11):1199-205

On February 4, 2021 Revolution Medicines, Inc. (Nasdaq: RVMD) reported the pricing of its underwritten public offering of 5,797,101 shares of common stock at a public offering price of $45.00 per share, before underwriting discounts and commissions (Press release, Revolution Medicines, FEB 4, 2021, View Source [SID1234575013]). All of the shares of common stock are being offered by Revolution Medicines. In addition, Revolution Medicines has granted the underwriters a 30-day option to purchase up to an additional 869,565 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Revolution Medicines, are expected to be approximately $260.9 million, excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on February 8, 2021, subject to customary closing conditions.

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J.P. Morgan, Cowen, SVB Leerink and Guggenheim Securities are acting as the joint book-running managers for the offering.

A registration statement relating to the shares being sold in this offering was declared effective by the Securities and Exchange Commission on February 3, 2021. The offering is being made only by means of a prospectus, copies of which may be obtained, when available, from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by telephone at 1-800-808-7525, ext. 6105, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On February 4, 2021 Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that the United States Food and Drug Administration (FDA) has granted fast track designation to TH1902 as a single agent for the treatment of patients with sortilin positive recurrent advanced solid tumors that are refractory to standard therapy (Press release, Theratechnologies, FEB 4, 2021, View Source [SID1234574991]).

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"Receiving fast track designation for TH1902 at this early stage of development is a significant recognition for our SORT1+ Technology and further supports the future development of TH1902. The designation, which applies to all solid tumours expressing sortilin, also highlights the broad applicability and immense medical need for innovative, targeted, and potentially more effective and better-tolerated therapies for cancer," said Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, Theratechnologies.

On February 4, 2021 AstraZeneca reported that British drugmaker and researchers from the UCL Division of Infection & Immunity will collaborate on two projects which will aim to contribute to the development of new cancer treatments (Press release, AstraZeneca, FEB 4, 2021, View Source [SID1234574705]).

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The new research collaborations will investigate immune checkpoints – key biochemical pathways that regulate the body’s immune responses.

Although immune checkpoints help to keep the body’s immune response at normal levels by not harming healthy cells, they can also block specialist immune cells from attacking and destroying cancer cells.

Over the last decade, the emergence of checkpoint inhibitor drugs have revolutionised cancer treatment and demonstrated benefit in clinical results for patients with solid tumours.

Meanwhile, the two AstraZeneca/UCL projects will focus on increasing understanding of immune checkpoint mechanisms and how to manipulate them.

The ultimate aim of the projects will to be to aid the development of new immunotherapy approaches.

AstraZeneca will provide a number of compounds for the projects, while UCL will use unique preclinical models and an array of molecular and cell biology techniques to study these pathways.

"These collaborations with AstraZeneca will bring together some of the very best minds in immuno-oncology," said Dr Kathryn Walsh, executive director, office of the Vice-Provost (Enterprise), UCL.

"Working together, experts from both institutions will push the boundaries of our understanding of the role of the body’s immune system. In the future, these insights will play a valuable role in how we will be able to develop new treatments to help patients with solid tumours," she added.

On February 4, 2021 Bayer AG reported a $2 billion deal to resolve future legal claims that its widely used weedkiller Roundup causes cancer, the German company said on Wednesday (Press release, Bayer, FEB 4, 2021, View Source [SID1234574704]).

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Bayer has been struggling to finalize the settlement of claims that Roundup and other glyphosate-based herbicides cause non-Hodgkin’s lymphoma, a type of cancer. Bayer inherited the business and the litigation as part of a $63 billion acquisition of Monsanto in 2018.

The company has said that decades of studies have shown Roundup and glyphosate are safe for human use.

Wednesday’s settlement would cover future claims brought by individuals who have been diagnosed with non-Hodgkin’s lymphoma and were exposed to Roundup before their diagnosis. The settlement also includes benefits for people who were exposed to Roundup and develop the cancer in the future.

Roundup, which Monsanto first brought to the market in 1974, is widely used by farmers across the United States and Brazil, alongside crops that are genetically engineered to withstand the its herbicidal effect.

Glyphosate will remain on the market. Bayer agreed to seek permission from the U.S. Environmental Protection Agency to provide a reference link on labels so consumers can find scientific studies on the weedkiller.

Under the proposed plan, Bayer will provide $2 billion for a four-year period as compensation and to cover outreach and diagnostic assistance. Future claimants could receive up to $200,000 under the deal.

The parties can agree to extend the settlement period.

The company said the settlement amount was disclosed last year.

The agreement must be approved by U.S. District Court Judge Vince Chhabria in San Francisco.

Chhabria in June questioned the legality of a prior settlement plan that Bayer proposed, which envisioned creating a panel of scientists who would rule on the viability of claims.

Under the revised deal, anyone who does not make a claim during the four-year period would then be able to sue in court, according Elizabeth Cabraser, an attorney for the proposed class. She also said anyone diagnosed with non-Hodgkin’s lymphoma who does not like their compensation offer under the class plan can go to the court system and try for a better result.

In June, Bayer reached a wider $9.6 billion settlement that would resolve the bulk of the more than 100,000 U.S. lawsuits that were already filed over Roundup.

Bayer’s stock has been battered by the litigation, but also by billions of euros in writedowns, and a bleaker profit outlook, in large part related to the $63 billion Monsanto takeover.

The group last year announced 9.25 billion euros in impairment charges on agricultural assets and shocked markets by predicting a slight decline in core earnings per share in 2021 on weaker demand by farmers.