On September 8, 2021 XBiotech Inc. (NASDAQ: XBIT) ("XBiotech") reported that Benjamin Musher M.D., will chair XBiotech’s clinical program for pancreatic cancer (Press release, XBiotech, SEP 8, 2021, View Source [SID1234587376]). The Company is developing a novel cancer drug, Natrunix, to be used in combination with cytotoxic anti-cancer agents. Natrunix specifically blocks a substance that has been shown to stimulate tumor blood supply and break down connective tissue, which can support tumor growth and destruction of healthy tissue. The anti-inflammatory activity of Natrunix is also being evaluated for its ability to reduce the toxicity and injury caused by the cytotoxic anti-cancer agents themselves.

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XBiotech’s pancreatic cancer program, 1-BETTER, launched with a randomized, double-blind, placebo-controlled Phase 1-2 study, allows the Company to evaluate dose levels, drug interaction and anti-cancer activity for Natrunix. Dr. Musher is Medical Director of Medical Oncology at Dan L. Duncan Comprehensive Cancer Center and Associate Professor at Baylor College of Medicine. Dr. Musher is a member of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and has authored numerous peer-reviewed articles in oncology, including treatments for pancreatic cancer. In addition to Natrunix, Dr. Musher has investigated cutting-edge pancreatic cancer therapies, including the use of tumor-targeting viruses. He has also researched and published on clinical practices relating to the treatment of pancreatic cancer, to better understand the decision-making processes and challenges faced by oncologists in the treatment of this extremely challenging form of cancer.

As chair of the 1-BETTER pancreatic cancer program, Dr. Musher will lead the clinical program and personally treat pancreatic cancer patients at the Dan L. Duncan Comprehensive Cancer Center, at St. Luke’s Hospital in Houston, Texas. Dr. Musher stated, "Pancreatic cancer is a devastating disease and remains the third leading cause of cancer-related death in the United States. Most patients with metastatic pancreatic cancer are eligible for only cytotoxic chemotherapy, which generally yields short-lived responses and can cause significant toxicity. More effective and rationally designed therapies are therefore desperately needed. By targeting cancer-related inflammation, Natrunix may facilitate better control of tumor growth, reduce toxicity from chemotherapy, and improve well-being of patients with advanced pancreatic cancer."

Dr. Musher will oversee the 1-BETTER study that will involve at least 20 other leading cancer centers around the country. The study will evaluate Natrunix in combination with ONIVYDE and 5-fluorouracil and generate preliminary data on overall survival, progression-free survival, time-to-treatment failure, and objective response rates. Numerous quality-of-life measures will also be explored, hopefully showing a reduction in chemotherapy-related toxicity.

John Simard, President and CEO of XBiotech commented, "We are honored to have Dr. Musher chair this study for which we are eagerly anticipating results."

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

On September 8, 2021 Sprint Bioscience AB (publ) reported that the company is broadening its pipeline with an additional drug program for the treatment of solid tumors (Press release, Sprint Bioscience, SEP 8, 2021, View Source [SID1234587375]). The program goes by the program name NIMA and aims to develop drugs to inhibit a naturally occurring protein that is associated with poor survival in several different forms of cancer.

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"We have once again been able to identify a target protein that constitutes a very attractive starting point for a new drug program. The ambition is to influence the microenvironment of the tumors so that the growth of cancer cells is inhibited and the body’s immune system can more easily fight them. We will in a time- and resource-efficient way drive the project to a point where it can dock into an international pharmaceutical company’s portfolio and be taken further to clinic development towards the market and cancer patients who need new treatment option"
Erik Kinnman, CEO, Sprint Bioscience

An important aspect of the development of a tumor is that the cancer cells can affect their environment to facilitate the growth of the tumor. This environment is called the tumor microenvironment and differs from the environment around the healthy cells in the body. The ability of cancer cells to reprogram the healthy cells present in the tumor facilitates tumor growth and can inhibit the body’s immune system.

The NIMA program focuses on a target protein that produces metabolites that are important for this reprogramming of the tumor’s microenvironment. Sprint Bioscience develops inhibitors of this target protein to restore balance and thereby prevent the growth of cancer cells while increasing the immune system’s ability to attack them. High levels of the current target protein have been found in tumors from, amongst others, ovarian cancer, breast cancer, and colorectal cancer. Patients with high levels of this protein have a poorer prognosis.

"We have once again been able to identify a target protein that constitutes a very attractive starting point for a new drug program. The ambition is to influence the microenvironment of the tumors so that the growth of cancer cells is inhibited and the body’s immune system can more easily fight them. We will in a time- and resource-efficient way drive the project to a point where it can dock into an international pharmaceutical company’s portfolio and be taken further to clinic development towards the market and cancer patients who need new treatment option,", says Erik Kinnman, CEO, Sprint Bioscience.

The initiation of the NIMA program is part of the company’s accelerating strategy to broaden its project portfolio in the cancer area and thereby create opportunities for further licensing deals that can generate additional multiple revenue streams.

On September 8, 2021 Sanofi reported that it has entered into a definitive merger agreement with Kadmon Holdings, Inc. (NASDAQ: KDMN) a biopharmaceutical company that discovers, develops, and markets transformative therapies for disease areas of significant unmet medical needs (Press release, Sanofi, SEP 8, 2021, View Source [SID1234587374]). The acquisition supports Sanofi’s strategy to continue to grow its General Medicines core assets and will immediately add Rezurock(belumosudil) to its transplant portfolio. Rezurock is a recently FDA-approved, first-in-class treatment for chronic graft-versus-host disease (cGVHD) for adult and pediatric patients 12 years and older who have failed at least two prior lines of systemic therapy.

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Shareholders of Kadmon common stock will receive $9.50 per share in cash, which represents a total equity value of approximately $1.9 billion (on a fully diluted basis). The Sanofi and Kadmon Boards of Directors unanimously approved the transaction.

"We are transforming and simplifying our General Medicines business and have shifted our focus on differentiated core assets in key markets," said Olivier Charmeil, Executive Vice President General Medicines. "We are thrilled to add Kadmon’s Rezurock to our well-established transplant portfolio. Our existing scale, expertise, and relationships in transplant create an ideal platform to achieve the full potential of Rezurock, which will address the significant unmet medical needs of patients with chronic graft-versus-host disease around the world."

"We are excited that Sanofi has acknowledged the value of Rezurock and the deep potential of our pipeline," said Harlan Waksal, M.D., President and Chief Executive Officer, Kadmon. "By leveraging Sanofi’s global resources and long-standing expertise in developing and commercializing innovative medicines, Rezurock is now well positioned for global accessibility, faster. I want to thank the entire Kadmon team, including management and the Board of Directors, and the Sanofi organization, for their ongoing commitment to patients and their caregivers."

Sanofi’s transplant business mainly consists of Thymoglobulin (anti-thymocyte globulin), a polyclonal, anti-human thymocyte antibody preparation that acts as a broad immunosuppressive and immunomodulating agent and Mozobil (plerixafor), a hematopoietic stem cell mobilizer. Both products are among General Medicines core assets and are currently registered and marketed in more than 65 countries.

In July 2021, the FDA approved Rezurock for the treatment of adult and pediatric patients 12 years and older with cGVHD after the failure of at least two prior lines of systemic therapy. Rezurock was launched in August in the United States. It is the first and only approved small molecule therapy that inhibits the Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response and fibrotic processes. Sanofi will work closely with regulatory authorities across different geographies to ensure that patients suffering from cGVHD can benefit from belumosudil treatment as early as possible. Kadmon is also developing Rezurock for the treatment of diffuse cutaneous systemic sclerosis, with an open-label Phase 2 clinical trial currently ongoing.

Kadmon’s pipeline includes drug candidates for immune and fibrotic diseases as well as immuno-oncology therapies.

The transaction is expected to be modestly dilutive to Sanofi’s EPS in 2022.

Transaction Terms

Under the terms of the merger agreement, holders of Kadmon’s common stock will receive $9.50 per share in an all-cash transaction, reflecting a total equity value of Kadmon of approximately $1.9 billion. The offer price represents a premium of 79% over the closing price on September 7, 2021 and a premium of approximately 113% over the 60 trading days volume weighted average price.

The consummation of the transaction is subject to customary closing conditions, including the approval of holders of a majority of the outstanding shares of Kadmon voting stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions. Following the successful completion of the merger, a wholly owned subsidiary of Sanofi will merge with Kadmon and the outstanding Kadmon shares will receive $9.50 per share in cash. Sanofi plans to fund the transaction with available cash resources. Subject to the satisfaction or waiver of customary closing conditions, Sanofi expects to complete the acquisition in the fourth quarter of 2021.

Weil, Gotshal & Manges LLP is acting as legal counsel to Sanofi. Cantor Fitzgerald & Co. and Moelis & Company LLC are acting as exclusive financial advisors to Kadmon in the transaction, while DLA Piper LLP (US) is acting as legal counsel.

On September 8, 2021 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or the "Company"), is an Australian-based clinical stage radiopharmaceutical company developing next-generation products to address the growing need for the use of radiopharmaceuticals in oncology (Press release, Clarity Pharmaceuticals, SEP 8, 2021, View Source [SID1234587369]). The Company commences trading on the Australian Securities Exchange (ASX) at 11:00am (Sydney, Australia time) today following the completion of an initial public offering (IPO).

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The IPO raised $92.0 million and was strongly supported by institutional, professional and retail investors. Jefferies (Australia) Pty Ltd and Bell Potter Securities Limited were Joint Lead Managers and Underwriters to the IPO.

Clarity is a global leader in Targeted Copper Theranostics (TCT), developed with its proprietary SAR Technology platform. TCT are the next-generation disruptive platform in radiopharmaceuticals that employ the "perfect pairing" of copper-64 (64Cu) and copper-67 (67Cu) for diagnosis and therapy respectively. TCT deliver a compelling combination of high accuracy and high precision in the treatment of a range of cancers, as well as providing supply and logistical advantages over current radiopharmaceuticals. TCT provide a highly efficacious, scalable, and cost-effective way to expand radiopharmaceuticals into the global oncology market.

Clarity’s proprietary SAR Technology platform can be used to develop a range of theranostic radiopharmaceuticals that target different types of cancer. At the heart of Clarity’s theranostic SAR Technology platform is a highly specific and highly stable bifunctional chelator (cage) that strongly binds and retains copper isotopes within it. The cage is linked to a targeting molecule, which finds and binds tumour specific receptors on cancer cells. Together with the targeting molecule and the isotope, the technology enables the development of radiopharmaceuticals for diagnosis and therapy in oncology.

Clarity has a diverse range of products in clinical trials which address both large indications (prostate cancer and breast cancer) as well as rare and orphan indications (neuroendocrine tumours (NETs) and neuroblastoma) of cancer, thereby positioning the products to take advantage of the high unmet needs that currently exist in respect of the medical treatment used for these types of cancers. The products in the clinical stage of development include:

SARTATE: for the treatment of neuroblastoma, Phase I/IIa; for the diagnosis of neuroendocrine tumours (NETs), Phase II;
SAR-Bombesin: a pan-cancer treatment product, including for the treatment of breast cancer and prostate cancer, Phase I; and
SAR-bisPSMA: for the treatment of prostate cancer, Phase I/IIa; for the diagnosis of prostate cancer, Phase I.
Clarity’s focus in the clinical development process is on high quality clinical sites and experienced investigators. The Company is targeting the lucrative US market for first product approvals and expects that it will have sufficient cash to fund its medium-term operational requirements and business objectives as a result of the funds raised under the IPO.

Clarity is led by a management team and Board who possess a diverse range of skills and expertise, together with

extensive experience in the radiopharmaceutical market. Alongside the management team and Board, Clarity has a Scientific Advisory Board, which consists of key opinion leaders who have significant research and clinical experience in global radiopharmaceuticals.

Clarity’s Executive Chairman, Dr Alan Taylor, commented: "Our Board and management team are committed to our strategy. We believe Clarity to be a global leader in targeted copper theranostics with best-in-class chelator technology. The IPO significantly advances our business and we are delighted to welcome our new shareholders and thank our existing shareholders for their continued support.

"Our proprietary SAR Technology platform addresses the growing need for the use of radiopharmaceuticals in oncology and we believe that targeting the US market for first clinical approvals will assist in potentially achieving large scale market penetration of our products.

"We look forward to continuing to grow the business, deliver on our strategy and move closer to our ultimate goal of developing better treatments for children and adults with cancer."

On September 8, 2021 Bristol Myers Squibb (NYSE:BMY) reported that it will announce results for the third quarter of 2021 on Wednesday, October 27, 2021 (Press release, Bristol-Myers Squibb, SEP 8, 2021, View Source [SID1234587367]). During a conference call at 8 a.m. ET on October 27, 2021, company executives will review financial results and address inquiries from investors and analysts.

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Investors and the general public are invited to listen to a live webcast of the call at View Source or by using this link which becomes active 15 minutes prior to the scheduled start time and entering your information to be connected. Investors and the general public can also access the live webcast by dialing in the U.S. toll free 800-263-0877 or international +1 313-209-7315, confirmation code: 8911662. Materials related to the call will be available at the same website prior to the conference call.

A replay of the call will be available on View Source or by dialing in the U.S. toll free 888-203-1112 or international +1 719-457-0820, confirmation code: 8911662. The replay will be available beginning at 11:30 a.m. ET on October 27 through 11:30 a.m. ET on November 10, 2021.