On March 4, 2021 NANOBIOTIX (Euronext : NANO –– NASDAQ: NBTX – the ‘‘Company’’), a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that the Company has reached an agreement with PharmaEngine, Inc. ("PharmaEngine") to terminate the License and Collaboration agreement that the Company and PharmaEngine entered into in August 2012 (Press release, Nanobiotix, MAR 4, 2021, View Source [SID1234576122]).

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As previously disclosed in the Nanobiotix prospectus filed with the U.S. Securities and Exchange Commission on December 11, 2020, in November 2020, Nanobiotix notified PharmaEngine of a material breach of the terms of the License and Collaboration agreement. In a letter dated December 1, 2020, PharmaEngine responded to the Company’s notification of material breach, denying a material breach of the License and Collaboration agreement, and asserting certain material breaches of that agreement by Nanobiotix. After discussion between the two parties, this agreement to terminate the License and Collaboration agreement represents a full resolution of outstanding disagreements over a number of issues with respect to the development of NBTXR3 in the Asia-Pacific region.

The License and Collaboration agreement provided PharmaEngine exclusive rights to further the development of NBTXR3 in the Asia-Pacific region. While both Nanobiotix and PharmaEngine believe in the potential of NBTXR3 to improve treatment outcomes for patients with cancer, the parties have had disagreements regarding the optimal strategy for development in the Asia-Pacific region. As such, Nanobiotix and PharmaEngine have mutually agreed to discontinue the collaboration.

Pursuant to their Termination and Release agreement, Nanobiotix will retain all rights to the development and commercialization of NBTXR3 in the Asia-Pacific region. PharmaEngine is to receive payments, not to exceed $5 million in total, upon the completion of various administrative steps in connection with the winding-up of the collaboration.

In the future, PharmaEngine will be entitled to receive a payment of $7.5 million upon a second regulatory approval of NBTXR3 in any jurisdiction of the world for any indication, unless the Company announces a collaboration with a new partner for the Asia-Pacific region within 6 months of the effective date of the agreement. If that occurs, PharmaEngine will be entitled to an immediate $2.5 million payment and will be eligible to receive a payment of the remaining $5 million upon such second regulatory approval of an NBTXR3-containing product. The Company has also agreed to pay royalties to PharmaEngine at low-single digit royalty rates with respect to sales of NBTXR3 in the Asia-Pacific region for a 10-year period commencing on the corresponding first date of sales in the region.

Retention of all rights regarding NBTXR3 will open new near- and long-term possibilities for the Company, and Nanobiotix will evaluate the Asia-Pacific region for potential inclusion in its upcoming global phase III registration trial in head and neck cancer.

About NBTXR3

NBTXR3 is a first-in-class radioenhancer composed of sterile, functionalized, crystalline hafnium oxide nanoparticles. The product candidate is designed to increase the radiotherapy energy deposit inside tumor cells through the nanoparticles’ high atomic number core packaged in the space for interaction with ionizing radiation, and subsequently increase of tumor cell death when compared to radiotherapy alone—without adding toxicity to adjacent healthy tissues. NBTXR3 requires a single, intratumoral administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The primary physical mechanism of action of NBTXR3 activated by radiotherapy could be universal, making it potentially applicable across any solid tumor indication where radiotherapy is a part of standard of care including head and neck, lung, prostate, liver, colorectal, and esophageal cancers. The biological secondary mechanism of action of NBTXR3 activated by radiotherapy has been shown in preclinical studies to prime adaptive immune response, which would potentially bring a new dimension to cancer immunotherapies.

On March 4, 2021 Genetron Holdings Limited ("Genetron Health" or the "Company", NASDAQ:GTH), a leading precision oncology platform company in China that specializes in offering molecular profiling tests, early cancer screening products and companion diagnostics development, reported that it will report unaudited financial results for the fourth quarter and full year ended December 31, 2020 on March 25, 2021 before the US market open (Press release, Genetron Health Technologies, MAR 4, 2021, View Source [SID1234576121]).

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Management will host a conference call for investors at 8:30 a.m. ET (8:30 p.m. Beijing time) on Thursday, March 25, 2021. The conference call can be accessed by dialing the following numbers:

Participants are encouraged to dial into the call at least 15 minutes in advance due to high call volumes.

A replay will be accessible through April 2, 2021 by dialing the following numbers:

A simultaneous webcast of the conference call will be available on the "News and Events" page of the Investors section of the Company’s website. A replay of the webcast will be available for 30 days following the event. For more information, please visit ir.genetronhealth.com.

On March 4, 2021 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at the Barclays Global Healthcare Conference, which will be held virtually from March 9-11, 2021 (Press release, Puma Biotechnology, MAR 4, 2021, View Source [SID1234576120]). Puma’s presentation will take place at 1:50 p.m. EST (10:50 a.m. PST) on Thursday, March 11, 2021.

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A live webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com. The presentation will be archived on the website and available for 30 days.

On March 4, 2021 UNC Lineberger Comprehensive Cancer Center researchers reported that have successfully used an experimental safety switch, incorporated as part of a chimeric antigen receptor T-cell (CAR-T) therapy, a type of immunotherapy, to reduce the severity of treatment side effects that sometimes occur (Press release, Lineberger Comprehensive Cancer Center, MAR 4, 2021, View Source [SID1234576119]). This advance was seen in a patient enrolled in a clinical trial using CAR-T to treat refractory acute B-cell leukemia. It demonstrates a proof-of-principle for possible expanded use of CAR-T immunotherapy paired with the safety switch.

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The researchers published their findings in the journal Blood as an ahead-of-print publication.

With CAR-T therapy, T-cells from a patient’s immune system are modified in a manufacturing facility to express part of an antibody that can bind to a surface protein on cancer cells. The modified T-cells, after being infused back into the patient, seek out and attack cancer cells throughout the body. Patients with leukemia or lymphoma have experienced complete remission when treated with CAR-T therapy but sometimes experience toxicities, which can be life-threatening, due to inflammatory responses or nervous system toxicities caused by the modified T-cells.

When using standard forms of cancer therapies, including pills and infused drugs, doctors can interrupt or lower drug dosing to respond to treatment toxicities. With cell-based immunotherapies, this is not possible after the cells are infused. So UNC Lineberger researchers engineered T-cells to include a safety switch, called inducible caspase-9, or iC9, that can be activated if toxic side effects develop. Administration of the drug rimiducid "triggers" the switch to activate the expression of caspase-9, potentially leading to reduced severe side effects from the CAR-T therapy.

"Because of our active Cellular Immunotherapy Program at UNC Lineberger, we can engineer and generate various CAR-T cells for clinical trials. In this case, we have produced specialized CAR-T cells that could benefit patients by enhancing safety," said Matthew Foster, MD, lead author of the study and an associate professor in the UNC School of Medicine and a UNC Lineberger member. "With the assistance of our partner Bellicum Pharmaceuticals, we collaborated to use the safety switch-triggering drug rimiducid with cells manufactured at UNC Lineberger."

UNC Lineberger has enrolled patients in an ongoing early-phase clinical trial to determine whether a novel CAR-T therapy with the iC9 safety switch is safe and effective against relapsed or refractory B-cell acute lymphoblastic leukemia, a difficult to treat, fast-moving cancer that occurs frequently in children, adolescents and young adults.

One of the participants in the study, a 26-year-old woman, experienced a severe side effect — immune effector cell-associated neurotoxicity syndrome (ICANS) — after being infused with CAR-T. Her clinicians quickly reduced the severity of the side effects by administering the drug rimiducid to activate the iC9 safety switch. As intended, Foster said the safety switch reduced the number of circulating modified T-cells by nearly 60 percent within four hours and by more than 90 percent within 24 hours. The drug nearly eliminated the toxicities within one day.

"Even though this case study only documents an outcome in one patient, the fact that the drug was so successful so quickly gives us hope that it could have wider applications in a larger group of leukemia patients," said Gianpietro Dotti, MD, director of the UNC Lineberger Cellular Immunotherapy Program and professor of medicine at the UNC School of Medicine. "It should be noted that while rimiducid mitigated her toxicities, it also lowered the number of iC9 T cells fighting her cancer by 90 percent. But there seemed to be sufficient T-cells still circulating to maintain an anticancer response."

This trial is ongoing but the investigators will next explore the effects of lower doses of rimiducid in patients with less severe toxicity as it could be a way to intervene early and prevent severe toxicity.

"Given these results and the well-established high response rates in B-cell acute lymphoblastic leukemia patients receiving CAR-T cells, it is reasonable to have a high bar in 2021 and expect that we can achieve both safety and efficacy from such therapies," concluded Foster.

The investigators also see the potential to use CAR-T designed with the built-in safety switch to treat other cancers. "The ability to use a safety switch may also allow us to treat patients with solid tumors where there may be concern about the CAR-T cells affecting non-cancer tissue," said Jonathan Serody, MD, director of the UNC Lineberger Cellular Therapy Program. "In those instances, side effects can be eliminated by activating the safety switch."

On March 4, 2021 OnKure, Inc., a privately-held biopharmaceutical company developing best-in-class, targeted oncology therapeutics, reported that it has raised $55 million in a Series B financing (Press release, OnKure, MAR 4, 2021, View Source [SID1234576118]). Proceeds will be used to advance the Company’s next generation histone deacetylase (HDAC) inhibitors further into clinical development and fund a growing pipeline of earlier stage molecules.

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The financing was led by Acorn Bioventures with participation from additional new investors Cormorant Asset Management, Surveyor Capital (a Citadel company), Samsara BioCapital, Perceptive Advisors and funds and accounts managed by BlackRock.

In connection with the financing, Isaac Manke, Ph.D., Partner at Acorn Bioventures, and Andrew Phillips, Ph.D., Managing Director at Cormorant Asset Management, will join the OnKure board of directors.

"I am grateful for the financial and strategic support from our new investors that will allow OnKure to accelerate the discovery and development of a robust pipeline focused on epigenetic regulation, delaying resistance and synthetic lethality" commented Tony Piscopio, Ph.D., Co-founder, President and Chief Executive Officer of OnKure. "Similar to the value accreting strategy we used at Array BioPharma in terms of discovering and developing best in class kinase inhibitors, OnKure is applying this rationale to HDAC inhibitors – a field in long need of quality molecules and a focused development strategy."

"OnKure has assembled a senior management team with a proven track record in drug discovery and development that has ultimately delivered better outcomes for cancer patients" commented Isaac Manke, Ph.D., Partner at Acorn Bioventures. "We are excited to partner with this team of industry veterans as they advance OnKure’s best-in class HDAC inhibitor OKI-179 in the clinic and expand its discovery capabilities."

"We are pleased to join other investors in supporting the accomplished leadership team at OnKure as they build a pipeline of innovative medicines directed toward significant patient needs in oncology" added Andrew Phillips, Ph.D., Managing Director at Cormorant Asset Management.

Solebury Capital served as financial advisor to OnKure for the offering.