On December 23, 2020 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company, reported the launch and active recruitment of a firstin-class biomarker study aligned with the recommendations from the official 2018 American Thoracic Society (ATS) policy statement on the early detection of lung cancer (Press release, Biodesix, DEC 23, 2020, View Source [SID1234573221]). The Nodify XL2 Classifier Clinical Utility Study in Low to Moderate Risk Lung Nodules (ALTITUDE), titled "A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Test in Incidentally Discovered Low to Moderate Risk Lung Nodules," is a randomized blinded controlled study with the objective of assessing how clinical decision making is impacted by the introduction of Nodify Lung test results into risk assessment. The study will focus on new, incidentally identified patients with lung nodules that are estimated to have low to moderate risk of lung cancer using the current standard of care.

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The study is designed to generate key data to provide further support for a testing strategy that improves on the current standard of care and that significantly enhances guidelines. Biodesix has selected Dr. Gerard Silvestri, Hillenbrand Professor of Thoracic Oncology at the Medical University of South Carolina, to lead this trial. Dr. Silvestri is an internationally recognized researcher in all aspects of lung cancer care but with focused expertise in the early detection, evaluation and management of pulmonary nodules.

"I am excited to serve as principal investigator for the ALTITUDE trial, a study that I consider to be the first of its kind," said Dr. Silvestri. "We expect the trial to demonstrate that having the results of the Nodify XL2 Lung tests will lead to patients with benign disease avoiding unnecessary and invasive procedures. I believe that it will establish a new standard for future biomarker studies for the early detection of lung cancer."

"I am excited to serve as principal investigator for the ALTITUDE trial, a study that I consider to be the first of its kind," said Dr. Silvestri. "We expect the trial to demonstrate that having the results of the Nodify XL2 Lung tests will lead to patients with benign disease avoiding unnecessary and invasive procedures. I believe that it will establish a new standard for future biomarker studies for the early detection of lung cancer."

With a total enrollment goal of 2,000 patients, Biodesix anticipates publishing interim results in 2022 and expects to complete the study in late 2023. "As a data-driven company, Biodesix is committed to continuing to study our tests and their impact on patients and the healthcare system. Through the ALTITUDE study, we want to better understand the impact on real-world decisions made in the clinic every day with the Nodify Lung test," said Scott Hutton, CEO of Biodesix. "We are proud that this important study will include leading experts in early detection of lung cancer from some of the most prestigious academic centers in the U.S."

On December 23, 2020 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on next-generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, reported that it has received a "Study May Proceed" letter from the US Food and Drug Administration (FDA) to begin a Phase Ib study evaluating CX-5461, a first-in-class G-quadruplex stabilizer, to treat solid tumors with BRCA2 or PALB2 mutations (Press release, Senhwa Biosciences, DEC 23, 2020, View Source [SID1234573240]).

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"The FDA’s approval of our Phase Ib clinical trial application for testing CX-5461 in patients with BRCA2 or PALB2 mutations is an important milestone and marks a new paradigm in the treatment of cancers with specific pathogenic mutations," stated Dr. John Soong, the Chief Medical Officer of Senhwa Biosciences.

In 2016, Canadian Cancer Trial Group (CCTG), a recipient of the Stand Up to Cancer’s Dream Team Grant selected CX-5461 to study in their Phase I trial. In the CCTG Trial, CX-5461 demonstrated clinically significant and lasting benefits in patients with specific tumor biomarkers that were resistant to platinum and other chemotherapeutics. This new Phase Ib trial will occur in both the US and Canada, and study endpoints include a re-confirmation of the efficacy signal. This trial is currently under review with Health Canada.

CX-5461 was recently named as a PCF (Prostate Cancer Foundation)-Pfizer Global Challenge Award recipient. Specifically, it will be used together with Pfizer’s PARP inhibitor (PARPi), Talazoparib, to evaluate the combined therapeutic potential in treating prostate cancer. For American men, prostate cancer is the second-leading cause of cancer death. Due to a DNA repair defect, BRCA1/2 deficient tumor cells are more sensitive to PARPi through the mechanism of synthetic lethality; however, PARPi resistance is commonly seen in clinical use. More than 40% of BRCA1/2-deficient patients fail to respond to PARPi.

"CX-5461 has proven human efficacy across certain tumor types by accelerating dsDNA breaks. We believe CX-5461 has great potential as a therapeutic for patients who have developed resistance to PAPRi or other chemotherapies. Addressing treatment for resistant tumors continues to be an unmet medical need in cancer treatment," said Dr. Tai-Sen Soong, CEO of Senhwa Biosciences.

About CX-5461

Specific mutations within the Homologous Recombination (HR) pathway may be exploited by CX-5461 through a synthetic lethality approach by targeting the DNA repair defects in Homologous Recombination Deficiency (HRD) tumors. Specifically, CX-5461 is designed to stabilize DNA G-quadruplexes of cancer cells which leads to disruption of the cell’s replication fork. While acting in concert with HR pathway deficiencies, such as BRCA1/2 mutations, replication forks stall and cause DNA breaks, ultimately resulting in cancer cell death.

On December 23, 2020 NETRIS Pharma, a clinical-stage biopharmaceutical company developing next generation molecules targeting cancer, reported the closing of a €16.1m Series A financing and the reinforcement of its Board of Directors (Press release, Netris Pharma, DEC 23, 2020, View Source [SID1234611184]). The round was subscribed by historical investors converting their outstanding loans, and joined by New Investors collectively investing €7.5m.

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Patrick Mehlen, NETRIS Pharma Founder and CEO, commented "NETRIS Pharma is proud to have achieved major milestones in these highly turbulent times and thank BPDG for its active role in this fundraising process. Further to the signature of a collaboration Agreement with MSD for the coming Phase 1B/2 trial in combination with Pembrolizumab,such funding creates opportunities to accelerate the clinical development plan of NETRIS Pharma in other indications of interest."

Banque Profil de Gestion (BPDG) acted as the sole advisor for the fundraising process led by Gianpaolo Chiriano, Managing Director and Head of Healthcare & Life Sciences at BPDG, who added: "we are glad to have contributed to the achievement of this milestone for NETRIS Pharma with the hope to impact lives of cancer patients."

Netris Pharma was founded as a spin-off of Centre Léon Bérard to develop a complete novel approach in oncology based on the biology of dependence receptors. The company, driven by scientific excellence and strong clinical insights, successfully develop NP137 targeting Netrin-1, which exhibited encouraging signs of clinical activity in its Phase 1A trial and extensions.

Netris Pharma will primarily use the proceeds of the Series A to conduct the planned Phase1B /2 clinical trial to investigate the safety and efficacy of NP137 in combination with KEYTRUDA in patients with advanced/metastatic uterine tumors and for general corporate purposes.

On December 23, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that the European Commission has approved Roche’s Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with Halozyme’s ENHANZE technology, administered by subcutaneous injection for the treatment of patients with early and metastatic HER2-positive breast cancer (Press release, Halozyme, DEC 23, 2020, View Source [SID1234573222]). This is the first time the European Commission has approved a product combining two monoclonal antibodies that can be administered by a single subcutaneous injection utilizing Halozyme’s ENHANZE technology.

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"We are pleased that HER2-positive breast cancer patients in Europe will now have the option to receive this important therapy in a substantially shorter period of time than standard IV therapy," said Dr. Helen Torley, president and chief executive officer. "The approval of Phesgo in Europe closes out a terrific year for Halozyme in which we received multiple regulatory clearances for products utilizing our ENHANZE technology, including 2 U.S. FDA approvals and now two European Commission approvals."

Phesgo is available in single-dose vials and can be administered via subcutaneous injection in approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose.(1) This is compared to approximately 150 minutes for a sequential infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines.(2,3)

The approval of Phesgo in Europe is based on results from the pivotal phase III FeDeriCa study, which met its primary endpoint, with Phesgo showing non-inferior levels of Perjeta and Herceptin in the blood and demonstrated comparable efficacy versus IV administration of the two medicines. The safety profile of Phesgo with chemotherapy was comparable to IV administration of Perjeta plus Herceptin and chemotherapy. No new safety signals were identified, including no meaningful difference in cardiac toxicity.(1,4)

Phesgo has the potential to help minimize pressure on healthcare systems by reducing administration time, as well as other costs associated with treatment, such as time spent in the infusion chair and drug preparation(5). In addition, Roche’s phase II PHranceSCa study showed that 85% (136/160) of people receiving treatment for HER2-positive breast cancer preferred treatment under the skin to IV administration due to less time in the clinic and more comfortable treatment administration.(1)

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

On December 23, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported progress from its ongoing license agreement with AstraZeneca (LSE/STO/Nasdaq: AZN), under which the program has achieved a preclinical milestone (Press release, Compugen, DEC 23, 2020, View Source [SID1234573223]). Under the terms of the agreement, Compugen provided an exclusive license to AstraZeneca for the development of bispecific and multi-specific antibody products based on one of Compugen’s pipeline programs, with AstraZeneca responsible for all research, development and commercial activities. In connection with this first milestone, Compugen is entitled to receive a $2 million payment from AstraZeneca.

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"AstraZeneca choosing Compugen as a partner for its bispecific and multi-specific development plans is testament to the power of our platform, and we are proud that this program has now advanced to demonstrate therapeutic potential," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "This license agreement has enabled Compugen to monetize one of our programs outside our development focus and is part of our larger strategy to selectively collaborate with biopharmaceutical companies to leverage our diverse, computationally-discovered pipeline for the development of novel cancer immunotherapies. We are delighted that AstraZeneca has chosen to continue the development of this bispecific program, providing further validation of Compugen’s discovery and development capabilities."

About the Compugen-AstraZeneca License Agreement
In April 2018, Compugen and AstraZeneca entered into an agreement by which Compugen provided an exclusive license to AstraZeneca for the development of bispecific and multi-specific antibody products derived from one of Compugen’s pipeline programs. AstraZeneca has the right to create multiple products under this license and is solely responsible for all research, development and commercial activities. Compugen received a $10 million upfront payment and is eligible to receive up to $200 million in development, regulatory and commercial milestones for the first product as well as tiered royalties on future product sales. If additional products are developed, additional milestones and royalties would be due to Compugen. Under the terms of the license agreement, Compugen retained all other rights to its entire pipeline of programs as monotherapies and in combination with other products.