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ONCOCYTE AND BURNING ROCK EXECUTE STRATEGIC AGREEMENT TO DISTRIBUTE DETERMARX IN CHINA

On December 15, 2020 Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, reported that it has signed an exclusive agreement in China to license DetermaRx, its proprietary test to identify high-risk, early-stage lung cancer patients who need treatment to improve their five-year survival, to Burning Rock Biotech Limited, a $2.5 billion market cap NASDAQ-listed (BNR) company (Press release, Oncocyte, DEC 15, 2020, View Source [SID1234572942]). Burning Rock is one of the fastest growing and largest companies in China’s next-generation sequencing (NGS) based cancer therapy selection market.

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Under the agreement, Oncocyte will receive upfront cash payments after transferring and installing DetermaRx technologies, and for a fixed number of tests performed when DetermaRx achieves inclusion in the United States National Comprehensive Cancer Network (NCCN) Guidelines. Oncocyte will also receive ongoing royalties per patient tested with DetermaRx. The transfer of the testing technology is scheduled to occur in the first quarter of 2021, and the technology installation is expected to be completed by the third quarter of 2021.

China represents the largest patient population in the world for DetermaRx. This agreement marks Oncocyte’s fifth global licensing agreement and completes the Company’s stated goal of reaching all the major world markets within the first year of launch.

DetermaRx is a treatment stratification test that identifies stage I-IIA non-small cell lung cancer (NSCLC) patients at high-risk of recurrence despite ostensibly curative surgery, who may benefit from the addition of chemotherapy. The test is reimbursed by Medicare. In a 250-patient prospective cohort, test-identified, low-risk patients had a five year freedom from recurrence (FFR) rate of 94.6%; test-identified high-risk or intermediate-risk patients who were treated with adjuvant platinum chemotherapy had 96.7% five year FFR compared to 71.7% five-year disease-free survival (DFS) for high-risk patients who did not receive chemotherapy. Recurrence rate in molecular high-risk stage IA patients was 25%, compared to only 3% in molecular low-risk stage IA patients.1

"This agreement with Burning Rock accelerates the ongoing expansion of our DetermaRx test to patients and physicians outside the U.S., and exemplifies our global growth strategy," said Ron Andrews, Chief Executive Officer and President of Oncocyte. "We believe aligning with one of the largest and fastest growing companies in China’s NGS-based cancer therapy selection market speaks to the strength of DetermaRx as a valuable treatment stratification tool to help clarify this critical treatment decision point in early stage tumors. We continue to see strong growth in all of our commercial metrics thus far in the fourth quarter, and this agreement helps us achieve our goal of completing distribution agreements for DetermaRx in all major rest-of-world markets within one year of the U.S. product launch. We are honored to partner with Burning Rock whose comprehensive portfolio of molecular tests for the oncology market allows us access to the largest eligible patient population in the world as well as China’s major cancer centers. In addition to expanding our available market, this important milestone also provides us with non-dilutive capital and an ongoing revenue stream to strengthen our growth trajectory as well as help reduce our operational cash burn."

Yusheng Han, Founder and Chief Executive Officer of Burning Rock added, "We are excited to be entering into this agreement with Oncocyte. As the leader of NGS application in oncology in China, we are committed to providing the best diagnostic solutions to Chinese patients and oncologists. China’s stage I-IIA non-squamous NSCLC incidence is estimated at over 100,000 per annum2. We believe Oncocyte’s risk stratification test fills a clear unmet need in identifying those patients who are at high risk and may benefit from adjuvant chemotherapy, versus low risk patients who do not have to undergo unnecessary chemo treatments, in a convenient and affordable manner. Combining DetermaRx with our products for genetic testing and MRD detection (currently under R&D), we can provide a comprehensive testing strategy for oncologists to ultimately benefit Chinese early-stage NSCLC patients by improving their survival and quality of life. We look forward to expanding this much-needed and promising test to the Chinese market and continuing to collaborate with Oncocyte in the future."

For a more complete description of the terms of the agreement, please read the Exclusive Sublicense Agreement that will be filed as an exhibit to Oncocyte’s Form 8-K on or about December 14, 2020.

IMMUTEP OPERATIONAL UPDATE

On December 15, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, reported that it provides an update on efti clinical programs (Press release, Immutep, DEC 15, 2020, View Source [SID1234572933]).

Eftilagimod alpha ("efti") Update

AIPAC – Phase IIb clinical trial

The Company presented in a spotlight presentation at the San Antonio Breast Cancer Symposium 2020, first Overall Survival (OS) data and is on track to report final overall survival data and overall response rate by mid calendar year 2021. Currently there are more than 66% of events compared to approx. 60% which were the basis of the OS data presented at the San Antonio Breast Cancer Conference.

TACTI-002 – Phase II clinical trial

The 3rd stage of 1st line NSCLC with an additional 74 patients in the US, Australia and Europe is now open for recruitment. The TACTI-002 Phase II study, which is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada), has been expanded by 74 additional patients, following the results presented at SITC (Free SITC Whitepaper) in November 2020.

Recruitment is ongoing for stage 2 of Part C (second line head and neck squamous cell carcinoma) and it is expected to open recruitment of stage 2 of Part B (second line non-small cell lung cancer) in the next year.

Phase II Clinical Trial in Head and Neck Cancer

Immutep continues to prepare for a new randomised, controlled Phase II clinical study in approximately 160 1st line HNSCC patients. Patients will be 1:1 randomised to receive efti in combination with an anti-PD-1 treatment, or anti-PD-1 monotherapy. The trial is intended to take place across clinical trial sites in the United States, Australia and Europe.

TACTI-mel – Phase I clinical trial

The results of Immutep’s Phase I TACTI-mel trial were recently published in the Journal for ImmunoTherapy of Cancer. The trial was conducted in Australia and evaluated efti in combination with pembrolizumab in metastatic melanoma.

INSIGHT-004 – Phase I clinical trial

INSIGHT-004, the fourth arm of the INSIGHT trial (INSIGHT-004 is also known as Stratum D of INSIGHT) which is being conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. is expected to deliver final data in 2021. First data from the study were presented at ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) 2020.

EOC Pharma – Phase II clinical trial

Preparations are ongoing for a new Phase II clinical study in China (152 patients) evaluating efti in combination with chemotherapy for the treatment of metastatic breast cancer.

Financial Update

In the current quarter, Immutep completed an equity financing and raised approximately A$29.6 million in a placement supported by high quality institutional investors from Australia and offshore.

In addition, given the recent exercise of warrants over American Depository Shares, which generated proceeds of approximately US$7.7 million (approx. AU$10.1 million), the Company is in an excellent financial position with a cash runway beyond end of calendar year 2022.

Peptomyc announces new equity financing round led by Aurora Science

On December 15, 2020 Peptomyc S.L., a biotech company specialized in the development of protein and peptide therapeutics for cancer treatment, reported the completion of an equity financing round of EUR 11.4 million (Press release, Peptomyc, DEC 15, 2020, View Source [SID1234572929]). The company is focused on the development of a new generation of cell penetrating peptides (CPPs) targeting the Myc oncoprotein for cancer treatment.

Peptomyc is relying on a strong syndicate of life sciences investors. This investment was led by AurorA Science and substantially supported by existing investors including Alta Life Sciences, HealthEquity, Business Angels and the CDTI. Also, Peptomyc’s employees had the opportunity to invest in the company.

This financing will enable Peptomyc to advance OMO103 until preliminary results of phase I clinical trial. OMO103 has already demonstrated its safety and anti-tumor activity in multiple types of experimental models of cancer and it is now ready to be tested in clinical studies. The treatment of the first patient with the lead candidate, OMO103, is expected to start in Q1, 2021.

"We are delighted to have attracted such high-profile investors to our company," said Laura Soucek, CEO of Peptomyc. "I am confident that their industrial background and extensive experience in bio-pharma and translational medicine will significantly contribute to the success of our product."

"We were excited to have the opportunity to participate in this financing" said Guido Guidi, chairman of AurorA Science. "Peptomyc is a promising company matching our industrial criteria, following a rigorous selection process managed by AurorA Science’s three partners, AurorA-TT, Rottapharm Biotech and Italfarmaco. We are glad to support a company with front edge science and outstanding potential to bring benefits to patients."

Of note: Peptomyc is already preparing for a new financing round for 2021 to ensure the swift execution of its ongoing and planned clinical development programs until completion of successful clinical Phase II studies.

Glycostem announces treatment of first patient in pivotal phase I/IIa trial of oNKord® in patients with Acute Myeloid Leukemia

On December 15, 2020 Glycostem Therapeutics B.V., a leading clinical-stage company focused on the development of therapeutic off-the-shelf Natural Killer (NK) cells, reported that the first patient has been dosed in its pivotal phase I/IIa trial of oNKord for the treatment of Acute Myeloid Leukemia (AML) (Press release, Glycostem Therapeutics, DEC 15, 2020, View Source [SID1234572900]). The WiNK trial will enroll 33 AML patients at eight clinical sites based in five European countries. oNKord is the company’s first-generation off-the-shelf allogeneic NK cellular immunotherapy product. Glycostem is furthermore developing a range of second (CAR-NK) and third generation (TCR-NK) NK products in-house.

"We are thrilled about the first patient being dosed in this pivotal trial. This important milestone potentially paves the way for a positive impact on the lives of patients with AML who are at high risk of relapse. The preliminary efficacy data obtained with oNKord is very promising and we are looking forward to the data from this study, which will allow us to draw conclusions regarding oNKord safety and tolerability and most importantly its efficacy for treatment of AML patients," tells Troels Jordansen, CEO at Glycostem.

"We are very excited about being involved in the WiNK trial and to learn what the efficacy of oNKord will be on eradicating measurable residual disease (MRD) in AML patients," tells Professor Heuser, Investigator and Head of the central laboratory for MRD assessment at the Hannover Medical School in Germany. "Currently, two thirds of MRD-positive AML patients who are in complete morphologic remission will relapse, and unfortunately, there is no cure for this group of patients if allogeneic stem cell transplantation is not an option. Therefore, the outcome of this trial is literally of vital importance and positive results could have a very significant impact on the prospects of current and future patients we are treating."

Evaluating safety, tolerability and efficacy

WiNK (ClinicalTrials.gov identifier: NCT04632316) is a prospective two-stage, open-label, single arm, multicenter phase I/IIa trial to evaluate the safety and efficacy of oNKord, an off-the-shelf, ex vivo-cultured allogeneic NK cell preparation, in 33 adults with AML who are in complete morphologic remission with residual measurable disease and with no strong indication for hematopoietic stem cell transplantation.

Stage A of the trial is designed to assess the safety and tolerability of escalating doses of oNKord in three cohorts of three subjects each. An Independent Data Monitoring Committee (IDMC) will review safety data of all treated subjects in each cohort and make recommendations before moving to the next dose. Stage B of the trial will enroll an additional 24 subjects to evaluate the safety, tolerability and efficacy of oNKord at the recommended phase II dose, as identified from stage A.

PreludeDx™ Presents New Data at SABCS Spotlight Session Re-Classifying Patients Meeting RTOG 9804 Low Risk Criteria as Elevated Risk Using DCISionRT®

On December 15, 2020 Prelude Corporation (PreludeDxä), a leader in molecular diagnostics and precision medicine for early stage breast cancer, presented clinical outcomes data last week at the San Antonio Breast Cancer Symposium (SABCS) that further validates the DCISionRT test results of an independent study by Kaiser Permanente Northwest published earlier this year in Clinical Cancer Research (Press release, Prelude Therapeutics, DEC 15, 2020, View Source [SID1234572899]). DCISionRT is a biologic risk signature that assess the 10-yr risk of a subsequent breast cancer recurrence. A Spotlight Poster presented at SABCS, showed that the DCISionRT test reclassified 45% of patients meeting RTOG 9804 low risk or ‘good risk’ criteria for Ductal Carcinoma In Situ (DCIS) as Decision Score (DS) Elevated Risk. These patients who were reclassified by the DCISionRT test to DS Elevated Risk had clinically elevated 10-year breast cancer rates when treated without radiation therapy (RT) and demonstrated an 84% relative benefit with RT.

The company’s Spotlight Poster, entitled DCIS biosignature reclassified patients, who met RTOG 9804 or ECOG-ACRIN E5194 low-risk clinicopathologic criteria into an elevated invasive risk group who benefited significantly from radiation therapy, was presented on Thursday, December 10 by Dr. Chirag Shah, Director of Breast Radiation Oncology and Director of Clinical Research – Radiation Oncology at Cleveland Clinic.

RTOG 9804 criteria is based on traditional clinical and pathological features and is used to identify low risk or ‘good risk’ DCIS patients. In this study, complete biomarker data was available for 535 women meeting ‘good risk’ clinicopathologic RTOG 9804-like criteria. In the DCISionRT DS Low Risk group there was no significant reduction from RT. However, in the DCISionRT DS Elevated Risk group, RT significantly reduced invasive breast cancer risk by 84%.

"In this study we examined the utility of the DCISionRT test to identify patients who otherwise met traditional ‘good-risk’ criteria but remained at an elevated invasive risk after lumpectomy," said
Dr. Shah. "The study supports the use of DCISionRT, which provides a ten-year breast event risk with and without radiation therapy after lumpectomy, as compared to traditional clinical and pathological features when making radiation therapy decisions following breast conserving surgery in patients with DCIS."

Similar results were previously reported by an independent validation of DCISionRT conducted by Kaiser Permanente Northwest (KPNW), which included a 455 patient cohort. DCISionRT reclassified approximately 50% of patients meeting ‘good risk’ criteria like RTOG 9804 as DS Elevated Risk. Women in the DS Elevated Risk category in the KPNW cohort had a 21% 10-yr invasive recurrence rate when treated with lumpectomy and without RT, and a 6% rate when receiving radiation therapy.

"We appreciate the opportunity to have worked alongside such esteemed physicians and organizations and are thrilled to announce another strong data set supporting the integration of DCISionRT into clinical practice management for DCIS," said Daniel Forche, President and CEO of PreludeDx. "Women and their physicians contemplating the next treatment steps now can make a personalized decision for radiation therapy that includes their individual tumor biology to add or omit radiation therapy after breast conserving surgery."

About DCISionRT for Breast DCIS

DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. DCISionRT combines the latest innovations in molecular biology with artificial intelligence and machine learning to assess a woman’s individual tumor biology along with other risk factors and provide a personalized recurrence risk. The test provides a Decision ScoreTM that identifies a woman’s risk as low or elevated. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.