On February 9, 2021 Tmunity Therapeutics, Inc., a clinical-stage biotherapeutics company specifically designed to deliver on the bold promise to ‘uncancer the world’ by creating the best T cell medicines for solid tumor patients, reported the expansion of its T cell engineered therapy collaboration with the Center for Cellular Immunotherapies (CCI) at the Perelman School of Medicine at the University of Pennsylvania (Penn) (Press release, Tmunity Therapeutics, FEB 9, 2021, View Source [SID1234574807]).

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Under the terms of the expanded collaboration, Tmunity receives further access and rights to certain platform and manufacturing technologies, as well as the exclusive licensing of a Penn-developed clinical stage asset, a Mesothelin CAR T-cell therapy product. Tmunity has also committed to further funding of T cell engineering research programs at Penn and will receive exclusive rights, subject to certain limitations, to products and technologies resulting from those programs. Tmunity will continue to have certain rights to intellectual property originating from the laboratories of its scientific founders at Penn including: Carl June, MD, Bruce Levine, PhD, and James Riley, PhD.

"We are delighted to see the further expansion of our existing scientific and clinical partnership with Penn to bring leading edge T cell engineered medicines to patients with solid tumors. This partnership with Dr. June and the Penn CCI team further expands our access and certain rights to discoveries, clinical programs, cell engineering, and manufacturing at the cutting edge of T cell engineering, including platform technologies in the field, such as safety switches, signaling domains, payload delivery, and novel approaches for cell persistence and durability, " said Usman ‘Oz’ Azam, President and Chief Executive Officer of Tmunity Therapeutics.

"We formed Tmunity to deliver the promise of T cell medicine to patients, bringing together all the essential expertise, technology, and scientific insight to make the next great leap," said Carl H. June, M.D., Director of the Center for Cellular Immunotherapies at Penn’s Perelman School of Medicine, and Director of the Parker Institute for Cancer Immunotherapy at the University of Pennsylvania. "I am tremendously proud of the progress we have accomplished to date and look forward to building on this success in the future."

Tmunity has licensed 4 clinical stage solid tumor CAR-T programs created at Penn and is supporting the further development of several more pipeline candidates through sponsored research agreements with Penn. Drs. June, Levine, Riley, and Chew are all individual equity holders in Tmunity. Penn receives sponsored research funding from Tmunity, and as inventors of some of the licensed technology, Drs. June, Levine, Riley, and Chew, along with Penn, may receive additional financial benefits under the license in the future. Penn is also an investor in the company and holds equity interests.

On February 9, 2021 Janssen Pharmaceutica NV (Janssen) reported results from the randomised, placebo-controlled double-blind Phase 3 ACIS study, which met the primary endpoint of radiographic progression-free survival (rPFS) with a 31 percent reduction in the risk of radiographic progression or death in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) receiving androgen deprivation therapy (ADT) (Press release, Johnson & Johnson, FEB 9, 2021, View Source [SID1234574806]). Patients in the trial received either a combination of apalutamide and abiraterone acetate plus prednisone (combination arm) or placebo and abiraterone acetate plus prednisone (control arm).1 Results will be featured in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Genitourinary (ASCO GU) Cancers Symposium, taking place virtually February 11-13, 2021 (Abstract #9; Rapid Abstract Session: Prostate Cancer, February 11 06:45 AM-8:00 PM CET).

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The primary efficacy analysis showed median rPFS was extended by six months in patients treated in the combination arm compared with patients in the control arm (22.6 vs. 16.6 months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; p<0.0001). The HR for radiographic progression or death as assessed by blinded independent central review (BICR) was 0.864 [95% CI, 0.718–1.040]. According to an updated analysis performed at a median follow-up of 54.8 months, a 30 percent reduction in the risk of radiographic progression or death was shown in the combination arm compared with the control arm (median time to rPFS 24 vs 16.6 months: HR 0.70 [95% CI, 0.60-0.83]). No statistically significant difference was demonstrated for secondary endpoints including overall survival (OS), time to initiation of cytotoxic chemotherapy, chronic opioid use, and pain progression between treatment arms.

The safety profile was consistent with prior studies of apalutamide, with no new safety signals observed. Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 63.3 percent in the combination arm versus 56.2 percent in the control arm.1 Grade 3/4 TEAEs that occurred more frequently in the combination versus control arm included fatigue (4.7 percent vs. 3.9 percent), hypertension (20.6 percent vs. 12.5 percent), fall (3.3 percent vs. 0.6 percent), skin rash (4.5 percent vs. 0.4 percent), cardiac disorders (9 percent vs. 5.7 percent), fractures and osteoporosis (4.1 percent vs. 1.4 percent), and seizures (0.2 percent vs. 0).1 Quality-of-life was comparable between treatment arms per Functional Assessment of Cancer Therapy–Prostate – (FACT-P Total).

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About the ACIS Study1

ACIS is a Phase 3 randomised, double-blind, placebo-controlled, multicentre clinical study evaluating the efficacy and safety of apalutamide and abiraterone acetate plus prednisone compared to placebo and abiraterone acetate plus prednisone in 982 patients with chemotherapy-naïve mCRPC disease who received ADT.1 Patients were randomised to receive either apalutamide and abiraterone acetate plus prednisone, or placebo and abiraterone acetate plus prednisone. The primary endpoint of the study was rPFS. Secondary endpoints of the study included OS, time to chronic opioid use, time to initiation of cytotoxic chemotherapy, and time to pain progression.1

About Metastatic Castration-Resistant Prostate Cancer

Metastatic castration-resistant prostate cancer (mCRPC) characterises cancer that no longer responds to ADT and has spread to other parts of the body. The most common metastatic sites are bones, followed by lymph nodes, lungs, and liver.2 Prostate cancer is the most common cancer in men in Europe, representing 25 percent of all male new cancer cases diagnosed.3 More than one million men around the world are diagnosed with prostate cancer each year.4

About apalutamide

Apalutamide is an orally administered, selective androgen receptor (AR) inhibitor approved in Europe and is indicated

in adult men for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease and
in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), also known as metastatic castration-sensitive prostate cancer (mCSPC), in combination with androgen deprivation therapy (ADT).5
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

About abiraterone acetate

Abiraterone acetate, an orally administered androgen biosynthesis inhibitor, in combination with prednisone or prednisolone is approved in Europe for

the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT);
the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of ADT in whom chemotherapy is not yet clinically indicated, and
the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.6
Additionally, abiraterone acetate was approved for the treatment of high-risk metastatic hormone-sensitive prostate cancer (mHSPC) by the U.S. Food and Drug Administration (FDA) on February 8, 2018.7,8 Since its first approval in Europe in 2011, abiraterone acetate has been approved in combination with prednisone or prednisolone, in more than 105 countries and has been prescribed to more than 700,000 patients worldwide.9

On February 9, 2021 Lassen Therapeutics, a biotechnology company developing antibodies as potential treatments for fibrosis and oncology, reported a collaboration with the Olivia Newton-John Cancer Research Institute (ONJCRI) in Melbourne, Australia (Press release, Lassen Therapeutics, FEB 9, 2021, View Source [SID1234574805]). The collaboration will study the role of IL-11 signaling and assess the potential of monoclonal antibodies that block IL-11 signaling in preclinical models of triple negative breast cancer.

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Combating tumor progression through inhibition of cytokines that play a key role in the tumor microenvironment, such as IL-11, is emerging as an important therapeutic approach.

"IL-11 is overexpressed in many types of cancer as well as in nearby cancer associated fibroblasts, which constitute an essential component of the tumor microenvironment," said Mark Barrett, Chief Executive Officer of Lassen. "Data suggest that IL-11 signaling between the tumor and the surrounding tumor microenvironment affects tumor proliferation, progression, and metastasis, and may also contribute to the development of resistance to chemotherapy and immunotherapy. Targeting the IL-11 axis in cancer therefore offers a therapeutic opportunity either as a single agent, or for patients with resistant disease, in combination with chemotherapy or immunotherapies. We believe our collaboration with the exceptional team at the ONJCRI will further elucidate the importance of IL-11 signaling in cancer."

The ONJCRI team is led by Matthias Ernst, Ph.D., director of the Institute and head of the Cancer and Inflammation Program, along with Ashwini Chand, Ph.D., head of the Cancer Therapeutics Development Group. Prof. Ernst is a member of Lassen’s scientific advisory board.

"Our collaboration with Lassen will explore IL-11 in different contexts, including combination with chemotherapy and immune checkpoint inhibitors," said Prof. Ernst. "We anticipate that the outcome of these preclinical studies will serve as a proof of principle of the efficacy of antibodies targeting the IL-11 receptor as a complement to existing treatment of primary tumors and metastatic lesions."

On February 9, 2021 Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported participation in a series of 1×1 meetings with institutional investors at the 10th Annual SV Leerink Global Healthcare Conference, occurring February 24 – 26, 2021 (Press release, Exicure, FEB 9, 2021, View Source [SID1234574804]).

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On February 9, 2021 Foundation Medicine, Inc. and its collaborators reported results from a prostate cancer study evaluating the landscape of genomic alterations identified by liquid biopsy in over 3,000 patients, as well as assessing concordance of liquid and tissue biopsy in over 800 patients (Press release, Foundation Medicine, FEB 9, 2021, View Source [SID1234574803]). The study demonstrated high concordance between targetable alterations identified using circulating tumor DNA (ctDNA) and tissue-based comprehensive genomic profiling (CGP) in patients with metastatic castration-resistant prostate cancer (mCRPC). It also found that, in many patients, liquid biopsy detects more acquired resistance mechanisms than tissue biopsy. The study, "Genomic analysis of circulating tumor DNA (ctDNA) in 3,334 patients with advanced prostate cancer identifies targetable BRCA alterations and AR resistance mechanisms," was published online in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). These data will also be presented as a poster highlight on Feb. 11 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU).

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Prostate cancer is the second most common cancer in men; 1 in 9 will be diagnosed during their lifetime.1 mCRPC occurs when prostate cancer grows and spreads to other parts of the body despite the use of androgen-deprivation therapy to block the action of male sex hormones.2 Because there have previously been limited treatment options for this specific disease area, there is generally a high mortality rate. In this study, genomic analysis of plasma collected from 3,334 patients with advanced prostate cancer (including 1,674 samples collected from Clovis Oncology’s TRITON2 and TRITON3 trials in which Foundation Medicine’s liquid biopsy test was utilized to screen patients for enrollment) demonstrated that nearly all (94%) of patients had detectable ctDNA.

"One of the most important findings in this study is that the majority of patients with advanced prostate cancer have abundant circulating tumor DNA that can be tested using comprehensive genomic profiling to support doctors as they consider targeted therapies for their patients," said Geoff Oxnard, M.D., VP, Global Medical Lead, Liquid Franchise at Foundation Medicine. "When tumor tissue is difficult to obtain, as is often the case in patients in mCRPC, liquid biopsy is a proven, minimally-invasive method to secure genomic insights, with the option to reflex to a tissue biopsy if ctDNA turns out to be insufficient to analyze."

Using the collected samples, researchers profiled the landscape of genomic alterations detected in ctDNA and assessed concordance with tissue-based CGP. Using Foundation Medicine’s liquid biopsy test, study investigators detected 93% of the BRCA1/2 mutations that had also been detected using tissue CGP. Additionally, they found that ctDNA harbored some BRCA1/2 alterations not identified by tissue testing. They concluded that the large percentage of mCRPC patients in the study with rich genomic signal from ctDNA, and the sensitive, specific detection of BRCA1/2 alterations, positions liquid biopsy as a compelling clinical complement to tissue CGP for these patients.

Further, a diverse variety of potential androgen receptor resistance alterations were detected in 42% of patients, which is higher than the percentage detected in the same patients’ tissue biopsies. This points to ctDNA’s capacity to provide a more comprehensive picture of the development of acquired resistance anywhere in the body than the testing of one lesion.

The poster highlight presentation will be available to ASCO (Free ASCO Whitepaper) GU registrants on Feb. 11 at 8 a.m.:

Abstract 25 – Genomic analysis of circulating tumor DNA in 3,334 patients with advanced prostate cancer to identify targetable BRCA alterations and AR resistance mechanisms.