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BostonGene and Weill Cornell Medicine Announce Publication in Cancer Discovery Revealing the Role of the Tumor Microenvironment in the Clinical Outcomes of Patients with DLBCL

On February 9, 2021 BostonGene Corporation, a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, and Weill Cornell Medicine, reported a publication in Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, BostonGene, FEB 9, 2021, View Source [SID1234574810]). The manuscript "Clinical and biological subtypes of B-cell lymphoma revealed by microenvironmental signatures" highlights the tumor microenvironment as a critical component of B-cell lymphoma biology and the effects of different microenvironments on diffuse large B-cell lymphoma (DLBCL) clinical behavior, establishing a significant opportunity for the development of novel and personalized therapeutic strategies for this disease.

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In this research study, the microenvironment subtypes of over 4,600 DLBCL patients were classified using curated and refined transcriptional signatures encompassing key microenvironment and cancer cells activities and processes. This analysis revealed four distinct DLBCL microenvironments (LMEs), each with its own set of unique biological and clinical properties. The LMEs were also found to correlate with different clinical outcomes and prognoses, and downstream preclinical mechanistic studies demonstrated that the LMEs could be applied in clinical decision-making for DLBCL patients.

"This study was designed to evaluate the role of the tumor microenvironment in DLBCL biology," said Leandro Cerchietti, M.D., Associate Professor of Medicine and a member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine. "The results revealed distinct DLBCL microenvironments with unique therapeutic vulnerabilities that can be utilized for optimization of DLBCL treatment strategies."

"The data demonstrate that this novel classification platform provides a roadmap for the therapeutic exploitation of the tumor microenvironment in DLBCL patients," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Together with Weill Cornell Medicine, we look forward to identifying new treatment strategies to ultimately improve the clinical outcomes of these patients."

Brooklyn ImmunoTherapeutics Announces Initiation of Phase 2 Trial of IRX-2 in Combination with Pembrolizumab and Chemotherapy in Triple Negative Breast Cancer

On February 9, 2021 Brooklyn ImmunoTherapeutics LLC ("Brooklyn"), a biopharmaceutical company focused on exploring the role that cytokine-based therapy can have in treating patients with cancer, reported the initiation of an open-label Phase 2 clinical trial of IRX-2 in combination with pembrolizumab (Keytruda) and chemotherapy in triple negative breast cancer (TNBC) (Press release, Brooklyn ImmunoTherapeutics, FEB 9, 2021, View Source [SID1234574809]). The trial will be conducted at the Providence Cancer Institute in Portland, Oregon.

IRX-2 is an allogeneic, cell-derived biologic with multiple active cytokine components, including IL-2, that act on various parts of the immune system associated with activation of the entire tumor microenvironment.

"In a Phase 1b clinical trial in early stage breast cancer, IRX-2 was well-tolerated as a single agent with no Grade 3 or 4 toxicities in patients and encouraging signs of activity including upregulation of PD-L1," said principal investigator David Page, M.D., medical oncologist and assistant member, Earle A. Chiles Research Institute, a division of Providence Cancer Institute. "These results provide a strong rationale for studying IRX-2 in combination with pembrolizumab, an immunotherapy that targets PD-1, and standard of care chemotherapy in triple negative breast cancer, a disease for which there is an urgent need for new treatment options."

"IRX-2 is currently being studied in a range of cancer indications, both as a single agent and in combination with other anti-cancer therapies, including checkpoint inhibitors," said Lynn Sadowski Mason, Executive Vice President, Clinical Operations of Brooklyn ImmunoTherapeutics. "We believe that the unique combination of cytokines in IRX-2 can improve outcomes for patients with solid tumor cancers based on its ability to activate the immune system in the tumor microenvironment. We look forward to the results of this clinical trial and to exploring potential new indications in the future."

About the Phase 2 Trial

The Phase 2 randomized, open-label trial is designed to assess the efficacy and safety of IRX-2 in patients with TNBC. Approximately 30 patients in total are expected to be enrolled. Patients with locally confirmed TNBC who have previously untreated locally advanced non-metastatic TNBC are eligible. Patients will receive alternating regimens of Pembrolizumab plus chemotherapy and subcutaneous IRX-2 injections twice a day for 10 days as neoadjuvant therapy prior to surgery. The primary efficacy endpoint is pathological Complete Response (pCR), and patients will be evaluated following definitive surgery. Please refer to www.clinicaltrials.gov (NCT04373031) for additional clinical trial details.

This study is being supported in part by a research grant from the Investigator-Initiated Studies Program of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Genprex, Inc. Announces $25 Million Registered Direct Offering Priced At-The-Market Under NASDAQ Rules, Without Warrants

On February 9, 2021 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported it has entered into securities purchase agreements with two healthcare-dedicated institutional investors for the purchase and sale of 4,000,000 shares of its common stock at a purchase price of $6.25 per share in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Genprex, FEB 9, 2021, View Source [SID1234574808]). No warrants will be issued in connection with the transaction. The closing of the offering is expected to occur on or about February 11, 2021, subject to the satisfaction of customary closing conditions.

A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-239134) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Tmunity Therapeutics Announces Expansion of T Cell Engineered Therapy Collaboration

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]).

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.

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Apalutamide▼ and Abiraterone Acetate Combination

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).

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