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BriaCell Presents Clinical Data at 2021 Keystone Symposium

On January 26, 2021 BriaCell Therapeutics Corp. ("BriaCell" or the "Company") (TSX-V:BCT) (OTCQB:BCTXF), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, reported the presentation of results from clinical studies with its lead product candidate, Bria-IMT, summarized in a poster session held January 25-27 during the 2021 Keystone Symposium, "Emerging Cell Therapies: Realizing the Vision of NextGen Cell Therapeutics," a virtual scientific conference (Press release, BriaCell Therapeutics, JAN 26, 2021, View Source [SID1234574784]).

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Overall, the data suggests a potentially significant survival benefit for the patients treated with the Bria-IMT regimen alone or in combination with checkpoint inhibitors, especially in those with moderately or well differentiated tumors or those who match Bria-IMT at 2 HLA alleles. We hypothesize that Bria-IMT, with a molecular signature most closely related to moderately or well differentiated tumors, may result in disease control especially in patients with moderately-well differentiated tumors. The patient data summarized and discussed belong to previously-disclosed patients (i.e., no incremental numbers enrolled).

Dr. Bill Williams, BriaCell’s President & CEO, presented the clinical and pathological data of Bria-IMT monotherapy (i.e., the Bria-IMT regimen alone) and Bria-IMT in combination with immune checkpoint inhibitors including pembrolizumab (KEYTRUDA; manufactured by Merck & Co., Inc.), and more recently, Incyte’s INCMGA00012 (under a corporate collaboration with Incyte Corporation), in advanced breast cancer.

Details and results on the poster presentation are summarized below:

Poster Title: Personalized off-the-shelf whole cell immunotherapy for cancer

Monotherapy Study – 27 patients: The patients were heavily pre-treated (median of 5 prior therapy regimens). Disease control including stable disease (SD), partial responses (PR) or complete responses (CR) was seen in 8 patients (30%) suggesting clinical benefit. Importantly, disease control was more frequent in patients who had 2 or more HLA matches with Bria-IMT (67%) or had moderately or well differentiated tumors (63%) suggesting the potential importance of these factors in designing the next generation of personalized immunotherapies.

Combination Study – 12 patients (Bria-IMT regimen with checkpoint inhibitors): The patients were heavily pre-treated (median of 6 prior therapy regimens). Disease control was seen in 4 patients (33%). Importantly, patients with moderately or well differentiated tumors were more likely to achieve disease control (3/4, 75%) suggesting clinical benefit in this subset of patients. Furthermore, the data suggests the potential additive or synergistic effects of check point inhibitors when combined with the Bria-IMT regimen.

Patients with moderately or well differentiated tumors: The patients with moderately or well differentiated tumors (monotherapy and combination therapy studies combined) were heavily pre-treated (median of 8 prior therapy regimens). Disease control was seen in 7 of 11 patients (64%) suggesting clinical benefit in this subset of patients. This included 2 of 5 patients with objective responses, both of whom had 2 or more HLA matches with Bria-IMT. Overall survival (OS), collected in 6 patients, was 12.5 months suggesting clinical benefit. In comparison, an OS of 7.2-9.8 months was reported in similar patients in the third line setting (Kazmi S, et al., Breast Cancer Res Treat. 2020).

Capitalizing on these findings, BriaCell has engineered cell lines to express specific HLA alleles allowing a single HLA match with ~99% and a double HLA match with ~90% of the population. These cell lines will provide a personalized approach to cancer immunotherapy that is pre-manufactured rather than prepared individually per patient, eliminating the time and complex manufacturing logistics of other personalized immunotherapies.

A copy of the poster will be posted at the following: View Source

TGEN-LED STUDY RESULTS SUGGEST A MORE ACCURATE DIAGNOSTIC FOR BREAST CANCER

On January 26, 2021 Translational Genomics Research Institute (TGen), an affiliate of City of Hope reported that Breast cancer, even at its initial stages, could be detected earlier and more accurately than current techniques using blood samples and a unique proteomics-based technology (Press release, TGen, JAN 26, 2021, View Source [SID1234574442])

Patrick Pirrotte, Ph.D., an Assistant Professor and Director of TGen’s Collaborative Center for Translational Mass Spectrometry, and an international team of researchers developed a test that can detect infinitesimally small breast cancer biomarkers that are shed into the bloodstream from cells surrounding cancer known as extracellular matrix (ECM), according to the findings of their study recently published in the scientific journal Breast Cancer Research.

For decades, physicians have relied on mammography breast imaging to look for cancer in a quest to provide prevention, early detection and reduce deaths. But the unintended consequences of both false positives and false negatives have off-set the hoped-for gains of this inexact type of screening, including complications from surgery and cardiovascular disease, and unnecessary biopsies of what turn out to be benign lesions.

ECM is the network of molecules — including collagen, enzymes and glycoproteins — that provide structural and biochemical support to surrounding cells, including cancer cells. During the early stages of cancer, these proteins and protein fragments — which form the tumor microenvironment — leak into circulating blood.

"Our data reinforces the idea that this release of ECM components into circulation, even at the earliest stages of malignancy, can be used to design a specific and sensitive biomarker panel to improve detection of breast cancer," said Dr. Pirrotte, the study’s senior author. "Using a highly specific and sensitive protein signature, we devised and verified a panel of blood-based biomarkers that could identify the earliest stages of breast cancer, and with no false positives."

To establish this protein signature, researchers employed blood samples from 20 patients with IDC breast cancer, and from 20 women without cancer who nonetheless had positive mammograms but benign pathology at biopsy. These results were compared to five groups of individuals diagnosed with other cancers: ovarian, lung, prostate, colon and melanoma.

Because the number of ECM molecules in blood is relatively low, researchers relied on proteomics and new sample preparation enrichment techniques, including the use of hydrogel nanoparticles, to accurately detect cancer-associated biomarkers. This technique binds proteins from ECM associated with cancer proliferation, migration, adhesion and metastasis, or the spread of cancer from one part of the body to another. Many of these proteins had never before been observed in blood samples.

"Our study results show a high degree of specificity of those markers as circulating proteins in breast cancer patients," said Khyatiben Pathak, Ph.D., a staff scientist in TGen’s Collaborative Center for Translational Mass Spectrometry and a study author. "Our results justify further studies with larger groups to evaluate whether this biomarker panel improves the positive predictive value of mammography for breast cancer detection."

Contributing to this research were George Mason University, Centro di Riferimento Oncologico di Aviano, Istituto Superiore di Sanità, Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario, University San Raffaele, and Istituto di Ricovero e Cura a Carattere Scientifico.

Funding for this study was provided by TGen and George Mason University. Additional support was provided by: National Cancer Institute, U.S. Department of Health and Human Services, Italian Istituto Superiore di Sanità, and Italian Ministry of Public Health.

The study — Shotgun proteomics coupled to nanoparticle-based biomarker enrichment reveals a novel panel of extracellular matrix proteins as candidate serum protein biomarkers for early-stage breast cancer detection — was published Dec. 2 in the journal Breast Cancer Research.

CELSION CORPORATION ANNOUNCES CLOSING OF $35 MILLION REGISTERED DIRECT OFFERING OF COMMON STOCK PRICED AT-THE-MARKET UNDER NASDAQ RULES

On January 26, 2021 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported the closing of its previously announced registered direct offering of 25,925,925 shares of common stock at a purchase price of $1.35 per share, priced at-the-market under Nasdaq rules, resulting in net proceeds of $32.6 million, after deducting placement agents’ fees but before expenses payable by the Company (Press release, Celsion, JAN 26, 2021, View Source [SID1234574346]).

A.G.P./Alliance Global Partners acted as the lead placement agent for the offering.

Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as co-placement agent for the offering.

Celsion intends to use the net proceeds for general corporate purposes, including research and development activities, capital expenditures and working capital.

This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-227236), previously filed with the Securities and Exchange Commission (the "SEC") on September 7, 2018 and declared effective on October 12, 2018, and an additional registration statement pursuant to Rule 462(b) (File No. 333-252320) under the Securities Act of 1933, as amended. The offering of the shares of common stock were made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering are filed with the SEC and are available on the SEC’s website at View Source or by contacting 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].

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

Epigenomics AG successfully places mandatory convertible bond in the full amount of EUR 5.5 million

On January 26, 2021 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company")reported that successfully completed the placement of the subordinated mandatory convertible notes, which the Company’s Executive Board resolved to issue with the approval of the Supervisory Board on January 7, 2021 (Press release, Epigenomics, JAN 26, 2021, View Source [SID1234574338]). In total, the mandatory convertible bond in the nominal amount of EUR 5,500,000.00 was fully placed. The offering was significantly oversubscribed. The mandatory convertible bond consists of 500,000 bonds, which are convertible into 5,000,000 registered shares of the Company. The gross proceeds from the issuance of the mandatory convertible bond amount to EUR 5.5 million.

Bristol Myers Squibb Donates JPY 5.5 Billion to Kyoto University to Support Its Cancer Research

On January 26, 2021 Bristol Myers Squibb (NYSE:BMY) reported a charitable donation totaling JPY 5.5 billion, or approximately USD 53 million, to Kyoto University, a leading state-run research university in Japan (Press release, Bristol-Myers Squibb, JAN 26, 2021, View Source;to-Support-Its-Cancer-Research/default.aspx [SID1234574337]). The donation, to be paid by Bristol-Myers Squibb K.K., will support immuno-oncology research being led by Tasuku Honjo, a Nobel laureate and Distinguished Professor of the university.

The funds will be used to finance the construction of the main building of the Center for Cancer Immunotherapy and Immunobiology, a newly established immuno-oncology research institute headed by Professor Honjo. Construction of the building, which will be named the Bristol Myers Squibb Building at the Center for Cancer Immunotherapy and Immunobiology, is scheduled to begin in 2021.

The Center for Cancer Immunotherapy and Immunobiology was established in April 2020 as a research institute within Kyoto University’s Graduate School of Medicine, and is the first ever Japanese academic institute dedicated solely to immuno-oncology research. The center serves as a hub for scholars from Japan and overseas pursuing scientific advancement of immuno-oncology in search of next-generation cancer treatments.

Professor Honjo, the founding director of the center, is a Distinguished Professor of the Kyoto University Institute for Advanced Study. In 2018 he won the Nobel Prize in Physiology or Medicine for his discovery in 1992 of the immune cell protein PD-1, which led to new therapies that have proven effective in the fight against cancer.

The Bristol Myers Squibb Building at the Center for Cancer Immunotherapy and Immunobiology will be located inside the university’s downtown Kyoto campus. Based on a design by Tadao Ando Architect & Associates, it will be a five-story complex with one underground floor with a total floor area of approximately 9,500 square meters, functioning as the main facility for the center in allowing researchers, faculty members and corporations to support early-career principal investigators and enhanced industry-academia collaboration.

Professor Tasuku Honjo said, "I have been working with researchers at BMS for a very long time on the development of Opdivo and other medicines. The donation we are receiving from BMS will help us build the Bristol Myers Squibb Building at the Center for Cancer Immunotherapy and Immunobiology in the Kyoto University Graduate School of Medicine. It is a major milestone in industry-academia collaboration that is based on mutual trust. The collaboration between academia and industry in drug development is more important than ever and it is a great pleasure to see the decades-long friendship between BMS and Kyoto University come to fruition in this way, lighting a beacon of hope for future cancer researchers."

Jean-Christophe Barland, President and CEO of Bristol-Myers Squibb K.K., said, "I am excited about the opportunity to support the world’s leading immuno-oncology research being undertaken at Kyoto University under Professor Honjo’s leadership. BMS is dedicated to the fight against cancer in Japan and around the world. For BMS who has been a pioneer in immuno-oncology, this financial contribution is a testament to our focus on, and commitment to, the discovery, development and delivery of innovative cancer treatments."