BriaCell Therapeutics Corp.

(TSXV:BCT) (OTCQB:BCTXF)

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Personalized Immunotherapy Could Be the Future for Advanced Breast Cancer Treatment

NetworkNewsWire Editorial Coverage

 

New York, NY – October 2, 2018 –  Personalized treatment for advanced breast cancer is a massive global medical need. According to latest figures from the Centers for Disease Control, in the United States alone more than 41,000 women die from breast cancer each year. Hope is on the horizon, however, as innovative biomedical companies apply their research and technologies to bring personalized immunotherapies to market for this unmet medical need. Among these companies is BriaCell Therapeutics Corp. (OTC:BCTXF) (TSX-V:BCT), an immune-oncology-focused biotech company developing the first off-the-shelf personalized immunotherapy for advanced breast cancer. The company’s technology is based on a targeted immunotherapy regime that has seen encouraging results in clinical trials. Other biotechs in the personalized cancer immunotherapy space include Gilead Sciences, Inc. (NASDAQ:GILD), the parent company of Kite Pharma; Cellectis S.A. (NASDAQ:CLLS); Neon Therapeutics, Inc. (NASDAQ:NTGN); and Loxo Oncology, Inc. (NASDAQ:LOXO).

 

Personalized Immunotherapy for Advanced Breast Cancer: Rationale

 

The global market for breast cancer treatment reached an estimated $12 billion in 2017 and is on pace to reach approximately $19 billion by 2025. Within this market, precision medicine shows considerable promise. Personalized immunotherapy, an example of precision medicine in which a treatment is tailored to the individual patient, broadly aims to stimulate a patient’s own immune system to combat cancer. This personalized approach allows a physician to tailor the treatment to each individual patient, thereby potentially achieving higher effectiveness and fewer side effects.

 

Focused on revolutionizing advanced breast cancer treatment aligned with this approach, BriaCell’s (OTCQB:BCTXF) (TSX.V:BCT) off-the-shelf personalized immunotherapy treatment can be quickly prepared for each individual patient and is designed to safely kill the tumor cells while saving time, high cost and manufacturing complexities associated with making personalized immunotherapies.

 

The need for this caliber of technology is significant in the field of oncology, considering that one in eight women will develop invasive breast cancer over the course of their lifetime. Aside from skin cancer, breast cancer is the most commonly diagnosed cancer among women in the United States, and breast cancer death rates are higher than those for any other cancer except lung cancer. Advanced breast cancer, also called metastatic or stage IV breast cancer, is the most advanced and deadly form of the disease, causing the majority of breast cancer-related deaths.

 

Predictable Anti-Tumor Response in Phase IIa Clinical Studies in Advanced Breast Cancer

 

BriaCell’s novel technology is being developed based on the recent positive proof-of-concept clinical findings of phase IIa studies of the company’s lead product candidate, Bria-IMT™, in heavily pretreated advanced breast cancer patients.

 

Bria-IMT is derived from a specific breast cancer cell line and is genetically engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system. BriaCell believes that Bria-IMT helps the body to recognize and kill tumor cells by activating both T cells that directly attack tumor cells, and B cells that produce anti-tumor antibodies.

 

The phase IIa study (listed in ClinicalTrials.gov as NCT03066947) showed potent anti-tumor activity of Bria-IMT in certain patients who shared certain HLA types with Bria-IMT. (HLA = Human Leukocyte Antigen typing is used to match patients and donors in transplants.) HLA biomarkers, found on most cells, are recognized by the immune system to determine self versus foreign cells. Importantly, preliminary phase IIa efficacy data in these patients, with the same HLA type as those on Bria-IMT, were similar or superior to those of other approved breast cancer drugs when at a similar clinical-stage of development.

 

Click here to view a slide presentation of the results.

 

Leading the advancement of Bria-IMT and BriaCell’s pipeline is the company’s president and CEO, Dr. Bill Williams, who has been personally involved in the development of 10 drugs in the market.

 

Based on the recent findings related to the mechanism of action of Bria-IMT and the potential to produce intensified anti-tumor activity when used in combination with certain drugs, BriaCell is now focusing on the combination study of Bria-IMT with pembrolizumab (Keytruda®, manufactured by Merck & Co., Inc.) or ipilimumab (Yervoy®, manufactured by Bristol-Myers Squibb Company). The combination study is listed in ClinicalTrials.gov as NCT03328026.

 

It is important to note that immune checkpoint inhibitors such as pembrolizumab (anti-PD-1) and ipilimumab (anti-CTLA-4) have come to the forefront in the fight against cancer with substantial benefits for some patients. The significance of immune checkpoints has been recognized by the Nobel committee by awarding Drs. Honjo (PD-1) and Allison (CTLA-4) with the 2018 Nobel Prize in Physiology or Medicine. This is highly encouraging for BriaCell because the company is using these check point inhibitors in combination with Bria-IMT in its ongoing Phase IIa studies in advanced breast cancer patients.

 

“We believe that combination studies with immune checkpoint inhibitors should create even more potent anti-cancer immune responses, leading to our strategy of combination studies of Bria-IMT with Keytruda or Yervoy,” Williams stated in the press release announcing the results. “In our view, the combination of Bria-IMT with Keytruda or Yervoy has the potential to provide a new therapeutic option and substantial clinical benefit in heavily pre-treated advanced breast cancer patients where there remains a significant unmet need.”

 

Preliminary Proof-of-Concept Clinical Trials

 

The first clinical trial used the original unmodified breast cancer cell line, with GM-CSF and low dose cyclophosphamide to boost the immune response.  In the trial, 14 patients were treated. Among positive results, no severe drug-related side effects were reported, and the treatment produced a post-treatment median survival rate about twice what was expected.

 

The second clinical trial used Bria-IMT (i.e., the original cell line modified to produce GMCSF) with cyclophosphamide and interferon-alpha in four advanced-stage cancer patients. The treatment was tolerated well with few side effects. The median overall survival was much longer than expected. The study also had one patient who responded extremely well to the treatment with an approximately 90 percent tumor reduction in the breast cancer.

 

After the treatment stopped (as required by the study), the patient’s breast cancer returned and had spread to the patient’s brain, lungs and other sites. Importantly, the patient was treated again with Bria-IMT, and the tumors were reduced at multiple sites, even in the brain.  This patient matched Bria-IMT for certain genes called HLA genes, which are used to match patients to tissues in tissue transplantation, such as for kidney transplants.

 

Recent Clinical Findings (Phase I/IIa Study: 2017-2018) 

 

As earlier noted, BriaCell achieved proof-of-concept in its phase IIa study of Bria-IMT with positive safety and excellent, predictable efficacy in patients with HLA matches with Bria-IMT. Importantly, initial safety data appeared superior to that of the other advanced or approved drugs for breast cancer when they were at a similar clinical stage of development. Most importantly, initial efficacy data was similar or superior to those of other advanced or approved drugs for breast cancer when they were at a similar clinical stage of development.

 

BriaCell Pipeline

 

BriaCell has developed a companion diagnostic test, BriaDX™, that would allow a physician to prepare a personalized premade treatment for each patient based on the presence of certain biomarkers (HLA type).  Testing is simple and performed on the patient’s saliva. This diagnostic test will be used in future clinical trials to accelerate the clinical development success for Bria-IMT and Bria-OTS™.

 

Based on BriaCell’s observation of superior tumor shrinking responses in the patients who shared certain biomarkers (i.e., HLA types) with Bria-IMT, BriaCell is developing Bria-OTS for advanced breast cancer. Bria-OTS includes a set of cell lines, each being similar to Bria-IMT, which are being engineered to express various premanufactured HLA types. With only 15 different HLA types, Bria-OTS cell line combinations are expected to cover more than 90 percent of the United States’ population. Bria-OTS is expected to enter the clinics in 2019.

 

As noted above, BriaDX is used to determine the HLA types of patients. Based on the results, one or two Bria-OTS premade cell lines will be selected to be administered to the patient. Thus, Bria-OTS is expected to provide the patient with fast, inexpensive, safe and effective personalized cancer immunotherapy treatment that can be readily ordered because it is premade.

 

This appears to be great news for patients and therapists who previously had few or no treatment options. The technology may be applicable to other cancers as well.

 

Other Biotechs on the Move

 

Gilead Sciences (NASDAQ:GILD) is the parent company of Kite Pharma, Inc., which develops immunotherapies. Kite Pharma’s therapies involve collecting and using the patient’s own immune cells to treat the cancer. The company’s focus is on developing engineered cell therapies that express either a chimeric antigen receptor (CAR) or a T cell receptor (TCR), depending on the type of cancer. With its dual platform approach, Kite Pharma’s technology is designed to address both hematological and solid tumor cancers. However, with this approach, each dose must be manufactured for each patient, which can be time consuming and costly, and may include a complex manufacturing system.

 

Cellectis S.A. (NASDAQ:CLLS) develops off-the-shelf immunotherapies using next-generation CAR T cells. Lead technology, TALEN®, is being developed to enable gene editing to precisely edit or change the genetic code within a person’s DNA. As with Kite Pharma’s approach, Cellectis’ manufacturing of treatment based on the patient’s own T cells could also be a costly and time consuming approach.

 

Neon Therapeutics’ (NASDAQ:NTGN) work on personalized immuno-oncology therapies lead the company to develop treatments across both T cell therapies and vaccines using neoantigen biology. Neon Therapeutics is developing multiple clinical strategies to target neoantigens, which are foreign substances encoded by tumor-specific mutated genes. This technology requires extensive genetic analysis of the patient’s tumor, another often time-consuming method saddled with potentially high cost.

 

Loxo Oncology (NASDAQ:LOXO) is focused on developing treatments for cancers caused by a single inappropriate DNA change, or an “oncogenic driver.” These drivers are responsible for both the initiation and the maintenance of a cancer. Loxo Oncology designs highly selective medicines that target these drivers as the underlying cause of a cancer. These therapies are targeted to the cancer of an individual patient, but do not work through the immune system and may be unlikely to eliminate all cancer cells from the body.

 

Personalized Cancer Immunotherapy: The Future of Treatment for Advanced Breast Cancer

 

Personalized, off-the-shelf treatments have the potential to revolutionize the way advanced breast cancer is treated. In a recent interview, Williams voiced the company’s commitment to bringing its personalized immunotherapy treatments to the patients with the disease.

 

“We remain confident in our technology’s potential to deliver clinical benefit to patients with advanced breast cancer, and are working hard to make Bria-OTS, BriaCell’s novel off-the-shelf personalized immunotherapy, available to advanced breast cancer patients as soon as possible,” he stated.

 

For more information about BriaCell Therapeutics, please visit BriaCell Therapeutics Corp. (OTCQB:BCTXF) (TSX.V:BCT).

 

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BriaCell Announces Positive Phase IIa Proof of Concept Data in Advanced Breast Cancer; Initiates Combination Study
  • BriaCell has achieved positive proof of concept in the Phase IIa study of Bria-IMT™ in advanced breast cancer patients
  • Data shows promising anti-tumor activity of Bria-IMT™ in heavily pre-treated advanced breast cancer patients
  • Impressive Phase IIa efficacy data is similar or superior to those of other approved breast cancer drugs of similar clinical-stage of development
  • Outstanding safety and tolerability profile for Bria-IMT™
  • Data confirms “HLA Matching Hypothesis” and supports BriaCell’s strategy for the development of Bria-OTS™
  • BriaCell has initiated a combination study of Bria-IMT™ with Keytruda (by Merck & Co., Inc.) or Yervoy (by Bristol-Myers Squibb Company)

 

BERKELEY, Calif. and VANCOUVER, British Columbia, Sept. 26, 2018 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (“BriaCell”, the “Company”) (TSX-V: BCT) (OTCQB:BCTXF), an immuno-oncology focused biotechnology company with a proprietary targeted immunotherapy technology, is pleased to announce that it has achieved proof of concept in the Phase IIa study of its lead clinical candidate, Bria-IMT™, in advanced breast cancer. The Company will host a webcast at 4:15 p.m. ET today to discuss these results.

 

To further enhance the anti-tumor activity of Bria-IMT™, the Company will focus on the combination study of the candidate with pembrolizumab [Keytruda®; manufactured by Merck & Co., Inc.] or ipilimumab [Yervoy®; manufactured by Bristol-Myers Squibb Company]. The combination study is listed in ClinicalTrials.gov as NCT03328026.

 

To date, 31 advanced stage breast cancer patients have been enrolled in the Phase IIa Bria-IMT™ monotherapy study. The Phase IIa confirmatory mechanism of action and proof of concept work is based on the first 20 patients, with assessment of the remaining 11 patients in progress.  Given the conclusive findings on the first 20 patients, enrollment for this monotherapy study is now closed, while enrollment for the combination study is open.

 

“Bria-IMT™ appears to be most effective in patients who match with Bria-IMT™ at 2 HLA loci (types) further supporting BriaCell’s HLA Matching Hypothesis, and the development of Bria-OTS™ to cover 90% of the patient population. We are delighted with these positive clinical findings that confirm our HLA Matching Hypothesis in the Phase I/IIa trial in advanced breast cancer showing significant tumor shrinkage without serious side effects,” stated BriaCell’s President and CEO Dr. Bill Williams. “We believe that combination studies with immune checkpoint inhibitors should create even more potent anti-cancer immune responses, leading to our strategy of combination studies of Bria-IMT™ with Keytruda® or Yervoy®.”

 

“This top-line data compares very well with data from existing breast cancer therapies which have a sizable market share when they were at a similar stage of clinical development, as well as with other promising breast cancer treatments currently under study.  In our view, the combination of Bria-IMT™ with Keytruda® or Yervoy® has the potential to provide a new therapeutic option and substantial clinical benefit in heavily pre-treated advanced breast cancer patients where there remains a significant unmet need,” Dr. Williams added.

 

Clinical Data Webcast

Dr. Williams will present Bria-IMT™’s proof of concept clinical data today, September 26, 2018, at 4:15 p.m. ET.

 

We welcome all our shareholders and prospective investors, partners and patients to attend the Company’s data announcement.

 

Webcast title:   BriaCell Therapeutics Corp. Conference Call
Start time:        Wed, Sep 26, 2018 4:15 p.m. ET
Conference ID: 10005555

Participant link (to view the slide presentation):http://public.viavid.com/index.php?id=131478

Participant Dial-In Numbers:

Toll-Free (North America) 1-855-327-6837
Toronto 1-416-915-3239
Montreal 1-514-375-0364
Vancouver 1-778-327-3988

Replay Dial-In Numbers:

Toll-Free (North America) 1-844-512-2921

From:  09/26/18 at 7:15 p.m. ET
To:       10/10/18 at 11:59 p.m. ET
Replay Pin Number:  10005555

The presentation will be available for download at: http://briacell.com/investor-relations/presentations/

 

About Bria-IMT™

Bria-IMT™ (SV-BR-1-GM), the Company’s lead product candidate, is derived from a specific breast cancer cell line. It is genetically engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system. BriaCell believes that Bria-IMT™ helps the body to recognize and kill tumor cells by activating both T cells that directly attack tumor cells and B cells that produce anti-tumor antibodies.

 

About BriaCell

BriaCell is an immuno-oncology focused biotechnology company developing targeted and safe approaches for the management of cancer.

 

BriaCell is currently conducting a Phase I/IIa clinical trial of Bria-IMT™, its lead candidate, in a combination study with pembrolizumab [Keytruda®; manufactured by Merck & Co., Inc.] or ipilimumab [Yervoy®; manufactured by Bristol-Myers Squibb Company]. The combination study is listed in ClinicalTrials.gov as NCT03328026.

 

BriaCell is developing Bria-OTS™, an off-the-shelf personalized immunotherapy, for advanced breast cancer. Bria-OTS™ immunotherapy treatments are personalized to match the patient without the need for personalized manufacturing. Bria-OTS™, which is expected to cover over 90% of the patient population, is designed to produce a potent and selective immune response against the cancer of each patient while eliminating the time, expense, and complex manufacturing logistics associated with other personalized immunotherapies.

 

For additional information on BriaCell, please visit website: http://www.BriaCell.com

 

Cautionary Note Regarding Forward-Looking Information

Except for the statements of historical fact, this news release contains “forward-looking information” within the meaning of the applicable Canadian securities legislation which involves known and unknown risks relevant to the Company in particular and to the biotechnology and pharmaceutical industries in general, uncertainties and other factors that may cause actual events to differ materially from current expectation. These risks are more fully described in the Company’s public filings available at www.sedar.com.

 

Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

 

Contact Information

For further information, please contact:
BriaCell Therapeutics Corp.:
Farrah Dean
Manager, Corporate Development
Email: farrah@BriaCell.com
Phone: 1-888-485-6340

 

Source: BriaCell Therapeutics Corp

BriaCell Therapeutics Corp. Discusses its Plan to Revolutionize Cancer Immunotherapy in Exclusive NetworkNewsWire Audio Interview

NEW YORK, Sept. 25, 2018 (GLOBE NEWSWIRE) — via NetworkWire – NetworkNewsAudio (NNA), a NetworkNewsWire (NNW) Solution that delivers clients unparalleled visibility, recognition and brand awareness in the investment community, today announces the online availability of its interview with BriaCell Therapeutics Corp. (OTC: BCTXF) (TSX.V: BCT) (“BriaCell” or “the Company”), focused on developing a targeted and safe approach to the management of cancer.

 

The interview can be heard at: http://nnw.fm/2EM9p

 

Please also visit BriaCell’s Recent News & Events Page: http://briacell.com/category/recent-events

 

NNW’s Stuart Smith introduces BriaCell’s CEO, Dr. Bill Williams in an interview that highlights the Company’s innovative business model, milestones and unique immunotherapeutic approach to cancer treatment.

 

BriaCell is an immune-oncology company developing the first off-the-shelf personalized immunotherapy for the treatment of advanced breast cancer. Dr. Williams notes that since the Company’s inception in 2014, it has made excellent progress through successfully conducting clinical trials for its lead immunotherapy candidate, Bria-IMT(Trademarked). BriaCell recently added new clinical sites for conducting its Phase IIa studies, which Dr. Williams says will be beneficial to the recruitment of eligible patients, as well as validation of the Company’s technology by leading academic experts.

 

Dr. Williams next highlights the strength of BriaCell’s management team, including his own expertise in moving therapies through clinical testing, bench-to-bedside research and drug development. The team also boasts R&D technical and scientific experience, with varied expertise in moving programs forward for developing therapeutics that will fulfill the FDA’s stringent marketing requirements, and become available to the patients who need them the most.

 

BriaCell has accomplished several milestones in 2018, including obtaining topline safety and efficacy clinical data in its clinical study and advancing BriaCell’s clinical programs. The Company published a comprehensive research paper for Frontiers in Immunology providing details on the mechanism by which its targeted immunotherapy is unique in harnessing the patient’s immune system to specifically attack cancer cells.

 

Moving forward, BriaCell is focused on several initiatives, including the start of a combination therapy study to further boost the efficacy of its lead candidate, as well as generating its personalized off-the-shelf immunotherapy treatments to cover 90% of patient population, a major focus of the Company, and one Dr. Williams believes is “going to revolutionize cancer immunotherapy.”

 

The discussion concludes with Dr. Williams attributing BriaCell’s focus on making a positive impact in patient’s lives, some entering the Company’s studies after exhausting all other options, as both rewarding and a key factor of success.

 

With a strategic path in place, Dr. Williams says, “We’re still, I believe, tremendously undervalued compared to our competitors… So we think that this is a great opportunity for investors to come in to get as excited about our story as we are and to follow us along as we start to change the face of the immuno-oncology space.”

 

About BriaCell

BriaCell is an immuno-oncology-focused biotechnology company developing targeted and safe approaches for the management of cancer.

 

BriaCell is currently conducting a Phase I/IIa clinical trial of Bria-IMT(Trademarked), its lead candidate, in patients with advanced breast cancer. This trial is listed in ClinicalTrials.gov as NCT03066947. Additionally, the FDA recently approved a combination study of Bria-IMT with pembrolizumab [Keytruda; manufactured by Merck & Co., Inc.] or ipilimumab [Yervoy; manufactured by Bristol-Myers Squibb Company]. The combination study is listed in ClinicalTrials.gov as NCT03328026.

 

BriaCell is developing Bria-OTS(Trademarked), an off-the-shelf personalized immunotherapy, for advanced breast cancer. Bria-OTS immunotherapy treatments are personalized to match the patient without the need for personalized manufacturing. Bria-OTS, which is expected to cover over 90% of the patient population, is designed to produce a potent and selective immune response against the cancer of each patient while eliminating the time, expense, and complex manufacturing logistics associated with other personalized immunotherapies.

 

For additional information on BriaCell, please visit website: http://www.BriaCell.com

 

Cautionary Note Regarding Forward-Looking Information

Except for the statements of historical fact, this news release contains “forward-looking information” within the meaning of the applicable Canadian securities legislation which involves known and unknown risks relevant to the Company in particular and to the biotechnology and pharmaceutical industries in general, uncertainties and other factors that may cause actual events to differ materially from current expectation. These risks are more fully described in the Company’s public filings available at www.sedar.com.

 

Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

Contact Information

For further information, please contact:
BriaCell Therapeutics Corp.:
Farrah Dean
Manager, Corporate Development
Email: Farrah@BriaCell.com
Phone: 1-888-485-6340

 

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BriaCell Adds New Clinical Site To Phase IIa Study in Advanced Breast Cancer and Expands R&D Team
  • The addition of the Cancer Center of Kansas (CCK) as a new clinical trial site is expected to accelerate patient enrollment in both clinical trials.
  • The hiring of Dr. Sunkari, an experienced Scientist, is intended to speed up the development of Bria-OTS™, BriaCell’s novel off-the-shelf personalized immunotherapy.

 

BERKELEY, Calif. and VANCOUVER, British Columbia, Aug. 08, 2018 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (“BriaCell”) (TSX-V:BCT) (OTCQB:BCTXF), an immuno-oncology focused biotechnology company with a proprietary targeted immunotherapy technology, is pleased to announce that the Cancer Center of Kansas (CCK) has been added as a new clinical trial site. BriaCell is currently conducting  an ongoing, multicenter, Phase IIa study of Bria-IMT™ (listed in ClinicalTrials.gov as NCT03066947) in advanced breast cancer, as well as the rollover combination study of Bria-IMT™ with pembrolizumab or ipilimumab (listed in ClinicalTrials.gov as NCT03328026). Dr. Shaker R. Dakhil, Board certified in Medical Oncology and Internal Medicine, will act as the clinical site’s principal investigator (PI). Under the direction of Dr. Dakhil, the Cancer Center of Kansas lists 16 offices, and 13 Sub Investigators. Dr. Dakhil will work closely with Cancer Insight, LLC., BriaCell’s contract research organization, to manage the clinical and regulatory aspects of the Phase IIa clinical trial in advanced breast cancer on behalf of BriaCell.

 

With its wide network of facilities and leading oncologists, CCK has been providing the patients in the State of Kansas with leading cancer-related research, diagnosis, and treatment since 1975. The Cancer Center of Kansas team, and its physicians, have received numerous awards for excellent patient care and expertise. The clinical site currently lists 16 offices in the State of Kansas, including their main location in Wichita, and 15 additional participating locations at McPherson, Junction City, Marysville, and Neodesha.

 

“We are thrilled to be working with a leading oncology team at a well-respected center such as CCK, as we continue the clinical development of Bria-IMT™ in advanced breast cancer,” stated Bill Williams, BriaCell’s President and CEO. “We anticipate that  multiple trial locations will provide treatment access to qualified patients in the US Midwest.  This new relationship should speed up the pace of recruiting for our Phase II clinical trial of Bria-IMT™ and the rollover study.  Our top priority is to obtain data from these studies which will enable us to make Bria-IMT™ immunotherapy available to patients as soon as possible. We believe Bria-IMT™ is a safe and effective treatment.  If data from the trial supports its effectiveness, Bria-IMT™ will fill a void in the treatment of advanced breast cancer, currently a huge unmet medical need.”

 

Dr. Shaker R. Dakhil will serve as the lead Principal Investigator (PI) for Bria-IMT™ and rollover studies. Board certified in Medical Oncology and Internal Medicine since 1981, Dr. Dakhil has served as President of CCK since 2000. He is a clinical Professor of Medicine at the University of Kansas School of Medicine – Wichita, and has served as PI for numerous cancer clinical trials.

 

Dr. Dakhil has lead several earlier cancer research projects, and was part of a three-physician team which developed the first implantable central venous catheter (known as port-a-cath), used in cancer care. Dr. Dakhil is a Fellow of the American College of Physicians, and holds membership in a number of professional societies in oncology. He has served as President of the Medical Society of Sedgwick County (1997) and is Past President of staff at Via Christi Hospital. Dr. Dakhil founded Wichita Cancer Foundation, a non-profit organization which provides financial assistance for cancer patients. He has been honored with numerous awards including the Healthcare Heroes Lifetime Achievement Award by the Wichita Business Journal in 2014, and has been named each year, from 2005 to 2011, in the Top 1% of Physicians in the Nation by Castle Connolly Medical Ltd. as nationally published by Newsweek, US News and World Report.

 

“We are grateful to have a top oncology expert such as Dr. Dakhil as the lead PI at CCK in our Phase I/IIa clinical trials of Bria-IMT™,”  Dr. Williams said.

 

“Bria-IMT™ may represent a significant advance in the safe and effective treatment of advanced breast cancer patients,” commented Dr. Dakhil. “Early data from the preliminary trials and ongoing trials have been encouraging, and it is our hope they will be substantiated by these clinical studies at our site. We are excited to be working with the  BriaCell team to make these treatments available to advanced breast cancer patients with poor survival prospects”.

 

The Phase IIa clinical trial of Bria-IMT™ and the Phase I/IIa rollover combination study with Keytruda® and Yervoy® in advanced breast cancer are currently being conducted at five top cancer centers: 1) St. Joseph Health-Sonoma County, Santa Rosa, CA, 2) Everett Clinic and Providence Regional Medical Center, Everett, WA, 3) Jefferson Breast Care Center, Philadelphia, PA, 4) Sylvester Comprehensive Cancer Center, University of Miami in Miami, FL, and 5) Cancer Center of Kansas, Wichita, KS. An earlier site at Florida Cancer Care in Plantation, FL was recently closed.

 

BriaCell is currently enrolling advanced breast cancer patients in a Phase IIa trial (NCT03066947) with Bria-IMT™ and a rollover trial (NCT03328026) with Bria-IMT™ in combination with other immunotherapies. For further information on the Phase IIa trials, please visit https://clinicaltrials.gov/ct2/show/NCT03066947?term=BriaCell&rank=2.

 

About The Cancer Center of Kansas

Founded by Dr. Harry Hynes in Wichita, KS, in 1975, Cancer Center of Kansas, provides personalized, quality and innovative cancer care to patients in the mid-west. The center’s mission has been to provide the latest and highest quality diagnostic and therapeutic care to cancer patients through their commitment to excellence in medical oncology and hematology. Since 1987, CCK began extending its coverage throughout the state to serve patients in rural areas such as McPherson, Junction City, Marysville, and Neodesha. Cancer Center of Kansas currently lists 16 participating offices and 14 physicians in the State of Kansas.

 

With its widespread network of facilities throughout the state of Kansas, top oncologists, and excellent patient care team, CCK is aiming to provide world class cancer care to patients. Their services are focused on multiple aspects of cancer treatment including– diagnosis and treatment, blood and marrow transplants, research and clinical trials, diagnostic imaging, advanced laboratory work, and an oral medications center to better serve their patients.

 

Throughout the years, the CCK team has received numerous distinctions, awards and recognitions at community, national, and international levels for the the center’s excellence in patient care, and the expertise of its physicians. For the full list of awards, please see: https://cancercenterofkansas.com/awards-recognition/.

 

For more information on the Cancer Center of Kansas, please visit https://cancercenterofkansas.com/.

 

BriaCell Expands R&D team: Hires Vivek Sunkari, Ph.D. as Senior  Scientist

BriaCell announces the expansion of its R&D team with the addition of Vivek Sunkari, Ph.D. as Senior  Scientist. Dr. Sunkari earned his Ph.D. in Molecular Medicine from Karolinska Institute, Sweden in 2013, where he identified several new pathogenic mechanisms involved in chronic tissue repair and regeneration processes. Dr. Sunkari, completed his translational immunology postdoctoral work at Stanford University focusing on the role of extracellular matrix molecules and their influence on immune and endocrine disorders. Prior to joining BriaCell, Dr. Sunkari was an immunology scientist, at Lake Pharma Inc., where he was involved in discovering antibodies for the treatment of immune disorders including immuno-oncology, and autoimmune diseases. Dr. Sunkari has authored numerous peer-reviewed publications, reviewed multiple articles for biomedical journals, and has been a member at a number of international scientific organizations. Additionally, Dr. Sunkari is a co-founder of LymeTek Inc., a start up company that focuses on Lyme Disease treatment and prevention.

 

About BriaCell

BriaCell is an immuno-oncology focused biotechnology company developing targeted and safe approaches for the management of cancer. Immunotherapy has come to the forefront in the fight against cancer because it uses the body’s own immune system in recognizing and selectively destroying cancer cells while leaving normal cells intact. In addition, immunotherapy is also considered to be a more potent approach than chemotherapy, and has the potential to prevent cancer recurrence.

 

Bria-IMT™ (SV-BR-1-GM), the Company’s lead product candidate, is derived from a specific breast cancer cell line. It is genetically engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system. BriaCell believes that Bria-IMT™ helps the body to recognize and kill tumor cells by activating both T cells that directly attack tumor cells, and B cells that produce anti-tumor antibodies.

 

The results of two previous proof-of-concept clinical trials (one with the precursor cell line not genetically engineered to produce GM-CSF and one with Bria-IMT™) produced encouraging results in patients with advanced breast cancer. Most notably, one patient with breast cancer that had spread to other sites (metastatic cancer) responded to Bria-IMT™ with a substantial reduction in tumor size and volume in these sites, including sites in the breast, the lung, soft tissues, and even the brain. BriaCell is currently conducting a Phase I/IIa clinical trial of Bria-IMT™ in patients with advanced breast cancer.  In this trial, to date, Bria-IMT™ treatment has been safe with instances of tumor reduction observed. This trial is listed in ClinicalTrials.gov as NCT03066947. The trial is being conducted along with the co-development of BriaDX™, the Company’s companion diagnostic test, to be able to predict the patients who will likely benefit the most from Bria-IMT™ treatments. Additionally, the FDA recently approved a rollover combination study of Bria-IMT™ with pembrolizumab [Keytruda®; manufactured by Merck & Co., Inc.] or ipilimumab [Yervoy®; manufactured by Bristol-Myers Squibb Company]. This study permits continuation of the Bria-IMT™ treatment for patients in the ongoing Phase I/IIa trials who stop responding to the treatment. The rollover trial is listed in ClinicalTrials.gov as NCT03328026.

 

Based on our observation of superior tumor shrinking responses in the patients who shared certain HLA types with Bria-IMT™, BriaCell is developing Bria-OTS™, an off-the-shelf personalized Immunotherapy, for advanced breast cancer.  Bria-OTS™ includes a set of cell lines, each being similar to Bria-IMT™, which are being engineered to express various pre-manufactured HLA types. With only 15 different HLA types, Bria-OTS™ cell line combinations are expected to cover over 90% of the United States’ population. BriaCell expects to use BriaDX™ to determine the HLA types of patients, and subsequently select one or two Bria-OTS™ cell lines with matching alleles to be administered to the patient. This should produce a potent and selective immune response against the cancer of each patient while eliminating the time, expense, and complex manufacturing logistics currently used for other personalized immunotherapies. In essence, Bria-OTS™ should provide a personalized treatment without the need for personalized manufacturing.

 

BriaCell’s small molecule program includes the development of novel, selective protein kinase C delta (PKCδ) inhibitors which have shown potent activity in a number of pre-clinical models of several different cancer indications as well as fibrotic diseases.

 

For additional information on BriaCell, please visit our website: http://briacell.com.

 

Cautionary Note Regarding Forward-Looking Information

Except for the statements of historical fact, this news release contains “forward-looking information” within the meaning of the applicable Canadian securities legislation which involves known and unknown risks relevant to the Company in particular and to the biotechnology and pharmaceutical industries in general, uncertainties and other factors that may cause actual events to differ materially from current expectation. These risks are more fully described in the Company’s public filings available at www.sedar.com.

 

Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

Contact Information

For further information, please contact:
BriaCell Therapeutics Corp.:
Farrah Dean
Manager, Corporate Development
Email: farrah@BriaCell.com
Phone: 1-888-485-6340

 

Source: BriaCell Therapeutics Corp

About BriaCell Therapeutics

Dedicated to enhance the lives of cancer patients who are facing limited therapeutic options, BriaCell Therapeutics Corp. (OTCQB: BCTXF; TSX: BCT.V)’s mission has been to develop novel immunotherapies, as the most cutting edge technology to fight cancer. Immunotherapies have become the forefront of the cancer treatments because they use the body’s immune system to destroy the cancer cells, offering higher levels of safety and efficacy than chemotherapy, with less likeliness of recurrence.

 

Designed by our team of scientists and clinicians, BriaCell’s proprietary whole-cell based technology platform continues to show its impressive potential to establish a new model for treating cancer patients. Our lead product candidate, Bria-IMT™ (SV-BR-1-GM), is a genetically engineered whole-cell based product candidate derived from a human breast cancer cell line. Bria-IMT™ is used in combination with multiple immune-modulators to powerfully trigger the immune system to recognize and eliminate cancerous cells.

 

In a preliminary Phase I clinical study in metastatic (i.e., Stage IV) breast cancer patients who had failed multiple treatments, Bria-IMT™ treatment significantly reduced the tumor size, without serious side effects. Importantly, the tumor regression was observed in other sites including the lung and even the brain -a difficult site. Impressively, the median lifespan of the patients was substantially longer than that of the comparable trials.

 

At our laboratory facility in Berkeley, CA, we are planning to expand our pipeline of oncology immunotherapy candidates using our proprietary technology platform.

 

Using the clinical data from the patients from the clinical studies, we are working to identify the molecular fingerprint of the patients for which Bria-IMT™ would be highly effective, and are planning to develop diagnostic testing products to identify this group. By directing the drug to the top-responders, we expect this approach to increase the likelihood of clinical trial success of Bria-IMT™ -to bring hope to thousands of cancer patients with few-to-no treatment options.

 

The company is currently recruiting its Phase I/IIa trial to further test Bria-IMT™ safety and activity in metastatic breast cancer patients. BriaCell maintains global rights for Bria-IMT™.

 

II. Breast Cancer: Facts & Statistics

 

  • According to the report published by the American Cancer Society in 2018, approximately 609,640 Americans are expected to die of cancer in 2018 (approximately 1,670 deaths per day), making cancer the second leading cause of death in the US, exceeded only by heart disease.
  • As of January 2018, the number of women with the history of invasive breast cancer is estimated at 3.1 million (excluding the estimated 268,670 new cases in 2018). The number is expected to increase by 12% to 4 mil in 2024. Approximately 20% of breast cancers occur in women younger than 50 and 43% occur in women older than 65.
  • According to the facts and figures released by the American Cancer Society in 2018, 266,120 of women, and 2,550 of men are expected to be diagnosed with invasive breast cancer in 2018 in the US alone. Excluding skin cancer, breast cancer is the most frequently diagnosed cancer in women in the US.
  • Breast cancer deaths in 2018 are estimated at 41,400 (40,920 women, 480 men), making breast cancer the 2nd leading cause of cancer death in women (after lung cancer).
  • As reported by the American Cancer Society in 2018, approximately 62% of breast cancer is detected in early stages (i.e., the cancer is found in the breast tissue, and has not spread to lymph nodes or other regions of the body), for which the 5-year survival rate is estimated at 99%. As soon as the cancer spreads to lymph nodes under the arm or nearby tissues (regional stage), the 5-year survival rate drops to 83%. However, once the cancer spreads to other lymph nodes or body parts {distant stage or metastatic (met-uh-STAT-ic) cancer}, the five year survival rate falls to as low as 27% (i.e. 73% of the patients die within 5 years). This shows the grave need for effective treatments for this deadly cancer.

 

PATENTS

 

Bria-IMT™
Filed with the United States Patent and Trademark Office (USPTO), the U.S. patent application number US 7,674,456 B2, Priority Date: June 14, 2004, includes the following:

 

  • Compositions and cell lines
  • Therapeutic methods of using compositions of SV-BR Cells
  • BriaCell has obtained the exclusive license to its patent application from St. Vincent’s Medical Center, and the resulting patent will have a term extending to 2024. Hatch-Waxman extension potentially applies (additional five years).

 

On March 7, 2017, BriaCell filed an international patent application under the Patent Cooperation Treaty (PCT) to further expand its intellectual property portfolio underlying the Company’s current and anticipated pipeline of whole-cell cancer vaccines, including Bria-IMT™, and related companion diagnostic tests. The PCT application is designed to complement and extend on two patent applications filed by the Company with the United States Patent and Trademark Office (USPTO) in 2016, as well as the Company’s granted patent covering Bria-IMT™ (US 7,674,456 B2). The PCT patent application provides ways to generate additional whole-cell cancer vaccines and strategies for patient-specific selection of the most likely effective vaccine. BriaCell is developing its diagnostic, referred to as BriaDx™, in parallel to Bria-IMT™ in the ongoing Phase I/IIa clinical study in patients with advanced breast cancer.

 

Additional patent applications are expected to be filed in 2018.

 

Small Molecule Program
We recently disclosed the allowance by the US Patent and Trademark Office (USPTO) and also the European Patent Office (EPO) of two patent applications related to protein kinase C delta (PKCδ) inhibitor technology, titled “PKC Delta Inhibitors for use as Therapeutics”.

 

MANAGEMENT

 

WILLIAM V. WILLIAMS, MD, FRCP, PRESIDENT & CEO
Dr. Williams is a seasoned biopharmaceutical executive with over 35 years of industry and academic expertise, including significant clinical management in multinational pharmaceutical companies. Dr. Williams served as VP of Exploratory Development at Incyte Corporation from 2005 – 2016. There he facilitated entry of over 20 compounds into the clinic, including ruxolitinib (Jakafi), baricitinib, and epacadostat. He was responsible for establishing proof-of-concept in several therapeutic areas, and has been involved in numerous new drug applications (NDAs) for therapeutics that achieved marketing authorization in multiple therapeutic areas including oncology. This includes Jakafi for myelofibrosis and polycythemia vera and baricitinib for rheumatoid arthritis.

 

GADI LEVIN, CA, MBA, CFO & CORPORATE SECRETARY
Mr. Gadi Levin has been appointed as BriaCell Therapeutics Corp.’s Chief Financial Officer in February 2016. Most recently, he acted as Chief Financial Officer of Labstyle Innovations Ltd, a biotechnology company focused on diabetes.

 

MARKUS LACHER, PH.D. SENIOR DIRECTOR, R&D
Dr. Lacher has joined BriaCell Therapeutics in July 2015. Previously, he served as a Senior Clinical Scientist, R&D at Cesca Therapeutics, Inc., a clinical-stage autologous cell therapy company where he played a lead role in the bone marrow transplantation program.

 

FARRAH DEAN, MSC, MBA, MANAGER, CORPORATE DEVELOPMENT
Farrah serves as Manager, Corporate Development at BriaCell Therapeutics Corp. Her experience includes working in investor relations at CytRx Corporation, and CCG Investor Relations. Farrah’s prior experience include Senior Associate Analyst in Equity Research at Oppenheimer & Co., Rodman & Renshaw, and ThinkEquity LLC.

 

CORPORATE PROFILE

 

BriaCell Therapeutics Corp. (BriaCell) is an immuno-oncology company which develops immunotherapy treatments for cancer. BriaCell is currently focused on the clinical development of Bria-IMT™ as a 2nd line treatment for patients with advance forms of breast cancer. In two Phase I clinical trials in Stage IV breast cancer patients who had failed prior treatments, the lifespan of the patients was significantly extended by Bria-IMT™ in some cases by fivefold. The tumor regression occurred rapidly with few side effects. Additionally, tumor regression was observed in other sites including the lung and the brain.

 

Source:  http://briacell.com/

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