Palm Beach, FL – May 5, 2023 – FinancialNewsMedia.com News Commentary – Breast cancer is the most commonly occurring disorder among the population majorly seen in females with rising disorder. It is a disorder that spreads the disease with increasing symptoms such as pain in the bones swelling of lymph nodes, breathing problems, and many more. Breast cancer development takes place with the presence of genes like Human Epidermal growth factor receptor 2 (HER2). Stimulation of cancer in the body with the presence of this protein extends the proliferation of the cells. Positive HER2 receptor patients having the most aggression in breast cancer than other types of breast cancer. Numerous treatments are available which are used to treat and eradicate the tumor and increase the target on HER2. Which enlarges the market of Breast cancer with an increasing number of patients every year with an increase in the recovery rate of breast cancer.   A report from Precedence Research projects that the global breast cancer market size was estimated at USD 31.89 billion in 2022 and is projected to hit around USD 70.51 billion by 2030 with a registered CAGR of 10.43% during the forecast period 2022 to 2030.  The report said: “Enhance research and development with increased new technologies and therapies developed in breast cancer which is prominently contributing to enhancing the market growth with increased demands from the medical sector for treating the patients with new treatments and medications. Government support with increasing providence for new developments in medications and increased efficiency and efficacy of the treatment and integration of newly developed medications in the medical sector.”   Active biotech and pharma companies in the markets this week include Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), Bristol Myers Squibb (NYSE: BMY), NANO-X IMAGING LTD (NASDAQ: NNOX), Soligenix, Inc. (NASDAQ: SNGX), Cardiff Oncology, Inc. (NASDAQ: CRDF).

Precedence Research said that key insights were: “By therapy, the targeted therapy segments involved the largest market; By cancer type, the hormone receptor segments extend the market share at the largest rate; By distribution channel, the hospital pharmacies segments developed their own pharmacies in the hospital with the highest market share; and By geography, The North American region holds the highest position in the market with increased market share.  On the basis of geography, North America holds the highest position in the market with an increased market share in breast cancer. Advanced developed technologies in the market with an increased number of treatments available for treating breast cancer with an increasing number of patients helps to propel the market growth with increased government initiative in developing new drug developments and increased efficacy of the medications with increased results help to enhance the market growth.”

Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS:  Oncolytics Biotech® Reports First Quarter 2023 Financial Results and Operational Highlights –

• Randomized phase 2 data from BRACELET-1 trial in HR+/HER2- metastatic breast cancer to be shared in an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting

• Guidance on the registration paths for pelareorep in HR+/HER2- metastatic breast and first-line pancreatic cancer expected in H2 2023

• $29.7 million in cash, cash equivalents, and marketable securities as of March 31, 2023 provides projected cash runway for at least 12 months

Oncolytics Biotech^® today announced recent operational highlights and financial results for the first quarter ended March 31, 2023. All dollar amounts are expressed in Canadian currency unless otherwise noted.

“Our core programs in breast and pancreatic cancer are moving towards registrational studies with compelling clinical data and important milestones expected this year,” said Dr. Matt Coffey, President and Chief Executive Officer. “The first of these milestones will come later this month when we report data from BRACELET-1, a randomized phase 2 trial expected to inform the design of a subsequent pivotal registrational study in HR+/HER2- metastatic breast cancer. Stakeholders across the breast cancer community have demonstrated a keen interest in this readout, which will add to a dataset that already includes statistically significant phase 2 results showing pelareorep’s ability to drive a robust overall survival benefit in this indication. Notably, the BRACELET-1 abstract was selected for an oral presentation at the upcoming ASCO meeting, providing a highly prestigious venue to discuss the results with potential partners and the clinical community.”

Dr. Coffey continued, “Looking into the second half of 2023, we expect to report updated results from GOBLET’s first-line pancreatic cancer cohort and provide guidance on the optimal registration paths for our breast and pancreatic cancer programs. With these programs both targeting large markets with significant clinical unmet needs and supported by robust clinical proof-of-concept data, we believe confirming their paths towards approval will represent important value-creating events and substantially de-risk and maintain pelareorep’s development pathway.”  CONTINUED… Read this full press release and more news for ONCY at:  https://www.financialnewsmedia.com/news-oncy/    

Other recent developments in the biotech industry of note include:

NANO-X IMAGING LTD (NASDAQ: NNOX) recently announced that it has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the multi-source Nanox.ARC, including the Nanox.CLOUD, its accompanying cloud-based infrastructure. Nanox.ARC is a stationary X-ray system intended to produce tomographic images of the human musculoskeletal system adjunctive to conventional radiography on adult patients. Representing a major advancement in X-ray technology, Nanox.ARC is a multi-source digital 3D tomosynthesis system that utilizes novel, cold cathode X-ray tubes, which the Company intends to offer using an innovative pay-per-scan business model.

The FDA cleared Nanox.ARC for use in professional healthcare ‎facilities or ‎radiological ‎environments, such as ‎hospitals, clinics, imaging ‎centers, and ‎other medical practices‎ by trained radiographers, ‎radiologists, and physicians, and has the potential to increase availability to medical imaging around the world, once approved by local regulatory authorities and deployed at scale.

Soligenix, Inc. (NASDAQ: SNGX) recently announced positive clinical results from a compatibility study evaluating HyBryte (synthetic hypericin sodium) in the treatment of cutaneous T-cell lymphoma (CTCL) using the commercially ready Daavlin Series 7 visible light device, which recently received 510(k) clearance from U.S. Food and Drug Administration (FDA). The open-label study (protocol HPN-CTCL-02) enrolled 9 patients to receive 8 weeks of HyBryte treatment of their cancerous lesions, with an assessment of treatment response conducted at week 10 using the Composite Assessment of Index Lesion Severity (CAILS) score. All subjects were enrolled by Brian Poligone, MD, PhD, at the Rochester Skin Lymphoma Medical Group.

“We were excited for the opportunity to work with Soligenix and make HyBryte available to our patients,” stated Brian Poligone, MD, PhD, Director of the Rochester Skin Lymphoma Medical Group, Fairport, NY, and Principal Investigator for the compatibility study and Leading Enrolling Investigator in the FLASH study. “Since the completion of the Phase 3 FLASH study, I have had a number of patients asking about possible access to this promising therapy. Fortunately, we were chosen to conduct this study and the patients’ enthusiasm for the product was evident by their willingness to participate in the trial, allowing for its rapid completion. I look forward to continuing to work with Soligenix to further advance the HyBryte program so my patients can have this much needed treatment option available to them.”

Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers, recently announced that the first patient was  dosed this month with its investigational drug onvansertib in its Phase 2 ONSEMBLE trial (NCT05593328). The trial is designed to demonstrate a clinically meaningful difference in response and onvansertib’s contribution to standard of care (SoC) FOLFIRI/bevacizumab for the second line treatment of patients with KRAS/NRAS-mutated metastatic colorectal cancer (mCRC).

“We are excited to be underway with our ONSEMBLE trial that builds on the promising efficacy and tolerability results demonstrated in our phase 1b/2 trial in mCRC,” said Fairooz Kabbinavar, MD, Chief Medical Officer of Cardiff Oncology. “mCRC is a difficult-to-treat cancer and patients in the second line setting need novel therapeutic options to improve clinical outcomes. Based on our open-label phase 1b/2 trial, we believe the combination of onvansertib with FOLFIRI/bevacizumab could positively impact patients’ responses to treatment and the durability of the responses. Nearly half of our planned 40 sites in the US are open to enroll patients and we’ve seen great enthusiasm from participating investigators.”

Bristol Myers Squibb (NYSE: BMY) recently announced that the European Commission (EC) has granted approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. This approval covers all European Union (EU) member states.

The approval is based on results from the pivotal Phase 3 TRANSFORM trial in which Breyanzi demonstrated statistically significant and clinically meaningful improvements in the study’s primary endpoint of event-free survival (EFS), and key secondary endpoints of complete responses (CR) and progression-free survival (PFS) compared to standard therapy (consisting of salvage immunochemotherapy followed by high-dose chemotherapy and hematopoietic stem cell transplant [HSCT]), along with a manageable and well-established safety profile.

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