CANbridge Pharmaceuticals to Present at the Jefferies Global Healthcare Conference 2022

On June 1, 2022 CANbridge Pharmaceuticals Inc. (HKEX:1228), a China-based global biopharmaceutical company committed to the research, development and commercialization of transformative rare disease and rare oncology therapies, reported that it will participate in and present at the Jefferies Global Healthcare Conference 2022 on Friday, June 10, 2022 at 12:45 PM ET (Press release, CANbridge Life Sciences, JUN 1, 2022, View Source [SID1234615370]).

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A live webcast of will be available on the "Presentations & Webcasts" located in the Investor page of the Company’s website. A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

Accutar Biotechnology Announces Fast Track Designation Granted by FDA to AC0176 for the Treatment of Metastatic Castration-Resistant Prostate Cancer

On June 1, 2022 Accutar Biotechnology, Inc., a clinical stage biotechnology company focusing on artificial intelligence (AI)-enabled drug discovery, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AC0176 for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC) with disease progression on or after treatment with androgen receptor signaling inhibitors (Press release, Accutar Biotechnology, JUN 1, 2022, View Source [SID1234615369]). AC0176 is an orally bioavailable, chimeric degrader molecule targeting the androgen receptor (AR). AC0176 is currently being evaluated in a Phase 1 clinical trial to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in patients with mCRPC.

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"mCRPC is a devastating cancer for men marked by high recurrence rate and poor survival. Receiving Fast Track designation from the FDA highlights the high unmet medical need for mCRPC and acknowledges the potential of AC0176 as a novel treatment for this patient population," said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. "AC0176 was designed to potently degrade both AR wildtype and prevalent AR mutations which confer drug resistance to current AR signaling inhibitors. We look forward to continued interaction with FDA as we quickly advance the development of this potentially promising treatment option for patients in need."

About Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Prostate cancer (PC) is the second most commonly diagnosed cancer among men worldwide, and the first among men in the United States. mCRPC is a lethal diagnosis, and more effective therapeutic approaches are urgently needed for patients, particularly those who progressed on AR signaling inhibitors. AR-reactivating mechanisms conferring resistance to AR signaling inhibitors include, AR amplification and overexpression, AR point mutations, AR splicing variants, intra-tumoral androgen synthesis, promiscuous AR activation by other factors, etc.

About AC0176

AC0176 is an investigational orally bioavailable, chimeric degrader of AR for the potential treatment of prostate cancers. In preclinical studies, AC0176 demonstrated potent and selective AR protein degradation, favorable pharmacological properties, as well as promising anti-tumor activity in animal models. AC0176 was designed to have broad coverage of AR wildtype and prevalent AR mutations, including but not limited to L702H, T878A, H875Y, W742C. AC0176 is being evaluated in a Phase 1 clinical trial, and information on the study can be found on www.clinicaltrials.gov (NCT05241613).

SQZ Biotechnologies to Present at Jefferies Healthcare Conference

On June 1, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported that Armon Sharei, Ph.D., Chief Executive Officer and Founder of SQZ Biotechnologies, will present at the Jefferies Healthcare Conference on June 8, in New York, NY (Press release, SQZ Biotech, JUN 1, 2022, View Source [SID1234615368]). Presentation time and webcast information is available below.

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PRESENTATION DETAILS

Wednesday, June 8
Jefferies Healthcare Conference
2:30-2:55 p.m. ET
Webcast

Conference webcast details and the company’s most recent corporate overview presentation will be available on the Investors section of the SQZ website. Replay will be available for 90 days.

Based on guidance from the SEC, investors should note that the company may announce future healthcare conference presentations on the Events & Presentations page of the Investor Relations section of its corporate website, investors.sqzbiotech.com. It is possible that the information posted there could be deemed to be material information.

Gamida Cell to Present Corporate Highlights at the Jefferies Healthcare Conference

On June 1, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, reported that company management will present its corporate highlights at the Jefferies Healthcare Conference, June 8, 2022 with a presentation at 11:00 a.m. ET in New York, NY (Press release, Gamida Cell, JUN 1, 2022, View Source [SID1234615367]).

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Management will discuss 2022 catalysts and potential milestones including the U.S. market opportunity for omidubicel upon potential U.S. Food and Drug Administration approval, accelerating the development of its first-in-class NAM-enabled natural killer (NK) cell therapy candidate, GDA-201, as a potential new approach for patients with follicular and diffuse large B-cell lymphomas, and expansion of its NAM-enabled cell therapy pipeline with multiple next-generation, genetically engineered NK cells.

A webcast of the event will be available on the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com, and will be available for at least 14 days following the event.

About Omidubicel

Omidubicel is an advanced cell therapy candidate under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the U.S. FDA and has also received Orphan Drug Designation in the U.S. and EU. Gamida Cell has completed an international, multi-center, randomized Phase 3 study (NCT0273029) evaluating the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing allogeneic bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant. That study achieved its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in a patient’s recovery from a stem cell transplant. The Phase 3 study also achieved its secondary endpoints of reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. Gamida Cell initiated a rolling BLA submission for omidubicel in the first quarter of 2022 with full BLA submission on track for the second quarter of 2022. In 2019, approximately 8,000 patients who were 12 years old and up with hematologic malignancies underwent an allogeneic stem cell transplant.1 Unfortunately it is estimated that another 1,200 patients were eligible for transplant but could not find a donor source.2 Omidubicel has the opportunity, upon FDA approval to improve outcomes for patients based on transplanter feedback and increase access for patients to get to transplant. Omidubicel has the potential to treat approximately 2000 – 2500 patients each year in the U.S. For more information about omidubicel, please visit View Source

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About GDA-201

Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy candidate for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. There are approximately 40,000 patients with relapsed/refractory lymphoma in the E.U.5 and U.S. which is the patient population that will be studied in the GDA-201 Phase 1/2 clinical trial.

For more information about GDA-201, please visit View Source For more information on the Phase 1/2 clinical trial of GDA-201, please visit www.clinicaltrials.gov.

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About NAM Technology

Our NAM-enabling technology, supported by positive Phase 3 data, is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (Nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.

Propanc Biopharma Believes PRP Reduced Toxicity Will Impact Cancer Patient Lives Significantly

On June 1, 2022 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that Chief Scientific Officer and Co-Founder, Dr Julian Kenyon MD, MB, ChB, believes the reduced toxicity of PRP compared to standard treatment approaches will impact cancer patient lives significantly. Many standard therapies for advanced cancer urgently need improvement, generally providing modest benefits and frequently causing adverse effects (Press release, Propanc, JUN 1, 2022, View Source [SID1234615366]). Propanc’s focus is to provide oncologists and their patients with therapies for metastatic cancer which are more effective than current therapies and have a substantially reduced side effect profile. According to Cancer Treatment Centers of America, for all the advances made in cancer treatment over the past several decades, one statistic has remained unchanged: Metastatic cancer accounts for up to 90% of all cancer deaths in the United States each year.

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While surgery is often safe and effective for early-stage cancer, many standard therapies for late-stage cancer inflict too much trauma and provide too little benefit. Side effects include hair loss, nausea and vomiting, as well as blood related (hematological) side effects, which may include a low cell count of infection fighting white blood cells (neutropenia), low red blood cell count (anemia) and low platelet count (thrombocytopenia). In many cases, patients are often admitted to intensive care from the side effects of treatment. Infection is a significant cause of death among cancer sufferers due to immune suppression. The COVID-19 pandemic further highlights the plights of this poor patient population, adding to the stress of undergoing treatment with side effects that can be life threatening. Other examples of effects from standard treatment approaches include skin and gastrointestinal toxicities. Severe side effects such as rupture of the bowel and severe hypertension often requiring emergency treatment.

"We are developing a new cancer treatment to extend life and reduce pain and suffering. Our vision is to provide therapies which are more effective than current therapies and safe, which avoid short-term side effects, such as loss of hair, and long-term effects, such as permanent damage to healthy tissues," said Dr Kenyon. "Patients need access to a follow up therapy which is safe and effective enough to minimize the risk of recurrence, post-surgery. Whilst such a follow up therapy is worthwhile for some cancers, it is usually moderately effective and often too toxic for long-term use. This is where our lead product candidate, PRP, fits in. We believe it works with a number of cancers over a prolonged period. Also, PRP exhibits minimal side effects, where patients are unlikely to be hospitalized as a result of receiving treatment."

"Our management team have worked extensively with scientific researchers internationally over the last 15 years and have improved our understanding of the mode of action of PRP and most importantly, enhanced the potency of the formulation to maximize its anti-cancer effects, whilst continuing to exhibit no serious side effects," said James Nathanielsz, Propanc’s Chief Executive Officer. "Our goal is to offer a cancer treatment which will improve the life expectancy of people with metastatic cancer and at minimal cost in terms of quality of life. We look forward to progressing PRP into a First-In-Human (FIH) study in advanced cancer patients."

Clinical experience was obtained via a compassionate use study in 46 late-stage cancer patients using a suppository formulation of two proenzymes, trypsinogen and chymotrypsinogen. Dr Kenyon concluded that no severe or serious adverse events related to the rectal administration were observed. Patients did not experience any hematological side effects as typically seen with classical chemotherapy regimens. No allergic reactions after rectal administration of suppositories were also observed.

A Good Laboratory Practice (GLP), non-clinical, 28-day repeat dose toxicity study of PRP administered via daily intravenous (I.V.) injections was also conducted. It was concluded that all dose levels were well tolerated. Furthermore, PRP was not associated with any morbidity or clinical signs of toxicity, no macroscopic pathology (disease) findings were considered treatment-related and all observed necroscopy (death related) findings were considered incidental. Also, no major toxicological findings or treatment-related changes were identified in organs examined by pathologists.

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine and skin cancers.