Squamous cell carcinoma of the oral cavity

LAVAL, QC / ACCESSWIRE / March 6, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology business, Salix Pharmaceuticals, Ltd., today announced that it is supporting a Phase 2 investigator-initiated study (IIS) of RELISTOR® (methylnaltrexone bromide: MNTX) in patients with resectable head and neck squamous cell carcinoma. An IIS is a study that is proposed, developed, and conducted by a qualified sponsor external to Bausch Health/Salix who assumes full responsibility for the study. The clinical study is being led by Juan P. Cata, M.D. at The University of Texas MD Anderson Cancer Center. The trial is designed to evaluate the potential of treating oral cavity squamous cell carcinoma patients with MNTX. It is a prospective, nonrandomized pilot "proof of concept" study where patients receive subcutaneous MNTX two weeks preoperatively and two weeks postoperatively. "The preclinical data and clinical suggestions point to potential activity against cancer," Robert Israel, M.D., Senior Vice President, Clinical and Medical Affairs, said. "Having Dr. Cata study this drug in head and neck cancer will shed light on how and if this agent could be further developed as a potential treatment option in neoplastic disease." Upon completion of the study, participants will be monitored every 3 months during the first two years. The primary endpoint is the successful administration of MNTX for two weeks preoperatively and postoperatively without interruption due to adverse events. Secondary endpoints include tumor viability, proliferation and apoptosis index, objective response rate, survival rates, and patient-reported outcomes. Identifier: NCT06162377. About RELISTOR RELISTOR® (methylnaltrexone bromide) is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. RELISTOR injection is also indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care. IMPORTANT SAFETY INFORMATION RELISTOR tablets and injection are contraindicated in patients with known or suspected mechanical gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation. Cases of gastrointestinal perforation have been reported in adult patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie's syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit pro using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn's disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom. If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their health care provider. Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal. Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal. The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. A dosage reduction of RELISTOR tablets and RELISTOR injection is recommended in patients with moderate and severe renal impairment (creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment. A dosage reduction of RELISTOR tablets is recommended in patients with moderate (Child-Pugh Class B) or severe (Child- Pugh Class C) hepatic impairment. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A). No dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions and dose adjust per Prescribing Information as may be indicated. In the clinical studies, the most common adverse reactions were: OIC in adult patients with chronic non-cancer pain RELISTOR tablets (≥ 2% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (14%), diarrhea (5%), headache (4%), abdominal distention (4%), vomiting (3%), hyperhidrosis (3%), anxiety (2%), muscle spasms (2%), rhinorrhea (2%), and chills (2%). RELISTOR injection (≥ 1% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (21%), nausea (9%), diarrhea (6%), hyperhidrosis (6%), hot flush (3%), tremor (1%), and chills (1%). OIC in adult patients with advanced illness RELISTOR injection (≥ 5% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (29%) flatulence (13%), nausea (12%), dizziness (7%), and diarrhea (6%). To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800- FDA-1088 or Please click here for full Prescribing Information for RELISTOR tablets and RELISTOR injection. About Salix Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit and connect with us on Twitter and LinkedIn. About Bausch Health Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit and connect with us on Twitter and LinkedIn. Forward-looking Statements This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in the Bausch Health most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration, and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch Health, including but not limited to its project development timelines, and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. ### Investor Contact: Media Contacts: ir@bauschhealth.com Kevin Wiggins (877) 281-6642 (toll-free) corporate.communications@bauschhealth.com (908) 541-3785 SOURCE: Salix Pharmaceuticals View the original press release on accesswire.com

The new test, created and patented by Guy Adami and Joel Schwartz of the UIC College of Dentistry, utilises a tiny brush to collect cells from lesions inside the mouth that may be cancerous The new cancer detection kit needs less than a minute of gentle brushing. (Credit: Lucia Adami) Researchers at the University of Illinois Chicago (UIC) have invented a new brush biopsy diagnostic kit that enables the early detection of oral cancer without surgery. The new test, created and patented by Guy Adami and Joel Schwartz of the UIC College of Dentistry, utilises a tiny brush to collect cells from lesions inside the mouth that may be cancerous. After that, the sample is examined for genetic indicators of oral squamous cell carcinoma, the ninth most common cancer worldwide. The cancer detection kit needs less than a minute of gentle brushing by a dentist or nurse to collect a sample, thereby improving the existing diagnostic standard of surgical biopsies. UIC is currently looking for commercialisation partnerships for the new screening technique. Oral medicine and diagnostic sciences associate professor Adami said: “So many patients get lost; they don’t follow up. “We’ve tried to keep our focus mainly on early Stage 1 and 2 cancers, so it actually works with the cancers that you want to detect.” The detection method operates by searching for tiny genetic segments known as microRNAs, which control how genes are expressed. It also worked using epithelial cells, the outermost layer of cells in the mouth of a patient. Furthermore, the patient then puts the brush in a tube of solution and sends it to a lab for microRNA analysis. The current version of the test is said to provide results to the clinic in days. Additionally, the brush approach only gathers cells from a single spot where treatment can be targeted if a tumour is discovered, in contrast to blood tests that look broadly for genetic signs of cancer. Schwartz said: “If you compare what we do, which is site-specific targeting of tissue, to the other tests out there, they don’t have a targeting of where the tumours actually are. “That makes it harder to start treatment rapidly after detection.” The test’s creators anticipate that it will make screening simpler, especially for patient populations with a greater incidence of oral squamous cell carcinoma or those who do not receive regular dental care. Adami and Schwartz said that the technology can help identify different oral disorders based on their distinct microRNA signatures.

Proceeds to accelerate clinical development of first-in-class bifunctional EGFR/TGF-β inhibitor, BCA101, for multiple cancer types, including 1L HPV-negative recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) Presented positive interim clinical data at 2023 ASCO Annual Meeting and ESMO Congress 2023 from ongoing Phase 1/1b dose expansion study of BCA101 in combination with pembrolizumab demonstrating clinically meaningful anti-tumor activity and tolerable safety profile in 1L HPV-negative R/M HNSCC Financing co-led by Braidwell LP and TPG, with participation from other new and existing leading healthcare investors BOSTON, MA, USA I December 12, 2023 I Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics to elicit a potent and durable immune response, today announced the completion of an oversubscribed $165 million Series C financing. The financing was co-led by Braidwell LP and TPG, which is investing in the company through TPG Life Sciences Innovations (TPG LSI) and The Rise Fund, with additional new investors including Deerfield Management, Fairmount, Aisling Capital and a leading biotechnology investor associated with one of the largest alternative asset managers. All existing Series B investors also participated in the round. “Momentum at Bicara is increasing following our BCA101 Phase 1/1b data presentations at key 2023 medical meetings,” said Claire Mazumdar, Ph.D., MBA, Chief Executive Officer of Bicara Therapeutics. “Our proof-of-concept data in frontline HPV-negative R/M HNSCC, a very difficult patient population to treat, underscore the promise of BCA101 as a new precision therapeutic option for these patients. With additional data readouts anticipated in 2024, we remain excited about the overall potential of BCA101 to help patients with HPV-negative R/M HNSCC, as well as other solid tumor types. We are thrilled to partner with this syndicate of new and existing leading healthcare investors, who share in our vision for BCA101 and Bicara’s bifunctional antibody platform.” In connection with the Series C financing, Carolyn Ng, Ph.D., Business Unit Partner with TPG LSI, has joined Bicara’s board of directors. “Bicara’s Phase 1/1b dose expansion study of BCA101 has delivered encouraging, clinically meaningful interim results and offers an excellent foundation from which to continue to build Bicara into a leading oncology company,” said Dr. Ng. “I am excited to join Bicara’s board of directors at such an important time and look forward to working with this talented management team and distinguished board of directors to advance new treatments for cancer patients.” With the completion of the Series C financing, Bicara has raised $273 million in 2023. About BCA101 BCA101 is a first-in-class, dual-action, bifunctional antibody designed to inhibit the epidermal growth factor receptor (EGFR) and disable transforming growth factor beta (TGF-β) directly at the tumor site. This approach is designed with the intent to allow BCA101 to inhibit tumor proliferation, while restoring the cytolytic activity of the local immune cells. BCA101 is currently being evaluated in a dose expansion phase of an open-label Phase 1/1b study in combination with pembrolizumab in patients with unresectable R/M HNSCC and advanced SqNSCLC and as a monotherapy for cutaneous squamous cell carcinoma. About Head and Neck Squamous Cell Carcinoma Head and neck squamous cell carcinomas (HNSCCs) develop from the mucosal epithelium in the oral cavity, pharynx and larynx and are the most common malignancies that arise in the head and neck. Oral cavity and larynx cancers are generally associated with tobacco consumption, alcohol abuse or both, whereas pharynx cancers are increasingly attributed to infection with human papillomavirus (HPV), primarily HPV-16. Thus, HNSCC can be biologically separated into HPV-negative and HPV-positive HNSCC, the latter carrying a more favorable prognosis. Treatment approaches for locally advanced HNSCC generally consist of surgery followed by chemoradiotherapy (CRT) for oral cavity cancers and primary or definitive CRT for pharynx and larynx cancers. The immune checkpoint inhibitors pembrolizumab and nivolumab are approved by the U.S. FDA for treatment of platinum-refractory recurrent or metastatic HNSCC, and pembrolizumab is approved as first-line monotherapy in patients with unresectable or metastatic disease with a CPS ≥1 or combined with platinum and 5-fluorouracil for patients with any CPS score. HNSCC is the sixth most common cancer worldwide, with approximately 890,000 new cases and 450,000 deaths in 2018. The incidence of HNSCC continues to rise and is anticipated to increase by 30% by 2030. 1 About Bicara Therapeutics Bicara Therapeutics is a clinical-stage biotechnology company developing first-in-class biologics engineered to combine the precision of well validated, tumor-targeting antibodies with the power of tumor microenvironment modulators. The Company’s bifunctional antibodies are designed to deliver an immunomodulatory payload directly to the tumor microenvironment to ramp up immune cell activity, offering the potential for synergistic therapeutic impact at the site of the tumor. Bicara’s lead product candidate, BCA101, is a first-in-class EGFR/TGF-β-trap bifunctional antibody in clinical development for multiple tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn or X . SOURCE: Bicara Therapeutics