Merck Sharp & Dohme (China) Ltd.

FLORHAM PARK, N.J., Oct. 03, 2022 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) for the treatment of unresectable, recurrent/metastatic human papilloma virus (HPV) 16-positive head and neck squamous cell carcinoma (HNSCC). “We are very pleased with the guidance received from FDA on key elements of the clinical program that will support the submission of a Biologics License Application (BLA) for our lead asset PDS0101,” said Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. “The interim safety and efficacy data we presented to the FDA has allowed us to move into a registrational trial ahead of our projected schedule. This, along with the recent capital raise, allows us to efficiently advance our clinical programs.” Earlier this year, the FDA granted Fast Track designation to the combination of PDS0101 and KEYTRUDA® (pembrolizumab) for the treatment of HPV16-positive HNSCC. The FDA’s Fast Track designation program is designed to aid in the development and to expedite the review of drug candidate applications that could potentially treat serious or life-threatening conditions. Treatments granted this designation are given the opportunity to have more frequent meetings and interactions with the FDA throughout the entire drug development and review process, with the goal of moving promising new drugs more rapidly through the process. Dr. Frank Bedu-Addo further commented, “PDS0101 represents a potentially transformative treatment approach for HPV16-positive HNSCC patients. We are committed to providing physicians and patients a possibly more effective and safer treatment option to address this debilitating and deadly disease.” About PDS Biotechnology PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech. About PDS0101 PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer, and also in second line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. A Phase 2 clinical study is also being conducted in both second- and third-line treatment of multiple advanced HPV-associated cancers in partnership with the National Cancer Institute (NCI). A third Phase 2 clinical trial in first line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center. A final Phase 2 clinical trial of PDS0101 monotherapy in first line treatment of newly diagnosed patients HPV16+ head and neck cancer patients is being conducted at the Mayo Clinic. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About VERSATILE-002 VERSATILE-002 is a single-arm Phase 2 trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune® technology, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). The combination is being evaluated in CPI-naïve and CPI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022. In June 2022, preliminary efficacy and safety data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting for CPI-naïve patients (PR link). Preliminary data from the first 19 patients demonstrated that 77% of the patients with available imaging (17 of 19) had either disease stabilization or tumor shrinkage. Additionally, the overall survival rate of these patients at 9-months was 87%.

UpsideHōM, a Fort Lauderdale, Florida-based startup looking to disrupt senior living, raised $2.25 million in an oversubscribed seed funding round. The round was co-led by Triple Impact Capital and Freestyle Capital and had additional participation from Techstars. WHAT THEY DO UpsideHōM offers fully managed apartments for older adults that come with a host of amenities, including on-demand concierge services, one bill for utilities, grocery delivery, regular housekeeping, virtual and in-person learning opportunities, and more. Seniors can also sign up for visits powered by Papa, a technology platform to coordinate in-home senior companionship. The idea is that by combining resources not typically available in an apartment complex with the communal aspects of a nursing home, seniors will be able to “age in proximity,” something that more than three-quarters of older adults wish to do. UpsideHōM has senior living communities in South Florida; Tampa, Florida; Jacksonville, Florida; Atlanta; and Raleigh, North Carolina. WHAT IT’S FOR The funds will go toward continuing company progression, specifically with the launch of UpsideHōM’s core technology platform later this year. “The launch of our customer-facing technology will take us one step further in our development and allow us to truly engage with our members in a brand new way,” Peter Badgley, UpsideHōM cofounder and COO, said in a statement. “Our goal is to consistently offer a seamless and comfortable experience for our members, from day one when they inquire about our services to move-in day and beyond. With the support of our investors, we have been given the opportunity to do just that while continuing to work toward our mission to positively impact and better people’s lives – particularly as they age.” The platform will enable residents to manage their healthcare, pharmacy needs and transportation as well as serve as a roommate finder, chat room and guide to local experiences. On the internal side, the platform will allow UpsideHōM’s team to manage all member and family engagement. MARKET SNAPSHOT While UpsideHōM differs from other startups in the space by offering senior living opportunities, there are a number of digital health companies creating tools for the older adult population. Assured Allies, which has a platform that helps link seniors to health services, recently scored $18.3 million in a Series A funding round. Avanlee Care, an “all-in-one” elderly care coordination startup, launched its corresponding app earlier this month. Remote care company Connect America moved into the senior care space with its recent acquisition of Royal Philips' Aging and Caregiving (ACG) business. In May, UK-based elderly caretech company Birdie landed £8.2 million in funding.

UK-based elderly caretech company Birdie has announced that is has raised £8.2 million led by international venture capital firm Index Ventures and with participation from Kamet Ventures. The investment will be used to expand the business and invest in product innovation. WHY IT MATTERS The pandemic has brought on a social care crisis across the globe. The number of people over 65 will double by 2050, and while people are living longer, they are falling sick at the same age. This increases pressure on an already strained care system, in which 25% of the UK’s home care providers are on the brink of bankruptcy and local authorities in England will face a £4.4 billion funding gap by 2023. Birdie is addressing this crisis by reinventing care for older people, partnering with care providers to support the ageing population in living healthily at home for longer. Birdie’s intuitive app provides a system for care providers to deliver more coordinated, personalised and preventative care. By using a SaaS-based platform like Birdie, the care community can utilise the technology to plan and assess care as well as support its delivery. Consequently, caregivers decrease time spent on non-critical work like admin, freeing them up to spend more time face-to-face with their care recipients. It also saves costs and allows carers to more easily communicate and share information with an older person’s other care providers, health practitioners, and their families. THE LARGER CONTEXT Last month, Apple Fitness + launched new programmes for pregnant people and seniors. Each of the new workout programmes features classes that average about 10 minutes in total and focus on the specific health needs of that group. ON THE RECORD Max Parmentier, Birdie CEO and co-founder, said: “Right now, the $1tn elderly care market is woefully underserved, even though it’s growing 8% per year. The care system is at breaking point and many older people aren’t getting the care they deserve. “We believe the future of care for older people should be helping them to live at home for as long as possible through the delivery of personalised and preventative care. Birdie is already the partner of choice for caregivers up and down the UK, and this funding will help us rapidly increase the number we partner with and what we can offer them - meaning more people benefiting from more affordable, quality care. We’re proud of our mission and the values we embody to pursue it.” James Deeley, chief executive of Alina Homecare, said: “Birdie has delivered from day one as a strong technology partner for our Group. Our values and aspirations are closely aligned and Birdie is transforming the way we deliver and monitor our care, with more than 30,000 visits channelled every month through their platform.”