Radyus Research, Inc.

BETHESDA, Md. and SINGAPORE, Sept. 23, 2024 /PRNewswire/ -- VerImmune Inc., ("VerImmune"), a venture-backed biotechnology company developing a groundbreaking Virus-inspired Particle (ViP™) platform technology, today announced the successful first closing of $4.5 million in its Pre-Series A financing round. The financing was led by Beiley Biofund, an early-stage venture capital firm focused on cutting-edge technologies that address high unmet medical needs. New investors, including Dr. John Ballantyne, PhD, co-founder and former CSO at Aldevron, participated in the round, alongside returning investors Proxima Ventures, Mana Ventures, Gaingels, and others. "We are extremely pleased to have completed the first closing of our Pre-Series A round. This funding signals strong market recognition of the potential for novel modalities to address unmet medical needs," said Dr Joshua Wang, PhD, Founder and CEO of VerImmune Inc. "We intend to use this capital to advance our conviction that ViP-based therapeutics will open the door to an entirely new approach to immunotherapy and other therapeutic areas." "We are very attracted by and delighted to invest in VerImmune's Virus-inspired Particle (ViP), which is both non-viral and well differentiated. In many ways, it is technically superior to other virus-like particle modalities in addressing well recognized existing challenges. We are also impressed by the progress of the company and are confident in its future success," said Dr. Che Hsu, PhD, General Manager of Beiley Biofund. "We are extremely pleased to continue our support for VerImmune. The company's ViP technology offers a new class of 'virally inspired' proteins that can function as a non-viral delivery system. For the first time in drug discovery, there are now systematic and efficient ways to manipulate proteins and their geometry beyond the traditional rules in recent years," said Haolin Sung, MBA Partner at Proxima Ventures. This closing also strengthens VerImmune's Board of Directors with the addition of two seasoned executives with extensive experience in early-stage product development for novel modalities: Dr. Che Hsu, PhD, General Manager of Beiley. Before joining Beiley, Dr. Hsu was a successful pharmaceutical life sciences executive with a strong track record of advancing programs from discovery through IND and beyond. He has held leadership roles at both early-stage startups and established companies such as Bristol Myers Squibb and Celgene, where he contributed to the development of innovative therapies. His experience spans both science and business, making him a valuable leader in the life sciences field. Dr. Hsu is also currently an MBA candidate in the Chicago Booth Executive MBA program at the University of Chicago. Dr. Marta New, PhD, MBA, an experienced drug developer and former venture capitalist. Dr. New previously held leadership roles as a partner at Agent Capital, principal investor at Baxalta Ventures, and commercial lead at Baxter International's Renal Franchise. She is currently the CEO of Radyus Research and will join VerImmune as an independent director. "We are thrilled to welcome Dr. Hsu and Dr. New to our Board of Directors," said Dr Roger Pomerantz, MD, FACP, Chair of VerImmune's Board. "Their expertise in novel modalities and deep industry knowledge will strengthen our strategic guidance and enhance our efforts toward clinical and commercial success." VerImmune plans to utilize the funds to advance the development of its lead product candidate, VERI-101, towards clinical trials. VERI-101 is a First-in-class cancer immunotherapy that leverages the ViP to redirect pre-existing immune memory from cytomegalovirus (CMV) infection toward tumors for destruction. The company also aims to expand and accelerate strategic partnerships to unlock the potential of its ViP platform technology. One such collaboration is VerImmune's ongoing research partnership with A*STAR's Bioprocessing Technology Institute (BTI) in Singapore, which focuses on biomanufacturing process innovations. About Beiley Biofund Beiley Biofund is a leading venture capital firm dedicated to advancing life sciences by partnering with innovators to develop breakthrough therapies and technologies. With a strong focus on addressing unmet medical needs, Beiley actively seeks out teams pioneering impactful treatments and works closely with them to craft effective development strategies, ensuring these innovations reach the patients who need them most. As an open-ended fund, Beiley provides not only financial backing but also access to extensive networks, enabling emerging biotech entrepreneurs to build and scale their ventures. Through strategic investments and market access support, Beiley is committed to fostering a collaborative ecosystem that drives entrepreneurial success, fuels the growth of life sciences innovation, and accelerates the delivery of transformative therapeutics. About Proxima Ventures Proxima Ventures is a highly respected venture capital fund specializing in innovative and disruptive medical and biotechnology investments. With a focus on supporting companies with exceptional growth potential, Proxima is led by a seasoned team with a proven track record in life sciences. The team combines deep global expertise, extensive industry experience, and a vast network of connections. Proxima invests in companies from the angel to growth stages. Through its leadership, Proxima has built a thriving medical entrepreneurship ecosystem, helping its portfolio companies access top-tier clinical and industrial resources, driving transformative outcomes across the sector. About VerImmune VerImmune Inc () is developing a highly innovative Virus-inspired Particle (ViP™) platform technology that has the potential to treat multiple diseases. VerImmune's primary focus lies in the field of Oncology, wherein the ViP technology enables a pioneering first-in-class cancer immunotherapy approach known as Anti-tumor Immune Redirection (AIR). This innovative method harnesses the body's pre-existing immune system, specifically by leveraging the immune memory from past infections or childhood vaccination to combat cancer. By taking a highly orthogonal approach, VerImmune's technology holds immense potential to revolutionize the Immuno-Oncology market, offering new treatment possibilities for patients facing limited options or resistance to current cancer therapies. Beyond Oncology, VerImmune is looking into other areas of high unmet needs via the utilization of ViPs with novel properties and/or payloads that exert highly disruptive mechanisms of action." SOURCE Verimmune Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Eisai's bullish Leqembi sales projection, Takeda's Alzheimer's licensing deal and the latest on the BIOSECURE Act made our news this week. Following a reportedly bullish assessment from Medicare, Eisai has projected a significant sales increase for Leqembi. Takeda paid $100 million upfront for an option to license an anti-amyloid vaccine from AC Immune. The House Oversight Committee voted overwhelmingly to advance a tweaked version of the BIOSECURE Act. And more. 1. Eisai predicts sharp Leqembi sales increase as launch efforts begin to bear fruit After filing hitch, Eisai and Biogen begin rolling FDA submission for subcutaneous Leqembi Eisai expects Leqembi sales for its 2024 fiscal year will reach 56.5 billion Japanese yen ($364 million), compared with 4.26 billion Japanese yen ($27 million) during the 2023 fiscal year that ended in March. The company believes it and partner Biogen have improved Alzheimer’s disease diagnosis and treatment infrastructure in the U.S. and Japan. Meanwhile, after a short delay, the two companies have started a rolling FDA submission for a subcutaneous version of the anti-amyloid antibody that can be dosed at home. 2. Takeda pays AC Immune $100M upfront for Alzheimer's drug as phase 2 readout nears Fellow Japanese drugmaker Takeda is also making a bet on Alzheimer’s disease, paying $100 million upfront for AC Immune’s anti-amyloid beta vaccines. One candidate in the deal, coded ACI-24.060, is in a phase 1b/2 trial in patients with prodromal Alzheimer’s or Down syndrome. The option exercise fee and milestone payments could add up to $2.1 billion. 3. House's updated biosecurity bill sets 2032 decoupling deadline for industry's work with WuXi AppTec, WuXi Biologics In new letter to Defense Department, WuXi AppTec refutes claim of secret data transfer The House Committee on Oversight and Accountability voted overwhelmingly to advance the BIOSECURE Act for a full House vote, Reuters reports. The updated version of the bill would give biopharma companies until Jan. 1, 2032, to end their existing contracts with WuXi AppTec and WuXi Biologics plus three gene sequencing firms targeted in the legislation. For potential new targets of the bill, companies would have five years to cut ties with them. Meanwhile, WuXi AppTec is also defending itself against a claim that it shared a U.S. client’s data with Beijing without consent. 4. After FTC stalled Sanofi deal, Shionogi secures Maze's Pompe disease drug for $150M Five months after the U.S. Federal Trade Commission derailed Sanofi’s proposal to acquire Maze Therapeutics’ Pompe disease program, Shionogi has picked up the asset for $150 million upfront and undisclosed milestones. The candidate, MZE001, is a GYS1 inhibitor designed to stop the toxic buildup of glycogen. It has the potential to become the first oral treatment for Pompe. 5. Shionogi's antiviral comes up short in global COVID-19 trial Shionogi also suffered a setback this week. Its once daily protease inhibitor ensitrelvir, which is approved in Japan under the brand name Xocova, failed to significantly beat placebo in reducing the time to sustained resolution of 15 common COVID-19 symptoms in a global phase 3 trial. Despite the primary endpoint miss, Shionogi noted a significant difference in the time to resolution of six COVID symptoms. 6. Hengrui licenses GLP-1 portfolio to $400M biotech startup backed by Bain, Atlas (PDF, Chinese) A new GLP-1 player has emerged with $400 million funding from Bain Capital, RTW Investments, Atlas Venture and Lyra Capital plus a portfolio of three cardiometabolic candidates from Jiangsu Hengrui Pharma. Hengrui out-licensed the meds for $110 million in upfront and near-term payments, plus a 19.9% stake in the startup, called Hercules. One of the candidates is a dual GLP-1/GIP receptor agonist, the same mechanism as Eli Lilly’s tirzepatide. Other News of Note:  7. Under FDA scrutiny, Aurobindo's Eugia tallies a 5th Form 483 in less than a year 8. Radyus and Dt&CRO partner to bring more South Korean biotechs to the US

Following the success of the mRNA Covid vaccines, cancer vaccines are seeing renewed interest after years of middling results. But a group of researchers suggests that more attention needs to be paid not to what goes into those vaccines, but how the parts are put together. In a recent paper published in Nature Biomedical Engineering , researchers led by Northwestern University’s Chad Mirkin describe how the placement of different antigens in a cancer vaccine impacts its efficacy. The paper builds on past work done by Mirkin’s lab that suggests the structure, or how the parts of a vaccine are arranged, impact a vaccine’s efficacy, not just its components. And from cancer vaccine research, Mirkin, Boston University professor and the paper’s first author Michelle Teplensky, and Khosla Ventures partner Adam Margolin are co-founding a new biotech known as Flashpoint Therapeutics. Flashpoint is still in its early stages — it’s putting together a seed round — but the biotech already has a lead program where it plans to put its initial focus. In the paper, the researchers test a cancer vaccine that has two antigen classes: one that triggers cytotoxic T cells and one that triggers helper T cells. The researchers found that a dual-antigen vaccine helped to activate more immune cells to fight the cancer compared to a vaccine with just one kind of antigen. But rather than just injecting all the necessary components as most vaccines do (what Mirkin terms the “blender approach”), the researchers arrange the antigens on a tiny ball-like structure with nucleotide strings attached to antigens going every which way, called a spherical nucleic acid (SNA). In one vaccine, the helper T cell antigens are placed at the ends of the strings, while the cytotoxic T cell antigens are encapsulated in the middle of the ball. In the other vaccine, the researchers reverse that arrangement. That SNA technology previously served as the foundation of Exicure, which is currently winding down operations and recently ended its collaborations with AbbVie and Ipsen . “Think about it. When in the history of pharmaceutical development did structure not matter?” Mirkin said. “Sometimes it’s a single atom that makes a difference between a potent drug and one that’s totally ineffective. Yet the attention on structure in vaccine development is almost zero, or has been almost zero. And so we’re going to change that.” When they gave the dual-antigen vaccines to mice with cancer, they found that the ones that got the second vaccine, where the helper T cell antigens were on the inside, had much slower tumor growth and survived for longer. They also gave the vaccine in combo with an anti-PD-1 checkpoint inhibitor. Mice who got the combo therapy with the second vaccine also had slower tumor growth and survived for longer compared to the other mice who got only a checkpoint inhibitor or the combo with the first vaccine. In previous papers as well, Mirkin’s lab has shown that changing the structure of a vaccine, but keeping the same composition, can impact the efficacy of a cancer vaccine. To Mirkin and Margolin, the cancer vaccine field is poised for success soon. The field has been marked by repeated failures, both commercial and clinical, but has seen renewed interest following the successes of Moderna and BioNTech’s mRNA Covid vaccines. Both biotechs are now working on experimental cancer vaccines. “I’ve been in the nucleic acid medicine space for a long time, and in the early days of nucleic acids, [they said] ‘well, you’ll never be able to make enough of them to really produce drugs.’ That’s wrong. ‘Well, you’ll never be able to deliver them to the appropriate cells and tissues to make things work.’ Well, that’s wrong.” Mirkin said. “You go through low hanging fruit, you go through a lot of failures and you learn, and I think we learned a lot. I think we’ve learned that admix approaches, while they can be effective in certain cases, fail in many cases, and in the cancer vaccine space they have had real problems,” he continued. Following the cancer vaccine research that Mirkin and his lab have done, Flashpoint Therapeutics hopes to move those therapies into patients. Flashpoint will be based in Palo Alto, CA, where Margolin is located, but it also has a “strong center of mass in Chicago,” and will be operating virtually. Margolin declined to comment on finances beyond the seed round. Its first indication will be HPV — though as a therapeutic rather than a preventative vaccine, Mirkin noted. Outside of its internal pipeline, Margolin said that partnering will be a significant part of Flashpoint’s business, given Big Pharma interest in the space. Moderna is partnered with Merck on its cancer vaccine, where the duo recently released promising early-stage data on a melanoma mRNA cancer vaccine that could reduce the chances a patient’s cancer returned and was fatal. However, that data release was not without debate on how its statistical analysis was conducted . Aside from the co-founders, Flashpoint’s current team includes Mark Booth, current EVP, commercial at TerSera Therapeutics and former president of Takeda North America; Nick Manusos, former VP of business development at Takeda; Ray Nimrod, who represented the Broad in the CRISPR/Cas9 cases; and Marta New, CEO of Radyus Research. “We think the field is at a flashpoint — the temperature where a liquid can undergo a phase transition to a gas — and Flashpoint Therapeutics has the technology that can enable the step change efficacy increase that can create a similar phase change in cancer vaccines,” Margolin said.