SynAffix BV

SAN FRANCISCO, CA, USA I October 28, 2024 I Kivu Bioscience, a biotech company developing next-generation antibody-drug conjugates to deliver best-in-class therapeutics, announced today the close of a $92 million Series A financing round led by Novo Holdings, with participation from Gimv, Red Tree Venture Capital, HealthCap as well as existing investors BioGeneration Ventures, M Ventures, and Brabantse Ontwikkelings Maatschappij (BOM). The funding will be used to advance multiple oncology programs into the clinic. “We’re excited to have the backing of this top-tier syndicate, who share our vision for developing kinder, gentler ADC therapies that are more effective and safer for cancer patients,” said Mohit Trikha, Ph.D., President and Chief Operating Officer of Kivu Bioscience. “Our next-generation ADCs address key limitations of current treatments, particularly by engineering stable ADCs we have the potential to reduce off-target side effects which in turn widens the therapeutic window. This funding allows us to accelerate the development of our Topo1i-based ADC pipeline to the clinic, where we plan to quickly differentiate Kivu’s products from past endeavors. We are inspired by patients and driven by data to accelerate transformative medicines.” Kivu is utilizing the proprietary Synaffix site-specific linker-payload technology to deliver next-generation ADC therapeutics. The GlycoConnect™ technology, which couples the linker specifically to asparagine-297, delivers a clean, highly homogenous product. This technology not only offers a clear manufacturing advantage over other conjugation techniques, but also produces an ADC that is more stable, significantly reducing off-target side effects. This approach widens the therapeutic window, improving the safety profile for patients. Addressing the discontinuation and dose-reduction rates seen with ADCs will establish Kivu’s place in treating solid tumors. “ADCs are an established modality for treating cancer, but tolerability issues limit the pace of advancement in the space. The early data from Kivu suggested superior stability of the constructs, clearly pointing toward targets that have been pursued by earlier generations of ADCs, but which failed due to high rates of drug discontinuation. That data in the hands of this outstanding management team tells an incredibly compelling story – one we are excited to support. We see tremendous opportunity for the Kivu pipeline to produce a new generation of targeted therapies as best-in-class novel ADCs across a broad range of cancers,” said Daniel O’Connell, M.D., Ph.D., Partner, Novo Holdings. Kivu’s assets are in late-stage preclinical studies and target areas of high unmet medical need. The company’s platform is differentiated by its superior ability to avoid the issues seen with currently marketed ADCs and addresses key limitations related to stability and therapeutic precision and delivery. The company is set to begin Phase 1 trials for its lead candidate in 2025. About Kivu Bioscience Kivu Bioscience is pioneering next-generation antibody-drug conjugates (ADCs) in oncology. The company’s proprietary linker-payload technology delivers enhanced safety and efficacy, minimizing off-target effects to improve patient outcomes. With multiple ADC programs in development and a team of industry veterans, Kivu is advancing its first two lead candidates to clinical trials expectedto begin in 2025. The company is headquartered in San Francisco, CA. For more information, visit www.kivubioscience.com . About Novo Holdings A/S Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation. Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novonesis A/S (Novozymes A/S) and manages an investment portfolio with a long-term return perspective. In addition to managing a broad portfolio of equities, bonds, real estate, infrastructure and private equity assets, Novo Holdings is a world-leading life sciences investor. Through its Seed, Venture, Growth, Asia, Planetary Health Investments and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development. As of year-end 2023, Novo Holdings had total assets of EUR 149 billion. www.novoholdings.dk . SOURCE: Kivu Biosciences

The Dutch biotech Synaffix has long been one of the top partners for biopharma companies working in antibody-drug conjugates. Now the company is spinning out a pipeline of drugs into a new company. Kivu Bioscience launched Monday with $92 million and a pipeline of three of Synaffix’s ADCs. In the race to create next-gen ADCs, Kivu said it hopes to make Topo1i-based medicines that are more durable, can be dosed higher and have less toxic impact on healthy parts of the body. The startup said it anticipates entering human trials with its first solid tumor ADC, codenamed KIVU-107, next year. A major investor is Novo Holdings. Daniel O’Connell, a Novo Holdings venture partner and Kivu board member, said the pitch was originally about manufacturing drugs, not carrying a pipeline. “The original pitch on hearing it was ‘OK, that’s a pretty interesting manufacturing play,'” O’Connell told Endpoints News . But as it investigated, Novo came to believe that the manufacturing benefit “really probably translates to a clinical benefit,” O’Connell said. “You have a cleaner, more stable product that’s going to ultimately deliver target payload right to the tumor without the indiscriminate loss of payload, which in other words is just naked chemo,” he said. Kivu’s president and operating chief Mohit Trikha is quite familiar with the busy ADC field. Trikha recalls first working on ADCs while at Centocor around the turn of the century. He worked on them again and again at later stops at Triphase Accelerator, Genentech and then AbbVie, where he led early development in the pharma’s oncology unit. The first generation of ADCs were potent but too toxic, Trikha said. Kivu hopes to overcome that by attaching the payload to the right spot on the antibody. It’s all about “location, location, location,” Trikha said. “This site-specific conjugation gives you very good stability,” the Kivu president said. Some of the previous conjugation technologies, he said, can be unstable and fall apart. It believes its linker technology will help the antibody hit fewer non-tumor cells than other ADCs. Trikha, who can speak somewhat philosophically, said that years ago he read Siddhartha Mukherjee ‘s book “The Emperor of All Maladies,” which chronicles the broad history of cancer. “You need guts to get in and you need guts to get out,” Trikha said. “This is a tough disease and most of our approaches have not panned out. We’ve had huge transformative gains in some cancers, but other cancers still remain a big unmet medical need.” The biotech — named after a Synaffix executive’s favorite lake on the border of the Democratic Republic of the Congo and Rwanda — has two additional preclinical ADCs for solid tumors. And oncology might not be the only malady that Kivu tackles. The biotech’s pipeline might eventually expand into autoimmune diseases, O’Connell said, though that is likely far in the future. “Within oncology, we’re going after targets that people have heard of,” O’Connell said. “We’re not going after targets with huge numbers of competitors, but we’re not interested in exploring novel biology.” He said the company could take a similar approach in autoimmune, “in a way that would deliver payloads that might have broader systemic issues if delivered as naked molecules.” Novo has been bullish on the ADC field, investing in other startups like Adcendo and Myricx Bio . Joining Novo in Kivu’s Series A were Gimv, Red Tree Venture Capital, HealthCap, BioGeneration Ventures, Merck KGaA’s M Ventures and Brabantse Ontwikkelings Maatschappij.

Dive Brief:Kivu Biosciences, a San Francisco-based biotechnology startup developing targeted drugs for cancer, has raised $92 million in a Series A round, the company said Monday.Kivu will use the funds to advance technology it claims can help address some of the current limitations of antibody-drug conjugates, or ADCs. Its technology, Kivu says, can yield ADCs that are more precise and stable when traveling to their targets in the body, which should reduce the risk of side effects. Kivu plans to start its first clinical trial in solid tumors next year.Novo Holdings led Kivu's Series A round, which also involved six other venture firms, including Gimv, Red Tree Venture Capital and BioGeneration Ventures.Dive Insight:ADCs, which chemically link a tumor-killing toxin to a targeted antibody, have captured the attention of biotech investors and pharmaceutical companies. While the drug type has been studied for decades, a series of recent technical advancements, clinical successes and approvals have driven interest higher, leading to dealmaking and the formation of new companies with twists on the concept.Some startups are using different payloads or linker molecules, for instance. Others are merging ADC drugs with different technologies. All aim to overcome some of the shortcomings of existing ADCs with drugs that are more precise or potent.Kivu is joining in. Chief Operating Officer Mohit Trikha said that ADC tolerability has limited how large of a dose developers can safely use, or cause people to stop treatment. Unstable linker molecules can also cause ADCs to release their payload prematurely, blunting their benefit.Kivu is using technology from Synaffix, which Lonza bought in 2023, to develop its ADCs. It claims to have proprietary linkers that stay stable for longer, ensuring the payload theyre attached to a commonly used ADC toxin called a topoisomerase inhibitor is precisely delivered.This technology allows us to target tumors and avoid systemic toxicity, Trikha said in an interview. Sometimes I refer to this as kindler, gentler ADCs, because when you think about a cancer patient you have to think about a benefit-to-risk ratio.Kivu is zeroing in on solid tumors earlier ADC technologies have struggled to treat due to toxicity and efficacy limitations, said Trikha, a former venture partner at Apple Tree Partners and oncology executive at AbbVie before that. The company didnt say which specific tumors its starting with, however.The companys name is a reference to Lake Kivu, which is on the border of the Democratic Republic of the Congo and Rwanda. The lake sits to the side of an active volcano and contains hundreds of cubic kilometers of carbon dioxide and methane. Though Lake Kivu is currently stable, it has the potential to one day explode in whats termed a limnic eruption, releasing a massive cloud of greenhouse gases.The company believes that situation resembles the tense work of unlocking the powerful potential of ADCs, while carefully managing [their] risks and side effects, Trikha said. '