Immunai Launches With $20M Seed Funding And Plan To Map The Immune System

Immunai came out of stealth mode Thursday with two things: a mission to map the entire immune system and its functions using machine learning, and a capital infusion of $20 million in seed funding.

Two Israeli investment firms, Viola Group and TLV Partners, led the seed round for the New York City-based company that is building the largest proprietary data set in the world for clinical immunological data for better detection, diagnosis and treatment of disease. By leveraging single-cell technologies and machine-learning algorithms, Immunai has mapped out millions of immune cells and their functions, Immunai CEO Noam Solomon told Crunchbase News.

Over the last several years, cell therapies and cancer immunotherapies have become the latest innovation in treatment options. Immunotherapy uses the body’s immune system to target and destroy cancer cells.

Cancers, such as melanoma and lung cancer, have responded well to immunotherapy drugs, also known as immune checkpoint inhibitors. However, the immune system is complex and it is not yet known how drugs affect immune cells. And for costly cell therapies, a slight variation in cell therapy products can have a significant influence on a patient’s response to the therapy, Solomon said.

“Drugs that improve immune response to cancer are transformational for some patients, but don’t work in 50 (percent) to 70 percent of other patients,” he said. “We are trying to understand what therapies work—when they work—by measuring the immune system at high resolutions. We can then use those insights to improve the design of combination therapies.”

Immunai leverages single-cell technologies to profile cells from a blood sample. Its proprietary database then uses machine-learning algorithms to map the hundreds of cell types and their states to create an immune profile. That profile is then used to support biomarker discovery and insights that identify how a cell responds to its changing environment.

Solomon and Immunai CTO Luis Voloch founded the company in January 2019, and were later joined by cancer immunology scientist Ansu Satpathy, and data scientist Danny Wells, a member of the Parker Institute for Cancer Immunotherapy.

The company has offices in San Francisco and Tel Aviv, Israel, and has already established clinical partnerships with 10 medical centers, as well as multiple commercial partnerships for cell therapy and checkpoint blockade with biopharma companies.

Immunai closed on the new round of funding three months ago and will use it to further the development of its technology and business functions while expanding its team of scientists, engineers and machine-learning experts, Solomon said.

“We have closed a substantial contract with a Fortune 100 company and will sign a few others in the next few weeks,” he said. “We are providing partnership models with hospitals, academia, biotech and biopharma partners with a goal of finding biomarkers for resistance and toxicity for drugs and to help partners accelerate the FDA approval of their drugs.”

Source. Crunchbase, May 14, 2020

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ArsenalBio emerges from stealth with $85 million and a dream team to fight cancer

The story behind ArsenalBio begins with Sean Parker’s Institute for Cancer Immunotherapy.

Founded in 2016, the Institute has been instrumental in providing a space for the top researchers into cancer across different fields to collaborate and communicate on the latest breakthroughs in settings that range from formal meetings to informal retreats.

It was at one of these informal retreats that luminaries like Dr. Bradley Bernstein, a professor of pathology and researcher at the Broad Institute; W. Nicholas Haining, vice president of discovery oncology at Merck Research Laboratories; Dr. Alexander Mason, an associate professor of immunology at the University of California San Francisco; and E. John Wherry, a professor of systems immunology at the University of Pennsylvania, began to talk about the current state of the art in cancer diagnostics and therapies and the technologies powering cell-based therapies to potentially cure cancer.

Parker suggested that rather than have each of these researchers spin their technologies out into separate companies that would develop one discrete innovation that would be needed to get to a cell-based therapy for solid tumors, the researchers should combine forces and build an arsenal of tools for the discovery and development of potential cures.

“I look at this as a tour de force of a combination of bringing academics together who typically would start separate companies and get them working together with a dream team management team,” says Beth Seidenberg, the founder of Westlake Village BioPartners and an investor in ArsenalBio. 

Indeed, the management team is just as impressive as the researchers behind the project. Kleiner Perkins founding partner Brooke Byers recruited Dr. Ken Drazan to serve as a consultant to the company as it was getting off the ground. Drazan, now the company’s chief executive, was the former president of the cancer research and diagnostics startup Grail and has served as an executive and founder at a number of healthcare startups and large medical companies.

With Drazan on board, the company quickly recruited the rest of the management team: Jane Grogan, the former principal scientist in charge of adaptive tumor and cell therapy at Genentech; Michael Kalos, the former vice president of immuno-oncology and cell therapies at Janssen Oncology; and Tarjei Mikkelsen, the former vice president of biology at 10x Genomics.

ArsenalBio initially formed as a shell company with seed financing from investors in 2018, basically on the back of its technical team and nascent executive staff.

Alongside the powerhouse executive team and scientific founders, ArsenalBio has now raked in $85 million in financing from investors including Westlake Village, the PICI, Kleiner Perkins, the University of California San Francisco Foundation Investment Company, Euclidean Capital and Osage University Partners.

The idea is to improve the ability of T cell therapies to fight a broader range of cancers more effectively. T cell treatments have already shown amazing promise with certain types of cancer, but have not been able to effectively treat the solid tumors that represent the deadliest manifestation of the disease.

To tackle solid tumors like sarcomas, carcinomas and lymphomas, doctors need to figure out how to deliver the T cells first to the area around the tumor and then to the right tissues where the tumor is spreading. That requires a set of biological instructions, which, in many cases have yet to be discovered.

“We need to get the cells to deal with the tumor microenvironment,” says Seidenberg.

T cells are the human body’s natural response to fighting off infections and disease. Cancers essentially turn off that natural immune response by signaling to the cells that a tumor is actually something they should ignore rather than attack.

“Our goal is to program [cells] by delivering additional  instructions to tell the T cell to ignore the instructions from the tumor… to ignore the signals,” says Drazan. 

The company is still developing its first product strategies now, Drazan says. But ArsenalBio will be selling two different types of technologies. The first will be the medicines themselves that will be used to cure certain types of cancer. The second will be the sequences of genes that can be used to counteract or override the signals that are coming from different types of tumors which prohibit T cells from performing their normal functions.

Drazan compared those sequences to programs on GitHub that other researchers, clinicians and companies could use to develop their own therapies.

“ArsenalBio allows us to rewrite vast stretches of code to give T cells dramatic new functions — that means they can be made to be more effective at killing cancer and a broad spectrum of other diseases,” said Sean Parker, founder and chairman of PICI and ArsenalBio director, in a statement. “It’s also very rewarding to see ArsenalBio born from the deep collaboration of PICI investigators — who worked together across research centers, hospitals and universities on the science behind these technologies. The company’s very existence demonstrates how much faster and better we can get therapies from bench to bedside when we collaborate and put patients first.”

Source. TechCrunch, Johnathan Schreiber, October 17, 2019

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Amphivena raises $62M Series C round to develop bispecific antibody in solid tumors

A company developing a bispecific antibody that already has clinical data in blood cancers has raised more than $60 million in its latest venture capital funding round that it plans to use to advance the drug in solid tumors.

South San Francisco, California-based Amphivena Therapeutics said Tuesday that it had raised $62 million in a Series C round, which NanoDimension and Qiming Venture Partners co-led. New investors included Clough Capital, Aju IB, Korys Merieux, Kaitai Capital, Industrial Investors and Nawton Limited, along with insider investors MPM Capital and funds managed by Tekla Capital Management and Franklin Berger.

The company is developing a bispecific T-cell engager antibody called AMV564, which targets CD33 and CD3. Such antibodies are immunotherapies designed to work by targeting both cancer cell-surface proteins and proteins expressed on the surfaces of T cells, enabling the latter to kill the former. The company has been developing the drug for acute myeloid leukemia and myelodysplastic syndromes, and it is currently in a Phase I study among relapsed or refractory AML.

The drug is designed to eliminate myeloid-derived suppressor cells, or MDSCs, while sparing normal neutrophils and monocytes. In addition to MDS and AML, the drug is in a Phase I study for solid tumors that the company said is open for enrollment, though searches for the name of the company of the drug on ClinicalTrials.gov only turned up the MDS and AML trials.

Updated data from the AML study presented at the European Hematology Association’s 2019 annual meeting in July from 33 patients across nine dose cohorts showed a complete response, a complete response with incomplete hematological recovery and a partial response. Grade 1 and 2 cytokine release syndrome – a side effect sometimes observed with bispecific antibodies – also occurred.

Amgen’s Blincyto (blinatumomab) is a bispecific T-cell engager currently on the market. The drug targets the CD19 antigen in acute lymphoblastic leukemia. Amgen is developing another bispecific antibody, AMG 420, that targets the BCMA antigen in multiple myeloma and produced a 70 percent overall response rate among patients who received the drug at 400 micrograms, the dose recommended for further study. Another bispecific antibody on the market is Roche’s Hemlibra (emicizumab-kxwh), used to treat hemophilia A.

In late June, the Food and Drug Administration issued a draft guidance for companies developing bispecific antibodies, in oncology as well as other disease areas. However, an expert said the guidance was flawed because it did not distinguish between Blincyto and Hemlibra’s very different mechanisms of action, despite both products falling under the category of “bispecific.”

Source. Medcity News, September, 24, 2019,  Alaric Dearment

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Themis raises €40M to run phase 3 chikungunya vaccine trial

Themis has raised €40 million ($44 million). The Merck-backed series D positions Themis to take its chikungunya vaccine through a phase 3 trial and move the lead candidate from its immuno-oncology R&D program into humans.

Austria’s Themis filed to raise €40 million through an IPO in Amsterdam last year only to hit pause on the plan in the face of “adverse market conditions.” The u-turn left Themis without the vast majority of the €30 million it planned to set aside for the phase 3 chikungunya vaccine trial, forcing it to look into “all strategic options” to fund further development.

Last month, Merck’s investment in Themis as part of a $200 million vaccine R&D deal made it clear that the biotech was lining up a private financing round. Now, Themis has shared further details of the round.

Themis has raised €40 million in a series D round co-led by new backers Farallon Capital and Hadean Ventures, which are respectively based in the U.S. and Scandinavia. Merck and Adjuvant Capital, both of which are U.S.-based, also invested in Themis for the first time, resulting in the biotech bringing in significant funding from North America.

“We definitely wanted to broaden our investor base and increase our financial flexibility. It was a deliberate decision to look for U.S. investors,” Themis CEO Erich Tauber said.

Existing members of the biotech’s syndicate such as Global Health Investment Fund, which led a €10 million series C at the start of last year, also participated, giving Themis €40 million to run a phase 3 chikungunya trial while advancing multiple other programs. Themis already has vaccines against Zika and Lassa fever in the clinic and has other infectious disease candidates in preclinical testing.

The chikungunya phase 3 is due to start in the coming months, enroll thousands of participants and deliver data around the middle of next year. Themis is considering taking the vaccine to market itself.

“It’s definitely a possibility to market a product like chikungunya as a small company. Another model is to partner this globally or regionally. We are working on all three tracks right now,” Tauber said.

Themis is also applying its measles technology to oncology, adding immune modulators and other agents to augment the natural oncolytic activity of the virus. The oncology R&D program started last year and, by leveraging the same manufacturing platform as the infectious disease pipeline, Themis has moved forward quickly. Two oncology drugs are due to enter the clinic by the end of next year.

Source. BioFierce, Nick Paul Taylor, September, 18, 2019

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BioNTech raises $325M series B round to advance cancer pipeline

BioNTech has raised $325 million (€289 million) in a private fundraising round. The series B positions the immuno-oncology player to advance its multidrug clinical pipeline and grow its manufacturing footprint.

Mainz, Germany-based BioNTech operated for a decade without raising a headline-grabbing round, opting instead to run on money from its billionaire majority owners and partnership fees, such as the $310 million in upfront and near-term milestones put up by Genentech. That changed early in 2018 when BioNTech raised $270 million in a Redmile Group-led series A round.

Now, BioNTech has raised $325 million in a round led by Fidelity Management & Research Company. Other existing investors including Redmile and the Struengmann Family Office contributed to the series B round, but two-thirds of the cash came from new investors.

BioNTech will use the cash to build on the work facilitated by its series A round. The company now has seven candidates in eight clinical trials. BioNTech’s most advanced assets are derived from its mRNA platform, which established it as a rival to CureVac and Moderna. But the pipeline now also features cell therapies, small molecules and immune checkpoint modulators.

The expansion and advancement of the pipeline has dialed up BioNTech’s fundraising needs. Some of the additional cash will fund studies of the candidates. Another slice will enable the expansion of BioNTech’s manufacturing capacity to support drug development and potentially commercialization.

Talking to Reuters at the time of the series A round, BioNTech identified the need to “invest enormously in manufacturing” as a key driver of its ongoing hunger for large sums of money. Reports earlier in the year suggested that BioNTech would sate that hunger with an $800 million IPO around the end of 2019. Crossover investors are among the organizations to contribute to the series B round.

In returning to private investors, BioNTech has raised one of the largest ever private biotech rounds in Europe. Immunocore raised a $320 million series A round in 2015, but few other European biotechs have raised triple-digit private rounds, let alone secured hauls of more than $300 million.

Source. FierceBioTech, Nick Paul Taylor, July 9, 2019

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Houston-based AlloVir Raises $120 Million Series B For Virus-Targeting Immunotherapies

By James Rowley 

Houston-based biopharmaceutical company AlloVir (formerly known as ViraCyte) recently announced $120 million in Series B funding. Fidelity Management and Research Company led the deal. Participating investors include Gilead Sciences, F2 Ventures, Invus, Leerink Partners, Redmile Group, EcoR1 Capital, and Samsara BioCapital.

AlloVir is also the first venture to publicly join the portfolio of ElevateBio, a recently-launched Cambridge, MA-based company which aims to advise and assist cell and gene therapy upstarts throughout the discovery, development, and commercialization lifecycle. Earlier this month, ElevateBio announced it raised $150 million in venture funding led by UBS Oncology Impact Fund. AlloVir financiers Samsara BioCapital, Redmile Group, and EcoR1 Capital also back ElevateBio.

According to a press release published by ElevateBio on Wednesday, AlloVir “is a leading innovator in allogenic, off-the-shelf, multi-virus specific T-cell immunotherapies.” What does that mean?

Let’s break it down:

“Allogenic,” meaning, basically, that biological material used to create the company’s treatments are sourced from (compatible) donors, rather than from the patient themselves.

 

“Off-the-shelf,” in this specific case, means that AlloVir’s products could be integrated into a treatment regime immediately, sitting in storage in the meantime. In the context of T-cell therapeutics (which we’ll get to in a moment), a treatment wouldn’t be “off the shelf” if it required sampling, modifying, and culturing cells from the patient.

 

Jumping out of order a bit: T cells are a foundational part of the human immune system. There are many types of T cells, all of which play specific roles in responding to infection. Cancer patients, HIV positive people, transplant recipients, people with chronic infections, people with autoimmune diseases, or other immuno-suppressed populations have lower counts of these key cells. This makes them more susceptible to infection and illness.

 

According to AlloVir, its primary T cell therapy offering, Viralym-M (ALVR105), can target six different viral pathogens, including: BK virus (which can affect kidney transplant patients), cytomegalovirus, adenovirus, Epstein-Barr virus (which causes mononucleosis, aka “mono”), JC virus, and human herpesvirus 6.

Preliminary research findings on the company’s next therapy, ALVR106, which “targets four common and devastating community-acquired respiratory viruses” were published in the journal Haematologica last month.

So, basically, AlloVir is in the business of sourcing and training immune cells from healthy donors to fight viral infections in folks with compromised immune systems.

AlloVir’s therapies are still in clinical trials. The company published results from its Phase 2 study in the Journal of Clinical Oncology, finding that 93 percent of treated patience "demonstrated a clinical response (or met clinical response criteria) following treatment with Viralym-M.” ElevateBio CEO David Hallal told Xconomy that AlloVir will start Phase 3 trials of Viralym-M in 2020.

AlloVir’s as-yet-unnamed ALVR106—targeting respiratory syncytial virus, influenza, parainfluenza virus, and human metapneumovirus—is expected to enter the first phase of clinical trials within the next 12 months, according to coverage in Biospace.

This latest funding round brings AlloVir’s total backing to at least $159 million. The company (which at the time was still called ViraCyte) filed a Form D with the SEC in September 2018. The regulatory filing disclosed the company closed at least $30 million out of a targeted $50 million funding round. It’s unclear whether ViraCyte has closed the remaining $20 million from that round.

Prior to that deal, the company raised $8.99 million in grant funding from the Cancer Prevention and Research Institute of Texas.

Note. The Crunnchbase News team are not doctors or medical researchers, and we don’t play them on the internet. If we got any part of this wrong, please email the author: jason@crunchbase.com

Source. Crunchbase, James Rowley, May 23, 2019

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