Immuno-Oncology Deals Continue Hot Streak

22 March, 2021

So far in 2021, Immuno-Oncology venture funding, IPOs, and partnerships have been exceptionally high in deal volume and values. Cancer continues to be the leading therapeutic area in the number and size of early deals, and the immuno-oncology pipeline continues to be a rich source of both follow-on agents as well as first-in-class programs.

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Here are some recent examples, according to FierceBiotech:

Bicara Debuts with $40M from Biocon to Bankroll Bifunctional Antibodies

Though checkpoint inhibitors have become a game changer for certain cancers, they don’t work for everyone—that’s why so many companies are developing combination approaches to boost their efficacy. Bicara Therapeutics' strategy is to pair these drugs with bifunctional antibodies, which are designed to trigger a powerful immune response in and around the tumor, but spare healthy cells from side effects.

Bicara launches with $40 million in seed money from Biocon, one of the top biopharma companies in India, to develop a pipeline of bifunctional antibodies. That includes lead program BC101, which zeroes in on EGFR-expressing cancer cells and blocks TGFβ, a protein that normally suppresses tumor growth but can be co-opted by cancer cells to promote their growth.

Bicara is developing its bifunctional antibodies for use alongside approved drugs such as checkpoint inhibitors as well as on their own. It’s testing BC101 alone and in combination with Merck’s PD-1 blocker Keytruda in patients with advanced EGFR-expressing tumors whose cancer has stopped responding to the standard of care. The phase 1/2 study kicked off at sites in the U.S. and Canada in July 2020.

“Immune checkpoint inhibitors and targeted therapies have been important advances in cancer care—but unfortunately, far too many patients either fail to respond or stop responding as their tumors grow resistant. Our dual-action biologics have the potential to bring new hope to these patients,” said Bicara CEO Claire Mazumdar, Ph.D., in a statement.

Bicara hopes its bifunctional antibodies will combat the immunosuppressive effects of the tumor microenvironment and spark an immune response to attack the cancer.

From Partner to Part of the Family: Takeda Pulls the Trigger on Maverick Buyout

Takeda tapped Maverick Therapeutics and its T-cell engager platform in early 2017 to create new treatments for previously undruggable cancer targets. The $125 million deal also had a 5-year buyout option, which Takeda is now exercising for up to $525 million in an upfront fee and development and regulatory milestones.

Takeda will pick up Maverick’s COBRA platform and the pipeline the company has built around it, including lead candidate MVC-101, now known as TAK-186, which is in a phase 1/2 study in solid tumors that express EGFR. The Japanese pharma will also get its hands on MVC-280, now TAK-280, which is poised to enter the clinic in patients with B7H3-expressing solid tumors. Takeda expects to begin that trial in the second half of its 2021 financial year, which runs from April 2021 to March 2022.

The duo expects to wrap the deal in the April to June time frame, the companies said in a statement recently. Upon closing, Maverick employees will become part of Takeda’s R&D unit.

Amunix Scores $117M to Fuel T-cell Engagers, Cytokines for Solid Tumors

Exactly one year after Amunix Pharmaceuticals raised $73 million, the tech-licensing company turned cancer biotech is drawing another $117 million from the venture capital well. The funds will fuel the development of T-cell engager and cytokine treatments for solid tumors, including the advancement of its lead asset into the clinic.

Amunix is developing its lead program, AMX-818, for the treatment of solid tumors that express HER2. AMX-818 is a T-cell engager, a drug that’s designed to unleash an immune attack against tumors at the site of the cancer, with the goal of shrinking tumors without triggering cytokine release syndrome (CRS), an immune overreaction sometimes seen with CAR-T therapies.

The company presented data showing the drug shrank large tumors in mice at the virtual meeting of the European Society for Medical Oncology in September last year.

Beyond pushing AMX-818 into the clinic, the funds will support the development of Amunix’s other T-cell engagers, including programs targeting PSMA, EGFR and TROP2, as well as its cytokine programs.

Amunix’s investors Redmile Group, Venrock, Casdin Capital, Omega Funds, Frazier Healthcare Partners, Longitude Capital and Polaris Partners returned for the series B round. Viking Global Investors led the round, with new backers including Bain Capital Life Sciences and BlackRock also joining in.

New Approaches to Treating Cancer with Off-the-Shelf Immune-Stimulating Bispecific Antibodies

Bispecific antibodies—engineered drugs that can bind to two different tumor antigens—inhibit cancer growth by hitting multiple targets at the same time. Now three Johns Hopkins research groups are describing promising early evidence that designing bispecifics so they simultaneously bind to tumor antigens and T cells could offer a viable approach to creating off-the-shelf immuno-oncology drug treatments.

One Hopkins team zeroed in on p53, a well-known tumor-suppressor gene that becomes inactivated in some cancers, but that has proven exceptionally difficult to re-activate with drugs. The Hopkins researchers designed a bispecific antibody that could target the mutant p53 protein without interfering with intact p53 in normal cells, they explained in the journal Science.

The bispecific antibody they designed has one arm that attaches to a fragment of the mutated p53 protein and another that binds with a T cell. In mouse models of multiple myeloma, the bispecific antibody stimulated T cells to kill cancer cells bearing mutant p53, the researchers reported. That caused the tumors to shrink.

Even when the p53 target was present at “extremely low” levels on the surface of the tumor cells, the researchers wrote, the bispecific antibody was still able to activate T cells to fight the cancer.

Merck KGaA Pens $1B Upfront, Biobucks Pact with Debiopharm for Next-Gen Cancer Asset

Germany’s Merck, looking to beef up its cancer pipeline and move beyond its checkpoint inhibitor Bavencio in the future, has signed up to in-license a late-stage oncology asset from Swiss biotech Debiopharm.

The drug pact zeroes in on xevinapant (aka Debio 1143), an oral inhibitor of apoptosis proteins antagonists, which the companies say is the only medicine in its class in late-stage clinical development and “has the potential to be first in class.”

This is no early nor preclinical asset either; it’s working its way through a Phase 3 trial in a tough area, namely previously untreated high-risk locally advanced squamous cell carcinoma of the head and neck (SCCHN).

While an increasingly common cancer, there are few treatment options out there specific for it, and a number of big pharmas have seen setbacks against this target in recent years, including Merck and its partner Pfizer’s own Bavencio, which flopped in SCCHN last year in the so-called Javelin study.

It will hope to have a better aim here and is putting down €188 million upfront and up to €710 million in biobucks, or $855 million, a pretty small upfront and total consideration for a late-stage drug, and one with an FDA breakthrough tag.

Xilio Raises $95M to Take Twists on Yervoy and IL-2 into Clinic

Xilio Therapeutics has raised $95 million to take IL-2 and CTLA-4 immunotherapies into clinical trials. The series C positions Xilio to provide early clinical validation of anti-cancer agents that are designed to remain inactive until they reach tumors.

Immuno-oncology drugs are typically given systemically, causing them to trigger immune responses that affect healthy and cancerous tissues alike. The resulting adverse events are unpleasant and can prevent physicians from administering the most efficacious dose. Patients suffer from both the side effects and worse outcomes due to the use of suboptimal doses.

Xilio, formerly known as Akrevia Therapeutics, is built on a platform designed to minimize the effect of cancer drugs on healthy tissues. The potential of the platform has attracted a who’s who of VCs.

Rock Springs Capital led the series C round with support from new backers including Bain Capital Life Sciences, Deerfield Management and RA Capital Management. Existing Xilio investors including Atlas Venture, SV Health Investors and Takeda Ventures also contributed to the financing.

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