Allarity Therapeutics Europe ApS

With dovitinib snatched back from Allarity’s pipeline, it’s unclear whether this is the end of the road for the multi-kinase inhibitor. Already reeling from the controversial termination of its CEO, Allarity Therapeutics has now been told that Novartis is rescinding the rights to a troubled cancer drug after the biotech failed to keep up with its payments. Allarity, under its previous Oncology Venture moniker, licensed the rights to the small molecule multi-kinase inhibitor dovitinib from Novartis back in 2018. But Allarity revealed in an SEC filing yesterday that the Big Pharma had written to the biotech a week ago “indicating their decision to terminate the agreement based on material breach for lack of financial payment.” Novartis had once touted dovitinib as a highly promising kidney cancer drug based on the strength of mid-phase data. But by the time Allarity got interested, the candidate had shown itself unable to outperform Bayer’s Nexavar in a phase 3 trial of metastatic renal cell cancer patients previously failed by anti-angiogenic therapies. Allarity was willing to give the drug a second chance. It licensed the asset in return for an undisclosed package of upfront and milestone payments, hoping to prove dovitinib’s worth by using its DRP biomarker platform to better select tumor patients who could benefit. By 2022, the company was forced to abandon plans to develop the drug as a monotherapy for a type of advanced kidney cancer after the FDA responded to Allarity’s application with a refusal to file letter. The biotech responded by refocusing its pipeline on combination therapies. As part of that retooled strategy, Allarity launched a phase 1b/2 study of stenoparib, a PARP inhibitor, in combination with dovitinib for second-line or later treatment of metastatic ovarian cancer. In the filing yesterday, Allarity said it remains “fully committed and primarily focused” on a phase 2 trial of stenoparib in ovarian cancer. The biotech reiterated that “encouraging results” were seen from the first five evaluable patients in December 2023 from that study. With dovitinib snatched back from Allarity’s pipeline, it’s unclear whether this is the end of the road for the multi-kinase inhibitor. Fierce Biotech has asked Novartis whether it has any plans to pick up development of the drug. The loss of the dovitinib license isn’t the only drama at Allarity. The company first revealed in December that CEO James Cullem was leaving the company. In yesterday’s filing, Allarity explained that Cullem had been fired “for ‘cause’ under his employment agreement,” although Cullem has apparently disputed this rationale. Allarity also attached Cullem’s letter resigning from the biotech’s board last week, in which the former CEO accused the company’s directors of “acts and omissions … that I consider directly injurious to the company, its shareholders and its creditors.” “We and our continuing members of the board disagree with the claims made by Mr. Cullem in the resignation email and take exception to Mr. Cullem’s characterizations of facts and his conclusions,” the company added in yesterday’s filling. Cullem had only been in the CEO role since June 2022, when he took over after Steve Carchedi stepped down to “pursue other opportunities.” Cullem has been replaced by co-founder and board member Thomas Jensen.

Oncology Ventures met with more than 250 early-stage cancer startups in the past four months. On Wednesday, the New York City-based investment fund announced the three that stood out as deserving of its capital. The fund invested in the three startups — VivorCare, Gabbi and Health Universe — because they all demonstrated an ability to tackle a specific problem within the cancer care space, said Ben Freeberg, Oncology Ventures’ founder and managing partner, in a recent interview. Cancer — the second leading cause of death in the U.S. — causes an annual economic burden greater than $21 billion. There are plenty of startups developing technology to enable better cancer care and reduce spending, but it remains difficult for investors to separate truly impactful companies from the hype. In the case of Oncology Venture’s most recent investments, the three startups stood out as worthy of the fund’s money because they all had “the right business model at the right time with the right teams,” Freeberg declared. VivorCare There are startups on the market that promise to save money by facilitating more personalized cancer care — such as simBioSys and Imagene AI — but VivorCare is the first platform that Freeberg has seen that is focused on cancer survivors. There are about 18 million cancer survivors in the country. After they finish their cancer treatments like chemotherapy and surgeries, they often feel “thrown back into the world,” Freeberg pointed out. “Your body just went through an incredible amount of pain, medicine and discomfort. But the oncologist is treating the next patient. You go get your checkups and scans every few months with your primary care doctor, but only 5% of them are well-trained and survivorship care guidelines. So you have this lost, confused patient that we know is in and out of the hospital all the time. How do you help them?” he explained. On VivorCare’s platform, patients are assigned nurse practitioners who are trained in survivorship care, and they design personalized care plans based on each patient’s medical history and life circumstances. The platform reduces patients’ fear of cancer recurrence by directing them toward the right scans and tests, as well as helps save money by keeping patients out of the hospital, Freeberg said. Gabbi There’s no shortage of early detection companies on the cancer care market, with companies like Grail, Freenome and Kheiron on the long list. Freeberg said that Oncology Ventures met with “a ton of” early detection-focused companies, but Gabbi was the most impressive because it’s “laser-focused on breast cancer and has a best-in-class proprietary data algorithm.” The algorithm determines a patient’s risk level of developing breast cancer based on a comprehensive set of data “that is more precise and accurate” than the one used in the Gail Model, which is the leading tool to help determine breast cancer risk to date, Freeberg explained. For example, a young female patient who is at high risk of developing breast cancer because she has dense breast tissue shouldn’t be getting a mammogram, because that really wouldn’t show anything. Instead, she should be getting something like a breast MRI or CT scan. Gabbi is building its platform so that in a case like this, it can step in and immediately direct this patient’s care team to schedule a breast MRI or CT scan. “This journey is normally nine months. Someone finds a lump, they go and get a mammogram, and then it comes back inconclusive because it wasn’t the right test. Then they go back to get a second mammogram three months later. There’s the same inconclusive results because again, it’s still the wrong test. Then they finally get an MRI, but it’s nine months later and their breast cancer just went from stage one to stage two to stage three, and their chance of survival went down from 99% to about 30%,” Freeberg said. In his view, most early detection startups don’t have a focus on helping patients during this specific phase of the cancer care journey: when the patient knows there is something wrong but needs help navigating the early steps on the cancer care process. Health Universe It’s challenging to determine which startups will end up winners in the healthcare AI and machine learning market, Freeberg said. Because of this uncertainty, the company chose to invest in Health Universe, a company that instead provides the underlying infrastructure to support the use of AI in healthcare settings. “This is a pick and shovel approach. During the gold rush, the people who made the most money were the ones who sold the picks and the shovels to the people mining for gold. So that’s exactly how we’re feeling here with Health Universe,” Freeberg declared. The startup is essentially “building GitHub, but purpose-built for healthcare AI researchers,” he explained. Researchers at large cancer centers and institutions go through a great deal of trouble to develop AI models. They’ll spend months developing a model, proving that it works and publishing research about it. But oftentimes, these tools just end up sitting on a shelf instead of being used in care settings. Health Universe is building a platform to actually commercialize and scale those models into the healthcare ecosystem, Freeberg said. 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