Eikonoklastes Closes Oversubscribed Series A Financing, Helping to Advance Immunotherapies Toward Clinical Trial Stage

On June 28, 2021 Eikonoklastes Therapeutics, a preclinical stage biopharmaceutical company, reported the closing of a Series A financing round, less than a year after the company emerged from stealth with its seed financing (Press release, Eikonoklastes Therapeutics, JUN 28, 2021, View Source [SID1234584423]).

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Eikonoklastes is developing next-generation tissue factor (TF) immunotherapies to treat a broad range of cancers beginning with Triple Negative Breast Cancer (TNBC), an aggressive and often lethal form of breast cancer that comprises 15% of all breast cancers. The therapies also have the potential to address several other non-cancer diseases with significant unmet clinical need. The company has engineered molecules which attack three key components of the tumor microenvironment (the tumor cells, the diseased neovasculature, and tumor stem cells) by activating the body’s natural immune system and is therefore efficacious without harming normal cells.

The most recent round of funding, led by CincyTech with participation from New York-based Elk Capital Ventures and others, will support Investigational New Drug (IND) enabling studies for Eikonoklastes Therapeutics’ L-ICON3 immune conjugate platform. Details of the financing were not disclosed, but Eikonoklastes Chief Executive Officer, Bruce Halpryn, Ph.D., said the initial target was significantly oversubscribed.

Halpryn said the new investor syndicate will help Eikonoklastes meet its objective of treating one of the most deadly cancers in medicine and establish a foundation for future growth. "We are thrilled to welcome Elk Capital and Jobs Ohio to our strong base of investors, as we seek to develop innovative medicines to treat patients with cancer and other severe diseases with substantial unmet clinical need," Halpryn said.

"We have made tremendous progress and have even bigger plans ahead of us," said Sam Lee, MD/MBA co-founder and Chief Business Officer. "We will continue strategically allocating capital to efficiently develop L-ICON3 toward the clinic and expand our platform capabilities."

"The Eikonoklastes management team has an impressive track record of building significant value," said Tom Finn, independent board member of Eikonoklastes and retired president of Procter & Gamble Global Personal Health Care. "The Series A financing positions the company to continue forging ahead towards bringing much needed new medicines to patients."

Jobs Ohio, Rev1, and other undisclosed investors also participated in the Series A financing.

BioVaxys Announces Non-Brokered Private Placement

On June 28, 2021 BioVaxys Technology Corp. (CSE: BIOV, FRA:5LB, OTCQB:BVAXF) ("BioVaxys" or the "Company") reported a non-brokered private placement (the "Private Placement") consisting of up to 9,090,909 units ("Units") at a price of $0.22 per Unit for total gross proceeds of up to approximately $2,000,000 (Press release, BioVaxys Technology, JUN 28, 2021, View Source [SID1234584456]). Each Unit consists of one common share (a "Common Share") and one whole Common Share purchase warrant (a "Warrant"). Each Warrant is exercisable for one additional Common Share at an exercise price of $0.50 for a period of 30 months.

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All securities issued pursuant to the Private Placement are subject to a statutory hold period of four months and one day from the date of issuance. The Company may pay cash finder’s fees on all or a portion of the Private Placement.

The Company intends to use the net proceeds of the Private Placement to advance its research and development programs and for working capital. Closing of the Private Placement is subject customary conditions of closing, including the approval of the Canadian Securities Exchange, and is expected to complete within the next week.

Bellicum Enters License Agreement with UNC Lineberger and Mass General for Use of CaspaCIDe® Safety Switch

On June 28, 2021 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported it has entered into a license agreement with the University of North Carolina Lineberger Comprehensive Cancer Center (UNC Lineberger) and Massachusetts General Hospital (Mass General) covering certain intellectual property and technology rights regarding the company’s CaspaCIDe (inducible caspase-9, or iC9) safety switch and related technologies, and the use of rimiducid (Press release, Bellicum Pharmaceuticals, JUN 28, 2021, View Source [SID1234584392]). CaspaCIDe may facilitate the use of cell therapies where cytokine release syndrome and neurotoxicities have been observed, in the pursuit of novel targets with on-target/off-tumor safety concerns, and in conjunction with next generation higher potency cell therapy constructs.

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This agreement with UNC Lineberger and Mass General covers four CAR-T programs incorporating Bellicum’s technology currently in development, two of which are owned by UNC Lineberger and two of which are co-owned by both institutions. Under this agreement, upon out-license of each program to an industry partner, Bellicum will receive an upfront payment and be entitled to a percentage of certain consideration paid to the institutions by the industry partner and a single digit percent royalty on the global sales of the product. Additional details of the financial arrangements are not disclosed.

"We are thrilled by the opportunity to expand the impact of our CaspaCIDe technology to benefit patients through this agreement with leading oncology research and treatment centers of excellence," said Rick Fair, President and CEO of Bellicum Pharmaceuticals. "We believe the agreement reflects the potential value of our switch technology, which may enhance the benefit/risk profile of cell therapies. We continue to incorporate the technology into our internal programs and intend to make it more broadly available via external collaborations."

"The unique inducible caspase-9 technology covered by this agreement has the potential to improve the safety profile of cellular immunotherapies, reduce the risk of serious adverse events, and improve patient outcomes," stated Gianpietro Dotti, M.D., Co-leader, Immunology Program, UNC Lineberger. "We are pleased to incorporate Bellicum’s CaspaCIDe into four of our promising cell therapy constructs."

About CaspaCIDe

CaspaCIDe (inducible caspase-9, or iC9) is Bellicum’s chemical induction of dimerization (CID) safety switch technology designated to eliminate cells in the event of toxicity. The CaspaCIDe switch consists of the CID-binding domain coupled to the signaling domain of caspase-9, an enzyme that is part of the apoptotic pathway. Infusion of rimiducid is designed to trigger activation of this domain of caspase-9, which in turn leads to selective apoptosis of the CaspaCIDe-containing cells. In clinical studies, use of CaspaCIDe has resulted in clinical improvement in most patients as early as 24 hours after rimiducid administration. Further, because CaspaCIDe is designed to be permanently incorporated into Bellicum’s cellular therapies, the safety switch has the potential to be available for use when needed long after the initial therapy is delivered.

Intelligent Medical Objects and Multiple Myeloma Research Foundation Partner to Enhance Data for Clinical Research

On June 28, 2021 Intelligent Medical Objects (IMO) a healthcare data quality and enablement company and market leader in medical terminology solutions, and the Multiple Myeloma Research Foundation (MMRF), a leading cancer nonprofit organization dedicated to accelerating a cure for multiple myeloma, reported a partnership to further improve the utility of the clinical data from its MMRF CureCloud and CoMMpass clinical trials (Press release, Multiple Myeloma Research Foundation, JUN 28, 2021, View Source [SID1234584424]).

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The partnership will expand data utility of the clinical data generated by the landmark CureCloud and CoMMpass research programs that are used by the MMRF’s partners to drive precision treatments for myeloma patients. The added capabilities provided by IMO’s data normalization services will enhance the utility of the MMRF’s data for use cases such as patient identification for clinical trials, cohort selection for health outcomes research, and the enhanced ability to provide analytic precision to the MMRF’s real-world data sources.

"We are looking forward to partnering with IMO to streamline data analysis," said Steven Labkoff, MD, MMRF’s Chief Data Officer. "As data leaves the electronic health records (EHRs) crucial metadata elements are often lost when EHRs create human-readable records. That metadata (ICD10, LOINC, RxNorm and other codes) is needed for secondary analysis and cohort creation. Without this information, it becomes a lot more complicated to analyze the data donated by our patients for analysis. By utilizing IMO technology, we will be able to re-introduce this data which in turn will help us to generate insights, and more importantly, help our researchers to more easily utilize our data in an effort to find cures."

Through the CureCloud and CoMMpass research programs, the MMRF has generated some of the richest oncology data sets to drive new precision treatments and a cure for each and every myeloma patient. Recognizing an opportunity to gain more impactful insights from that data, MMRF partnered with IMO to leverage its technology, IMO Precision Normalize, a product that standardizes inconsistent diagnosis, procedure, medication, and lab data from diverse systems into common, clinically validated terminology.

"Any organization that’s in the business of collecting and analyzing clinical data needs to maximize the quality of that data, and the quality of that data depends on the ability to easily and quickly normalize it to precise and understandable standards," said Dale Sanders, Chief Strategy Officer, IMO. "We are excited and grateful to partner with the MMRF to improve oncology patient care and treatment, as well as data quality for MMRF’s partners."

Currently, as healthcare data moves out of the EHR and is aggregated for analytics, it can be inconsistent, incomplete, and inaccurate. Decision-making may be compromised, which may put patient safety and outcomes at risk. Used by over 500,000 physicians during point of care documentation, IMO clinical terminology forms the foundation of IMO Precision Normalize, helping IT leaders and data stewards address the challenges that come with managing and leveraging data derived from multiple health information systems and sources.

To learn more about IMO Precision Normalize visit here.

About IMO

Intelligent Medical Objects (IMO) is a healthcare data enablement company. From clinical documentation at the point of care to complex approaches to population health management, IMO ensures clinical data integrity and quality—making patient information fit-for-purpose across the healthcare ecosystem. For almost three decades, IMO’s footprint in EHRs—across more than 4,500 US hospitals—powers our expert ability to capture and preserve clinical intent wherever and however data is used. Our primary clients span individual doctors and physician groups, hospitals and clinics, large integrated delivery networks, inpatient ORs and surgical centers, global electronic health record providers, health information exchanges, clinical data registries, payers, life sciences companies, and healthcare analytics vendors.

IMO is built on a culture that celebrates and practices diversity, equity, and inclusion. Our employees strive every day to make a meaningful impact in healthcare. IMO’s technology platform and evolving portfolio of products are grounded in our industry leading medical terminologies, which are clinically vetted and always current, capturing data at the highest level of specificity. IMO understands how data must then be transformed to efficiently extract the greatest value. In short, IMO is the catalyst that enables accurate documentation, precise population cohorting, optimized reimbursements, robust analytics, and better care decisions to optimize patient outcomes.

Houston-Based Tvardi Therapeutics Raises $74 Million in Series B Funding

On June 27, 2021 Tvardi Therapeutics, a Houston biopharmaceutical company, reported that it had raised $74 million in a new round of financing that will send its drug candidates through mid-stage clinical trials for treatment of cancer and fibrosis (Press release, Tvardi Therapeutics, JUN 27, 2021, View Source [SID1234584511]). The company, founded in 2017, specializes in the development of STAT3 inhibitors, which induce death in cancer cells. Tvardi CEO Imran Alibhai said the latest round of funding will help the company move out of "stealth mode" and raise its public profile.

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"With this financing we are positioned to advance the clinical development" of the company’s drug candidates, Alibhai said. The money will also help the company to expand its workforce, he added. The company’s latest round of financing is known as Series B. Series B is the third round of fundraising for new companies that typically comes after the startups have met certain milestones in their growth.

Officials with the company say the key molecule used in its drugs, TTI-101, has been shown in early clinical studies to be well tolerated among patients and can shrink a broad range of tumors.