On March 25, 2024 CureLab Oncologya clinical-stage biotech company, reported that it has been granted a patent in Canada for its novel biological agent, Elenagen, which has been shown to provide clinical benefits for cancer patients (Press release, CureLab Oncology, MAR 25, 2024, View Source [SID1234641406]). Elenagen belongs to a novel class of biological agents that use supercoiled circular DNA (plasmids) to increase anti-tumor immunity and boost the effectiveness of existing therapies.

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Elenagen has demonstrated a desirable safety profile and a statistically significant clinical benefit for cancer patients by enhancing the anti-cancer effects of chemotherapy. Experimental results also indicate mitigation of chronic inflammation, anti-aging effects, and stimulation of an immune response to a tumor. For example, in a recent study published in Frontiers in Oncology, a research team found that disease progression was significantly delayed in a group of stage III and IV platinum-resistant ovarian cancer patients who received gemcitabine in combination with Elenagen, compared to the group who received gemcitabine alone.

Elenagen addresses an urgent need in Canada

Cancer remains a significant health concern and a substantial economic burden in Canada. Recent studies indicate that in 2021, the total economic cost of cancer in Canada exceeded $26 billion, with a significant portion borne directly by patients and families. These rising costs highlight the urgent need for innovative solutions. The costs of cancer care are highest in the initial treatment period, emphasizing the critical need for advances in prevention and early detection, such as promising vaccine technologies. Elenagen has the potential to alleviate a portion of those costs, while also improving outcomes and quality of life for those affected by cancer.

"For too long, we’ve witnessed the devastating toll cancer takes on Canadian families. Elenagen represents a beacon of hope, moving us closer to a world where a cancer diagnosis doesn’t have to be a devastating sentence," said Alexander Shneider, Ph.D., founder and CEO of CureLab Oncology. "By mitigating the effects of cancer in Canada, we aim to alleviate substantial long-term healthcare costs and improve quality of life for countless patients."

A veterinary version of Elenagen called Elenavet, and the entire IP rights for cancer treatment in dogs, cats and horses has been exclusively licensed by CureLab Oncology to its sister company, CureLab Veterinary Inc. ElenaVet is a gene therapy that enhances the animal’s anticancer immune response. In comparative medicine studies, ElenaVet saved 10 out of 11 dogs with breast cancer and precluded or delayed the metastatic process in dogs with melanoma. Similar results were observed with cats.

About Elenagen
CureLab’s lead investigational compound is code-named Elenagen, an experimental DNA therapy that consists of a circular piece of DNA called a plasmid that includes a gene for a human protein called p62/SQSTM1. In clinical studies conducted ex-US, Elenagen demonstrated desirable safety profile and statistically significant clinical benefit for cancer patients by enhancing the anti-cancer effects of chemotherapy. Experimental results also indicate mitigation of chronic inflammation, anti-aging effects, and stimulation of an immune response to the tumor.

On March 25, 2024 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, and AnHeart Therapeutics Ltd. (AnHeart), a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, reported that the companies have entered into a definitive agreement for Nuvation Bio to acquire AnHeart in an all-stock transaction (the Acquisition) (Press release, Nuvation Bio, MAR 25, 2024, View Source [SID1234641422]). Immediately following the closing of the Acquisition, the former shareholders of AnHeart will own approximately 33% and the current stockholders of Nuvation Bio will own approximately 67% of Nuvation Bio on a fully diluted basis. The Acquisition, which has been approved by the board of directors of each company and is subject to approval by AnHeart’s shareholders and other customary closing conditions, will position Nuvation Bio as a late-stage global oncology company with multiple programs in clinical development. The Acquisition is expected to close in the second quarter of 2024.

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"This transaction represents a significant milestone for our company and reflects Nuvation Bio’s continued commitment to developing therapies for patients with the most difficult-to-treat cancers," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "AnHeart’s lead asset, taletrectinib, which will become our lead asset as it completes two pivotal studies, is a differentiated, next-generation ROS1 inhibitor with a potentially best-in-class profile that may overcome the significant limitations of existing therapies. We are impressed by what the AnHeart team has done to develop this asset and intend to build on the progress made to date."

Dr. Hung added, "Nuvation Bio is well capitalized, and this all-stock transaction maintains our robust cash balance and removes any need for near-term financing to develop both new assets and our current pipeline. With our combined talented teams and resources, we will continue to focus on executing the development strategy for our differentiated pipeline. We expect this deal will bring Nuvation Bio much closer to realizing our goal of delivering novel cancer therapies to patients, and we look forward to this exciting next chapter together with the AnHeart team."

"AnHeart, named for our deep sense of service to patients, has worked tirelessly over the past five years to advance our pipeline of next-generation precision oncology medicines. We are excited to continue our mission as part of Nuvation Bio given their shared vision to improve the lives of people with cancer," said Junyuan Jerry Wang, Ph.D., Co-Founder and Chief Executive Officer of AnHeart. "We believe the pipeline and financial strength of the combined company have the potential to create a market leader, and we look forward to working with David and the Nuvation Bio team to bring new cancer therapies to patients in need of better options."

Management and Organization

Nuvation Bio will continue to be led by its current management team, including David Hung, M.D., its Founder, Chief Executive Officer, and President, and expects AnHeart’s employees in China and the United States to join the Nuvation Bio team. Following the closing of the Acquisition, Min Cui, Ph.D., Founder and Managing Director of Decheng Capital, an investor in AnHeart, and Junyuan Jerry Wang, Ph.D., Co-Founder and Chief Executive Officer of AnHeart, will join the Nuvation Bio board of directors.

Transaction Details

At the closing of the Acquisition, Nuvation Bio will issue to the AnHeart securityholders, in exchange for all outstanding AnHeart shares, options, and other securities, approximately 43,590,197 shares of Nuvation Bio’s Class A common stock (inclusive of the shares of Class A common stock underlying the AnHeart equity awards to be assumed by Nuvation Bio), 851,212 shares of Nuvation Bio’s Series A Non-Voting Convertible Preferred Stock, and warrants collectively exercisable for 2,893,731 shares of Nuvation Bio’s Class A common stock at an exercise price of $11.50 per share.

Subject to approval by the Nuvation Bio stockholders (the Nuvation Bio Stockholder Approval), each share of Series A Non-Voting Convertible Preferred Stock issued by Nuvation Bio in the Acquisition will initially be convertible into 100 shares of Class A common stock. Additionally, the warrants issued in the Acquisition will be restricted until receipt of the Nuvation Bio Stockholder Approval. Any shareholders of AnHeart who are not accredited investors will receive cash for their AnHeart shares in lieu of receiving Nuvation Bio securities.

The holders of approximately 90% of AnHeart’s outstanding shares have entered into voting agreements, pursuant to which they have agreed to, among other matters, vote in favor of the Acquisition.

In connection with the execution of the definitive merger agreement, Dr. Hung entered into a voting agreement, pursuant to which he agreed to vote his shares of Nuvation Bio stock, representing approximately 27% of Nuvation Bio’s outstanding shares, for the Nuvation Bio Stockholder Approval. The closing of the Acquisition does not require the approval of the Nuvation Bio stockholders.

Nuvation Bio and AnHeart intend that the Acquisition will qualify as a tax-free reorganization. As AnHeart’s parent company after the Acquisition, Nuvation Bio will own all of AnHeart’s assets, including AnHeart’s intellectual property.

For further information regarding the terms and conditions contained in the definitive transaction agreement, please see Nuvation Bio’s current report on Form 8-K, which will be filed with the U.S. Securities and Exchange Commission (the SEC) in connection with the Acquisition.

Pipeline Updates

Taletrectinib is being evaluated for the treatment of patients with ROS1-positive NSCLC in two pivotal Phase 2 studies, TRUST-I (NCT04395677) in China and TRUST-II (NCT04919811), a global pivotal study. Nuvation Bio will continue to advance both studies.
Taletrectinib has been granted Breakthrough Therapy Designations by the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) for the treatment of advanced or metastatic ROS1-positive NSCLC.
The NMPA has accepted and granted Priority Review Designation to New Drug Applications for taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who either have or have not previously been treated with ROS1 TKIs.
Nuvation Bio will continue to develop safusidenib, a novel, selective, potent, oral mIDH1 inhibitor being evaluated by AnHeart in a global Phase 2 study (NCT05303519) in patients with grades 2 and 3 IDH1-mutant glioma.
Nuvation Bio will continue to advance all clinical studies for its internally discovered pipeline candidates, including the Phase 1b studies of NUV-868 and the recently initiated Phase 1/2 study of NUV-1511.
Conference Call

Nuvation Bio will schedule a conference call to discuss the acquisition after it has closed.

Advisors

Evercore is acting as Nuvation Bio’s exclusive financial advisor and Cooley LLP is acting as legal counsel, alongside Morrison & Foerster LLP as intellectual property counsel, Haiwen & Partners as Chinese legal counsel, and Conyers as Cayman Islands legal counsel. Davis Polk & Wardwell LLP is acting as legal counsel for AnHeart, alongside Fangda Partners as Chinese legal counsel and Walkers (Cayman) LLP as Cayman Islands legal counsel.

Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, reported financial results for the fourth quarter and full year 2023, as well as corporate and clinical highlights (Press release, Equillium, MAR 25, 2024, View Source [SID1234641407]).

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"The past year we have been focused on clinical execution that has set up the potential milestones we have in front of us in 2024," said Bruce Steel, chief executive officer at Equillium. "The Phase 1b EQUALISE study of itolizumab in patients with lupus nephritis is now complete. We presented positive data from this study at the annual meetings of both ASN and ACR in the fourth quarter last year and we expect to deliver the topline data to our partner Ono in the coming weeks. We expect to announce the results of the interim review by the data monitoring committee of our Phase 3 EQUATOR study of itolizumab in patients with acute graft-versus-host disease in the third quarter, which would represent the final data deliverable to trigger Ono’s option exercise period, which will expire three months following such deliverables. If Ono exercises their option to acquire our rights to itolizumab we would receive an exercise payment of approximately $331 million, which would significantly extend our cash runway beyond the second half of 2025—our current guidance—and we would remain eligible to receive approximately $101 million in additional milestone payments.

"Our lead multi-cytokine inhibitor, EQ101, a first in class, tri-specific inhibitor targeting IL-2, IL-9 and IL-15, has completed enrollment in a Phase 2 study for the treatment of moderate to severe alopecia areata. There remains a large unmet medical need for safer alternatives to JAK inhibitors, which carry black-box warnings and are today the only approved class of drugs to treat alopecia areata patients. This is the first study in which EQ101 has been tested in alopecia areata patients, where we are looking for signs of clinical activity above historically low observed placebo responses. We’re pleased to have completed enrollment of this study and look forward to announcing topline data in the second quarter this year."

"In addition to clinical execution, we have also focused efforts on advancing the rest of our novel multi-cytokine inhibitor programs," said Steve Connelly, chief scientific officer at Equillium. "EQ302, our first-in-class, bi-specific inhibitor of IL-15 and IL-21, is a second-generation peptide with improved potency that is orally deliverable and stable in the gut. We believe this represents a compelling product profile well positioned to target gastrointestinal indications including celiac disease, inflammatory bowel disease, and eosinophilic esophagitis. We look forward to advancing this program towards the clinic."

Option exercise payment is denominated in Japanese yen (5 billion) and subject to currency exchange rates at the time of payment.

Q4 2023 Highlights:

•
Presented positive data from the Phase 1b EQUALISE study of itolizumab in lupus nephritis patients at the annual meetings of both ASN and ACR. The presentations highlighted a well-tolerated safety profile and data that demonstrated high complete and partial response rates with rapid and deep reductions in urine protein creatinine ratios in highly proteinuric patients when itolizumab was added to mycophenolate mofetil and corticosteroids.

•
Hosted an Analyst & Investor Day featuring Arash Mostaghimi, MD, MPA, MPH, associate professor of dermatology at Harvard Medical School, that highlighted Equillium’s pipeline, the multi-cytokine platform and clinical-stage multi-cytokine inhibitors, with a focus on EQ101, currently in a Phase 2 clinical study for moderate to severe alopecia areata.

•
Announced a presentation at the 18th Annual Peptide Therapeutics Symposium highlighting EQ302, a first-in-class, second generation, orally deliverable multi-cytokine inhibitor targeting IL-15 and IL-21. The presentation outlined the origins of EQ302 from its parent peptide and data illustrating that adding hydrocarbon staples to the peptide conferred increased stability in the gastrointestinal tract while retaining its cytokine inhibitory properties.

Anticipated Upcoming Milestones:

•
EQ101: Phase 2 clinical study in subjects with moderate to severe alopecia areata – topline data anticipated in Q2 2024

•
Itolizumab: EQUALISE lupus nephritis topline data to Ono anticipated in the coming weeks; EQUATOR acute graft-versus-host disease interim review anticipated in Q3 2024

•
Ono option exercise decision anticipated in 2H 2024

Fourth Quarter and Full Year 2023 Financial Results

Revenue for the fourth quarter of 2023 was $9.2 million, compared with $15.8 million for the same period in 2022. For the full year of 2023, revenue was $36.1 million, compared with $15.8 million for the full year of 2022. Revenue in 2023 and 2022 consisted entirely of itolizumab development funding and amortization of the upfront payment from Ono resulting from the Asset Purchase Agreement with Ono executed in December 2022, which included such development funding retroactive to the beginning of the third quarter of 2022.

Research and development (R&D) expenses for the fourth quarter of 2023 were $9.2 million, compared with $8.5 million for the same period in 2022. For the full year of 2023, R&D expenses were $37.0 million, compared with $37.5 million for the full year of 2022. The nominal year-over-year decrease in R&D expenses was driven by a decrease in non-clinical research expenses and lower employee compensation and benefits, which were partially offset by increased clinical development expenses, primarily driven by the EQUATOR, EQ101 and EQ102 clinical studies.

General and administrative (G&A) expenses for the fourth quarter of 2023 were $3.2 million, compared with $5.2 million for the same period in 2022. For the full year of 2023, G&A expenses were $13.6 million, compared with $17.2 million for the full year of 2022. The year-over-year decrease was driven by decreased legal expenses primarily related to 2022 business development activities, lower employee compensation and benefits, and lower consulting and general overhead expenses, which were partially offset by greater audit and tax related professional fees.

Net loss for the fourth quarter of 2023 was $2.3 million, or $(0.07) per basic share and diluted share, compared with net income of $2.8 million, or $0.08 per basic and diluted share for the same period in 2022. Net loss for the full year of 2023 was $13.3 million, or $(0.38) per basic and diluted share, compared with a net loss of $62.4 million, or $(1.85) per basic and diluted share for the full year of 2022. The decrease in net loss for the full year of 2023 compared to the full year of 2022 was primarily due to lower operating expenses driven by the non-cash in-process R&D expense related to the acquisition of Bioniz Therapeutics, Inc. in 2022 and lower G&A expenses, greater revenue related to the Ono partnership, greater income on investments, and less interest expense due to the retirement of our former debt facility, which was partially offset by greater income tax expense.

Cash, cash equivalents and short-term investments totaled $40.9 million as of December 31, 2023, compared to $71.0 million as of December 31, 2022. Net cash used in operating activities in the fourth quarter was $5.7 million. Equillium believes that its cash, cash equivalents and short-term investments on the balance sheet as of December 31, 2023, will be sufficient to fund its currently planned operations into the second half of 2025, assuming no further repurchases under our stock repurchase program.

About Multi-Cytokine Platform and Multi-Cytokine Inhibitors EQ101 & EQ302

Our proprietary multi-cytokine platform generates rationally designed composite peptides that selectively block key cytokines at the shared receptor level targeting pathogenic cytokine redundancies and synergies while preserving non-pathogenic signaling. This approach is expected to avoid the broad immuno-suppression and off-target safety liabilities that may be associated with other therapeutic classes, such as Janus kinase inhibitors. Many immune-mediated diseases are driven by the same combination of dysregulated cytokines, and we believe identifying the key cytokines for these diseases will allow us to target and develop customized treatment strategies for multiple autoimmune and inflammatory diseases.

Current platform assets include EQ101, a clinical stage, first-in-class, selective, tri-specific inhibitor of IL-2, IL-9, and IL-15 for intravenous and subcutaneous delivery and EQ302, a preclinical stage, first-in-class, selective, bi-specific inhibitor of IL-15 and IL-21 for oral delivery.

About Itolizumab

Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM signaling pathway to downregulate pathogenic T effector cells while preserving T regulatory cells critical for maintaining a balanced immune response. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases.

On March 25, 2024 Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company with a focus in lung diseases, reported that it has entered into a new master collaborative research agreement (MCRA) with Memorial Sloan Kettering Cancer Center (MSK) under which the teams will collaborate on a development plan for diagnostic tests aimed at improving the treatment of cancer (Press release, Biodesix, MAR 25, 2024, View Source [SID1234641423]).

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Biodesix will utilize its array of genomics, proteomics, and data mining capabilities with the aim of developing and commercializing oncology biomarker assays in collaboration with MSK. Bio-Rad will provide its industry-leading digital PCR assay technology in support of this important work.

The collaborators, represented by Dr. Howard Scher (MSK) and Dr. Gary Pestano (Biodesix), will share an update at the 31st International Precision Medicine Tri-Con meeting (PMTC) on March 25: "An Industry | Academic Collaboration Framework Focused on Novel Diagnostic Test Development in Oncology".

"The expansion of our previous master sponsored research agreement (MSRA) into a master collaborative research agreement with MSK is a significant milestone for Biodesix and for biomarkers in oncology diagnostics. Biodesix looks forward to co-developing and validating new test concepts under these agreements," said Scott Hutton, CEO, Biodesix.

"We look forward to working with Biodesix to develop the next generation of highly multiplexed digital PCR assays as part of our expanding oncology offering," said Simon May, EVP and President of Life Sciences at Bio-Rad Laboratories. "Bio-Rad provides the leading solution for digital PCR, and we are committed to providing oncology researchers and commercial partners with technologies that enable everything from biomarker discovery to clinical trials and patient monitoring of minimal residual disease.

On March 25, 2024 Edgewood Oncology, a clinical-stage biotechnology company focused on delivering BTX-A51 to patients with hematologic malignancies and genetically-defined solid tumors, reported to have emerged from stealth with $20 million in Series A financing backed by Alta Partners to advance the clinical development of BTX-A51 in acute myeloid leukemia (AML) and a precision medicine approach to breast cancer (Press release, Edgewood Oncology, MAR 25, 2024, View Source [SID1234641424]). BTX-A51 is a first-in-class, small molecule, multi-kinase inhibitor of casein kinase 1 alpha (CK1), cyclin-dependent kinase 7 (CDK7) and CDK9 that synergistically co-targets master regulators of cancer to promote programmed cell death, or apoptosis.

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Edgewood acquired the rights to BTX-A51 from Yissum, the technology transfer company of The Hebrew University of Jerusalem, in 2023 and will use the Series A funding to advance efficacy studies in AML and breast cancer.

"We formed Edgewood Oncology because of the synergistic mechanism of action and promising safety and anti-tumor data that was observed with BTX-A51 in Phase 1 in AML and solid tumor patients. We look forward to further developing this compound using a precision medicine approach in patient populations who lack effective treatment options," said David N. Cook, Ph.D., chief executive officer, Edgewood Oncology. "Furthermore, we have taken a virtual approach to drug development, which allows us to remain highly-focused, agile and efficient as we advance this investigational compound in the clinic."

Testing the Use of Combination Therapy in AML

There exists a significant unmet need for improved first-line regimens in AML as well as for patients with relapsed or refractory (R/R) disease. In a Phase 1 study in heavily pre-treated R/R AML patients, monotherapy BTX-A51 demonstrated a favorable safety profile and encouraging antileukemic activity. As a next step, Edgewood initiated a study of BTX-A51 in combination with azacitidine in R/R AML patients in December 2023. The aim of this Phase 2, multicenter, open-

label study is to evaluate the response rate (CR, CRh and CRi) as well as the safety, toxicity and pharmacokinetics of BTX-A51 in combination with azacitidine in patients with R/R AML.

"We’re incredibly excited about the potential of BTX-A51in this patient population, and we also have good reason to believe that BTX-A51 could be complementary to standard of care in first-line unfit AML," said Zung Thai, M.D., Ph.D., chief medical officer, Edgewood Oncology. "In Phase 1 monotherapy, we observed several complete responses and a wide therapeutic window and our preclinical data also suggest that BTX-A51 acts synergistically with both azacitidine and venetoclax in human leukemia cells and animal models."

Edgewood is expecting to initiate a Phase 2 study in breast cancer in patients with a genetically-defined profile in Q2 2024.

Leadership Team Comprised of Seasoned Biotech Veterans

"Edgewood’s leadership team not only has a strong track record in company formation and drug development, but Dr. Thai brings an in-depth understanding of BTX-A51, having led all clinical and regulatory efforts for this program during his tenure at BiotheryX," said Dan Janney, managing partner, Alta Partners. "Moreover, we believe Edgewood’s virtual approach to drug development is the best strategy to get innovative new medicines to patients as quickly and efficiently as possible."

The executive team includes Dr. Cook as chief executive officer, and Dr. Thai as chief medical officer. BTX-A51’s scientific founder is Yinon Ben-Neriah, M.D., Ph.D., professor of Immunology and Cancer Research, The Hebrew University of Jerusalem. The company’s board of directors includes Dr. Cook, Dan Janney, and Isan Chen, M.D., a noted clinical oncologist and co-founder, president and chief executive officer, MBrace Therapeutics, Inc.