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Laekna Therapeutics Announces Dosing of First Patients in the U.S. and China in Phase Ib/III Study of Afuresertib in Combination with Fulvestrant in HR+/HER2- Breast Cancer

On May 26, 2022 Laekna Therapeutics, a clinical-stage biotechnology company developing innovative medicines to treat cancer and liver diseases, reported that two first patients have been dosed in the U.S. and China, respectively, in a Phase Ib/III clinical trial that evaluates the efficacy and safety of afuresertib in combination with fulvestrant, an estrogen receptor antagonist, in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer who failed after 1-2 lines of CDK4/6 inhibitors, endocrine, or chemotherapy treatments (Press release, Laekna Therapeutics, MAY 26, 2022, View Source;breast-cancer-301555843.html [SID1234615149]).

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Afuresertib is an investigational AKT kinase inhibitor with global exclusive rights obtained from Novartis. The lead investigator of the study in China is Professor Binghe Xu, Academician of the Chinese Academy of Engineering and Director of the National Clinical Research Center for Cancer, while Professor Peter Kaufman, Lead Medical Oncologist from The University of Vermont Medical Center, is the lead investigator of the study in the U.S. Patient enrollment has begun simultaneously at the Piedmont Cancer Institute in the U.S. and Tianjin Medical University Cancer Institute & Hospital in China, and will soon begin in several other sites. Laekna will initiate a Phase III global pivotal trial after afuresertib plus fulvestrant shows a manageable safety profile in the Phase Ib study.

Breast cancer is the most common cancer among women worldwide. About 62% and 68% of all breast cancer patients in China and the U.S. are HR+/HER2- respectively[1,2]. "Although most patients with this type of breast cancer initially benefit from endocrine ±CDK4/6 inhibitors and/or chemotherapy as first- or second-line treatment, resistance occurs in most patients in about two years. I look forward to the results from the clinical study of afuresertib in combination with fulvestrant, which could offer a new treatment option for treatment-resistant breast cancer," said Professor Xu.

"Our team has been working closely with the investigators to overcome obstacles and dose the first patients both in the U.S. and China according to schedule, which demonstrated Laekna’s robust global clinical development capabilities," said Dr. Yong Yue, Chief Medical Officer of Laekna Therapeutics. "Our next step is to expedite simultaneous global development of afuresertib plus fulvestrant to bring hope to patients who have developed treatment resistance."

Quest Diagnostics to Speak at the Jefferies Healthcare Conference

On May 26, 2022 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it is scheduled to speak at the Jefferies Healthcare Conference (Press release, Quest Diagnostics, MAY 26, 2022, View Source [SID1234615148]). Steve Rusckowski, Chairman, CEO and President and Jim Davis, CEO-elect, will discuss the company’s vision, goals, and capital deployment strategies. The presentation is scheduled for Friday, June 10, 2022, at 11:00 a.m. Eastern Time.

The presentation and Q&A session will be webcast live during the conference and will be available on the company’s investor relations page which can be accessed at ir.QuestDiagnostics.com. In addition, the archived webcast will be available within 24 hours after the conclusion of the live event and will remain available until August 10, 2022.

Alpha Tau Medical Announces First Quarter 2022 Financial Results and Provides Corporate Update

On May 26, 2022 Alpha Tau Medical Ltd. (NASDAQ: DRTS) (NASDAQ: DRTSW), ("Alpha Tau" or the "Company"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported first quarter 2022 financial results and provided a corporate update (Press release, Alpha Tau Medical, MAY 26, 2022, View Source [SID1234615147]).

"2022 is an important year for the Company, as we look to initiate a number of important clinical trials across large global markets, including our first U.S. pivotal trial as well as trials in internal organs such as the prostate," commented Alpha Tau CEO Uzi Sofer. "The first quarter of 2022 already saw us reach a number of meaningful milestones, including our first U.S. data read out and our debut as a public company traded on NASDAQ under symbol "DRTS." We are also working in parallel to expand our manufacturing capabilities and to strengthen our supply chain in the U.S., Israel, and Asia, as part of the expansion of our clinical trial activities and future commercialization."

First quarter 2022 Corporate Highlights:

Reported results in January 2022 from the first pilot multi-center study of Alpha DaRT in the United States, led by Memorial Sloan Kettering Cancer Center. In this trial of malignant skin and soft tissue cancer patients, a complete response, as measured by RECIST criteria, was observed in all ten out of ten tumors treated (100%), with no product-related serious adverse events reported. Alongside these data, a 98% overall response rate was observed in a pooled analysis of superficial tumors treated that reached their efficacy endpoint measurement by quarter end, across the Company’s various trials.
Completed patient recruitment in the Company’s Japanese pivotal trial in head and neck cancer, with data submission targeted for the second half of 2022.
Entered into a sponsored research agreement with investigators at The University of Texas MD Anderson Cancer Center in January 2022 to evaluate the combination of Alpha DaRT with DNA-repair inhibitors and immune checkpoint inhibitors for the treatment of breast tumors.
Completed its business combination in March 2022 with Healthcare Capital Corp., a special purpose acquisition company, together with a concurrent Private Investment in Public Equity (PIPE) financing, raising a total of approximately $104 million in gross proceeds, and commenced trading of its shares and warrants on the Nasdaq Capital Market under the symbols "DRTS" and "DRTSW", respectively.
Appointed Ruth (Ruti) Alon to its Board of Directors in March 2022. Ms. Alon brings a wealth of healthcare experience and serves on the boards of multiple private and public companies in the sector.
Upcoming 2022 Milestone Targets Include:

First Israeli patient in the prostate cancer feasibility trial in the second quarter of 2022.
Initiation of multi-center pivotal U.S. trial in skin cancers in the middle of 2022.
Recruitment in the Canadian feasibility trial in pancreatic tumors to begin in the second half of 2022.
Submission of Alpha DaRT pivotal trial in head and neck cancer to Japan’s PMDA in the second half of 2022 for marketing authorization.
Financial results for the first quarter ended March 31, 2022

R&D expenses for the quarter ended March 31, 2022 were $5.2 million, compared to $2.2 million for the same period in 2021, primarily due to increased R&D activity and increased share-based compensation costs.

Marketing expenses for the quarter ended March 31, 2022 were $0.2 million, compared to $0.2 million for the same period in 2021.

G&A expenses for the quarter ended March 31, 2022 were $3.3 million, compared to $0.4 million for the same period in 2021, primarily due to costs associated with the merger with Healthcare Capital Corp., increased professional fees and share-based compensation.

Financial expenses, net, for the quarter ended March 31, 2022 were $17.0 million, compared to $9.0 million for the same period in 2021, primarily due to an increase in the revaluation of warrants.

For the quarter ended March 31, 2022, the Company had a net loss of $25.7 million, or ($0.54) per share, compared to a loss of $11.7 million, or ($0.29) per share, in the same period in 2021.

Balance Sheet Highlights

As of March 31, 2022, the Company had cash and cash equivalents, restricted cash and short term deposits in the amount of $107.0 million, compared to $31.9 million on December 31, 2021. In addition, incremental proceeds of approximately $13 million from the original PIPE were received after March 31, 2022. The Company expects that this cash balance will be sufficient to fund operations for at least two years.

In addition, the Company’s Board of Directors approved a program for the buyback of the Company’s publicly traded warrants in an amount of up to $3 million. Repurchases may be started or suspended at any time without prior notice, depending on market conditions and other factors.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral insertion of radium-224 impregnated seeds. When the radium decays, its short-lived daughters are released from the seed, and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

Leap Therapeutics to Present Initial Data from the Investigator-Sponsored Study of DKN-01 Plus Docetaxel in Patients with Prostate Cancer at the 2022 ASCO Annual Meeting

On May 26, 2022 Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that initial clinical data from the investigator-sponsored Phase 1b/2a dose escalation and dose expansion study testing Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, as monotherapy or in combination with docetaxel in metastatic castration-resistant prostate cancer (mCRPC) will be presented at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago, IL on June 3-7, 2022 (Press release, Leap Therapeutics, MAY 26, 2022, View Source [SID1234615146]).

"As the initial data show, DKN-01 in combination with docetaxel is a promising therapy option for prostate cancer patients, particularly for those with aggressive variant prostate cancer," said David Wise, MD, PhD, Medical Oncologist at Perlmutter Cancer Center, NYU Langone Health and principal investigator on the study. "DKN-01, as a monotherapy and in combination with docetaxel, was well tolerated by patients, with partial responses in all of the patients treated with DKN-01 in combination with docetaxel who had measurable disease. Accrual into the Phase 2 portion of this study is ongoing, alongside preclinical and correlative studies aiming to further investigate the mechanism of action of DKN-01 in prostate cancer and to identify the best clinical path forward."

Key Initial Findings from the Investigator-Sponsored Phase 1b/2a Clinical Trial:

Data that will be presented at ASCO (Free ASCO Whitepaper) is from the completed Phase 1 portion of the study. Thirteen patients were enrolled, with 7 patients in the DKN-01 monotherapy cohort and 6 patients in the DKN-01 plus docetaxel combination cohort. The primary endpoint of the Phase 1 dose escalation cohorts was safety, characterized by dose-limiting toxicity (DLT). The study also aims to study correlations between DKK1 expression and tumor genetics, histology and anti-tumor activity.

Highlights from the data include:

No DLTs were observed at DKN-01 300mg or 600mg dose levels as monotherapy or in combination with docetaxel, and no treatment-related adverse events occurred in either cohort
No partial responses (PR) were seen in the monotherapy cohort with best overall response of stable disease in 2 out of 5 evaluable patients
In the combination cohort, all 5 evaluable patients had a PR as measured by RECIST (3 confirmed, 2 unconfirmed) and by PSA50
Confirmed partial responses in the combination cohort were observed in both DKK1 high and low expressing tumors, including in 2 out of 3 patients with aggressive variant prostate cancer (AVPC)
Further accrual into the phase 2 part of this study is ongoing, alongside preclinical and correlative studies aimed at investigating the mechanism of action of DKN-01 in prostate cancer.

Protagonist Therapeutics to Present Updated Phase 2 Rusfertide Clinical Results in Polycythemia Vera (PV) at ASCO 2022

On May 26, 2022 Protagonist Therapeutics (Nasdaq: PTGX) reported new data from its ongoing Phase 2 REVIVE study evaluating rusfertide in patients with polycythemia vera (PV) (Press release, Protagonist, MAY 26, 2022, View Source [SID1234615145]). These results will be shared as an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held in Chicago from June 3-7, 2022.

"We are pleased to observe that administration of rusfertide continues to provide PV patients with an effective therapy that leads to rapid and sustained hematocrit control, and potentially offers patients a better quality of life by keeping them essentially phlebotomy-free for up to 18 months," said Ronald Hoffman, M.D., Director of the Myeloproliferative Disorders Research Program at the Icahn School of Medicine at Mount Sinai and principal investigator of the REVIVE study. "Importantly, the new results show that rusfertide administration suspension, due to the brief clinical hold, directly led to increases in hematocrit levels, red blood cell counts, and phlebotomy rates. In contrast, resumption of rusfertide quickly restored the therapeutic benefits for patients, confirming the direct and rapid effect of rusfertide and its potential utility in treating this serious disease."

"These highly promising new results continue to demonstrate the rapid therapeutic effect of rusfertide and its utility as an effective potential treatment across all categories of PV patients, independent of patient risk category, or concurrent therapy with other cytoreductive treatments including hydroxyurea, interferons or JAK inhibitors," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer of Protagonist. "Taken together, these data reaffirm our belief in the potential of rusfertide to provide a highly effective treatment option for patients with PV, providing an opportunity to fundamentally transform the management of this disease. Rusfertide continues to be the primary focus of our corporate resources and efforts, and we continue to explore the full therapeutic potential of rusfertide with a sharp focus on the execution of the recently initiated Phase 3 VERIFY study."

Summary of Key Results

Updated Results from Phase 2 Studies Evaluating Rusfertide in Patients with PV

REVIVE Study

The ongoing Phase 2 REVIVE study was designed to evaluate rusfertide in patients with phlebotomy-dependent PV for up to 18 months. Results from the 70 phlebotomy-dependent PV patients continued to demonstrate that rusfertide treatment essentially eliminated the need for therapeutic phlebotomy (TP), and led to rapid, sustained, and durable control of hematocrit (HCT) levels below 45% without a clinically meaningful increase in white blood cell numbers of PV-related thromboses. Rusfertide treatment also led to normalization of iron stores and improved symptoms including concentration.

Furthermore, the new data showed that treatment suspension in PV patients led to increases in hematocrit levels, RBC count, and phlebotomy rates. In contrast, resumption of rusfertide treatment in those patients led to significant improvement in those parameters, providing further evidence of the rapid and beneficial therapeutic effect of rusfertide in PV. Upon the lifting of the clinical hold placed on rusfertide in PV, about 85% of patients resumed treatment with rusfertide.

PACIFIC Study

The ongoing Phase 2 PACIFIC study enrolled 20 patients with confirmed high HCT levels above 48% to evaluate rusfertide as an induction therapy. Results demonstrated that all erythrocytotic PV patients on rusfertide induction therapy with twice weekly dosing achieved rapid, sustained and durable HCT control below 45%, and without the need for TP.

Details for the ASCO (Free ASCO Whitepaper) 2022 oral presentation are as follows:

Title: Rusfertide (PTG-300) treatment in phlebotomy-dependent polycythemia vera patients.
Authors: Ronald Hoffman, M.D., The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, Protagonist Therapeutics
Abstract Number: #7003
Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presentation Date and Time: June 7, 2022 at 10:45 a.m. CT

About Rusfertide

Rusfertide (PTG-300) is an investigational, injectable hepcidin mimetic that is currently being developed for various disorders associated with iron overload and/or excessive erythrocytosis (red blood cell production). Rusfertide regulates iron homeostasis and controls the absorption, storage, and distribution of iron in the body. Discovered through Protagonist’s peptide technology platform, rusfertide is currently being investigated in the REVIVE Phase 2 proof-of-concept clinical trial for polycythemia vera (PV), a rare chronic blood disorder that affects about 160,000 patients in the U.S., the PACIFIC Phase 2 study in PV subjects with high hematocrit levels, and a recently completed Phase 2a study for hereditary hemochromatosis. The VERIFY Phase 3 study is currently underway.