On May 10, 2022 Bridge Biotherapeutics Inc. (KQ288330), a South Korean clinical-stage biotechnology company focused on developing novel drugs for cancer, fibrosis and inflammation, reported it will deliver an oral presentation highlighting the analysis data from the first-in-patient study of BBT-176[1] at the International Association for the Study of Lung Cancer 2022 World Conference on Lung Cancer (IASLC 2022 WCLC) (Press release, Bridge Biotherapeutics, MAY 10, 2022, View Source [SID1234614147]).

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At its latest presentation to investors, Bridge Biotherapeutics shared interim Phase 1 study data of BBT-176 in advanced non-small cell lung cancer (NSCLC) showing that the drug candidate was well-tolerated and demonstrated efficacy against EGFR-mutation positive NSCLC, including C797S containing EGFR triple mutations. According to the company’s presentation, BBT-176 has shown anti-tumor efficacy with two partial response cases, one in the 160 mg QD cohort (51 percent tumor shrinkage) and the other in the 320 mg QD cohort (30 percent tumor shrinkage).

Pharmacokinetics data show that BBT-176 exhibits dose-dependent exposure. In addition, safety data have shown that adverse events (AEs) typically associated with EGFR inhibitors have been found but were limited to Grade 1-3 adverse events. The Phase 1 dose escalation study will be continued through an exploratory cohort to determine the maximum tolerable dose (MTD) and recommended Phase 2 dose (RP2D).

Sang-Yoon Lee, M.D., Bridge Biotherapeutics’ chief medical officer, said, "We are encouraged by these interim results from our Phase 1 trial of BBT-176, a fourth-generation EGFR TKI. In addition to continuing the trial, Bridge Biotherapeutics is promoting innovation by exploring the potential clinical value of liquid biopsies for both diagnosis and evaluation of therapeutic responses in NSCLC. We believe this will be another innovative aspect of our clinical development of BBT-176. Bridge Biotherapeutics remains focused on delivering novel treatment options to address the high unmet medical needs of advanced NSCLC patients."

The company’s oral presentation on BBT-176 is expected to be held on August 8, during IASLC 2022 WCLC, in Vienna, Austria.

On May 10, 2022 Celsius Holdings, Inc., (Nasdaq: CELH), maker of the leading global fitness drink, CELSIUS reported preliminary financial results for the first quarter ended March 31, 2022 (Press release, Celsius Therapeutics, MAY 10, 2022, View Source [SID1234614146]). Management will host a conference call today at 4:30 p.m. Eastern Time to discuss the results with the investment community.

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A PDF containing our first quarter 2022 results and full financial tables is available at:
View Source

To participate in the conference call, please call one of the following telephone numbers at least 10 minutes before the start of the call:

Webcast: View Source

An audio replay of the call will be available on the Company’s website at:
View Source

On May 10, 2022 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported that the first patient has been dosed in its open-label, multicenter ACLX-001 Phase 1 clinical trial (NCT04155749) to evaluate the company’s novel ARC-SparX program in patients with relapsed or refractory multiple myeloma (r/r MM) (Press release, Arcellx, MAY 10, 2022, View Source [SID1234614145]). ARC-SparX is a universal cell therapy platform comprised of SparX (soluble protein antigen-receptor X-linkers) proteins engineered to target BCMA on myeloma cells together with ARC-T (Antigen Receptor Complex-T) cells that are dosed separately and are engineered to activate only when engaged with a SparX protein bound to a myeloma cell. Both the ARC-T cells and SparX proteins utilize the company’s proprietary novel synthetic binding scaffold called the D-Domain.

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"Our ARC-SparX platform, powered by our proprietary D-Domain technology, has the potential to yield transformative therapies that can unleash the full potential of CAR-Ts to treat challenging conditions, including solid tumors. By addressing antigen heterogeneity and dose limiting toxicities, ARC-SparX could help many patients and address significant unmet clinical needs," said Rami Elghandour, Arcellx’s chairman and chief executive officer. "ACLX-001 is intended to demonstrate the advantages for our ARC-SparX platform technology and may potentially enable rapid development of future ARC-SparX programs in our portfolio. We look forward to enrolling additional patients in this study and evaluating the clinical outcomes."

"We are excited to be participating in this clinical trial to evaluate ACLX-001 in patients with relapsed or refractory multiple myeloma," said Binod Dhakal, M.D., M.S., associate professor of medicine, Division of Hematology/Oncology, Medical College of Wisconsin, and clinical investigator on both Phase 1 trials of CART-ddBCMA and ACLX-001. "ARC-SparX provides physicians with the ability to control the dose and frequency of SparX administration. This may allow the physician to better manage toxicities associated with traditional CAR-T therapies, potentially increasing patient access to this treatment option."

Initial data from the ACLX-001 Phase 1 study is expected in 2023. For more information about the clinical trial program, visit ClinicalTrials.gov (NCT04155749).

About the ARC-SparX Platform Technology
The ARC-SparX platform is designed to allow for controllability and adaptability to potentially reduce toxicities that are often associated with serious dose-limiting adverse events and to overcome tumor heterogeneity. It is a modular therapy which utilizes a universal ARC-T cell combined with an off-the-shelf SparX protein to separate the tumor-recognition and tumor-killing functions. SparX (soluble protein antigen-receptor X-linkers) proteins utilize our D-Domain technology engineered to recognize antigens on the surface of diseased cells and flags those cells for detection by the ARC-T cells. ARC-T cells express a D-Domain-based CAR engineered to specifically recognize a unique TAG in the SparX protein. ARC-T cells are dosed separately and only activated to kill the target cell when they encounter a SparX protein bound to the target antigen and thus are controlled through SparX dose modulation. Arcellx has developed a collection of SparX proteins that bind different antigens on the surface of diseased cells. Multiple SparX proteins with different antigen specificity can be administered to potentially address antigen heterogeneity or antigen escape that contribute to relapsed and refractory disease.

About the Phase 1 Study Evaluating ACLX-001 for Patients with Relapsed or Refractory Multiple Myeloma (NCT04155749)
The Phase 1 study evaluating ACLX-001 in adults with relapsed or refractory multiple myeloma (r/r MM) is a first-in-human, open-label, multicenter, dose escalation clinical trial designed to evaluate ARC-SparX, in which a matrix escalation of either ARC-T cells or SparX-001 or both may be escalated based on clinical correlative data, including pharmacokinetics of SparX-001 and ARC-T expansion. The primary objective of this study is to evaluate the safety and tolerability of ARC-SparX. A secondary objective is to identify a dosing strategy associated with ARC-T cell expansion kinetics that results in the best mix of efficacy, as determined by International Myeloma Working Group response criteria, and safety profile.

On May 10, 2022 Eiger Biopharmaceuticals Inc. ("Eiger",Nasdaq: EIGR) and AnGes Inc. ("AnGes", TYO: 4563) reported that the companies entered into an agreement for the regulatory approval, marketing, and distribution of Zokinvy (lonafarnib) for the treatment of Hutchinson-Gilford progeria syndrome (HGPS or progeria) and processing-deficient progeroid laminopathies (PL) in Japan (Press release, Eiger Biopharmaceuticals, MAY 10, 2022, View Source [SID1234614144]).

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Under the terms of the agreement, AnGes is responsible for obtaining and maintaining regulatory approval for Zokinvy in Japan and will be the exclusive partner for distribution and commercialization. Eiger will receive upfront and milestone payments up to $1.5M as well as earn revenue from the sale of Zokinvy to AnGes.

"We are thrilled to build a new partnership with Eiger for Zokinvy in Japan. We are committed to obtaining regulatory approval in an expeditious manner to deliver Zokinvy to the HGPS and PL patients in Japan," said Ei Yamada, President and CEO, AnGes. "In parallel with the regulatory approval process, we will persistently advance our preparations to initiate the diagnostic test for HGPS as part of developing the genetic disease diagnosis testing of new-born babies at AnGes Clinical Research Laboratories (ACRL) established last year."

"We are pleased to enter into this partnership with AnGes to seek regulatory approval and commercialization of Zokinvy in Japan to help patients suffering from progeria and progeroid laminopathies," said David Cory, President and CEO, Eiger. "This collaboration is representative of Eiger’s strategic approach to fully leverage our innovative therapies to enhance shareholder value and support underserved patients around the world."

About progeria and progeroid laminopathies

Progeria, also known as Hutchinson-Gilford progeria syndrome, and progeroid laminopathies are separate and distinct ultra-rare, fatal, genetic premature aging diseases that accelerate mortality in young patients. It is estimated that there are 400 children worldwide with progeria and 200 children with progeroid laminopathies.

Progeria is caused by a point mutation in the LMNA gene, yielding the farnesylated aberrant protein, progerin. Progeroid laminopathies are genetic conditions of accelerated aging caused by a constellation of mutations in the LMNA and/or ZMPSTE24 genes yielding farnesylated proteins that are distinct from progerin. While non–progerin producing, these genetic mutations result in disease manifestations with phenotypes that have overlap with, but are distinct from, progeria.

Without Zokinvy therapy, children with progeria commonly die of the same heart disease that affects millions of normally aging adults (arteriosclerosis), by an average age of 14.5 years. Disease manifestations include severe failure to thrive, scleroderma–like skin, global lipodystrophy, alopecia, joint contractures, skeletal dysplasia, global accelerated atherosclerosis with cardiovascular decline, and debilitating strokes.

About Zokinvy (lonafarnib)

Zokinvy was approved in the U.S. in November 2020 to reduce the risk of death with HGPS (progeria), and to treat processing-deficient progeroid laminopathies. It is indicated for adults and children over 12 months of age.

Zokinvy blocks the accumulation of defective, farnesylated proteins which form tight associations with the nuclear envelope, leading to cellular instability and premature aging in children and young adults with progeria and processing-deficient progeroid laminopathies.

Zokinvy is a first-in-class disease-modifying agent that has demonstrated a statistically significant survival benefit in children and young adults with progeria. In patients with progeria, Zokinvy reduced the incidence of mortality by 60% (p=0.0064) and increased average survival time by at least 2.5 years. The most commonly reported adverse reactions were gastrointestinal (vomiting, diarrhea, nausea), and most were mild or moderate (Grade 1 or 2) in severity. Many progeria patients have received continuous Zokinvy therapy for more than 10 years.

Eiger licensed exclusive worldwide rights to lonafarnib from Merck, known as MSD outside of the United States and Canada. Merck will not receive any milestone payments for the development of lonafarnib for the treatment of progeria and has waived royalty obligations from Eiger for a specified quantity of lonafarnib.

For more information including prescribing information for Zokinvy in the U.S. please go to www.zokinvy.com. Please click here for the full U.S. important safety information. Eiger has filed a marketing authorization application with the European Medicines Agency and expects a CHMP opinion in Q2 2022. Zokinvy is not approved for any indication in Japan.

On May 10, 2022 RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, reported on May 10th, 2022, that its phase IIb study in prostate cancer, BRaVac, has reached "Database Lock" (Press release, RhoVac, MAY 10, 2022, View Source [SID1234614143]). This means that all data from the trial is now finally reported, cleaned and "locked" in the data base. The next step will be analysis to produce the results. As previously stated, RhoVac anticipates having its primary results no later than at the beginning of June.

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RhoVac started the clinical phase IIb trial (BRaVac) with the company’s drug candidate, RV001, (onilcamotide) late 2019, in prostate cancer patients with a biochemical recurrence (a rise in PSA) after local curative intent therapy. In November of 2020, RhoVac was awarded Fast Track Designation by the FDA for its drug candidate in this cancer indication. Patient recruitment was conducted in six European countries (Finland, Sweden, Denmark, the United Kingdom, Belgium and Germany) and in the United States. Recruitment ended in September 2021, when 180 patients had been included. The objective of the study is to show that onilcamotide can significantly prevent or delay disease progression in these patients, something for which no standard therapy is available today. Interim safety reviews have been conducted and no unexpected adverse reactions have been identified, confirming the anticipated safety of the drug. Now, the study has reached "Database Lock" with only a few weeks to go until the primary results are known. All results, including subgroup analyses, will be available in the summer.

CEO, Anders Månsson, comments: "BRaVac started at the end of 2019, and much of the study has been run in pandemic conditions, which it has taken extraordinary efforts to overcome. We are happy to conclude that we have overcome all obstacles, that our intermediary safety reviews have all been positive, and now, after database lock, we await with excitement and anticipation what the primary results will bring in terms of efficacy."

This disclosure contains information that RhoVac is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 10-05-2022 20:50 CET.