On May 17, 2023 Avenge Bio, Inc. ("Avenge"), a clinical stage, oncology-focused biotechnology company developing the LOCOcyte Immunotherapy platform for the precision administration of potent immune effector molecules to treat solid tumors, reported participation in the upcoming scientific and investor conferences (Press release, Avenge Bio, MAY 17, 2023, View Source;investor-conferences-301826580.html [SID1234631824]):

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5th Annual Allogenic Cell Therapies Summit – May 22-25, 2023
Location: The Westin Boston Seaport District | Boston, MA
Date & Time: Thursday, May 25, 2023 – Advancing Durability & Persistence Focus Day – 12:30 PM ET
Presenter: Omid Veiseh, PhD (Rice University & Co-Founder, Avenge Bio)
Seminar: Cell Generated Immunotherapies Eradicating Solid Tumors

American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting – June 2-6, 2023
Location: McCormick Place | Chicago, IL
Session Type/Title: Poster Session – Gynecologic Cancer
Date & Time: Monday, June 5, 2023 – 1:15-4:15 PM CT
Abstract #: TPS5616
Poster Board #: 309a
Poster Title: A Phase 1/2 Open-Label, Multicenter, Dose Escalation, and Expansion Study of AVB-001, an Intraperitoneally Administered, Cell-Generated, Human IL-2 Immunotherapy in Patients with Platinum-Resistant, High-Grade, Serous Adenocarcinoma of the Ovary, Primary Peritoneum, or Fallopian Tube
Clinical Trial #: NCT05538624
Presenter: Shannon N. Westin, MD, MPH (MD Anderson Cancer Center)

BIO International Convention – June 5-8, 2023
Location: Boston Convention & Exhibition Center (BCEC) | Boston, MA
Members of the executive team will be participating in one-on-one partnering meetings. To schedule a meeting, please submit a request via the partnering platform.

Jefferies Healthcare Conference – June 7-9, 2023
Location: Marriott Marquis | New York, NY | Track 3
Date & Time: Wednesday, June 7, 2023 – 11:00-11:25 AM ET
Avenge will have an in-person presentation by Michael Heffernan, Chief Executive Officer. Members of the executive team will be available to participate in one-on-one investor meetings.

About LOCOcyte Platform

Our LOCOcyte allogeneic cell-based immunotherapy platform enables potent localized modulation of the immune system which also precipitates a systemic immune response, allowing us to treat previously intractable cancers. The technology leverages three unique advantages:

Potent immune effector molecules are generated by synthetically engineering allogeneic cells creating a ready-to-use therapy,

Therapy is localized in proximity to the primary tumor site and generates innate and adaptive immune response, and

The immunomodulator trains the patient’s immune system generating a robust immune response that seeks and eradicates distal metastasis without systemic toxicity.

On May 17, 2023 Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standards of care to cure cancer and infectious diseases, reported the start of its open-label Phase 1/2 study evaluating Debio 0123, a brain-penetrant and highly selective WEE1 inhibitor, in combination with temozolomide (TMZ) in patients with recurrent or progressive glioblastoma and in combination with TMZ/RT (SOC) in newly diagnosed patients (Press release, Debiopharm, MAY 17, 2023, View Source [SID1234631823]). The initial phase of this study aims to define the recommended phase 2 doses of Debio 0123.

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GBM is among the most aggressive and common lethal tumors of the central nervous system. This disease represents a major cause of morbidity and mortality affecting more than 13,000 Americans and causing the death of about 10,000 patients in 2022 1. If left untreated, in some cases GBM can lead to the patient’s death in approximately 3 months. This type of cancer tends to occur more often in adults between 65-75 years of age. Throughout the continuum of this devastating disease, patients face serious quality of life issues including motor deficits, personality changes, cognitive deficits, language disorders (aphasia) or visual field defects. The disease’s poor prognosis constitutes a serious public health concern.

With its Debio 0123 WEE1 inhibitor, Debiopharm is seeking to meet the urgent need for novel treatment interventions to improve clinical outcomes and quality of life for patients suffering from newly diagnosed or recurrent GBM. In cancer cells, DDR pathways are often upregulated due to genomic instability, elevating the chances of resistance to DNA-damaging therapies. Therefore, blocking DNA repair pathways through inhibition of essential kinases such as WEE1 might contribute to increase the cancer’s vulnerability to standard of care therapies. Moreover, preclinical results presented at AACR (Free AACR Whitepaper) 2023 have shown that Debio 0123 successfully crosses the blood brain barrier and inhibits tumor growth. Furthermore, the in vivo combination of Debio 0123 with TMZ demonstrated significantly increased antitumor activity.

"I am very excited to witness the development of a new generation of brain penetrant drugs. Having drugs like this allows us to explore novel treatments for brain tumors, which remains an ongoing challenge." Dr. Jordi Rodon Ahnert, MD, PhD, MD Anderson Cancer Center, Houston, Texas.

"The combination of Debio 0123 with temozolomide is promising. Treatment with Debio 0123 to inhibit WEE1 has the advantage of selectively impacting tumor cells, which, due to the increasing replication stress during the S-phase, become more reliant on the proper functioning of the G2-M checkpoint. Debio 0123 acting at both S-phase and G2-M checkpoint can thus make GBM cells more vulnerable to DNA-damaging agents like temozolomide" expressed Dr. Victor Rodriguez-Freixinos, Associate Medical Direction in Oncology at Debiopharm.

"Due to its physiological and structural properties, the blood brain barrier represents a unique challenge for drug delivery and a massive obstacle to patient’s care. Thus, Debio 0123 brain permeability represents an important source of hope to patients suffering from brain cancers" stated Dr. Patrick Roth, University Hospital Zürich.

About Glioblastoma

Glioblastomas are fast-growing and aggressive brain tumors that can arise de novo or evolve from lower grade gliomas. GBM may be asymptomatic until it reaches a significant size. Aside from diagnostic challenges, nearly all GBM recur, and effective treatment options are limited. The widely accepted SOC for patients with newly diagnosed GBMs consists of surgical resection, followed by radiation therapy with concurrent TMZ. Despite treatment, nearly all GBM recur, the 5-year survival rate is still only 6.8% 1 and treatment options are very limited.

About Debio 0123

Debio 0123 is a brain-penetrant, highly selective WEE1 kinase inhibitor. WEE1 is a key regulator of the G2/M and S phase checkpoints, activated in response to DNA damage, allowing cells to repair their DNA before resuming their cell cycle. WEE1 inhibition, particularly in combination with DNA damaging agents, induces an overload of DNA breaks. In conjunction with abrogation of other checkpoints such as G1, the compound pushes the cells through cycle without DNA repair, promoting mitotic catastrophe and inducing apoptosis of cancer cells. Currently in research for solid tumors in monotherapy and combination, Debio 0123 is being developed to respond to high unmet needs of patients living with the burden of difficult-to-treat cancers.

About DNA-Damage Repair (DDR)

When cells have damaged DNA, they need to undergo a repair process called DDR to be able to survive. Cancer cells use their hyperactive DDR response to divide and grow uncontrollably, which promotes cancer expansion. Inhibition of DDR, particularly in combination with other anticancer agents, induces an overall arrest in the uncontrollable cancer cell cycle. This ultimately activates a self-destruction program in cancer cells. DDR inhibitors such as Debiopharm’s WEE1 and USP1 inhibitors, are being tested in clinical and preclinical studies.

On May 17, 2023 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that the Investigational New Drug (IND) for a Phase I study of the first-in-class anti-CD24 monoclonal antibody ATG-031 has received clearance from the U.S. Food and Drug Administration (FDA) (Press release, Antengene, MAY 17, 2023, View Source [SID1234631822]).

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The PERFORM trial is a first-in-human, multi-center, open-label, Phase I dose-finding study of ATG-031 in patients with advanced solid tumors or B-NHL. The primary objective of the study is to evaluate the safety and tolerability of ATG-031 as a monotherapy, and to determine the appropriate dose for Phase II studies. The secondary objective is to characterize the pharmacology, evaluate the immunogenicity, and assess the preliminary efficacy of ATG-031.

ATG-031 is a first-in-class humanized anti-CD24 monoclonal antibody which inhibits the "don’t eat me" signal in the tumor microenvironment (TME). ATG-031 was designed to specifically bind with the CD24 expressed on cancer cells with high affinity and block the interaction between CD24 and the Siglec-10 receptor expressed on the surface of tumor associated macrophages (TAMs), to enhance the macrophage-mediated phagocytosis of cancer cells and promote cytotoxic T-cell function in the tumor microenvironment.

"Targeting the so-called ‘don’t eat me’ signal is a promising therapeutic strategy for cancer treatment. In comparison to existing ‘don’t eat me’ blockers such as anti-CD47 monoclonal antibodies, ATG-031 demonstrated a wider therapeutic window and the ability to overcome the on-target-off-tumor toxicities observed with CD47 inhibitors," said Dr. Bing Hou, Antengene’s Executive Director of Drug Discovery and a co-inventor of ATG-031. "CD24 is a small and highly glycosylated protein that makes the development of antibodies particularly challenging. Through our persistent experimental efforts and by adopting unique discovery and screening strategies as well as leveraging our deep expertise on the target’s biology, Antengene’s discovery scientists successfully advanced ATG-031, an antibody with optimal characteristics, into clinical development in just three years. We are thrilled to see our in-house developed first-in-class drug entering the clinic and taking a major step towards benefiting patients."

"We believe that therapies that can effectively mobilize the macrophage activity in the tumor microenvironment will be a very important element of cancer care," said Dr. Bo Shan, Antengene’s Chief Scientific Officer. "The potential role of ATG-031 is supported by robust preclinical data that showed potent single agent in vivo efficacy and synergistic effects with chemotherapy or checkpoint inhibitors (CPIs). Therefore, we are very optimistic about the clinical development of ATG-031 and look forward to initiating the patient enrolment as early as possible."

"In this clinical program for ATG-031, we will deploy an in-house developed companion diagnostic (CDx) antibody, thus adding a precision-medicine element to the program," said Dr. Amily Zhang, Antengene’s Chief Medical Officer. "In addition to serving as a patient selection tool, the CDx antibody will help us to better understand the CD24 expression in normal and cancerous tissue. We are excited to learn more about the safety, tolerability and efficacy of ATG-031 through the clinical program and look forward to sharing the first data from this study in 2024."

"ATG-031 is the world’s first anti-CD24 antibody to be advanced to the clinic in oncology and Antengene’s third drug candidate cleared to enter clinical studies in the U.S.," said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. "I am very proud of the entire R&D organization, for innovating and advancing this proprietary asset, from bench to patient, in such a robust and efficient manner. We believe that targeting CD24 could represent a major oncological advancement and anticipate more exciting progress with this clinical program."

About ATG-031

ATG-031 is a first-in-class humanized CD24 monoclonal antibody which inhibits the "don’t eat me" signal and enhances macrophage-mediated phagocytosis of cancer cells. Tumor cells evade the surveillance of the human immune system by over-expressing "don’t eat me" surface proteins that signal macrophages to prevent the detection and phagocytosis of cancer cells. CD24 (cluster of differentiation 24) is a prominent "don’t eat me" signal that plays a significant role in tumor immune evasion by suppressing macrophage-mediated phagocytosis. Compared to CD47, another well-known "don’t eat me" target, CD24 has more restricted distribution in normal tissue and higher expression in cancerous tissue. In addition，unlike CD47，CD24 is not expressed on human red blood cells，allowing for a wider therapeutic window and minimal on-target-off-tumor toxicity as a CD24-targeted therapy.

As a novel innate immune checkpoint, CD24 orchestrates immune evasion through its interaction with the inhibitory receptor called Siglec-10 (sialic-acid-binding Ig-like lectin 10) expressed on tumor-associated macrophages (TAMs). Preclinical data presented in 2023 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR 2023) demonstrated that ATG-031 can specifically bind to CD24 with nM affinity and block the interaction of CD24 and Siglec-10. Furthermore, ATG-31 induces efficient phagocytosis with a picomolar EC50 and stimulate the pro-inflammatory cytokines production by macrophages.

On May 17, 2023 EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported unaudited financial results for the first quarter ended March 31, 2023 (Press release, EDAP TMS, MAY 17, 2023, View Source [SID1234631821]).

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"After achieving record results in the fourth quarter of 2022, we continued to see growing demand through the first quarter of 2023, with our strongest Q1 revenue performance on record," said Ryan Rhodes, Chief Executive Officer of EDAP. "We placed seven Focal One units, including six equipment sales and one operating lease. Based upon the positive feedback from urologists, particularly at this year’s recent EAU & AUA meetings, we expect momentum for the Focal One platform to continue throughout 2023, driven by our state-of-the-art technology, our positive clinical outcomes demonstrating excellent oncologic control, and our world-class sales and customer support team."

"Beyond our commercial performance, we also announced positive results from two clinical studies utilizing Focal One, both conducted at leading academic urology centers. Results from these studies clearly demonstrate the safety, efficacy, and benefits of Focal One that support both continued growth and increased utilization of the technology. As Focal One continues to grow, we are also making commercial progress in other areas. We recently received approval of ExactVuTM micro-ultrasound in Japan, representing a significant regulatory milestone for EDAP that introduces this innovative platform to the world’s second largest medical device market. As we continue to invest in expanding both clinical and commercial activities to drive bottom line performance, we maintain a strong cash position to support both short and long-term growth."

Business Update:

Placed six Focal One machines in the U.S., including five equipment sales and one operating lease. One additional Focal One unit was sold outside of the U.S. in the first quarter of 2023. We observed continued strong momentum in securing new placements across both academic medical centers and community hospitals, as clinicians and providers increasingly recognize Focal One HIFU as an essential option for select patients diagnosed with prostate cancer.
In January, the Company announced positive clinical results from the Endo-HIFU-R1 Phase 2 study evaluating the safety of therapeutic HIFU for the treatment of rectal endometriosis. Of the 60 patients evaluated, 96.7% demonstrated positive safety with no or non-significant adverse events (Clavien 1), 3.3% presented Clavien 2 complications and zero patients presented Clavien 3 complications. Positive effects were also observed in endometriosis symptom reduction and improvement of quality of life at one, three and six months. A significant reduction of the volume of lesions was also observed upon MRI evaluation at six months.
In March, the Company announced positive results from the largest, multicenter, non-inferiority study ever conducted to prospectively evaluate HIFU against radical prostatectomy (RP) as a first line treatment for patients with localized prostate cancer (grade groups <3) at the 38th Annual Congress of the European Association of Urology (EAU). Results demonstrated salvage treatment free survival rate (STFS) at 30 months of 90.1% in the HIFU-treated arm versus 86.8% in patients who underwent RP. In addition, risk of salvage treatment was greater than 1.2-fold higher after RP. International Continence Society (ICS) scores as a measure of urinary incontinence were significantly lower after HIFU and IIEF-5 as a measure of erectile function decreased significantly less after HIFU than after RP, despite the HIFU-treated group being an average of 9.6 years older.
In April, EDAP received approval from Japan’s Pharmaceutical and Medical Devices Agency ("PMDA") for commercialization of ExactVu. ExactVu is a 29 MHz micro-ultrasound platform allowing urologists unparalleled visualization of prostate ultrasound images, detection of suspicious areas in real-time and biopsy results representing cancer aggressiveness. The Japanese market is the second largest global market for advanced medical device technology, with prostate cancer as the most common cancer diagnosis in Japanese men with over 100,000 new prostate cancer diagnoses annually.
Also in April, the Company hosted a global webcast featuring a live broadcast of a Focal One procedure performed by Andre Abreu, MD and Amir H. Lebastchi, MD, Assistant Professors of Clinical Urology at Keck Medicine of the University of Southern California (USC), the first U.S. institution to acquire and adopt EDAP’s robotic HIFU technology.
Several plenary presentations and instructional courses were delivered by leading academic urologists at the Annual Meeting of the American Urological Association (AUA), held April 28th to May 1st, showcasing the Focal One platform’s ability to meet accepted oncological standards for management of prostate cancer, while preserving sexual function and urinary control. Additionally, ExactVu was featured in the AUA Accredited Hands-on Ultrasound Skills Training Course under the guidance of expert faculty.
First Quarter 2023 Results

Total revenue for the first quarter 2023 was EUR 14.8 million (USD 15.9 million), an increase of 13.8% as compared to total revenue of EUR 13.0 million (USD 14.5 million) for the same period in 2022.

Total revenue in the HIFU business for the first quarter 2023 was EUR 5.3 million (USD 5.7 million), an increase of 39.5% as compared to EUR 3.8 million (USD 4.3 million) for the first quarter of 2022. The increase was driven by six Focal One units sold in the first quarter 2023 versus four units sold in the first quarter 2022.

Total revenue in the LITHO business for the first quarter 2023 was EUR 2.8 million (USD 3.0 million), as compared to EUR 2.2 million (USD 2.5 million) for the first quarter of 2022. The improvement was driven by four lithotripsy unit sold in the first quarter of 2023 as compared to one unit sold in the first quarter of 2022.

Total revenue in the Distribution business for the first quarter 2023 was EUR 6.8 million (USD 7.3 million), as compared to EUR 7.0 million (USD 7.8 million) for the first quarter of 2022. The decrease was driven primarily by eight ExactVu units sold during the first quarter of 2023 as compared to nine units sold during the first quarter of 2022.

Gross profit for the first quarter 2023 was EUR 6.0 million (USD 6.5 million), compared to EUR 5.8 million (USD 6.4 million) for the year-ago period. Gross profit margin on net sales was 40.8% in the first quarter of 2023, compared to 44.3% in the year-ago period. The decrease in gross profit rate year-over-year was primarily due to investments in service and applications in the U.S.

Operating expenses were EUR 12.6 million (USD 13.6 million) for the first quarter of 2023, compared to EUR 5.9 million (USD 6.6 million) for the same period in 2022. The significant increase in operating expenses is mainly due to the ongoing build-out of the U.S. team and commercial infrastructure, and non-recurring expenses linked to the leadership succession plan.

Operating loss for the first quarter of 2023 was EUR 6.6 million (USD 7.1 million), compared to an operating loss of EUR 0.1 million (USD 0.1 million) in the first quarter of 2022.

Net loss for the first quarter of 2023 was EUR 7.5 million (USD 8.1 million), or EUR 0.2 per diluted share, as compared to net income of EUR 0.4 million (USD 0.4 million), or EUR 0.01 per diluted share in the year-ago period.

As of March 31, 2023, the company held cash and cash equivalents of EUR 58.3 million (USD 63.4 million) as compared to EUR 63.1 million (USD 67.5 million) as of December 31, 2022.

Conference Call

A conference call and webcast to discuss first quarter 2023 financial results will be hosted by Ryan Rhodes, Chief Executive Officer, François Dietsch, Chief Financial Officer and Ken Mobeck, Chief Financial Officer of the U.S. subsidiary, today Wednesday, May 17th, 2023 at 8:30am EDT. Please refer to the information below for conference call dial-in information and webcast registration.

Date: Wednesday, May 17th @ 8:30am Eastern Time
Domestic: 1-877-451-6152
International: 1-201-389-0879
Passcode: 13738488
CallMe: LINK (active15 minutes prior to conference call)
Webcast: View Source;tp_key=a5bd40c443

About the Endo-HIFU-R1 Phase 2 Study

The Endo-HIFU-R1 Phase 2 study was designed and conducted to evaluate the safety and efficacy of therapeutic high-Intensity focused ultrasound (HIFU) for the treatment of rectal endometriosis with EDAP’s Focal One Robotic HIFU device. At six-months follow up, of the 60 patients enrolled and treated with Focal One HIFU across four centers in France between August 2020 and March 2022, 96.7% demonstrated positive safety with no or non-significant adverse events (Clavien 1), 3.3% presented Clavien 2 complications and zero patients presented Clavien 3 complications. Additional endpoints included evaluation of the effect of HIFU treatment on endometriosis symptoms and Quality of Life (QoL). A significant decrease in endometriosis symptom level (acute pelvic pain, dyspareunia, diarrhea, constipation, rectal bleeding, false urges, tenesmus, rectal spams, posterior pelvic pain and asthenia) and an improvement in almost all evaluated QoL criteria (physical functioning, role limitation due to emotional problems, energy – fatigue, emotional well-being, social functioning, bodily pain, general health, and on physical and mental global score components) were observed at the first post-treatment evaluation at one month, and those benefits were maintained at three and six months following HIFU treatment. The study also blindly evaluated the evolution of nodule volume via MRI, with a significant reduction of the volume of lesions observed at six months. Results from the study were presented by study coordinator, Pr. Gil Dubernard of Croix Rousse University Hospital (Lyon, France) at the Paris Santé Femmes French Congress on Friday, January 27, 2023.

On May 17, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company using its proprietary RADR artificial intelligence ("AI") and machine learning ("ML") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that Panna Sharma, CEO and President, will present at the Lytham Partners Spring 2023 Investor Conference on Thursday, May 18, 2023 (Press release, Lantern Pharma, MAY 17, 2023, View Source [SID1234631820]). The fireside chat-style webcast will be available to all registered attendees. Details of the webcast can be found below:

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Lytham Partners Spring 2023 Investor Conference, Thursday, May 18th at 9:00 a.m. ET.
Presenter: Panna Sharma, CEO & President.
Webcast Link: View Source
Lantern management will also be participating in one-on-one virtual investor meetings throughout the conference. To arrange a meeting with management, please contact Lytham Partners at 1×[email protected] or register at View Source