On June 9, 2022 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, reported Dr. Klaus Paulini, Chief Executive Officer of Aeterna Zentaris, will present at the JMP Securities Life Sciences Conference on Wednesday, June 15, 2022 at 12:30 PM ET being held in New York, New York (Press release, AEterna Zentaris, JUN 9, 2022, View Source;id=233641&p=2232418&I=1206939-c7Z3G6f3m8 [SID1234615831]).

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In addition to the presentation, management will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information, please visit the conference website.

A live video webcast of the presentation will be available on the Company’s website on the Events page in the Investors section of the Company’s website (zentaris.com). The webcast replay will be archived for 90 days following the event.

On June 9, 2022 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System, that destroys tumors by freezing as an alternative to surgical tumor removal ("ProSense"), reported that KTRFIOS IMPORTACAO E EXPORTACAO LTDA., IceCure’s distributor in Brazil ("KTRFIOS"), has submitted a regulatory filing to the Brazilian Health Regulatory Agency ("ANVISA") for the approval of ProSense for several indications (Press release, IceCure Medical, JUN 9, 2022, View Source [SID1234615847]). KTRFIOS has submitted this regulatory filing as part of an agreement signed with IceCure which includes KTRFIOS’ guarantee of at least $6.6 million in total sales for five years following such regulatory approval and a down payment of $344,000 for 50% of the initial order.

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The indications for use included in the ANVISA application are for oncology, including ablation of benign and malignant tissues in breast, prostate, kidney, lung, liver, musculoskeletal, and skin tissues, as well as for palliative intervention and other indications.

According to the World Health Organization’s (WHO) Cancer Tomorrow | IARC project, Brazil had a population of over 200 million with an estimated 592,000 cancer cases in 2020, 88,500 of which were breast cancer. The WHO expects the number of breast cancer cases in Brazil to rise to 99,800 by 2025. Therefore, IceCure believes there is a clear need for minimally-invasive cancer treatments, such as ProSense, in the Brazilian market.

"We are very pleased to be working with KTRFIOS in Brazil, a significant healthcare market in Latin America, and to achieve this major milestone. This regulatory application reflects the broad number of indications for which our ProSense system can provide a highly effective, minimally invasive, and safe method of treatment for cancer patients," stated IceCure CEO Eyal Shamir. "Regulatory approvals in Brazil would add to our global regulatory landscape which now encompasses various indications across 14 countries including the U.S. and Europe."

On June 9, 2022 Massive Bio, Inc., a leader in precision medicine and artificial intelligence (AI)-enabled patient-centric clinical trial enrollment for oncology, and AdhereTech, a pioneer and leading provider of smart devices that connect patients to care with real-time interventions, reported their partnership to provide advanced, data-driven digital health technology solutions, focusing in oral oncolytic agents providing real-time integrated access to care for cancer patients to precision oncology drugs and leading-edge clinical trials (Press release, Massive Bio, JUN 9, 2022, View Source [SID1234615799]). Both companies were recognized in the 2022 NYC Digital Health 100, which showcases the most exciting digital health companies in the New York region.

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Massive Bio and AdhereTech have committed to combining their products and services to offer global, comprehensive solutions to measure, analyze and monitor precision oncology medication adherence for patients participating in clinical trials and those prescribed commercially available treatments. Both companies currently are contracted with leading pharmaceutical companies and major specialty pharmacies. Their work with payers, pharmacies, and pharmaceutical companies to develop adherence programs utilizing device-generated data to optimize processes and improve cost-effective measures for specialty drug and clinical trial programs that may save the industry hundreds of billions of dollars per year.

"While the conversation around digital health and pharma has expanded well beyond adherence, in oncology it provides the link between cost-effective treatments, and an opportunity to prioritize clinical trials when most appropriate," mentioned Selin Kurnaz, CEO and Co-Founder of Massive Bio. "Even modest improvements can lead to huge cost savings for payers and the pharmaceutical research industry while allowing streamlined access in real-time to effective on-label precision oncology treatments. It is a win-win situation for all stakeholders, from patients to specialty pharmacies, payers, and the commercial and cancer research ecosystem. AdhereTech is one of the few companies successfully achieving those goals, and we are excited about this collaboration."

With over 13,000 active cancer clinical trials in the US at any given time, and dozens of biomarkers and precision oncology molecules under study, Massive Bio aims to use AI and patient-centric concierge services at scale to reach cancer patients globally and accelerate the oncology research and development infrastructure. Massive Bio had recently announced the launch of its NASA-style Oncology Clinical Trial Command Center (OCTCC) to disrupt and accelerate trial enrollment, and also the launch of its 100K Cancer Clinical Trial Singularity Program aimed at matching 100,000 cancer patients in real-time to cutting-edge clinical trials using its Massive Bio’s AI-based technology, website and apps across iOS and Android platforms, expanding their presence as a global company with country-level success in 12 markets.

AdhereTech is a leader in medication programs, providing commercialized digital solutions to measure and manage medication adherence in a variety of settings, including academics, clinical trials, and commercially prescribed treatments. It develops and produces treatment management solutions utilizing smart devices with integrated cellular technology that seamlessly connects patients in real-time to confirm when patients take their medication and provides two-way communications to ensure dosing regimens are followed and reports and escalate the reasons for and missed doses.

"The Aidia System creates personalized patient support with specialty pharmacies and healthcare teams, enabling timely health interventions when necessary, and clinical trials can benefit from those key interventions," said Chris O’Brien, Chief Executive Officer of AdhereTech. "Upon learning of Massive Bio’s traction in the oncology space and the opportunities of using our Aidia System, expansive network, and real-world data to help patients, physicians and the cancer research industry at a technology-enabled scale, it made absolute sense to explore and operationalize this partnership."

"Our AI-enabled clinical trial and precision oncology therapy-finding technology works at its best when paired up with real-time patient-reported insights" said Arturo Loaiza-Bonilla, M.D., Co-Founder of Massive Bio. "By leveraging real-time data from AdhereTech’s Smart Adherence System in combination with our SYNERGY-AI cancer trial matching platform, we can identify key opportunities for clinical trial enrollment while also optimizing medication adherence and access in both precision oncology care and cancer research."

"At AdhereTech, we strive to bring data, analytics, and new technologies to market to serve patients and life science companies with better resources in the vital clinical research and treatment realms," said Gregory Gallo, Chief Revenue Officer of AdhereTech. "We’re excited to partner with a cutting-edge solutions provider in the critical oncology therapeutic category. Integrating technology and resources will streamline patient journeys and achieve more consistent engagement, enhance care, and ultimately improve outcomes and scientific advances," added Gallo.

On June 9, 2022 Aptevo Therapeutics Inc. ("Aptevo" or the "Company") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported new remission data on four additional patients (Press release, Aptevo Therapeutics, JUN 9, 2022, View Source [SID1234615832]). The new data includes one patient who achieved a complete remission (CR), one patient who achieved a complete remission with incomplete hematologic recovery (CRi) and two patients who achieved bone marrow complete remissions, or morphological leukemia-free state (MLFS), in the Company’s on-going multi-cohort, multi-center Phase 1b expansion trial evaluating APVO436 for the treatment of acute myeloid leukemia (AML). The Company also provided an update on a myelodysplastic syndrome (MDS) patient from the dose escalation part of the trial.

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Cohort 1 currently has the highest enrollment rate in the trial and preliminary data show that a total of four out of 11 response-evaluable patients (36%) reported on to date, have experienced remission while on therapy. Of the three new cohort 1 patients announced today, one is a CR, one is a CRi, and one is a bone marrow complete remission (MLFS). Cohort 1 is a combination arm of the trial that includes relapsed patients and those with primary refractory AML that failed to respond to frontline standard induction chemotherapy. Cohort 1 patients receive standard chemotherapy drug cytarabine or the standard chemotherapy triple drug combination MEC (mitoxantrone, etoposide, cytarabine) plus APVO436.

The fourth new patient reported on today participated in cohort 3, a monotherapy arm of the trial, and achieved a bone marrow complete remission (MLFS).

"We are enthusiastic about sharing this remission data for four new patients, including three cohort 1 participants who are receiving APVO436 in combination with standard of care, after experiencing relapsed/refractory disease, meaning they did not respond or stopped responding to prior therapy, narrowing their options for further treatment," said Dirk Huebner, Chief Medical Officer at Aptevo Therapeutics. "The observed data are very encouraging and show a positive trend in the trial, potentially establishing a path for APVO436 in combination therapy."

The Company also announced today that a patient with high-risk myelodysplastic syndrome (MDS) enrolled in the dose escalation trial remains stable and continues treatment with APVO436 now exceeding 18 months. Prior to joining the trial, this patient received and failed treatment with a hypomethylating agent, a situation that is commonly expected to be a poor prognostic event associated with short survival probability of approximately four to six months.

In this study, a "complete remission (CR)" is defined as a patient with no evidence of leukemia after treatment. This means the bone marrow contains < 5% leukemic blasts and hematologic (blood) recovery that includes normal white blood cell and platelet counts and other markers of healthy blood.

A "CRi" is defined as a complete remission except for residual thrombocytopenia or neutropenia. A "bone marrow complete remission (MLFS)" is defined as bone marrow blasts consistent with complete remission, <5%, but where peripheral blood recovery has not yet been observed.

On June 9, 2022 ORPHELIA Pharma and Gustave Roussy reported the publication in the scientific journal Pharmaceuticals of the work related to the development of the first temozolomide oral suspension for the treatment of young children and adults with cancer and presenting difficulties to swallow temozolomide capsules (Annereau M. et al., Pharmaceuticals, 2022) (Press release, ORPHELIA Pharma, JUN 9, 2022, View Source;utm_medium=rss&utm_campaign=orphelia-pharma-and-gustave-roussy-announce-the-publication-in-pharmaceuticals-of-the-scientific-work-related-to-the-development-of-the-first-temozolomide-oral-suspension-for-children [SID1234615800]).

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"Since 2015, we have been manufacturing a liquid temozolomide hospital compounded formulation to address the needs of young patients treated in our hospital and a few partner centers," explains Maxime Annereau, pharmacist at Gustave Roussy and the originator of this project. "In collaboration with ORPHELIA Pharma, we carried out the necessary research work to optimize the physico-chemical properties and the stability of the suspension. Then we conducted a palatability study in order to select the aroma capable of covering the bitterness of temozolomide in the most efficient way. The development of this concentrated suspension has made it possible to obtain a form adapted to the needs of patients and caregivers", he adds.

"The work done in collaboration with our partner Gustave Roussy led to a prototype of KIMOZO, an industrialized and patented version of this drinkable and highly concentrated suspension. KIMOZO is currently in an advanced phase of clinical development," says Jeremy Bastid, Chief Development Officer of ORPHELIA Pharma. "Temozolomide is an essential drug in the management of many pediatric cancers, including relapsed or refractory neuroblastoma which unfortunately affects very young children. Thanks to the results of this collaboration, we intend to make this pediatric formulation available to patients soon," he concludes.

About KIMOZO 40 mg/ml

KIMOZO 40 mg/ml is a liquid, taste-masked and ready-to-use oral formulation of temozolomide developed in collaboration between the pharmacists and clinicians of Gustave Roussy and the development team of ORPHELIA Pharma. The formulation of KIMOZO has been covered by a patent application in Europe and in the US.