Ascendis Pharma to Participate in the 42nd Annual J.P. Morgan Healthcare Conference

On December 28, 2023 Ascendis Pharma A/S (Nasdaq: ASND) reported that Jan Mikkelsen, President & Chief Executive Officer, Scott Smith, Executive Vice President & Chief Financial Officer, and Kennett Sprogøe, Ph.D., Executive Vice President, Head of Research & Product Development, will participate in the 42nd Annual J.P. Morgan Healthcare Conference (Press release, Ascendis Pharma, DEC 28, 2023, View Source [SID1234638822]).

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Details:

Event 42nd Annual J.P. Morgan Healthcare Conference
Location San Francisco, CA
Date Monday, January 8, 2024
Time 12:00-12:40 p.m. Eastern Time / 9:00-9:40 a.m. Pacific Time

A live webcast of the event will be available via the Investors & News section of the Ascendis Pharma website at investors.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.

Circio Holding ASA: Requested Conversion of Convertible Bonds

On December 28, 2023 Circio reported the reference is made to Circio Holding ASA’s (the "Company") stock exchange reported on 9 March 2023, in which the Company announced that it had requested Atlas Special Opportunities, LLC ("Atlas") to subscribe and pay for the first tranche of convertible bonds under the Investment Agreement entered into between Atlas and the Company, consisting of 75 convertible bonds (Press release, Circio, DEC 28, 2023, View Source [SID1234638821]).

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Atlas has, by a notice of conversion issued to Nordic Trustee AS, requested conversion of convertible bonds with a nominal value of NOK 500,000 which, pursuant to the bond terms, are convertible into 77,097 new shares in the Company at a conversion price of NOK 6.4853.

The Company’s share capital will accordingly be increased by NOK 46,258.20 by the issuance of 77,097 new shares upon completion of the conversion by registration of the share capital increase in the Norwegian Register of Business Enterprises (Nw.: Foretaksregisteret). Following the conversion, the Company’s total share capital will be NOK 4,484,286.60, divided into 7,473,811 shares, each with a nominal value of NOK 0.60.

Be Biopharma to Present at the 42nd Annual J.P. Morgan Healthcare Conference

On December 28, 2023 Be Biopharma, Inc. ("Be Bio"), a company pioneering the discovery and development of Engineered B Cell Medicines (BCMs), reported that Chief Executive Officer Joanne Smith-Farrell, Ph.D., will present at the 42nd Annual J.P. Morgan Healthcare Conference being held at the Westin St. Francis in San Francisco, CA on Wednesday, January 10, 2024 (Press release, Be Biopharma, DEC 28, 2023, View Source [SID1234638820]).

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42nd Annual J.P. Morgan Healthcare Conference
Presentation Date: Wednesday, January 10, 2024
Presentation Time: 8:30 am PT

About Engineered B Cell Medicines – A New Class of Cellular Medicines

The B cell is a powerful cell that produces thousands of proteins per cell per second at constant levels, over decades. Precision genome editing can now be used to engineer B Cells that produce therapeutic proteins of interest, driving a new class of cellular medicines – Engineered B Cell Medicines (BCMs) – with the potential to be durable, allogeneic, redosable and administered without pre-conditioning. The promise of BCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas.

Elpiscience and Astellas Enter into Research Collaboration and License Agreement for Novel Bispecific Macrophage Engager

On December 28, 2023 Elpiscience Biopharma, Ltd. (Chairman and CEO: Darren Ji, MD, Ph.D., "Elpiscience") and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported a research collaboration and license agreement for novel bi-specific macrophage engagers, ES019 and another program (Press release, Astellas, DEC 28, 2023, View Source [SID1234638819]). The two companies will collaboratively conduct early-stage research for these two programs. Elpiscience will also grant Astellas the right to add up to two additional programs to be included in the collaboration. If Astellas exercises its option, Elpiscience will grant Astellas the exclusive right to further research, develop, manufacture and commercialize the products for each program.

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Elpiscience is a privately held, clinical-stage biopharmaceutical company dedicated to developing next-generation immuno-oncology therapies for cancer patients worldwide. Their Bispecific Macrophage Engager Platform (BiME) is anti-tumor associated antigen (TAA) and anti-signal-regulatory protein α (SIRPα) bispecific antibody-based platform to activate Tumor Associated Macrophage (TAM) phagocytosis killing towards specific TAA expressing tumor cells. BiME shows highly potent phagocytosis due to engagement of the Fc receptor on TAM and the tumor cells via TAA and SIRPα, and blockade of CD47-SIRPα "don’t eat me" signaling1. This platform is utilized for ES019, an anti-PD-L1/SIRPα bispecific antibody.

TAMs are the most abundant leukocytes within Tumor Microenvironment (TME) of many cancer types and correlate with poor prognosis and immune checkpoint inhibitor resistance. The programs emerging from the BiME platform are expected to offer new options for cancer patients who do not respond to existing cancer immunotherapies, by modulating TAM and reprogramming the TME status.

Elpiscience will receive up to US $37 million, including the upfront payment and license option fees. In addition, Elpiscience will receive research funding from Astellas to advance the programs. After Astellas exercises its option, Elpiscience is eligible to potentially receive more than US $1.7 billion in payments for the achievement of future development, regulatory, and commercial milestones. Elpiscience is also eligible to receive single-digit to lower double-digit percent royalty payments on net sales for licensed products per each program.

Darren Ji, MD, Ph.D., Chairman and CEO, Elpiscience
"We are pleased to collaborate with Astellas, a world leader of innovative medicines, on developing game-changing therapies for cancer. BiME innovated at Elpiscience represents a paradigm shift from the conventional cell engagers dominated by T cells. The therapeutic molecules generated from the BiME platform have the potential of changing the clinical practice for tumors where tumor-associated macrophages are highly abundant, and no effective therapies are available. We look forward to working with Astellas to bring these exciting sciences to the bedside of global patients."

Adam Pearson, Chief Strategy Officer, Astellas
"Astellas has a strong commitment to developing innovative cancer treatments and have positioned Immuno-Oncology as one of the Primary Focuses of our R&D strategy2. Elpiscience has outstanding expertise in developing next generation immunotherapies. We hope this collaboration will bring synergies between the two companies’ cutting-edge research and will ultimately lead to the development of new treatments for patients with cancer."

"don’t eat me" signaling: CD47 is a protein that emits a "don’t eat me" signal. When CD47 on tumor cells bind with SIRPα on macrophages, the macrophages suppress phagocytosis.
2 Astellas’ R&D strategy: Astellas has established a Focus Area Approach for its research and development strategy. For more information, please visit our website at Areas of Interest | Astellas Pharma Inc.

Beyond Cancer™ Phase 1 Study Clears Cohort 1 in Patients with Advanced Relapsed or Refractory Unresectable Primary or Metastatic Cutaneous or Subcutaneous Solid Tumors

On December 27, 2023 Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc. (NASDAQ: XAIR) and a clinical stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, reported that the Phase 1 Study evaluating UNO in advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous solid tumors has cleared the first cohort of 25,000 ppm single dose UNO by the Safety Review Committee with no reported dose limiting toxicities (Press release, Beyond Air, DEC 27, 2023, View Source [SID1234638837]).

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The first-in-human, open-label, non-randomized Phase 1 study is being conducted in two parts: Dose Escalation and Dose Expansion. The Dose Escalation consists of three UNO cohorts (25,000, 50,000 and 100,000 ppm) of three to six patients. The Dose Expansion will begin once the recommended dose is determined in the Dose Escalation portion. The primary objective of the trial is to assess the safety and tolerability of UNO with a secondary objective of assessment of efficacy by immune biomarker response to UNO therapy.

"We are delighted to advance to the next cohort of our Phase 1 trial with no reported dose limiting toxicities," said Dr. Jedidiah Monson, Beyond Cancer’s Chief Medical Officer. "The well tolerated administration of UNO is encouraging and the feasibility of UNO administration in patients has been demonstrated. We look forward to completing Dose Escalation, advancing the UNO development program to the Dose Expansion portion of the study, and future combinations with immune checkpoint inhibitors. We expect to build upon the positive initial preliminary efficacy data presented at this year’s SITC (Free SITC Whitepaper) annual meeting demonstrating evidence of immune system activation with further updates at major medical conferences in 2024."

Additional information about this trial is available at clinicaltrials.gov (NCT#05351502).

About Nitric Oxide
Nitric Oxide (NO) is a potent molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens.