On May 9, 2022 Enara Bio, a biotechnology company advancing novel T-cell receptor (TCR) directed immunotherapies against unconventional, shared, cancer-specific antigens, reported that three abstracts from the Company and its academic collaborators have been selected for presentation at the 12th International CD1-MR1 European Molecular Biology Organization (EMBO) Meeting, which will be held in Gothenberg, Sweden, 22-26 May 2022 (Press release, Enara Bio, MAY 9, 2022, View Source [SID1234613975]).

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The three abstracts cover pioneering research being conducted by Enara Bio in collaboration with leading immunology and MR1 research groups at Monash University and the University of Oxford towards the identification and validation of cancer-specific MR1 ligands and the development of MR1-targeted T-cell receptor cell therapies (TCR-T).

MR1 is an unconventional antigen-presenting molecule that presents metabolites to the immune system in the context of cancer and infection. The monomorphic nature of MR1 strongly suggests that therapies based on MR1-displayed antigens could be effective across the entire human population. These unique properties make MR1 a promising target for off-the-shelf, HLA-independent, TCR-based immunotherapies for solid tumors.

The first presentation, from Enara scientists, highlights the progress the Company is making with its lead autologous MR1-targeting TCR-T program. The two other presentations, led by scientists from Jamie Rossjohn’s and Tony Purcell’s groups at the Monash Biomedicine Discovery Institute (BDI), and Nicola Ternette’s group at the University of Oxford’s Nuffield Department of Medicine, describe novel immunopeptidomic and metabolomic methods to identify and characterize the cancer-specific MR1 ligandome.

Joe Dukes, Vice President, Head of Research at Enara Bio, commented: "We are very pleased to be presenting important abstracts at the upcoming CD1-MR1 EMBO meeting, which showcase the continued developments we are making in partnership with our world-class collaborators to advance the next generation of cancer immunotherapies designed to treat a broad patient population. We have made remarkable progress in our mission to characterize unconventional immunotherapy targets, such as ligands presented by MR1, which we hope will enable development of a pipeline of product candidates that can be advanced into clinical development."

Details of the poster presentations (which will be available on the Company website at the time of the meeting) are as follows:

Enara Bio

– Abstract Title: A novel TCR-T cell therapy targeting a cancer-specific antigen presented by monomorphic MR1 to overcome the challenge of HLA restricted TCR therapies.
– Presenter: Dr. Jonathan Silk

Monash University

– Abstract Title: Design and testing of cleavable constructs for identification and functional validation of MR1 ligands.
– Presenter: Dr. Patricia Illing

The University of Oxford

– Abstract Title: Development of a metabolomics-based MR1 ligand discovery platform using proteomics instrumentation
– Presenter: Dr. Thierry Schmidlin

On May 9, 2022 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported that it will release its financial results for the first quarter 2022 and provide a business update on Monday, May 16, 2022 (Press release, Protalix, MAY 9, 2022, View Source [SID1234613974]).

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Management will host a conference call with investors to discuss the financial results and provide an update on recent corporate and clinical developments at 8:30 a.m. Eastern Daylight Time (EDT).

The conference will be webcast live from the Company’s website and will be available via the following links:

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.

On May 9, 2022 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it has completed the divestiture of Sunosi (solriamfetol) in the U.S. to Axsome Therapeutics, Inc. (Nasdaq: AXSM) (Press release, Jazz Pharmaceuticals, MAY 9, 2022, View Source [SID1234613973]).

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Under the terms of the agreement, Jazz received an upfront payment of $53 million, and will receive a high single-digit royalty on Axsome’s U.S. net sales of Sunosi in current indications and a mid-single-digit royalty on Axsome’s U.S. net sales of Sunosi in future indications. Subject to the satisfaction of conditions to closing, the ex-U.S. transaction is expected to close within 60 days.

"The divestiture of Sunosi enables us to sharpen our focus on the strategic areas where we see the most opportunity for sustainable growth and enhanced shareholder value," said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. "Looking forward, Jazz will continue to invest in our highest strategic priorities, driving the transformation of Jazz to an innovative, global biopharmaceutical leader, and delivering improved top- and bottom-line growth through operational excellence."

About Sunosi (solriamfetol)

Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA). Sunosi received U.S. Food and Drug Administration approval on March 20, 2019, to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA and was designated a Schedule IV medicine by the U.S. Drug Enforcement Agency on June 17, 2019. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize solriamfetol from Aerial Biopharma LLC. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to solriamfetol, excluding certain jurisdictions in Asia. SK Biopharmaceuticals Co., Ltd., the discoverer of the compound, maintains rights in 12 Asian markets, including Korea, China and Japan. Sunosi has orphan drug designation for narcolepsy in the United States.

Important Safety Information for Sunosi

SUNOSI (solriamfetol) is available in 75 mg and 150 mg tablets and is a federally controlled substance (C-IV) because it contains solriamfetol that can be a target for people who abuse prescription medicines or street drugs. Keep SUNOSI in a safe place to protect it from theft. Never give or sell your SUNOSI to anyone else, because it may cause death or harm them and it is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Before taking SUNOSI, tell your doctor about all of your medical conditions, including if you:

have heart problems, high blood pressure, kidney problems, diabetes, or high cholesterol
have had a heart attack or a stroke
have a history of mental health problems (including psychosis and bipolar disorders), or of drug or alcohol abuse or addiction
are pregnant or planning to become pregnant. It is not known if SUNOSI will harm your unborn baby
are breastfeeding or plan to breastfeed. It is not known if SUNOSI passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take SUNOSI.
What are the possible side effects of SUNOSI?

SUNOSI may cause serious side effects, including:

Increased blood pressure and heart rate. SUNOSI can cause blood pressure and heart rate increases that can increase the risk of heart attack, stroke, heart failure, and death. Your doctor should check your blood pressure before and during treatment with SUNOSI. Your doctor may decrease your dose or tell you to stop taking SUNOSI if you develop high blood pressure that does not go away during treatment with SUNOSI.
Mental (psychiatric) symptoms including anxiety, problems sleeping (insomnia), irritability, and agitation. Tell your doctor if you develop any of these symptoms. Your doctor may change your dose or tell you to stop taking SUNOSI if you develop side effects during treatment with SUNOSI.
The most common side effects of SUNOSI include:

headache
decreased appetite
problems sleeping
nausea
anxiety
These are not all the possible side effects of SUNOSI. Call your doctor for advice about side effects.

On May 9, 2022 Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a commercial-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological and neuropsychiatric diseases, plans to hold its upcoming first quarter 2022 earnings call and webcast, reporting financial results for the quarter ended March 31, 2022, and provide a review of recent accomplishments and anticipated upcoming milestones, on Wednesday, May 11, 2022 at 8:30 a.m. ET (Press release, Biohaven Pharmaceutical, MAY 9, 2022, View Source [SID1234613972]). The earnings call and webcast will follow Biohaven’s issuance of its first quarter 2022 earnings release and the filing of its quarterly report on Form 10-Q for the quarter ended March 31, 2022 on Tuesday, May 10, 2022.

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To access the call on May 11, 2022, please dial 877-407-9120 (domestic) or 412-902-1009 (international). The conference call webcast and accompanying slide presentation can be accessed through the "Investors" section of Biohaven’s website at www.biohavenpharma.com. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. A replay of the call will be made available for two weeks following the conference call. To hear a replay of the call, dial 877-660-6853 (domestic) or 201-612-7415 (international) with conference ID 13728089. An archived webcast will be available on Biohaven’s website.

On May 9, 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 the publication of clinical data from its dose escalation cohorts in its ongoing Phase 1 study of CART-ddBCMA for the treatment of patients with relapsed or refractory multiple myeloma (r/r MM) (Press release, Arcellx, MAY 9, 2022, View Source [SID1234613971]). The data were published in Blood Advances, the open-access journal of the American Society of Hematology (ASH) (Free ASH Whitepaper).

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The publication entitled, "Phase 1 Study of CART-ddBCMA for the treatment of subjects with relapsed and refractory multiple myeloma," reported the following:

Twelve patients in the dose escalation cohorts received a single dose of either 100×106 CART-ddBCMA (DL1, n=6) or 300×106 CART-ddBCMA (DL2, n=6) following a standard lymphodepletion regimen.
No cases of Grade 3 or higher CRS or ICANS occurred at DL1, the recommended Phase 2 dose.
No Parkinsonian-like movement disorders or atypical neurological toxicities were observed.
The maximally tolerated dose was not reached.
All patients dosed responded to CART-ddBCMA (ORR 100%) and 9/12 (75%) patients achieved CR/sCR.
Responses deepened over time and at the data cut (November 4, 2021; median follow-up 56 weeks), 7/9 (78%) of evaluable patients achieved minimal residual disease negativity at 10-5 or greater.
These findings demonstrate the potential safety of CART-ddBCMA cells and durable responses to CART-ddBCMA in r/r MM patients.
The full online publication can be accessed here.

"We are honored to have the clinical results of the first 12 patients treated in the dose escalation cohorts with CART-ddBCMA published in a prominent hematologic journal," said Rami Elghandour, Arcellx’s chairman and chief executive officer. "Given these initial results, we expanded our Phase 1 study at our intended Phase 2 pivotal study dose of 100 million cells, and believe these data are indicative of the potential for CART-ddBCMA to be a best-in-class treatment option for patients with multiple myeloma. We look forward to presenting new clinical data at ASCO (Free ASCO Whitepaper) on June 5 and initiating our Phase 2 pivotal study for CART-ddBCMA in the second half of this year."

About Multiple Myeloma
Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient’s immune function. Multiple myeloma is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years. Because MM tends to afflict patients at an advanced stage of life, patients often have multiple co-morbidities and toxicities that can quickly escalate and become life-endangering.

About CART-ddBCMA
CART-ddBCMA is Arcellx’s BCMA-specific CAR-modified T-cell therapy utilizing the company’s novel BCMA-targeting binding domain for the treatment of patients with relapsed or refractory multiple myeloma. CART-ddBCMA is currently in a Phase 1 study. Arcellx’s proprietary binding domains are novel synthetic proteins designed to bind specific therapeutic targets. CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.