On January 24, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that data from its Phase 1 UNIVERSAL trial of ALLO-715, an anti-BCMA AlloCAR T product candidate for relapsed/refractory (r/r) multiple myeloma (MM) has been published in Nature Medicine (Press release, Allogene, JAN 24, 2023, View Source [SID1234626484]).

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UNIVERSAL is the first and only allogeneic CAR T study to demonstrate that significant responses can be achieved with a single dose in patients with relapsed/refractory multiple myeloma. These initial study results published in Nature Medicine reinforce our belief that ALLO-715 can induce deep, clinically meaningful responses in patients with an allogeneic cell therapy. AlloCAR T product candidates may be able to meaningfully reduce the barriers faced by patients with multiple myeloma when seeking to access cell therapy," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene.

"While new autologous CAR T therapies are a significant advance for patients with multiple myeloma, challenges inherent to those treatments remain, including manufacturing constraints and out-of-specification product, lengthy vein-to-vein time requiring bridging therapy or prolonged courses of treatment. These groundbreaking results demonstrate the potential for an off-the-shelf cell therapy to be delivered on demand to patients at scale," said Sham Mailankody, MBBS, Clinical Director of Cellular Therapy Service and Associate Attending Physician, Memorial Sloan Kettering Cancer Center in New York, New York. "It is my hope that this publication demonstrating significant proof-of-concept for allogeneic CAR T will set the stage for many more advances in the field of cell therapy for myeloma."

The Phase 1 UNIVERSAL study is a dose escalation trial in patients with heavily pretreated r/r MM. The Nature Medicine publication includes data from the first 48 patients enrolled with a data cutoff of October 2021. All patients treated were refractory to their last line of treatment and no bridging therapy was used in this trial. Data demonstrated the ability for an allogeneic CAR T to achieve response rates in line with certain approved autologous CAR T therapies and durable remissions with a manageable safety profile while treating 92% of all enrolled patients and all product manufactured and released as per product specifications.

Updated data from the UNIVERSAL study were presented at the Company’s R&D Showcase in November 2022 and the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2022.

On January 24, 2023 Helsinn Group ("Helsinn"), a fully integrated global biopharma company with a track record of over forty years of commercial execution and a strong focus in oncology and rare diseases, and Immedica Pharma AB, a pharmaceutical company focused on commercialisation of rare and specialty care products, reported that the companies have entered an exclusive long-term license and distribution agreement for the commercialisation of two cancer supportive care products indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV) in core European markets : AKYNZEO (Netupitant-Palonosetron fixed combination) and ALOXI (Palonosetron) (Press release, Helsinn, JAN 24, 2023, View Source [SID1234626482]).

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Under the licence and distribution agreement Immedica will commercialise AKYNZEO in Portugal, Spain, France, Switzerland, the Netherlands, Belgium, Luxembourg and Liechtenstein, ALOXI in Switzerland, Belgium, Liechtenstein.

Anders Edvell, CEO of Immedica commented: "We are very pleased to have signed this agreement with Helsinn. Side-effects of cancer treatments have a significant impact on the quality of life of these severely ill patients. AKYNZEO and ALOXI are also an important addition to Immedica’s Oncology & Haematology portfolio."

Dr. Melanie Rolli, Helsinn Group CEO, commented: "This partnership will provide important treatment options for CINV across Europe. We look forward to working closely with Immedica in the months and years ahead to ensure more and more patients can access these important supportive care products."

On January 23, 2023 Sandoz, the global leader in off-patent (generic and biosimilar) medicines, reported that it has signed an agreement to acquire worldwide product rights for leading systemic antifungal agent Mycamine (micafungin sodium, Funguard in Japan) from Astellas (Press release, Sandoz, JAN 24, 2023, View Source,%C2%AE%20in%20Japan)%20from%20Astellas [SID1234626466]).

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Closing is anticipated in the course of H1, 2023, subject to standard conditions and regulatory approvals.

Astellas reported Mycamine sales of JPY 18.9 billion (USD 135 million) for the year ending March 31, 2022. The announcement comes after Sandoz successfully completed the acquisition of GSK’s global cephalosporins portfolio in October 2021.

Sandoz CEO Richard Saynor said: "Acquiring this leading and respected global brand will significantly reinforce the Sandoz global hospital offering, as well as complement our existing global leadership position in generic antibiotics."

He added: "This will also be an important addition to our growing portfolio of anti-infective therapies aimed at combatting the spread of antimicrobial resistance, by providing the right drug to the right patient at the right time."

Sandoz Anti-Infectives global medical lead Nicholas Adomakoh said: "Modern medicine is increasingly characterized by the need for complex interventions involving highly vulnerable patients. This welcome and timely portfolio addition will allow us to respond even better to the needs of patients and clinicians across the healthcare continuum."

Mycamine is a leading global echinocandin, one of three major classes of antifungal agents, with a global patient base of well over two million. It is a therapy of choice in hospitals and intensive care units worldwide, a proven prophylactic in hematology and oncology patients, and widely used in organ transplants.

Mycamine is indicated for treatment of invasive candidiasis and espophageal candidiasis, which are currently both on the rise with a higher occurrence of associated hospital outbreaks, as well as prevention of candida and aspergillus infections in patients undergoing hematopoietic stem cell transplantation.

On January 23, 2023 Clinigen Limited (‘Clinigen’) (‘the Company’), the global pharmaceutical services company, reported the company has entered into an agreement to divest Proleukin (interleukin-2 (aldesleukin)), to Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) (‘Iovance’), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor infiltrating lymphocyte (TIL) and peripheral-blood lymphocyte (PBL)) (Press release, Clinigen Group, JAN 23, 2023, View Source [SID1234635196]).

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Terms of the agreement include an upfront payment of £166.7 million, a £41.7 million milestone payment upon first approval of lifileucel in advanced melanoma, and double-digit Proleukin global sales royalties from Iovance to Clinigen. The transaction is expected to close in the first quarter of 2023, subject to required regulatory approvals and clearances and other customary closing conditions.

The divestment of Proleukin is an important step in Clinigen’s previously stated strategy of increasing its focus on those areas of the pharmaceutical services market where it has a growing and sustainable competitive advantage. Clinigen provides a strong and highly differentiated offering in pharmaceutical services where the platform provides market-leading access solutions from the clinical phase through to the commercial stage of the drug product life cycle.

David Bryant, Interim Chief Executive Officer of Clinigen, said: "Today’s announcement is a significant milestone for Clinigen as it continues its evolution as a business focused on critical high-value pharmaceutical services. The divestment helps accelerate that services focus, while returning value to the business and allowing Clinigen to benefit from potential future economic value in Proleukin.

"We have had a long-standing partnership with Iovance and believe they are the right partner to take Proleukin forward and ensure continued availability of this important medicine to patients and healthcare professionals."

Greenhill & Co is serving as financial advisor and White & Case LLP as legal advisor to Clinigen.

On January 23, 2023 Viewpoint Molecular Targeting, Inc., a precision oncology company developing alpha-particle therapies and complementary diagnostic imaging agents, reported the first dosing of two neuroendocrine tumor patients with therapeutic intent. VMT-α-NET, which is being developed for the treatment and diagnosis of somatostatin receptor subtype 2 (SSTR2) expressing neuroendocrine tumors, was administered to the patients in early December (Press release, Viewpoint Molecular Targeting, JAN 23, 2023, View Source [SID1234628253]). The dosed patients were diagnosed with confirmed-advanced somatostatin expressing neuroendocrine tumors (NETs).

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The administration of VMT-α-NET was under the supervision of the patients’ doctor, Dr. Ishida Sen MBBS, Director and Head of Nuclear Medicine at Fortis Hospital, New Delhi, in partnership with BJ Madan, a diagnostic & therapeutic radiopharmaceutical company in New Delhi. No acute adverse reactions were observed in the first 10 days post administration and patients remain stable and in good condition.

"Preclinical and clinical data associated with this new radiopharmaceutical demonstrates significant potential to help our NET patients," noted Dr. Sen. "We are pleased that the patients are doing well, and we have appreciated the professionalism and scientific strength of the Viewpoint team."

Under compassionate use circumstances, VMT-α-NET may be made available to qualified doctors in some countries. In this circumstance, Viewpoint supplied drug precursors and isotopes for the local production of its proprietary radiotherapeutic, VMT-α-NET.

"We are highly committed to the rapid development of alpha-particle radionuclide therapy for cancer," said Viewpoint CEO Thijs Spoor. "We are pleased to support Dr Sen’s team in making this product available for her patients."

The progress of these patients will be followed by Dr. Sen and her team over the coming months. The safety and effectiveness of the treatments will be evaluated by Dr. Sen’s team with laboratory testing, observation of NET-associated symptoms, and repeat medical imaging.

In the U.S., VMT-α-NET will imminently enter a Phase 1 imaging and therapy study, to be conducted at various hospitals and clinics. VMT-α-NET, is categorized as an investigational new drug by the U.S. Food and Drug Association and the administration of VMT-α-NET for compassionate use is completely independent from and not within the scope of the Company’s Phase 1 trial.