On September 13, 2021 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, and Adicet Bio, Inc. (Nasdaq: ACET), a biotechnology company discovering and developing first-in-class allogeneic gamma delta T cell therapies for cancer and other diseases, reported a collaboration to accelerate the discovery of gamma delta T cell therapies against five undisclosed targets (Press release, Twist Bioscience, SEP 13, 2021, View Source [SID1234587633]). The companies will work together to engineer immune cells with fully human chimeric antigen receptors (CARs) and T-cell receptors (TCRs) directed to disease-specific cell surface antigens. This precise and targeted engagement is designed to provide a superior potential to facilitate recognition and killing of tumor cells.

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Under the terms of the collaboration, Twist will leverage its proprietary single chain fragment variable (scFv) and VHH (nanobody) technologies from its Library of Libraries to discover unique target-specific binders. These targeting technologies will enable Adicet Bio’s engineering and discovery of unique CARs used in the generation of novel gamma delta CAR T cell products. Twist will receive an upfront technology license fee for each program as well as clinical and regulatory milestones and royalties for any product resulting from the selected targets.

"We are excited to leverage Twist’s proprietary antibody discovery capabilities to potentially rapidly identify and optimize unique antibodies against key targets to further enhance our pipeline, both in cancer and other diseases," said Chen Schor, President and Chief Executive Officer of Adicet. "We’ve selected five key targets where we believe our expertise in gamma delta T cell therapies could be augmented with Twist’s ability to identify highly potent, specific antibodies and look forward to a robust partnership."

"There is huge potential in using gamma delta T cells for the treatment of a wide range of cancers, and Adicet is leading the development in this field," commented Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "We look forward to partnering with Adicet to translate these target-engagement technologies into next-generation off-the-shelf, CAR-T therapies and to potentially accelerate the treatment of patients with cancer."

On September 13, 2021 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE protein biologic technology platform, reported the advancement of GTB-3650 into IND-enabling studies, with which it plans to supplant the ongoing Phase 1 program with GTB-3550 (Press release, GT Biopharma, SEP 13, 2021, View Source;trike-into-ind-enabling-studies-301374947.html [SID1234587648]).

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Therapeutic and commercial advantages of GTB-3650 compared to GTB-3550 include:

Based on second generation camelid single-domain antibody technology that holds several advantages over traditional IgG monoclonal antibodies
Improved potency and enhanced binding affinity
Similar preclinical safety profile
Commercial manufacturing capabilities through arrangement with Cytovance
Proprietary patented molecule, which unlike GTB-3550, is wholly owned by GT Biopharma
"We look forward to advancing GTB-3650 toward the clinic" noted Greg Berk, M.D., GT Biopharma’s President of R&D and Chief Medical Officer. "This transition marks the next logical evolution of our TriKE platform. As the company focuses its resources on the most promising pipeline candidates, GTB-3650 will now be able to take advantage of the strong evidence gathered from our first-generation pilot TriKE program. Complementing this development advance, has been the transition of all manufacturing processes to Cytovance Biologics, a leading specialty cGMP contract manufacturing organization. We have now achieved another strategic milestone consistent with our mission to advance novel immuno-oncology drugs to patients with advanced cancers", commented Dr. Berk.

About Camelid Antibodies

Camelid antibodies are single domain antibodies (sdAbs) from the Camelidae family of mammals that include llamas, camels, and alpacas. These animals produce 2 main types of antibodies. One type of antibody camelids produce is the conventional antibody that is made up of 2 heavy chains and 2 light chains. They also produce another type of antibody that is made up of only 2 heavy chains and no light chain. This is known as heavy chain IgG (hcIgG). While these antibodies do not contain the CH1 region, they retain an antigen binding domain called the VHH region. VHH antibodies, also known as single domain antibodies, contain only the VHH region from the camelid antibody. Camelid antibodies have key characteristics, which include high affinity and specificity (equivalent to conventional antibodies), high thermostability, good solubility and strictly monomeric behavior, small size, relatively low production cost, ease of genetic engineering, format flexibility or modularity, low immunogenicity, and a higher penetration rate into tissues.

About GTB-3650

GTB-3650 is the Company’s lead second-generation Tri-Specific Killer Engager TriKE program currently in preclinical development for the treatment of relapsed/refractory acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS).

On September 13, 2021 Immunocore Holdings Plc (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, reported that new data and analysis from the Company’s lead program, tebentafusp, and its proprietary soluble TCR bispecific ImmTAC platform will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, which will be held virtually from September 16-21, 2021 (Press release, Immunocore, SEP 13, 2021, View Source [SID1234587701]).

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ORAL PRESENTATION
Title: Early reduction in ctDNA, regardless of best RECIST response, is associated with overall survival (OS) on tebentafusp in previously treated metastatic uveal melanoma (mUM) patients

Abstract ID: 17570
Presenter: Alexander Shoushtari
Abstract & full data set available: Friday, 17 September 2021, 18:00 CEST

POSTER PRESENTATIONS
Title: Similar overall survival in tebentafusp-treated 2L+ metastatic uveal melanoma regardless of prior immunotherapy

Abstract ID: 1013P
Presenter: Joseph M. Piulats
Title: Demonstration of T cell redirection and immune activation in skin rash following tebentafusp treatment

Abstract ID: 1772P
Presenter: Ramon Stäger
Title: Characterization of cytokine release syndrome (CRS) following treatment with tebentafusp in previously untreated patients with metastatic uveal melanoma

Abstract ID: 1014P
Presenter: April Salama
Title: Characterization of liver function tests following tebentafusp in phase 3 randomized trial comparing tebentafusp with investigator’s choice in first line metastatic uveal melanoma (mUM)

Abstract ID: 1018P
Presenter: Bartosz Chmielowski
Title: Genomic correlates of clinical outcomes in patients with metastatic uveal melanoma (mUM) treated with tebentafusp (tebe)

Abstract ID: 1770P
Presenter: Luis de la Cruz Merino
Title: ImmTAC redirect exhausted tumor infiltrating T cells, an effect enhanced by pembrolizumab against PD-L1+ tumors

Poster #: 1016P
Presenter: Kristina Petrovic
Title: PRAME expression and ImmTAC TCR bispecific sensitivity in acute myeloid leukaemia in the presence and absence of the hypomethylating agent decitabine

Abstract ID: 853P
Presenter: Camille Britton-Rivet
The abstracts referenced above our available on the ESMO (Free ESMO Whitepaper) website.

On September 13, 2021 Celsion presented the Corporate Presentation (Presentation, Celsion, SEP 13, 2021, View Source [SID1234590265]).

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On September 13, 2021 Nuformix plc (LSE: NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, reported that it has signed an exclusive global licensing agreement with Oxilio Ltd ("Oxilio"), a privately held pharmaceutical development company, for NXP001 (a proprietary new form of aprepitant) for oncology indications (Press release, Nuformix, SEP 13, 2021, View Source [SID1234621606]).

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Under the terms of the licensing agreement, Oxilio has obtained an exclusive licence to research, develop and commercialise NXP001 globally for oncology indications. Nuformix is eligible to receive an undisclosed upfront payment, development milestone payments and a royalty on net sales, capped at £2 million per annum.

• On 23 September 2020, Nuformix granted an exclusive option to Oxilio to license NXP001 globally for oncology indications. This triggered an undisclosed upfront payment.
• On 22 March 2021, Oxilio exercised its option to acquire a licence for NXP001. Oxilio and Nuformix then began working together to finalise an exclusive global licensing agreement for NXP001.

Dr Anne Brindley, CEO of Nuformix, said: "We are delighted to complete the licensing agreement with Oxilio-achieving this exclusive global licensing deal for NXP001 in oncology is a major step forward as it validates the Nuformix technology and intellectual property, and also endorses our strategy of repurposing drugs and licensing at an early stage. Nuformix will now concentrate on developing its two lead assets NXP002 and NXP004."

Dr Simon Yaxley, Co-Founder and Director of Oxilio said: "We are pleased to expand our clinical development pipeline with the licensing of NXP001, which is highly complementary to our strategy of identifying, repurposing and commercialising existing drugs to address unmet needs in cancer therapy. NXP001, a novel form of aprepitant with improved properties, and its Phase 1 study demonstrates the potential for improved bioavailability without needing a complex formulation. Our hope is for the consolidated efforts under the agreement to enable Oxilio to accelerate the development of NXP001 and bring new treatment options to a broad range of cancer patients."