On May 18, 2023 ImaginAb, Inc., a global biotechnology company focused on the development of radiopharmaceuticals for the diagnosis and treatment of cancer, reported lead selection and progression to IND-enabling studies of IAB56, a minibody designed to target the αvβ6 integrin for use as Lu-177 radiopharmaceutical therapy in solid tumors. In parallel, the DLL3 targeting program, IAB57, will further assess several leads in the coming quarter prior to initiation of IND-enabling studies later in 2023 (Press release, ImaginAb, May 18, 2023, View Source [SID1234631866]). ImaginAb’s discovery team developed IAB56 and IAB57 at its Los Angeles R&D site via screening and selection of high affinity minibodies and cys-dibodies with demonstrated therapeutic efficacy in preclinical models.

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The αvβ6 integrin is a pan-cancer antigen implicated in a broad range of solid tumors including ovarian, pancreatic, breast, oral and liver cancer amongst others. The target shows expression which is highly specific to malignant diseases with very little or no expression in healthy tissues, making it an attractive candidate for targeted radiotherapy of solid cancers.

Delta-like ligand 3 (DLL3) is highly selective for SCLC and neuroendocrine tumors, with minimal to no expression in healthy tissues. Given the rapid recurrence of SCLC following existing therapeutic option, there remains a significant need to improve prognosis for patients suffering from this disease.

Ian Wilson, Chief Executive Officer of ImaginAb, said:

"The ImaginAb team has experience in the discovery, development, and manufacture of radiopharmaceuticals. Focusing our discovery team on the identification and progression of new radiopharmaceutical therapy agents based on our proprietary platform of biologics was a natural step for ImaginAb. We are excited to announce these new developments and look forward to sharing news on these and other candidate molecules as new milestones are met."

On May 18, 2023 OncoResponse, a clinical-stage biotech company advancing immunotherapies derived from the immune systems of Elite Cancer Responders, reported that it has been awarded a $13 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) (Press release, OncoResponse, May 18, 2023, View Source [SID1234631865]). The Company concurrently raised $14 million in new funding from existing investors, led by RiverVest Venture Partners and including ARCH Venture Partners, Canaan Partners, 3B Future Health Fund, Bering Capital, Takeda Ventures, InterVest and others.

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The CPRIT award and investment will support the advancement of OR502, a best-in-class anti-LILRB2 antibody poised to move to IND and clinical studies. Funds from the existing syndicate will also support continued advancement of the Company’s lead immunotherapy candidate OR2805, a fully human monoclonal antibody identified from an Elite Responder using OncoResponse’s proprietary B-cell discovery platform. OR2805 is currently being evaluated in a Phase 1 clinical trial.

"We are thrilled to receive this recognition from CPRIT in supporting the potential of our immunotherapy candidate OR502. We greatly appreciate the additional support from our investors as we continue to make significant progress with our drug development efforts advancing immunotherapies derived from clues of Elite Responders," said Clifford Stocks, Chief Executive Officer of OncoResponse. "We are excited by the data generated to date supporting the ability of OR502 to modulate inhibitory macrophages in the tumor microenvironment and induce anti-tumor activity."

"We are pleased to support OncoResponse in their efforts to develop new and innovative immunotherapy treatments for cancer," said John McKearn, PhD, Managing Director of RiverVest Venture Partners. "The Company has made significant progress in building their pipeline and we look forward to further insights from future clinical studies."

On May 18, 2023 Navrogen, Inc., a biopharmaceutical company specialized in developing therapies for cancer and immune-related disorders, reported a publication describing new criteria for antibody-drug conjugate (ADC) development and preclinical efficacy of NAV-001 ADC against mesothelin-expressing tumor types (Press release, Navrogen, May 18, 2023, View Source [SID1234631864]). The publication is presented in the international peer-reviewed PLOS ONE journal and can be accessed at View Source

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NAV-001 ADC targets the cell surface mesothelin protein that is over-expressed by a number of cancers including triple negative breast, metastatic colorectal, non-small cell lung, pancreatic, ovarian and mesothelioma cancers. The publication highlights the negative impact on ADC efficacy caused by direct binding of tumor-produced Humoral Immuno-Oncology (HIO) factors to the ADC antibody component that in turn suppresses its ability to effectively internalize into antigen-expressing target cells thereby lowering its therapeutic efficacy. HIO factor binding to antibody is dependent on its three dimensional structure dictated by amino acids located in the antibody variable domain. Navrogen’s proprietary HIO factor screening platform enables the identification of antibodies that are naturally non-bound by HIO factors while its block-removed immunoglobulin technology (BRITE) platform enables engineering of HIO-refractory ADCs via replacement of amino acids responsible for HIO factor binding. NAV-001 was identified via HIO screening and contains a potent anti-cancer payload with topoisomerase II inhibitory activity. Preclinical studies using patient-derived xenograft (PDX) models have demonstrated NAV-001 single-dose efficacy across a wide array of mesothelin-positive cancers. Based on these data, NAV-001 is advancing towards clinical development as a single agent therapeutic against mesothelin expressing cancers along with a mesothelin diagnostic for patient pre-screening.

"NAV-001 is one of several assets that we have generated overcoming the negative impact that HIO factors can have on antibody-based therapeutics, including ADCs", said Dr. Nicholas Nicolaides, senior author. Implementing HIO screening into ADC development is another feature that may further improve the efficacy of this class of anti-cancer therapeutics".

On May 18, 2023 Shanghai Stock Exchange listed company HitGen Inc. ("HitGen", SSE: 688222.SH) reported that it has entered into a research agreement with ARase Therapeutics, Inc. ("ARase"), a biotechnology company developing first-in-class therapeutics targeting ADP-ribose hydrolases, novel targets that function in therapeutically proven cancer stress pathways (Press release, HitGen, May 18, 2023, View Source [SID1234631863]). HitGen will utilize its DNA-encoded library (DEL) technology platform, centered around the design, synthesis and screening of DELs, to identify novel inhibitors of ARase’s validated oncology targets. HitGen will also support ARase programs from hit-to-lead chemistry to pre-clinical development.

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HitGen is a world leader in the development of DEL technology and applications to early-stage small molecule drug discovery. Their platform includes over 1.2 trillion small molecules generated by the DEL technology and the efficiency of the screening process has made it possible for HitGen to enable drug discovery projects for many organizations around the world.

"We are very excited to work with HitGen. They will be instrumental in progressing our preclinical portfolio and we look forward to leveraging their screening platform and drug discovery capabilities in combination with our deep expertise in ADP-ribosylation and drug development," said Paul Chang PhD. CEO/CSO and founder, ARase Therapeutic.

"I am delighted to see HitGen and ARase enter this drug discovery research collaboration. HitGen’s world leading DEL technologies have enabled generation of novel chemical starting points for many innovative discovery programmes by companies like ARase. We look forward to working together with ARase research teams progressing their therapeutic programmes for serious unmet medical needs," said Dr. Jin Li, Chairman of the Board and CEO of HitGen Inc.

On May 18, 2023 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology is designed to make immune cells more effective in killing tumor cells, reported pre-clinical data demonstrating that using INTASYL to silence TIGIT and CBL-B may be used to improve the anti-tumor response of NK cells, creating a more effective cell therapy for treating cancer (Press release, Phio Pharmaceuticals, May 18, 2023, View Source [SID1234631862]).

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NK cells are the body’s first line of defense against cancer. Unlike T cells, NK cells can recognize and kill tumor cells without prior exposure. Incorporating INTASYL’s RNAi treatment into ex vivo NK cell expansion protocols prior to adoptive cell therapy (ACT) is a strategy to reduce the expression of inhibitory proteins such as TIGIT or CBL-B to improve anti-tumor response.

"These data demonstrate the power of the INTASYL platform to enhance the activity of adoptive cell therapies to better address cancer," said James Cardia, Phio’s VP of Discovery. "Furthermore, these studies in addition to recent studies with PH-762 and PH-894, highlight the multiple applications of INTASYL, for both direct therapeutic applications as well as in combination with ACT therapy. INTASYL has the broad applicability to silence not only extracellular targets (TIGIT) but also intracellular targets that antibodies cannot address (CBL-B)."