On October 7, 2021 AffyImmune Therapeutics, Inc., a clinical stage biotechnology company developing and deploying its Tune & Track platform for the use of CAR T cells to treat solid tumors, reported the close of a $30 million Series A+ funding by ORI Capital (ORI) (Press release, AffyImmune Therapeutics, OCT 7, 2021, View Source [SID1234590916]). The Company’s "Tune & Track" platform finely tunes the affinity of CAR T cells to reduce toxicity and increase CAR T cell longevity while allowing in vivo monitoring through a proprietary tracking system.

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The funding will be used to advance the Phase 1 study of AffyImmune’s lead asset, AIC1000, for the treatment of anaplastic thyroid cancer and refractory poorly differentiated thyroid cancer. In addition, AffyImmune will be able to conduct IND-enabling efforts for two additional pipeline candidates, and fund select drug discovery activities. AffyImmune also plans to double its headcount in the next nine months, with a focus on expanding its in-house discovery and leadership teams.

"We are delighted to strengthen AffyImmune’s relationship with ORI with this additional financing," said AffyImmune President & COO Eric von Hofe, Ph.D. "ORI’s dedication to transformative science and deep industry knowledge have been invaluable to our company strategy and growth, and their latest investment highlights the potential of our cutting-edge Tune & Track platform to revolutionize the treatment of solid tumors across a variety of cancers."

"We’re excited to further our investment in AffyImmune, as existing CAR T therapies have not been able to treat solid tumors or have only been effective in a small number of solid cancer patients," said Simone Song, Founder and Senior Partner at ORI Capital and Chairperson of AffyImmune’s Board of Directors. "AffyImmune’s pioneering Tune & Track technology platform will address the critical challenges in CAR T drug development for solid tumors including toxicity, antigen loss, T cell exhaustion, tumor microenvironment, and T cell trafficking. The Tune & Track platform will be life-changing for cancer patients faced with a diagnosis of advanced solid tumors."

As part of the financing, Elaine Yang, Director at ORI Capital, will join the Board of Directors of AffyImmune. "I am excited for this new role and the opportunity to provide counsel and support during AffyImmune’s next phase of growth," said Ms. Yang. "AffyImmune is advancing a leading pipeline of affinity-tuned CAR T therapies to treat solid tumors based on its Tune and Track technology platform, and I look forward to working with their management team and Board," said Ms. Yang.

On October 7, 2021 Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE: LLY), reported that preclinical characterization data for two new agents, LOXO-783 and LOXO-435, will be presented at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), held October 7-10, 2021 (Press release, Eli Lilly, OCT 7, 2021, View Source [SID1234590915]). The data will be presented as part of the plenary session titled "New Drugs on the Horizon II" as well as in individual poster presentations.

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LOXO-783 is a potent, highly mutant-selective and brain-penetrant allosteric PI3Kα H1047R inhibitor that is designed to spare wild-type PI3Kα, other PI3K isoforms, and other kinases. LOXO-435 is a potent and highly isoform-selective FGFR3 inhibitor with preserved activity against FGFR3 gatekeeper resistance mutations. Investigational new drug applications (INDs) are planned for both programs in 2022.

"LOXO-783 and LOXO-435 each represent years of diligent work by our discovery teams to build molecules that meet exacting target product profiles. In the case of both PI3Kα H1047R-mutated cancers and FGFR3-mutated cancers, patients deserve medicines purpose-built to their disease biology and we believe that these molecules have the potential to markedly improve on the efficacy and tolerability of existing agents," said Jacob Van Naarden, chief executive officer of Loxo Oncology at Lilly and President of Lilly Oncology. "We look forward to filing INDs for both programs in 2022 and subsequently moving into the clinic."

Details on oral and poster presentations are below:

Presentation Title: Discovery of mutant-selective PI3Kα and isoform-selective FGFR3 inhibitors: Insights from the Loxo Oncology at Lilly Discovery Model
Presentation Date & Time: Saturday, October 9, 4:00 p.m. ET
Session: Plenary Session 6: New Drugs on the Horizon II
Presenter: David Hyman, M.D.

Poster Title: Preclinical characterization of LOXO-435 (LOX-24350), a potent and highly isoform-selective FGFR3 inhibitor
Abstract Number: 141
Available: Thursday, October 7, 9 a.m. ET
Presenter: Joshua Ballard

Poster Title: Preclinical characterization of LOXO-783 (LOX-22783), a highly potent, mutant-selective and brain-penetrant allosteric PI3Kα H1047R inhibitor
Abstract Number: 142
Available: Thursday, October 7, 9 a.m. ET
Presenter: Anke Klippel, Ph.D.

About Loxo Oncology at Lilly
Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. Loxo Oncology at Lilly brings together the focus and spirit of a biotech with the scale and resources of large pharma, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new oncology medicines that unequivocally work early in clinical development and will matter to patients.

On October 7, 2021 PierianDx, the global leader in clinical genomics knowledge, reported that it will partner with Florida Cancer Specialists & Research Institute (FCS) to support expanded access to the highest quality genomic testing on solid tumors and hematologic malignancies and lymph nodes leveraging NGS technology (Press release, PierianDx, OCT 7, 2021, View Source [SID1234590914]). Under the partnership, FCS will locally analyze and interpret sequencing data generated with the Illumina TruSight Oncology 500 Research Use Only assay and the Invitae VariantPlex, LiquidPlex, and FusionPlex panels using PierianDx Clinical Genomic Workspace (CGW) to rapidly and accurately detect mutations and offer the best therapeutic options for patients.

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Historical approaches to precision medicine testing include centralized testing performed at large national laboratories where the laboratory typically has little-to-no interaction with the patient and limited treating physician interaction. By localizing genomic testing, FCS patients will benefit from more direct access to testing within the context of care. Offering these tests in the FCS laboratory will also enable improved collaboration between the diagnostic team who interpret the test results and the treating physicians, which drives alignment across the care team and increases confidence in the clinical utility of genomic testing.

The genomic test results at Florida Cancer Specialists will be delivered via a customizable report generated by the PierianDx CGW. Powered by a comprehensive knowledgebase and secure and scalable data analysis platform, the PierianDx CGW will enable Florida Cancer Specialists to quickly and accurately classify and interpret variants to inform treatment or match patients to the right trial within the practice’s large network of participating clinical trials.

According to Florida Cancer Specialists CEO Nathan H. Walcker, "We see tremendous clinical and strategic value to performing this very important testing in-house. By offering in-house genomic testing, we will continue to seek the best options for care for our patient population by quickly and efficiently providing existing treatments as well as optimizing clinical trial matching opportunities. We look forward to partnering with PierianDx to provide even greater tools to our physician partners at FCS and enabling wider access to high complexity testing to the patients we are privileged to serve."

"We are thrilled to provide our best-in-class bioinformatics and knowledge platform to support personalized, community-based cancer care," states Mark McDonough, CEO of PierianDx. "Partnering with leading-edge institutions like Florida Cancer Specialists aligns perfectly with our mission to democratize clinical genomics and to optimally serve physicians and the patients they treat."

On October 7, 2021 Crown Bioscience, a JSR Life Sciences company and leader in translational services that help biopharmaceutical companies accelerate new drug development programs, reported the launch of its ‘3D Ex Vivo Patient Tissue Platform’ (Press release, Crown Bioscience, OCT 7, 2021, View Source [SID1234590913]). Using freshly collected patient tumor material, this new service can accurately measure oncology and immuno-oncology drug-induced tumor killing and endogenous immune cell proliferation in a high throughput format. Researchers are presenting data on the new platform at this year’s AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), which is happening virtually on October 7-10, 2021.

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The proprietary technology, developed at Crown Bioscience’s recently acquired site in Leiden, The Netherlands (formerly known as OcellO B.V.), aims to improve clinical success rates by using the most patient-relevant tumor samples to better predict tumor response to potential drug candidates.

"Our goal is to leverage our core technologies to build a translational model system that adequately captures the tumor architecture and microenvironment, and improves the predictability of patient responses to treatment protocols for existing and potential therapeutic candidates," said Leo Price, PhD, Senior Vice President, In Vitro. "We believe this approach provides greater translational relevance in drug development by using immuno-competent primary human tumor tissue to help analyze drug candidate responses before the program enters clinical trial. This approach is an optimal fit with our mission to help deliver the right drug to the right patient at the right time."

The ‘3D Ex Vivo Patient Tissue Platform’ utilizes patient tumor tissue isolated from biopsies, surgical resections, ascites, or pleural effusion samples that are processed within 24 hours to preserve the tumor microenvironment. The automated high throughput platform uses high content 3D imaging and image analysis to quantify distinct responses of individual cell populations in fresh patient tissues. These analyses can assess responses to different doses of therapeutic candidates at various timepoints and can determine the effects of the drug or combination of drugs on tumor killing and immune cell proliferation.

"We believe this new service can help fill a critical gap in today’s research landscape with early translational patient-relevant ex vivo models that can assess efficacy and determine mechanisms of action," commented Armin Spura, PhD, Chief Executive Officer of Crown Bioscience. "This new service offering is designed to help mitigate the high failure rates of clinical programs in oncology, and was one of the objectives coming out of our recent OcellO acquisition. We are delighted to provide immediate value to our customers from this investment and look forward to the future value that this acquisition will bring."

AACR-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper)
Researchers from CrownBio are conducting a poster presentation titled, "Novel Near Vivo Drug Response Platform for Oncology using 3D Ex Vivo Patient-Derived Microtumors" at the annual conference. The poster summarizes:

This 3D high content assay on ex vivo patient tumor material preserves native tumor microenvironement and architecture

Ex vivo testing using ultra fresh patient tumor samples maintains intact endogenous immune cell populations

Ongoing clinical trial collaborations with tissue providers for ovarian cancer, bladder cancer, NSCLC, and other tumor samples

On October 7, 2021 Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") reported that the company now controls 100% of the share capital of Genkyotex SA ("Genkyotex"), after the completion of a centralized squeeze out offer to all minority shareholders (Press release, Calliditas Therapeutics, OCT 7, 2021, View Source [SID1234590894]).

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Genkyotex’s lead product candidate, setanaxib, is a first-in-class NOX inhibitor that targets NOX 1 and NOX 4, which are major drivers of fibrogenesis in multiple organs. In Q4 2021, Calliditas plans to initiate a 52-week, randomized, placebo-controlled, double-blind, trial with an adaptive phase 2b/3 design with setanaxib in 318 patients with primary biliary cholangitis (PBC). As previously announced in August 2021, Calliditas received FDA fast track designation for setanaxib in PBC. Calliditas will also initiate a Phase 2 proof-of-concept study in head and neck cancer in 2021, which will investigate the administration of setanaxib in conjunction with immunotherapy targeting cancer associated fibroblasts (CAFs).

"We are delighted to have completed our acquisition of Genkyotex, which means that we now can fully integrate the business and thereby leverage the platform optimally", said CEO Renée Aguiar-Lucander.

Subsequent to the squeeze-out, Genkyotex has become a wholly owned subsidiary of Calliditas and have been delisted from the Euronext stock exchanges.

The information was sent for publication, through the agency of the contact persons set out above, on October 7, 2021 at 8:00 a.m. CET.