On November 8, 2021 Scandion Oncology A/S, the Cancer Drug Resistance Company, reported that the timeline for read-out of the dose-finding clinical Phase Ib study PANTAX will be extended, and read-out is now expected in Q2-Q3 2022 (Press release, Scandion Oncology, NOV 8, 2021, View Source,c3448642 [SID1234594784]). The reasons are challenging patient recruitment and a staggered study design. Disregarding this postponement, the study is performing as well as the Company could have hoped for.

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In the PANTAX study, Scandion Oncology enrolls patients with unresectable or metastatic pancreatic cancer. The recruitment rate of patients in this very fragile patient population has been lower than anticipated. At the same time, the clinical sites have opened slower than planned. As previously communicated, the study expanded to Germany as a way to increase recruitment rate and to internationalize the study in preparation for the anticipated randomized Phase II study.

However, the German Competent Authority has required the study to change to a staggered design which implies that patient enrollment is slower than previously anticipated since single patients are only allowed to be included every two weeks until a cohort is completed, followed by a four-week interval between cohorts. The result is a very thorough dose-finding study, requiring longer time to completion.

Currently, there are four sites recruiting, two in Denmark and two in Germany. To further increase the recruitment rate, Scandion Oncology will open one additional site in Germany.

All in all, the consequence is that the timeline for a read-out of the study will be postponed, and the read-out is now expected in Q2-Q3 2022.

"It is very important to state that the timelines are delayed solely due to an unfortunate situation of slower recruitment rates and the impact of the staggered design from the German Competent Authority. Disregarding the delay, the study is performing as well as we could have hoped for. We see a strong potential in combining SCO-101 with nab-paclitaxel and gemcitabine for first line metastatic or inoperable pancreatic cancer", said Bo Rode Hansen, President & CEO of Scandion Oncology.

PANTAX is a dose-finding clinical Phase Ib study in patients with unresectable or metastatic pancreatic cancer who are offered SCO-101 as a first line add-on therapy to their standard chemotherapy.

This information is information that Scandion Oncology A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on November 8, 2021, at 08:30 CET

On November 8, 2021 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported it plans to report third quarter financial results and provide a corporate update on Friday, November 12, 2021, via press release, prior to the market open (Press release, NexImmune, NOV 8, 2021, View Source [SID1234594956]).

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The press release will be accessible under the investor section of the NexImmune’s website at www.neximmune.com.

On November 8, 2021 Race Oncology Limited ("Race") reported that it has entered into a strategic collaborative research agreement with the University of Wollongong (UOW) to undertake preclinical evaluation of new Zantrene formulations designed by Race (Press release, Race Oncology, NOV 8, 2021, View Source [SID1234595209]). This collaboration is expected to provide significant value to the company by expanding the market potential of Zantrene for new and existing cancer indications. All IP generated will be owned by Race royalty free.

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"This is an exciting and valuable collaboration for Race as we develop new Zantrene formulations and expand our pipeline. We are very much looking forward to working with Professor Ranson on this important program and building on the clinical lead we have in the m6A RNA methylation field via our FTO targeted drug Zantrene."

Chief Scientific Officer, Dr Daniel Tillett
Improved Formulations of Zantrene
Current administration of Zantrene requires the use of a central venous catheter in a hospital setting. While this is standard practice for the delivery of many chemotherapy drugs, longer-acting and more patient-friendly routes of administration are desirable if the full market potential of Zantrene is to be achieved.

Through a series of internal and collaborative programs, Race has designed and is developing several new proprietary Zantrene formulations that offer the potential for long-acting peripheral IV administration in an outpatient setting. Additional programs have identified a number of formulation approaches that could allow Zantrene to be delivered orally.The UOW collaboration provides Race with access to the lab, instrumental capabilities and expertise required to rapidly advance formulation development at lower cost and greater speed, while generating and capturing new patentable IP.

"As our preclinical programs mature, having the capacity to rapidly evaluate and subtly optimise formulations is an essential requirement in pharmaceutical development. I worked extensively on cancer drug development projects with Prof. Ranson while at UOW and a big part of our success can be attributed to an outstanding young PhD student and later postdoc with us, Dr Benjamin Buckley. It is fantastic to now have Ben’s expertise on the Race team and to be working together again alongside Prof Ranson to develop and expand our leading asset Zantrene."

Principal Scientist, Professor Michael Kelso
Team
These programs are to be led by Professor Marie Ranson in collaboration with Race’s Principal Scientist, Professor Michael Kelso. Prof Ranson is an esteemed cancer biologist with extensive experience in drug development and formulation. She has joint appointments at the Illawarra Health and Medical Research Institute and Molecular Horizons Institute at the University Wollongong. Professor Ranson has published more than 110 peer-reviewed scientific papers in the area of oncology and drug development, holds several patents and has attracted over $20 million in research and industry funding.

"As a scientist who spends most of my time investigating basic biological processes, the opportunity to work with Race to develop new drug formulations that could translate into tangible benefits for cancer patients is extremely exciting. Zantrene shows immense promise as an effective new cancer drug and I am delighted to be working with my former UOW colleagues, Prof Kelso and Dr Buckley, in this collaboration with Race".

Professor Ranson
To support this program, Race has recruited a new Senior Scientist, Dr Benjamin Buckley, to perform work in Prof. Ranson’s lab. Dr Buckley brings over 8 years of doctoral training and postdoctoral experience in drug discovery and development to the Race team.

"I’m thrilled to be joining the team at Race and advancing formulations that can further realise the potential of Zantrene. Working in the Ranson Lab and leveraging the state-of-the-art facilities, expertise and instrumentation available at both UOW and the Illawarra Health and Medical Research Institute adds considerable value to Race’s ‘Three Pillar’ strategy. Together with Profs Ranson, Kelso and the Race team, I very much look forward to capitalising on Zantrene’s significant first-mover advantage and showing the true clinical value of targeting FTO in difficult-to-treat cancers".

Dr Ben Buckley
This collaboration is to start immediately with results to be reported over the coming 12 months. While the contract value is not material in dollar terms, it is significant in that it transforms our R&D capability, so we can optimise and enhance Zantrene formulations and their utility in additional patient settings.

On November 8, 2021 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that Rob Ross, M.D., chief executive officer, will participate in a fireside chat at the upcoming Cowen Fifth Annual IO Next Summit on Monday, November 15, 2021 at 12:45 p.m. ET (Press release, Surface Oncology, NOV 8, 2021, View Source [SID1234594681]).

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The live audio and subsequent archived webcast of the fireside chat will be accessible from the Events & Presentations page of the company’s website.

On November 8, 2021 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, reported financial results for the third quarter ended September 30, 2021 and provided a corporate update (Press release, Black Diamond Therapeutics, NOV 8, 2021, View Source [SID1234594709]).

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"Black Diamond’s approach remains deeply rooted in our proprietary Mutation-Allostery-Pharmacology (MAP) drug discovery engine, which leverages population-level genetic sequencing that allows for the identification of novel oncogenic mutations. We are well-positioned to advance differentiated MasterKey programs across a range of oncogenic targets for patient populations with unmet need," said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We are excited by the continuing progression of our pipeline of MasterKey inhibitor programs, including the BDTX-189 MasterKey-01 study, our BDTX-1535 program with an IND filing anticipated by the first half of 2022, and our BRAF and fibroblast growth factor receptor (FGFR) programs."

Recent Developments

BDTX-189:

Black Diamond remains on-track with preparations for initiating the Phase 2 portion of the MasterKey-01 Phase 1/2 study of BDTX-189 by the end of 2021. The Company completed the Phase 1 dose-escalation portion of the study and has selected the recommended Phase 2 dose for BDTX-189.
BDTX-1535:

Black Diamond continues to advance BDTX-1535 through IND-enabling studies and expects to file an IND application by the first half of 2022.
In October 2021, Black Diamond presented pre-clinical data for BDTX-1535 at the ANE International Conference:
In cell-based assays, BDTX-1535 achieved potent and selective inhibition of a range of EGFR mutations expressed in glioblastoma (GBM) and non-small cell lung cancer (NSCLC), including canonical, non-canonical, and drug-resistance mutations, such as EGFR-C797S that can arise following treatment with osimertinib.
BDTX-1535 demonstrated a favorable brain-penetrant pharmacokinetic (PK) profile in mouse, rat, and dog models.
In a range of tumor models, including intercranial GBM models and lung cancer drug resistance models expressing the targeted EGFR mutations, BDTX-1535 showed dose-dependent tumor growth inhibition and achieved complete regression without notable impact on body weight.
Early-Stage Pipeline:

Black Diamond continues to progress its early-stage pipeline programs designed to target cancers driven by mutations in BRAF and FGFR. The Company anticipates IND filings for both programs in 2022.
In October 2021, Black Diamond presented pre-clinical data for both the BRAF and FGFR programs at the ANE International Conference:
BRAF:
The presentation described pre-clinical data for a lead compound from Black Diamond’s BRAF program, which is designed for potency and selectivity against a spectrum of non-canonical Class II/III mutations, in addition to Class I mutations (V600E).
In cell-based assays, the lead compound demonstrated potent inhibition of a spectrum of Class I/II/III BRAF mutations.
In contrast to current-generation BRAF inhibitors, such as encorafenib and vemurafenib, treatment of cells harboring wild type BRAF (WT-BRAF) with the Black Diamond compound was not observed to lead to an increase in pERK, a signal of paradoxical activation.
In a BRAF-KIAA1549 fusion allograft tumor model, the lead compound exhibited dose-dependent inhibition of pERK and anti-tumor efficacy.
FGFR:
The presentation was illustrative of the Black Diamond approach, centered on a four-pronged optimization strategy with the goal of delivering an inhibitor that has broad coverage of FGFR2 and FGFR3 oncogenes, while sparing inhibition of FGFR1 and retaining activity against resistance mutations.
In cell-based assays, FGFR program compounds demonstrated potent and selective inhibition of a spectrum of FGFR2/3 oncogenic mutations, while sparing FGFR1. Additionally, FGFR program compounds demonstrated improved potency against resistance mutations.
In an in vivo study conducted in a UM-UC-14 (FGFR3-S249C) mouse model, FGFR program compounds demonstrated anti-tumor activity. Additionally, in mouse and rat models, FGFR program compounds did not promote hyperphosphatemia.
Corporate:

In September 2021, Black Diamond entered into a strategic partnership with OpenEye Scientific to incorporate OpenEye’s Orion molecular design platform into Black Diamond’s proprietary Mutation-Allostery-Pharmacology (MAP) drug discovery engine to help advance MasterKey inhibitor cancer therapies. OpenEye’s Orion Software-as-a-Service platform enables Black Diamond to perform rapid simulations and analysis of protein motion.
Financial Highlights

Black Diamond ended the third quarter of 2021 with $235.0 million in cash, cash equivalents, and investments compared to $315.1 million as of December 31, 2020. Net cash used in operations was $26.5 million for the third quarter of 2021 compared to $11.5 million for the third quarter of 2020.
Research and development (R&D) expenses were $27.6 million for the third quarter of 2021 compared to $12.9 million for the third quarter of 2020. The increase in R&D expenses was primarily related to an increase in headcount and increased spend across preclinical and clinical development.
General and administrative (G&A) expenses were $7.7 million for the third quarter of 2021 compared to $5.6 million for the third quarter of 2020. The increase in G&A expenses was primarily due to an increase in personnel and other corporate-related costs.