On September 9, 2022 Volastra Therapeutics, an oncology company focused on exploiting chromosomal instability (CIN), reported new data from its lead program, a KIF18A inhibitor, validating its therapeutic approach of synthetic lethality to induce tumor cell death (Press release, Volastra Therapeutics, SEP 9, 2022, View Source;utm_medium=rss&utm_campaign=volastra-therapeutics-to-present-preclinical-data-from-kif18a-inhibitor-program-targeting-chromosomally-unstable-tumors-at-faseb-aneuploidy-conference [SID1234619327]). The data will be presented at the 2022 Consequences of Aneuploidy Conference, organized by the Federation of American Societies for Experimental Biology (FASEB), which takes place September 11 – 16, 2022, in Southbridge, Mass.

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KIF18A is a mitotic kinesin that regulates chromosome alignment during cell division. Leveraging its proprietary CINtech platform, Volastra discovered that CIN-high cancer cells are more dependent on chromosome alignment machinery like KIF18A and are thus more vulnerable to KIF18A inhibition than normal cells.

"Despite the prevalence of chromosomal instability across many tumor types, it has not been fully exploited therapeutically. We are excited to share new preclinical data from our KIF18A inhibitor program showing the ability of this compound to inhibit tumor growth in multiple different models of CIN-high cancer, while leaving normal proliferating cells intact," said Michael Su, Ph.D., Chief Scientific Officer at Volastra. "These findings set our KIF18A inhibitor apart from traditional chemotherapies, which can have a detrimental impact on healthy cells. We anticipate initiating a Phase 1 study for this potential best-in-class KIF18A inhibitor in the second half of 2023."

The FASEB keynote speaker, Professor David Pellman, M.D., of the Dana-Farber Cancer Institute and Volastra Scientific Advisory Board member, states, "The therapeutic potential of targeting chromosomal instability is increasingly compelling. These new data from Volastra’s KIF18A inhibitor further support the promise of developing new and better cancer therapies through a deep understanding of this vulnerability."

Details of Volastra’s oral data presentation at the Consequences of Aneuploidy Conference are as follows:

Title: "Discovery and Development of KIF18A Inhibitors for the Treatment of Chromosomally Unstable Tumors"

Session: Aneuploidy and Tumor Therapy

Date and Time: Tuesday, September 13, 2022; 2:20 p.m. ET

Presenter: Christina Eng, Ph.D., Vice President, Head of Biology, Volastra Therapeutics

About Volastra’s CINtech Platform

Volastra’s CINtech platform harnesses a deep biological understanding of chromosomal instability (CIN) as cancer’s most targetable vulnerability to develop promising therapies for patients. CINtech integrates proprietary imaging technologies, model cell line systems and computational analytics to drive a broad and differentiated pipeline. Volastra recently announced a multi-year, up to $1.1 billion, drug discovery collaboration with Bristol Myers Squibb leveraging Volastra’s proprietary CINtech platform to identify CIN-related targets. In addition, Volastra has a partnership with Microsoft to develop AI technologies for the interrogation of CIN.

On September 9, 2022 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate virtually in a fireside chat at the H.C. Wainwright Global Investment Conference taking place September 12 – 14, 2022 (Press release, TG Therapeutics, SEP 9, 2022, View Source [SID1234619326]).

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A webcast of the fireside chat will be available for on demand download beginning on Monday, September 12, 2022, at 7:00 AM ET on the conference website. The webcast will also be available on TG’s website at View Source

On September 9, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that will host a conference call and simultaneous webcast to share updates on the company’s oncology portfolio in conjunction with the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress on Monday, September 12, 2022 (Press release, Regeneron, SEP 9, 2022, View Source [SID1234619325]). The webcast is scheduled for 8:00 AM ET (2:00 PM CEST) and may be accessed from the "Investors & Media" page of Regeneron’s website at View Source To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the webcast will be archived on the Company’s website for at least 30 days.

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On September 9, 2022 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported that company management will participate in an upcoming investor conference (Press release, Instil Bio, SEP 9, 2022, View Source [SID1234619323]):

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Morgan Stanley 20th Annual Global Healthcare Conference
Fireside Chat: Monday, September 12, 2022 at 2:50 p.m. ET

A live webcast, if recorded, of each presentation can be accessed under "News & Events" in the Investors section of the Company’s website at www.instilbio.com. The archived webcast will be available on the Company’s website shortly after the event.

On September 9, 2022 Immunocore Holdings plc (Nasdaq: IMCR), a commercial-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, autoimmune and infectious diseases, reported that initial Phase 1 data for the first off-the-shelf ImmTAC targeting PRAME, demonstrating that IMC-F106C is well tolerated and resulted in durable responses across multiple solid tumor types (Press release, Immunocore, SEP 9, 2022, View Source [SID1234619322]).

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The initial data from the ongoing Phase 1 dose escalation trial of IMC-F106C is the subject of a presentation today at 4:40 PM CEST/10:40 AM EDT, in the Investigational Immunotherapy Proffered Paper session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. The presentation can be accessed in the ‘News & Events’ section of the Investor Relations section of the Company’s website.

"The durable responses in heavily pre-treated patients show that our PRAME-targeted bispecific therapy, IMC-F106C, can deliver meaningful benefits to patients across a range of cancer types," said Bahija Jallal, Chief Executive Officer of Immunocore. "Based on this promising data, we have initiated expansion arms in multiple tumor types to further assess the efficacy."

Initial Phase 1 Clinical Data
As of 18 July 2022, 55 patients have been treated across 10 dose cohorts. IMC-F106C was well-tolerated, with treatment-related adverse events (AEs) that were manageable and consistent with the mechanism of action. The most frequent treatment-related AE reported was cytokine release syndrome (CRS), which was mostly Grade 1 (none were Grade ≥3) and occurred predominantly during the initial three doses. None of the related AEs led to treatment discontinuation or patient death.

Dr. Omid Hamid, Chief, Translational Research and Immunotherapy, Co-Director, Melanoma Therapeutics at Cedars-Sinai Cancer at the Angeles Clinic and Research Institute, said: "ImmTAC therapies are designed to provide potent and target-specific T-cell response, overcoming resistance in immune excluded tumors. Through redirection and activation of non-tumor-specific T cells, as shown in this trial with IMC-F106C, we can influence a diverse range of tumors leading to durable response. This trial shows tolerability and activity in a wide range of tumors, including checkpoint inhibitor pre-treated patients. I look forward to upcoming cohorts in combination with checkpoint inhibitors and chemotherapy."

Doses of ≥ 20 mcg were clinically active and had consistent and robust interferon gamma induction, a specific marker of T cell activation. Most of the patients in these active dose cohorts were enrolled without prospective PRAME testing. In these patients, PRAME expression was analyzed retrospectively; the vast majority were positive, and the average expression was high (median H score 188).

In the clinically active dose cohorts, durable partial responses (PR) were observed in 2/6 patients with cutaneous melanoma, 2/4 with ovarian cancer and 3/6 with tebentafusp-naïve uveal melanoma (UM) (0/5 response in patients with UM who had progressed on prior tebentafusp). All ovarian patients were platinum-resistant, and all cutaneous melanoma patients had progressed on prior anti-PD1 and anti-CTLA4. Six of the seven PRs are still ongoing, including two for over seven months. Ten additional efficacy evaluable patients across four other tumor types had a best RECIST response of stable disease or progressive disease. A majority of patients evaluable for circulating tumor DNA (ctDNA) had at least a 50% reduction.

Ongoing Expansion Arms in Four Cancer Types
The Company has initiated patient enrollment into four expansion arms in cutaneous melanoma, ovarian, non-small cell lung cancer (NSCLC), and endometrial cancers. The IMC-F106C-101 trial is adaptive and includes the option for Phase 2 expansion, allowing for approximately 100 patients treated per tumor type in the Phase 1 and 2 expansion arms. Dose escalation continues in additional solid tumors as well as plans for combination arms with standards-of-care.

About the Trial (IMC-F106C-101)
The Phase 1 dose escalation trial was designed to determine the maximum tolerated dose (MTD), as well as to evaluate the safety, preliminary anti-tumor activity and pharmacokinetics of IMC-F106C, a bispecific protein built on Immunocore’s ImmTAC technology, and the Company’s first molecule to target the PRAME antigen.

Following pre-screening for the HLA-A*02:01 allele and, where required, for PRAME expression, patients were infused on a weekly dosing regimen, with intra-patient escalation during the initial three weeks. Tumor types with high PRAME prevalence were enrolled regardless of PRAME expression testing, which was evaluated retrospectively. Tumor types with lower PRAME prevalence required testing for PRAME expression prior to study entry. Patients were first scanned at nine weeks, and every nine weeks thereafter.

Conference Call Information
Immunocore will host a live webcast and conference call today beginning at 12:30 PM EDT to discuss the results with Dr. Omid Hamid, Chief, Translational Research and Immunotherapy, Co-Director, Melanoma Therapeutics at Cedars-Sinai Cancer at the Angeles Clinic and Research Institute. A live webcast of the conference call will be available under ‘News & Events’ in the Investor Relations section of Immunocore Holdings’ website at www.immunocore.com. The presentation from today’s call and the archived webcast will be available on Immunocore’s website after the conference call concludes and will be available for 30 days following the call.