On October 1, 2021 T-knife Therapeutics, Inc., a biopharmaceutical company dedicated to developing novel therapeutics to fight cancer, reported that three abstracts highlighting its lead product candidate TK-8001, a T cell receptor (TCR) engineered T cell therapy (TCR-T) being developed to treat MAGE-A1 positive solid tumors, will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting taking place November 10-14, 2021 (Press release, T-Knife, OCT 1, 2021, View Source [SID1234591706]).

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"TK-8001 is a novel CD8 TCR-T targeting MAGE-A1, a tumor-specific antigen associated with aggressive cancers and poor clinical prognosis," stated Eugen Leo, Chief Medical Officer of T-knife. "The presentations at SITC (Free SITC Whitepaper) will cover important aspects of our work related with TK-8001, including favorable preclinical data comparing TK-8001 to human donor-derived TCRs, the potential benefits of MAGE-A1 as a cancer target, and the design of our forthcoming IMAG1NE Phase 1/2 study intended to evaluate the safety and efficacy of TK-8001 in select patients with MAGE-A1 expressing solid tumors."

Poster Presentation Details

Title: Optimal-affinity MAGE-A1-specific T cell receptors (TCRs) generated using the humanized TCR-transgenic mouse platform HuTCR are superior to human donor-derived TCRs
Abstract ID: 225
Date: Friday, Nov. 12, 2021
Time: 7:00 am – 5:00 pm

Title: MAGE-A1 protein expression pattern in > 5,000 tumor and healthy tissue samples: Validation of MAGE-A1 as an ideal target for TCR-based cell therapy
Abstract ID: 95
Date: Friday, Nov. 12, 2021
Time: 7:00 am – 5:00 pm

Title: A first-in-human, Phase 1/2 clinical trial of TK-8001, a MAGE-A1 directed T cell receptor in patients with advanced-stage solid tumors (The "IMAG1NE" trial)
Abstract ID: 499
Date: Friday, Nov. 12, 2021
Time: 7:00 am – 5:00 pm

About TK-8001 TCR-T
TK-8001 is a CD8 TCR-T specific for the Melanoma-associated Antigen Gene-A1, or MAGE-A1. MAGE-A1 is associated with hallmarks of aggressive cancers and poor clinical prognosis, and there is an emerging body of evidence indicating its involvement as a potential driver of tumorigenesis. MAGE-A1 represents an attractive therapeutic target given the high unmet need in MAGE-A1 expressing cancers, no reported protein expression in healthy tissues other than testis and significant consistency of expression between the primary tumor and metastases. As high affinity TCRs specific for MAGE-A1 peptides in humans are eliminated through central tolerance, we believe our HuTCR platform is a differentiated means to discover and select MAGE-A1 specific TCRs with an optimal affinity and high specificity profile.

About the IMAG1NE Phase 1/2 Trial
The IMAG1NE Phase 1/2 trial is an open-label, multi-center Phase 1/2 trial designed to evaluate the safety and efficacy of TK-8001 in patients with MAGE-A1 positive solid tumors. The Phase 1 portion of the IMAG1NE trial is planned to enroll approximately 6 to 18 patients to assess the initial safety and tolerability of ascending dose levels of TK-8001. A key outcome of the Phase 1 portion of the trial is to select a dose to be evaluated in the Phase 2 part of the study. The Phase 2 portion of the IMAG1NE trial is designed to enroll approximately 30 additional participants to assess the efficacy of TK-8001 across a range of tumor indications.

On October 1, 2021 Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, reported three upcoming poster presentations at the 36th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Annual Meeting, to be held in Washington, D.C., as well as virtually November 10-14, 2021 (Press release, Apexigen, OCT 1, 2021, View Source [SID1234590984]). Sotigalimab, Apexigen’s lead immuno-oncology therapeutic, is a potentially first-in-class and best-in-class CD40 agonist, with unique epitope specificity and Fc receptor engagement for optimal therapeutic effect and tolerability.

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Details are as follows:

Title of the Presentation: Phase II of CD40 Agonistic Antibody Sotigalimab (APX005M) in Combination with Nivolumab in Subjects with Metastatic Melanoma with Confirmed Disease Progression on Anti-PD-1 Therapy
Abstract ID: 389
Presenter: Harriet Kluger, M.D., Professor of Medical Oncology at Yale School of Medicine

Title of the Presentation: Multiomic biomarker signatures identify subsets of patients who may benefit from either nivolumab or sotigalimab in combination with chemotherapy in metastatic pancreatic cancer
Abstract ID: 343
Presenter: Deena Maurer, Ph.D., Translational and Regulatory Affairs Scientist Fellow at the Parker Institute for Cancer Immunotherapy

Title of the Presentation: INNATE: Immunotherapy during neoadjuvant therapy for rectal cancer to elucidate local and systemic therapeutic responses
Abstract ID: 411
Presenter: Todd Aguilera, M.D., Ph.D., Assistant Professor of Radiation Oncology at UT Southwestern Medical Center

The posters will be available on-demand through the SITC (Free SITC Whitepaper) conference portal starting Friday, November 12, 2021, at 7:00 a.m. ET.

On October 1, 2021 BioNTech SE (BNTX) reported the first colorectal cancer patient has been treated with its individualized mRNA cancer vaccine BNT122 (autogene cevumeran, RO7198457) in a phase 2 trial (Press release, BioNTech, OCT 1, 2021, View Source [SID1234590695]). It is planned to enroll about 200 patients to evaluate the efficacy of BNT122 compared to watchful waiting after surgery and chemotherapy. The trial has been initiated in the United States, Germany, Spain and Belgium.

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Özlem Türeci, Chief Medical Officer of BioNTech, said: "Many cancers progress in such a way that the patient initially appears tumor-free after surgery, but after some time tumor foci that were initially invisible grow and form metastases. In this clinical trial in patients with colorectal cancer, we aim to identify high-risk patients with a blood test and investigate whether an individualized mRNA vaccine can prevent such relapses."

On October 1, 2021 Nagourney Cancer Institute reported that According to a presentation on September 30th by scientists from New South Wales Australia at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pancreatic Cancer, tumor samples removed from each patient hold the key to selecting the most effective cancer treatments (Press release, Nagourney Cancer Institute, OCT 1, 2021, View Source [SID1234590692]).

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The session entitled "The KPC model has helped advance pancreatic cancer therapy: Agree or disagree?" debated the role of mouse models for the development of cancer treatments and provided participants the opportunity to see the very real importance of human cancer tissue studies for drug selection.

"We are very pleased to see that the research community has come to appreciate the role of tumor tissue removed from each patient for the selection of chemotherapy drugs and combinations" said Dr. Robert Nagourney, who participated in the symposium and is director at the Nagourney Cancer Institute, where his group pioneered these human tumor tests over the past two decades.

With more than 10,000 human cancer studies to date, Dr. Nagourney has one of the largest databases in the world and has published extensively with results of clinical trials using these techniques in breast, ovarian, lung and other cancers. With a 2-fold improvement in clinical response reported and improved one-year survival in over 2500 published patient outcomes, the ex vivo analysis of programmed cell death (EVA/PCD) platform offers real hope for patients with advanced and hard to treat cancers like pancreatic.

"We have conducted over 200 pancreatic cancer patient studies and have improved the outcome for many patients who were deemed untreatable," said Nagourney. "One such patient recently rounded 11 years in remission after he presented with widely metastatic pancreatic cancer in April of 2009."

"Animal models and standard protocols can’t possibly provide those kinds of results in diseases like metastatic pancreatic cancer" he added.

Pancreatic cancer is the 3rd leading cause of cancer death in the United States with annual incidence that has risen dramatically in the past 2 decades. With only a 10% five-year survival, pancreatic cancer represents one of the greatest unmet needs in modern medical oncology.

On October 1, 2021 Roivant Sciences, a biopharmaceutical company dedicated to improving the delivery of healthcare to patients, reported that it has closed its business combination with Montes Archimedes Acquisition Corp. (Nasdaq: MAAC), a special purpose acquisition company, as well as a concurrent PIPE financing (Press release, Silicon Therapeutics, OCT 1, 2021, https://discovery.roivant.com/news/press-releases/roivant-sciences-announces-close-of-business-combination-with-montes-archimedes-acquisition-corp-and-concurrent-pipe-financing/ [SID1234590684]).

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Outstanding shares and warrants of MAAC have been exchanged for newly issued Roivant shares and warrants, which will begin trading on Nasdaq under the ticker symbols "ROIV" and "ROIVW" later today. At the close of this transaction on Sept. 30, 2021, Roivant’s consolidated cash position is approximately $2.5 billion.

"Roivant was founded to address inefficiencies in the traditional pharma model. As we begin our life as a public company, we now have the opportunity to accelerate that vision and create significant value for patients, shareholders, and society," said Matt Gline, Chief Executive Officer of Roivant Sciences. "I would like to thank our new investors for their support as we continue to advance transformational medicines and novel modalities."

In addition, the company announced that Richard Pulik has joined Roivant as chief financial officer. Mr. Pulik brings over twenty years of industry experience.

Prior to joining Roivant, Mr. Pulik was the global head of business development & licensing and portfolio management, oncology at Novartis and a member of Novartis’s Innovation Management Board and the Novartis oncology leadership team. Mr. Pulik joined Novartis in 2012 as a senior director, mergers & acquisitions based in Basel, Switzerland. Earlier in his career Mr. Pulik worked at Bank of America Merrill Lynch, Monitor Group and UBS Investment Bank, focusing on mergers and acquisitions and strategy in the healthcare sector. Mr. Pulik received a bachelor of science degree in finance from The Wharton School and a Bachelor of Arts degree in economics and international relations at the University of Pennsylvania in 2001.

"I am humbled to join a company that has accomplished so much over the last seven years," said Mr. Pulik. "I look forward to working with its leadership to create a next-generation biopharma company that develops meaningful medicines for patients around the world."

Roivant R&D Day
Roivant held a virtual R&D Day on the afternoon of September 28th highlighting the company’s drug discovery platform and recent clinical milestones. Recordings of R&D Day presentations and corresponding slides are available at https://investor.roivant.com/news-events/events.

Advisors
J.P. Morgan Securities LLC served as a financial advisor and capital markets advisor to Roivant and as a lead placement agent for the PIPE. SVB Leerink LLC served as a capital markets advisor to Roivant and as a lead placement agent for the PIPE. Goldman Sachs & Co. LLC served as a financial advisor to Roivant. Cowen and Company, LLC served as a financial advisor and capital markets advisor to Roivant. Citigroup Global Markets Inc. served as a placement agent for the PIPE. Truist Securities, Inc. served as a capital markets advisor to Roivant and as a placement agent for the PIPE. Davis Polk & Wardwell LLP acted as legal counsel to Roivant. Kirkland & Ellis LLP acted as legal counsel to MAAC. Okapi Partners served as the proxy solicitor for MAAC.