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.

On October 1, 2021 Cancer Research Institute (CRI) reported that Next week on October 7-8, 2021, the Cancer Research Institute (CRI)—a nonprofit organization dedicated to harnessing the immune system’s power to control and potentially cure all types of cancer—will offer its 2021 CRI Immunotherapy Patient Summit as a free, virtual event (Press release, Cancer Research Institute, OCT 1, 2021, View Source [SID1234590683]). Tamron Hall—Emmy Award-winning host of the Tamron Hall television show, executive producer, author, and philanthropist—will moderate the Summit for the second year.

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"This event that brings medical experts together with thousands of patients to discuss the growing promise of cancer immunotherapy happens nowhere else," Hall said. "For those of us who have lost someone to cancer or are going through treatment right now, the CRI Summit offers a vital lifeline of helpful information, connecting patients and their caregivers to clinical trials and emerging treatments, and I am proud to be a part of it."

Over the course of two days, the Summit will highlight the growing implications of immunotherapy for more than 10 cancer types, provide education on the basics of immunotherapy and how clinical trials work, and address cancer care disparities for the first time as part of this program.

"This is our fifth CRI Immunotherapy Patient Summit and our second in an online format open and available to anyone, again free of charge as with all our Summits," said Jill O’Donnell-Tormey, Ph.D., chief executive officer and director of scientific affairs at Cancer Research Institute. "Immunotherapy is no longer just a research frontier. Clinical breakthroughs are multiplying, and this Summit is where patients, caregivers, health care professionals, and advocates alike can gain insight on the full range of advances, learn about clinical trial options, and ask their questions."

The expanded Summit program begins on Thursday, October 7, at 1:00 PM ET and runs from 1:00 PM to 5:30 PM ET on Thursday and on Friday, October 8. Highlights include:

Breakout sessions led by top academic experts on the progress of immunotherapy against a wide range of cancer types—encouraging questions from the patients present
A panel of diverse patient advocates to discuss racial disparities in cancer care—addressing financial and social barriers—and ways to respond through self-advocacy and support networks
Nuts-and-bolts sessions on the science behind immunotherapy and how clinical trials work.
Patients and caregivers registered for the Summit also can request a free, confidential one-on-one consultation in English or Spanish with one of CRI’s Clinical Trial Navigators, who can help locate immunotherapy clinical trials appropriate to an individual’s diagnosis, treatment history, and circumstances.

Summit registration is available at: View Source

Day 1 topics and speakers will include:

Immunotherapy 101: The Basics and Beyond
Ellen Puré, Ph.D., University of Pennsylvania
Live Q&A moderated by Tamron Hall

Immunotherapy Clinical Trials
Kunle Odunsi, M.D., Ph.D., University of Chicago

Immunotherapy Patient Perspectives
Moderated by Stephen Estrada, Colorectal Cancer Veteran

Blood Cancer and Immunotherapy
Hearn Jay Cho, M.D., Ph.D., Mount Sinai Tisch Cancer Institute

Colorectal Cancer and Immunotherapy
Van Morris, M.D., The University of Texas MD Anderson Cancer Center

Brain Cancer and Immunotherapy
David A. Reardon, M.D., Harvard Medical School and Dana-Farber Cancer Institute

Head and Neck Cancer and Immunotherapy
Nabil F. Saba, M.D., FACP, Winship Cancer Institute at Emory University

Day 2 topics and speakers will include:

Conversation About Cancer Care Disparities
Moderated by Karen Peterson, Breast Cancer Veteran

Breast Cancer and Immunotherapy
Leisha Emens, M.D., Ph.D., University of Pittsburgh Medical Center

Lung Cancer and Immunotherapy
Patrick Forde, M.D., Johns Hopkins Medicine

Prostate Cancer and Immunotherapy
Ana Aparicio, M.D., The University of Texas MD Anderson Cancer Center

Ovarian Cancer and Immunotherapy
Dmitriy Zamarin, M.D., Ph.D., Memorial Sloan Kettering Cancer Center

Melanoma and Immunotherapy
Margaret Callahan, M.D., Ph.D., Memorial Sloan Kettering Cancer Center

Bladder Cancer and Immunotherapy
Arjun Balar, M.D., Perlmutter Cancer Center at New York University Langone Health

Support for the 2021 CRI Immunotherapy Patient Summit is generously provided by the following:

Sponsors
Gold: Bristol Myers Squibb
Silver: Merck
Bronze: Genentech, GSK, Lilly Oncology, Novartis, Pfizer, Regeneron, Sanofi Genzyme

Friend
Foundation Medicine

Host Institutions
The University of Texas MD Anderson Cancer Center, NYU Langone Health

On October 1, 2021 Biofrontera AG reported that currently holds a 100 % stake in the US-based subsidiary Biofrontera Inc (Press release, Biofrontera, OCT 1, 2021, View Source [SID1234590682]).

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On July 6, 2021, Biofrontera AG published an insider information pursuant to Article 17 MAR announcing that Biofrontera Inc. intends to raise capital by means of an initial public offering and a stock exchange listing in the United States ("IPO").

Within the scope of the IPO, up to 3,450,000 shares of Biofrontera Inc. are to be placed with US investors in a price range of USD 5.00 to USD 7.00 per share. The shares of Biofrontera Inc. to be offered in the IPO are to be issued from a capital increase. A sale of shares of Biofrontera Inc. by Biofrontera AG as part of the IPO is currently not intended. The shares of Biofrontera Inc. are to be listed on NASDAQ.

The management board of Biofrontera AG has resolved today, with the approval of the supervisory board, that it is in favor of Biofrontera Inc. performing the IPO.

A registration statement relating to the securities to be offered in the IPO by Biofrontera Inc. has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This public disclosure of inside information according to article 17 MAR shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On October 1, 2021 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that new clinical and preclinical data will be presented at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), which will be held on November 10-14, 2021 (Press release, Compugen, OCT 1, 2021, https://www.prnewswire.com/news-releases/compugen-to-present-clinical-data-from-anti-tigit-com902-monotherapy-and-triple-combination-dose-escalation-studies-at-sitc-2021-301389580.html [SID1234590667]).

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Poster Presentation Details:

Title: COM902 (anti-TIGIT antibody) monotherapy – preliminary evaluation of safety, tolerability, pharmacokinetics, and receptor occupancy in patients with advanced solid tumors (NCT04354246).
Abstract Number: 477
Lead Author: Dumbrava, E, E
Date: Friday, November 12, 2021

Title: COM701 in combination with BMS-986207 (anti-TIGIT antibody) and nivolumab – preliminary results of safety, tolerability, and pharmacokinetics in patients with advanced solid tumors (NCT04570839).
Abstract Number: 478
Lead Author: Dumbrava, E, E
Date: Saturday, November 13, 2021

Title: Novel DNAM-1 axis member, PVRIG, is potentially a dominant checkpoint involved in stem-like memory T cells – dendritic cell interaction.
Abstract Number: 252
Lead Author: Alteber, Z
Date: Saturday, November 13, 2021