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Third Arc Bio Launches with Oversubscribed $165 Million Series A Financing to Deliver Superior Biologics for Solid Tumors and Inflammatory & Immunology (I&I) Diseases

On July 23, 2024 Third Arc Bio Inc., a biotech company developing multifunctional antibodies that are optimized for best-in-class T cell engagement across solid tumors and inflammatory & immunology (I&I) disease, reported a $165 million oversubscribed Series A financing that will advance the company through clinical studies to address significant unmet needs in oncology and autoimmunity (Press release, Third Arc Bio, JUL 23, 2024, View Source;immunology-ii-diseases-302201952.html [SID1234645021]).

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The company was launched in 2022 with seed financing from Omega Funds and has since advanced multiple programs that will enter the clinic starting in early 2025. The Series A investor syndicate was led by Vida Ventures and co-led by Cormorant Asset Management and Hillhouse Investment. Omega Funds continued their strong support of the company in the Series A and additional investors include Goldman Sachs Alternatives, BVF Partners LP, funds and accounts advised by T. Rowe Price Associates, Inc., Janus Henderson Investors, funds managed by abrdn Inc., Marshall Wace, Foresite Capital, Logos Capital, Freepoint Capital Group, and AbbVie Ventures.

"With a powerful discovery engine and a stellar development team, the company is well-positioned to deliver best-in-class therapies and regimens," said Peter Lebowitz, MD, PhD, Chief Executive Officer (CEO) of Third Arc Bio. "We are grateful for the strong support from Omega Funds and our investor syndicate, who believe in the value of our precise and targeted approach to modulating the immune response with advanced biologics."

"Less than three years ago, we decided to help realize the scientific vision of Third Arc Bio’s founding team by pairing the latest innovation in antibody development with the pursuit of high impact targets in oncology and autoimmunity," said Francesco Draetta, Managing Partner of Omega Funds. "We are delighted to have played a role in the company’s rapid growth since its inception. This latest oversubscribed financing reflects the hard work and progress of the talented Third Arc team and the broad interest in their approach. We are very excited to see the potential impact that these drugs could have for patients."

"The Third Arc Bio team has an outstanding track record of developing impactful medicines, including multiple approved drugs that have redefined standard-of-care in oncology and I&I," said Arjun Goyal, MD, Co-Founder and Managing Director of Vida Ventures. "We are tremendously excited to lead this round alongside a high-caliber syndicate of life science and strategic investors at a pivotal time for the company’s growth. With Third Arc’s leading portfolio of best-in-class biologics, multiple INDs planned for 2025, and an extraordinary team of drug developers, the company is poised to create bold new treatments leveraging T cell biology for patients globally."

Third Arc Bio’s accomplished leadership team has collectively brought 19 drugs from discovery and development to commercialization:

Peter F. Lebowitz, MD, PhD joined Third Arc Bio as CEO in January of 2024. Peter is a renowned industry leader with extensive drug development experience, including from his prior role as Global Head of Oncology R&D for Johnson & Johnson. Under Peter’s leadership, J&J Oncology achieved 13 major new drug approvals with first and best-in-class medicines. The innovative approach to drug development was reflected in 13 FDA Breakthrough Therapy Designations and 38 New England Journal Publications. Prior to J&J, Peter also served in multiple leadership roles at GSK including as Vice President, Global Head of Oncology Early Clinical Development and Vice President, Medical Development Leader in Late Development at GlaxoSmithKline where he successfully filed 10 Investigational New Drug applications and played a crucial role in the global registration of two oncology medicines.
Sanjaya Singh, PhD is the founder and Chief Scientific Officer of Third Arc Bio. He is a leading expert in biotherapeutics with more than 25 years of experience. Sanjaya is a co-inventor of multiple immunology and immuno-oncology compounds, including Risankizumab (Skyrizi). Sanjaya’s industry experience includes Global Head of Janssen Biotherapeutics, Johnson & Johnson, Boehringer Ingelheim, Biotherapeutics Discovery and Tanox, Inc. (acquired by Genentech). Sanjaya is co-founder and Scientific Advisory Board member of Aliada Therapeutics.
Joe Erhardt, PhD is the Chief Operating Officer of Third Arc Bio and is a highly experienced drug developer, having served for over 20 years in roles from early discovery through late clinical development. In his prior roles, including his most recent role as Vice President, Global Head of Oncology Discovery and External Innovation at Johnson & Johnson, Joe has had operational oversight of expansive portfolios as well as licensing and collaboration for oncology discovery and early development. Joe has delivered a significant number of internal and external candidates in discovery and clinical pipelines across a range of modalities including T cell redirection, T cell costimulation, antibody drug conjugates (ADCs), and targeted radiotherapy.

Pinetree Therapeutics Announces Exclusive Option and Global License Agreement for Preclinical EGFR Degrader Candidate with AstraZeneca

On July 23, 2024 Pinetree Therapeutics, Inc. ("Pinetree" or the "Company"), a biotechnology company pioneering next generation targeted protein degraders (TPD) to combat drug resistance in oncology and beyond, reported it has entered into an exclusive option and global license agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) for a preclinical EGFR degrader candidate (Press release, PineTree Therapeutics, JUL 23, 2024, View Source [SID1234645020]).

Under the terms of the agreement, AstraZeneca will be granted an exclusive option to license Pinetree’s preclinical EGFR degrader for global development and commercialization. In exchange, Pinetree will receive upfront and near-term payments of up to $45 million and is eligible to receive additional development and commercial milestone payments for a total deal value of over $500 million, as well as tiered royalties on net sales worldwide.

"We are excited to announce this option and license agreement with AstraZeneca, a leading global biopharmaceutical company, to advance one of our novel receptor degrader programs into the clinic," said Dr. Hojuhn Song, Founder and CEO of Pinetree. "Pinetree’s pan-EGFR degrader was developed from AbReptor, our proprietary multispecific antibody platform and has demonstrated promising preclinical anti-tumor activity in drug- and TKI-resistant tumors as well as enhanced activity when used in combination with current EGFR inhibitors."

"Targeted protein degradation is a promising therapeutic modality. We are pleased to enter into this agreement with Pinetree, for an exclusive option to license its pan-EGFR degrader for investigation in EGFR expressing tumors, including those with EGFR mutations" said Puja Sapra, Senior Vice President, Oncology Targeted Discovery, Oncology R&D, AstraZeneca.

Pinetree is also advancing multiple preclinical candidates derived from its AbReptor TPD platform with potential in oncology and other therapeutics areas.

Verastem Oncology Announces Pricing of $55.0 Million Public Offering of Common Stock, Warrants and Pre-Funded Warrants

On July 23, 2024 Verastem Oncology, (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported the pricing of an underwritten public offering of 13,333,334 shares of its common stock and accompanying warrants to purchase up to 13,333,334 shares of its common stock at a combined offering price to the public of $3.00 per share and accompanying warrant (Press release, Verastem, JUL 23, 2024, View Source [SID1234645019]). In lieu of common stock to certain investors, Verastem Oncology offered pre-funded warrants to purchase up to an aggregate of 5,000,000 shares of its common stock and accompanying warrants to purchase up to 5,000,000 shares of its common stock at a combined offering price to the public of $2.999 per pre-funded warrant and accompanying warrant, which represents the per share public offering price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant. The warrants have an exercise price of $3.50 per share, are exercisable immediately and will expire 18 months from the date of issuance. The warrants will be exercisable, at the option of each holder, in whole or in part by delivering a duly executed exercise notice and by payment in full of the exercise price for the number of shares of common stock purchased upon such exercise. Cashless exercise of the warrants are limited to certain circumstances as defined within the warrant.

The gross proceeds from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Verastem Oncology, are expected to be approximately $55.0 million. The offering is expected to close on July 25, 2024, subject to customary conditions. All of the securities to be sold in the offering are to be sold by Verastem Oncology.

Guggenheim Securities and Cantor are acting as joint book-running managers for the offering.

Verastem Oncology intends to use the net proceeds from the public offering to fund the potential launch of avutometinib and defactinib in LGSOC, continued clinical research and development of product candidates, and for working capital and other general corporate purposes, which may include capital expenditures, research and development expenditures, clinical trial expenditures, potential commercial launch expenditures, milestone payments under collaboration and in-license agreements, and possible acquisitions.

A shelf registration statement on Form S-3 relating to the public offering of the securities described above was declared effective by the Securities and Exchange Commission (SEC) on November 20, 2023. The offering is being made by means of a written prospectus and prospectus supplement that form a part of the registration statement. Before you invest, you should read the preliminary prospectus supplement relating to and describing the terms of the public offering, the accompanying base prospectus, and the related registration statement and other documents that Verastem Oncology has filed with the SEC for more complete information about Verastem Oncology and the offering. An electronic copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering is free and can be found by visiting EDGAR on the SEC website at www.sec.gov. An electronic copy of the final prospectus supplement and accompanying prospectus relating to the offering will be available on the SEC website at www.sec.gov or may be obtained, when available, by contacting Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, or by telephone at (212) 518-9544, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th floor, New York, New York 10022.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Medigene to Present at ESMO Congress 2024

On July 23, 2024 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported the presentation of two posters at the ESMO (Free ESMO Whitepaper) Congress 2024 being held on September 13-17, 2024, in Barcelona, Spain (Press release, MediGene, JUL 23, 2024, View Source [SID1234645018]). The posters will be showcasing recent advancements in the Company’s library of T cell receptors (TCR) targeting Kirsten rat sarcoma viral oncogene homologue (KRAS) as well as its UniTope & TraCR technology, a universal tagging and tracking system for TCR-T cells.

The full abstracts will be published online on the ESMO (Free ESMO Whitepaper) website (View Source) on Monday, September 9, 2024, at 00:05 am CEST.

Details of the poster presentations are as follows:

Abstract and title: "Advancing a multi-dimension KRAS mutation-specific T cell receptor (TCR) library with a 3S TCR targeting the G12D mutation to address large global patient populations."
Authors: Kirsty Crame, Dominik Alterauge, Anne Wiebe Mohr, Julia Bittmann, Doris Brechtefeld, Mario Catarinella, Kathrin Davari, Maja Buerdek, Petra U Prinz, Andrea Coluccio, Dolores J Schendel and Giulia Longinotti
Final presentation number: 1143P
Date/time: Saturday, September 14, 2024, Poster lunch session from noon to 1:00 pm CEST in Hall 6, poster will be on display from 9:00 am to 5:00 pm CEST
Category: Investigational Immunotherapy

Abstract and title: "UniTope & TraCR – Universal tagging and tracking system for TCR-T cells integrated directly in the TCR constant region."
Authors: Kirsty Crame, Kanuj Mishra, Justyna Ogonek, Dolores Schendel and Barbara Lösch
Final presentation number: 1144P
Date/time: Saturday, September 14, 2024, Poster lunch session from noon to 1 pm CEST in Hall 6, poster will be on display from 9:00 am to 5:00 pm CEST
Category: Investigational Immunotherapy

Initiation of Rolling NDA and Interim Duration of Therapy Data

On July 23, 2024 Verastem, Inc. (the "Company" or "Verastem") reported initiating the rolling submission of a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") seeking accelerated approval of the combination of avutometinib and defactinib for patients with recurrent Kirsten rat sarcoma viral oncogene homolog ("KRAS") mutant ("KRAS mt") low-grade serous ovarian cancer ("LGSOC") who received at least one prior systemic therapy (Press release, Verastem, JUL 23, 2024, View Source [SID1234645017]). The rolling review process allows Verastem to submit completed sections of an application for review by the FDA before all sections become available. The initial sections of the application will include the completed nonclinical and quality sections. The Company plans to seek the broadest label possible with mature RAMP 201 data to inform final indication. Previously, the FDA granted Orphan Drug Designation for the combination in LGSOC and Breakthrough Therapy Designation for the combination for treatment of patients with LGSOC with recurrent disease after one or more prior lines of therapy, including platinum-based chemotherapy. The Company plans to request a priority review of the NDA. Currently, there are no FDA-approved treatments specifically for recurrent LGSOC.

The Company estimates the total annual incident addressable market opportunity for this product candidate to be approximately $300 million for KRAS mt and approximately $270 million KRAS wild-type ("KRAS wt") populations, respectively. The Company estimates the total prevalent addressable market opportunity to be approximately $1.7 billion for KRAS mt and approximately $1.1 billion for KRAS wt populations, respectively. The Company’s estimates of the patient population, pricing and revenue opportunities for its product candidates, including for KRAS mt and KRAS wt patients with LGSOC, are based on a number of internal and third-party estimates and assumptions, including, without limitation, internal forecasts, the median duration of treatment from initial interim clinical data and the assumed prices at which we can commercialize our product candidates. Specifically, the Company’s estimates of total addressable market opportunities are based on: (a) estimated annual incidence of KRAS mt and KRAS wt populations of approximately 500 and 1,000 patients, respectively, (b) estimated prevalence of KRAS mt and KRAS wt populations of approximately 2,800 and 4,200 patients, respectively, (c) the average duration of therapy as observed in Verastem clinical trials of 18 months and eight months for KRAS mt and KRAS wt populations, respectively, and (d) an estimated cost of therapy of $34,000 per month consistent with other recent oncology drug launches.

The average duration of therapy included in this calculation is based, in part, on the estimated duration of therapy for patients dosed with the combination of avutometinib and defactinib for the combined Parts A, B, and C in RAMP 201 as of the latest data cutoff in February 2024. Amongst 115 patients, 58 enrolled with KRAS mutated LGSOC and 57 had wild-type, or non-mutated, KRAS. The estimated median duration of therapy for all patients is nine months and the estimated mean duration of therapy is 14 months. For KRAS mt, the estimated median duration of therapy is 14 months and the estimated mean duration of therapy is 18 months with 31 patients still on treatment as of the data cutoff date. For KRAS wt, the estimated median duration of therapy is seven months and the estimated mean duration of therapy is 11 months with 12 patients still on treatment as of the data cutoff date.

Estimated median duration of therapy was calculated using Kaplan-Meier methods. Estimated mean duration of therapy was calculated by projecting complete time on treatment for patients still on treatment by sampling from an exponential distribution conditional on the observed duration through the cutoff date.

GenFleet Collaboration

In August 2023, the Company entered into a collaboration and option agreement (the "GenFleet Agreement") with GenFleet Therapeutics (Shanghai), Inc. ("GenFleet") pursuant to which GenFleet granted the Company options to obtain exclusive development and commercialization rights worldwide outside of mainland China, Hong Kong, Macau, and Taiwan (the "GenFleet Territory") for up to three oncology programs targeting RAS pathway driven cancers (the "GenFleet Options"). The Company may exercise its GenFleet Options on a program-by-program basis. An investigational new drug application by GenFleet in China for GFH375/VS-7375, an oral KRAS G12D (ON/OFF) inhibitor, was cleared in June 2024, following which GenFleet initiated Phase 1/2 trial in solid tumors with KRAS G12D mutation for GFH375/VS-7375 in China in June 2024. In July 2024, the Company announced that the first patient had been dosed in a Phase 1/2 trial in China, conducted by GenFleet, evaluating GFH375/VS-7375, a KRAS G12D (ON/OFF) inhibitor. The Phase 1 study is being conducted in approximately 20 hospitals in China and will evaluate the safety and efficacy of GFH375/VS-7375 in patients with advanced KRAS G12D mutant solid tumors. The Phase 1 study will determine the recommended Phase 2 dose (RP2D) and then further evaluate in Phase 2 the efficacy and safety of GFH375/VS-7375 in patients with advanced solid tumors, such as pancreatic ductal adenocarcinoma, colorectal cancer and non-small cell lung cancer.

Note Regarding Presentation of Clinical Data and Market Opportunities

Interim, initial "top-line" and preliminary data or statistical analyses and projections based thereon, may not be predictive of the results from final, more mature clinical data.

Interim, initial "top-line," and preliminary data or statistical analyses from clinical trials, including the estimated and projected duration of therapy for RAMP 201 patients based on initial topline results with a minimum of five months follow up, may change as more mature patient data becomes available, may be more or less positive than the final data, and may be subject to audit and verification procedures that could result in material changes in the mature data. Thus, such interim and projected data should be considered carefully and with caution and may not necessarily be predictive of the results from final, more mature clinical data.

The estimated mean and median duration of therapy of patients in our RAMP 201 trial are based on interim clinical data and estimates and projections extrapolated thereof. Such interim results and the estimated projections based thereon may not be reproduced in any current or potential future clinical trials, and thus should be considered carefully and with caution, and may not necessarily be predictive of the results from final, more mature clinical data. More mature data from the RAMP 201 trial may materially differ from and be less positive than the interim and initial topline data reported herein Material adverse differences in final data, compared to preliminary or interim data, could severely and adversely affect our financial results, business and business prospects, including our estimates of the addressable market opportunity.

The market opportunities for our product candidates can be smaller than we estimate or the approvals that we obtain may be based on a narrower definition of the patient population.

The potential market opportunity for The Company’s product candidates is difficult to estimate precisely. For example, the number of patients suffering from each of recurrent KRAS mutant LGSOC and KRAS wild-type LGSOC populations we are targeting is small and has not been established with precision. Due to the rarity of our target indications, there is no comprehensive patient registry or other method of establishing with precision the actual number of patients with KRAS mutant LGSOC and KRAS wild-type LGSOC. As a result, we have had to rely on other available sources to derive clinical prevalence estimates for our target indications. Management of the Company makes estimates, including those contained in this Current Report on Form 8-K, regarding the incidence and prevalence of target patient populations, the rate of recurrence and the median survival for particular diseases, including with respect to LGSOC, based on various third-party sources and internally generated analysis and use such estimates in making decisions regarding the Company’s drug development strategy determining indications on which to focus in preclinical or clinical trials.

Management’s estimates of the patient population, pricing and revenue opportunities for the Company’s product candidates, including KRAS mt and KRAS wt for patients with LGSOC, are based on a number of internal and third-party estimates, including, without limitation, internal forecasts of potential market penetration, the median duration of treatment from initial interim clinical data and the assumed prices at which we can commercialize our product candidates. These estimates may be inaccurate or based on imprecise data. For example, if approved by the FDA, the market opportunity of the Company’s product candidates will depend on, among other things, acceptance by the medical community, patient access, drug pricing and reimbursement. The number of patients in the addressable market may turn out to be lower than expected, patients may not be otherwise amenable to treatment with the Company’s drugs, or new patients may become increasingly difficult to identify or gain access to, all of which may significantly harm the Company’s business, financial condition, results of operations, and prospects. Further, if any approval that the Company obtains is based on a narrower definition of patient populations than the Company had anticipated, the potential market for the Company’s product candidates will be smaller than management’s current estimates. A smaller patient population in our target indications would have a materially adverse effect on the Company’s ability to achieve commercialization and generate revenues.