1stOncology™: Cancer Intelligence Service – Page 8139 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Rakuten Medical Announces FDA Acceptance of an Investigational New Drug (IND) Application for RM-1995, a Conjugate of IR700 and anti-CD25 Antibody

On December 15, 2021 Rakuten Medical, Inc reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application to begin clinical studies of RM-1995 photoimmunotherapy in patients with advanced cutaneous squamous cell carcinoma or with head and neck squamous cell carcinoma (Press release, Rakuten Medical, DEC 15, 2021, View Source [SID1234597253]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

RM-1995 photoimmunotherapy treatment is an investigational drug-device combination being developed by Rakuten Medical, Inc. The drug portion of the treatment, RM-1995, is a conjugate of a photoactivatable dye (IRDye 700DX [IR700]) and a monoclonal antibody specific for cell-surface interleukin 2 (IL-2) receptor α-chain (CD25). The device portion of the treatment is a laser device system (PIT690 Laser System) used to activate IR700 by illumination with 690nm nonthermal red light. Tumor-resident regulatory T cells (Tregs), that inhibit antitumor immune responses to promote tumor growth, can be specifically targeted with anti-CD25 antibodies1. Rakuten Medical, Inc is investigating RM-1995 as a potential new treatment to provide targeted, direct reduction of Tregs specifically within light-treated tumor lesions to induce systemic anticancer immune responses.

"We are very excited to have achieved this regulatory milestone and delighted to be moving RM-1995 into the clinic," said Mickey Mikitani, Chief Executive Officer of Rakuten Medical, Inc. "RM-1995 has the potential to attack the cancer in a novel way, targeting Tregs. Based on data from preclinical studies, RM-1995 photoimmunotherapy treatment is expected to result in acute killing of Tregs within the tumor. We are developing drugs using various antibodies in our drug discovery program based on Rakuten Medical’s IlluminoxTM platform, and RM-1995 is the second pipeline drug developed on this platform. We will continue to advance our business with a sense of speed so that we can deliver these important treatments to as many patients as possible."

Syndax Announces Pricing of $75.3 Million Public Offering

On December 15, 2021 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported the pricing of an underwritten public offering of 3,157,144 shares of its common stock, and to certain investors pre-funded warrants to purchase 1,142,856 shares of its common stock at an exercise price of $0.0001 (Press release, Syndax, DEC 15, 2021, View Source [SID1234597251]). The public offering price of each share of common stock is $17.50 and the public offering price of each pre-funded warrant is $17.4999 per underlying share, which represents the per share public offering price for the common stock less the $0.0001 per share exercise price for each such pre-funded warrant. The aggregate gross proceeds from this offering are expected to be approximately $75.3 million, before deducting underwriting discounts and commissions and other offering expenses payable by Syndax. In addition, Syndax granted the underwriters a 30-day option to purchase up to an additional 645,000 shares of common stock. All of the shares of common stock and pre-funded warrants are being sold by Syndax. The offering is expected to close on December 20, 2021, subject to customary closing conditions.

Goldman Sachs & Co. LLC and Cowen are acting as joint book-running managers for the offering. BTIG is acting as lead manager for the offering. B. Riley Securities is acting as co-manager for the offering.

The shares are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the website of the SEC at www.sec.gov. When available, copies of the preliminary prospectus supplement, final prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Goldman Sachs and Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by email at [email protected], or by phone at (833) 297-2926.

This press release 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. Any offer, if at all, will be made only by means of a prospectus supplement and accompanying prospectus, which are a part of the effective registration statement.

Inventia Life Science Accelerates Growth with $25M Series B and Launches 3D Cell Culture Platform into US Market

On December 15, 2021 Inventia Life Science, a world leader in advanced 3D cell cultures for research and clinical purposes, has reported the close of a US $25M Series B funding round, led by Blackbird Ventures (Press release, Inventia Life Science, DEC 15, 2021, View Source [SID1234597250]). Inventia has also announced the launch of its US operations with the appointment of Dwayne Dexter as its Director of US Sales. Through this Series B round of financing, Inventia plans to market its RASTRUM 3D cell culture platform worldwide and grow its team from 36 to 150 employees by the end of 2024. In particular, it aims to develop a strong presence in the US, where the biomedical research and drug discovery markets are currently estimated to be worth more than US $40 billion. This Series B brings Inventia’s total funding to date to US $32 million. The round also included significant re-investment from Skip Capital.

"This new round of financing is a very significant milestone for Inventia. The funds will enable us to scale up and take full advantage of the increasing global interest in such things as new approaches to cancer research, and the development and validation of new drugs," says Inventia’s Founder and CEO, Dr. Julio Ribeiro. "The biomedical applications for the use of the RASTRUM platform are very diverse. For example, it can be of enormous benefit to the pharma industry, by allowing new drugs to be tested in a 3D cellular environment and eliminated if necessary, long before they reach the stage of clinical trials. This can reduce by hundreds of millions of dollars the total cost of bringing a successful drug to market. Similarly, cancer researchers can now work at scale with cell models that mimic the human body almost exactly and produce research results that are more accurate and predictive than before."

Alongside this Series B round of funding, Inventia has also appointed Dr. Dwayne Dexter as its Director of US Sales. Dwayne will be instrumental in growing the pharmaceutical and academic customer base and driving adoption of Inventia’s technology in the US and Canada. Currently, three of the leading US pharmaceutical companies are Inventia customers. Prior to joining Inventia, Dwayne served as the Director of US Operations at Mimetas, a US-based organ-on-a-chip provider.

Niki Scevak, Partner at Blackbird Ventures, commented on the news, saying, "We are thrilled to help accelerate the adoption globally of Inventia’s unique 3D cell culture platform. It’s a technology that improves cancer and other cellular research in a fundamental way, and the benefits of this will reshape many biomedical industries, in particular the pharmaceutical industry," said Scevak. "Our financial support of Inventia reflects our firm belief that there is a broad-based and urgent need in the biomedical world for what the company has developed and that its impact is going to be truly generational."

Kim Jackson, Founder at Skip Capital, commented, "Inventia has phenomenal founders who are building a high growth biotech company. I believe their technology will revolutionize the way that pioneering researchers in areas such as cancer discover and test new and innovative drugs."

Repare Therapeutics Insiders Establish New and Modified Automatic Securities Disposition Plans

On December 15, 2021 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, reported that each of its: President and Chief Executive Officer, Lloyd Segal; Executive Vice President and Chief Financial Officer, Steve Forte; Executive Vice-President and Chief Scientific Officer, Michael Zinda; Executive Vice-President and Chief Medical Officer, Maria Kohler; Executive Vice-President Discovery, Cameron Black; and Executive Vice President, Head of Business & Corporate Development, Kim Seth (collectively, the "Executives"), as well as certain other insiders of the Company (the "Other Insiders" and collectively with the Executives, the "Participants"), have terminated existing Automatic Securities Disposition Plans ("ASDPs") and established new ASDPs or modified existing ASDPs in accordance with applicable United States and Canadian securities legislation, including the recommended practices set forth in the recently issued Canadian Securities Administrators’ Staff Notice 55-317 ("Staff Notice 55-317") and the Company’s internal policies (Press release, Repare Therapeutics, DEC 15, 2021, View Source [SID1234597249]).

While Repare is listed on the Nasdaq Global Select Market, it is also considered a reporting issuer under the Securities Act (Québec) and is therefore announcing the foregoing establishment or amendment of the ASDPs in furtherance of the recently published guidance provided by the Canadian Securities Administrators in Staff Notice 55-317.

Under U.S. and Canadian securities laws and the Company’s trading policies, insiders of Repare are subject to limits on their ability to sell shares in the Company. The ASDPs address this issue by permitting trades to be made in accordance with pre-arranged instructions given when Participants are not in possession of any material undisclosed information.

Up to 328,681 common shares of Repare may be sold under the ASDPs implemented or modified by the Executives in the aggregate, and up to 95,320 common shares of Repare may be sold under the ASDPs implemented by the Other Insiders. The ASDPs are designed to allow for an orderly disposition of each of the Participants’ shares in Repare at prevailing market prices over the course of the 12 to 24 months that the ASDPs are expected to be in place. Sales of the common shares under the ASDPs will only commence after the Company has announced and filed its next annual financial statements for the fiscal year ended December 31, 2021, in accordance with the recent recommended practices set forth in Staff Notice 55-317.

Each Participant has provided for clear trading parameters and other instructions in writing to the independent dealers administering the ASDPs, specifying the number of securities to be sold and setting out minimum trade prices, which in most cases exceed the current trading price of the Company’s common shares, and the dates or frequencies of sales. The ASDPs prohibit the dealer administering the ASDPs from consulting with the Participants regarding any sales under the ASDPs and prohibit the Participants from disclosing to the dealer any information concerning the Company that might influence the execution of the ASDPs

The ASDPs contain meaningful restrictions on the ability of the Participants to amend, suspend or terminate the ASDPs that have the effect of ensuring that the Participants cannot benefit from material non-public information.

AngioDynamics to Report Fiscal 2022 Second Quarter Financial Results on January 6, 2022

On December 15, 2021 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that it will report financial results for the second quarter of fiscal year 2022 before the market open on Thursday, January 6, 2022 (Press release, AngioDynamics, DEC 15, 2021, View Source [SID1234597248]). The Company’s management will host a conference call at 8:00 a.m. ET the same day to discuss the results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13725681.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Thursday, January 6, 2022, until 11:59 p.m. ET on Thursday, January 13, 2022. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13725681.