On March 16, 2022 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, reported FDA clearance to proceed with a Phase 1b/2 clinical trial of its anti-CTLA-4 monoclonal antibody (mAb), ADG126, in combination with the anti-PD-1 antibody pembrolizumab (Press release, Adagene, MAR 16, 2022, View Source [SID1234610161]). The global trial (ADG126-P001 / KEYNOTE-C98) will evaluate patients with advanced/metastatic solid tumors at multiple sites in the U.S. and Asia Pacific (APAC).

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ADG126 SAFEbody is designed for conditional activation in the tumor microenvironment (TME), as well as to enhance the efficacy profile by potent Treg depletion and to maintain its physiological function by soft ligand blocking in order to expand the therapeutic index and further address safety concerns with existing CTLA-4 therapies.

"The FDA clearance of this trial represents a major step forward in our wholly-owned CTLA-4 program. It builds on a strong safety profile for ADG126 SAFEbody and its parental antibody ADG116, respectively, as a single agent and the ability to achieve doses that may unlock the full potential of CTLA-4 as a proven target for strong ADCC-mediated Treg depletion in the TME. Our goal is to establish the CTLA-4 pathway as the cornerstone of cancer treatment in both single-agent and combination regimens," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "We are excited to initiate our clinical trial evaluating combination therapy with ADG126, which leverages SAFEbody precision masking technology to address toxicity limitations. This multi-regional trial of ADG126 with pembrolizumab also reflects our commitment to bringing highly differentiated therapies to cancer patients globally."

SAFEbody technology is designed to address safety and tolerability challenges associated with many antibody therapeutics by using precision masking technology to shield the binding domain of the biologic therapy. Through activation in the TME, this allows for tumor-specific targeting of antibodies, while minimizing on-target off-tumor toxicity in healthy tissues.

The ADG126-P001 trial is expected to dose the first patients soon. The trial is designed to evaluate safety and tolerability, and to determine the recommended Phase 2 dose for ADG126 in combination with pembrolizumab. The trial will begin with dose-escalation (ADG126 at 6 mg/kg) followed by dose expansion at the recommended dose for early efficacy evaluation. A combination cohort of ADG126 with the anti-PD-1 therapy, toripalimab is also being initiated in Australia.

On March 16, 2022 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, reported that it has agreed to sell approximately 13,934,427 shares of its common stock to a select group of institutional and accredited investors in a private placement (Press release, 2seventy bio, MAR 16, 2022, View Source [SID1234610160]). Upon the closing of the financing, 2seventy bio will receive gross proceeds of approximately $170 million, before payment of offering commissions and expenses, based on a price of $12.20 per share, the closing price of 2seventy bio’s common stock on Nasdaq on March 15, 2022. The financing is expected to close on March 17, 2022, subject to customary closing conditions. Proceeds from the financing will support 2seventy bio’s ongoing research and development activities as well as general corporate purposes and working capital.

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The private placement included top healthcare investors: 683 Capital, Armistice Capital, Bain Capital Life Sciences, Boxer Capital, CaaS Capital, Casdin Capital, Cowen Healthcare Investments, EcoR1 Capital, Heights Capital, Janus Henderson Investors, Madison Avenue Partners, Newtyn Management, Nick Leschly & family, RTW Investments, LP, and existing investors.

"Roughly 100 days into the launch of 2seventy bio, we have taken important steps to secure the company’s financial foundation. We have increasing conviction in the ABECMA U.S. commercial launch, we are executing on a plan to rebalance our burn, and we have secured important funding from leading healthcare investors. Taken together, we expect these steps will get us through critical milestones and into 2025," said Nick Leschly, chief kairos officer. "After conducting diligence to understand our platform, pipeline and the commercial outlook for ABECMA, we are pleased to welcome many new investors to our shareholder base. We believe you end up with the investors you deserve, and we have a shareholder base that has a common belief in our mission, an un-incremental, long-term orientation, and the ability to go deep on the science."

2seventy bio ended 2021 with cash, cash equivalents and marketable securities of $362.2 million. Combined with the company’s expectations for U.S. ABECMA commercial sales in 2022, a reduction in expected net cash spend for 2022 to a range of $190 to $220 million, and the net proceeds from the private placement, the company anticipates that it will have sufficient cash and cash equivalents to fund current planned operations into 2025. 2seventy bio anticipates that this runway will bring the company through meaningful clinical data updates, new INDs and continued progress in the commercialization of ABECMA.

Goldman Sachs & Co. LLC acted as exclusive placement agent. The shares of common stock described above are being sold in a private placement and have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. The company has agreed to file a resale registration statement with the Securities and Exchange Commission, for purposes of registering the resale of the shares of common stock issued in the offering.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the shares of common stock described above, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the shares or common stock described above under the resale registration statement will only be by means of a prospectus.

On March 16, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will host a conference call and webcast on Wednesday, March 23, 2022 at 5:00 p.m. (EDT) to discuss corporate developments and financial results for the fourth quarter ended December 31, 2021 (Press release, Navidea Biopharmaceuticals, MAR 16, 2022, View Source [SID1234610155]).

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Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

To participate in the call and webcast, please refer to the information below:

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On March 16, 2022 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that senior leadership plans to present at the following conferences in March (Press release, Iovance Biotherapeutics, MAR 16, 2022, View Source [SID1234610154]):

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Oppenheimer Healthcare Conference
Fireside Chat: March 16 at 12:40 p.m. ET
Barclays Global Healthcare Conference
Fireside Chat: March 17 at 10:45 a.m. ET
The live and archived webcasts will be available at View Source

On March 16, 2022 Seagen Inc. (Nasdaq:SGEN) and Sanofi reported an exclusive collaboration agreement to design, develop, and commercialize antibody-drug conjugates (ADCs) for up to three cancer targets (Press release, Seagen, MAR 16, 2022, View Source [SID1234610153]). The collaboration will utilize Sanofi’s proprietary monoclonal antibody (mAb) technology and Seagen’s proprietary ADC technology. ADCs are antibodies engineered to deliver potent anti-cancer drugs to tumor cells expressing a specific protein and Sanofi currently has one ADC in development.

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Clay Siegall, PhD
President and Chief Executive Officer, Seagen
"We are excited to be working with Sanofi, a global biopharmaceutical leader, to identify new ways to potentially address unmet medical needs of cancer patients. Jointly developing novel ADCs by combining antibodies from Sanofi with Seagen’s proprietary ADC technology, aligns with our strategic priorities to expand the global potential of our pipeline with new first- or best-in-class programs."

John Reed, M.D., Ph.D.
Global Head of Research and Development, Sanofi
"This collaboration will enable the synergistic combination of molecules and platforms to produce candidate medicines with the potential of bringing renewed hope to cancer patients and their families. We look forward to joining forces with Seagen to collaboratively design and develop promising medicines by advancing antibody-drug conjugate science."

Under the terms of the collaboration, Seagen and Sanofi will co-fund global development activities and share equally in any future profits. In addition, Sanofi will make an undisclosed payment to Seagen for each of the three targets as they are selected. The first target under the collaboration has already been designated.