On July 11, 2022 Overland ADCT BioPharma, a joint venture created by Overland Pharmaceuticals ("Overland") and ADC Therapeutics SA (NYSE: ADCT), reported the first patient has been dosed in China with ZYNLONTA in combination with rituximab compared to standard immunochemotherapy in the LOTIS-5 confirmatory Phase 3 global clinical trial in second-line or later, transplant ineligible patients with diffuse large B-cell lymphoma (DLBCL) (Press release, ADC Therapeutics, JUL 11, 2022, View Source [SID1234616579]).

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In April 2021, ZYNLONTA was granted accelerated approval by the U.S. Food and Drug Administration (FDA) as the first and only CD19-targeted antibody drug conjugate (ADC) as a single-agent treatment for adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy. The joint venture has now joined the LOTIS-5 global confirmatory Phase 3 clinical trial of ZYNLONTA, which is intended to support a supplemental Biologics License Application (sBLA) for ZYNLONTA in the U.S. and China in second-line, transplant-ineligible patients.

ZYNLONTA, Overland ADCT BioPharma’s lead product candidate, is an ADC composed of a humanized monoclonal antibody directed against human CD19 and conjugated to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. In clinical trials, ZYNLONTA has demonstrated significant single-agent clinical activity across a broad population of patients with r/r DLBCL, mantle cell lymphoma and follicular lymphoma.

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

On July 11, 2022 Innoviva, Inc. (Nasdaq: INVA), a diversified holding company with a portfolio of royalties and a growing portfolio of innovative healthcare assets, and La Jolla Pharmaceutical Company (Nasdaq: LJPC), which is dedicated to the commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases, reported that they have entered into a definitive merger agreement whereby Innoviva will acquire La Jolla (Press release, La Jolla Pharmaceutical, JUL 11, 2022, View Source [SID1234616577]). Innoviva has agreed to pay $5.95 per share for La Jolla, representing a premium of approximately 70% to the 30-day volume-weighted average price (VWAP), and an incremental $0.28 per share for additional cash proceeds received in connection with the divestiture of a non-core asset. Under the terms of the merger agreement, Innoviva, through a wholly owned subsidiary, will commence a tender offer on or before July 25, 2022 to acquire all of the outstanding shares of La Jolla for $6.23 per share in cash, or an implied enterprise value of approximately $149 million.

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La Jolla’s lead product, GIAPREZA (angiotensin II), was approved by the Food and Drug Administration (FDA) in December 2017 to increase blood pressure in adults with septic or other distributive shock. La Jolla’s second asset, XERAVA (eravacycline), was approved by the FDA in August 2018 for the treatment of complicated intra-abdominal infections (cIAIs) in patients 18 years of age and older. This acquisition strengthens Innoviva’s portfolio in infectious diseases, anchored by the company’s recent purchase of Entasis Therapeutics Holdings Inc., an advanced late-stage clinical biopharmaceutical company focused on the discovery and development of novel antibacterial products.

"This acquisition represents a significant step forward in advancing our strategy to diversify operations and adds a highly complementary commercial franchise to our portfolio to accelerate long-term growth," said Pavel Raifeld, Chief Executive Officer of Innoviva. "We look forward to welcoming the La Jolla team to Innoviva and building upon the success of GIAPREZA and XERAVA."

"We are pleased to announce the acquisition of La Jolla by Innoviva, which we believe provides our stockholders with immediate value at a compelling premium," said Larry Edwards, President and Chief Executive Officer of La Jolla. "With Innoviva’s shared commitment to improve outcomes in patients suffering from life-threatening diseases, Innoviva can continue to advance our mission and maximize the potential of our innovative therapies."

Assuming the minimum tender condition is met, any shares not tendered in the tender offer will be acquired in a second-step merger at the same cash price as paid in the tender offer. Closing of the transaction is subject to specified closing conditions, including that a majority of La Jolla’s shares of common stock are validly tendered and not validly withdrawn. On closing, La Jolla will become a wholly owned subsidiary of Innoviva, and shares of La Jolla’s common stock will no longer be listed on any public market.

The transaction was unanimously approved by the La Jolla and Innoviva boards of directors and is expected to close within 30 business days. Additionally, certain La Jolla stockholders holding approximately 40% of La Jolla’s outstanding shares of common stock, have signed a support agreement under which such stockholders agreed, among other things, to tender their shares in the tender offer and support the merger.

Cowen and Company, LLC is acting as financial advisor to La Jolla and Gibson, Dunn & Crutcher LLP is acting as its legal advisor. Moelis & Company LLC is acting as financial advisor to Innoviva and Willkie Farr & Gallagher LLP is acting as legal advisor to Innoviva.

On July 11, 2022 Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule therapeutics, reported that it has raised $50 million in a Series D financing round, co-led by new investors Sands Capital and Vivo Capital, with additional participation from new investor Dreavent 6 (Press release, Inspirna, JUL 11, 2022, View Source [SID1234616576]). Existing investors also participated in the financing round including Novo Holdings A/S, Sofinnova Partners, Sixty Degree Capital Fund, New York City Investment Fund LLC, Lepu Holdings, and additional investors. In addition, Michael Ginder, of Sands Capital, and Jack Nielsen, of Vivo Capital, will join Inspirna’s Board of Directors.

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Proceeds from the financing will support the clinical development of Inspirna’s lead drug candidate RGX-202-01 ("RGX-202"), a first-in-class oral small molecule inhibitor of SLC6a8 to treat RAS mutant advanced colorectal cancer (CRC), and RGX-104, an oral small molecule activator of LXR/APOE to treat lung cancer and endometrial cancer. The financing will provide the company with the funds necessary to further evaluate efficacy and safety for RGX-202 in second-line RAS mutant CRC in an ongoing Phase 1b clinical trial, for which the company recently disclosed interim data in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

"I would like to thank both our new and existing investors for the confidence they continue to demonstrate in the potential of our unique drug candidates to make a profound impact on patients in the clinic," said Masoud Tavazoie, MD, PhD, and Chief Executive Officer and co-founder of Inspirna. "We are currently evaluating RGX-202 and RGX-104 in clinical trials in high unmet medical need settings and, with renewed support from our investors, are now well-positioned to further build on the promising efficacy signals and safety profiles for these drug candidates."

On June 11, 2022 Genmab A/S (Nasdaq: GMAB) reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, JUL 11, 2022, View Source [SID1234616575]).

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The share buy-back program is expected to be completed no later than August 31, 2022 and comprises up to 370,000 shares.

The following transactions were executed under the program from July 4, 2022 to July 8, 2022:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 380,883 shares as treasury shares, corresponding to 0.58% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 22 dated June 17, 2022.

On July 11, 2022 Redx (AIM: REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that it will be presenting at the Proactive One2One Virtual Investor Forum on Thursday 14 July 2022 (Press release, Redx Pharma, JUL 11, 2022, View Source [SID1234616574]). The webinar event will begin at 18:00 BST and investors can register to attend here: View Source There will also be the opportunity for investors to ask questions during the event.

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Lisa Anson, Chief Executive Officer of Redx, will be presenting an overview of the Company following the recent successful fundraise of £34.3m and strong progress reported at the time of the Company’s Interim Financial Results in June. This included the acceptance of the Investigational New Drug (IND) submission for JZP815, a pan-RAF inhibitor from the Company’s partnership with Jazz Pharmaceuticals. JZP815 is the fifth molecule from the Redx Discovery Engine to enter the clinical stage of development, highlighting the strength of Redx’s worldclass medicinal chemistry expertise and drug discovery capabilities. The presentation will also include updates on the clinical programmes for Redx