Levena Biopharma, A Sorrento Company, Announces Positive Clinical Data for Its Out-Licensed A166 Product Candidate, A Third-Generation Anti-HER2-ADC, In Treating Heavily Pretreated HER2-Positive Breast Cancer Patients

On May 3, 2022 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported that its license and development partner, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun"), presented at this year’s Chinese Society of Clinical Oncology (CSCO) Guideline Conference (April 23-24, 2022) Phase 1 data for its anti-HER2-ADC, A166 (Press release, Sorrento Therapeutics, MAY 3, 2022, View Source [SID1234613406]). To generate this site-specific third generation ADC, Kelun partnered with Levena Biopharma, a Sorrento company, which provided the proprietary ADC technologies for the generation and production of A166, including (1) a proprietary small molecule toxin, Duostatin-5, a tubulin inhibitor, (2) K-Lock, a site-specific conjugation chemistry and (3) an enzymatically cleavable linker. Compared to Kadcyla, the first Antibody-Drug Conjugate approved for the treatment of HER2-positive metastatic breast cancer, A166 demonstrated potentially better efficacy, as shown in the overall response rate (ORR) of 73.9% with A166 at 4.8mg/kg versus Kadcyla, which had an ORR of 31.3%, as well as the progression-free survival (PFS) of 12.3 months with A166 versus 6 months with Kadcyla.

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Epizyme Announces Date of First Quarter 2022 Financial Results

On May 3, 2022 Epizyme, (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering transformative therapies for cancer patients against novel epigenetic targets, reported that management will host a conference call to discuss its first quarter 2022 financial results and provide a business update on Tuesday, May 10, 2022 at 8:30 a.m. ET (Press release, Epizyme, MAY 3, 2022, View Source [SID1234613423]).

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To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 5369344. A live webcast will be available in the investor section of the company’s website at www.epizyme.com, and will be archived for 60 days following the call.

Aura Biosciences Presents Preclinical Data Highlighting AU-011’s Anti-Tumor Activity in Choroidal Metastasis, an Additional Ocular Oncology Indication at the 2022 ARVO Annual Meeting

On May 3, 2022 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported the presentation of preclinical data for its first VDC product candidate, AU‑011 (Press release, Aura Biosciences, MAY 3, 2022, View Source [SID1234613440]). AU-011 is in development for the treatment of multiple ocular oncology indications, including primary choroidal melanoma and choroidal metastasis. The results presented today highlight AU-011’s targeted cytotoxicity towards tumor cells derived from the most common cancer types known to metastasize to the choroid. The results were presented as part of the 2022 Association of Research in Vision and Ophthalmology (ARVO) Annual Meeting taking place in Denver, CO on May 1 – 4 and virtually on May 11 – 12.

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"The data presented at ARVO demonstrates AU-011’s potent cytotoxicity in human cancer cell lines as well as in multiple in vivo tumor models including breast, renal and colon cancer which are well known to metastasize to the choroid," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. "These results support our commitment to build our ocular oncology franchise and provide a potential novel treatment for patients with cancers in the eye. We look forward to submitting the IND in choroidal metastases in the second half of this year."

In vitro potency was observed across a panel of human cancer cell lines. Cells were treated with AU-011 followed by light activation, and dose-dependent cell binding and cytotoxicity were noted. Addition of heparin to the binding studies prevented AU-011 association with the tumor cells demonstrating AU-011’s specific targeting of tumor associated heparan sulfate proteoglycans (HSPGs). Syngeneic murine models of breast, colon, and renal cancer were employed to evaluate AU-011’s anti-tumor activity in vivo and dose-dependent efficacy was observed across all models. The studies herein support further development of AU-011 for choroidal metastasis.

Details for the presentation are as follows:

Title: A first in class Virus-Like Drug Conjugate (VDC) shows anti-tumor activity in Cancers that Commonly Metastasize to the Choroid
Presentation Number: 2616
Presenter: Anneli Savinainen, Aura Biosciences
Session Title: Where art thou tumor? – Ocular tumor physiology and metastases
Date and time: Tuesday, May 3 at 3:00 – 3:17 PM ET
Location: 1AB Mile High Ballroom (Denver Convention Center)

The presentation can be accessed by visiting the "Scientific Presentations" section of "VDC Platform" page of the Aura Biosciences website.

Fresenius Kabi prolongs the production and supply contract with Cerus Corporation for an additional 10 years

On May 3, 2022 Fresenius Kabi and the U.S. based company Cerus Corporation reported that it signed a new agreement for the production of systems for pathogen inactivation in blood components (Press release, Fresenius, MAY 3, 2022, View Source [SID1234613391]). The collaboration will help expanding access to pathogen-reduced blood components to patients. For many years, Cerus and Fresenius Kabi have collaborated regarding medical products specializing in pathogen inactivation for platelets and plasma. Since market launch of Cerus’ INTERCEPT systems, more than 11 million units have been in use worldwide.

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Tubulis Closes €60 Million Series B Financing to Accelerate its ADC Pipeline and Expand its Breadth of Platform Technologies

On May 3, 2022 Tubulis reported the successful completion of a €60 million (USD $63 million) Series B financing led by Andera Partners with participation from new investors Evotec and Fund+ (Press release, Tubulis, MAY 3, 2022, View Source [SID1234613407]). All existing investors also participated in the round, including Bayern Kapital (with Wachstumsfonds Bayern 2), BioMedPartners, coparion, High-Tech Gründerfonds (HTGF), OCCIDENT and Seventure Partners. The new capital will be used to advance Tubulis’ proprietary pipeline of uniquely assembled antibody drug conjugates (ADCs), towards clinical evaluation as well as introduce programs addressing a range of solid tumor indications. The proceeds will enable the company to deliver the true therapeutic potential of ADCs through further innovation of novel payload classes and identification of new cancer targets.

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"This funding emphasizes that Tubulis is uniquely positioned to consolidate the findings of the last 20 years in the ADC field and translate this understanding into meaningful therapeutic benefits for patients. We have reached an important inflection point in the development of our platform technologies as well as our pipeline of highly novel protein-drug conjugates and we are now focused on unlocking new avenues in the treatment of solid tumors bringing safe and effective ADCs to patients," said Dominik Schumacher, PhD, CEO and co-founder of Tubulis. "With this capital in place, we will execute on our growth strategy, including important focus areas for our pipeline and for how we can apply our proprietary technologies, biologic insights and new mechanisms of action to enable the true therapeutic value inherent in targeted therapeutics."

In conjunction with the round, Sofia Ioannidou, PhD, Partner at Andera Partners, Thomas Hanke, PhD, EVP, Head of Academic Partnerships at Evotec as well as Jan Van den Bossche, Partner at Fund+ will join Tubulis’ Board of Directors consisting of Sebastian Pünzeler, PhD, Principal at coparion, Dominik Schumacher, PhD, CEO of Tubulis and Christian Grøndahl, MD, DVM, PhD, MBA, the Chairman of the Board. In addition, Valentin Piëch, PhD, Partner at BioMedPartners will take over the board seat from Michael Wacker, PhD, General Partner at BioMedPartners. Biographies for all board members can be found here.

"With its unique toolkit of proprietary technologies and its pipeline of differentiated ADC candidates, Tubulis holds a compelling position in the ADC field," stated Andera Partners’ Sofia Ioannidou, PhD. "We look forward to supporting this talented team in bringing innovative ADCs to patients and are confident that Tubulis has the potential to become a leader in the next era of ADC drug development."

Tubulis’ capability of creating a pipeline of antibody-drug conjugates is based on a diverse range of targeting molecules, novel payloads, and proprietary conjugation technologies. They enable the discovery of truly innovative ADCs that go beyond traditional payload classes and can increase antibody conjugation options via novel chemical groups leading to stable, high drug-to-antibody ratios. Tubulis has developed superior Topoisomerase-I linker-payloads with significantly improved pharmacokinetic properties and unique conjugation chemistry enabling access to a novel payload class that has been chemically challenging for conjugation in the past.

The company’s lead tumor-targeting assets build upon this technological breadth and are currently in preclinical development addressing several high unmet medical need indications. Tubulis’ pipeline also includes a program for hematological tumors, which is on the path towards IND-readiness. Tubulis remains focused on pairing novel payloads with disease-specific targets to tackle the five deadliest cancer indications globally.

Baker McKenzie (Julia Braun) served as counsel for new Series B investors and CMS (Stefan-Ulrich Müller) for Tubulis.