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Transactions in connection with share buy-back program

On April 6, 2021 Genmab 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, APR 6, 2021, View Source [SID1234577602]).

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The share buy-back program is expected to be completed no later than June 30, 2021 and comprises up to 200,000 shares.

The following transactions were executed under the program from March 29, 2021 to March 31, 2021:

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

Following these transactions, Genmab holds 202,977 shares as treasury shares, corresponding to 0.31% 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. 11 dated February 23, 2021.

Volastra Therapeutics Extends Seed Financing to $44 Million to Advance Drug Discovery Programs to Prevent Cancer Metastasis

On April 6, 2021 Volastra Therapeutics, a biotechnology company developing novel therapies for the prevention and treatment of metastatic cancer, reported the extension of its original $12 million seed round to a total of $44 million (Press release, Volastra Therapeutics, APR 6, 2021, View Source [SID1234577601]). New investors Vida Ventures and Catalio Capital Management joined a syndicate that includes Polaris Partners, Droia Ventures, ARCH Venture Partners and Quark Venture.

The funding supports the further build-out of Volastra’s technology platform, which exploits unique insights into chromosomal instability (CIN) to rapidly identify and validate novel targets to block metastasis. In the U.S. alone, more than 350,000 people a year are diagnosed with metastatic cancer. Less than a third respond to targeted or immuno-therapies, making metastasis one of the most pressing unsolved challenges in cancer.

"The support of our new and existing investors reflects the increasing interest around CIN as a core driver in cancer biology," said Charles Hugh-Jones, M.D., Volastra’s Chief Executive Officer. "This latest financing places us in a position of strength to advance our bold vision to change the treatment paradigm for patients with metastatic cancers."

"Our initial investment in Volastra reflected our excitement about the potential of this novel approach to address an unmet need in oncology," said Amy Schulman, Volastra Director and Managing Partner, Polaris. "With this seed extension, we are delighted to expand our syndicate with Vida Ventures and Catalio Capital Management, who share our commitment to identifying and funding innovation that has the potential to have a meaningful impact for patients."

Volastra’s scientific founders were the first to identify CIN as a key driver of metastatic cancer. The company is developing proprietary computational and experimental approaches to understand CIN biology and drive drug discovery. Among Volastra’s tools is a proprietary technology suite to bulk-measure and exploit vulnerabilities in chromosomally unstable cancer cells.

"Volastra’s approach is focused on defining and treating the biology of metastasis," said Lewis Cantley, Ph.D., Professor of Cancer Biology in Medicine and Meyer Director of the Sandra and Edward Meyer Cancer Center, Weill Cornell Medical College. "In just over a year, the Volastra team has shepherded this science into the next stage of development, building technologies to identify CIN at scale and developing novel compounds to block metastasis. By leveraging these unique insights into CIN, we are one step closer to unlocking new therapeutic options for some of the toughest-to-treat solid tumors."

Volastra recently announced a partnership with Dewpoint Therapeutics to discover novel molecules capable of blocking immuno-suppressive signaling in CIN-high tumors. In addition, Volastra announced a collaboration with Microsoft to develop proprietary artificial intelligence algorithms to detect and predict metastatic potential in human tissue samples

Study reported in BMC Gastroenterology shows significantly better performance characteristics of Epigenomics’ liver cancer panel compared to the current standard of care for the early detection of HCC

On April 6, 2021 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported that a study recently published in BMC Gastroenterology shows that the Epigenomics new liver cancer panel represents a new and valuable alternative for the early detection of hepatocellular carcinoma (liver cancer, HCC) in cirrhotic patients (Press release, Epigenomics, APR 6, 2021, View Source [SID1234577597]).

Greg Hamilton, CEO of Epigenomics AG, commented: "HCC is in the top 10 of most common cancers in both men and women worldwide, occurring in approximately 4.5 million U.S. adults. In addition, HCC is considered the second leading cause of cancer-related deaths world-wide with more than 780,000 deaths annually. However, early detection offers a good chance of curative treatment. The performance of the currently recommended surveillance methods, however, are suboptimal, as are the low participation rates in surveillance. In this respect, we are very pleased with the results of the study, as it demonstrates that our liver cancer panel can address the significant clinical need for novel minimally invasive testing to aid in the detection of HCC at an early stage, and thus save lives."

The study compared patients with cirrhosis who had early-stage treatable liver cancer with patients having cirrhosis but no cancer. As reported in the study, when combined with AFP (alpha-fetoprotein) measurement in an ad hoc analysis, the new Epigenomics Next Generation Sequencing (NGS) panel achieved a sensitivity of 68 % at a specificity of 97 %.

The current standard of care for HCC surveillance is ultrasound plus AFP with a sensitivity of 63% and a specificity of 84%. Consequently, the Epigenomics’ blood-based panel provides a very simple and affordable method that may improve clinical performance and could be particularly applicable in settings where resources for surveillance by imaging may be limited. Such a blood test can help detect HCC at an early stage and thus prevent cancer-related deaths, because after all, patients’ chances of survival decrease rapidly if the disease is detected late.

Outpace Bio raises $30 Million to design next generation cell therapies

On April 5, 2021 Outpace Bio, a spinout from Lyell Immunopharma, reported that the company has landed $30 million in Series A funding to design new proteins that solve problems in cell therapies (Press release, Outpace Bio, APR 5, 2021, View Source [SID1234637777]). Lyell’s focus is developing new T cell therapies to fight cancer. To get started, Outpace is collaborating with Lyell to develop molecular controls for T cells that could refine and strengthen targeted cell therapies. Beyond that, the company plans to establish a series of partnerships to develop a variety of next-generation cell therapies

Outpace co-founders Marc Lajoie and Scott Boyken both trained in the Baker lab at the Institute for Protein Design at the University of Washington, which specializes in "de novo protein design." Rather than finding proteins that already exist and then trying to customize them, de novo protein design means building completely original proteins from basic building blocks, using advanced computer algorithms to predict the created protein’s final 3D shape.

Legend Biotech, J&J finish off rolling submission for CAR-T hopeful, approach finish line

On April 5, 2021 China’s Legend Biotech and Janssen reported that they have finished off the rolling submission to the FDA for their partnered cell therapy hopeful cilta-cel (Press release, Legend Biotech, APR 5, 2021, View Source [SID1234577717]).

The closely watched asset, the star of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s meeting a few years’ back, saw Johnson & Johnson’s U.S. submission for adults with relapsed and/or refractory multiple myeloma completed in the first quarter, according to a new form filed with the Securities and Exchange Commission from Legend.

Analysts at Jefferies said this is a "critical first step" toward nabbing an approval for the therapy by year-end. There’s another two months for the biologics license application to be accepted and then, if its nabs a priority review, another six months for approval, meaning it could be given the green light toward the end of 2021, for which it has been previously guided.

This comes just a few weeks after Bristol Myers Squibb and partner bluebird bio nabbed an approval for Abecma—formerly known as idecabtagene vicleucel, or ide-cel—to treat adults whose multiple myeloma has progressed after at least four previous rounds of treatment.

The March approval was the first CAR-T med approved in multiple myeloma and the first CAR-T in the B-cell maturation antigen-targeted class. J&J and Legend are now hoping to be close behind.

In recent data out late last year at the annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), the pair unveiled the first phase 2 readout for its prospect, which banished multiple myeloma in two-thirds of patients and shrank tumors in 97% of patients.

RELATED: ASH (Free ASH Whitepaper): J&J, Legend’s anti-BCMA CAR-T keeps it consistent in phase 2 as FDA filing looms

The data, presented virtually at ASH (Free ASH Whitepaper)’s annual meeting in December, came from 97 patients whose cancer had returned after a median of six prior treatments or had not responded to treatment in the first place.

The investigators followed the patients for a median of one year after treatment. J&J’s Janssen unit previously reported data from 29 patients from the phase 1b part of the trial, showing the treatment—ciltacabtagene autoleucel, or cilta-cel—eliminated tumors in 86% of patients and shrank tumors in all 29 of them for a 100% overall response rate.

Jefferies said in a note to clients that, while the duo won’t be first, "We think round 8-9 months difference in the timing of market arrival does not offer much first mover advantage for [BMS/bluebird bio’s] ide-cel given its inferior clinical profile to cilta-cel."