On September 21, 2020 Norbert Bischofberger’s Kronos Bio reported that it has filed to raise up to $100 million in a Nasdaq IPO (Press release, Kronos Bio, SEP 21, 2020, View Source [SID1234565544]). The IPO haul will set Kronos up to start a registrational phase 2/3 trial of a first-line acute myeloid leukemia (AML) drug licensed from Bischofberger’s former employer Gilead.

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Kronos set out in 2017 to use its small molecule microarray platform to identify targets on proteins that are impossible to drug using conventional methods. Last year, Kronos raised $105 million to take its lead assets through preclinical. Then, just months ago, Kronos accelerated its progress by picking up a portfolio of SYK inhibitors from Gilead led by clinical-phase cancer prospect entospletinib.

Gilead published data on the use of entospletinib in combination with induction chemotherapy in AML patients in 2018 but, with the cocktail delivering a complete response rate in line with historical results from standard of care, the big biotech never forged ahead into another study.

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Kronos sees an opportunity to deliver more impressive results by zeroing in on AML patients with NPM1 mutations. A retrospective analysis of 53 AML patients studied by Gilead found the complete response rate in patients with NPM1 mutation was 87%. The response rate in patients without any mutation was 54%.

The figures were generated in a retrospective analysis of small numbers of patients, raising the risk that they give a false impression of the efficacy of entospletinib in the genetic subpopulation. But the data are in line with Kronos’ preclinical hypothesis, emboldening it to move into phase 2/3.

Kronos plans to talk to regulators about the study in the first half of 2021 and begin the trial later in the year. If Kronos hits that timeline, it expects to have data from the registrational study in 2023.

The biotech needs money to bankroll the plan, including to make a $29 million payment to Gilead upon the initiation of the phase 2/3, and has turned to public investors for support. Kronos wants to raise enough money to fund its phase 2/3 and a planned phase 1/2 trial of CDK9 inhibitor KB-074 in advanced solid tumor patients. The phase 1/2 is due to start next year.

Kronos’ pipeline reflects its focus on transcriptional regulatory networks (TRNs), clusters of proteins that manage gene expression to control healthy cell development and function. TRNs can become dysregulated for reasons including aberrant transcription factor expression, leading to cancer cells. Kronos is set up to identify critical nodes in TRNs and, in doing so, find new ways to treat disease.

The availability of Gilead’s SYK inhibitors for licensing is enabling Kronos to accelerate the validation of its thinking. Kronos paid $3 million upfront in cash and issued a $3 million convertible promissory note to Gilead to secure the assets. Bigger payouts are to come, starting with the $29 million upon the initiation of the phase 2/3 and continuing through to up to $115 million in sales milestones.

On September 21, 2020 Samsung Biologics (207940.KS) and AstraZeneca reported a long-term supply agreement, valued at approximately $330.8 million (Press release, Samsung Bioepis, SEP 21, 2020, View Source [SID1234565505]). Under this agreement, Samsung Biologics will provide large-scale commercial manufacturing for drug substance in its Plant 3 as well as drug product to support AstraZeneca’s biologics therapeutics, which could be increased to $545.6 million.

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Strategic Manufacturing Partnership Ceremony between AstraZeneca and Samsung Biologics
By leveraging Samsung Biologics’ robust expertise and capabilities in the manufacturing of high-quality biopharmaceuticals, this new partnership will enable AstraZeneca to expand its biologics manufacturing capabilities into Asia Pacific. According to AstraZeneca, this collaboration agreement is also expected to accelerate Korean bio-health innovation.

Prior to this deal, a LOI signing event was held in June this year at Samsung Biologics’ headquarters in Incheon with executives of both companies, Samsung Biologics CEO Tae Han Kim and AstraZeneca Korea’s country president Juno Kim in attendance. Leif Johansson, Chairman of the Board and Ms. Margareta Ozolins Nordvall, Senior Vice President Supply APAC of AstraZeneca joined the event via a virtual meeting platform due to global travel restrictions amid COVID-19.

South Korean government officials, Mr. Jae Joon Kim, Director of Bio-Convergence Industry from Ministry of Trade, Industry, and Energy and Ms. Tae Gil Jung, Director of Division of Health Industry Promotion from Ministry of Health and Welfare also joined the signing event.

"This long-term partnership with Samsung Biologics strengthens our manufacturing capabilities, and ensures we are well-positioned to continue to deliver our exciting portfolio of new and established biologics medicines to patients with quality, speed and efficiency," said Pam Cheng, EVP Global Operations and IT, AstraZeneca.

"We are very proud to partner with AstraZeneca, a company that uses a rich history of science-led innovation to serve patients," said Dr. Tae Han Kim, CEO of Samsung Biologics. "At Samsung Biologics, our people share this common purpose to help our clients bring innovative solutions to an array of diseases, and we look forward to delivering on our promise to aid in AstraZeneca’s ongoing expansion program."

On September 21, 2020 Light Chain Bioscience reported that it has achieved two milestones and received corresponding payments under its research and collaboration agreement with the LamKap Bio Group, Pfäffikon, Switzerland (Press release, Light Chain Bioscience, SEP 21, 2020, View Source [SID1234565460]).

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The collaboration aims at developing bispecific antibodies capable of re-targeting T cells to tumor cells as well as blocking the immune checkpoint CD47 on the same tumors for the treatment of solid cancers. These milestones were achieved upon the successful completion of the discovery phase and designation by LamKap Bio of bispecific antibodies as clinical development candidates with approval to advance to IND-enabling studies and GMP manufacturing with its partner Lonza, Basel, Switzerland.

"It is very satisfying to have reached these first important milestones. This is the result of a truly collaborative effort. The successful identification of therapeutic bispecific antibody candidates harnessing different modes of action to kill tumor cells further validates our κλ body platform" said Nicolas Fischer, Light Chain Bioscience’s Chief Executive Officer. "We believe that the native human structure of these bispecific candidates represents a significant advantage for the treatment of patients."

On September 21, 2020 BioProtect ltd., a private company with a unique bioabsorbable polymer spacer balloon platform, reported the final closing of $25 million of its Series D equity financing from an unnamed strategic investor and Peregrine Ventures (Press release, BioProtect, SEP 21, 2020, View Source [SID1234565459]).

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These investors are joining the round led by Almeda Ventures and Vincent Tchenguiz, chairman of Consensus Business Group, a prominent private equity investor in Israel and the UK, with the participation of KB Investments of South Korea and Triventures.

Proceeds of the round will finance the ongoing multicenter FDA clinical trial of BioProtect’s lead product, the ProSpace balloon spacer, which protects prostate cancer patients undergoing radiation therapy, as well as the expansion of the technology platform.

Every year, more than 1.1 million men are diagnosed with prostate cancer worldwide and approximately 400,000 will undergo prostate radiotherapy. Historically prostate radiation therapy was limited by concerns over risk of rectal toxicity following radiotherapy.

The ProSpace balloon spacer helps reduction of radiation therapy risks by pushing the prostate away from adjacent organ at risk, the rectum. Once injected the spacer offers physicians a consistent gap of over 1.5cm, which is visible under trans rectal ultrasound as well as CT. The spacer remains stable during radiation therapy and is gradually absorbed after radiation therapy is completed.

BioProtect’s future pipeline represents a $4 billion opportunity, with additional applications for cervical cancer radiation therapy, pancreas radiation and general surgery. The versatility and physician appeal of a bioabsorbable polymer balloon spacer was further validated last year when a BioProtect spinout for musculoskeletal applications, Orthospace, was acquired by Stryker for a reported $220M.

Gil Rosen, CEO of BioProtect, stated on the round, "This financing will allow the company to complete the pivotal study, gain FDA approval, and accelerate development of the next indication to our platform."

On September 21, 2020 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company reported that it has been recognized as Best New Drug Developer at the World ADC Digital Awards, held during the World ADC Digital Event (Press release, Sutro Biopharma, SEP 21, 2020, View Source [SID1234565458]).

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"We are honored to receive the World ADC Best New Drug Developer Award," said Bill Newell, Sutro’s Chief Executive Officer. "The award recognizes our three innovative clinical development candidate ADCs. STRO-001 and STRO-002 are currently in Phase 1 clinical studies and CC-99712 is under investigation in a Phase 1b/2 clinical trial by our partner Bristol Myers Squibb. We are encouraged by our emerging and promising clinical data and the patient benefit that these product candidates may offer."

Our unique, rapid and precise protein engineering technology is focused on the design and manufacture of homogeneous potential best-in-class oncology therapeutics. In addition to the three clinical candidates, two more are projected to enter the clinic in 2021. "The presentation of this award to Sutro is particularly pleasing given that it represents recognition by some of the most talented professionals in the biopharmaceutical industry. It is a tribute to the innovation, commitment and contributions of our talented Sutro team," said Dr. Trevor Hallam, Sutro’s Chief Scientific Officer.

The World ADC Awards showcases companies, teams and individuals in the industry, across 9 categories, at the forefront of cancer research today. Finalists and winners were shortlisted from over 1,000 votes cast and each submission was evaluated by a panel of seven judges.