On January 11, 2023 Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") reported that following a review of safety data collected to date, the ACCENT clinical trial’s Safety Review Committee has approved dose escalation of AMP945 and recruitment of another patient cohort (Press release, Amplia Therapeutics, JAN 10, 2023, View Source;[email protected] [SID1234626160]).

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The first stage of the ACCENT trial is designed to identify the most suitable dose of AMP945 to combine with gemcitabine/nab-paclitaxel chemotherapy in patients with advanced pancreatic cancer. Accordingly, ascending doses of AMP945 are given in combination with standard gemcitabine/nabpaclitaxel chemotherapy while safety, pharmacokinetics and pharmacodynamics are monitored. Dose escalation of AMP945 will continue until either a dose-limiting safety signal is identified or the pharmacodynamic effect of AMP945 reaches a plateau. The Company expects that up to four cohorts of three patients may be required to identify the most suitable dose of AMP945.

Following completion of recruitment of the first cohort in late 2022, drug safety and tolerability was monitored for a minimum of one treatment cycle (28 days). The ACCENT trial’s Safety Review Committee has now examined the available safety, pharmacokinetic and pharmacodynamic data and concluded that dose escalation to a further cohort is warranted.

On January 10, 2023 Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, reported preliminary, unaudited financial results for the fourth quarter and year ended December 31, 2022 and an accelerated launch timeline for MACI arthroscopic delivery, which is now anticipated to be launched in 2024 (Press release, Vericel, JAN 10, 2023, View Source [SID1234626159]).

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Preliminary, Unaudited Fourth-Quarter and Full-Year 2022 Financial Results

Total net revenue for full-year 2022 expected to be approximately $164 to $165 million
MACI net revenue for full-year 2022 expected to be approximately $132 million
Burn Care net revenue for full-year 2022 expected to be approximately $32.5 million
Fourth quarter MACI revenue growth expected to be approximately 24% versus prior year
Expect tenth straight quarter with positive adjusted EBITDA and Operating Cash Flow
As of December 31, 2022, the Company had approximately $140 million in cash and investments and no debt

Recent Business Highlights and Updates

Following a Type C meeting with the FDA, the Company is planning to initiate a human factors validation study to support expanding the MACI label to include arthroscopic administration of MACI for the treatment of cartilage defects of the knee and now anticipates an accelerated potential commercial launch of arthroscopic MACI in 2024
Announced FDA approval of NexoBrid (anacaulase-bcdb) on December 28, 2022 for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns, with U.S. commercial availability expected in the second quarter of 2023
Expect to hold a pre-IND meeting with the FDA in the first half of 2023 to discuss the MACI development program for the treatment of cartilage defects in the ankle

"We made tremendous progress advancing our pipeline and expanding our business in 2022, highlighted by an accelerated regulatory pathway for the MACI arthroscopic delivery program and the recent approval of NexoBrid," said Nick Colangelo, President and CEO of Vericel. "We also had very strong MACI performance to close the year and we look forward to building on this momentum in 2023 across both of our franchises, as we expect accelerating total revenue growth this year and further acceleration in 2024 driven by a full year of NexoBrid on the market and the planned launch of arthroscopic MACI."

Vericel is scheduled to present at the 41st Annual J.P. Morgan Healthcare Conference at 10:30 a.m. ET (7:30 a.m. PT) on Wednesday, January 11, 2023. A webcast of the presentation will be available on the Investor Relations section of the Vericel Corporation website at: View Source

On January 10, 2023 We are proud to reported the acquisition of Oncolines, a Netherlands-based CRO that provides early biology services and cell-line profiling assays. Oncolines is Symeres’ third acquisition in the past ten months and will take group revenues to over €100m (Press release, Symeres, JAN 10, 2023, View Source [SID1234626157]).

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Oncolines, part of NTRC Holding, and based in Oss, the Netherlands, is a high-quality CRO that offers precision medicine services in the fields of oncology and immunotherapy. Their mission is to help clients bring improved and novel therapies to the right patient population, faster.

Clients are clinical and pre-clinical biopharma customers that seek to differentiate their drug candidates. The company offers cancer cell-line profiling assays through a panel of over 200 cell lines, combination studies to identify novel synergies and mechanistic cell biology.

The business employs approximately 20 people and will remain under management of the Founder and current Managing Director, Dr. Guido Zaman. Oncolines is located 25 km from Symeres HQ, further contributing to the seamless integration of its offering into Symeres’ portfolio.

This acquisition complements Symeres’ drug discovery capabilities with high-quality biology and biophysics capabilities in oncology. Symeres will extend Oncolines’ services across the broader Symeres platform, resulting in a more integrated offering to better service new and existing customers.

Dr. Guido Zaman, Managing Director of Oncolines, stated: "We are excited to be joining Symeres, a leading transatlantic drug discovery contract research, development and manufacturing organization with over 30 years of drug discovery and synthetic and medical chemistry expertise. Partnering our biology and cell-line profiling capabilities with Symeres’ larger scale in North America and Europe is a natural fit, both for our employees and customers."

Dr. Eelco Ebbers, Co-Founder and CEO of Symeres, stated: "We are delighted to welcome Oncolines into the Symeres Group. Working with Guido has been a rewarding experience and there is a clear cultural fit and alignment in strategic vision. The acquisition captures an exciting opportunity for Symeres in oncology and immunotherapy as well as personalized medicine."

On January 10, 2023 Sana Biotechnology presented its corporate presentation (Presentation, Sana Biotechnology, JAN 10, 2023, View Source [SID1234626156]).

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On January 10, 2023 Revolution medicine presented its corporate presentation (Presentation, Revolution Medicines, JAN 10, 2023, View Source [SID1234626154]).

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