On August 25, 2022 Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that initial data from the Phase 3 study of its drug candidate rivoceranib combined with camrelizumab versus sorafenib as a first-line therapy for unresectable hepatocellular carcinoma(uHCC) was accepted for a late-breaking proffered paper presentation at the annual Congress of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) on September 10, 2022 in Paris (Press release, Elevar Therapeutics, AUG 25, 2022, View Source [SID1234618654]).

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Details of the presentation are as follows:

Title: Camrelizumab (C) plus rivoceranib (R) vs. sorafenib (S) as first-line therapy for unresectable hepatocellular carcinoma (uHCC): a randomized, phase Ⅲ trial

Presenter: Shukui Qin, M.D., Ph.D., professor and chief physician of the Cancer Center of Jinling Hospital, Nanjing University of Chinese Medicine

Event, Date, Time and Location: ESMO (Free ESMO Whitepaper),Saturday, Sept. 10, 8:40 a.m. – 8:50 a.m. CEST, 7.1.C – Cannes Auditorium

Session: Proffered Paper Session 1: GI, upper digestive

Presentation Number: LBA35

About Rivoceranib

Rivoceranib is the first small-molecule tyrosine kinase inhibitor (TKI) to be approved in gastric cancer in China (December 2014). Rivoceranib is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression. Rivoceranib is co-developed by Jiangsu Hengrui Pharmaceuticals Co., Ltd. (JHP) in China and by Elevar Therapeutics, Inc. globally (excluding China). It has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Clinical studies are ongoing in multiple solid tumor types including gastric cancer (as a monotherapy and in combination with paclitaxel), hepatocellular carcinoma (HCC) (in combination with camrelizumab), adenoid cystic carcinoma (as monotherapy) and colorectal cancer (in combination with Lonsurf). Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in HCC (U.S.). Elevar holds the global rights (excluding China) and has partnered for the development and marketing of rivoceranib with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is currently approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, JHP, under the brand name Aitan.

On August 25, 2022 Century Therapeutics, Inc., (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, reported that the company has been notified by the U.S. Food and Drug Administration (FDA) that the Company’s ELiPSE-1 clinical study may proceed to assess CNTY-101 in patients with relapsed or refractory CD19 positive B-cell malignancies (Press release, Century Therapeutics, AUG 25, 2022, View Source [SID1234618653]). CNTY-101 is the first allogeneic cell therapy product candidate engineered with four powerful and complementary functionalities, including a CD19 CAR for tumor targeting, IL-15 support for enhanced persistence, Allo-EvasionTM technology to prevent host rejection and enhance persistence and a safety switch to provide the option to eliminate the drug product if ever necessary. CNTY-101 is manufactured from a clonal iPSC master cell bank that yields homogeneous product, in which all infused cells have the intended modifications.

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"This IND clearance is a significant milestone for Century as we execute on our vision to merge two disruptive platforms, precision gene editing and the powerful potential of iPSCs, to potentially move the allogeneic cell therapy field forward, and continue on our path to becoming a leader in the space," said Lalo Flores, Chief Executive Officer, Century Therapeutics. "We believe that CNTY-101, our first and wholly owned product candidate, will be the most technically advanced and differentiated CD19-targeted cell product when it enters the clinic, which is anticipated to occur later this year. We look forward to assessing the potential of Allo-EvasionTM to prevent immunological rejection and enhance persistence of multiple dosing of CNTY-101 regimens with the aim to increase the proportion of patients that achieve durable responses."

"CNTY-101 is the first allogeneic cell product candidate with six genetic modifications incorporated using sequential rounds of CRISPR-mediated homologous recombination and repair that has received IND clearance by the FDA," said Luis Borges, Chief Scientific Officer, Century Therapeutics. "We believe CNTY-101 will demonstrate the power of Century’s iPSC technology and cell engineering technology platforms. This accomplishment is a testament to the expertise and dedication of our team as we continue to make progress developing our pipeline of iPSC-derived NK and T cell product candidates."

The Phase 1 trial, ELiPSE-1 (NCT05336409), is intended to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CNTY-101 in patients with relapsed or refractory CD19-positive B-cell malignancies. All patients will receive an initial standard dose of conditioning chemotherapy consisting of cyclophosphamide (300 mg/m2) and fludarabine (30mg/m2) for 3 days. Schedule A of the trial includes a single-dose escalation of CNTY-101 and subcutaneous IL-2. Schedule B will evaluate a three-dose schedule per cycle of CNTY-101. Patients who demonstrate a clinical benefit are eligible for additional cycles of treatment with or without additional lymphodepletion pending FDA consent. We anticipate initiation of the Phase 1 trial later this year.

About Allo-EvasionTM

Century’s proprietary Allo-EvasionTM technology is used to engineer cell therapy product candidates with the potential to evade identification by the host immune system so they can be dosed multiple times without rejection, enabling increased persistence of the cells during the treatment period and potentially leading to deeper and more durable responses. More specifically, Allo-EvasionTM 1.0 technology incorporates three gene edits designed to avoid recognition by patient/host CD8+ T cells, CD4+ T cells and NK cells. Knockout of beta-2-microglobulin or β2m, designed to prevent CD8+ T cell recognition, knock-out of the Class II Major Histocompatibility Complex Transactivator, or CIITA, designed to prevent CD4+ T cell recognition, and knock-in of the HLA-E gene, designed to enable higher expression of the HLA-E protein to prevent killing of CNTY-101 cells by host NK cells. Allo-EvasionTM technology may allow the implementation of more flexible and effective repeat dosing protocols for off-the-shelf product candidates.

About CNTY-101

CNTY-101 is an investigational off-the-shelf cancer immunotherapy product candidate that utilizes iPSC-derived natural killer (NK) cells with a CD19-directed chimeric antigen receptor (CAR) and includes Century’s core Allo-EvasionTM edits designed to overcome the three major pathways of host versus graft rejection – CD8+ T cells, CD4+ T cells and NK cells. In addition, the product candidate is engineered to express IL-15 to provide homeostatic cytokine support, which has been shown pre-clinically to improve functionality and persistence. Further, to potentially improve safety, the iNK cells were engineered with an EGFR safety switch, and proof-of-concept studies have demonstrated that the cells can be quickly eliminated by the administration of cetuximab, an antibody against EGFR approved by the U.S. Food and Drug Administration (FDA) for certain cancers. Initiation of the Phase 1, ELiPSE-1 trial in relapsed or refractory CD19-positive B-cell malignancies in multiple centers in the United States is anticipated to begin in the second half of 2022.

On August 25, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that the Company expands its clinical and commercial manufacturing platform for small molecule therapeutics by acquiring Central Glass Germany GmbH from the Japanese chemical manufacturing company Central Glass Co. Ltd (Press release, Evotec, AUG 25, 2022, View Source [SID1234618650]).

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Going forward, Central Glass Germany GmbH will operate as Evotec Drug Substance (Germany) GmbH ("Evotec DS"). The Company is located on a pharmaceutical manufacturing campus in Halle/Westphalia, Germany and is operating with a team of ~60 chemical manufacturing experts. The facility is EU cGMP certified and provides highly flexible drug substance manufacturing space with over 5,000 square meters of floor space.

The acquisition of the Central Glass site in Germany enhances and accelerates Evotec’s strategy of pursuing integrated discovery and development of new medicines that matter. The significant reactor capacity and long-standing chemical expertise brought in by Evotec DS provide a high quality, European-based solution to Evotec’s partners for the development and commercialisation of drug substance. Once integrated into Evotec’s existing drug substance development and manufacturing platform, the new site will offer the Company’s partners highly flexible product lifecycle management strategies, particularly in the field of precision medicines and in rare diseases.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "Our understanding of diseases continuously grows in depth – and with it the number of rare diseases that we can meaningfully distinguish and target with precision medicine. Evotec DS reinforces our commitment to rare diseases by integrating the manufacturing of such drugs into the drug discovery and development continuum. We very warmly welcome the team into the Evotec family and are excited to leverage their skills and expertise for our partners."

The contract was signed on 24 August at a purchase price of € 1. The transaction is subject to customary closing conditions and is anticipated to close on 1 November 2022. Evotec intends to invest meaningfully in the coming years to establish the facility as a leading European centre of excellence for rare disease drug substance manufacturing. Earnings accretion is expected to be achieved by 2023/24.

On August 25, 2022 Vivesto AB reported that Interim report for the period January 1, 2022 – June 30, 2022 (Press release, Vivesto, AUG 25, 2022, View Source [SID1234618649]).

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SIGNIFICANT EVENTS DURING THE SECOND QUARTER
In April Daniel Tesfa was appointed Chief Medical Officer.
In April Vivesto signed an agreement with leading US CRO Visikol Inc. to evaluate anti-cancer drug formulations using, among other things, its proprietary drug delivery platforms.
In May the Annual General Meeting resolved on re-election of Hege Hellström and Peter Zonabend as well as new election of Pål Ryfors and Roger Tell as members of the Board of Directors. Anders Härfstrand, Andrea Buscaglia and Birgit Stattin Norinder had declined re-election. Peter Zonabend was elected as Chairman of the Board.
In June Vivesto announced that the Board of Directors of the company had agreed with the company’s CEO, Francois Martelet, to mutually terminate his employment as of 21 July 2022.
In June Robert Maiorana was appointed acting CFO, with effect from July 1, 2022.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
In August, Vivesto’s and Elevar’s partner Inceptua began the commercial launch of Apealea in Germany.
In July Vivesto announced that the company has decided to wind down its activities in Russia following the Russian invasion of Ukraine, ongoing hostilities and international sanctions. The wind down of Vivesto’s activities in Russia means that a write down of SEK 44.6 million is carried out during the third quarter of 2022, equal to the net book value of the capitalized development costs for Paclical after amortization as of June 30, 2022.
In July Christer Nordstedt was appointed acting CEO. Christer Nordstedt will hold the position until the recruitment of a permanent CEO is completed.
SECOND QUARTER: APRIL 1, 2022 – JUNE 30, 2022
Consolidated net sales amounted to TSEK 0 (4,596)
Operating profit/loss was TSEK -36,323 (-56,165)
Net profit/loss after tax amounted to TSEK -38,514 (-57,677)
Earnings per share amounted to SEK -0.07 (-0.12)
THE PERIOD: JANUARY 1, 2022 – JUNE 30, 2022
Consolidated net sales amounted to TSEK 0 (4,633)
Operating profit/loss was TSEK -62,652 (-97,007)
Net profit/loss after tax amounted to TSEK -64,971 (-98,886)
Earnings per share amounted to SEK -0.13 (-0.22)
Short-term investments, cash and cash equivalents amounted to TSEK 188,828 (176,302)
Equity/assets ratio was 95% (77%)
CEO REVIEW
It is an honor to have taken up the role of acting CEO here at Vivesto in mid-July. As a Doctor and scientist I am proud and glad to be leading a company that is focused on developing medicines for hard-to-treat cancers where there remains such a high unmet medical need. My first few weeks in the role have been highly engaging and I’ve really enjoyed getting to know the Vivesto team and doing a deep dive into each of our development programs. As acting CEO I aim to lead Vivesto to the best of my ability until a permanent replacement is appointed. The last quarter has been a time of change for Vivesto with new recruits and appointments among the senior leadership team.
Daniel Tesfa M.D. Ph.D., our new Chief Medical Officer joined the business in early July and he is responsible for leading the clinical development of our oncology programs. Daniel brings extensive experience in clinical development and precision oncology, most recently, from Swedish biopharmaceutical company SOBI (Swedish Orphan Biovitrum AB), where he led clinical development. Daniel has already made a positive impact and is working very closely with our Chief Scientific Officer, Reinhard Koenig, M.D. PH.D. Robert Maiorana was appointed to the role of acting Chief Financial Officer from 1 July. Robert has worked at Vivesto since the second half of 2020 and as Finance Manager since March 2021 and is thus well familiar with the business and the company. The search for a permanent Chief Financial Officer is ongoing.
The financial markets for listed biotech companies have been challenging during last quarter with increasing concerns about the impact of rising inflation and the resulting cost to business. Geopolitical tensions have also added to business uncertainty. In early July, Vivesto announced that, like most other companies, we have decided to wind down operations in Russia as a result of Russia’s invasion of Ukraine. This meant that distribution activities for Paclical (Apealea) in Russia and the Commonwealth of Independent States (CIS) have been paused until further notice. The challenging macroeconomic environment and geopolitical tensions in eastern Europe are beyond Vivesto’s control, but today we are in a resilient position as we are well capitalized following the rights issue earlier this year and we hold no debt.
We remain focused on adding value by developing new cancer medicines and and new treatment options. Preparations for the next clinical study of Cantrixil for metastatic ovarian cancer are ongoing. Docetaxel micellar is being evaluated in a Phase I investigator-initiated trial in metastatic prostate cancer instigated by the Swiss Group for Clinical Cancer Research (SAKK). Recruitment is progressing steadily and we look forward to the completion.
We have been in regular contact with our global strategic partner Elevar over the last quarter. Inceptua, Elevar’s distribution partner in Europe, continues to work on the launch of Apealea. In August, Inceptua announced the launch of Apealea in Germany. This is an important milestone as Germany is the first major global market where Apealea has been commercially launched. In the UK Inceptua is interacting with National Health Service (NHS) to secure reimbursement for Apealea. Until now Inceptua has secured a maximum list price for Apealea allowing private market access to the drug. The launches in Europe are out of our direct control and we continue to give our full support to Elevar and Inceptua to maximize the chances of success when the launch of Apealea proceeds on a country-by-country basis over the next couple of years.
In April we announced that we had signed a research agreement with Visikol Inc., a prominent U.S. contract research services provider, for Visikol to evaluate, among other things, the cellular effects of new and existing anti-cancer drug formulations developed using Vivesto’s XR-17 and XR-18 technologies. This will allow us to select promising developmental drug candidates and further expand our current and future oncology pipeline focused on hard-to-treat and late-stage cancers. I look forward to sharing more information with you in due course when it is appropriate to do so.
Many thanks for your continued support.

Christer Nordstedt, acting CEO of Vivesto

The report is available on the company’s website: View Source

Invitation to presentation of Vivesto’s Q2 report
Vivesto will hold a conference call and an online presentation of the Q2 report on August 25, 2022, at 10.00 am CEST. The call will be hosted by Acting CEO Christer Nordstedt and Acting CFO Robert Maiorana. The presentation will be in English and followed by a question-and-answer session. The conference call will be broadcast live on the web via the link:
View Source

On August 25, 2022 Evogene Ltd. (Nasdaq: EVGN, TASE: EVGN) (the "Company", "Evogene"), a leading computational biology company targeting to revolutionize life-science product discovery and development across multiple market segments, reported the receipt of a formal notification from The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with Listing Rule 5450(a)(1), which requires the Company’s ordinary shares to maintain a minimum bid price of $1.00 per share (Press release, Evogene, AUG 25, 2022, View Source [SID1234618647]).

The Nasdaq staff made this determination of compliance after the closing bid price of the Company’s ordinary shares was at $1.00 per share or greater for the prior 10 consecutive business days. Accordingly, the Company has regained compliance with Nasdaq Listing Rule 5450(a)(1) and Nasdaq considers the prior bid price deficiency matter now closed.

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