Engitix Announces $54m Series A Financing and a Strategic Collaboration with Dompé Farmaceutici Using Exscalate’s AI Supercomputing Power to Advance its Drug Discovery Pipeline in Fibrosis and Cancer

On January 19, 2022 Engitix Ltd (‘Engitix’), a biopharmaceutical company with a pioneering and proprietary human extracellular matrix (ECM) drug target discovery platform reported the close of its $54m Series A financing as well as a strategic collaboration with Dompé farmaceutici S.P.A ("Dompé") (Press release, Engitix, JAN 19, 2022, View Source [SID1234605561]).

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The round was co-led by existing investor Netherton Investments, a fund investing on behalf of Mike Platt, and included new investor Dompé, an Italian and US-based biopharmaceutical company. Following the financing, Mike Platt, the highly successful fund manager and co-founder and Managing Director of BlueCrest Capital Management and Gianluca Rossetti, Corporate Business Development Director at Dompé, have joined Engitix’s board of directors.

The agreement with Dompé, a biopharmaceutical company with next-generation chemo- and bioinformatic tools and an AI-driven drug discovery platform to deliver precision engineered medicines, includes both equity investment and a multi-year, multi-programme strategic R&D collaboration to support identification of new treatments against fibrosis and liver-associated solid tumours.

Engitix has established a portfolio of internal programmes in primary sclerosing cholangitis (PSC), adenocarcinoma (PDAC) and liver metastasis, and hepatocellular carcinoma (HCC), as well as partnered drug discovery programmes in fibrosis and solid tumours using its ECM platform.

Dompé will provide direct access to facilities, resources and expertise including its Exscalate structure-based drug design platform that exploits the capabilities of the Italian supercomputer center, CINECA, to accelerate its own drug discovery and development. The deal is ground-breaking as Engitix retains full control over its assets and programmes enabling it to transition from a technology platform to a biopharmaceutical product company, with Dompé being an important shareholder and eligible for clinical and commercial milestones and royalties on marketed products developed under the collaboration.

Marcello Allegretti, CSO of Dompé said, "Our mission is to improve people’s lives and we partner with the best academic and industrial groups to accelerate the research that will bring new solutions to patients’ unmet needs. We look forward to working with the Engitix team to combine the power of Exscalate with Engitix’s deep understanding of the biology of the fibrosis and solid tumours microenvironment and the unique strength of its ECM platform. Our collaboration will enable us to accelerate the clinical translation of targets beyond our four key in-house therapeutic areas of ophthalmology, metabolic disorders, oncology, and pain management."

The financing will be used to invest in Engitix’s internal drug discovery pipeline through IND-enabling studies, expand its ECM discovery platform and bioinformatics capabilities into new therapeutic areas, and to expand its team, facilities and operations.

Alongside its internal pipeline, Engitix will seek to expand its pharma and biotech collaborations. It has an exclusive license agreement with Takeda in Non-Alcoholic SteatoHepatitis (NASH) and liver fibrosis worth more than $500m biodollars, and a previous partnership with Morphic Therapeutics in inflammatory bowel disease (IBD).

Dr Giuseppe Mazza co-founder and CEO of Engitix said, "This financing and new partnership with Dompé enables us to continue our evolution from a platform to multi-asset mutli-programmes pre-clinical stage company and to continue to prove the value of our human ECM platform. We are pleased to have the continued backing of Mike Platt, and to have secured the support of Dompé as a partner and investor. This round will enable us to advance our pre-clinical programmes against targets identified using our ECM platform through candidate selection and IND-enabling studies."

Mike Platt said, "I am prepared to take a risk and invest in innovative technology early, backing highly passionate teams with strong leadership. Having invested from the start, Engitix’s progress and achievements within less than two years from its seed financing have been impressive. The value of Engitix’s platform has been proven through the partnerships it has established and the pipeline of opportunities it has built. The collaboration with Dompé propels it to the next stage and I look forward to working with the board and investors to maximise Engitix’s full potential."

In 2020 Engitix moved its headquarters to London’s WestWorks, White City Place (WCP), a growing campus of life sciences companies including a number of biotech and global pharma organisations notably GammaDelta Therapeutics, Autolus and Synthace, as well as Novartis. The Company plans to acquire more laboratory and office space to support its expansion to around 80 full time employees and to establish a fully integrated automated laboratory for high throughput screening (HTS) using its ECM platform.

Oasmia announces intention to change its name to Vivesto

On January 19, 2022 Oasmia Pharmaceutical AB, an oncology-focused specialty pharmaceutical company, reported plans to change its name to Vivesto AB (Press release, Oasmia, JAN 19, 2022, View Source [SID1234605558]). The proposed name change is subject to approval at a company Extraordinary General Meeting (EGM) to be held on 21 February 2022. The new name will, after approval by the EGM, be formally registered with the Companies Registration Office following completion of the recently announced Rights Issue.

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Francois Martelet, CEO, said: "Since I became CEO in March 2020, the new management team and Board has set out a focused strategy to transform the business and build an oncology-focused specialty pharmaceutical company with a diversified portfolio. We’ve strengthened our finances by reducing unnecessary operational expenditure and resolved a number of inherited legal issues, at the same time as driving the value of our existing portfolio and expanding our R&D capabilities to make us an attractive partner for promising oncology assets. As we continue to develop Cantrixil, the first in-licensed therapy in our string of pearls strategy and focus on additional in-licensing and M&A opportunities, we believe this is the right time to mark the transformed prospects of our business with a new identity. Vivesto reflects our optimism for the future and our commitment to improving survival and quality of life for patients with hard-to-treat and late-stage cancers through R&D and innovation."

Oasmia has worked closely with the respected Brand Institute London UK to develop its new identity. Vivesto was ranked highly for brand recognition and relevance by patients, medical professionals and investors surveyed in Europe, the US and Sweden.

Online presentation today at 14:00 CET
The company will hold an online presentation today at 14:00 CET. The presentation will be given by CEO Francois Martelet and CFO Fredrik Järrsten in English. The presentation will be broadcast live via the link: View Source

Questions can be sent in advance to [email protected] or by phone to +46 72-376 90 10.

OASMIA RESOLVES ON A FULLY SECURED RIGHTS ISSUE OF APPROXIMATELY SEK 151 MILLION

On January 19, 2022 Oasmia’s Board of Directors reported that subject to approval from the Extraordinary General Meeting on 21 February 2022, to carry out the Rights Issue of approximately SEK 151 million before deduction of issue costs (Press release, Oasmia, JAN 19, 2022, View Source [SID1234605557]).

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Those who are registered as shareholders on the record date of 4 March 2022 have the preferential right to subscribe for new shares in proportion to their existing shareholdings. Subscription of shares may also take place without subscription rights.

The Board of Directors’ resolution on the Rights Issue is subject to approval by the Extraordinary General Meeting on 21 February 2022. For further information, please see separate press release with notice of the Extraordinary General Meeting.

Terms of the Rights Issue

Those who are registered shareholders in Oasmia on the record date 4 March 2022, receive one (1) subscription right for each (1) share. The subscription rights grant the holder preferential right to subscribe for new shares, whereby five (5) subscription rights entitle the shareholder to subscribe for one (1) new share. In addition, investors are offered the possibility to subscribe for shares without subscription rights.

In the event that not all shares are subscribed for under subscription rights, the Board of Directors shall, within the maximum amount of the Rights Issue, resolve on allotment of shares without subscription rights. Allotment will then take place in the following order of priority: primarily, allotment shall be made to those who subscribed for shares under subscription rights, regardless of whether the subscriber was a shareholder on the record date or not, pro rata in relation to the number of subscription rights exercised for subscription and, to the extent that this cannot be done, by drawing lots; secondarily, allotment shall be made to others who have signed up for subscription without subscription rights. In the event that they cannot receive full allotment, allotment shall be made pro rata in proportion to the number of shares subscribed for by each and, to the extent that this cannot be done, by drawing lots; and in the third and final stage, any remaining shares shall be allotted to the parties who have guaranteed the Rights Issue, in relation to the guarantee undertakings made.

The subscription price is SEK 1.68 per new share. Assuming that the Rights Issue is fully subscribed, the share capital will be increased by a maximum of SEK 8,967,390.9 from SEK 44,836,954.6 to SEK 53,804,345.5, by new issue of a maximum of 89,673,909 new shares, resulting in the total number of shares increasing from 448,369,546 shares to 538,043,455 shares. Assuming full subscription, Oasmia will receive total proceeds of approximately SEK 151 million, before deduction of issue costs.

The subscription period runs from 8 March 2022 through 22 March 2022. The Board of Directors of Oasmia is entitled to extend the subscription period and the time for payment which, if applicable, will be announced by the Company in a press release no later than 22 March 2022. Trading in subscription rights will take place on Nasdaq Stockholm during the period from 8 March 2022 through 17 March 2022 and the trading in paid-up subscribed shares (Sw: betalda tecknade aktier) during the period from 8 March 2022 through 4 April 2022.

Shareholders who choose not to participate in the Rights Issue will, assuming that the Rights Issue is fully subscribed, have their shareholdings diluted by approximately 16.7 percent, but are able to financially compensate for this dilution by selling their subscription rights.

Subscription commitments and guarantee undertakings

The Company’s largest shareholder, Per Arwidsson through Arwidsro Investment AB and Fastighets AB Arwidsro, representing approximately 24.8 percent of the total number of shares and votes in Oasmia, has undertaken to subscribe for its pro-rata share of the shares in the Rights Issue.

Additionally, a consortium of external investors have given guarantee commitments to Oasmia of SEK 113 million, corresponding to approximately 75.2 percent of the Rights Issue. Thus, the Rights Issue is fully secured. For the guarantee undertakings, a cash compensation of 6.5 percent is paid on the guaranteed amount.

Prospectus

Complete terms and conditions for the Rights Issue and other information about the Company as well as information about subscription commitments and guarantee undertakings will be available in the prospectus that the Company is expected to publish on 3 March 2022.

Preliminary timetable

The below timetable for the Rights Issue is preliminary and may be adjusted.

2 March 2022 Last day of trading in shares including right to participate in the Rights Issue
3 March 2022 First day of trading in shares excluding right to participate in the Rights Issue
3 March 2022 Estimated date for publication of the prospectus
4 March 2022 Record date for participation in the Rights Issue, i.e. holders of shares who are registered in the share register on this date will receive subscription rights for participation in the Rights Issue
8 March – 17 March 2022 Trading in subscription rights
8 March – 22 March 2022 Subscription period
8 March – 4 April 2022 Trading in paid-up subscribed shares (Sw: betalda tecknade aktier)
24 March 2022 Estimated date for publication of preliminary results of the Rights Issue
25 March 2022 Estimated date for publication of final results of the Rights Issue
Online presentation today at 14:00 CET

The company will hold an online presentation today at 14:00 CET. The presentation will be given by CEO Francois Martelet and CFO Fredrik Järrsten in English. The presentation will be broadcast live via the link: View Source

Questions can be sent in advance to [email protected] or by phone to +46 72-376 90 10.

Advisers

In connection with the Rights Issue, Oasmia has appointed Danske Bank A/S, Danmark, Sverige Filial as financial adviser and Sole Bookrunner. Törngren Magnell & Partners Advokatfirma KB acts as legal adviser to the Company and Schjødt acts as legal adviser to Danske Bank.

Lupin Signs First Partnership Agreement with Foncoo for China

On January 19, 2022 Global pharma major Lupin Limited (Lupin) reported that it has entered into a partnership with Shenzhen Foncoo Pharmaceutical Co. Ltd (Foncoo) (Press release, Lupin, JAN 19, 2022, View Source [SID1234605542]). This is Lupin’s first partnership arrangement in China and reinforces Lupin’s commitment to bringing high quality generic and complex generic medicines to patients around the world.

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Dr. Fabrice Egros, President – Growth Markets, Lupin said, "Lupin continues to invest in key growth markets. With China’s growing commitment to affordable and accessible healthcare, Lupin is committed to serving the healthcare needs of the Chinese population by providing high quality generic and complex generic products. We are very excited about our partnership with Foncoo. We will continue exploring additional partnership opportunities in China to leverage our global portfolio including complex generics and specialty medicines."

Mr. Peng Yan, General Manager, Foncoo said, "Foncoo’s successful experiences on importing registration and marketing of the generic formulations and Lupin’s strong capability of making high-quality medicines make us perfect match to each other and our collaboration will have a bright future most likely. We expect that the successful launch of our first product in China will come smoothly and soon. We will also continue exploring more opportunities to work with Lupin for providing more and more high-valued and complex medicines to the Chinese physicians and patients."

HUTCHMED Highlights Fruquintinib Clinical Data to be Presented at the 2022 ASCO Gastrointestinal Cancers Symposium

On January 19, 2022 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) reported that updated analysis of the ongoing international Phase I/Ib trial of fruquintinib will be presented at the upcoming 2022 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, taking place on January 20-22, 2022 (Press release, Hutchison China MediTech, JAN 19, 2022, View Source [SID1234605536]). The meeting will be held virtually and in person at the Moscone Center in San Francisco, California, US.

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Further details of the presentation are as follows:

Title: Phase I/Ib trial of fruquintinib in patients with advanced solid tumors: preliminary results of the dose expansion cohorts in refractory metastatic colorectal cancer
Presenter: Arvind Dasari, MD, MS, MD Anderson Cancer Center
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Abstract No.: 93
Date & Time: Saturday, January 22, 2022
Location: Moscone Center – West, Level 1, West Hall and virtually

About Colorectal Cancer ("CRC")
CRC is a cancer that starts in either the colon or rectum. CRC is the third most common cancer worldwide, estimated to have caused more than 915,000 deaths in 2020.[1] In the U.S., an estimated 150,000 people were diagnosed with CRC and 53,000 people died from CRC in 2021.[2] In Europe, CRC is the second most common cancer, with an estimated 507,000 new cases and 240,000 deaths in 2020.[2] In Japan, CRC is the most common cancer, with an estimated 147,000 new cases and 59,000 deaths in 2020.[2]

About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

About Fruquintinib Approval in China
Metastatic CRC in China: Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in late November 2018 under the brand name ELUNATE. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. ELUNATE is indicated for the treatment of patients with metastatic CRC who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Results of the FRESCO study[3], a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic CRC in China, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).

About Fruquintinib Development Beyond CRC Monotherapy
The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated:

Gastric Cancer ("GC") in China: In October 2017, HUTCHMED initiated the FRUTIGA study, a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for second-line treatment of advanced gastric or esophagogastric junction ("GEJ") adenocarcinoma. The trial is designed to enroll patients who did not respond to first-line standard chemotherapy. Subjects receive either fruquintinib combined with paclitaxel or placebo combined with paclitaxel. Patients are randomized at a 1:1 ratio and stratified according to factors such as stomach vs. GEJ tumor type and performance status. The primary efficacy endpoint is overall survival (OS). Secondary efficacy endpoints include progression-free survival (as defined by RECIST 1.1), objective response rate, disease control rate, duration of response, and quality-of-life score (EORTC QLQ-C30, version 3.0). Biomarkers related to the antitumor activity of fruquintinib will also be explored (clinicaltrials.gov identifier: NCT03223376). In June 2020, HUTCHMED completed a planned interim data review. Based on the preset criteria, the Independent Data Monitoring Committee (IDMC) recommended that the trial continue.

Immunotherapy combinations: HUTCHMED has entered into collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317, developed by BeiGene, Ltd) and sintilimab (IBI308, developed by Innovent Biologics, Inc. and marketed as TYVYT in China).

Metastatic breast and endometrial cancers in the U.S.: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase Ib/II study in the U.S. to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced, refractory triple negative breast cancer ("TNBC") and endometrial cancer ("EMC"). This study is being conducted to investigate if the addition of fruquintinib can potentially induce activity to immune checkpoint inhibitor therapy in TNBC and EMC. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04577963. Safety and preliminary efficacy of fruquintinib were demonstrated in advanced solid tumors, including TNBC, in a Phase I study conducted in China (NCT01645215) and a Phase I/Ib study is ongoing in the United States (NCT03251378).

Gastric, colorectal and non-small cell lung cancers in China & Korea: BeiGene, Ltd. initiated this open-label, multi-center, Phase II study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced or metastatic, unresectable GC, CRC or non-small cell lung cancer ("NSCLC"). Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04716634.

Solid tumors in China: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase II study to assess the safety and efficacy of fruquintinib in combination with sintilimab in patients with advanced EMC, cervical cancer, CRC, GC, hepatocellular carcinoma (HCC), NSCLC or renal cell carcinoma (RCC). Additional details of the study may be found at clinicaltrials.gov, using identifier NCT03903705. Preliminary results of certain cohorts were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) and the Chinese Society of Clinical Oncology Annual Meeting (CSCO).