On April 23, 2021 Coherus BioSciences, Inc. (Nasdaq: CHRS) reported that it has received notice from immuno-oncology partner Junshi Biosciences that the Independent Data Monitoring Committee of the JUPITER-06 clinical trial has determined that toripalimab, an anti-PD-1 monoclonal antibody, in combination with paclitaxel/cisplatin as first-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC), has achieved the pre-specified primary endpoints of progression free survival (PFS) and overall survival (OS) at the interim analysis. JUPITER-06 is a randomized, double-blind, placebo-controlled, multi-center, phase 3 clinical trial initiated in 2019 with 514 patients enrolled (Press release, Coherus Biosciences, APR 23, 2021, View Source [SID1234578430]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The interim analysis showed that toripalimab, in combination with paclitaxel/cisplatin, significantly prolonged the PFS and OS of patients with advanced ESCC, compared with paclitaxel/cisplatin chemotherapy alone. Data from the study are expected later this year.

Earlier in 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. More than 2,100 patients have received toripalimab treatment in clinical trials, and pivotal clinical trials are ongoing or completed evaluating toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin. In the U.S., a rolling submission of the first toripalimab Biologics License Application (BLA) is underway for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The U.S. Food and Drug Administration (FDA) has granted toripalimab Breakthrough Therapy Designation for this indication. Additionally, FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

About Esophageal Squamous Cell Carcinoma (ESCC)
Esophageal cancer is a primary malignant tumor of the esophageal mucosa epithelium. ESCC and adenocarcinoma are the two main histological subtypes of esophageal cancer. Approximately 6,000 patients in the United States are diagnosed annually with esophageal squamous cell carcinoma. The current standard first-line treatment is platinum-based chemotherapy. The prognosis of patients with advanced ESCC is poor with five-year survival rates of less than 20%.

About JUPITER-06 Study
JUPITER-06 is a randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial evaluating the efficacy and safety of toripalimab combined with paclitaxel/cisplatin versus placebo combined with paclitaxel/cisplatin as first-line treatments for advanced esophageal squamous cell carcinoma. The JUPITER-06 Clinicaltrials.gov identifier is NCT03829969. Professor Ruihua Xu from the Sun Yat-sen University Cancer Hospital is the principal investigator of the JUPITER-06 study. A total of 514 patients were enrolled in the study. The primary endpoints are PFS as assessed by the Blinded Independent Review Committee and OS. Secondary endpoints include the PFS assessed by investigator, objective response rate, disease control rate and duration of response.

On April 23, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported U.S. Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients (Press release, Hoffmann-La Roche, APR 23, 2021, View Source [SID1234578389]). MMR is a molecular mechanism that functions to correct certain errors that can spontaneously occur during DNA replication. Testing can identify patients eligible for treatment with JEMPERLI (dostarlimab-gxly) monotherapy, an anti-PD1 immunotherapy from GlaxoSmithKline (GSK) that was approved by the FDA on 22 April 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Endometrial cancer is the most common gynecologic cancer in the U.S. and the fourth most common cancer in women in North America.2 In addition, about 90,000 women globally die from endometrial cancer each year.1 There are limited treatment options for women whose disease progresses on or after first-line therapy and this is the first companion diagnostic to identify endometrial cancer patients eligible for anti-PD1 immunotherapy.

"We are excited to launch this companion diagnostic test with GSK to help recurrent or advanced endometrial cancer patients with limited treatment options," said Thomas Schinecker, CEO of Roche Diagnostics. "This test provides clinicians with an effective tool to identify patients best suited for treatment with GSK’s JEMPERLI, providing a new therapeutic option for women with MMR-deficient endometrial cancer whose disease progresses on or following initial chemotherapy treatment."

MMR deficiency is most common in endometrial cancer. This companion diagnostic (CDx) provides clinicians with a standardised testing option that uses a comprehensive panel of DNA mismatch repair (MMR) biomarkers tested by immunohistochemistry (IHC). FDA approval of the VENTANA MMR RxDx Panel provides clinicians with access to a fully automated, easy-to-use MMR test to identify patients who are eligible for therapy with JEMPERLI.

About the VENTANA MMR RxDx Panel
The VENTANA MMR RxDx Panel is a label expansion of Roche’s current on-market VENTANA MMR IHC Panel. VENTANA MMR RxDx Panel is a qualitative immunohistochemistry test intended for use in the assessment of mismatch repair (MMR) proteins (MLH1, PMS2, MSH2 and MSH6) in formalin-fixed, paraffin-embedded (FFPE) endometrial carcinoma tissue by light microscopy. The OptiView DAB IHC Detection Kit is used for MLH1, MSH2 and MSH6, and the OptiView DAB IHC Detection Kit with the OptiView Amplification Kit is used for PMS2 on a VENTANA BenchMark ULTRA instrument. DNA mismatch repair (MMR) proteins have been clinically proven to be predictive biomarkers for PD-1 targeted therapy; specifically, a loss of expression of one or more MMR proteins might predict an increased likelihood of response to such therapy.3,4,5 PD-1 inhibitors can be effective in cancers with a high frequency of MMR deficiency and/or microsatellite-instability, high (MSI-H) including endometrial cancer.3,5 MMR is a conserved molecular mechanism that functions to correct the improper base substitutions that spontaneously occur during DNA replication. Defects in the MMR machinery have been attributed to mutations in the MMR proteins.

On April 23, 2021 Anavo Therapeutics, a global leader in unlocking the full therapeutic potential of human phosphatase biology, reported with a EUR 20 million (approx. $24 million) seed financing (Press release, Anavo Therapeutics, APR 23, 2021, View Source [SID1234578407]). Anavo’s mission is to pioneer systematic drug discovery and development approaches aimed at phosphatases, a rich and largely untapped therapeutic target class. The funds will be used to advance a proprietary drug discovery portfolio in oncology and establish a versatile and robust platform to address the target space broadly across multiple indications. Anavo’s leadership team, Dr. Birgit Zech and Dr. Gerhard Müller, are building on several years of joint experience in the biopharmaceutical industry and have demonstrated the ability to navigate rapidly emerging sectors in biopharma most recently as co-founders of Gotham Therapeutics. The founding team is further complemented by Claus Schalper, a renowned finance expert and serial biotech entrepreneur.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Phosphatases and kinases regulate the activity of numerous crucial signaling pathways by removing or adding a phosphate group from proteins or other biomolecules. Imbalances in this process can lead to a multitude of diseases. While kinases have been exploited by drug developers worldwide, phosphatases stayed largely untouched after setbacks earlier in this century.

Anavo’s approach focuses on combining profound understanding of phosphatase biology with deep drug discovery expertise and state-of-the-art technologies to design first-in-class and best-in-class small molecule modulators of phosphatase activity. The company has attracted world-leading phosphatase biology expertise to its advisory board in Mathieu Bollen, Professor of Molecular Cell Biology at University of Leuven, and Nicholas Tonks, Professor of Cancer Research at Cold Spring Harbor Laboratory. Taken together, both have authored and co-authored more than 500 scientific publications on phosphatases and related physiological processes.

"Anavo was founded to unlock the full potential of phosphatase-targeting allosteric modulators and has attracted one of the largest European biotech seed rounds to date. Recent progress especially around SHP2 has demonstrated that the time is ripe to address phosphatase drug discovery more systematically and on a much larger scale," said Dr. Birgit Zech, Chief Executive Officer of Anavo Therapeutics. "With Mathieu Bollen and Nicholas Tonks as our initial scientific advisory board members, we have attracted two world-leading scientists in phosphatase biology which complements our deep drug discovery know-how."

"Academic research on the human phosphatome has moved way ahead of the industry and we are now sitting on a real treasure trove of potential therapeutic avenues to explore, targets to validate, and programs worth translating into preclinical and clinical evaluation," said Dr. Gerhard Müller, Chief Scientific Officer of Anavo Therapeutics. "Among all target classes currently defined as ‘undruggable’, we expect phosphatases to have the deepest and most profound impact on clinical outcomes once addressed in a systematic and coherent fashion."

Therese Liechtenstein, Principal at M Ventures, added: "Anavo’s novel approach and its experienced management team provide us with the best tools and key ingredients to address challenges in phosphatase drug discovery, and unlock this rich target class. We are excited to be part of Anavo and their mission."

Simone Botti, Junior Partner at INKEF Capital, added: "The progress that has been made with SHP2 in our industry has revived the phosphatase sector but is only scratching the surface of this largely untapped attractive molecular target class. We are very pleased to support Anavo, a company poised to deliver first-in-class therapeutics in oncology and establish itself as a world leader in phosphatase drug discovery."

Therese Liechtenstein and Simone Botti will be joined by Sakae Asanuma, President and CEO of Taiho Ventures, and Debora Dumont, Managing Partner at Bioqube Ventures, on Anavo’s Board of Directors.

On April 23, 2021 InDex Pharmaceuticals Holding AB (publ) reported the Annual Report for 2020 (Press release, InDex Pharmaceuticals, APR 23, 2021, View Source [SID1234578390]). The Annual Report is attached as a PDF and is available on the company’s website, View Source

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The printed Annual Report is mailed to shareholders and other stakeholders who specifically request it. Send request to [email protected], or by mail to InDex Pharmaceuticals Holding AB (publ), Berzelius väg 13, 171 65 Solna, Sweden.

On April 23, 2021 iCo Therapeutics Inc. ("iCo" or the "Company") (TSXV: iCo) (OTCQB: iCoTF) reported that, in connection with its proposed business combination with Satellos Bioscience Inc. ("Satellos") by way of a plan of arrangement (the "Arrangement"), as previously announced on March 22, 2021, it intends to offer on a private placement basis (the "Financing") 85,294,117 subscription receipts (the "Subscription Receipts") at a price of $0.085 per Subscription Receipt for aggregate gross proceeds of approximately C$7.25 million, representing an upsize from the C$6 million financing announced on March 22, 2021 (Press release, iCo Therapeutics, APR 23, 2021, View Source [SID1234578391]). Each Subscription Receipt will entitle the holder thereof to receive, upon satisfaction of certain escrow release conditions, and without payment of additional consideration, one common share in the Resulting Issuer (as described below). The proceeds from the Financing are to be placed in escrow and, upon satisfaction of the release conditions and completion of the Arrangement, will be used for research, development, and general corporate expenses of the Resulting Issuer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The common shares underlying the Subscription Receipts are subject to a lock-up agreement and the Subscription Receipts and the underlying common shares of the Resulting Issuer will be subject to a hold period expiring 4 months and one day from the date of issuance in accordance with applicable Canadian securities laws. The Financing is anticipated to close on or about April 27, 2021, subject to approval by the TSX Venture Exchange (the "Exchange").

The Financing is led by Bloom Burton Securities Inc. ("Bloom Burton") and includes Richardson Wealth Ltd. (together the "Agents"). In connection with the Financing and in accordance with the policies of the Exchange, the Agents will receive: (i) a cash fee equal to 6.0% of the gross proceeds raised in connection with the Financing; and (ii) warrants equal to 6.0% of the number of Subscription Receipts issued in connection with the Financing (the "Broker Warrants"). Each Broker Warrant shall entitle the holder thereof to buy one common share of the Resulting Issuer at the issue price in connection with the Arrangement. The term of the Broker Warrants shall be 24 months from the expected closing date of Financing. 51254637.6

Completion of the Arrangement is subject to, among other things, the approval of the Exchange, the Supreme Court of British Columbia and the shareholders of iCo and Satellos (collectively, the "Shareholders"). iCo shares will remain halted for trading pending the approval of the Arrangement by the Supreme Court of British Columbia, the Shareholders and the permission of the Exchange. Upon closing of the Arrangement, Satellos will become a wholly owned subsidiary of iCo, and the parties expect to complete an amalgamation of iCo and Satellos, with the resulting entity named "Satellos Bioscience Inc" (the "Resulting Issuer"). Upon the conclusion of the Financing, the holders of the Subscription Receipts will represent approximately 14% of the issued and outstanding common shares of the Resulting Issuer.

William Jarosz, the CEO of iCo noted, "We are very pleased by the success and expansion of the private placement. Following the private placement and Arrangement, the Company will be better capitalized around a more diverse set of clinical programs in various stages of development with very bright prospects for the future under the leadership of Satellos, a company addressing unmet needs in muscle wasting diseases, including Duchenne Muscular Dystrophy. We are also grateful for the support of existing investors participating in this financing who recognized the value of this new strategic direction for the Company."

Frank Gleeson, the CEO of Satellos, added: "We view the Financing as an extremely encouraging endorsement of the proposed business combination of iCo and Satellos and the potential for its new technology platform which aims to attack and treat a devastating series of muscle wasting diseases. Together with iCo management, we are focused on completing the Arrangement so that we can begin to execute on what we believe is an exciting plan for the future."