On May 2, 2021 Jacobio Pharmaceuticals (1167.HK) reported the U.S. Food and Drug Administration (FDA) has approved company’s Investigational New Drug (IND) application to develop a KRAS G12C inhibitor (Press release, Jacobio Pharmaceuticals, MAY 2, 2021, View Source [SID1234579033]). IND application to the National Medical Products Administration (NMPA) in China was accepted on March 17. It will be used to treat advanced solid tumors with the KRAS G12C mutation, including but not limited to non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other advanced solid tumors. Patient enrollment for clinical trials in the U.S. and China will begin in the second half of 2021.

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JAB-21822 is Jacobio’s innovative in-house small molecule anti-cancer drug, which is designed to target the KRAS G12C mutation. The global incidence of the KRAS G12C mutation in patients with NSCLC, ovarian cancer, CRC and pancreatic cancer reached approximately 295,000 in 2019. To date, there has been no approved and marketed KRAS G12C inhibitor globally.

JAB-21822 has best-in-class potential among KRAS G12C inhibitors. Internal pre-clinical head-to-head animal studies comparisons have shown JAB-21822 to have a superior pharmacokinetic (PK) profile and favorable tolerability as well as potential for a superior dosing profile in comparison with its competitors.

KRAS is the most frequently mutated oncogene in human cancers. KRAS mutations promote a variety of fatal tumors in humans and are present in more than 90% of pancreatic cancers. There are very limited effective treatment options for patients with pancreatic cancer, evidenced by the fact that only 7.2% of patients with pancreatic cancer have a 5-year overall survival rate in China. KRAS mutations are also found in CRC (40%), NSCLC (25%), thyroid cancer, ovarian cancer, and bladder cancer.

Although KRAS and its role as an oncogene was discovered as early as 30 years ago, no therapeutic agent directly targeting KRAS has been clinically approved despite decades of research. KRAS has long been considered "undruggable" for several reasons. Firstly, it is a very small-sized molecule that has a relatively smooth surface with few deep pockets for drug-binding. Secondly, because of the high picomolar affinity of KRAS towards nucleotide GTP, drugs are generally unable to reach a certain concentration to compete with GTP in binding the nucleotide binding domain to the protein.

Dr. Wayne Long, Jacobio’s Vice President of Chemistry said, "The strategy of the use of allosteric inhibitors is a breakthrough of this previously "undruggable" target. Jacobio has developed the highly selective KRAS G12C inhibitor JAB-21822 based on our own allosteric inhibitor platform and an "iterative chemotype evolution" approach."

Based on the in-depth understanding of KRAS G12C, Jacobio has further discovered two inhibitors targeting KRAS G12D and KRAS G12V. The KRAS G12D inhibitor has obtained highly active and selective lead drug molecules, while KRAS G12V has also obtained multiple hits. These two inhibitors are expected to be submitted as INDs in 2022-2023 and 2023-2024, respectively. To date, there is no IND application for these two targets globally.

"KRAS G12D and KRAS G12V are two exciting programs that cement our position in the top tier of global biotech companies," said Dr. Steve Zhou, Chief Biologist and Senior Vice President of Jacobio. "The R&D of KRAS G12D inhibitors draws on our experience and expertise of the KRAS G12C inhibitor. The combination of various advantages including development experience, coupled with our in-house chemical library and focused library design, as well as small molecule drug development capabilities based on the allosteric inhibitor platform, puts us in a favorable position in the global R&D landscape of KRAS inhibitors."

Jacobio has six programs targeting the RAS pathway, including SHP2 inhibitors (upstream from the RAS pathway). Clinical studies have shown that SHP2 inhibitors may potentially be the best combination therapy partners for KRAS inhibitors. Jacobio is one of the few biotech companies in the world that has both SHP2 inhibitors and KRAS inhibitors, which brings much convenience and flexibility to the clinical trials of in-house combination therapy.

On May 2, 2021 ImmunoPrecise reported that it will be participating in the Biotechgate Digital Partnering event being hosted virtually May 3-7, 2021 (Press release, ImmunoPrecise Antibodies, MAY 2, 2021, View Source [SID1234578954]). The digital partnering event is designed to support business development through pre-arranged 1-on-1 meetings.

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Learn more about the digital partnering event here

On May 1, 2021 iCo Therapeutics ("iCo" or the "Company") (TSX-V: ICO) (OTCQB: ICOTF), reported financial results for the year ended December 31, 2020 (Press release, iCo Therapeutics, MAY 1, 2021, View Source [SID1234578999]). Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards ("IFRS").

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William Jarosz, CEO of iCo Therapeutics Inc., noted "We were very pleased by the progress of our Oral Amp B program during the year with our compound being safe and well tolerated in Phase 1b clinical trials and potential as a therapeutic agent for novel Coronavirus. We are also excited for the new strategic directions that are open for us in this new year with Satellos, and the associated concurrent financing, previously announced."

The Company also announced the resignation of Susan Koppy as President of the Company and from the Board of Directors, effective April 30, 2021. "While I’ve had a long affiliation with iCo, I now feel that the Company is on a solid trajectory. For personal reasons, it’s the right time for me to move on and tender my resignation. I wish the Company every success," noted Susan Koppy.

"We have benefitted from the guidance that Susan has provided for Business Development and thank her for all her hard work," said William Jarosz. The Company expects to appoint new officers and new members to the Board in conjunction with the Satellos transaction.

Operational and Financial Highlights
Corporate

On March 21, 2021, the Company entered into an agreement (the "Arrangement Agreement"), providing for the business combination of iCo and Satellos Bioscience Inc. ("Satellos") by way of a plan of arrangement (the "Arrangement") in accordance with Section 192 of the Canada Business Corporations Act (the "CBCA"). Pursuant to 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"), operating in the life sciences industry. Following the Arrangement, and the Concurrent Financing (described below) shareholders of iCo will hold an approximately 27.7% ownership interest, and the shareholders of Satellos will hold approximately 58.8.% of the outstanding common shares of the Resulting Issuer.

The completion of the Arrangement will result in a reverse takeover of iCo as defined in the policies of the TSX Venture Exchange (the "Exchange"). Completion of the Arrangement is subject to, among other things, the approval of the Exchange, court approval, and approval from iCo and Satellos’ shareholders. 51255844.3 As part of the Arrangement, iCo has closed a private placement (the "Concurrent Financing") of subscription receipts (the "Subscription Receipts") issuing 85,294,117 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. Each Subscription Receipt entitles 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. The proceeds from the Concurrent Financing have been 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.

Also, subsequent to year end, warrant holders exercised 27,435,000 for proceeds of $1,763,795 to the Company.

Oral Amp B Delivery System
On February 25, 2020, iCo announced the completion of the Phase 1b study in which both (100 mg and 400 mg) doses of the oral Amphotericin B were well tolerated with no adverse events reported, including no signs of kidney or other toxicity.

On April 15, 2020, iCo announced pharmacokinetic results from the Phase 1b study. The oral Amphotericin B at the 100 mg dose achieved a median plasma Cmax of 25 ng AmB/mL and AUC (0-inf) 990 hr* ng/mL after day 1 of dosing and a median plasma Cmax of 44 ng AmB/mL and AUC (0-inf) 1998 hr*ng/mL after 10 day of dosing. This approximate doubling of the AUC (0-inf) measure between day 1 and day 10 was observed not only at the 100 mg dose but at the 400 mg dose as well.

On December 31, 2020, iCo and Skymount Medical, Inc. ("Skymount") announced that they entered into a non-binding Memorandum of Understanding to develop iCo-019, iCo’s oral Amphotericin B formulation. Skymount is expected to initially commit up to $US 550,000 for pre-clinical work targeting the use of iCo019 as a therapeutic product for infections relating to COVID-19.

On March 15, 2021, iCo announced that its wholly owned subsidiary, Amphotericin B Technologies, Inc., entered into an agreement with IIT Research Institute to test the in vivo efficacy of iCo’s novel oral amphotericin B asset ("iCo-019") against SARS-CoV-2, the causative agent of COVID-19 in the hACE2 mouse model (the "iCo-019 Study"). iCo anticipates that the iCo-019 Study will be completed by the end of Q2 2021.

Financial results for Year End 2020
We incurred a total comprehensive loss of $1,470,112 for the year ended December 31, 2020 compared to a total comprehensive loss of $1,932,202 for the year ended December 31, 2019, representing a decrease of $462,090. The decrease is primarily the result of lower general and administrative expenses offset by lower research and development tax credits recognized during 2020.

Research and development expenses were $895,112 for the year ended December 31, 2020 compared to $917,475 for the year ended December 31, 2019, representing a decrease of $22,363 or 2%. For both years the research and development expenses primarily reflected contract research expenses for a Phase 1b clinical trial conducted on the Oral Amp B program.

For the year ended December 31, 2020 general and administrative expenses were $760,464 compared to $1,288,198 for the year ended December 31, 2019, representing a decrease of $527,734. The decrease reflects lower consulting and professional fees during the period. The Company’s participation in the 51255844.3 IMMUNE bankruptcy process last year caused an increase in consulting and professional fees in the prior year.

Liquidity and Outstanding Share Capital As at December 31, 2020, we had cash and cash equivalents of $65,413 compared to $989,937 as at December 31, 2019. Subsequent to year end, warrant holders exercised 27,435,000 for proceeds of $1,763,795 to the Company. As at April 27, 2021 we had an unlimited number of authorized common shares with 181,182,713 common shares issued and outstanding. For complete financial results, please see our filings at www.sedar.com.