On March 13, 2022 Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, reported that it has entered into a license agreement with Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) to develop and commercialize NEFECON for the treatment of primary IgA nephropathy (IgAN) in South Korea, expanding its license in addition to rights held in Greater China and Singapore (Press release, Everest Medicines, MAR 13, 2022, View Source [SID1234610010]). The deal signals the Company’s latest efforts to further enhance its international commercial footprint.

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"We’re thrilled to strengthen our partnership with Calliditas by extending our license agreement to include South Korea and working towards our shared vision of developing and commercializing NEFECON as a potential novel therapy for the treatment of IgAN globally," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "While primary IgAN is more common in Asia than elsewhere in the world, there are no established treatments for patients living with the chronic condition, underscoring the significant and urgent unmet need for innovative medicines."

"South Korea is the third largest pharmaceutical market in the Asia Pacific region —after China and Japan—and represents tremendous opportunity," said Kevin Yong Guo, Chief Commercial Officer of Everest Medicines. "South Korea’s sophisticated healthcare model enables innovative medicines such as NEFECON to have a higher potential likelihood of healthcare coverage once approved. We look forward to working closely with all contributing parties to bring NEFECON to patients living with IgAN in South Korea as quickly as possible."

"We continue to have a fruitful and positive collaboration with Everest and are delighted that we have come to an agreement also around South Korea," said CEO Renée Aguiar-Lucander of Calliditas.

In the coming months, Everest Medicines will collaborate with the Ministry of Food and Drug Safety of South Korea to prepare regulatory filings and a New Drug Application (NDA) for NEFECON for the treatment of primary IgAN.

Under the terms of the agreement, Calliditas receives an initial upfront payment of USD$3 million at signing of the agreement.

About NEFECON

NEFECON (approved in the United States under accelerated approval under another trade name) is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. NEFECON was designed as a 4 mg delayed release capsule and is enteric coated so that it would remain intact until it reaches the ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer’s patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1) causing IgA nephropathy. It is unclear to what extent NEFECON’s efficacy is mediated via local effects in the ileum vs systemic effects. In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize NEFECON in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine’s territories.

About Primary Immunoglobulin A Nephropathy

Primary immunoglobulin A nephropathy (IgA nephropathy or IgAN or Berger’s Disease) is a progressive, chronic autoimmune disease that attacks the kidneys and occurs when galactose-deficient IgA1 are recognized by autoantibodies, creating IgA1 immune complexes that become deposited in the glomerular mesangium of the kidney.1,2 This deposition in the kidney can lead to progressive kidney damage and potentially a clinical course resulting in end- stage renal disease. IgAN most often develops between late teens and late 30s.2,3

On March 13, 2022 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepted a supplemental New Drug Application (sNDA) for Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of patients with relapsed or refractory Waldenström’s Macroglobulinemia (R/R WM) b(Press release, InnoCare Pharma, MAR 13, 2022, View Source [SID1234610009]).

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"According to the evaluation of the Independent Review Committee (IRC) and the principal investigators, the treatment of R/R WM patients with orelabrutinib at a dose of 150mg once a day reached the primary end point, showing encouraging efficacy, which is expected to improve with the extension of treatment time," said Professor Daobin Zhou, Director of Hematology Department of Peking Union Medical College Hospital. "Meanwhile, orelabrutinib is well tolerated with safety profile in the treatment of WM patients. The incidence of adverse events, especially off-target related serious adverse events, is significantly lower in the clinical trial."

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said, "WM poses a threat to patients’ lives. We are encouraged that NMPA has accepted the supplemental New Drug Application for orelabrutinib in the treatment of R/R WM. This sNDA includes 47 patients from 16 clinical centers in China. We hope that orelabrutinib will bring a novel treatment option to R/R WM patients."

On December 25, 2020, orelabrutinib received approval from NMPA in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL).

About Waldenström’s Macroglobulinemia

Waldenström’s macroglobulinemia is a relatively slow-growing lymphoma characterized by the invasion of bone marrow by lymphoplasmacytic cells secreting monoclonal immunoglobulin M (IgM). The disease usually affects older adults and is primarily found in the bone marrow, although it may also impact lymph nodes and the spleen.

About Orelabrutinib

Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.

On Dec. 25 2020, orelabrutinib received approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients.

In addition to the approved indications, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies.

Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA).

Attributed to its excellent selectivity and clinical safety profiles, orelabrutinib is also evaluated in the global phase II studies for the treatment of Multiple Sclerosis (MS), phase II clinical trials for the treatment of Systemic Lupus Erythematosus (SLE) and Primary Immune Thrombocytopenia (ITP) in China.

On March 11, 2022 InnoCure Therapeutics (hereinafter referred to as InnoCure), a new drug development bio-venture, reported the company has completed Series A funding (Press release, InnoCure Therapeutics, MAR 11, 2022, View Source;mode=view&idx=6&sk=&sw=&offset=20&category= [SID1234651741]). Four investment institutions participated and successfully raised a total of 5.5 billion won. Based on this funding, it plans to secure leading substances for preclinical chronic myeloid leukemia treatment, Parkinson’s disease, and RAS-specific mutant protein targets.

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According to the financial investment industry on the 19th, InnoCure raised 5.5 billion won in funds by issuing redeemable convertible preferred stocks. The four institutions that participated in InnoCure’s Series A funding are Starset Investment, Laguna Investment, Suin Investment, and G&Tech Venture Investment.

InnoCure is seeking to be listed on KOSDAQ in 2024 and aims to IPO through a technology special case method when the global clinical entry of three or more products becomes visible.

InnoCure is a bio venture that develops new drugs using the next-generation protein degradation mechanism PROTAC (Proteolysis-Targeting Chimaera) technology. It was founded in January 2018 by CEO Yoo Hye-dong, who participated in the development of new drugs such as the development of alternative drugs for the nano-anticancer drug Abraxane at Celgene.

Based on Series A funding, InnoCure plans to complete preclinical trials for the T315I mutation treatment for chronic myeloid leukemia using PROTAC technology by mid-2022. It is also focusing on securing a leading substance that selectively decomposes RAS-specific mutant proteins that were difficult to approach with small-molecule inhibitor development methods.

PROTAC is an innovative technology that can fundamentally decompose undruggable target proteins that were difficult to approach with existing small-molecule compound methods. PROTAC’s catalytic function is used to achieve high therapeutic effects with small doses, reduce side effects, and overcome resistance to existing treatments, so it is being used in the development of cancer or intractable disease treatments.

On March 11, 2022 Cannabics Pharmaceuticals Inc. (the "Company") reported that it entered into a forbearance agreement (the "Agreement") with an institutional investor (the "Investor") relating to that certain Senior Secured Promissory Note in the original principal amount of $1,375,000 due on December 21, 2021 (the "February Note") (Filing, 8-K, Cannabics Pharmaceuticals, MAR 11, 2022, View Source [SID1234610151]). The February Note was issued by the Company to the Investor in connection with that certain Securities Purchase Agreement dated as of December 16, 2020, and amended as of February 22, 2021.

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Pursuant to the Agreement, the Investor, through May 7, 2022 (the "Forbearance Period"), agreed to forbear from exercising any rights and remedies against the Company related to the outstanding payments under the February Note and to waive certain other defaults under the February Note and related rights pursuant to the Registration Rights Agreement entered into in December 2020 between the Company and the Investor (the "Registration Rights Agreement"). This description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the form of Forbearance Agreement filed as Exhibit 10.1 to this report and is incorporated herein by reference.

As previously described in a Form 8-K filed with the Securities and Exchange Commission on February 17, 2022, on February 15, 2022 the Company entered into a forbearance agreement with the Investor relating to the February Note pursuant to which the Investor had agreed to forbear, through March 7, 2022, from exercising any rights and remedies against the Company related to the outstanding payments under the February Note and to waive certain other defaults under the February Note and related rights pursuant to the Registration Rights Agreement.

On March 11, 2022 Helix BioPharma Corp. (TSX: "HBP") ("Helix" or the "Company"), a clinical-stage biopharmaceutical company developing unique therapies in the field of immuno-oncology, based on its proprietary technological platform DOS47, today anreportednounces that it has closed a private placement financing for gross proceeds of $1,001,000 from the issuance of 3,850,000 common share at a price of $0.26 per common share (Press release, Helix BioPharma, MAR 11, 2022, View Source [SID1234610028]).

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In addition, the Company announces that it has applied to the Toronto Stock Exchange (the "TSX") to introduce an
Incentive Plan (as defined below) to temporarily reduce the exercise price of its issued and outstanding common
share purchase warrants ("Warrants") that are not held by insiders of the Company, or non-arm’s length parties,
including all such Warrants expiring on March 31, 2022 to May 12, 2026 ("Eligible Warrants"), from their current
respective exercise prices to a reduced exercise price of $0.26 (the "Incentive Exercise Price").

Private Placement
Mr. Jerzy Wilczewski ("Mr. Wilczewski"), an insider of the Company, subscribed for all 3,850,000 of the common
shares issued under the private placement. As a result of the closing of the private placement, Mr. Wilczewski owns,
or exercises control or direction over, 23,467,153 common shares, representing approximately 15.94% of the issued
and outstanding common shares of the Company on a non-diluted basis, or approximately 24.95% on a partially
diluted basis, assuming the full exercise of the 17,659,500 common share purchase warrants that Mr. Wilczewski
owns or exercises control or direction over.

"I strongly believe in the new strategy and look forward to further advancements of the company’s L-DOS47 drug
platform" said Mr. Wilczewski. "We are very appreciative of Mr. Wilczewski’s continued support" said Dr. Majewski,
Helix’s Interim Chief Executive Officer.
The Company intends to use the net proceeds of the private placement for working capital and advancing the
Company’s L-DOS47 drug development program.

The purchase of common shares by Mr. Wilczewski is considered a "related party transaction" within the meaning of
Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61- 101"). The
Company relied on exemptions from the formal valuation and minority approval requirements in sections 5.5(a) and
5.7(1)(a) of MI 61-101 in respect of Mr. Wilczewski ‘s purchase of common shares. The Company did not file a material change report in respect of the related party transaction less than 21 days prior to the closing of the private
placement, which the Company deems reasonable in the circumstances so as to be able to avail itself of the proceeds of the private placement in an expeditious manner.

Warrant Incentive Program
The Company has applied to the TSX to temporarily reduce the exercise price of all of its issued and outstanding
Eligible Warrants, being those Warrants that are not held by insiders of the Company or non-arm’s length parties,
including all such Warrants expiring on March 31, 2022 to May 12, 2026, from their current respective exercise prices
ranging from $0.70 to $1.98 to a reduced Incentive Exercise Price of $0.26 as an incentive (the "Incentive Program") to the holders of Eligible Warrants to exercise such Eligible Warrants over a limited period commencing on March 28, 2022 until April 28, 2022 (the "Early Exercise Period"). The implementation of the Incentive Program is subject to the approval of the TSX.

Proceeds received by the Company from the exercise of Eligible Warrants, if any, will be used for working capital and
advancing the Company’s L-DOS47 drug development program. The terms and conditions of the Incentive Program
and the method of exercising Eligible Warrants pursuant to the Program will be set forth in a letter which will be
delivered to each holder of Eligible Warrants at their registered address. New certificates representing the Eligible
Warrants will not be issued in connection with the Incentive Program.

The Eligible Warrants include an aggregate of 49,806,469 warrants that if exercised at the Incentive Exercise Price
will result in the Company receiving gross proceeds of up to $12,949,682 There can be no assurances as to the
number of Eligible Warrants that will be exercised under the Incentive Program or if any Eligible Warrants will be
exercised under the Incentive Program at all.

The dates of each private placement under which the Eligible Warrants were issued, the original issue price of the
units of which the Eligible Warrants formed a part of, the total number of Eligible Warrants, the original exercise price
of the Eligible Warrants, the current expiry dates of the Warrants and the proposed Incentive Exercise Price of the
Eligible Warrants are as follows:

In connection with the proposed adoption of the Incentive Program, the Company also announces that it is extending the exercise period of a total of 3,680,000 Warrants (the "Extended Warrants"), all of which are held by arm’s length parties, until April 28, 2022 (the "Warrant Extension"). The Extended Warrants were issued pursuant to a private placement of the Company that closed in April 2015, have a current exercise price of $1.54 (prior to the contemplated adjustment pursuant to the Incentive Program) and an expiry date of March 31, 2022 and represent approximately 2.55 % of the Company’s issued and outstanding Common Shares. The expiry date of the Extended Warrants is being extended in order to provide the holders of such Warrants with the opportunity to exercise their Extended Warrants pursuant to the terms of the Incentive Program. The Warrant Extension is subject to the approval of the TSX.