On December 20, 2021 EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, reported a strategically focused expansion of its neurology pipeline with the acquisition of the rights to develop cladribine for the treatment of generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD) (Press release, EMD Serono, DEC 20, 2021, View Source [SID1234597486]). The company entered into an agreement to secure the global rights by acquiring Chord Therapeutics, a Swiss-based biotech company focused on rare neuroinflammatory diseases.

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"Cladribine has a unique mechanism of action which is relevant in antibody-mediated disease such as NMOSD and gMG. In exploratory studies, cladribine demonstrated promising results in these diseases. These data have prompted us to initiate further development with cladribine in gMG and NMOSD to potentially bring a new therapeutic option to patients and expand our portfolio in this area," said Danny Bar-Zohar, MD, Head of Global Development for the biopharma business of Merck KGaA, Darmstadt, Germany.

Cladribine is a well characterized molecule that has been extensively studied across MS and oncologic disorders and has shown promising results in exploratory studies in gMG and NMOSD. EMD Serono plans to leverage its existing capabilities to further develop an oral cladribine product tailored specifically for these indications. The transaction is expected to be closed in early 2022 after satisfactory completion of customary closing conditions.

Generalized myasthenia gravis is a disease in which patients experience weakness in ocular, limb, and respiratory muscles and that has a significant impact on Quality of Life. It is estimated that 700,000 people around the world are living with gMG. NMOSD, also known as Devic´s disease, is an autoimmune disease, often misdiagnosed as MS due to similar symptoms. NMOSD is estimated to impact 200,000 people around the world.

On December 20, 2021 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported the agreement by an healthcare-focused institutional investor to exercise certain warrants to purchase up to an aggregate of 150,000,000 ordinary shares represented by 5,000,000 American Depositary Shares (ADSs) having an exercise price of $2.00 per ADS issued by Can-Fite in August 2021, at an exercise price of $2.00 per ADSs (Press release, Can-Fite BioPharma, DEC 20, 2021, View Source [SID1234597540]).

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The ADSs and the ordinary shares issuable upon exercise of the warrants are registered pursuant to a registration statement on Form F-1 (File No. 333-259085) which became effective by the Securities and Exchange Commission (SEC) on August 31, 2021. The gross proceeds to Can-Fite from the exercise of the warrants are expected to be $10.0 million, prior to deducting placement agent fees and offering expenses.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

In consideration for the immediate exercise of the warrants for cash, the exercising holder will be issued new unregistered warrants to purchase ordinary shares represented by ADSs in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"). The warrants will be exercisable into an aggregate of up to 180,000,000 ordinary shares represented by 6,000,000 ADS, at an exercise price of $2.00 per ADS and have a term of exercise equal to five (5) years following the effectiveness of an initial resale registration statement registering the ADSs issuable upon the exercise of the warrants.

Can-Fite intends to use the net proceeds from the offering for working capital including for the launch of the Phase II study in NASH and Phase III liver cancer study as well as other general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the 1933 Act and, along with the ADSs or the ordinary shares issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. The Company has agreed to file a registration statement with the SEC covering the resale of the ADSs and ordinary shares of issuable upon exercise of the new warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On December 20, 2021, Coeptis Pharmaceuticals, Inc. ("Coeptis"), our wholly-owned subsidiary, reported that it entered into amendment No. 1 to that certain promissory note in the original principal amount of $2,300,000 related to CD038-GEAR-NK-Auto to (i) make a payment of $550,000 towards the outstanding principal amount, (ii) extend the maturity date for the outstanding balance from December 31, 2021 to March 31, 2022 and increase the minimum percentage ownership from 20% to 25% (Filing, 8-K, Coeptis Pharmaceuticals, DEC 20, 2021, View Source [SID1234597761]). Pursuant to the amendment, if the promissory note is timely paid by March 31, 2022, Coeptis will maintain its 50% ownership interest in the CD038-GEAR-NK(Auto) product candidate, and if the promissory note is not timely paid by March 31, 2022, Coeptis’ ownership interest in such assets will automatically be reduced to 25% and the promissory note will be automatically cancelled and will no longer be due or payable. The original promissory note was described in our Current Report on Form 8-K that was filed with the SEC on August 19, 2021.

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Simultaneous with the entering into of such amendment, Coeptis paid in full the outstanding amount due under that certain promissory note in the original principal amount of $950,000 related to CD038-SNP-DIAG. Upon the making of such payment, Coeptis secured its 50% ownership of the CD038-SNP-DIAG product candidate.

In addition, on December 20, 2021, we and VyGen-Bio, Inc. entered into a long form Co-development and Steering Committee Agreement, which agreement governs the relationship between us and VyGen-Bio related to development efforts and revenue sharing for both CD038-GEAR-NK(Auto) and CD038-SNP-DIAG product candidates. A copy of the Co-development and Steering Committee Agreement attached at Exhibits 4.1 to this Current Report on Form 8-K.

On December 20, 2021 FibroGen, Inc. (Nasdaq: FGEN), a leading biopharmaceutical company discovering, developing, and commercializing first-in-class therapeutics, and HiFiBiO Therapeutics, a private, multinational clinical-stage biotherapeutics company with expertise in immune modulation and single cell science, reported an extension of their partnership with FibroGen’s exercise of an exclusive license option for HiFiBiO’s anti-CCR8 monoclonal antibody program (HFB1011) (Press release, HiFiBiO Therapeutics, DEC 20, 2021, View Source [SID1234597440]).

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"We are pleased to add the HiFiBiO CCR8 program and the HFB101110 molecule to our preclinical development pipeline," said John Hunter, Chief Scientific Officer, FibroGen. "With this addition in the immuno-oncology space, we have the exciting opportunity to further expand our early development pipeline."

"We are excited to strengthen our FibroGen partnership with the license of HFB1011, a unique program targeting CCR8, a GPCR majorly expressed on regulatory T cells in the tumor microenvironment. Our antibody, identified by using our single B cell cloning platform, is another demonstration of our Drug Intelligent Science (DIS) approach for novel drug discovery and development. Together with the Galectin-9 program (HFB2009), we expand our collaboration with FibroGen to develop transformative medicines in immuno-oncology", said Liang Schweizer, Ph.D., Chief Executive Officer, HiFiBiO.

Under the terms of the agreement, HiFiBiO will receive a $35 million upfront payment from FibroGen in addition to potential clinical, regulatory, and commercial milestones. HiFiBiO will also be eligible to receive royalties based upon net sales.

FibroGen will have the sole right to develop all products in the CCR8 program worldwide. The development candidate is expected to enter clinical development in 2023.

About CCR8

CCR8 is a GPCR with prevalent and highly specific expression on immunosuppressive tumor infiltrating regulatory T cells (Tregs) across different tumor types. Stimulation of CCR8 by its ligand results in proliferation of Tregs and immune-suppression in the tumor microenvironment. Targeting CCR8 with an antibody able to mediate cell killing through antibody-dependent cellular cytotoxicity (ADCC) offers the potential to selectively deplete highly immunosuppressive Tregs in the tumor microenvironment and promote anti-tumor immunity.

On December 20, 2021 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), reported that Lineage and its subsidiary, Cell Cure Neurosciences Ltd., have entered into an exclusive worldwide collaboration and license agreement with Roche and Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), for the development and commercialization of a retinal pigment epithelium (RPE) cell therapy for the treatment of ocular disorders, including advanced dry age-related macular degeneration (dry AMD) with geographic atrophy (GA) (Press release, Lineage Cell Therapeutics, DEC 20, 2021, View Source [SID1234597458]).

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Genentech will assume responsibility for further clinical development and commercialization of Lineage’s OpRegen program, which currently is being evaluated in a Phase 1/2a open-label, dose escalation clinical safety and efficacy study in patients with advanced dry AMD with GA. Under the terms of the collaboration agreement, Lineage will complete activities related to the ongoing clinical study, for which enrollment is complete, and perform certain manufacturing activities. Genentech will pay Lineage a $50 million upfront payment and Lineage is eligible to receive up to $620 million in additional development, approval and sales milestone payments, in addition to tiered double- digit royalties.

"Genentech is a clear global leader in ophthalmology and has demonstrated a longstanding commitment to patients, innovative research and successful product development," said Brian M. Culley, Lineage’s CEO. "Their desire to combine our cell therapy technology with their ophthalmology expertise and capabilities will help advance the OpRegen program more rapidly and we believe successfully to patients with serious ocular disorders, such as dry age-related macular degeneration. Lineage’s objective is to pioneer a new branch of regenerative medicine, based on transplanting whole cells into the body to restore activity lost to aging, injury or disease. We believe the results we have demonstrated to date with OpRegen represent a paradigm change many did not believe possible with cell therapy, by restoring retinal tissue and potentially halting or reversing the expansion of geographic atrophy. I am incredibly proud of what the Lineage team has accomplished with the OpRegen program and look forward to joining forces with the Genentech team as they work to take this program to the next level and potentially to patients in need of treatment."

Mr. Culley continued, "Looking ahead, Lineage will remain focused on advancing our spinal cord injury and oncology programs as well as announcing new disease settings where we plan to deploy our technology, either on our own or through strategic alliances. All of us at Lineage are immensely proud to have the opportunity and responsibility to advance a new and exciting branch of medicine, and our aim is to make a profound impact on the patients who serve as our inspiration."

"Genentech has a longstanding commitment to discovering and developing novel drugs for the treatment of serious eye disorders such as with advanced dry AMD with GA, which is one of our focus areas within ophthalmology," said James Sabry, M.D., Ph.D., global head of Pharma Partnering, Roche. "We are excited to partner with Lineage Cell Therapeutics to advance potential new therapies in an area of high unmet medical need."

Conference Call Information

Lineage will host a live conference call and webcast today beginning at 8 a.m. ET to discuss the collaboration with the Roche Group and Genentech. Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through December 27, 2021, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 5174206.

About OpRegen

OpRegen has been developed in part through contributions and financial grants made by Hadasit Medical Research Services and Development Ltd. ("Hadasit") and the Israeli Innovation Authority (the "IIA"). Lineage is obligated to pay a portion of upfront, milestone and royalty payments it receives to Hadasit and the IIA. OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with a best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new "thaw-and-inject" formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study was to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen has been well tolerated to date and there have been no new, unexpected ocular or systemic adverse events or serious adverse events related to OpRegen or study procedures that have not been previously reported.