On May 15, 2020 MV BioTherapeutics reported the launch of the company website that provides most relevant information on the technology and pipeline of MV BioTherapeutics (Press release, MV BioTherapeutics, MAY 15, 2020, View Source [SID1234632273]). We have changed the original name of the company from MicroVaccines to MV BioTherapeutics (from now on MV).

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"During the past years we have developed therapeutic live biotherapeutics with different mode of action as compared to the original live attenuated microbial vaccines, which were exemplified as microvaccines" says Dr. Fabio Grassi, founder and Chairman of MV.

"With two lead indications and potential future developments of this promising application, it was important to characterize the company as non-exclusively dedicated to vaccines that is a very specific pharmaceutical area."

The abbreviation MV is directly related to the two patented microorganisms ApyraMed and ApyraVax

On May 15, 2020 Affibody AB ("Affibody") and Inmagene Biopharmaceuticals ("Inmagene") reported a strategic partnership to develop and commercialize ABY-035, a bispecific molecule targeting Interleukin-17A (IL-17), for multiple auto-immune diseases (Press release, Affibody, MAY 15, 2020, View Source [SID1234575707]). Inmagene will be responsible for commercialization in mainland China, Hong Kong, Taiwan, and Macau (Greater China), and South Korea, as well as development activities in the Asia Pacific region, excluding Japan. Affibody will retain global commercial rights outside of Greater China and South Korea. The partners will work together to enroll patients into global registrational trials to support Biologics License Applications (BLAs) in multiple indications worldwide.

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Under the terms of the agreement, Affibody will receive a $10 million upfront payment and is eligible to receive up to $215.5 million in additional regulatory and sales milestones, plus royalties on sales in Inmagene’s commercialization territory. Additionally, Inmagene will share the global development costs of select clinical trials and be eligible to receive payments and royalties from Affibody relating to certain global development and commercialization milestones. Affibody will be responsible for the manufacturing and supply of ABY-035 for development and commercialization worldwide and is not precluded from additional collaboration and licensing agreements in territories not covered by this agreement.

Currently in Phase 2 development, ABY-035 is an innovative fusion protein targeting IL-17. ABY-035 combines Affibody’s proprietary protein therapeutics platform (Affibody technology), which confers greater potency in a small molecular format, and the Albumod technology which provides a long half-life. Together, these features provide the potential for best-in-class efficacy in a convenient, less frequent and at-home subcutaneous administration. In the ongoing Phase 2 Psoriasis Trial, ABY-035 has demonstrated a strong safety profile and clear clinical benefits.

"Based on ABY-035’s strong clinical data and significant advantages over antibody-based IL-17 therapies, we believe it has the best-in-class potential," said Jonathan Wang, Ph.D., Inmagene’s Chairman and CEO. "ABY-035 may provide affordable solutions to Chinese patients with high unmet medical needs and become a key pillar for Inmagene to establish a leadership position in China’s immunology related therapeutic areas."

With rich experience in bringing multiple relevant biologics targeting IL-17, IL-1, IL6, T cell and B cell to China as well as the US and Europe markets, the Inmagene clinical development team will work closely with Affibody to conduct global trials in multiple regions to shorten the development timelines. Inmagene will take the lead of the global development strategy and implementation in two indications.

"This creative alliance between Affibody and Inmagene is poised to deliver on ABY-035’s best-in-class potential by accelerating the time to commercialization across multiple indications and accessing a significant market opportunity in Greater China" said David Bejker, CEO of Affibody. "With the extensive track record of the Inmagene team, we will be able to leverage access to the Chinese market, providing additional opportunities for development and commercialization. The team’s vision of creating the leading Chinese immunology company is one we are excited to be a part of."

About ABY-035

ABY-035 is a novel bispecific agent, potently targeting both subunits of IL-17A as well as albumin, which has been specifically designed to utilize the strengths of Affibody’s technology platform to create a very small protein drug (18 kDa, an eighth of the size of an antibody) with very high apparent affinity to IL-17A (KD ~300fM) and antibody-like half-life due to the strong (KD ~50pM) binding affinity to serum albumin.

Accumulated patient data from ~150 psoriasis patients, some of which have been dosed for more than two years, support a safe and efficacious product profile with best-in-class potential.

ABY-035 is currently being evaluated in an open-label extension of the double-blinded, placebo controlled, 52 week, Phase 2 proof-of-concept study (AFFIRM-35, NCT03591887) which has enrolled 108 moderate-to-severe psoriasis patients in centers throughout Germany to evaluate the efficacy, safety and tolerability of ABY-035. The primary efficacy measure is PASI 90 at twelve weeks. Secondary endpoints include absolute and relative PASI-measures at weeks 12, 24, and 52; DLQI; itch and pain VAS; safety and tolerability, and pharmacokinetics.

In a Phase 1/2 study, ABY-035 demonstrated favorable safety and tolerability across multiple doses and dosing regimens with rapid and sustained efficacy in patients. The primary objective of this study was to evaluate mechanism of action, safety, tolerability and pharmacokinetics of ABY-035.

On May 15, 2020 LegoChem Biosciences, Inc. ("LCB") (KOSDAQ:141080), based in Daejeon, South Korea, reported that a worldwide license agreement with Iksuda Therapeutics ("Iksuda") for the development and commercialization of LCB73, a CD19-targeted ADC candidate for hematological tumors. (Press release, LegoChem Biosciences, MAY 15, 2020, View Source [SID1234573676]).

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Under the terms of the agreement, Iksuda will make an upfront payment of USD 5 million and LCB is eligible to receive development, regulatory and commercial milestone payments of up to USD 222 million as well as royalties on commercial sales. LCB is also entitled to receive a prearranged percentage of sublicense revenue if Iksuda enters into license agreement with third party companies. All payments will be shared with LCB’s partner Light Chain Bioscience (Novimmune SA).

LCB73 has been generated in a partnership between LCB and Swiss-based Light Chain Bioscience’s (Novimmune SA) by combining LCB’s cancer-selectively activated next-generation linker and toxin platform with Light Chain Bioscience’s proprietary antibody targeting CD19. Preclinical data of LCB73 along with the clinical outcome of other CD19-targeted therapies suggest that the ADC may be an effective treatment option for various B-cell hematological cancers including diffuse large B-cell lymphoma (DLBCL) and Burkitt lymphoma.

We are very pleased to expand our partnership with Iksuda to advance the development of LCB73, in addition to the recent license agreement which enables the application of our ADC platform to Iksuda’s pipeline of Next Generation ADCs," said Dr. Yong-Zu Kim, CEO & President of LCB. "This particular ADC program will set a significant milestone as it is our first lead ADC candidate utilizing our next-generation prodrug payload, whose commercial and clinical potential will be explored through this collaboration."

"We have been very impressed with preclinical data using LCB73 which have demonstrated significant single-agent anti-cancer activity in B cell malignancies and a competitive toxicity profile," said Dr. David Simpson, CEO of Iksuda. "We look forward to advancing this candidate into the clinic in the most efficient manner, utilizing our extensive UK and US based ADC expertise to drive preclinical and clinical development activities."

On May 15, 2020 LegoChem Biosciences, Inc. ("LCB"), based in DaeJeon South Korea, reported a worldwide license agreement with Iksuda Therapeutics ("Iksuda") for the development and commercialization of LCB73, a CD19-targeted ADC candidate for hematological tumors (Press release, Light Chain Bioscience, MAY 15, 2020, View Source [SID1234562776]).

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Under the terms of the agreement, Iksuda will make an upfront payment of $5 million and LCB is eligible to receive development, regulatory and commercial milestone payments of up to $222 million as well as royalties on commercial sales. LCB is also entitled to receive a prearranged percentage of sublicense revenue if Iksuda enters into License agreement with third party companies. All payments will be shared with LCB’s partner Light Chain Bioscience (Novimmune SA).

LCB73 has been generated in a partnership between LCB and Swiss-based Light Chain Bioscience (Novimmune SA) by combining LCB’s cancer-selectively activated next-generation linker and toxin platform with Light Chain Bioscience’s proprietary antibody targeting CD19. Preclinical data of LCB73 along with clinical outcome of other CD19-targeted therapies suggest that the ADC may be an effective treatment option for various B-cell hematological cancers including diffuse large B-cell lymphoma (DLBCL) and Burkitt lymphoma.

"We are very pleased to expand our partnership with Iksuda to advance development of LCB73, in addition to the recent license agreement which enables application of our ADC platform to Iksuda’s pipeline of Next Generation ADCs ." said Dr. Yong-Zu Kim, CEO & President of LCB. "This particular ADC program will set a significant milestone as it is our first lead ADC candidate utilizing our next-generation prodrug payload, whose commercial and clinical potential will be explored through this collaboration."

"We have been very impressed with preclinical data using LCB73 which have demonstrated significant single-agent anti-cancer activity in B cell malignancies and a competitive toxicity profile" said Dr. David Simpson, CEO of Iksuda. "We look forward to advancing this candidate into the clinic in a the most efficient manner, utilizing our extensive UK and US based ADC expertise to drive pre-clinical and clinical development activities."

On May 15, 2020 Orgenesis Inc. (NASDAQ: ORGS) ("Orgenesis" or the "Company"), a pioneering global biotech company committed to accelerating commercialization and transforming the delivery of cell and gene therapies (CGTs) while lowering costs, reported that its Board of Directors has authorized a repurchase plan (the "Repurchase Plan") of up to $10 million of the Company’s common stock from time to time on the open market or in privately negotiated block transactions (Press release, Orgenesis, MAY 15, 2020, View Source [SID1234561685]).

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The timing and amount of any shares repurchased shall be subject to management’s discretion and will depend upon a variety of factors including general and business market conditions, corporate and regulatory requirements, share price, and alternative investment opportunities. Any share repurchases shall be in accordance with the Company’s repurchase plan under Rule 10b-18 under the Securities Exchange Act of 1934. The Repurchase Plan shall commence on May 29, 2020. The Repurchase Plan does not obligate the Company to acquire any specific number of shares in any period, and may be expanded, extended, modified, suspended or discontinued by the Board at any time. Any repurchased shares will be retired and returned to the Company’s treasury.

The Repurchase Plan will be funded using the Company’s working capital. As of March 31, 2020 the Company had cash on hand of approximately $107 million. As of May 8, 2020, Orgenesis had approximately 22 million shares of common stock outstanding.

Vered Caplan, CEO of Orgenesis, commented, "Earlier this year, we completed the sale of Masthercell for approximately $127 million in net proceeds. Not only does this transaction strengthen our balance sheet, but it clearly illustrates our ability to create significant value for shareholders. Nevertheless, we are even more excited about the growth prospects now for our Cell & Gene Therapy (CGT) Biotech Platform, which we believe provides a pathway for groundbreaking autologous therapies to become commercially available on an industrial scale and at prices accessible to large populations. Since the beginning of this year alone, we are making significant traction building our pipeline of advanced POCare Therapeutics, broadening our suite of POCare Technologies, and expanding our POCare Network with some of the leading hospitals and research institutes in the world. I truly believe Orgenesis is well positioned to lead the CGT industry by lowering costs, accelerating commercialization and transforming the delivery of CGTs. For this reason, we are excited to announce board approval for the stock buyback at this time given the current share price, which we do not believe reflects the underlying value of the business. Between upcoming catalysts and opportunistic share repurchases, we are committed to maximizing long-term shareholder value."