LegoChem Biosciences / Light Chain Bioscience and Iksuda enter Licensing Agreement for Antibody Drug Conjugate program

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."

Orgenesis Announces Stock Repurchase Plan of Up to $10 Million

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."

Race starts preclinical breast cancer study for Bisantrene

On May 15, 2020 Race Oncology reported that it has entered into a collaborative preclinical research program with The University of Newcastle (Press release, Race Oncology, MAY 15, 2020, View Source [SID1234561649]).

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Eminent cancer researcher, Associate Professor Nikki Verrills of the Hunter Medical Research Institute, will lead the project.

The aim of this research program is to identify combinations of current breast cancer drugs that when paired with Bisantrene show equivalent efficacy to existing treatment options, but with significantly reduced serious side effects.

"This is an exciting development for Race and we are looking forward to collaborating with Nikki’s team," Chief Scientific Officer, Dr Daniel Tillett said.

"Historical trial data has shown that Bisantrene can provide the same level of treatment as existing chemotherapy drugs, yet with considerably less damage to the patient’s heart. We believe that this research may potentially unlock a number of new combinations and opportunities for the Company."

Current breast cancer treatments can result in serious and life threatening side effects such as life-long damage to the patient’s heart.

Many breast cancer patients are cured of their cancers only to later die of treatment-induced heart failure.

Any new intellectual property resulting from this research will be wholly-owned by Race and the expenditure is eligible for a rebate under the Australian Government’s R&D Tax Incentive Program.

Bisantrene was the subject of a large Phase III single agent clinical trial in the USA in advanced breast cancer patients in the late 1980s and early 1990s.

The trial showed that Bisantrene had the same efficacy as the standard of care treatment, doxorubicin, but caused significantly less damage to the patient’s heart (4% with Bisantrene, 23% with doxorubicin).

Race is pursuing Bisantrene combination therapies in breast cancer and other solid tumours, as part of its ‘5-Path’ strategy. This could lead to new cancer treatments with improved safety and efficacy (ASX announcement 14 November 2019).

The results of this study will support the Phase I/IIa human trial of a Bisantrene in breast cancer, currently scheduled to begin in Australia in late 2020.

Associate Professor Nikki Verrills said she was thrilled to work with Race on the project.

"Being able to apply our cancer expertise to Bisantrene, which has so much potential for improving the lives of cancer patients, is very exciting."

Race starts preclinical breast cancer study for Bisantrene

On May 15, 2020 Race Oncology reported that it has entered into a collaborative preclinical research program with The University of Newcastle (Press release, Race Oncology, MAY 15, 2020, View Source;utm_medium=rss&utm_campaign=race-starts-preclinical-breast-cancer-study-for-bisantrene [SID1234561258]).

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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

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Eminent cancer researcher, Associate Professor Nikki Verrills of the Hunter Medical Research Institute, will lead the project.

The aim of this research program is to identify combinations of current breast cancer drugs that when paired with Bisantrene show equivalent efficacy to existing treatment options, but with significantly reduced serious side effects.

"This is an exciting development for Race and we are looking forward to collaborating with Nikki’s team," Chief Scientific Officer, Dr Daniel Tillett said.

"Historical trial data has shown that Bisantrene can provide the same level of treatment as existing chemotherapy drugs, yet with considerably less damage to the patient’s heart. We believe that this research may potentially unlock a number of new combinations and opportunities for the Company."

Current breast cancer treatments can result in serious and life threatening side effects such as life-long damage to the patient’s heart.

Many breast cancer patients are cured of their cancers only to later die of treatment-induced heart failure.

Any new intellectual property resulting from this research will be wholly-owned by Race and the expenditure is eligible for a rebate under the Australian Government’s R&D Tax Incentive Program.

Bisantrene was the subject of a large Phase III single agent clinical trial in the USA in advanced breast cancer patients in the late 1980s and early 1990s.

The trial showed that Bisantrene had the same efficacy as the standard of care treatment, doxorubicin, but caused significantly less damage to the patient’s heart (4% with Bisantrene, 23% with doxorubicin).

Race is pursuing Bisantrene combination therapies in breast cancer and other solid tumours, as part of its ‘5-Path’ strategy. This could lead to new cancer treatments with improved safety and efficacy (ASX announcement 14 November 2019).

The results of this study will support the Phase I/IIa human trial of a Bisantrene in breast cancer, currently scheduled to begin in Australia in late 2020.

Associate Professor Nikki Verrills said she was thrilled to work with Race on the project.

"Being able to apply our cancer expertise to Bisantrene, which has so much potential for improving the lives of cancer patients, is very exciting."

Tetra Bio-Pharma Announces Sizing of Public Offering

On May 15, 2020 Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSXV:TBP) (OTCQB:TBPMF), reported that, in connection with its previously announced overnight marketed offering, a syndicate of agents led by Raymond James Ltd. and Canaccord Genuity Corp. (collectively, the "Agents"), have agreed to sell 33,089,000 units ("Units") of the Company at a price of $0.26 per Unit (the "Issue Price") for aggregate gross proceeds of approximately $8.6 million (the "Offering") (Press release, Tetra Bio Pharma, MAY 15, 2020, View Source [SID1234561074]). Each Unit will consist of one common share in the capital of Tetra (a "Common Share") and one common share purchase warrant (a "Warrant"). Each Warrant will entitle the holder thereof to acquire one Common Share at a price of $0.32 for a period of 36 months from the closing date of the Offering.

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The Company has also granted the Agents an option (the "Over-Allotment Option") to sell up to an additional 15% of the Units sold under the Offering, at the Issue Price. The Over-Allotment Option may be exercised in whole or in part to purchase Common Shares, Warrants or Units as determined by the Agents upon written notice to the Company at any time up to 30 days following the closing date of the Offering.

The Offering is being conducted pursuant to the Company’s Canadian base shelf prospectus dated April 1, 2020 (the "Base Shelf Prospectus"). A prospectus supplement (the "Prospectus Supplement") relating to the Offering will be filed in each of the provinces of Canada. Copies of the Prospectus Supplement and accompanying Base Shelf Prospectus will be available under the Company’s profile on SEDAR at www.sedar.com.

The Company intends to use the net proceeds of the Offering to continue the development of its clinical program, including Phase 2 and phase 3 clinical trials, toxicology, regulatory and manufacturing expenses related to QIXLEEF (PPP001).

The Offering is expected to close on or about May 22, 2020, subject to customary closing conditions.

Closing of the Offering is subject to certain conditions including, but not limited to, the receipt of all necessary approvals including the approval of the TSX Venture Exchange.