On June 1, 2022 IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") reported that it intends to (i) issue shares of common stock of the Company ("Shares") in payment of the outstanding C$5,450,000 aggregate principal amount of the Company’s convertible unsecured subordinated debentures due June 30, 2022 (the "Debentures") and (ii) issue 573,684 Shares at a deemed price of C$0.38 per Share in payment of an aggregate of C$218,000 interest due on the Debentures as of June 30, 2022 (Press release, IntelGenx, JUN 1, 2022, View Source [SID1234615365]).

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Under the terms of the trust indenture governing the Debentures, as supplemented (the "Indenture"), the Company has the option to (i) satisfy its obligation to repay all or any portion of the principal amount of the Debentures outstanding by issuing and delivering Shares at a deemed price of 95% of the current market price (as defined in the Indenture) of the Shares at the maturity date, and (ii) pay the semi-annual interest on the Debentures in Shares (by dividing each $40 of interest amount by the closing price of the Shares on the day immediately preceding the public announcement by the Company of its intention to pay interest in Shares), in each case subject to customary conditions set forth in the Indenture. Holders of Debentures should refer to the Indenture, available under the Company’s profile on SEDAR at www.sedar.com, for a complete description of the terms of the Debentures.

The issuance of the Shares in repayment of the principal of the Debentures and in payment of interest on the Debentures is subject to the acceptance by the Toronto Stock Exchange ("TSX"). The Shares issued in repayment of the principal of the Debentures and in payment of interest on the Debentures will be issued pursuant to exemptions from the prospectus requirements of applicable securities laws.

The Debentures are listed on the TSX under the symbol "IGX.DB".

On June 1, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, reported the activation of the initial clinical sites to screen and enroll patients in the company-sponsored Phase 1/2 study evaluating a cryopreserved formulation of GDA-201, a readily available cell therapy candidate for the treatment of follicular and diffuse large B cell lymphomas (NCT05296525) (Press release, Gamida Cell, JUN 1, 2022, View Source [SID1234615381]). On April 26, 2022, Gamida had announced that the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application and removed the clinical hold for a cryopreserved formulation of GDA-201.

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"We are excited to be screening patients for enrollment in our company-sponsored Phase 1/2 clinical study of our novel, cryopreserved formulation of GDA-201, which has the potential to address the significant unmet need that exists for patients with follicular and diffuse large B cell lymphomas having relapsed or refractory disease," said Ronit Simantov, M.D., chief medical and scientific officer of Gamida Cell. "As described in previously announced clinical data, an investigator-sponsored (IS) study evaluating the fresh formulation of GDA-201 demonstrated encouraging results in heavily pretreated patients with lymphoma. With the initiation of enrollment, we look forward to dosing the first patient in our clinical study of the novel cryopreserved formulation of GDA-201."

GDA-201 leverages Gamida Cell’s proprietary NAM technology platform to expand the number and functionality of NK cells to direct tumor cell killing properties and antibody-dependent cellular cytotoxicity (ADCC). In an investigator-sponsored Phase 1/2 study in patients with relapsed or refractory lymphoma, treatment with the fresh formulation of GDA-201 with rituximab demonstrated significant clinical activity. Of the 19 patients with non-Hodgkin lymphoma (NHL), 13 complete responses and one partial response were observed, with an overall response rate of 74% and a complete response rate of 68%. The most common Grade 3/4 adverse events were thrombocytopenia, hypertension, neutropenia, febrile neutropenia, and anemia. At the December 2021 Annual Meeting of American Society of Hematology (ASH) (Free ASH Whitepaper), two-year follow-up data were reported on outcomes and cytokine biomarkers associated with survival. The data demonstrated a median duration of response of 16 months (range 5-36 months) and an overall survival at two years of 78% (95% CI, 51%–91%). In the IS study, GDA-201 was well-tolerated and no dose-limiting toxicities were observed in 19 patients with NHL and 16 patients with multiple myeloma.

The study of the cryopreserved formulation of GDA-201 is currently open to enrollment at Henry Ford Health (Detroit, MI) and the Masonic Cancer Center at the University of Minnesota; additional sites will be added in the coming months and updated in Clinicaltrials.gov (NCT05296525). The Phase 1 portion of the study is designed to evaluate the safety of GDA-201 in patients with follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL)/high grade B-cell lymphoma (HGBCL), marginal zone lymphoma or mantle cell lymphoma. The Phase 2 expansion phase is designed to evaluate the safety and efficacy of GDA-201 in two patient cohorts, FL and DLBCL/HGBCL. The study will include patients who have relapsed or refractory lymphoma after at least two prior treatments, which may include CAR-T or stem cell transplant.

About NAM Technology

Our NAM-enabling technology, supported by positive Phase 3 data, is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.

About GDA-201

Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy candidate for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. There are approximately 40,000 patients with relapsed/refractory lymphoma in the US and EU, which is the patient population that will be studied in the GDA-201 Phase 1/2 clinical trial.

For more information about GDA-201, please visit View Source For more information on the Phase 1/2 clinical trial of GDA-201, please visit www.clinicaltrials.gov.

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

On June 1, 2022 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported the pricing of an underwritten public offering of 10,000,000 shares of its common stock at a public offering price of $4.75 per share (Press release, Concert Pharmaceuticals, JUN 1, 2022, View Source [SID1234615398]). The gross proceeds to Concert, before deducting underwriting discounts and commissions and estimated offering expenses payable by Concert, are expected to be approximately $47.5 million. Concert has granted the underwriters a 30-day option to purchase up to an additional 1,500,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

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All shares in the offering are being sold by Concert. The offering is expected to close on or about June 6, 2022, subject to the satisfaction of customary closing conditions.

Concert intends to use the net proceeds from the offering, together with its current cash and cash equivalents, to complete clinical development supporting the filing of its New Drug Application for CTP-543 for the treatment of moderate to severe alopecia areata in adults, conduct pre-commercial activities related to CTP-543 and support its pipeline development, working capital needs and other general corporate purposes.

Jefferies and Truist Securities are acting as joint book-running managers for the offering. JMP Securities, A Citizens Company, and Mizuho Securities are acting as lead managers, and H.C. Wainwright & Co. is acting as co-manager for the offering.

The offering is being made only by means of a written prospectus supplement and prospectus forming part of a shelf registration statement previously filed with the Securities and Exchange Commission (SEC) and declared effective on November 16, 2020. A preliminary prospectus supplement relating to the offering was filed with the SEC. The final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may also be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected] or Truist Securities, Inc., Attention: Prospectus Department, 3333 Peachtree Road NE, 9th floor, Atlanta, Georgia 30326, by telephone at (800) 685-4786, email: [email protected].

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

On June 1, 2022 Doma Biopharmaceutical reported the closing of a Series A financing round of RMB 950 million (Press release, Doma Biopharmaceutical, JUN 1, 2022, View Source [SID1234636146]). The investors included Biocytogen, China Life Private Equity Investment, PICC Capital, SDIC Venture Capital, Suzhou Industrial Park, Taiping Healthcare Fund, and CMB International. As the founding shareholders of Doma Pharmaceutical, the investors aspired to build the company into a China-based integrated incubator for sustained life sciences innovations by pooling cutting-edge technologies, outstanding talents, and longterm capital inputs.

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Doma was established in Suzhou BioBAY in September 2021 with a vision to develop innovative drugs and disruptive biotechnologies. The company has successfully incubated dynamic biotech companies with novel proprietary drug pipelines/biotechnologies, while giving birth to an industry cluster for innovative life sciences. That has been made possible by the company’s optimal integration of talents, technologies/products and capital on the shareholders’ robust open R&D service platform. As a fully integrated incubator for life science innovations, the company will empower incubatees with diverse.

"We are grateful to our founding shareholders for their contributions to the Series A financing, which has set the company in motion," said Dr. Huang Rui, Director and Chief Operating Officer of Doma. "The past decade has seen rapid progress in life sciences research in China and an increasing number of qualified and experienced high-caliber talents in the industry. That has given us the confidence to integrate science, industry, talent, and capital resources to build the company into a fully integrated incubation platform for life science innovations in China. On this platform, we will create a series of innovative and vibrant biotech companies that seek to address real clinical needs, identify market value, improve public health, and realize sustainable development by taking groundbreaking approaches. Going forward, Doma aims to incubate world-class companies based in China. That entails joint efforts with technology innovators, top talents, investors, and industrial partners to develop innovative target drugs, dual anti-ADC drugs, oncolytic viruses, cell therapies, pet drugs, diagnostic reagents, and AI products."

"We are honored to be a part in the co-investment for the establishment of Doma," said Dr. Shen Yuelei, Chairman of Biocytogen, one of the founding shareholders. "Biocytogen boasts world-leading technology platforms for gene editing, antibody drug discovery and screening, innovative animal model development, and clinical drug development, as well as the ability to develop new drugs throughout the process from early target validation to preclinical research and clinical development of pharmaceutical molecules. Besides, Biocytogen’s Project Integrum program and unique drug development platform will bolster Doma’s R&D capabilities, helping the company incubate more innovative and dynamic biotech.

"It is a trend inevitable for China to become a pharmaceutical powerhouse through rapid construction of a biopharma innovation incubator and a biopharma industry cluster with global influence, while platform companies have emerged as one of the key drivers to enhance the industrial capacity," said Jiang Li, Managing Director of China Life Private Equity Investment. "Doma is incubating new antibody drug companies with premier biopharma talents at home and abroad working on Biocytogen’s antibody drug development service platform and the unique Project Integrum platform. A bright future can be anticipated from its distinctive operating model that combines industrial incubation and drug pipeline development. We hope that our collaboration with Biocytogen and Doma will result in greater concentration and flow of advanced technologies, high-end talents, abundant capital, and other innovation factors, faster commercialization of scientific and technological findings, incubation of more new biotech companies, and globalization of local businesses. These outcomes will ultimately accelerate China’s bioeconomy growth and secure strategic advantages, while providing humanity with more innovative and effective pharmaceuticals."

"Life sciences is a subject that keeps exploring new ways to prolong life and cure illness, carrying the hopes and expectations of all mankind," said Shu Wanting, Managing Director of PICC Capital. "To embark on a novel industrial growth path, China must be an innovator rather than a follower, while being more patient and persistent along the way. We are very pleased to be one of the founding shareholders of Doma, standing ready to contribute to the company’s biotech industry cluster incubation by combining our extensive industry experience, top-tier talents, and long-term capital inputs with those of other shareholders. We hope that Doma will soon roll out a series of new products that will make a big difference in treating diseases and extending people’s lives.

Flagship Pioneering, a world-renowned biotech incubator, a biotech platform should be versatile within the same sector and able to quickly adapt successful R&D cases to succeeding R&D processes within the same sector. The more versatile a biotech platform is, the more functional and valuable it becomes. With its unique industry incubation system and Biocytogen’s Project Integrum resources, Doma has the potential to become an excellent biotech platform. We expect the company to become ‘China’s Flagship Pioneering’."

On June 1, 2022 Theolytics is a biotechnology company harnessing viruses to combat disease reported the company has been awarded a Biomedical catalyst grant by Innovate UK to progress a novel therapy for multiple myeloma patients (Press release, Theolytics, JUN 1, 2022, View Source [SID1234630918]).

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Multiple myeloma is an incurable blood cancer, for which cancer-killing (‘oncolytic’) viruses are an emerging therapy offering hope. The therapy selectively infects and kills cancer cells – targeting heterogeneous, systemic cancers based on their phenotype rather than molecular targets, providing the promise of durable remission and curative potential.

This grant will focus on translating Theolytics’ lead candidate to clinic-readiness. The work includes partnering with the University of Sheffield to investigate the efficacy of Theolytics’ lead candidate

in clinically representative, drug-resistant models of multiple myeloma. This project will further validate this novel therapy, positioning the lead oncolytic virus candidate for testing in Phase I clinical trials.

Margaret Duffy, Chief Scientific Officer and Co-Founder said: "The myeloma treatment landscape has changed considerably in recent years; despite some promising clinical results with BCMA targeted therapies, lasting remissions remain a challenge for many myeloma patients. Due to the unique mechanism of this oncolytic virus candidate, we wish to offer hope to those with advanced, refractory disease. This grant provides the opportunity to advance our candidate to the clinics and we are grateful to Innovate UK for their continued support of Theolytics’ work."

Michelle Lawson, Academic Collaborator, University of Sheffield said: "I am absolutely thrilled to be working in collaboration with Theolytics on this exciting project to further demonstrate the efficacy of their lead candidate in our preclinical models of myeloma, as subsequent in-patient use could ultimately lead to much-needed improvements in outcomes for myeloma patients with advanced disease."