On April 26, 2022 Abbott (NYSE: ABT) reported that received notice of an unsolicited mini-tender offer by TRC Capital Investment Corporation (TRC) to purchase up to 1,000,000 Abbott common shares, representing approximately 0.06% of the company’s outstanding shares (Press release, Abbott, APR 26, 2022, View Source [SID1234612952]). TRC’s offer price of $112.38 per share in cash is approximately 4.5% lower than the $117.69 closing price of Abbott common shares on April 14, 2022, the last closing price prior to commencement of the offer.

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Abbott does not recommend or endorse TRC’s unsolicited below-market mini-tender offer and recommends that shareholders not tender their shares because the offer is at a price significantly below the current market price of Abbott common shares. Abbott is not affiliated or associated in any way with TRC, its mini-tender offer or the mini-tender offer documentation.

Abbott urges shareholders to obtain current market quotations for their shares, to consult with their broker or financial advisor, and to exercise caution with respect to TRC’s mini-tender offer. Abbott recommends that shareholders who have not responded to TRC’s offer take no action. Abbott also recommends that shareholders who have already tendered their shares withdraw those shares in accordance with TRC’s offering documents prior to the expiration of the offer. The offer is currently scheduled to expire at 12:01 a.m. New York City time on Tuesday, May 17, 2022, unless the offer is extended or earlier terminated.

TRC has made similar below-market mini-tender offers for other companies’ shares. Mini-tender offers are devised to seek less than 5% of a company’s stock, thereby avoiding many filing, disclosure and procedural requirements of the U.S. Securities and Exchange Commission (SEC).

The SEC has cautioned investors that some bidders making mini-tender offers at below-market prices are "hoping that they will catch investors off guard if the investors do not compare the offer price to the current market price." The SEC’s guidance to investors on mini-tender offers is available at View Source

Abbott encourages brokers and dealers, as well as other market participants, to review the SEC’s letter regarding broker-dealer mini-tender offer dissemination and disclosure at View Source

Abbott requests that a copy of this press release be included with all distributions of materials relating to TRC’s mini-tender offer related to Abbott common shares.

On 26, 2022 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported Brian M. Culley, Lineage’s Chief Executive Officer, will present at the B. Riley Securities 2022 Neuro & Ophthalmology Virtual Investor Conference, in a fireside chat hosted by Mayank Mamtani, Managing Director, Senior Biotech Research Analyst and Group Head of Healthcare Research at B. Riley Securities, on Wednesday April 27th, 2022 at 3:30pm EST (Press release, Lineage Cell Therapeutics, APR 26, 2022, View Source [SID1234612968]).

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Interested parties can register to view both the live event and replay on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.

On April Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, reported 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 (Press release, Gamida Cell, APR 26, 2022, View Source [SID1234612985]). GDA-201 is an off-the-shelf cell therapy candidate for the treatment of patients with follicular and diffuse large B cell lymphomas. Gamida Cell expects to initiate a company-sponsored Phase 1/2 clinical study in patients with follicular and diffuse large B-cell lymphomas in 2022.

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"FDA clearance of our IND for the cryopreserved formulation of GDA-201 represents a significant milestone for the company and reflects our team’s expertise in the development of NAM-enabled cell therapies," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "Previously announced data from an investigator-sponsored (IS) study evaluating the fresh formulation of GDA-201 demonstrated durable complete responses in heavily pretreated patients with relapsed or refractory lymphoma. We are pleased to advance our plans to begin the company sponsored Phase 1/2 study and progress our novel cryopreserved formulation of GDA-201 with objective to address the unmet need that exists for patients with follicular and diffuse large B cell lymphomas."

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%. 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 most common Grade 3/4 adverse events were thrombocytopenia, hypertension, neutropenia, febrile neutropenia, and anemia. There was no incidents of cytokine release syndrome (CRS), neurotoxic events, GvHD or marrow aplasia.

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 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.

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.

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.

On April 26, 2022 Novartis reported its first quarter financial results 2022 (Presentation, Novartis, APR 26, 2022, View Source [SID1234613001]).

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On April 26, 2022 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next-generation antibody therapeutics, reported the positive results from the GLP toxicology study of PMC-403, the Company’s novel TIE2-activating antibody (Press release, PharmAbcine, APR 26, 2022, View Source;bmode=view&idx=11279911&t=board [SID1234649181]).

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PMC-403 can stabilize and repair damaged and pathologically leaky blood vessels, and it is being developed to treat AMD (Age-related Macular Degeneration), one of the most prevalent neovascular ophthalmology diseases.

With the goal of establishing safety profile in animal models before entering the human trial, the study was conducted to evaluate the toxicokinetics and toxicity of PMC-403. The drug was administered via monthly intravitreal injection to monkeys in different dosing groups.

The result of the study showed that there were no serious safety issues in the test subjects (n=32). There were no unscheduled deaths and no organ weight changes even when PMC-403 was administered with twice the dosage of that of the existing drugs.

"We concluded that PMC-403 is safe enough to be administered in human trials," said Dr. Jin-San Yoo, CEO of PharmAbcine. "The vessel-normalizing mechanism makes PMC-403 a potent drug that can offer longer dosing interval and also be utilized in many other vessel-related diseases, such as chronic kidney diseases, ARDS (Acute Respiratory Distress Syndrome), and sepsis."

Dr. Yoo added, "In addition to the study result, Dr. Quan Dong Nguyen, our newly appointed Scientific Advisory Board member and a world-renowned expert in ophthalmology from Stanford University, will provide tremendous insight to our development efforts. Both of these events are critical milestones in the preparation of PMC-403 for the Phase I clinical trial in ophthalmology. The Company will submit the IND package in 3Q22."