On June 2, 2022 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, reported the pricing of an underwritten public offering of 10,000,000 American Depositary Shares (the "ADSs"), each ADS representing one ordinary share of the Company, at a public offering price of $0.40 per ADS, for aggregate gross proceeds of $4 million, prior to deducting underwriting discounts and commissions, and other offering expenses (Press release, TC Biopharm, JUN 2, 2022, View Source [SID1234615473]). In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 1,500,000 ADSs at the public offering price per share, less the underwriting discounts and commissions, to cover over-allotments, if any.

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The offering is expected to close on or about June 7, 2022, subject to satisfaction of customary closing conditions.

EF Hutton, division of Benchmark Investments, LLC, is acting as sole book-running manager for the offering.

A registration statement on Form F-1 (File No. 333-265159), was filed with the Securities and Exchange Commission ("SEC") and was declared effective on June [2], 2022. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source Electronic copies of the final prospectus relating to this offering, when available, may be obtained from EF Hutton, division of Benchmark Investments, LLC, 590 Madison Avenue, 39th Floor, New York, NY 10022, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 404-7002.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 registration or qualification under the securities laws of any such state or jurisdiction.

On June 2, 2022 Aptose Biosciences, Inc. (NASDAQ: APTO, TSX: APS), reported that in the section of updated clinical findings with HM43239, the fifth bullet point should read "Eight total responses, including seven CRs and one PR, and favorable safety achieved at three separate dose levels (80 mg, 120 mg, 160 mg)" (Press release, Aptose Biosciences, JUN 2, 2022, View Source [SID1234615524]). The corrected release follows:

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Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, today released highlights from a key opinion leader (KOL) and corporate update event held today, June 2, 2022. The event included an up-to-date review of clinical data for Aptose’s two investigational products under development for hematologic malignancies: HM43239, an oral, myeloid kinome inhibitor in an international Phase 1/2 trial in patients with relapsed or refractory acute myeloid leukemia (AML); and luxeptinib, an oral, dual lymphoid and myeloid kinome inhibitor in a Phase 1 a/b trial in patients with relapsed or refractory B-cell malignancies, and in a separate Phase 1 a/b trial in patients with relapsed or refractory AML or high risk myelodysplastic syndrome (MDS).

Guest KOLs included Brian Druker, M.D., of the Oregon Health & Science University, Naval G. Daver, M.D., of The University of Texas MD Anderson Cancer Center, and Brian Andrew Jonas, M.D., Ph.D., of the University of California, Davis, Comprehensive Cancer Center, who discussed the current treatment landscape and unmet medical need in treating patients with acute myeloid leukemia (AML), as well as their experiences with Aptose’s investigational therapies.

The webcast of the presentation, including the Q&A with the guest KOLs, is available on Aptose’s website here.

Aptose provided updated clinical findings with HM43239, a potent suppressor of FLT3, SYK, JAK 1/2 and mutant forms of cKIT kinases operative in AML:

Clinically validated in a highly diverse set of relapsed/refractory (R/R) AML patients
Fast Track Designation supported by multiple complete remissions (CRs) in FLT3-mutant refractory R/R AML, including those who failed prior therapy with other FLT3 inhibitors
New CRi at 160 mg dose in a R/R AML patient with wildtype FLT3 and other adverse mutations
Patient with CRi at 120 mg dose bridged to hematopoietic stem cell transplantation
Eight total responses, including seven CRs and one PR, and favorable safety achieved at three separate dose levels (80 mg, 120 mg, 160 mg)
One DLT of muscle weakness (not rhabdomyolysis) reported at 200 mg
Three separate doses (80 mg, 120 mg, 160 mg) selected for Expansion Clinical Trials
Single agent Expansion Clinical Trials in FLT3-mutated and FLT3-unmutated AML expected to begin in the second half of 2022
Combination (HM43239 with venetoclax) Expansion Clinical Trials in FLT3-mutated and FLT3-unmutated AML expected to begin in the first half of 2023
Aptose also reviewed clinical findings with the new G3 formulation of luxeptinib (Lux):

G3 formulation was designed to increase plasma exposure and lower pill burden
Patients already administered G3 formulation at 50 mg, 100 mg and 200 mg
G3 formulation is being tested in patients with R/R B-cell malignancies and R/R AML
G3 formulation encouraging with rapid absorption and exposures maintained over 3 days
Plan transition from G1 to G3 continuous dosing if PK modeling studies are supportive
"We’re pleased to announce a new complete remission (CRi) today with HM43239 in a relapsed AML patient with wildtype FLT3 and mutations in diverse genes (RAS, BCOR, U2AF1, SETBP1), expanding the genotypes and R/R AML patient population that may respond to this drug that has thus far been generally well tolerated," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "We’ve identified three doses and target patient populations for our next stage of Expansion Clinical Trials with HM43239, as we move along a pathway toward registrational studies. For Lux, our new G3 formulation appears to be significantly better absorbed than the original formulation and we continue to believe in its potential as a unique dual lymphoid and myeloid kinome inhibitor."

On June 1, 2022 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported that President and Chief Executive Officer, Theodore (Ted) Ashburn, M.D., Ph.D., will participate in a fireside chat at the Jefferies Global Healthcare Conference on Wednesday, June 8, 2022 at 3:30 p.m. ET in New York, NY (Press release, Oncorus, JUN 1, 2022, View Source [SID1234615321]).

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A live webcast of the fireside chat can be accessed by visiting the Investors & Media section of Oncorus’ website at View Source A replay of the webcast will be archived on Oncorus’ website for 90 days following the event.

On June 1, 2022 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported it has entered into a worldwide license and collaboration agreement with Roche for the development and commercialization of camonsertib (also known as RP-3500), a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase) for the treatment of tumors with specific synthetic-lethal genomic alterations including those in the ATM gene (Ataxia-Telangiectasia mutated kinase) (Press release, Repare Therapeutics, JUN 1, 2022, View Source [SID1234615337]). Under the collaboration, Roche will assume development of camonsertib with the potential to expand development into additional tumors and multiple combination studies.

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"Camonsertib has the potential to help cancer patients across numerous solid tumors as a monotherapy and possibly in combination with other agents," said Kim Seth, Ph.D., EVP and Head of Business & Corporate Development at Repare. "Given the encouraging data Repare has generated for camonsertib as a potentially best-in-class ATR inhibitor with a promising tolerability profile and patient selection insights in areas of high unmet medical need, and Roche’s leading global footprint and unique expertise in precision oncology, we are confident that Roche is the ideal partner for us to drive the broad global development and commercialization of camonsertib."

"Roche is excited about the emerging DNA damage response field, which represents a promising new approach to precision oncology," said James Sabry, M.D., Ph.D., Global Head of Pharma Partnering, Roche. "We are looking forward to partnering with Repare Therapeutics to further develop camonsertib as a new potential treatment option for patients with significant unmet medical needs across a range of tumor types. The collaboration with Repare builds on Roche’s strategy of personalized healthcare and further strengthens our leadership in oncology."

Under the terms of the agreement, Repare will receive a $125 million upfront payment, and is eligible to receive up to $1.2 billion in potential clinical, regulatory, commercial and sales milestones, including up to $55 million in potential near-term payments, and royalties on global net sales ranging from high-single-digits to high-teens. The collaboration also provides Repare with the ability to opt-in to a 50/50 U.S. co-development and profit share arrangement, including participation in U.S. co-promotion if U.S. regulatory approval is received. If Repare chooses to exercise its co-development and profit share option, it will continue to be eligible to receive certain clinical, regulatory, commercial and sales milestone payments, in addition to full ex-U.S. royalties.

The transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary closing conditions.

Company Conference Call:

The Company will host a conference call with accompanying slides for analysts and investors today at 5:00 p.m. Eastern Time to further discuss the collaboration. To access the call, please dial (877) 870-4263 (U.S.) or (855) 669-9657 (Canada) or (412) 317-0790 (international) at least 10 minutes prior to the start time and ask to be joined to the Repare Therapeutics call. A live video webcast will be available in the Investor section of the Company’s website at View Source A webcast replay will also be archived for at least 30 days.

About Repare Therapeutics’ SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.

On June 1, 2022 Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound, mocravimod, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for mocravimod in combination with allogeneic Hematopoietic Stem Cell Transplant (HSCT) for post remission therapy of Acute Myeloid Leukemia (AML) patients (Press release, Priothera, JUN 1, 2022, View Source [SID1234615355]). FDA’s Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs.

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Priothera is working to initiate the MO-TRANS global Phase 2b/3 study in Europe, US and Japan, to assess the efficacy and safety of mocravimod as an adjunctive and maintenance therapy in adult AML patients undergoing allogeneic HSCT. The MO-TRANS study is expected to start in the second half of 2022 and preliminary data from this study are expected by the end of 2024.

Karen Von Graevenitz, Head of Regulatory Affair at Priothera, commented ""The Fast Track designation grant for mocravimod in combination with allogeneic HSCT is an important milestoneand underlines the significant unmet need in AML patients undergoing HSCT, a serious disease where currently no available therapy exists. The designation means mocravimod will be eligible for expedited review and we will work closely with the US FDA to advance the global Phase 2/3 trial which is due to start in the second half of 2022."

Florent Gros, Co-Founder and CEO of Priothera, added: "Following being granted orphan drug designations for mocravimod in the US and Europe, we are pleased to have been granted Fast Track designation for this highly promising compound. This important regulatory milestone moves us a step closer to bringing mocravimod to patients with AML and other hematologic malignancies."

About Mocravimod
Mocravimod (also known as KRP203), is a synthetic, sphingosine 1-phosphate receptor (S1PR) modulator. This novel investigational drug has been assessed in Phase 1 and Phase 2 trials for safety and tolerability, as well as for efficacy in several autoimmune indications. Promising data from a Phase 1b/2a clinical study in patients with hematological malignancies led Priothera to further develop mocravimod for the treatment of blood cancers.

Mocravimod will be investigated as an adjunctive and maintenance treatment in a Phase 2b/3 study as a potential treatment for patients with Acute Myeloid Leukemia (AML) receiving allogeneic hematopoietic stem cell transplantation (HSCT). Allogeneic HSCT is the only potentially curative approach for AML patients, but current treatments have unacceptably high mortality and morbidity rates.

Priothera leverages S1PR modulator’s unique mode of action to maintain anti-leukemia activity – graft-versus leukemia (GVL) while reducing tissue damage resulting from graft-versus-host disease (GVHD), a consequence of allogeneic HSCT. This novel treatment approach – mocravimod being the only S1PR modulator treating blood cancers – tackles a high unmet medical need and intends to add quality life to patients.