On December 20, 2022 NanOlogy LLC, a clinical-stage interventional oncology drug company, reported publication of a research article entitled Early Phase Trial of Intracystic Injection of Large Surface Area Microparticle Paclitaxel (LSAM-PTX) for Treatment of Mucinous Pancreatic Cysts in Endoscopy International Open (Press release, NanOlogy, DEC 20, 2022, View Source;utm_medium=rss&utm_campaign=nanology-publishes-results-from-a-clinical-trial-of-intracystic-lsam-ptx-in-mucinous-pancreatic-cysts [SID1234625448]).

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Nineteen subjects completed the multicenter open-label dose escalation/confirmation study (NCT03188991), which followed subjects for 6 months to evaluate safety, tolerability, plasma paclitaxel concentration, and change in cyst volume.

No dose limiting toxicities, treatment-related serious adverse events, or clinically significant laboratory changes were reported. Systemic paclitaxel concentration did not exceed 3.5 ng/mL at any timepoint measured supporting the lack of systemic toxicity. By Week 24 a cyst volume reduction (10-78%) was seen in 71% of subjects.

Certain mucinous pancreatic cysts are at high risk for progression to pancreatic cancer. Such cysts are particularly worrisome in nonoperable patients who currently have limited options beyond active surveillance. Results from the trial are intended to support future research in this patient subset to evaluate whether intracystic LSAM-PTX can decrease the rate of progression. The treatment is covered by a recently issued US patent (11,523,983) entitled Treatment of Epithelial Cysts by Intracystic Injection of Antineoplastic Particles. The patent is valid until July 2038 with corresponding filings globally.

Enrollment is also complete (n=54) in a NanOlogy-sponsored clinical trial of intratumoral (IT) LSAM-PTX with systemic chemotherapy in locally advanced pancreatic cancer (LAPC). IT LSAM-PTX was well tolerated with encouraging signals of activity. Results are pending publication.

Pancreatic cancer remains an elusive target for pharmaceutical drug research. NanOlogy views LSAM-PTX as a potential therapeutic platform across the disease spectrum aimed at both stopping progression of high-risk lesions and offering meaningful clinical benefit to pancreatic cancer patients without adding to systemic toxicity.

In all, NanOlogy clinical programs have advanced tumor directed LSAM investigational drugs in multiple solid tumors including pancreas, lung, bladder, peritoneal, ovarian, prostate, and dermal cancers. More than 170 patients have been treated to date across its clinical trials with preliminary signals of tumor and immune response and no confirmed drug-related serious adverse events. Review articles of preclinical and clinical studies supporting LSAM-PTX and another investigational drug, Large Surface Area Microparticle Docetaxel (LSAM-DTX), have been published previously.

On December 19, 2022 Oncotelic Therapeutics, Inc (OTCQB:OTLC) ("Oncotelic", the "Company" or "We"), a clinical stage biotechnology company, reported that it presented new clinical confirming TGF-β2 as the appropriate target for gliomas at the 12th AACR (Free AACR Whitepaper)-JCA Joint Conference: Breakthroughs in Cancer Research— Translating Knowledge into Practice December 10 – 14, 2022, Maui, Hawaii (Press release, Oncotelic, DEC 20, 2022, View Source [SID1234625446]).

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TGF- β consists of three highly similar isoforms: β1, β2, β3

Retrospective analysis TCGA database demonstrated that high TGF-β2, but not TGF-β1 nor TGF-β3, is prognostic indicator for worse OS.

Reduced TGF-β2 in Pediatric Brainstem Patients increased OS from 9 mos to 22 mos, N=95 pts, p<0.0001.

Reduced TGF-β2 in Gliomas patients treated with TMZ increased OS from 25 mos to 94 mos, N=230 pts, p<0.0001.

Reduced TGF-β2 in Gliomas patients treated with Radiation increased OS from 25 mos to 94 mos, N=293 pts, p<0.0001.

The presentation is now available on our website (www.oncotelic.com). Abstract # B22. OT-101 for DMG

"The immunosuppressive growth factor, TGF-β, plays a major role in formation of desmoplasia and promoting tumor growth and metastasis. However, the recent failure of bintrafusp alfa, a bifunctional fusion protein immunotherapy combined a TGF-β1 trap with the anti-PD-L1, which GlaxoSmithKline acquired for 4.2B, casted doubt on the field. The new data presented at JCA confirmed our commitment to TGF-β2 and explained the spectacular failure of the bintrafusp alfa" said Dr. Vuong Trieu, CEO and Chairman of Oncotelic.

On December 20, 2022 Magenta Therapeutics (Nasdaq: MGTA) reported that, per the clinical trial protocol for the MGTA-117 Phase 1/2 Dose Escalation Clinical Trial in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), it has stopped dosing participants at the Cohort 4 dosing level (0.13 mg/kg) and plans to dose additional participants at the Cohort 3 dosing level (0.08 mg/kg) (Press release, Magenta Therapeutics, DEC 20, 2022, View Source [SID1234625445]).

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Three participants have been dosed in Cohort 4, and dose-limiting toxicities (DLTs) were observed in the second and third dosed participants. The first participant completed the 21-day DLT observation period with no DLTs. Subsequent to the Company’s investor presentation on December 13, 2022, it was reported to the Company that the second dosed participant in Cohort 4 experienced a Grade 4 Serious Adverse Event (SAE) (respiratory) considered possibly related to MGTA-117. This SAE was later determined to be a DLT and a Suspected Unexpected Serious Adverse Reaction (SUSAR) due to lung involvement. This participant also experienced Grade 4 aspartate transaminase (AST) and Grade 3 alanine transaminase (ALT) elevations without clinically significant changes in bilirubin, gamma glutamyl transferase or alkaline phosphatase. On December 15, 2022, the Company received a report of a respiratory SAE for the third dosed participant. This SAE was subsequently determined to be the second DLT in Cohort 4, thereby triggering prespecified stopping rules for further dosing in Cohort 4. As of the date of this press release, the clinical trial sites have reported that the first participant with a DLT has demonstrated improved respiratory status and AST/ALT enzyme levels, and the second participant with a DLT had improved respiratory status.

Magenta reported the clinical data and other information applicable to the first observed DLT to the U.S. Food and Drug Administration (FDA) today. Magenta also informed the FDA that the information applicable to the DLT event in the second participant is forthcoming.

In accordance with the clinical trial protocol and following the recommendation of the trial’s safety Cohort Review Committee on December 19, 2022, Magenta plans to continue enrollment at the Cohort 3 dose level. As presented at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 12, 2022, no DLTs were observed in the fifteen participants dosed in the first three Cohorts in the clinical trial. Three out of the four participants in Cohort 3 for whom paired bone marrow samples were collected at baseline and post-dosing had depletion of cancer blast cells in both blood and bone marrow. The Company continues to believe that the benefit/risk profile at the Cohort 3 dose level is acceptable to continue enrolling participants in this trial.

On December 20, 2022 Invitae (NYSE: NVTA), a leading medical genetics company, reported that it has completed a transaction with Integrated DNA Technologies, Inc. (IDT), which includes the sale of Next Generation Sequencing (NGS) research assays under the trademarked name Archer, also known as the Research Use Only (RUO) kitted solutions (Press release, Invitae, DEC 20, 2022, View Source [SID1234625444]). The transaction also includes certain licensed rights to Invitae’s Anchored Multiplex PCR (AMPTM) technology. The transaction value includes total cash consideration of approximately $48 million, subject to certain adjustments. As part of the transaction, Invitae also entered into a supply agreement with IDT to support Invitae’s PCM services.

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This divestiture is part of Invitae’s portfolio optimization efforts and renewed strategic focus to achieve profitable growth in its core genetic testing business, fueling the pursuit of the significant market opportunities of its precision oncology LDT services. This transaction is expected to add to Invitae’s cash position, contribute to the company’s commitment to reduce cash burn and extend its cash runway.

"Today is the next step in executing our business realignment strategy and we’re pleased to complete this transaction with IDT. Many of our talented employees are transferring to IDT immediately, and we expect a seamless transition for the customers that rely on the RUO kitted solutions," said Ken Knight, president and chief executive officer of Invitae. "AMP technology, the foundation for our precision oncology services, including related patents and proprietary know-how, will remain with Invitae, and we’re looking forward to serving patients, physicians and biopharma partners with these emerging offerings."

On December 20, 2022 IMV Inc. ("IMV" or the "Company") (NASDAQ: IMV; TSX: IMV), a clinical-stage biopharmaceutical company advancing a portfolio of therapies based on the Company’s immune-educating platform, DPX, to potentially treat solid and hematologic cancers, reported the closing of its previously announced registered direct offering (the "Offering") for the sale of an aggregate of 3,448,276 common shares (or common share equivalents) (each, a "Share" and, collectively, the "Shares") and warrants to purchase up to an aggregate of 3,448,276 common shares (each, a "Warrant" and, collectively, the "Warrants") at a purchase price of US$2.61 per common share (or common share equivalent) and accompanying Warrant priced at-the-market under the Nasdaq Capital Market (the "Nasdaq") rules (Press release, IMV, DEC 20, 2022, View Source [SID1234625443]). The Warrants have an exercise price of US$2.50 per share, are exercisable immediately, and will expire five years following their date of issuance.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the Offering.

The gross proceeds from the Offering to IMV, before deducting placement agent commissions and other offering expenses and excluding any proceeds that may be received upon exercise of the Warrants, were approximately US$9 million. IMV intends to use the net proceeds from the Offering to continue the clinical development of its lead product candidate, maveropepimut-S, in diffuse large B cell lymphoma (DLBCL), ovarian cancer, the completion of its ongoing basket trial and to continue the development of its proprietary drug delivery platform (DPX) and for general corporate purposes.

The Offering was made pursuant to a registration statement on Form F-10 (File No. 333-266082), effective upon filing with the United States Securities and Exchange Commission (the "SEC") on July 25, 2022 (the "Registration Statement"), and the Company’s Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated July 22, 2022. IMV offered and sold the securities in the United States only. No securities were offered or sold to Canadian purchasers.

A prospectus supplement and accompanying Base Shelf Prospectus relating to the Offering and describing the terms thereof was filed with the applicable securities commissions in Canada and with the SEC in the United States and is available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov, as applicable. Electronic copies of the prospectus supplement and accompanying Base Shelf Prospectus may be obtained upon request by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, or by calling (212) 856-5711 or by emailing [email protected].

For the purpose of Toronto Stock Exchange ("TSX") approval, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as NASDAQ, provided that the transaction is being completed in compliance with the requirements of such other recognized exchange