bioAffinity Technologies Publishes Peer-Reviewed Results of High-Throughput Flow Cytometry Use for Evaluating Lung Health in PLOS ONE

On September 14, 2022 bioAffinity Technologies, (NASDAQ: BIAF, BIAFW), a biotechnology company that develops noninvasive, early-stage diagnostics to detect cancer and diseases of the lung, reported publication of its research in high-throughput flow cytometry analysis of sputum (Press release, BioAffinity Technologies, SEP 14, 2022, View Source [SID1234619562]). The journal PLOS ONE, published Sputum analysis by flow cytometry; an effective platform to analyze the lung environment reporting on results of analyzing sputum by flow cytometry as the basis for high-throughput diagnostic tests to determine the health of the lung.

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"The PLOS ONE paper presents our unique method for determining the health of an individual’s lungs"

"The PLOS ONE paper presents our unique method for determining the health of an individual’s lungs," bioAffinity President and CEO Maria Zannes said. "Flow cytometry allows for analysis of whole cells and cell populations that make up the lung environment. Our research provides a better understanding of how disease changes the lung environment and how flow cytometry can be used as a diagnostic tool by analyzing sputum. Flow cytometry is successfully used to diagnose blood cancers, particularly at early stage. In the paper, we describe an innovative and highly efficient method to analyze sputum for the presence of lung cancer, with the potential to focus on other diseases such as COPD and asthma."

bioAffinity Technologies is addressing the need for noninvasive diagnosis of early-stage cancer and diseases of the lung, and targeted cancer treatment. The Company develops proprietary noninvasive diagnostic tests using technology that preferentially targets cancer cells and cell populations indicative of a diseased state. The Company’s first product, CyPath Lung, is a non-invasive test that has shown high sensitivity and specificity for the detection of early-stage lung cancer. The test is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Services. Research and optimization of the Company’s platform technologies are conducted in its laboratories at The University of Texas at San Antonio.

About CyPath Lung

CyPath Lung is a noninvasive test for the early detection of lung cancer which uses flow cytometry to count and characterize cells in a person’s sputum, or phlegm. The test’s automated analysis of the flow cytometry data detects cell populations that indicate cancer is present. CyPath Lung has the potential to increase overall diagnostic accuracy of lung cancer diagnosis leading to increased survival while lowering the number of unnecessary invasive procedures, reducing patient anxiety, and lowering medical costs. CyPath Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Services.

Oncotelic Presenting Data for OT101 Against Diffuse Intrinsic Pontine Glioma (DIPG) at the 2022 Society for Neuro-Oncology (SNO) Annual Meeting

On September 14, 2022 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), developer of treatments for rare and orphan indications, including Parkinson Disease and DIPG, reported that the Company will have two poster presentations at the upcoming 2022 Society for Neuro-Oncology (SNO) Annual Meeting on November 16-20, 2022, Tampa Bay, Florida (Press release, Oncotelic, SEP 14, 2022, View Source [SID1234619561]).

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Abstract Number: DDEL-16

Title: Delivery of OT-101 – TGF-2 Antisense- for the treatment of glioblastoma
Session Date: Friday November 18, 2022
Presentation Time: 7:30 PM – 9:30 PM
Abstract Number: RTID-04

Title: Clinical potential of targeting transforming growth factor beta 2 with OT-101 for post-radiation consolidation in diffuse intrinsic pontine glioma
Session Date: Friday November 18, 2022
Presentation Time: 7:30 PM – 9:30 PM
"There is no standard treatment for progressive DIPG after the failure of radiation therapy and no salvage regimen has been shown to extend survival. Therefore, there is an urgent need for therapeutic innovations for treatment of DIPG. We believe that OT-101 may offer hope for salvage therapy of pediatric DIPG patients who have this rare and fatal disease." said Dr. Vuong Trieu, CEO Oncotelic. "Now that JVCo is completed with the formation of Sapu Bioscience, we are accelerating clinical development of OT-101 for DIPG. Looking forward to providing updates on this important program".

About Dr. Fatih Uckun, DIPG Lead

The Chief Medical Officer of Oncotelic, Dr. Fatih Uckun MD, PhD, is an internationally renowned KOL in pediatric cancer research and treatment. Dr. Uckun is an elected Member of the American Society for Clinical Investigation (ASCI), an honor society for physician-scientists, and an active member of several professional organizations. He received numerous awards for his work on monoclonal antibodies, recombinant cytokines and fusion proteins, radiation sensitizers, kinase inhibitors and targeted therapeutics for difficult-to-treat cancers, including the Stohlman Memorial Award of the Leukemia Society of America (now known as Leukemia and Lymphoma Society), the highest honor given to a Leukemia Society Clinical Scholar. Dr. Uckun completed his residency training in pediatrics, clinical fellowship training in Hematology/Oncology/Blood and Bone Marrow Stem Cell Transplantation as well as postdoctoral research training in immunology at the University of Minnesota. Dr. Uckun has more than 30 years of professional experience in developmental therapeutics with a special emphasis on targeted therapeutics/precision medicines and biopharmaceuticals against childhood cancer. Dr. Uckun worked as a Professor of Pediatrics, Therapeutic Radiology-Radiation Oncology, Pharmacology, as well as Director of the Biotherapy Institute at the University of Minnesota (1986-1997), where he became the first recipient of the highly prestigious Endowed Hughes Chair in Biotherapy, and as a Professor of Pediatrics and Head of Translational Research in Leukemia and Lymphoma of the Children’s Center for Cancer and Blood Diseases at the University of Southern California (2009-2015). From 2012-2015, Dr. Uckun served as chair of the Biotargeting Working Group and a Member of the Coordination and Governance Committee of the NCI Alliance for Nanotechnology in Cancer. Prior to joining Oncotelic, Dr. Uckun served as Head of Immuno-Oncology at Ares Pharmaceuticals and Executive Medical Director and Strategy Lead in Global Oncology and Hematology at Syneos Health. Prior to this, he was Chief Scientific Officer of Jupiter Research Institute and, before that, held senior-level scientific and research positions at Parker Hughes Institute and its cancer center, Paradigm Pharmaceuticals, and the Children’s Cancer Study Group, an NCI-funded cooperative clinical trials consortium that coordinated pediatric leukemia trials at 120 institutions in the US, Canada, Australia and Europe. As a Vice Chair of the New Agents Committee as well as Member of the Leukemia Steering Committee of the Children’s Cancer Study Group, Dr. Uckun has helped design and direct several Phase I-III studies in pediatric cancer patients.

Lantern Pharma to Present Positive Preclinical Data on the Efficacy of LP-184 for Pancreatic Cancer at the AACR Special Conference for Pancreatic Cancer

On September 14, 2022Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning ("M.L.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that it will present positive preclinical data on the in vivo efficacy of its drug candidate LP-184 for pancreatic cancer at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference for Pancreatic Cancer, Sept 13-16th, 2022, in Boston, MA (Press release, Lantern Pharma, SEP 14, 2022, View Source [SID1234619560]).

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LP-184 is a small molecule drug candidate and next generation acylfulvene that preferentially damages DNA in cancer cells that harbor mutations in DNA damage repair (DDR) genes and that overexpress the enzyme PTGR1. Pancreatic cancer cells are expected to be sensitive to LP-184 treatment as around 25% of these cancers harbor both elevated levels of PTGR1 and mutations in DDR genes.

The AACR (Free AACR Whitepaper) poster, which is being presented in collaboration with Igor Astsaturov, M.D., Ph.D. at The Marvin and Concetta Greenberg Pancreatic Cancer Institute at Fox Chase Cancer Center, shows that LP-184 treatment has potent anti-tumor effects in mouse models of pancreatic cancer that harbor mutations in the DDR genes ATR or BRCA1. After two rounds of LP-184 treatment, the ATR and BRCA1 pancreatic cancer mouse models had tumor growth inhibitions of 140% and 112%, respectively. In these mice, LP-184 treatment was generally well-tolerated and minimal differences were observed in body weight and blood counts relative to treatment control groups.

The AACR (Free AACR Whitepaper) presentation will show additional data demonstrating that LP-184 can act synergistically in vitro and in vivo with several standard of care or FDA approved agents, including spironolactone and radiation therapy. These results continue to demonstrate LP-184’s potential as a therapeutic agent for pancreatic cancer as a monotherapy or in combination with other approved therapies.

LP-184 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of pancreatic cancer, malignant gliomas, and ATRT, and was also granted a Rare Pediatric Disease Designation for ATRT. These designations and continued positive preclinical data will help to accelerate LP-184 towards a targeted IND submission in Q1 2023 and Phase 1 clinical trials anticipated to commence in Q2 2023.

Details of the poster presentation are listed below and can be found on the AACR (Free AACR Whitepaper) conference website. A full version of the poster will be available on Lantern’s website on September 19th, 2022.

Title: LP-184, a tumor site activated small molecule synthetic lethal therapeutic, is synthetically lethal in pancreatic cancers with DNA damage repair defects
Date and Time: September 14, 2022, 4:00pm ET
Poster Number: B033
Presenter: Aditya Kulkarni, Ph.D., Lantern Pharma

About Lantern Pharma

Lantern Pharma (NASDAQ: LTRN) is a clinical-stage oncology-focused biopharmaceutical company leveraging its proprietary RADR A.I. and machine learning platform to discover biomarker signatures that identify patients most likely to respond to its pipeline of genomically-targeted therapeutics. Lantern is currently developing four drug candidates and an ADC program across nine disclosed tumor targets, including two phase 2 programs. By targeting drugs to patients whose genomic profile identifies them as having the highest probability of benefiting from the drug, Lantern’s approach represents the potential to deliver best-in-class outcomes.

Sarepta Therapeutics Prices $1.0 Billion of Convertible Senior Notes Due 2027

On September 14, 2022 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, reported the pricing of $980.0 million aggregate principal amount of convertible senior unsecured notes that will mature on September 15, 2027, unless earlier redeemed, repurchased or converted (Press release, Sarepta Therapeutics, SEP 14, 2022, View Source [SID1234619559]). The notes are being offered and sold only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Act") (the "Rule 144A offering"). Sarepta has also granted the initial purchasers of the notes an option to purchase up to an additional $150 million aggregate principal amount of notes. The sale of the notes to the initial purchasers is expected to settle on September 16, 2022, subject to customary closing conditions.

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An entity affiliated with a member of Sarepta’s Board of Directors has agreed to purchase $20 million aggregate principal amount of the notes in a separate concurrent private placement under Section 4(a)(2) of the Act (the "concurrent private placement" and together with the Rule 144A offering, the "offerings"). The offering of the notes in the Rule 144A offering is not conditioned upon the closing of the concurrent private placement, but the concurrent private placement is conditioned upon the closing of the Rule 144A offering.

Sarepta estimates that the net proceeds of the offerings will be approximately $979.4 million (or approximately $1.1 billion if the initial purchasers’ option to purchase additional shares is exercised in full), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses payable by Sarepta. Sarepta intends to use $110.7 million of the net proceeds from the offerings to pay the cost of the capped call transactions described below, and approximately $248.3 million to repurchase approximately $150.6 million in aggregate principal amount of its 1.50% Convertible Senior Notes due 2024 (the "2024 Notes"), inclusive of any applicable premium and accrued interest (described below). In addition, Sarepta intends to use approximately $585.5 million of the net proceeds from the offerings to repay borrowings under, to pay accrued and unpaid interest and prepayment fees under, and terminate its credit agreement and the remaining net proceeds to fund general corporate purposes. Sarepta anticipates that, along with current cash and projected revenue, this offering is sufficient to fund operations to profitability.

The notes will be senior, unsecured obligations of Sarepta and bear cash interest at a rate of 1.25%, payable on March 15 and September 15 of each year, beginning on March 15, 2023. The notes will be convertible, only during certain periods and subject to certain circumstances, into cash, shares of Sarepta’s common stock, or a combination of cash and shares of Sarepta’s common stock, at Sarepta’s election. The initial conversion rate for the notes is 7.0439 shares of Sarepta’s common stock per $1,000 principal amount of notes, which is equivalent to an initial conversion price of approximately $141.97 per share of Sarepta’s common stock, representing an approximately 35.0% conversion premium based on the last reported sale price of Sarepta’s common stock on September 13, 2022. Prior to September 20, 2025, the notes will not be redeemable. On or after September 20, 2025 and on or before the 41st scheduled trading day immediately preceding the maturity date, Sarepta may redeem for cash all or part of the notes (subject to certain conditions), at its option, if the last reported sale price of Sarepta’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive), including the trading day immediately preceding the date on which Sarepta provides notice of redemption, during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which Sarepta provides notice of redemption.

In connection with the pricing of the notes and the concurrent private placement, Sarepta entered into privately negotiated capped call transactions with certain of the initial purchasers or their respective affiliates and certain other financial institutions (the "option counterparties"). The capped call transactions are expected generally to reduce the potential dilution to Sarepta’s common stock upon conversion of any notes and/or offset any potential cash payments Sarepta is required to make in excess of the principal amount of converted notes, as the case may be, subject to a cap. The cap price of the capped call transactions will initially be $210.32 per share, which represents a premium of 100.0% over the last reported sale price of Sarepta’s common stock of $105.16 per share on September 13, 2022, and is subject to certain adjustments under the terms of the capped call transactions. If the initial purchasers of the notes exercise their option to purchase additional notes, Sarepta expects to enter into additional capped call transactions with the option counterparties.

Sarepta has been advised that, in connection with establishing their initial hedges of the capped call transactions, the option counterparties or their respective affiliates expect to purchase shares of Sarepta’s common stock and/or enter into various derivative transactions with respect to Sarepta’s common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of Sarepta’s common stock or the notes at that time. In addition, the option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Sarepta’s common stock and/or by purchasing or selling Sarepta’s common stock or other securities of Sarepta’s in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so during any observation period related to a conversion of notes). This activity could also cause or avoid an increase or a decrease in the market price of Sarepta’s common stock or the notes, which could affect the ability of holders to convert the notes and, to the extent the activity occurs following conversion or during any observation period related to a conversion of the notes, it could affect the number of shares of Sarepta’s common stock and value of the consideration that holders will receive upon conversion of the notes.

Contemporaneously with the pricing of the notes in this offering, Sarepta entered into separate, privately negotiated transactions with certain holders of its 2024 Notes to repurchase approximately $150.6 million in aggregate principal amount of the 2024 Notes for approximately $248.3 million in cash, inclusive of any applicable premium and interest (the "concurrent note repurchases"). The terms of the concurrent note repurchases were individually negotiated with certain holders of the 2024 Notes.

Sarepta expects that holders of any 2024 Notes that Sarepta has agreed to repurchase that have hedged their equity price risk with respect to such notes (the "hedged holders") will, concurrently with or shortly after the pricing of the notes, unwind their hedge positions by buying Sarepta’s common stock and/or entering into or unwinding various derivative transactions with respect to Sarepta’s common stock.

In connection with the issuance of the 2024 Notes, Sarepta entered into capped call transactions (the "existing capped call transactions") with certain financial institutions (the "existing option counterparties"). Sarepta intends to enter into agreements with the existing option counterparties concurrently with or shortly after the closing of this offering to terminate a portion of the existing capped call transactions in a notional amount corresponding to the principal amount of the 2024 Notes repurchased in the concurrent note repurchases. In connection with any such termination of a corresponding portion of the existing capped call transactions, Sarepta expects that such existing option counterparties and/or their respective affiliates will sell shares of Sarepta’s common stock in secondary market transactions, and/or unwind various derivative transactions with respect to Sarepta’s common stock. In connection with such terminations, Sarepta anticipates that it will receive proceeds from the existing counterparties, which it intends to use for general corporate purposes.

Any repurchase of the 2024 Notes and the termination of a corresponding portion of the existing capped call transactions described above, and the potential related market activities by holders of the 2024 Notes participating in the concurrent note repurchases and the existing counterparties, as applicable, could increase (or reduce the size of any decrease in) or decrease (or reduce the size of any increase in) the market price of Sarepta’s common stock, which may affect the trading price of the notes at that time. Sarepta cannot predict the magnitude of such market activity or the overall effect it will have on the price of the notes or Sarepta’s common stock.

The offer and sale of the notes are not being registered under the Securities Act, or any state securities laws. The notes may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act and any applicable state securities laws.

This news release does not constitute an offer to sell or a solicitation of an offer to buy 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 laws of such jurisdiction.

TRACON Pharmaceuticals Announces Fast Track Designation by the FDA for Envafolimab for the Treatment of the Soft Tissue Sarcoma Subtypes of UPS and MFS

On September 14, 2022 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported that the U.S. Food and Drug Administration (FDA) has granted fast track designation for the development of envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy (Press release, Tracon Pharmaceuticals, SEP 14, 2022, View Source [SID1234619557]).

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"We applied for fast track designation based on activity observed in the ENVASARC Phase 2 pivotal trial and are pleased to receive this notification from the FDA," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Soft tissue sarcoma is a disease in need of new treatments and we expect to provide data through the ENVASARC pivotal trial showing superior efficacy and safety of envafolimab compared to currently approved therapy for refractory soft tissue sarcoma. Accrual in the pivotal ENVASARC trial remains robust and we expect to report an independent data monitoring committee interim safety review [and interim efficacy review in the fourth quarter."

The FDA designed the fast track process to facilitate the development and expedite the review of drugs to treat serious or life-threatening diseases or conditions and fill unmet medical needs. Fast track designation can confer important benefits, including the potential eligibility for priority review of a Biologics License Application, if relevant criteria are met, as discussed in our Annual Report on Form 10-K for the year ended December 31, 2021.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.