On September 7, 2022 CytRx Corporation (OTCQB: CYTR) ("CytRx" or the "Company"), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, reported it has been awarded a key patent by the European Patent Office, and that the period for parties to oppose the patent has lapsed without opposition (Press release, CytRx, SEP 7, 2022, View Source [SID1234619194]).

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European Patent No. 3310800 covers the incorporation of the LADR backbone in a variety of drug compounds. The LADR backbone is attached to active pharmaceutical agents in order to target the agents to the diseased tissue, which the Company expects to reduce off-target side effects and allow for higher dosing of the active pharmaceutical ingredient. Dose-limiting toxicities are key limitations to untargeted pharmaceuticals.

CytRx notes that a US patent – US Patent No. 11,384,104 – covering the LADR platform has also recently been issued, which when combined with the European patent results in broad international protection of this important new technology.

In addition to intellectual property to protect the LADR platform, CytRx has also pursued patent protection covering certain specific drugs that incorporate the LADR backbone. For example, the Company recently received US patent number 11,377,473, a patent covering one of its lead pre-clinical candidates, which is based on derivatives of auristatin-E attached to the LADR backbone.

On September 7, 2022 Guided Therapeutics, Inc. or the "Company" (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, reported that it had raised approximately $3.3 million through the sale of 6.6 million shares of the Company’s common stock at 50 cents each (Press release, Guided Therapeutics, SEP 7, 2022, View Source [SID1234619193]). For each common share purchased, the investors also will receive one warrant to purchase an additional share for 50 cents and one warrant to purchase an additional share for 65 cents. Both warrants have a term of four years. If the shares are registered within six months, the warrants will not have a cashless exercise option and they do not carry any anti-dilution features. Investors include certain members of the Company’s board and other long term investors.

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As a part of this transaction, the Company has agreed to exchange certain debt and equity owned by Auctus Funds, LLC, a long term investor in the Company. Under the terms of the agreement, Auctus will exchange $1,060,911 owed to it in debt and 8,775,000 warrants they currently hold that are priced between 15 cents and 20 cents for $1.95 Million worth of units in the new financing, equating to 3.9 Million common shares, 3.9 million warrants priced at 50 cents and 3.9 million warrants priced at 65 cents plus residual debt of approximately $490,000 to be paid to Auctus over an 18 month period in four equal installments.

The primary use of proceeds is to fund the completion and filing of clinical study data needed for FDA approval of the Company’s LuViva Advanced Cervical Scan, which received IRB approval last month for starting the study this quarter. Additional use of proceeds is to support international distribution partners to grow sales throughout the remainder of 2022 and into 2023, as well as for general and administrative costs. Some funds will be used to further reduce debt and allow the Company to continue its efforts to uplist to Nasdaq. To this point, this bridge financing has brought the Company’s stockholders’ equity to nearly break even, assuming current existing exchange agreements are implemented. The Company has informed Nasdaq that it intends to keep its application for uplisting open and to implement the uplist process when market conditions and Company progress make the uplist financing less dilutive. The current S-1/A connected with the uplist will be withdrawn.

"We are extremely pleased that our existing team of fundamental investors has stepped up to fund the Company under reasonable terms, thus positioning the Company for a future uplisting when market conditions may be more favorable and the Company is further along with both the US and Chinese regulators." said Gene Cartwright, CEO of Guided Therapeutics. "The amount and timing of the funding should allow us the flexibility to accomplish many of the Company’s most important goals over the next 12 to 18 months."

On September 7, 2022 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported the launch, in the U.S. market, of Lenalidomide Capsules, a therapeutic equivalent generic version of REVLIMID (lenalidomide) Capsules approved by U.S. Food and Drug Administration (USFDA) (Press release, Dr Reddy’s, SEP 7, 2022, View Source [SID1234619192]). With this volume-limited launch, Dr. Reddy’s is eligible for first-to-market, 180 days of generic drug exclusivity for Lenalidomide Capsules in 2.5 mg and 20 mg strengths.

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"We are pleased with the first-to-market launch of two of our six strengths of Lenalidomide Capsules with 180-day market exclusivity," says Marc Kikuchi, CEO, North America Generics, Dr. Reddy’s Laboratories. "Bringing a more affordable generic version to market creates greater patient access for this important drug."

As previously announced, Celgene agreed to provide Dr. Reddy’s with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S. in settlement of all outstanding claims of its litigation. The agreed-upon percentages remain confidential. As part of the settlement, Dr. Reddy’s is also licensed to sell generic lenalidomide capsules in the U.S. without volume limitation beginning on January 31, 2026.

Dr. Reddy’s Lenalidomide Capsules are available in strengths of 2.5 mg, 5 mg, and 10 mg, each in a bottle-count size of 28, as well as 15 mg, 20 mg, and 25 mg strengths, each in a bottle-count size of 21.

Please click here to see the full prescribing information, along with boxed warning for Dr. Reddy’s Lenalidomide Capsules.

See full prescribing information for complete boxed warning.

EMBRYO-FETAL TOXICITY

Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study similar to birth defects caused by thalidomide in humans. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death.
Pregnancy must be excluded before start of treatment. Prevent pregnancy during treatment by the use of two reliable methods of contraception.
Lenalidomide capsules are available only through a restricted distribution program, called the Lenalidomide REMS program.

HEMATOLOGIC TOXICITY.

Lenalidomide can cause significant neutropenia and thrombocytopenia.

VENOUS AND ARTERIAL THROMBOEMBOLISM

Significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with multiple myeloma receiving lenalidomide with dexamethasone. Anti-thrombotic prophylaxis is recommended.

Revlimid is a trademark of Celgene, a wholly-owned subsidiary of Bristol Myers Squibb.

RDY-0822-441

On September 7, 2022 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing first-in-class allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapies for cancer, reported that company management will participate in two upcoming investor conferences in September (Press release, Adicet Bio, SEP 7, 2022, View Source [SID1234619191]).

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Details of the events are as follows:

H.C. Wainwright 24th Annual Global Investment Conference, September 12-14, 2022, New York, New York

An on-demand presentation given by Chen Schor, President & CEO will be available beginning Monday, September 12, 2022 at 7:00 A.M. ET
Jefferies Cell and Genetic Medicine Summit, September 29-30, 2022, New York, New York

Chen Schor, President & CEO, will present a corporate overview on Friday, September 30, 2022, at 8:00 A.M. ET.
The live audio webcast of the presentations can be accessed on the Investors section of Adicet Bio’s website at View Source An archived replay will be available for 30 days following the presentation.

On September 7, 2022 NANOBIOTIX (Euronext: NANO – Nasdaq: NBTX), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, and LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing paradigm-shifting medicines to patients in China and major Asian markets reported randomization of the first patient in Asia in NANORAY-312, a global Phase 3 registrational trial evaluating NBTXR3 for the treatment of elderly patients with locally advanced head and neck squamous cell carcinoma ("LA-HNSCC") who are ineligible for platinum-based chemotherapy (Press release, Nanobiotix, SEP 7, 2022, View Source [SID1234619190]).

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"We believe NBTXR3 has demonstrated the potential to improve treatment outcomes in multiple solid tumor indications, including in Study 102, the Nanobiotix Phase 1 trial evaluating the product candidate for the treatment of elderly patients with locally advanced head and neck squamous cell carcinoma," said Yizhe Wang, Ph.D., Chief Executive Officer, LianBio. "We look forward to working with our clinical partners at sites across Greater China and South Korea to evaluate NBTXR3 in this difficult-to-treat patient population. With radiotherapy usage on the rise in Asia, we believe NBTXR3 may become an important part of the treatment landscape for patients with cancer in the region."

NANORAY-312 is a global, two-arm, randomized, Investigator’s Choice Phase 3 registrational study that is designed to investigate the efficacy and safety of radiotherapy-activated NBTXR3 with or without cetuximab versus radiotherapy with or without cetuximab in high-risk, chemotherapy-ineligible elderly patients with LA-HNSCC. Eligible participants for NANORAY-312 will be treated with NBTXR3 at a 1:1 ratio after an Investigator’s Choice of radiotherapy alone or radiotherapy in combination with cetuximab. This pivotal trial is expected to enroll 500 patients globally, with approximately 100 patients expected to be enrolled in LianBio’s licensed territories participating in the study.

NANORAY-312 builds on Nanobiotix Study 102, a Phase 1 trial evaluating safety and early signs of efficacy for radiotherapy-activated NBTXR3 in high-risk elderly LA-HNSCC patients who are chemotherapy-ineligible and intolerant to cetuximab. To date, Study 102 has demonstrated median overall survival of 17.9 months in the all-treated population (n=56) and 23.0 months in the evaluable patients (n=44).

LianBio holds exclusive rights to develop and commercialize NBTXR3 in Greater China, South Korea, Singapore and Thailand.

About NBTXR3

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across solid tumors that can be treated with radiotherapy and across different therapeutic combinations. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of radiotherapy-activated NBTXR3 in the NANORAY-312 population.