On October 24, 2023 Lipocine presented its corporate presentation (Presentation, Lipocine, OCT 24, 2023, View Source [SID1234636300]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On October 24, 2023 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported that its IMA203 TCR-T program has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA Center for Biologics Evaluation and Research (CBER) in multiple relapsed and/or refractory HLA-A*02:01-positive and PRAME-expressing cancers, including cutaneous melanoma, uveal melanoma, endometrial carcinoma, synovial sarcoma, and ovarian cancer. IMA203 is a TCR-T cell therapy targeting PRAME, a protein frequently expressed in a large variety of solid tumors (Press release, Immatics, OCT 24, 2023, View Source [SID1234636299]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The FDA RMAT designation for multiple indications underscores the broad potential of IMA203 and the benefits it may provide for advanced-stage solid tumor patients. This is an important regulatory milestone and a recognition of our clinical development progress for this program," said Cedrik Britten, Chief Medical Officer of Immatics. "The close support from the FDA resulting from the RMAT status enhances our efforts to accelerate bringing IMA203 to cancer patients by enabling real-time discussions on patient populations, trial design and CMC."

Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes for promising pipeline products, including cell therapies, that includes all the benefits of Fast Track and Breakthrough designation programs. An investigational cell therapy is eligible for RMAT designation if it meets the definition of regenerative medicine therapy, it is intended to treat, modify, reverse, or cure a serious or life-threatening disease; and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for that disease. Advantages of the RMAT designation include early interactions with the FDA that may be used to discuss potential surrogate or intermediate endpoints for accelerated approval and potential ways to satisfy post-approval requirements, potential priority review of the biologics license application (BLA) and other opportunities to expedite development and review.

Based on publicly available information1, it is the Company’s understanding that this is the first time that FDA has granted a RMAT designation for an oncology drug candidate for more than two solid tumor indications. As of Sep 30, 2023, the U.S. FDA has received at least 238 requests for RMAT designations and granted 922.

About IMA203 and target PRAME
ACTengine IMA203 T cells are directed against an HLA-A*02:01-presented peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers, thereby supporting the program’s potential to address a broad cancer patient population. Immatics’ PRAME peptide is present at a high copy number per tumor cell and is homogeneously and specifically expressed in tumor tissue. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform, XPRESIDENT. Through its proprietary TCR discovery and engineering platform XCEPTOR, Immatics has generated a highly specific T cell receptor (TCR) against this target for its TCR-based cell therapy approach, ACTengine IMA203.

ACTengine IMA203 TCR-T is currently being evaluated in three ongoing Phase 1b dose expansion cohorts in last-line patients: Cohort A IMA203 GEN1 monotherapy, Cohort B IMA203 in combination with an immune checkpoint inhibitor (deprioritized) and Cohort C IMA203CD8 GEN2 monotherapy, where IMA203 engineered T cells are co-transduced with a CD8αβ co-receptor.

About ACTengine
ACTengine is a personalized cell therapy approach for patients with advanced solid tumors. The patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor. The approach is also known as TCR-engineered cell therapy (TCR-T). All Immatics’ ACTengine product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.

The ACTengine T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth.

On October 24, 2023 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC)(OTC PINK:ENSCW), a clinical-stage company applying transformative chemistry to improve prescription drug safety, reported that it has entered into a securities purchase agreement (the "SPA") with investors ("Investors") in the form of senior secured convertible notes (the "Notes") and warrants exercisable for Ensysce common stock (the "Warrants") in a private placement for an aggregate investment of $1.7 million (Press release, Ensysce Biosciences, OCT 24, 2023, View Source [SID1234636298]). The initial closing is expected to occur on or before October 26th and will raise $566,667, prior to fees and offering expenses.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Lynn Kirkpatrick, CEO of Ensysce commented, "The financing is an excellent step allowing us to advance the clinical development of our highly unique TAAP and MPAR technologies. The funding will support the completion of a time of onset study and regulatory milestones for PF614, our lead product. We are very pleased that we were able to secure this additional funding to continue our progress and support our mission to deliver superior pain relief options while also providing abuse and overdose protection for opioid products."

The Notes, with total gross proceeds expected to be $1.7 million before fees and expenses, are convertible into shares of Ensysce common stock ("Common Stock") at a conversion price of $1.5675, the base price set at the time of execution of the SPA. The Notes have a maturity date of 6 months from the applicable closing date, will be issued with an original discount of 8% and will bear interest from date of issuance at 6% per annum. Monthly principal payments and interest in cash, or at the election of the purchaser in whole or in part which may occur at any time, in common stock will begin approximately 90 days after each respective closing. The Warrants to be issued at the initial closing will have the right to purchase up to 1,255,697 shares of common stock at an exercise price of $1.5675, the same as the conversion price, and are exercisable for five years following the date of issuance. An initial $566,667 of funding will be secured upon the initial closing upon satisfaction of certain conditions with a second closing of $1,133,333 under similar terms expected to occur upon satisfaction of certain conditions.

The conversion price for the Notes of $1.5675 and the exercise price for the Warrants of $1.5675 meet a minimum price requirement established by The Nasdaq Stock Market in connection with a potential issuance of 20% or more of the common stock of a public company or 20% or more of the voting power outstanding before the potential issuance. If the Company is not able to pay the principal and interest on the Notes when due and the Company needs to issue more shares of Common Stock or on terms different than those provided by the transaction documents, the Company might, in certain circumstances, be required to obtain stockholder approval before doing so.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful. This news release is being issued pursuant to and in accordance with Rule 135c under the Securities Act of 1933, as amended.

On October 24, 2023 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported that effective October 20, 2023, the compensation committee of the Company’s board of directors granted options to purchase an aggregate of 64,500 shares of the common stock of the Company to eight newly hired employees with a per share exercise price of $3.54, the closing trading price on the grant date (Press release, Coherus Biosciences, OCT 24, 2023, View Source [SID1234636297]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The stock options were granted pursuant to the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan, which was approved by the Company’s board of directors in June 2016 under Rule 5635(c)(4) of the Nasdaq Global Select Market for equity grants to induce new employees to enter into employment with the Company.

On October 24, 2023 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the third quarter of fiscal year 2023 (Press release, Chugai, OCT 24, 2023, View Source [SID1234636296]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the third quarter of this year, we saw a continuation of the increase in both revenue and profits on a Core-basis from the first half. Sales increased both in domestic and overseas, driven by steady growth in new products such as Polivy, Vabysmo in Japan and by more than double-digit growth overseas in mainstay products Hemlibra and Alecensa. In R&D, Chugai made steady progress with in-house projects, mainly in late-stage development. An application for crovalimab in the treatment of paroxysmal nocturnal hemoglobinuria (PNH) was accepted for filing in the U.S. In addition, Alecensa achieved its primary endpoint in a global phase III study as a post-operative adjuvant therapy for early-stage ALK-positive non-small cell lung cancer (NSCLC), and Enspryng started a global phase III study for thyroid ophthalmopathy (TED), its fifth indication, and is being simultaneously developed in multiple diseases. We will continue to drive innovation to deliver innovative new drugs to patients as quickly as possible," said Dr. Osamu Okuda, Chugai’s President and CEO.

< Third Quarter Financial Results (Core results, January to September 2023) >

Chugai reported increased revenue and operating profit for the first nine months (Core-basis) compared to the same period of the previous fiscal year, consistent with second-quarter results.

Revenue increased in approximately 15% overall, with growth in both domestic and overseas sales and other revenue. Domestic sales increased by approximately 10%. In the oncology field, the growth was approximately 3% year-on-year due to the contribution of steady market penetration of new product Polivy, and the growth of mainstay product Tecentriq despite the impact of biosimilars and NHI drug price revisions on mature products such as Avastin and Herceptin. In the specialty field, sales increased by approximately 20%, driven by the penetration of new products Vabysmo for ophthalmology and Evrysdi for neuroscience, as well as the contribution of mainstay products Hemlibra for hemophilia and Enspryng for neuroscience, and the supply of Ronapreve for COVID-19 treatment to the government in the first quarter. Overseas sales increased by approximately 20% due to solid growth in exports of Hemlibra and Alecensa. Other revenue increased by approximately 13%, mainly due to the increase in royalties and profit-sharing income related to Hemlibra. Revenue on IFRS basis, including Non-Core items, decreased due to the one-time impact of the lump-sum income from the settlement agreement with Alexion Pharmaceuticals, Inc in the previous year.

Cost to sales ratio rose by 2.4% points year-on-year to 43.1%, mainly due to the impact of foreign exchange. Research and development expenses increased due to investments into drug discovery and early development, including the start of operation of Chugai Life Science Park Yokohama, and the progress of development projects. Also selling, general and administration expenses increased mainly due to various expenses. For other operating income (expense), an income of ¥16.3 billion was recorded, mainly due to the recognition of income from disposal of product rights and gain on sale of property, plant and equipment. As a result, Core operating profit totaled ¥340.5 billion (+13.9%).

The company also made good progress in research and development. Among our in-house projects, Actemra obtained approval for an additional indication of cytokine release syndrome induced by cancer therapy. Late-stage projects progressed including the U.S. Food and Drug Administration (FDA) acceptance of application of crovalimab for the treatment of PNH, and Alecensa achieving the primary endpoint in a global phase III study in patients with early-stage ALK-positive NSCLC, demonstrating the efficacy in adjuvant therapy for the first time as an ALK inhibitor. A global phase III study for Enspryng for treatment of TED, an ophthalmic disease, has been initiated. The drug is now being developed for four diseases simultaneously. As for projects in-licensed from Roche, Phesgo, a subcutaneous combination of Perjeta and Herceptin, which are standard treatments for HER2-positive breast cancer administered by intravenous injections, has received approval in Japan as a treatment for HER2-positive breast cancer and colorectal cancer. In addition, a new immune checkpoint inhibitor tobemstomig (RG6139) in solid tumors has entered the pipeline.

[2023 third quarter results]

Billion JPY 2023
Jan – Sep 2022
Jan – Sep % change
Core results
　Revenue 837.6 729.3 +14.8%
　　Sales 742.1 644.7 +15.1%
　　Other revenue 95.5 84.6 +12.9%
　Operating profit 340.5 299.0 +13.9%
　Net income 250.3 213.0 +17.5%
IFRS results*
　Revenue 837.6 821.2 +2.0%
　Operating profit 317.6 383.8 -17.2%
　Net income 234.3 271.9 -13.8%
*IFRS results in 2022 include non-Core items, such as the income and other related items, which totaled ¥90.7 billion associated with the settlement agreement between Chugai and Alexion Pharmaceuticals, Inc., which are excluded from the Core results Chugai adopts to manage recurring business activities.

[Sales breakdown]

Billion JPY 2023
Jan – Sep 2022
Jan – Sep % change
Sales 742.1 644.7 +15.1%
　Domestic sales 429.2 387.6 +10.7%
　　Oncology 191.4 186.5 +2.6%
　　Specialty 237.9 201.0 +18.4%
　Overseas sales 312.9 257.1 +21.7%
[Oncology field (Domestic) Top5-selling medicines]

Billion JPY 2023
Jan – Sep 2022
Jan – Sep % change
　Tecentriq 47.9 43.9 +9.1%
　Avastin 38.2 50.9 -25.0%
　Polivy 25.5 9.1 +180.2%
　Perjeta 24.6 23.5 +4.7%
　Alecensa 22.0 20.9 +5.3%
[Specialty field (Domestic) Top5-selling medicines]

Billion JPY 2023
Jan – Sep 2022
Jan – Sep % change
　Ronapreve* 81.2 60.8 +33.6%
　Hemlibra 40.5 35.2 +15.1%
　Actemra 32.2 31.2 +3.2%
　Enspryng 16.9 11.5 +47.0%
　Vabysmo 10.8 3.2 +237.5%
*Ronapreve has not been listed in the National Health Insurance (NHI) price list.

About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting Non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders.