On November 22, 2021 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, reported Gaurav Shah, M.D., Chief Executive Officer, will participate in a fireside chat at the Evercore ISI 4th Annual HEALTHCONx Virtual Conference on Wednesday, Dec. 1, 2021 at 10:55 a.m. ET (Press release, Rocket Pharmaceuticals, NOV 22, 2021, View Source [SID1234595920]).

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A live audio webcast of the presentation will be available under "Events" in the Investors section of the Company’s website at View Source The webcast replay will be available on the Rocket website following the conference.

On November 22, 2021 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company mainly focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported that the Company has received a No Objection Letter from Health Canada in response to the Clinical Trial Application (CTA) of CT041, an autologous CAR T-cell product candidate against the claudin18.2 protein, "CLDN18.2" (Press release, Carsgen Therapeutics, NOV 22, 2021, View Source;301429649.html [SID1234595937]).

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As of this announcement, CT041 is the only CLDN18.2-targeted CAR T-cell product candidate globally that is being studied in clinical trials with IND clearance from both the FDA and the NMPA, and CTA authorization from Health Canada.

About CT041

CT041 is an autologous CAR T-cell product candidate against the protein CLDN18.2 that has the potential to be the first in its class globally. CT041 targets the treatment of CLDN18.2 positive solid tumors with a primary focus on gastric/gastroesophageal junction cancer (GC/GEJ) and pancreatic cancer (PC). CT041 has demonstrated promising therapeutic efficacy and favorable safety in ongoing clinical trials. CARsgen believes that CT041 has the potential to become a backbone therapy for GC/GEJ and PC in the future and benefit a large population of patients worldwide.

In addition to the investigator-initiated trials in China, CARsgen has initiated a Phase Ib/II clinical trial for advanced GC/GEJ or PC in China and a Phase 1b clinical trial for advanced GC/GEJ or PC in North America. CT041 was granted PRIME Eligibility by the EMA for the treatment of advanced GC. CT041 received Orphan Drug designation for the treatment of GC/GEJ from the U.S. FDA in 2020 and Orphan Medicinal Product designation for the treatment of gastric cancer from the EMA in 2021. CARsgen has applied to the NMPA for the required regulatory approval for initiating the pivotal Phase II clinical trial in China. The company also intends to conduct a pivotal Phase 2 clinical trial in North America in 2022.

On November 22, 2021 Scopus BioPharma Inc. (Nasdaq: "SCPS"), a clinical-stage biopharmaceutical company developing transformational therapeutics for serious diseases with significant unmet medical need, reported it has entered into securities purchase agreements with certain institutional investors in connection with a private placement priced at-the-market under Nasdaq rules of 3,000,000 shares of common stock, series A additional investment options (the "Series A AIOs") to purchase up to 1,500,000 shares of common stock, and series B additional investment options (the "Series B AIOs", together with the Series A AIOs, the "AIOs") to purchase up to 1,500,000 shares of common stock at a purchase price of $3.25 per share and associated AIOs for gross proceeds of $9.75 million, before deducting placement agent fees and other estimated offering expenses payable by the Company (Press release, Scopus BioPharma, NOV 22, 2021, View Source(Nasdaq%3A%20%E2%80%9CSCPS%E2%80%9D),private%20placement%20priced%20at%2Dthe%2D [SID1234595886]). The offering is expected to close on or about November 22, 2021, subject to satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

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The Series A AIOs are exercisable immediately with a term of five years following the authorized share increase date and have an exercise price of $3.125 per share. The Series B AIOs are exercisable upon the authorized share increase date with a term of five years following the authorized share increase date and have an exercise price of $3.125 per share.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

Under an agreement with the investors, the Company is required to file an initial registration statement with the Securities and Exchange Commission (the "SEC") covering the resale of the shares of the Company’s common stock and the shares of common stock underlying the AIOs no later than January 4, 2022 and to use commercially reasonable efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than the later of (i) February 15, 2022 and (ii) 30 days after the authorized share increase date.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

On November 22, 2021 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported Andrew Robbins, Chief Executive Officer and President will participate in a fireside chat and one-on-one investor meetings during the Piper Sandler 33rd Annual Healthcare Conference, taking place virtually November 29 – December 2, 2021 (Press release, Cogent Biosciences, NOV 22, 2021, View Source [SID1234595905]).

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The pre-recorded fireside chat will be available to conference attendees starting at 10:00 a.m. ET today and will remain available through the end of the conference on Thursday, December 2. Access to the recording will be available under the "Events" tab on the investor relations section of the Cogent Biosciences website at: View Source

On November 22, 2021 NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, reported that data from Phase 1 of an ongoing study at the Society for Neuro-Oncology (SNO) annual meeting (Press release, NeoImmuneTech, NOV 22, 2021, View Source [SID1234595922]). The data show that NT-I7, a novel long-acting human IL-7, was well tolerated following chemoradiation in patients with high-grade gliomas (HGG), supporting continued evaluation in the Phase 2 portion of the study.

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The data were presented as an oral presentaion, titled "A phase I/II study evaluating the safety and efficacy of a novel long-acting interleukin-7, NT-I7, for patients with newly diagnosed high-grade gliomas after chemoradiotherapy," by lead author Jian Li Campian, M.D., Ph.D., of Mayo Clinic. The data show that NT-I7’s maximum tolerated dose in this cohort was 720 µg/kg. Despite the concomitant administration of chemotherapy (temozolomide, TMZ), the absolute lymphocyte count (ALC) persistently increased 1.3–4.1 fold at week 4 after NT-I7 injection, suggesting that NT-I7 as a single agent could be an effective approach to counteract the treatment-related lymphopenia associated with shorter survival that is commonly observed in HGG patients after chemoradiation.

The median progression-free survival for MGMTp unmethylated GBM was 11.6 months, compared to 5.3 months commonly reported in chemoradiation studies. Strikingly, NT-I7 single agent preferentially expanded memory stem T cells (Tscm), a self-renewing T cell subset that has shown better antitumor activity compared with other memory T cell subsets. Thus, although further studies are necessary to determine the clinical benefit, NT-I7 as a single agent added to neoadjuvant chemotherapy has shown encouraging efficacy signals in this aggressive indication.

"We are pleased to report encouraging data on NT-I7 following chemotherapy in high-grade gliomas, which are aggressive and can have a severe impact on patients," said Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech. "NT-I7’s demonstrated ability to increase ALC and its high tolerability in this patient population supports continued investigation to further assess its potential to improve outcomes for patients living with this devastating disease."

About NT-I7
NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.