On January 5, 2023 OncoResponse, a clinical-stage biotech company advancing immunotherapies derived from the immune systems of Elite Cancer Responders, reported that Clifford Stocks, Chief Executive Officer, will present a company overview at the 41st Annual J.P. Morgan Healthcare Conference on Thursday, January 12, 2023, at 11 a.m. PST (Press release, OncoResponse, JAN 5, 2023, View Source [SID1234625928]).

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Following the live event, the accompanying slide presentation will be accessible on the Events & Presentations page of the OncoResponse website at View Source

On January 5, 2023 Jubilant Therapeutics Inc., a clinical stage biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, reported that the United States Food and Drug Administration (US FDA) has granted Orphan Drug Designation for JBI-802 for the treatment of small cell lung cancer (SCLC) and acute myeloid leukemia (AML) (Press release, Jubilant Therapeutics, JAN 5, 2023, View Source [SID1234625927]).

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JBI-802 is a dual epigenetic modulator engineered in a single pharmacophore to achieve optimal inhibition of the transcriptional regulator CoREST, which regulates the development of cellular lineages responsible for neuroendocrine tumors like SCLC and hematopoietic tumors like AML.

This unique profile has shown synergistic anti-tumor activity and it is expected to overcome tolerability limitations of first-generation, single target epigenetic modulators.

"JBI-802 is the lead product candidate from our TIBEO (Therapeutic Index and Brain Exposure Optimization) Discovery Engine. It is our unique approach of structure-based drug design to generate novel pharmacophores with improved target product profile compared to existing agents. The Orphan Drug Designations (ODD) were supported by several relevant preclinical models. In SCLC, JBI-802 showed unique activity not just in normal neuroendocrine models but also in the ‘variant’ models driven by MYC amplification. This data also supports the ongoing Ph I/II clinical trial in neuroendocrine tumor patients. In AML the activity was uniquely seen in models of erythroleukemia, a subset of leukemia, with a unique erythroid phenotype and a very high unmet need based on its aggressive nature and limited therapy. This designation and emerging clinical data from the ongoing fist-in-human JBI-802 study will now underpin expansion of our clinical activities in thrombocythemia, leukemia and other erythroid tumors like MPN," said Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc.

The US FDA’s Office of Orphan Products Development (OOPD) grants orphan designation status to a drug that is intended to treat a rare disease or condition that affects fewer than 200,000 persons in the United States.

About JBI-802

JBI-802 is an oral, potent and selective dual inhibitor of two epigenetic targets of the CoREST complex: LSD1 and HDAC6. It targets stem cell modulation by inhibiting LSD1 and modulates immune suppression with isoform selective HDAC6 inhibition. Preclinical research has demonstrated its synergistic anti-tumor activity, which is superior vs. either target alone inhibitors and has a favorable safety profile with no significant safety concerns or accumulation. It is being clinically evaluated in multiple neuroendocrine tumors including SCLC, with a goal to expand in to hematological cancers such as acute myelogenous leukemia, essential thrombocythemia, and other myeloproliferative cancers. Positive clinical data was recently reported for bomedemstat, a LSD1 only inhibitor, in essential thrombocythemia, thereby establishing a pivotal role of epigenetic modulators in hematological malignancies.

On January 5, 2023 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported that John Climaco, Chief Executive Officer of CNS Pharmaceuticals will present at the Virtual Investor 2023 Companies to Watch Event on Wednesday, January 18, 2023 at 10:00 AM ET (Press release, CNS Pharmaceuticals, JAN 5, 2023, View Source [SID1234625926]).

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A live video webcast of the presentation will be available on the Events page of the Investors section of the Company’s website (cnspharma.com). A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.

On January 5, 2023 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, reported that the New Drug Application (NDA) for parsaclisib (PI3Kδ inhibitor, R&D code: IBI376) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two previous systemic therapies has been accepted for review by China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) and granted Priority Review designation (Press release, Innovent Biologics, JAN 5, 2023, View Source [SID1234625925]).

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The acceptance and Priority Review designation for this NDA are based on the results from a multi-center, single-arm, open-label pivotal Phase II study conducted in China (NCT04298879), most recently presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting.

As of the December 12, 2021 data cut-off date, the objective response rate (ORR) seen with parsaclisib monotherapy was 86.9% (53/61, 95%CI: 75.8%, 94.2%) in FL patients who had received at least two previous systemic treatments (n=61), 19 patients (31.1%) had a complete response (CR) and 34 patients (55.7%) achieved a partial response (PR). The median duration of response (DOR) and median progression-free survival (PFS) were not yet achieved, and the majority of patients continued to be in remission. Among the 61 patients treated with parsaclisib, twenty-seven patients (44.3%) experienced grade ≥ 3 treatment emergent adverse events (TEAEs), and the most common grade ≥ 3 TEAEs was a decrease in neutrophil count (n=10, 16.4%). The results also showed that parsaclisib was generally well tolerated with a manageable safety profile.

Dr. Weili Zhao of Shanghai Jiaotong University Ruijin Hospital, commented: "FL is the second most prevalent type of non-Hodgkin’s lymphoma (NHL), accounting for about one-fifth of NHL patients, and is the most common indolent NHL. Although most patients with FL respond to first-line therapy, relapse is common and it is difficult to cure with current therapies, placing a significant burden of disease on patients. We look forward to seeing more patients with relapsed or refractory FL benefit once approved."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "Treatment options for relapsed or refractory FL remain limited and there is a huge unmet clinical need. The NDA for parsaclisib in China was accepted and granted Priority Review designation, which is a milestone for the clinical research for parsaclisib, and if approved, will expand Innovent’s pipeline with one more innovative product in the field of hematology. We will actively cooperate with regulatory authorities and hope to obtain early approval of this indication, which could lead to more treatment options for patients with relapsed or refractory follicular lymphoma."

About Follicular Lymphoma

According to GLOBOCAN 2020 estimates, there were approximately 93,000 new cases of non-Hodgkin lymphoma (NHL) in China. Follicular lymphoma (FL) is the second most common NHL, accounting for 22% – 35% of NHL patients in Western countries and 8.1% – 23.5% of NHL patients in China. FL is a B-cell cancer that originates from the uncontrolled division of specific types of B-cells known as centrocytes and centroblasts. Although it is classified as an indolent lymphoma, where current immunochemotherapy is efficacious, FL may still relapse and transform into an aggressive lymphoma, which may lead to death within 1 to 2 years. There is an unmet medical need for treatment options for recurrent/refractory follicular lymphoma.

About Parsaclisib

Parsaclisib is a highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ) discovered by Incyte. Pivotal trials of parsaclisib in combination with ruxolitinib for the treatment of patients with myelofibrosis are underway.

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates, including parsaclisib (PI3Kδ inhibitor). Under the terms of the collaboration agreement, Innovent has received the rights to develop and commercialize parsaclisib in Mainland China, Hong Kong, Macau and Taiwan.

On January 5, 2023 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported the pricing of an upsized underwritten public offering consisting of 55,876,297 shares of its common stock at a public offering price of $2.45 per share and pre-funded warrants to purchase 25,000,000 shares of its common stock (Press release, Geron, JAN 5, 2023, View Source [SID1234625924]). The pre-funded warrants are being sold at a public offering price of $2.449 per pre-funded warrant. All of the securities in the offering are to be sold by Geron. In addition, Geron has granted the underwriters a 30-day option to purchase up to an additional 12,131,444 shares of its common stock, less underwriting discounts and commissions. The offering is expected to close on or about January 10, 2023, subject to the satisfaction of customary closing conditions.

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The gross proceeds to Geron from this underwritten public offering, before deducting the underwriting discount and other estimated offering expenses, are expected to be approximately $198.1 million. Geron currently intends to use the net proceeds from this public offering, together with its existing cash, cash equivalents, restricted cash and current and noncurrent marketable securities, to fund preparatory activities for the potential U.S. commercial launch of imetelstat in lower risk MDS, and, if approved, to fund the potential U.S. commercial launch of imetelstat. Geron intends to use the remaining proceeds, if any, for working capital and general corporate purposes.

Goldman Sachs & Co. LLC and Stifel are acting as joint book-running managers for the offering. Wedbush PacGrow and Baird are acting as co-lead managers for the offering. B. Riley Securities and Needham & Company are acting as co-managers for the offering.

An automatically effective shelf registration statement on Form S-3 relating to the public offering of the shares of common stock and pre-funded warrants described above was filed with the Securities and Exchange Commission (SEC) on January 4, 2023. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s web site at www.sec.gov. When available, copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Goldman Sachs & Co. LLC, at Prospectus Department, 200 West Street, New York, New York 10282, by telephone at 1-866-471-2526 or by email at [email protected]; and Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at [email protected].

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