1stOncology™: Cancer Intelligence Service – Page 6065 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Sapience Therapeutics to Present at the Guggenheim Healthcare Talks 2023 Oncology Day

On January 26, 2023 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, announced today that management will present at the Guggenheim Healthcare Talks 2023 Oncology Day, being held February 8-9, 2023, in New York, NY (Press release, Sapience Therapeutics, JAN 26, 2023, View Source [SID1234626600]).

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!

Sapience CEO and President, Dr. Barry Kappel, will participate in a fireside chat with Guggenheim research analyst Michael Schmidt on Wednesday, February 8, 2023, at 11:20 am ET. Company management will also participate in one-on-one meetings with investors during the conference.

Sana Biotechnology Announces FDA Clearance of Investigational New Drug Application for SC291, a Hypoimmune-modified, CD19-targeted Allogeneic CAR T Therapy for Patients with B-Cell Malignancies

On January 26, 2023 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application to initiate a first-in-human study of SC291 in patients with various B-cell malignancies (Press release, Sana Biotechnology, JAN 26, 2023, View Source [SID1234626599]).

SC291 is a CD19-targeted allogeneic CAR T cell therapy developed using Sana’s hypoimmune platform. The goal of the hypoimmune platform is to overcome the immunologic rejection of allogeneic cells, which if true for SC291 may result in longer CAR T cell persistence and a higher rate of durable complete responses for patients with B-cell lymphomas or leukemias. The hypoimmune platform includes disruption of major histocompatibility (MHC) class I and MHC class II expression to hide cells from the adaptive immune system, which includes antibody and T cell responses, as well as overexpression of CD47 to inhibit activation of the innate immune cell system, in particular macrophages and natural killer (NK) cells. The company has presented data across multiple preclinical models highlighting the potential of this platform to cloak cells from immune recognition and the potential of SC291 as a therapeutic for patients with B-cell malignancies.

"The clearance of our SC291 IND is an important milestone, putting us closer to our goal of making an important medicine for patients with B-cell lymphomas and leukemias," said Steve Harr, Sana’s President and CEO. "We look forward to understanding the safety, potency, and persistence of these cells in patients, and we are optimistic that SC291 can become an important medicine for patients with these difficult cancers. Furthermore, this platform forms the backbone for additional development of CAR T cells targeting CD22, BCMA, and beyond. We expect initial clinical data from the SC291 study later this year and believe insights from this study will better inform our opportunities across the broader platform, both for CAR T cells and for programs outside of cancer such as our pancreatic islet cell therapy for patients with type 1 diabetes."

About Hypoimmune Platform

Sana’s hypoimmune platform is designed to create cells ex vivo that can "hide" from the patient’s immune system to enable the transplant of allogeneic cells without the need for immunosuppression. We are applying the hypoimmune technology to both donor-derived allogeneic T cells, with the goal of making potent and persistent CAR T cells at scale, and pluripotent stem cells, which can then be differentiated into multiple cell types at scale. Preclinical data demonstrate across a variety of cell types that these transplanted allogeneic cells are able to evade both the innate and adaptive arms of the immune system while retaining their activity. Our most advanced programs utilizing this platform include an allogeneic CAR T program targeting CD19+ cancers, an allogeneic CAR T program targeting CD22+ cancers, an allogeneic CAR T program targeting BCMA+ cancers, and stem-cell derived beta islet cells for patients with type 1 diabetes.

Panbela Announces Pricing of Approximately $15 Million Public Offering

On January 26, 2023 Panbela Therapeutics, Inc. (Nasdaq: PBLA), ("Panbela" or the "Company"), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported the pricing of a public offering of (i) 6,675,000 shares of its common stock (or pre-funded warrants in lieu thereof) and (ii) warrants to purchase up to 13,350,000 shares of its common stock (the "Public Warrants") at a purchase price of $2.25 per share and associated Public Warrant (Press release, Panbela Therapeutics, JAN 26, 2023, View Source [SID1234626598]). The Public Warrants will have an exercise price of $2.75 per share, are exercisable upon issuance, and will expire five years following the date of issuance. The offering is expected to close on or about January 30, 2023, subject to customary closing conditions.

Roth Capital Partners is acting as lead placement agent and Maxim Group LLC is acting as coplacement agent of the offering.

Gross proceeds, before deducting placement agent fees and commissions and offering expenses, are expected to be approximately $15.0 million. The Company intends to use the net proceeds from the proposed offering for the continued clinical development of its product candidates ivospemin (SBP-101) and eflornithine (CPP-1X), working capital, business development and other general corporate purposes, which may include repayment of debt.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-268854), as amended, that was declared effective by the U.S. Securities and Exchange Commission ("SEC"), on January 25, 2023, and an additional registration statement filed with the SEC on January 26, 2023 pursuant to Rule 462(b) under the Securities Act of 1933, as amended. The offering is being made solely by means of a prospectus. Copies of the accompanying prospectus relating to and describing the terms of the offering may be obtained, when available, at the SEC’s website at www.sec.gov or by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660 or by email at [email protected].

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any 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 prior to registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

About Panbela’s Pipeline

The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of catalysts with programs ranging from pre-clinical to registration studies.

SBP-101 Ivospemin

Ivospemin is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. It has shown signals of tumor growth inhibition in clinical studies of metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of 48%, both exceeding what is typical for the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, ivospemin has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the previous Panbela-sponsored clinical trials provide support for continued evaluation of ivospemin in the ASPIRE trial. For more information, please visit View Source

Flynpovi

Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increase polyamine export and catabolism. In a Phase 3 clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal tract anatomy in the recent Phase 3 trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), Flynpovi showed statistically significant benefit compared to both single agents (p≤0.02) in delaying surgical events in the lower GI for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP.

CPP-1X

CPP-1X (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes. Preclinical studies as well as Phase 1 or Phase 2 investigatorinitiated trials suggest that CPP-1X treatment may be well-tolerated and has potential activity.

Entry into a Material Definitive Agreement

On January 26, 2023 Kiromic BioPharma, Inc. (the "Company") reported that it has entered into a note purchase agreement (the "Agreement") with an accredited investor (the "Investor") and pursuant to the Agreement issued a 25% Senior Secured Convertible Promissory Note (the "Note") to the Investor (Filing, Kiromic, JAN 26, 2023, View Source [SID1234626597]). The Note has a principal amount of $2,000,000, bears interest at a rate of 25% per annum (the "Stated Rate") and matures on January 20, 2024 (the "Maturity Date"), on which the principal balance and accrued but unpaid interest under the Note shall be due and payable. The Stated Rate will increase to 27% per annum or the highest rate then allowed under applicable law (whichever is lower) upon occurrence of an event of default, including the failure by the Company to make payment of principal or interest due under the Note on the Maturity Date, and any commencement by the Company of a case under any applicable bankruptcy or insolvency laws. Pursuant to the Agreement, the Company may sell and issue up to a maximum aggregate principal amount of $6 million for all Notes issued pursuant to the Agreement to the Investor in two subsequent closings to occur on or before February 15, 2023 and March 15, 2023.

The Note is convertible into shares (the "Conversion Shares") of the Company’s common stock, par value $0.001 per share (the "Common Stock"), at an initial conversion price of $0.35 per share (the "Conversion Price"), subject to a beneficial ownership limitation equivalent to 9.99% (the "Beneficial Ownership Limitation") and a share cap of 4,080,435 shares (the "Share Cap"), representing 19.9% of the total issued and outstanding shares of Common Stock as of January 20, 2023, in the event that the Conversion Price is lower than $0.2074 per share, representing the lower of the closing price immediately preceding the Issuance Date or the average closing price of the Common Stock for the five trading days immediately preceding the Issuance Date.

The unpaid principal of and interest on the Note constitute unsubordinated obligations of the Company and are senior and preferred in right of payment to all subordinated indebtedness and equity securities of the Company outstanding as of the Issuance Date; provided, however, that the Company may incur or guarantee additional indebtedness after the Issuance Date, whether such indebtedness are senior, pari passu or junior to the obligations under the Note, which are secured by all of the Company’s right, title and interest, in and to, (i) all fixtures (as defined in the Uniform Commercial Code, the "UCC") and equipment (as defined in the UCC), and (ii) all of the Company’s intellectual property as specified in the Note, subject to certain exclusions as described in the Note.

The foregoing description of the Agreement and the Note is qualified in its entirety by reference to the full text of such Agreement and Note, a copy of which is attached hereto as exhibits 10.1 and 10.2, respectively, and incorporated herein by reference.

Item 2.03

Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

Reference is made to the disclosure set forth under Item 1.01 above, which disclosure is incorporated herein by reference.

Item 3.02

Unregistered Sales of Equity Securities

Reference is made to the disclosure set forth under Item 1.01 above, which disclosure is incorporated herein by reference. The issuance of the Note was made in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended.

Celularity Completes Strategic Review of 2023 Initiatives, Including Anticipated Biomaterials Production Ramp-up and Pipeline Prioritization of Next-Generation Product Candidates

On January 26, 2023 Celularity Inc. (Nasdaq: CELU) ("Celularity," the "Company"), a U.S.-based biotechnology company developing placental-derived allogenic cell therapies and biomaterial-based regenerative therapeutics products, reported the results of a strategic review of its 2023 key initiatives (Press release, Celularity, JAN 26, 2023, View Source [SID1234626596]). This strategic review included the recently announced territory distribution agreement covering more than 100 countries for Celularity’s Halal-Certified products and the exclusive distribution agreement with the Tamer Group in Saudi Arabia. Celularity’s review also included pipeline prioritization and targeted expense reductions to align operating priorities in advance of an anticipated biomaterials production ramp-up this year.

"Celularity’s novel business model leverages a diversified portfolio of therapeutic technologies all derived from a single source material — the post-partum placenta. As the Company that pioneered the use of placental-derived stem, progenitor and immune cells, and as an innovator in placental biomaterial product development, Celularity’s business model is to generate commercial revenue from both cellular and regenerative therapeutics, including technologies that combine cellular and regenerative therapeutics. Already this year, we’ve been presented with a series of unique opportunities, and the environment continues to be extremely favorable," said Robert J. Hariri, M.D., Ph.D. Celularity’s CEO, Chairman and Founder. "As we invest to scale production of our commercial biomaterial products to meet expected demand in the United States and the Middle East, we are prioritizing our most promising cell therapy product candidates and programs, and are rebalancing our workforce and identifying targeted expense reductions to support these priorities."

Advanced Biomaterial Products

Celularity markets a suite of commercial placenta-derived biomaterial products. Most recently, the Company announced an exclusive territory agreement with CH Trading Group, an international import, export, and trading company, to distribute Celularity’s branded regenerative biomaterial products — which are Halal-Certified under globally recognized Circle H International Inc. standards — in more than 100 countries.

Celularity’s advanced biomaterial products include:

Biovance, a decellularized, dehydrated human amniotic membrane derived from the placenta of a healthy, full-term pregnancy. Biovance is an intact, extracellular matrix structure that is indicated for use in the United States as a natural scaffold to support the body’s wound healing process.
Biovance 3L and Biovance 3L Ocular, tri-layer human amniotic membrane products focused on the surgical and ocular markets and available in both sheet and disk form.
Interfyl, a human connective tissue matrix derived from the placenta of a healthy, full-term pregnancy. It is indicated for use in the United States to replace or supplement damaged or inadequate integumental tissue resulting from wounds, trauma, or surgery.
CentaFlex, a decellularized human placental matrix derived from the umbilical cord that is indicated for use in the United States as a surgical covering, wrap or barrier to protect and support the repair of damaged tissue.
Opportunities in Osteoarthritis for Advanced Biomaterials and Combination Biomaterial-Cell Therapies

In a preclinical in vivo study of Celularity’s placental extracellular matrix (ECM) product candidate in a joint destructive, acid-derived osteoarthritis (OA) model, a 31-40 percent improvement of chondrogenic properties at Day 60 was observed. Additionally, a reduction in the number of pro-inflammatory cytokines at Day 60, including Monocyte Chemoattractant Protein-1 (MCP-1), was observed.

Celularity plans to complete the required preclinical work on its ECM product candidate over the next several months to support an investigational new drug (IND) application this year for the formation of new cartilage.

Celularity also is conducting preclinical work in knee osteoarthritis (KOA) using its placenta-derived exosomes (pEXO). In a rat study, scientifically measurable improvements in chondrogenesis, reduction in pain and pro-inflammatory cytokines in the synovial fluid were observed after injection into the arthritic knee at Day 60.

Celularity’s initial focus is osteoarthritis of the knee, which accounts for 80 percent of the total OA burden worldwide according to the World Health Organization. A 2017 study published in Proceedings of the National Academy of Sciences estimated that individuals now have a 45 percent lifetime risk of developing symptomatic KOA, resulting in a market with 9.3 percent compound annual growth rate (CAGR) reaching $12.02 billion by 2029, according to Data Bridge Market Research.

Degenerative Diseases

Crohn’s Disease. Celularity previously announced its re-analysis of long-term follow-up data from three legacy Phase 1, Phase 1b/2a and Phase 1b studies of its legacy placental-derived mesenchymal-like adherent stromal cell (MLASC) therapy in patients with moderate-to-severe Crohn’s disease, which showed clinically meaningful and durable benefit for up to two years in the limited number of patients studied. The Company will continue to assess MLASC therapy for this condition using its next-generation MLASC therapeutic candidate, as well as pursuing development partnering opportunities.
Fasculoscapulohumeral Muscular Dystrophy (FSHD). FSHD is one of the most common genetically defined progressive muscular dystrophies. The Company will investigate its next-generation placental-derived MLASCs with their anti-inflammatory, immune-modulatory, and regenerative properties to potentially bring a novel treatment approach to FSHD. Importantly, FSHD also serves as a model for potential age-related loss of muscle mass.
T-cell Programs

Hematologic Cancers and Solid Tumors. Celularity will continue to develop CYCART-19, an allogeneic placental-derived T-cell therapy engineered with a CD19 chimeric antigen receptor (CAR) with T-cell receptor (TCR) knockout that has demonstrated potent anti-tumor activity both in vitro and in vivo. The Company continues to work to address FDA questions on its IND and anticipates commencing its Phase 1 trial in 2023.
Celularity will continue to partner with Imugene Ltd. (ASX: IMU) to utilize its novel onCARlytics (CF33-CD19) technology to prime solid tumor cells to express CD19, making them a target for CD19 CAR-T therapy. Celularity also will continue to advance other select innovative T-cell programs through preclinical development.
Other Oncology Programs

Acute Myeloid Leukemia (AML). Celularity continues to review emerging cohort data from its CYNK-001 unmodified natural killer cell trial for the treatment of Relapsed Refractory (rrAML) and minimal resistant disease AML. This trial has progressed through to Cohort 6b in patients with rrAML and continues to successfully achieve its objective of evaluating safety and biological activity, understanding the optimal lymphodepletion regimen and the roles of both IL-15 and IL-2 in achieving NK-Cell persistence. The trial data also continue to provide important insights which will enable us to optimize our genetically modified NK cell and CAR-NK platforms moving forward to address the significant unmet medical need for patients.
Glioblastoma Multiforme (GBM). Celularity has worked with investigators to gain further insight into the optimal approach for utilizing cell therapies in the management of GBM. Celularity has determined not to pursue this trial, which uses only unmodified NK cells, at this time. The Company will continue to strategically enhance its NK platform, including modified and unmodified NK cells, to address some of the very significant challenges posed in treating this devastating disease.

HER2+ Gastric Cancer. Celularity continues to believe that genetically modified NK cells will be an important option to improve the current standard of care. However, given the Company’s strategic review, it will deprioritize this study while it continues to optimize its modified and unmodified NK cell platform.
As part of Celularity’s reprioritization efforts, the Company has notified a substantial portion of its workforce that their employment may be impacted in order to achieve its strategic objectives. While Celularity is hopeful that there will be no need to substantially reduce its headcount, the notifications were provided in accordance with applicable law and to maintain full transparency with its employees.