On October 13, 2020 Codiak BioSciences, Inc. ("Codiak"), a clinical-stage company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, reported the pricing of its initial public offering of 5,500,000 shares of its common stock at a public offering price of $15.00 per share, for gross proceeds of approximately $82.5 million, before deducting underwriting discounts and commissions and offering expenses (Press release, Codiak Biosciences, OCT 13, 2020, View Source [SID1234568425]). All of the shares are being offered by Codiak. In addition, Codiak has granted the underwriters a 30-day option to purchase up to 825,000 additional shares of common stock at the initial public offering price, less underwriting discounts and commissions.

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The shares are scheduled to begin trading on the Nasdaq Global Market on October 14, 2020 under the ticker symbol "CDAK," and the offering is expected to close on October 16, 2020, subject to customary closing conditions.

Goldman Sachs & Co. LLC, Evercore ISI and William Blair are acting as joint book-running managers for the offering and as representatives of the underwriters. Wedbush PacGrow is acting as lead manager for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and became effective on October 13, 2020. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 1-866-471-2526, or email: [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, telephone: (888) 474-0200, or email: [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, telephone: 1-800-621-0687, or email: [email protected].

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

On October 13, 2020 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company utilizing a proprietary human memory B cell platform to discover and develop first-in-class antibody therapeutics, with a focus on oncology and infectious diseases, including COVID-19, reported the full exercise of the underwriters’ option to purchase an additional 487,500 shares of common stock at the public offering price of $12.00 per share, resulting in additional gross proceeds of approximately $5.9 million, in connection with the Company’s previously announced initial public offering of common stock (Press release, Immunome, OCT 13, 2020, View Source [SID1234568424]). After giving effect to the full exercise of the over-allotment option, the total number of shares sold by Immunome in the initial public offering was 3,737,500 shares and the gross proceeds were approximately $44.9 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. All of the shares were sold by Immunome. Immunome’s common stock began trading on the Nasdaq Capital Market on October 2, 2020, under the ticker symbol "IMNM".

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Ladenburg Thalmann & Co. Inc. and Chardan acted as book-running managers for the offering.

A registration statement relating to the offering of these securities has been declared effective by the Securities and Exchange Commission on October 1, 2020. The offering was made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained by vising www.sec.gov or from Ladenburg Thalmann & Co. Inc., 277 Park Avenue, 26th Floor, New York, NY 10172, or by calling (212) 409-2000, or by emailing [email protected] or Chardan Capital Markets, LLC, 17 State Street, 21st floor, New York, New York 10004, or by calling (646) 465-9001.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or 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 jurisdiction.

On October 13, 2020 Cedilla Therapeutics, a private biotechnology company developing targeted small molecules for the treatment of cancer and other diseases caused by protein dysregulation, reported the closing of a $57.6 million Series B financing (Press release, Cedilla Therapeutics, OCT 13, 2020, View Source [SID1234568423]). The financing was co-led by Casdin Capital and Boxer Capital of Tavistock Group and included new investors Eli Lilly and Company and Schroder Adveq, as well as other undisclosed institutional investors, along with existing investor Third Rock Ventures. In connection with the financing, Eli Casdin, Chief Investment Officer and Founder of Casdin Capital, and Dominik Naczynski, Senior Vice President at Boxer Capital, will join the Company’s Board of Directors.

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"Cedilla was founded on the understanding that therapeutic targets exist in multiple proteoforms, or protein states, which can be evaluated for functional relevance and exploited to create novel opportunities for intervention, even where conventional approaches have failed," said Alexandra Glucksmann, Ph.D., Cedilla’s president and chief executive officer. "Over the past two years, we have honed our integrated approach and we are now prepared to advance target-specific efforts toward the clinic. We appreciate the support of our new and existing investors, which will enable us to name our first two development candidates, expand our discovery-stage research and work toward our goal of delivering novel small molecules that can redirect the course of disease and deliver profound benefit to patients."

Cedilla identifies previously unexploited proteoforms of high-value targets. While prior attempts to drug these targets have focused only on their canonical states, Cedilla has discovered the means to affect function or stability by engaging pivotal, post-translationally modified states. Cedilla’s product candidates are designed with mechanisms best fit to modulate these functionally-relevant proteoforms, which may include protein inhibition or degradation. Proceeds from this financing will support ongoing efforts to build a broad portfolio of small molecule medicines, including the identification and preclinical development of Cedilla’s first two product candidates.

"Cedilla is establishing an entirely new approach to drug development, based on a deep understanding of proteomics and a unique ability to identify and modulate functionally-relevant proteoforms of high-value targets," said Eli Casdin, Chief Investment Officer and Founder of Casdin Capital. "It is a big idea with powerful potential and we are excited to partner with the management team to accelerate the next stage of the company’s growth."

On October 13, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that its leadership will present at the Jefferies Virtual Global Healthcare Conference on November 17-19 (Press release, TYME, OCT 13, 2020, View Source [SID1234568421]). In one-on-one sessions, the Company will present its corporate overview for fiscal year 2021 with a special focus on multiple growth opportunities driven by advances in the science of cancer cell metabolism, SM-88 (racemetyrosine) late-stage trials in pancreatic cancer, SM-88 HopES trial in ultra-rare metastatic sarcoma, proof-of-concept RESPOnD trial evaluating TYME-19 in COVID-19, and expanding clinical plans for its cancer-metabolism pipeline candidate SM-88 in prostate, breast and hematological cancers.

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Event: Jefferies Virtual Global Healthcare Conference
Place: Waldorf Hilton, London
Presentation Date: November 17-19, 2020
Format: One-on-one sessions

The presentation will be accessible on the events page under the investor relations section of Tyme Technologies’ website at www.tymeinc.com.

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. Learn more.

About TYME-18

TYME-18 is composed of a proprietary surfactant delivery agent with a specific sulfonic acid component. It is designed for intra-tumoral administration of difficult to treat tumors and leverages the acidic tumor microenvironment and signaling pathways to kill cancer cells. TYME-18 is distinct in composition, but like SM-88, aims to leverage susceptibilities of a cancer that are related to its altered metabolism. Initial preclinical data for TYME-18 in animal tumor models demonstrate rapid and complete tumor regression, with no reported local or systemic toxicities. TYME-18 continues to be studied as a potential therapy for difficult to treat tumors that may not be eligible for surgical or other interventions. Learn more.

About TYME-19

TYME-19 is a potent, well characterized synthetic antiviral bile acid that is being evaluated as a potential oral therapy for COVID-19. In preclinical testing, TYME-19 repeatedly prevented COVID-19 viral replication without attributable cytotoxicity in treated cells. COVID-19 hijacks a cell’s ability to make proteins and lipids and divert these processes to make viral proteins and lipids in order to reproduce. COVID-19 accomplishes this by inducing stress in the endoplasmic reticulum (ER), where cells process proteins, which enables the virus to remodel protein and lipid synthesis. In preclinical testing, TYME-19 has been shown to counteract these effects, preventing viral replication, by reducing ER stress. TYME-19 is believed to physically degrade viruses by solubilizing the protective lipid layer and other structural components, which prevent a virus from binding to and infecting a cell.

About TYME-88-Panc Pivotal Trial

The TYME-88-Panc pivotal trial applies the latest advances in the field of cancer metabolism by evaluating the efficacy and safety of an oral investigational compound that targets the metabolic mechanisms of the disease at its source. A prospective, open label pivotal trial in metastatic pancreatic cancer for patients who have failed two lines of any prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in advanced pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate. Learn more.

On October 13, 2020 CytRx Corporation (OTCQB:CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, highlighted that ImmunityBio, Inc. and NantKwest, Inc. (collectively, the "Companies") reported the addition of a third cohort to their ongoing Phase 2 study of a novel combination immunotherapy – which includes CytRx’s licensed drug aldoxorubicin – for locally advanced or metastatic pancreatic cancer (QUILT-88) (Press release, CytRx, OCT 13, 2020, View Source [SID1234568419]). According to the Companies, the third cohort will enable pancreatic cancer patients who have failed all approved standards of care to participate in the study.

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As previously noted in CytRx’s October 7, 2020 press release regarding the reportedly promising treatment delivered to former Senator Harry Reid for his stage IV pancreatic cancer, this randomized, open-label study is evaluating the safety and efficacy of a combination immunotherapy that includes aldoxorubicin, ImmunityBio’s IL-15 superagonist Anktiva (N-803), NantKwest’s PD-L1 t-haNK, and standard of care. The study results will be compared to standard of care chemotherapy for first- and second-line treatment. However, the third-line cohort is a single arm with no comparator. Each cohort will be evaluated independently to provide more precise comparative data for each disease stage.

Trial Sites and Enrollment

There are presently three trial sites activated: Hoag Memorial Hospital Presbyterian in Orange County, Calif., The Chan Soon-Shiong Institute for Medicine in Los Angeles County, Calif., and Avera McKennan Hospital and University Health Center in Sioux Falls, South Dakota. The latter site will serve patients in the tri-state area (Iowa, Nebraska and South Dakota). Forty patients are currently enrolled in or being evaluated for the trial.

The Companies’ combination immunotherapy is designed to harness the body’s immune system to target, kill, and "remember" cancer cells. The agents being assessed in the study are designed to find pancreatic cancer cells and initiate a large immune response against them, which may allow the body to develop its own antibodies to fight the cancer.

Study Details

Each treatment setting, as well as each first- and second-line or later maintenance treatment, will be evaluated independently as Cohort A, Cohort B, and Cohort C, respectively, with Cohorts A and B having independent experimental and control arms. The study will initially enroll 298 subjects across all three cohorts. The primary objective of Cohorts A and B is progression-free survival (PFS) and the objective of Cohort C is overall survival (OS) per RECIST V1.1. Secondary objectives include initial safety and additional efficacy measures, including overall response rate (ORR), complete response (CR) rate, durability of response (DoR), disease control rate (DCR), and overall survival (OS).

"Pancreatic cancer is the fourth leading cause of cancer-related deaths in the United States and requires significant advancements in treatment to improve outcomes for patients," said Steven A. Kriegsman, CytRx’s Chairman and Chief Executive Officer. "We commend the Companies for adding a third cohort and expanding this Phase 2 study of their combination immunotherapy that includes aldoxorubicin. We are encouraged that aldoxorubicin continues to play a role in their mission to recruit and amplify the power of the human body’s own immune system to target and destroy even the most difficult cancer cells."

CytRx out-licensed global development, manufacturing and commercialization rights for aldoxorubicin to ImmunityBio in 2017. The Company has an agreement with ImmunityBio that can yield up to $343 million in potential milestone payments as well as prospective royalties on sales of aldoxorubicin.