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Sensei Biotherapeutics Announces $28.5 Million Financing To Advance Clinical Pipeline and Immunophage™ Platform Targeting Multiple Cancers

On October 7, 2020 Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing personalized yet off the shelf immunotherapies for cancer and infectious diseases, reported the completion of a $28.5 million equity financing (Press release, Sensei Biotherapeutics, OCT 7, 2020, View Source [SID1234568204]). The financing was co-led by Cambrian Biopharma and H&S Ventures, along with participation from new investors Future Ventures, Christian Angermayer’s Apeiron Investment Group, and Presight Ventures, Apeiron’s U.S. arm.

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Sensei is currently advancing multiple clinical and pre-clinical studies with their lead Immunophage program, SNS-301, a bacteriophage engineered to express aspartate β-hydroxylase (ASPH), a tumor associated antigen. The proceeds from the Series AA financing will enable the further development of SNS-301 and enable the advancement of Sensei’s pipeline of novel immunotherapies based on its Immunophage platform, which combines a vaccine’s ability to generate antigen-specific B- and T-cells with payloads of immunomodulatory nanobodies. Sensei Bio is building an extensive R&D infrastructure for the discovery of Immunophage, including GMP manufacturing, and is creating libraries of Immunophage that will be combined to create personalized yet off the shelf cocktails based on the genetic profile of each patient’s tumor.

"With this new funding, we advance our vision for establishing a new and disruptive class of immunotherapies called Immunophage, based on engineered bacteriophage," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "We are poised for significant progress as this funding enables us to expand our clinical programs for SNS-301 and operate our Immunophage platform at scale. We are grateful for the support from both new and existing investors and I look forward to further realizing Sensei’s potential and building out this new class of immunotherapies."

"Sensei’s phage platform represents a transformative leap in immuno-oncology, with a cancer vaccine that can induce all the elements of a robust anti-tumor immune response. With experienced management and scientific teams, Sensei is well positioned to become a leader in next generation of immune-oncology therapeutics," said James Peyer, CEO of Cambrian Biopharma. "We are pleased to support their highly unique platform approach and advance these therapies clinically."

In its next stage of growth, Sensei Bio will employ its proprietary platform to discover novel classes of cancer immunotherapies and advance lead candidates toward the clinic. These approaches include the following:

The development of select immunomodulatory nanobodies, camelid-based antibodies, that can be deployed as Immunophage payloads or stand-alone therapeutics.
The expansion of Sensei’s library based approach by engineering Immunophage targeting additional tumor associated antigens.
The deployment of customized yet off-the-shelf Immunophage cocktail therapies targeting tumor associated antigens, neoantigens, and virally-based cancer antigens.
A novel antibody-based approach to novel checkpoint inhibition and other methods of altering the tumor microenvironment toward anti-tumor immunity.
Potential expansion of its therapeutic area focus into infectious diseases based on partnerships with Pharma companies and government entities.

Guardant Health Announces Pricing of Public Offering of Common Stock by Selling Stockholder

On October 7, 2020 Guardant Health, Inc. (Nasdaq: GH) ("Guardant Health"), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics, reported the pricing of an underwritten public offering of 7,000,000 shares of its common stock at a public offering price of $102.00 per share, before deducting underwriting discounts and commissions, all of which are being sold by SoftBank Investment Advisers (Press release, Guardant Health, OCT 7, 2020, View Source [SID1234568203]). In addition, SoftBank Investment Advisers has granted the underwriter a 30-day option to purchase up to 700,000 additional shares of common stock at the public offering price, less underwriting discounts and commissions. Guardant Health is not selling any of its shares in the offering and will not receive any of the proceeds from the sale of shares in the offering by SoftBank Investment Advisers. The offering is expected to close on October 9, 2020, subject to the satisfaction of customary closing conditions.

J.P. Morgan Securities LLC is acting as sole book-running manager of the offering.

The public offering is being made pursuant to an automatic shelf registration statement on Form S-3 that was filed by Guardant Health with the U.S. Securities and Exchange Commission (the "SEC") and automatically became effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus, when available, may be obtained by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected].

CytRx Highlights Use of Licensed Drug Aldoxorubicin in Treatment of Former Senate Majority Leader Harry Reid’s Pancreatic Cancer

On October 7, 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, reported that highlighted the use of its licensed drug – aldoxorubicin – in the combination immunotherapy used by ImmunityBio, Inc. and NantKwest, Inc. to treat former Senate Majority Leader Harry Reid’s stage IV pancreatic cancer (Press release, CytRx, OCT 7, 2020, View Source [SID1234568202]). It was widely reported in June 2020 that former Senator Reid described himself as being in "complete remission" after receiving experimental treatment pioneered by the Chief Executive Officer of ImmunityBio and NantKwest.1

Earlier this year, CytRx highlighted that ImmunityBio and NantKwest announced the initiation of a Phase 2 randomized, two-cohort, open-label study for first and second-line treatment of locally advanced or metastatic pancreatic cancer (QUILT-88). The study received Food and Drug Administration ("FDA") authorization and was slated to initially enroll 268 subjects across both cohorts. It has been indicated that enrollment was expected to begin in June 2020.

"We wish former Senator Reid the best now that he is reportedly in complete remission and hope that his combination immunotherapy treatment can become the basis for treating other individuals with pancreatic cancer," said Steven A. Kriegsman, CytRx’s Chairman and CEO. "Although former Senator Reid is only one person and other comprehensive studies and trials are necessary and required, we continue to be encouraged with the progress and results of this promising pancreatic cancer treatment that includes aldoxorubicin."

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.

OncoNano Announces Positive Clinical Data for Cancer Imaging Agent ONM-100 at The World Molecular Imaging Congress

On October 7, 2020 OncoNano Medicine, Inc. reported positive results from its ongoing Phase 2a study of ONM-100, an innovative imaging agent used in intraoperative surgical resection of solid tumors (Press release, OncoNano Medicine, OCT 7, 2020, View Source [SID1234568201]). The data, presented today at the World Molecular Imaging Congress (WMIC) Virtual 2020, demonstrate successful imaging of various solid tumors.

"As low pH is a hallmark of all solid tumors, our novel imaging agent ONM-100 has the potential to become a useful tool for successful tumor resection surgeries," said Ravi Srinivasan, Ph.D., President of OncoNano Medicine. "These data indicate that ONM-100 was well-tolerated and was able to visualize various solid tumor types. We are encouraged by these findings and are excited to continue developing ONM-100 to address this persistent and challenging unmet need in detection of cancer."

OncoNano is currently enrolling patients in the Phase 2a trial to further evaluate the safety and pharmacokinetic/pharmacodynamic (PK/PD) profile of ONM-100. More information can be found at ClinicalTrials.gov

Presentation Overview

TITLE: Image Guided Robotic Prostatectomy Using the pH-Activated Micellar Imaging Agent ONM-100 – A Phase 2 Study of Tumor and Camera Agnostic Detection of Solid Cancers

PRESENTER: Aditya Bagrodia, M.D., Assistant Professor, Department of Urology, University of Texas Southwestern Medical Center

Results announced today are based on 16 patients with various cancers (4 breast, 5 head and neck, 6 prostate and 1 ovarian), all of whom received a single intravenous dose of ONM-100 the same day as, or previous to the day of surgery. The findings indicate that ONM-100:

Is well tolerated at doses 3X higher than doses administered in Phase 1
Detects pathologically confirmed tumor regions through the prostatic capsule, indicating imaging feasibility during robotic prostatectomy
Demonstrates ability to provide fluorescence signals even within a few hours after dosing, which combined with a half-life > 55 hours enables a wide imaging window
Can feasibly image breast, head and neck, prostate, and ovarian cancers.
About ONM-100

ONM-100 is OncoNano’s lead product candidate under development. ONM-100 utilizes a proprietary pH-sensitive micelle platform to encapsulate a fluorescent tag and exploit a universal biomarker of all solid cancers – the relatively acidic pH of the tumor microenvironment – to intraoperatively image tumors. ONM‑100 micelles remain inactive at normal physiological pH until exposure to the acidic tumor microenvironment triggers micelle dissociation and fluorescent tag activation. This has the potential to make tumors visible during surgery with standard surgical imaging equipment. ONM-100 is currently in Phase 2 clinical trials. ONM-100 was partially funded for clinical research by the Cancer Prevention and Research Institute of Texas (CPRIT).

Greenwich LifeSciences, Inc. to Participate at Upcoming Investor and Partnering Conferences

On October 7, 2020 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that it was selected to present at the 2020 BIO Investor Forum conference to be held virtually from October 13-15, 2020 and will be participating at the BIO-Europe partnering conference to be held virtually from October 26-29, 2020 (Press release, Greenwich LifeSciences, OCT 7, 2020, View Source [SID1234568200]).

At the BIO Investor Forum, Snehal Patel, CEO of Greenwich LifeSciences will present and will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference. The presentation will highlight the Company’s GP2 program and its plans to commence a Phase III clinical trial, will include a pre-recorded audio track available to conference attendees on demand, and will be simultaneously made available on the investor section of the Company’s website at: View Source

At the BIO-Europe partnering conference, the Company will seek to meet with international pharmaceutical companies seeking to license marketing rights for promising therapeutics for their respective regions. The Company previously initiated a global and regional out-licensing process with industry leading advisor, Torreya Partners, which is expected to continue as the upcoming GP2 Phase III trial commences.

About BIO Investor Forum

The 19th annual BIO Investor Forum is an international biotech investor conference focused on early and established private companies as well as emerging public companies. The event features plenary sessions, business roundtables and therapeutic workshops, company presentations, and scheduled one-to-one meetings. For more information, please visit the conference website at: View Source

About BIO-Europe

The 26th annual BIO-Europe global life sciences partnering conference includes access to company pitches, program sessions, and sponsor and showcase company content. The event is expected to bring together over 4,000 executives from more than 2,000 life sciences companies spanning an estimated 60+ countries. Program content includes business development, therapeutic areas, startup innovations, digital health, and scheduled one-to-one meetings. For more information, please visit the conference website at: https://informaconnect.com/bioeurope/

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.