On December 8, 2020 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it has closed a previously announced private financing with a group of institutional accredited investors led by Bain Capital Life Sciences, with participation from new and existing investors, including Ally Bridge Group, Omega Funds, OrbiMed Advisors, EcoR1 Capital, and Samsara BioCapital (Press release, Syros Pharmaceuticals, DEC 8, 2020, View Source [SID1234572442]).

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In this financing, Syros sold an aggregate of 10,312,500 shares of its common stock and pre-funded warrants (Pre-Funded Warrants) to purchase an aggregate of 1,000,000 shares of common stock, and accompanying warrants (Warrants) to purchase an aggregate of up to 2,828,125 additional shares of common stock (or Pre-Funded Warrants in lieu thereof) at a price of $8.00 per share and accompanying Warrant (or $7.99 per Pre-Funded Warrant and accompanying Warrant). The price per Pre-Funded Warrant and accompanying Warrant represents the price of $8.00 per share and accompanying Warrant to be sold in the private placement, minus the $0.01 per share exercise price of each such Pre-Funded Warrant. The exercise price of the Warrants is $11.00 per share, or if exercised for a Pre-Funded Warrant in lieu thereof, $10.99 per Pre-Funded Warrant (representing the Warrant exercise price of $11.00 per share minus the $0.01 per share exercise price of each such Pre-Funded Warrant). The Warrants are exercisable at any time during the period beginning on June 8, 2021 and ending on December 8, 2025. The Pre-Funded Warrants are exercisable at any time after their original issuance and will not expire. The gross proceeds from the sales of common stock and Pre-Funded Warrants are $90.5 million, before deducting offering expenses.

Net proceeds from this financing are expected to be used to advance Syros’ clinical development pipeline, business development activities, working capital and other general corporate purposes.

The securities sold in the private placement have not been registered under the Securities Act of 1933, as amended (Securities Act), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the shares of common stock issued and sold in the private placement no later than the 30th day after the closing of the offering. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

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

On December 8, 2020 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported that it has entered into an underwriting agreement with Kingswood Capital Markets, division of Benchmark Investments, Inc. and Aegis Capital Corp (Press release, Cel-Sci, DEC 8, 2020, View Source [SID1234572458]). under which the underwriters have agreed to purchase on a firm commitment basis a minimum of 1,000,000 shares of common stock of the Company, at a price to the public of $14.65 per share (the "Public Price"), representing a 5% discount to the Company’s December 8, 2020 closing share price. The closing of the offering is expected to occur on or about December 11, 2020, subject to customary closing conditions.

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Kingswood Capital Markets, division of Benchmark Investments, Inc. and Aegis Capital Corp. are acting as the joint book-running managers for the offering.

The Company also has granted to the underwriters a 30-day option to purchase up to 15% of the offering at the Public Price. The use of proceeds will be to fund the continued development of Multikine* and LEAPS, the expansion of the Company’s manufacturing facility and for other general corporate purposes.

The shares of common stock described above are being offered by CEL-SCI pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226558) filed with the Securities and Exchange Commission (SEC) and the accompanying prospectus contained therein. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering has been filed with the SEC. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained on the SEC’s website at View Source or by contacting Kingswood Capital Markets, Attention: Syndicate Desk, 17 Battery Place, Suite 625, New York, NY 10004, by email at [email protected], or by telephone at (212) 404-7002.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 December 7, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported updated data from its ongoing Phase 1, open-label, dose escalation study of CA-4948, an IRAK4 kinase inhibitor, for the treatment of patients with relapsed or refractory (R/R) non-Hodgkin’s lymphoma (NHL), including patients with diffuse large B-cell lymphoma (DLBCL), Waldenström’s macroglobulinemia (WM) and oncogenic MYD88 mutations, and also declared the recommended Phase 2 dose of the investigational drug (Press release, Curis, DEC 7, 2020, View Source [SID1234572336]). The new results, which will be shared in a virtual oral presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, show that the recommended Phase 2 dose of 300 mg BID of CA-4948 monotherapy provides potent and durable anti-cancer activity in patients with relapsed or refractory non-Hodgkin’s lymphoma.

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"We are tremendously pleased to report that IRAK4 inhibition with CA-4948 monotherapy could potentially offer a novel treatment approach for patients with NHL," said James Dentzer, President and Chief Executive Officer of Curis. "We believe these preliminary data, demonstrating the tolerability and durable anti-cancer activity of single-agent CA-4948 therapy for these extremely sick patients, validate our development approach for this program and reaffirm our enthusiasm for the therapeutic potential of a combination therapy with proven synergistic treatments like ibrutinib. Anti-cancer activity was observed across multiple dose levels, which provides additional flexibility as we continue to develop CA-4948 for NHL. Among the active dose levels, we believe that 300 mg twice-daily has the potential to strike the most favorable balance of durable anti-cancer activity and tolerability for long-term treatment. We are also highly encouraged by the data gathered on our two exploratory biomarkers, which we believe support a compelling patient enrichment strategy. We are eager to work with our investigators, clinicians, and the broader patient community to advance the development of this novel treatment approach in a patient population in need of better treatment options."

"CA-4948 consistently reduced tumor burden at the recommended Phase 2 dose of 300 mg twice daily. Data like these, even at this early stage, are compelling for the patients and physicians contending with this degree of relapsed or refractory disease," said Robert Martell, Head of R&D of Curis. "These are patients facing the poorest prognoses after numerous prior lines of other therapies failed to meaningfully temper their disease progression. For these patients, any degree of tumor reduction may represent a significant improvement. Equally promising is the prospect of long-term tumor reduction and tolerability. This profile, along with the unique synergistic potential of a CA-4948/BTK inhibitor combination, could potentially offer a groundbreaking development in a disease area with considerable need."

The reported updated preliminary data are from Curis’s ongoing Phase 1, open-label, dose escalation 3+3 study designed to evaluate the safety and tolerability of CA-4948, in addition to pharmacokinetics, pharmacodynamics, anti-cancer activity, and biomarker correlations, in patients with R/R NHL. Seven dosing cohorts have been treated in continuous 21-day cycles at levels of 50 mg and 100 mg once-daily (QD), and 50 mg, 100 mg, 200 mg, 300 mg, or 400 mg twice-daily (BID). The data being reported from this ongoing trial are preliminary and subject to change.

Key findings from the ongoing Phase 1 study include:

CA-4948 was demonstrated to be generally well-tolerated, most AEs have been Grade 1-2.
Preliminary tolerability profile supports potential long-term treatment and combination with other active drugs against NHL.
Enrolled patients include those with DLBCL, WM, marginal zone lymphoma (MZL), follicular lymphoma (FL), lymphoplasmacytic lymphoma (LPL), transformed high-grade-B-Cell lymphoma (HGBCL), and mantle cell lymphoma (MCL).
Patients enrolled experienced a median of 4 prior lines of treatment (range 1-8).
Anti-cancer activity, as measured by reduction of tumor burden, was observed in:
6 of 7 evaluable patients receiving RP2D of 300 mg BID, with a mean reduction of 27% (ranging from 6% to 67%).
One patient with WM, who dose escalated from 50mg to 100mg to 200mg to 300mg (all doses, BID), experienced dose-dependent reductions in tumor burden at each dose level, eventually reaching a tumor burden reduction of 67% (partial response) following escalation to the 300mg BID dose. This patient continues to remain on therapy after 728 days (as of December 7th, 2020).
3 patients have been on therapy for greater than 1 year.
Encouraging early data for two potential biomarkers (NF-κB p-p50 and MYD88).
Early data for NF-κB p-p50 biomarker may support patient selection:
Patients whose tumors do not exhibit NF-κB activity may not be amenable to NF-κB downregulation.
7 of 7 patients testing negative for p-p50 at baseline experienced disease progression.
2 of these patients were dosed at 200mg BID.
Patients whose tumors do exhibit NF-κB activity may be amenable to NF-κB downregulation.
6 of 7 patients testing positive for p-p50 at baseline achieved stable disease or tumor shrinkage.
1 of these patients was dosed at 300mg BID.
Early data for MYD88 biomarker may support patient enrichment:
Both patients identified as positive for MYD88 mutation experienced tumor reduction, including a partial response.
More data are needed to confirm this potential predictive biomarker, but we believe positive patient outcomes are consistent with the thesis that patients with MYD88-mutated tumors should benefit from IRAK4 inhibition.
Webcast Event Information

Curis management will host a virtual KOL event tomorrow, December 8, 2020 at 8:00 am ET to discuss these results with Dr. Amit Verma, Professor of Medicine-Oncology at Albert Einstein College of Medicine, and Director of the MDS Program at Montefiore Medical Center located in Bronx, NY. To access the webcast, please visit the Events and Presentations section of the Curis website at View Source

On December 7, 2020 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that on Friday, December 4, 2020 the Company entered into a commercial manufacturing and supply framework agreement (the "CMO Agreement") with the Company’s partner in China, Qilu Pharmaceutical Co., Ltd. ("Qilu") (Press release, Sesen Bio, DEC 7, 2020, View Source [SID1234572352]).

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Under the CMO Agreement, Qilu will be part of the contract manufacturing network for global commercial supply of Vicineum. The Company’s lead program, Vicineum, is currently in the follow-up stage of a Phase 3 registration trial in the United States ("US") for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC"). The Company is on track to complete the BLA for Vicineum and submit to the FDA later this month.

In July 2020, the Company and Qilu entered into an agreement which grants Qilu an exclusive license to develop, manufacture and commercialize Vicineum in China.

"NMIBC is a disease area that has chronically suffered from manufacturing and CMC issues with significant impacts on patient care," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Given this, we have taken a thoughtful approach to our supply chain and partnerships in order to meet the significant anticipated global demand for Vicineum. Qilu has a large and experienced manufacturing team and currently supplies products for commercial sale around the world. The CMO Agreement represents an exciting expansion of our strong partnership with Qilu and will help Sesen Bio to reliably meet the projected global demand, while also creating an opportunity to reduce the cost of goods."

The Company believes that the technology transfer to Qilu for manufacturing of Vicineum is on track to be completed in mid-2021. Upon completion of the technology transfer, Sesen Bio is entitled to receive a $2M milestone payment.

In addition to Fujifilm and Baxter, the CMO partnership with Qilu expands the Company’s network of world-class partners committed to providing reliable supply of Vicineum around the world.

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicineum for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On December 7, 2020 Artiva Biotherapeutics, Inc., an oncology company focused on developing and commercializing primary allogeneic natural killer (NK) cell therapies to treat cancer, reported U.S. Food and Drug Administration (FDA) allowance of the company’s investigational new drug (IND) application for AB-101, an optimized and cryopreserved off-the-shelf NK cell therapy (Press release, Artiva Biotherapeutics, DEC 7, 2020, View Source [SID1234572369]). Artiva plans to conduct a Phase 1/2 clinical trial at up to 20 U.S. cancer centers to assess the safety and clinical activity of AB-101 alone and in combination with the anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL) who have progressed beyond two or more prior lines of therapy.

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"Monoclonal antibodies are mainstays of cancer therapy, but many patients have sub-optimal responses, and those who progress have limited options," said Tom Farrell, President and CEO of Artiva. "With AB-101, we intend to leverage our proprietary off-the-shelf NK cell platform to enhance and extend the clinical application of monoclonal antibodies and other cancer targeted therapies that rely on NK cells to mediate their anti-cancer activity."

AB-101 is a cryopreserved NK cell product candidate with high and consistent expression of tumor-engaging receptors including the high-affinity variant of CD16. These NK cell attributes have demonstrated improved outcomes for cancer patients in both the transplant and therapeutic monoclonal antibody settings. Furthermore, in preclinical models, AB-101 demonstrates enhanced antibody-dependent cellular cytotoxicity with a variety of therapeutic antibodies.

"Allogeneic NK cells have been tested in clinical trials for more than a decade. Based on this experience, we expect that AB-101 will be well tolerated. This contrasts with T-cell therapies that are associated with life-threatening cytokine release syndrome, neurotoxicity, and graft-versus-host-disease," said Jason Litten, MD, Chief Medical Officer of Artiva.

About the Clinical Trial

After receiving standard lymphodepleting chemotherapy, patients will receive eight weekly doses of up to four billion NK cells per AB-101 dose. The primary endpoint is objective response rate, per the 2014 Lugano Criteria. In Phase 2, indolent and aggressive NHL patients will receive AB-101 plus rituximab combination therapy in two parallel Simon two-Stage designed cohorts, each with independent interim analyses for objective clinical response.

About AB-101 NK Cell Therapy

Leveraging a proprietary manufacturing platform that enables expansion and cryopreservation of cord blood-derived NK cells, Artiva is advancing AB-101 as a universal primary NK cell product candidate for use in combination with targeting therapies such as monoclonal antibodies or NK cell engagers. Starting cord blood units are selected for B-KIR haplotype and the homozygous polymorphism of CD16 that confers high affinity binding to antibodies, including monoclonal antibody therapies. Starting cells are isolated then expanded and activated utilizing a proprietary campaign-based manufacturing process in a state-of the art GMP facility. AB-101 is delivered as cryopreserved vials of one billion highly active NK cells in an infusion-ready media for thawing and administration on demand at the clinical trial site. The manufacturing process generates thousands of cryovials of AB-101 from a single cord blood unit.