On November 15, 2019 Gracell Biotechnologies Co., Ltd. ("Gracell"), a clinical-stage immune cell therapy company, reported five presentations to be delivered at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida, held from December 7-10 (Press release, Gracell Biotechnologies, NOV 15, 2019, View Source [SID1234551391]).

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The presentations centre on Gracell’s breakthrough FasTCAR technology, and other two platform technology in four product categories used in the treatment of hematological malignancies, each with well-defined objectives, including:

FasT CAR-19 (GC007F)
Dual CAR-19-22 (GC022)
Dual CAR-BCMA-19 (GC012)
Donor CAR-19 (GC007G)
The four product candidates are currently being studied in ongoing phase I clinical trials conducted by Gracell, Hebei Yanda Lu Daopei Hospital, and Xinqiao Hospital of AMU, and six other hospitals nationwide in China.

"These clinical studies demonstrated Gracell’s product development strategy and strong capabilities to bring multiple novel therapies through clinical investigations," said Dr. William CAO, CEO of Gracell. "These invaluable data provides guidance for and enhance our confidence in pipeline selection."

Oral presentations:

A Feasibility and Safety Study of a New CD19-Directed Fast CAR-T Therapy for Refractory and Relapsed B cell Acute Lymphoblastic Leukemia
Abstract #825
Session Name: 612. Acute Lymphoblastic Leukemia: Clinical Studies: Therapeutics Strategies
Presenter: Peihua Lu, M.D., Hebei Yanda Lu Daopei Hospital
Location: Orange County Convention Center, Tangerine 1 (WF1), Level 2
Time: 5:00 pm, Monday, December 9, 2019
View Source

Anti-CD19/CD22 Dual CAR-T Therapy for Refractory and Relapsed B-Cell Acute Lymphoblastic Leukemia
Abstract #284
Session Name: 612. Acute Lymphoblastic Leukemia: Clinical Studies: Novel Therapies
Presenter: Peihua Lu, M.D., Hebei Yanda Lu Daopei Hospital
Location: Orange County Convention Center, W224, Level 2
Time: 4:15pm, Saturday, December 7, 2019
View Source

Poster presentations:

CD19-Directed Fast CART Therapy for Relapsed/Refractory Acute Lymphoblastic Leukemia: From Bench to Bedside
Abstract #1340
Session Name: 614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation: Poster I
Presenter: Cheng Zhang, M.D., Xinqiao Hospital of AMU
Location: Orange County Convention Center, Hall B, Level 2
5:30-7:30 pm, Saturday, December 7, 2019
View Source

A Bcma and CD19 Bispecific CAR-T for Relapsed and Refractory Multiple Myeloma
Abstract # 3147
Session Name: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Presenter: Hua Zhang, PhD., Gracell Biotechnology Ltd., Shanghai, China, Shanghai, China
Location: Orange County Convention Center, Hall B, Level 2
6:00 PM-8:00 pm, Sunday, December 8, 2019
View Source

Role of Donor-Derived CD19.CAR-T Cells in Treating Patients That Relapsed after Allogeneic Hematopoietic Stem Cell Transplantation
Abstract #4561
Session Name: 723. Clinical Allogeneic and Autologous Transplantation: Late Complications and Approaches to Disease Recurrence: Poster III
Presenter: Cheng Zhang, M.D., Xinqiao Hospital of AMU
Location: Orange County Convention Center, Hall B, Level 2
6:00-8:00 pm, Monday, December 9, 2019
View Source

About FasT CAR-19

FasT CAR-19, or GC007F, is an investigational CD19-targeted CAR-T cell therapy for adolescent and adult patients with refractory or relapsed B-ALL, as well as aggressive non-Hodgkin lymphoma. Thanks to Gracell’s patented FasTCAR technology, the bioprocessing time for GC007F has been significantly reduced from two weeks to 24 hours with substantially lower cost. The improved CAR-T cell fitness resulted in superior proliferation capabilities, potency, and extensive bone marrow migration making GC007F a potential best-in-class therapy for refractory or relapsed B-ALL.

About Dual CAR-19-22

Dual CAR-19-22, or GC022, is an investigational CAR-T cell therapy redirected to target CD19 and CD22, in treating patients with CD19+, or/and CD22+ relapsed/refractory B-ALL. A low toxicity with dose-dependent high CR rate including patients who previously treated with CD19 CAR-T cells were observed.

About Dual CAR-BCMA-19

Dual CAR-BCMA-19, or GC012, is an investigational CAR-T cell therapy redirected to target BCMA and CD19, in treating patients with BCMA+, or/and CD19+ relapsed/refractory multiple myeloma. Previous research shows CD19 could express on the myeloma progenitor cells, while BCMA is a well validated target for MM.

About Donor CAR-19

Donor CAR-19, or GC007G, is an investigational CD19 targeted CAR-T cell therapy manufactured in use of donor’s lymphocytes. The objective of this study is to further investigate and better understand the safety and efficacy of donor derived CAR-T cells in treatment of relapsed and refractory B-ALL patients.

About B-ALL

B-ALL is a sub-type of acute lymphoblastic leukemia, although rare, is one of the most common forms of cancer in children between the ages of two and five and adults over the age of 50[1]. In 2015, ALL affected around 876,000 people globally and resulted in 110,000 deaths worldwide[2]. It is also the most common cause of cancer and death from cancer among children. ALL is typically treated initially with chemotherapy aimed at bringing about remission. This is then followed by further chemotherapy carried out over several years.

About MM

Myeloma begins when a plasma cell becomes abnormal. The abnormal cell divides to make copies of itself. These abnormal plasma cells are called myeloma cells. In time, myeloma cells collect in the bone marrow. They may damage the solid part of the bone. When myeloma cells collect in several of your bones, the disease is called "multiple myeloma." This disease may also harm other tissues and organs, such as the kidneys. Myeloma cells make antibodies called M proteins and other proteins. These proteins can collect in the blood, urine, and organs[3].

On November 15, 2019 The board of directors of LIDDS AB reported that it has decided to carry out a directed issue of 562,500 shares at a subscription price of SEK 16 per share (Press release, Lidds, NOV 15, 2019, View Source [SID1234555901]). LIDDS will through the directed share issue receive proceeds amounting to SEK 9.0 million, before transaction costs.

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The board of directors of LIDDS has, based on the authorization given by the annual general meeting on May 16, 2019, decided to carry out a directed issue of 562.500 shares to new and current investors.

The subscription price in the Directed Share Issue is set to SEK 16,00 and has been determined by volume weighted average price during the last 20 business days with a discount of 5%. Through the Directed Share Issue, LIDDS will raise SEK 9.0 million before transaction costs. The Directed Share Issue entails a dilution of approximately 2.4 percent of the number of shares and the votes in the Company. Through the Directed Share Issue, the number of outstanding shares and votes will increase by 562,500 shares from 23,692,388 shares to 24,254,888 shares. The share capital will increase by SEK 29,812.50 from SEK 1,255,696.56 to SEK 1,285,509.07.

The reason for the deviation from the shareholders’ preferential rights, is to strengthen the shareholder base and to finance LIDDS’ exciting development projects. The Directed Share Issue will primarily be used to finance the NZ-TLR9 immuno-oncology project which includes an upcoming Phase I clinical trial.

Subscribers in the Directed Share Issue are new shareholders and existing shareholders.

On November 15, 2019 CTI BioPharma Corp. (the "Company") reported that it has entered into an Open Market Sale AgreementSM (the "Sale Agreement") with Jefferies LLC ("Jefferies") to sell shares of the Company’s common stock, par value $0.001 per share, having aggregate sales proceeds of up to $15,000,000, from time to time, through an "at the market" equity offering program under which Jefferies will act as sales agent (Filing, 8-K, CTI BioPharma, NOV 15, 2019, View Source [SID1234551376]).

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Under the Sale Agreement, the Company will set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales are requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the Sale Agreement, Jefferies may sell the shares by methods deemed to be an "at-the-market" offering as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, including sales made directly on The Nasdaq Capital Market or on any other existing trading market for the common stock. Jefferies will use commercially reasonable efforts in conducting such sales activities consistent with its normal trading and sales practices, applicable state and federal laws, rules and regulations and the rules of The Nasdaq Stock Market LLC. The Company and Jefferies may each terminate the Sale Agreement at any time upon one trading day’s prior notice. Under the terms of the Sale Agreement, the Company may also sell shares to Jefferies acting as principal for Jefferies’ own account.

The compensation to Jefferies for sales of the Company’s common stock will be an amount equal to 3.0% of the gross proceeds of any shares of common stock sold under the Sale Agreement. The Company has no obligation to sell any shares under the Sale Agreement, and may at any time suspend solicitation and offers under the Sale Agreement.

The shares will be issued pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-221382) (the "Registration Statement"), filed with the Securities and Exchange Commission (the "SEC") on November 7, 2017, as amended on November 21, 2017, December 5, 2017, January 24, 2018 and January 31, 2018. On the date hereof, the Company will file a prospectus supplement (the "Prospectus Supplement") with the SEC in connection with the offer and sale of the shares pursuant to the Sale Agreement.

The foregoing description of the Sale Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The legal opinion of Wilson Sonsini Goodrich & Rosati, Professional Corporation relating to the shares of common stock being offered is filed as Exhibit 5.1 to this Current Report on Form 8-K.

This Current Report shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any sale of such 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 November 15, 2019 Heat Biologics, Inc. (Nasdaq:HTBX), a biopharmaceutical company developing therapeutics designed to activate a patient’s immune system against cancer, reported financial and clinical updates for the third quarter ended September 30, 2019 (Press release, Heat Biologics, NOV 15, 2019, View Source [SID1234551377]).

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Jeff Wolf, Heat’s CEO, commented, "We remain encouraged by the positive top line data from our Phase 2 trial for HS-110 in advanced non-small cell lung cancer (NSCLC) in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, Opdivo (nivolumab) and with Merck’s anti-PD-1 checkpoint inhibitor Keytruda (pembrolizumab), which completed enrollment in July 2019. We recently presented a subset of this data in a poster presentation at The Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting, in which we reported that 61% of patients in our Phase 2 Cohort B achieved disease stabilization per iRECIST, a patient population whose disease had progressed following prior checkpoint inhibitor therapy. Based on this data, we look forward to advancing our clinical trials and intend to aggressively explore all options for the future development of HS-110, including possible collaboration and licensing opportunities."

"We ended the quarter with approximately $15.0 million in cash, cash equivalents and short-term investments. We believe we are well funded to advance our clinical activities though additional major milestones and continue to manage expenses accordingly."

Third Quarter 2019 Financial Results

Research and development expenses decreased to $3.1 million for the quarter ended September 30, 2019 compared to $4.4 million for the quarter ended September 30, 2018. The decrease of approximately $1.3 million is due to the lower PTX-35 expense for 2019, primarily reflecting decreased manufacturing costs, offset by increased Phase 2 trial expenses, including outsourced clinical trial support services and payments to investigator sites.
General and administrative expense increased to $2.0 million for the quarter ended September 30, 2019 compared to $1.6 million for the quarter ended September 30, 2018. The $0.4 million increase is primarily attributable to increased personnel costs, including stock-based compensation expense.
Net loss attributable to Heat Biologics was approximately $6.2 million, or ($0.18) per basic and diluted share for the quarter ended September 30, 2019 compared to a net loss of approximately $3.7 million, or ($0.16) per basic and diluted share for the quarter ended September 30, 2018.
As of September 30, 2019, the Company had approximately $15.0 million in cash, cash equivalents and short-term investments with an additional $6.9 million in grant funds from Cancer Prevention Research Institute of Texas (CPRIT) that it expects to receive after filing an IND for PTX-35.

On November 15, 2019 AIM ImmunoTech (NYSE American:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers and immune-deficiency diseases – such as severe chronic fatigue syndrome (CFS) – reported for the third quarter ended September 30, 2019, and has filed its form 10-Q with the U.S. Securities and Exchange Commission, which is available on the Company’s website (Press release, AIM ImmunoTech, NOV 15, 2019, View Source [SID1234551393]).

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Recent Highlights

Reported positive safety data in Phase 1 stage 4 ovarian cancer clinical study using Ampligen
Announced the U.S. Department of Defense’s (DOD) $6.42M "Breakthrough Award" to Roswell Park Comprehensive Cancer Center to fund a clinical trial to study Ampligen as a potential synergistic agent in combination with several other immunotherapies, such as pembrolizumab, in the treatment of brain-metastatic breast cancer.
Announced a second DOD "Breakthrough Award" of $8.3 million to fund a similar Phase 2 clinical trial to study Ampligen as part of a new treatment for brain-metastatic breast cancer at the Moffitt Cancer Center
Received clearance from the FDA for exportation of Ampligen to Argentina for the treatment of severe chronic fatigue syndrome
AIM ImmunoTech CEO Thomas K. Equels commented: "We continue to rapidly progress our clinical activities, as illustrated by a number of major upcoming expected milestones. These include:

In as early as the end of the first quarter of 2020, publication of data from a Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer at University of Pittsburgh Medical Center.
In as early as 11 months, interim data from a follow-up Phase 2 study of advanced recurrent ovarian cancer using cisplatin, pembrolizumab, plus Ampligen at University of Pittsburgh Medical Center.
In as early as five months, interim data from a Phase 2 study of metastatic triple-negative breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab, at Roswell Park Comprehensive Cancer Center.
In as early as one month, first enrollment in a Phase 1 study evaluating the safety and tolerability of a combination of Ampligen and celecoxib, with or without Intron A, when given along with chemotherapy in the treatment of patients with early-stage triple negative breast cancer.
In as early as three months, submission to the U.S. Food and Drug Administration of the protocol for two separate but parallel Phase 2 clinical trials to study Ampligen as a potential synergistic agent in combination with several other immunotherapies – including pembrolizumab and Intron A – in the treatment of brain-metastatic breast cancer (See details above in Recent Highlights).
Balance Sheet Highlights

As of September 30, 2019, AIM ImmunoTech had cash, cash equivalents and marketable securities of $11,730,000 compared with $1,825,000 as of December 31, 2019. The increase is primarily due to capital raises totaling approximately $10 million.

"The $10 million that we raised over the past few months provides us a substantial runway to support our activities while we await reportable data in the six ongoing immuno-oncology clinical trials studying Ampligen. Our role in these trials is solely to supply the Ampligen, as the trials are funded by grants from prestigious third parties directly to the clinical sites. We believe this third-party funding provides substantial validation of our platform and we look forward to providing further updates in the near-term. Meanwhile, we continue to carefully manage expenses in a way we believe will allow us to concentrate on near-term clinical goals, and as our short-term clinical trial manufacturing objectives are reached we expect to further reduce our burn rate."

Third Quarter Financial Highlights

Research and development-related expenses for the third quarter of 2019 were $1,190,000, compared with $1,595,000 million for the third quarter of 2018. Costs decreased primarily due to a general reduction in the level of Ampligen manufacturing and a decrease in clinical research costs.

General and administrative expenses for the third quarter of 2019 were $1,846,000, compared with $1,273,000 for the third quarter of 2018. The increase in G&A expenses during the current period was mainly due to an increase in stock-based compensation, an increase in public relations expenses, an increase in investment banking fees and an increase in legal fees.

The net loss from continuing operations for the third quarter of 2019 was $2,948,000, compared with $3,078,000 for the third quarter of 2018.