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FDA Approves New First-Line Treatment for Extensive-Stage Small Cell Lung Cancer

On March 27, 2020 Bonnie J Addario Lung Cancer Foundation reported the Food and Drug Administration approved durvalumab (IMFINZI, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) (Press release, Bonnie J Addario Lung Cancer Foundation, MAR 27, 2020, View Source [SID1234555996]).

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Efficacy of this combination in patients with previously untreated ES-SCLC was investigated in CASPIAN, a randomized, multicenter, active-controlled, open-label, trial (NCT03043872). The evaluation was based on the comparison of patients randomized to durvalumab plus chemotherapy vs. chemotherapy alone. The major efficacy outcome measure was overall survival (OS). Additional efficacy outcome measures were investigator-assessed progression-free survival (PFS) and objective response rate (ORR), per RECIST v1.1.

Median OS was 13.0 months (95% CI: 11.5, 14.8) in the durvalumab plus chemotherapy arm compared with 10.3 months (95% CI: 9.3, 11.2) in the chemotherapy alone arm (hazard ratio 0.73; 95% CI: 0.59, 0.91; p=0.0047).

Investigator-assessed PFS (96% of total planned events) showed a HR of 0.78 (95% CI: 0.65, 0.94), with median PFS of 5.1 months (95% CI: 4.7, 6.2) in the durvalumab plus chemotherapy arm and 5.4 months (95% CI: 4.8, 6.2) in the chemotherapy alone arm. The investigator-assessed confirmed ORR was 68% (95% CI: 62%, 73%) in the durvalumab plus chemotherapy arm and 58% (95% CI: 52%, 63%) in the chemotherapy alone arm.

The most common adverse reactions (≥20%) in patients with ES-SCLC were nausea, fatigue/asthenia, and alopecia.

For ES-SCLC, durvalumab is to be administered prior to chemotherapy on the same day. The recommended durvalumab dose when administered with etoposide and either carboplatin or cisplatin is 1500 mg every 3 weeks prior to chemotherapy and then every 4 weeks as a single agent.

View full prescribing information for IMFINZI.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

FDA granted this application priority review and granted durvalumab orphan drug designation for this indication. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Entry into a Material Definitive Agreement

On March 27, 2020 Merrimack Pharmaceuticals, Inc. (the "Company") reported that it has entered into an Asset Purchase Agreement (the "Asset Purchase Agreement") with Celator Pharmaceuticals, Inc. (the "Buyer"), pursuant to which the Buyer agreed to purchase certain assets (the "Transferred Assets") relating to certain of the Company’s preclinical nanoliposome programs (the "Transaction") (Filing, 8-K, Merrimack, MAR 27, 2020, View Source [SID1234555983]). The Company and the Buyer completed the Transaction simultaneously with the execution of the Asset Purchase Agreement. Under the terms of the Asset Purchase Agreement, the Buyer agreed to pay to the Company upfront cash payment of $2.25 million, and also agreed to reimburse the Company for certain specified expenses and to assume certain liabilities with respect to the acquired assets.

Pursuant to the Asset Purchase Agreement, the Company assigned to the Buyer the previously disclosed intellectual property license agreement among the Company, Ipsen S.A. and Ipsen Biopharm Ltd. (together with Ipsen S.A., "Ipsen"), dated as of April 3, 2017, pursuant to which Ipsen granted the Company licenses to certain patents. On March 27, 2020, the Company and the Buyer also entered into an intellectual property license agreement pursuant to which the Buyer granted to the Company an exclusive license to certain specified know-how included in the Transferred Assets and an exclusive sublicense to the patents which are the subject of the license agreement with Ipsen, in each case to exploit certain specified nanoliposome products.

Both the Company and the Buyer have agreed to indemnify the other for losses arising from certain breaches of the Asset Purchase Agreement and for certain other potential liabilities, subject to certain limitations. The Asset Purchase Agreement also contains customary representations and warranties and covenants. The assertions embodied in those representations and warranties were made solely for purposes of the Asset Purchase Agreement and may be subject to important qualifications and limitations agreed to by the Company and the Buyer in connection with negotiating its terms. Moreover, the representations and warranties may be subject to a contractual standard of materiality that may be different from what may be viewed as material to stockholders or may have been used for the purpose of allocating risk between the Company and the Buyer rather than establishing matters as facts. For the foregoing reasons, no person should rely on such representations and warranties as statements of factual information at the time they were made or otherwise.

The foregoing description of the Asset Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the terms of the Asset Purchase Agreement, a copy of which is filed as Exhibit 2.1 hereto and incorporated herein by reference.

GenScript ProBio Congratulates XlifeSciences on the Start of TAEST16001 Early Phase Clinical Trial

On March 27, 2020 Guangzhou XlifeSciences, a partner of GenScript ProBio (GenScript’s CDMO segment) reported that the early phase clinical trial of TAEST16001 project has been started (Press release, GenScript, MAR 27, 2020, View Source [SID1234555958]). GenScript ProBio extends congratulations on this.

This clinical trial project is China’s first TCR-T project targeted at solid tumor therapy, marking a milestone in immunotherapy in China. In 2019, XlifeSciences entrusted TCR-T products with complete independent intellectual property rights to GenScript ProBio. It is the first cooperation project between the parties, where GenScript ProBio works on plasmid and virus process development and clinical manufacturing and will be further responsible for commercial manufacturing.

"We congratulate XLifeSciences on the successful launch of TAEST16001 early phase clinical trial, which marks a milestone in the industry," said Dr. Brian Min, CEO of GenScript ProBio. "We are honored to offer technology and manufacturing support in such a meaningful project. With a one-stop high-quality plasmid and virus platform, GenScript ProBio facilitates XLifeSciences to complete all pre-clinical CMC research for IND filing. We will continue to follow up on the clinical trial. We wish that the clinical project proceeds smoothly so as to relieve patients from pain as soon as possible. We are optimistic about the prospects of the project. As China’s first company that has built the plasmid facility for gene and cell therapy, GenScript ProBio has well-established technological platform and quality system, and is capable of providing quality services to more customers.

Seneca Biopharma, Inc. Reports Year End 2019 Fiscal Results

On March 27, 2020 Seneca Biopharma, Inc. (Nasdaq: SNCA), a biopharmaceutical company focused on developing novel treatments for diseases of high unmet medical need, reported its financial results for the year ended December 31, 2019 (Press release, Seneca Biopharma, MAR 27, 2020, View Source [SID1234555956]).

Business Highlights for the Year Ended December 31, 2019

In early 2019, the Company shifted its operating strategy and focus away from the development of our neural stem cell treatments and initiated an out-licensing effort to partner these programs, while seeking to in-license or acquire novel therapeutics that are complementary to our current technologies and could benefit from our development experience.

On July 17, 2019, we effected a 1-for-20 reverse stock split of our common stock;

In July of 2019, we completed an underwritten public offering of our securities resulting in gross proceeds of approximately $7.5 million;

On October 28, 2019, we changed our name from Neuralstem, Inc. to Seneca Biopharma, Inc.

Financial Results for the Year Ended December 31, 2019

Cash Position and Liquidity: At December 31, 2019, cash was approximately $5.1 million as compared to approximately $5.8 million at December 31, 2018. The $0.7 million decrease is due to cash used in operations of approximately $7.3 million partially offset by the proceeds from our July 2019 underwritten offering.

Operating Loss: Operating loss for the year ended December 31, 2019 was $8.6 million compared to a loss of $8.3 million for 2018. The increase in operating loss for the year was primarily due to the absence of revenue and a small increase in research and development expenses. General and administrative expenses totaled approximately $4.6 million during the two periods.

Net Loss: Net loss for the year ended December 31, 2019 was $8.4 million, or $3.80 per share, compared to a loss of $4.9 million, or $7.80 per share on a post-reverse stock-split basis, for 2018. The change in net loss was primarily attributed to non-cash related changes in the fair value of our liability classified stock purchase warrants.

R&D Expense: Research and development expense for the year ended December 31, 2019 was $4.1 million as compared to $4.0 million for the year ended December 31, 2018. The increase was primarily attributable to an increase in external consulting services engaged in the technical evaluation of our internal programs as well as the evaluation of certain potential assets we considered for acquisition. These costs were partially offset by lower clinical trial expenditures as we wound down clinical activates.

G&A Expense: General and administrative expense were approximately $4.6 million for both 2019 and 2018. As noted above, in early 2019, the Company shifted its operating strategy and initiated an out-licensing effort to partner our neural stem cell treatments while seeking to acquire novel therapeutics with the potential to be complementary to our current technologies and that could benefit from our development experience. Associated with this shift in strategic focus, our G&A expenses in 2019 reflect an enhanced internal management structure including individual consultants in key roles.

Liquidity: In January 2020, the Company entered into an agreement with certain accredited investors from our July 2019 underwritten offering. Under this agreement the exercise price of certain warrants issued in the July offering were reduced from $2.70 to $1.36 to induce the immediate cash exercise of such warrants. The Company received approximately $6.8 million in net proceeds. We believe that the proceeds from the warrant exercise, along with our cash as of December 31, 2019, will be sufficient to fund our planned operations for more than 12 months.

"With the proceeds from the January 2020 transaction, we have the capital to build out our management team and continue our initiative of evaluating new therapeutic products for development as well as seeking partners for our promising neural stem-cell therapeutic NSI-566" commented Dr. Kenneth Carter, Seneca’s Executive Chairman. "On this front, our China-based subsidiary is readying a new facility which will be utilized to complete activities for our China-based stroke trial from which we are expecting top line data by the end of this year. In addition, we recently held a discussion with the US FDA regarding a path forward for our ALS program. We will provide additional information on these programs when certain activities are concluded."

Alphamab Oncology Announces Clinical Supply Collaboration with Pfizer on KN026 in Combination with Ibrance(R) (palbociclib)

On March 27, 2020 Alphamab Oncology (stock code: 9966HK) reported that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Jiangsu Alphamab"), a wholly-owned subsidiary of the Company, has entered a clinical supply agreement with Pfizer Inc. ("Pfizer") to advance a clinical study to investigate KN026 in combination with Ibrance (palbociclib), an oral CDK4/6 inhibitor, in patients with previously-treated locally advanced and/or metastatic HER2-positive breast cancer (Press release, Alphamab, MAR 27, 2020, View Source [SID1234555955]). Jiangsu Alphamab, as the study sponsor, will oversee and run the trial, and Pfizer will supply palbociclib.

Dr. Ting XU, Founder, Chairman and CEO of Alphamab Oncology commented, "Through the collaboration with Pfizer, we are on the right track to investigate the combination of KN026 and a CDK4/6 inhibitor for patients with HER2-positive breast cancer as a chemo-free regimen. By combining KN026 with palbociclib, we believe it has the potential to provide more effective treatment options for patients with HER2‑positive breast cancer."

This Phase Ib/II clinical trial is a multicenter, open-label study, aiming to evaluate efficacy, safety and tolerability of KN026 in combination with palbociclib in patients with locally advanced unresectable or metastatic HER2-positive breast cancer.

KN026 received IND approval from the National Medical Products Administration of China and U.S. Food and Drug Administration in 2018. Currently, it is in multiple phase I/II clinical trials in China and phase I clinical trials in the United States, targeting HER2 expression solid tumors cancers, such as breast cancer, gastric cancer, urothelial cancer and gynecological cancers.

About KN026

KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. In pre-clinical studies, KN026 has demonstrated potentially equivalent or superior efficacy compared with Trastuzumab w/o combination with Pertuzumab. KN026 has increased binding capacity as well as better inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines. KN026 phase I trials have shown good safety and preliminary efficacy.