On March 26, 2020 Bolt Biotherapeutics, Inc., a private biotechnology company developing its Immune-Stimulating Antibody Conjugate (ISAC) platform technology to harness the power of the immune system to treat cancer, reported that patient dosing has begun in the company’s Phase 1, open-label, dose-escalation and dose expansion study of BDC-1001 monotherapy for patients with HER2-expressed solid tumors (Press release, Bolt Biotherapeutics, MAR 26, 2020, View Source [SID1234555887]). BDC-1001 is an ISAC comprised of trastuzumab conjugated to Bolt’s proprietary TLR7/8 agonist payload.

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"The initiation of this study represents a significant milestone for the company as it is our first Boltbody therapeutic program to enter the clinic," stated Randall Schatzman, Ph.D., chief executive officer of Bolt. "Bolt’s leadership in the ISAC field will continue to drive the development of myeloid-based cancer therapeutics. There is a significant unmet need for patients with solid tumors that express HER2 that cannot be addressed by current immuno-oncology therapeutics."

Dr. Schatzman continued, "Based on an assessment of our ongoing program by the safety committee, we are now proceeding with the second cohort of our study. Bolt is eager to explore the potential of BDC-1001 for treating HER2-expressing cancers, which includes patients with breast and gastric cancers that are refractory to Herceptin and Kadcyla, as well as cancers for which no HER2-targeting therapies have yet been approved. We look forward to working with the medical community to bring the promise of this exciting new approach to patients and anticipate initial data will drive our future development plans."

The program has generated compelling preclinical data demonstrating complete, durable regression of established tumors resistant to trastuzumab and immunological memory providing protection against tumor cells that no longer express the HER2 antigen in syngeneic mouse cancer models.

About the BDC-1001 Phase 1 Study in HER2-Expressed Solid Tumors
The Phase 1, multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and proof of mechanism of BDC-1001 in HER2-expressing solid tumors. The first portion of the study includes a monotherapy dose-escalation phase in which cohorts of patients will receive ascending intravenous doses of BDC-1001 to determine the maximum tolerated dose and/or the recommended dose for the expansion cohorts and Phase 2 based on safety and tolerability. The second portion of the study is a dose expansion phase in which patients will receive BDC-1001 monotherapy to evaluate antitumor activity of the recommended Phase 2 dose and to further evaluate the safety and tolerability of BDC-1001. Please refer to clinicaltrials.gov NCT04278144 for additional clinical trial information.

About Bolt Biotherapeutics’ Immune-Stimulating Antibody Conjugate (ISAC) Platform Technology
The Boltbody platform consists of Immune Stimulating Antibody Conjugates (ISACs) that harness the ability of innate immune agonists to convert cold tumors into immunologically hot tumors thereby illuminating tumors to the immune system and allowing them to be invaded by tumor killing cells. Boltbody ISACs have demonstrated the ability to eliminate tumors following systemic administration as monotherapy in preclinical models and have also led to the development of immunological memory, which is predicted to translate into more durable clinical responses for patients.

On March 26, 2020 Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology reported its 2019 financial results and provides a business update (Press release, Pulmatrix, MAR 26, 2020, View Source [SID1234555886]).

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"2019 was a transformative year at Pulmatrix marked by significant clinical and corporate milestones," said Ted Raad, Chief Executive Officer of Pulmatrix. "We built significant momentum with regulatory accomplishments, strategic partnerships expanding our global reach, and most importantly, the advancement of both Pulmazole and PUR1800 programs. Our PUR1800 licensing agreement with the Lung Cancer Initiative at Johnson & Johnson and Pulmazole strategic partnership with Cipla Technologies LLC demonstrate the strength of Pulmatrix’s iSPERSE platform to enhance the safety and efficacy of promising drug candidates and we are thrilled to be collaborating with these leading, global partners."

Mr. Raad continued, "On the clinical front, we initiated our ongoing Phase 2 clinical study of Pulmazole for the treatment of ABPA, which we believe has the potential to change the standard of care for patients with asthma and ABPA. In collaboration with Johnson & Johnson, we plan to initiate the PUR1800 Ph1b clinical study and chronic toxicology studies in mid-2020. In parallel, we are working to advance a new proprietary iSPERSE enabled 505(b)(2) program into the clinic in 2021. However, the novel coronavirus may adversely impact the planned timelines for each of these trials should institutions need to suspend enrollments or should we voluntarily suspend enrollment at sites due to risks related to the coronavirus. We will evaluate these issues on an ongoing basis."

2019 and Recent Highlights:

Initiated Phase 2 trial evaluating Pulmazole, an inhaled iSPERSE formulation of the antifungal itraconazole, for the treatment of Allergic Bronchopulmonary Aspergillosis ("ABPA") in patients with asthma.
Announced kinase inhibitor licensing and development agreement with the Lung Cancer Initiative at Johnson & Johnson. The agreement provides the Lung Cancer Initiative option to access a portfolio of narrow spectrum kinase inhibitors intended for development in lung cancer interception. Under the terms of the agreement, Pulmatrix received a $7.2M upfront payment with eligibility for additional milestone and royalty payments.
Entered into strategic partnership with Cipla Technologies LLC ("Cipla") for the worldwide development and commercialization of Pulmazole. Under the terms of the partnership, Pulmatrix received a $22M upfront payment, fully funding the Phase 2 study. The partnership leverages Cipla’s expertise in respiratory drug development and global commercialization capability and footprint (the "Cipla collaboration").
Received U.S. FDA Fast Track designation for Pulmazole for the treatment of ABPA.
Strengthened intellectual property portfolio with issuance of US patent covering iSPERSE formulations for Pulmazole.
Announced research collaboration with Nocion Therapeutics to explore inhaled drug delivery technologies.
Completed $16.6M public offering extending cash runway through data for ongoing Pulmazole Phase 2 program.
Strengthened Board of Directors with appointment of life sciences executive Rick Batycky.
Financials

As of December 31, 2019, Pulmatrix had $23.4 million in cash and cash equivalents, compared to $2.6 million for the year ended December 31, 2018.

Revenue for 2019 was $7.9 million, compared to $0.2 million for 2018. The increase was the result of the recognition of revenue pursuant to the Cipla Collaboration.

Research and development expense was $12.8 million in 2019 compared to $13.0 million in 2018. The decrease year–over–year was primarily due to decreased spend of $1.6 million in employment costs as a result of decreased share based compensation expense and $0.6 million on the PUR1800 project as a result of the completion of a pre-clinical toxicology study in 2018, partially offset by increased spend of $2.0 million on the Pulmazole project.

General and administrative expense was $8.5 million for 2019 and $7.5 million for 2018. The increase year-over-year was due to a $0.3 million royalty payment made to the Cystic Fibrosis Foundation which resulted from the Cipla Collaboration and increases of $0.3 million of legal and patent costs, $0.2 million of employment costs and $0.2 million in professional consulting expense.

Goodwill had an impairment charge of $7.3 million in 2019 compared to a $0.1 million charge in 2018.

Net loss for 2019 and 2018 were both $20.6 million. The net loss in 2019 was primarily attributable to spend on the Pulmazole project as we advance our Phase 2b clinical study and PUR1800 manufacturing costs for the upcoming Phase 1b clinical study.

On March 26, 2020 CG Oncology, Inc. has reported an exclusive license, development and commercialization agreement with Kissei Pharmaceutical Co., Ltd. ("Kissei") for its oncolytic immunotherapy drug CG0070 for Japan, South Korea, Taiwan and other Asian countries with the exception of China (Press release, Cold Genesys, MAR 26, 2020, View Source [SID1234555885]). CG Oncology has completed an investigational Phase 2 study of CG0070 in the United States in patients with BCG-unresponsive, non-muscle-invasive bladder cancer (NMIBC). In addition, CG Oncology is studying the use of CG0070 in combination with immune checkpoint inhibitors in bladder cancer and other solid tumors.

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"We are very excited to partner with Kissei, an R&D-oriented Japanese pharmaceutical company that shares our interests in developing innovative medicines for patients with debilitating urological and oncology conditions," said Arthur Kuan, CEO of CG Oncology. "Kissei possesses a track record of commercial success with both in-licensed and proprietary therapies in Asian markets, and their dedication to develop CG0070 in these territories makes Kissei an ideal partner. We sincerely look forward to collaborating with them to accelerate the development of CG0070 and to globalize patient access to a potentially important new therapeutic."

Under the terms of this agreement, CG Oncology receives a licensing fee of $10 million in cash, with the potential for an additional $100 million in development and commercial milestone payments, and will receive certain royalties on sales of CG0070 in the territories licensed by Kissei. CG Oncology also receives a $30 million equity investment from Kissei. Further financial details of the agreement were not disclosed.

"Through our extensive experience with in-licensed and proprietary therapies, we have strong expertise to successfully develop and commercialize CG0070 in Japan, and other countries," said Mutsuo Kanzawa, Chairman and CEO of Kissei. "We look forward to collaborating closely with CG Oncology to address the significant unmet medical needs of patients with this innovative medication."

About CG0070

CG0070, a selectively replicative oncolytic immunotherapy based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroys bladder tumor cells through their defective retinoblastoma (Rb) pathway. CG0070 was designed to work in two complementary ways. First, it replicates inside the tumor’s cells with dysfunctional Rb pathways, causing tumor cell lysis and immunogenic cell death. Then, the rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, which can stimulate a systemic anti-tumor immune response that involves the body’s own white blood cells. In advanced clinical studies, CG0070 has been shown to be a safe and efficacious agent in NMIBC following BCG failure. The scientific rationale and clinical results to date of CG0070 make it a promising agent to be developed for a variety of solid tumor types to be used alone or in combination with immune checkpoint inhibitors.

On March 26, 2020 EpiVax Oncology, Inc., a precision cancer immunotherapy company, reported it has reduced the timeline from biopsy to vaccine to under 4 weeks for its personalized neoantigen therapeutic cancer vaccines (Press release, EpiVax, MAR 26, 2020, View Source [SID1234555884]).

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CEO and Co-Founder, Gad Berdugo, MSc Eng., MBA, stated, "This is a real game changer for personalized cancer vaccines. It will enable our precision immunotherapy to treat patients in the neoadjuvant clinical setting before surgical removal of their tumors, potentially improving the patient’s clinical outcome."

Dominique Bridon, PhD, CTO said, "Personalized cancer vaccines are created based on information obtained from an individual’s tumor. Previously, the process to create an a personalized vaccine starting from tumor biopsy took at least 12 to 18 weeks. We expect that reducing this time to less than 4 weeks will improve the effectiveness of our personalized vaccine candidates in attacking the tumor."

Arjun Balar, MD, Associate Professor of Medicine, Director Genitourinary Medical Oncology Program, NYU Laura and Isaac Perlmutter Cancer Center, NYU Langone Health said, "The ability to generate a vaccine that is ready for use in a patient in under 4 weeks is a critical advancement. Patients with metastatic disease cannot wait for effective therapy. Moreover, a rapid biopsy to vaccine administration time opens the door to presurgical or neoadjuvant "window of opportunity" studies. These studies will definitively address the biological effects of a personalized cancer vaccine in the tumor-microenviornment. This is something that has long been missing in previous approaches to cancer vaccines."

Gary D Steinberg, MD, Professor of Urology, Director Bladder Cancer program, NYU Langone Health stated, "High grade bladder cancer is an aggressive disease that will progress and metastasize to other parts of the body. Thus, therapeutic interventions need to be provided in a timely fashion without unnecessary delay. With a personalized cancer vaccine process under 4 weeks, we can safely create a vaccine to treat all stages of aggressive cancer including in the neoadjuvant, adjuvant and metastatic setting. Ideally, we will also be able to treat patients with high grade non-muscle invasive cancer. This is a significant advance in the armamentarium of newly developed treatments for this cancer which kills over 17,000 people per year in the US."

Epivax Oncology’s neopeptides are patient specific peptides that are designed using Ancer: EpiVax Oncology’s advanced in-silico neoantigen prediction platform powered by machine learning based algorithms that have been refined over more than 20 years by Providence-based EpiVax Inc.

On March 26, 2020 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported the closing of the offering of 630,500 shares of its common stock at a price of $12.22 per share, for total gross proceeds of approximately $7.7 million, before deducting underwriting discounts and other offering expenses payable by the Company (Press release, Cel-Sci, MAR 26, 2020, View Source [SID1234555883]). Additionally, the Company has granted the underwriter a 45-day option to purchase up to 94,575 additional shares to cover over-allotments.

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Aegis Capital Corp. acted as the sole book-running manager for the offering.

This offering was made pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226558) filed with the Securities and Exchange Commission (SEC). A prospectus supplement and accompanying base prospectus relating to the offering were filed with the SEC and are available on the SEC’s website at View Source and may be obtained from Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th floor, New York, NY 10019, by email at [email protected], or by telephone at (212) 813-1010.

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.