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Arcus Biosciences to Participate at the 2021 Wedbush PacGrow Virtual Healthcare Conference

On August 4, 2021 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, reported that management will present at the 2021 Wedbush PacGrow Virtual Healthcare Conference on Wednesday, August 11, 2021 at 1:45 p.m. Eastern Time (Press release, Arcus Biosciences, AUG 4, 2021, View Source [SID1234585749]).

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A live audio webcast of the presentation will be available by visiting the "Investors" section of the Arcus website at www.arcusbio.com. A replay of the webcast will be available for at least two weeks following the live event.

Calidi Biotherapeutics Announces Agreement with Northwestern University for Exclusive Commercial Rights to their IND for Treatment of Malignant Glioma

On August 4, 2021 Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company at the forefront of stem cell-based delivery of oncolytic viruses, reported that it has executed a license agreement with Northwestern University for the exclusive commercialization rights to the IND and data generated from Northwestern’s Phase 1 clinical trial treating brain tumor patients with an engineered oncolytic adenovirus delivered by neural stem cells ("NSC-CRAd-S-pk7") (Press release, Calidi Biotherapeutics, AUG 4, 2021, View Source [SID1234585746]). The license is for Calidi’s commercial development of stem-cell based products loaded with adenovirus. A group of prominent neurosurgeons and neuro-oncologists led by Dr. Maciej S. Lesniak, Chair of the Department of Neurological Surgery, at Northwestern University Feinberg School of Medicine, and Dr. Roger Stupp, Chief of Neuro-Oncology in the department of Neurology at Northwestern University, has successfully completed a Phase 1, first-in-human clinical trial with NSC-CRAd-S-pk7, hereafter referred to as NeuroNova-1 (NNV-1), in patients with newly diagnosed malignant glioma. This trial resulted from a 13 year collaboration with Dr. Karen Aboody at the City of Hope Comprehensive Cancer Center, who developed the tumor-tropic neural stem cell line.

"We share the same excitement and passion of Dr. Lesniak about the potential of NeuroNova-1," said Allan J. Camaisa, CEO and Chairman of Calidi Biotherapeutics. "This exclusive worldwide license and the upcoming Phase 2 clinical trial with NeuroNova-1 will further expand and diversify our product pipeline and portfolio, making Calidi’s solutions more versatile across a variety of cancer indications. We look forward to sharing our cell delivery expertise in future trials with a world-class institution like Northwestern University."

In preclinical models, the neural stem cells were capable of effectively targeting the delivery of the viral payload selectively to glioma cells, warranting the translation of this therapeutic approach to the clinical setting.

"Northwestern University’s neurosurgery and neuro-oncology teams are looking forward to continued collaboration with Calidi Biotherapeutics for the Phase 2 trial of NeuroNova-1," said Maciej S. Lesniak, MD, MHCM, FAANS, Professor of Neurological Surgery and Chair, Department of Neurological Surgery, Northwestern University Feinberg School of Medicine. "We chose to partner with Calidi over other companies, on account of their extensive expertise and proprietary methods in stem cell-based platforms for delivery and potentiation of oncolytic viruses. We will draw from their significant experience and expertise in this field to further enhance the next generation of NeuroNova-1."

"Our team is very pleased to help further development of NeuroNova-1," said Boris Minev, MD, President, Medical and Scientific Affairs at Calidi Biotherapeutics. "This novel agent has a significant potential for glioma treatment, especially in patients having very difficult to treat gliomas with unmethylated MGMT promoters. These promising findings have been published in the June 29, 2021 issue of the prestigious journal: Lancet Oncology." An article referencing this journal publication was recently published in Apple News: Medical Xpress, entitled: Novel therapy may improve survival for patients with malignant gliomas (Article).

Under the License Agreement, Northwestern granted to Calidi a worldwide, twelve-year exclusivity for use of the clinical data in the commercial development of NSC-CRAd-S-pk7 for therapeutic and preventive uses in oncology and a right of reference to NU IND 17365 which relates to the treatment of newly diagnosed glioma.

Strand Therapeutics Awarded Two Phase I NIH SBIR Grants to Advance Programmable, Long-Lasting mRNA Therapeutics for Melanoma and Breast Cancer

On August 4, 2021 Strand Therapeutics, a privately held developer of next-generation, programmable mRNA therapeutics for cancer immunotherapy and other diseases, reported that the company was awarded two Phase I Small Business Innovation Research (SBIR) grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) to develop mRNA-based therapeutics for melanoma and triple negative breast cancer (TNBC) (Press release, Strand Therapeutics, AUG 4, 2021, View Source [SID1234585745]). The total funding amount awarded to Strand is approximately $800,000.

While there have been advances in the development of treatment options for melanoma, the number of diagnoses continues to increase. Furthermore, standard of care using anti-PD-1 immunotherapy has been limited with not all patients responding to the therapy. To address this need, the first award granted to Strand will support the development of programmable mRNA circuits that express cytokines which regulate the activation of immune cells, to stimulate an adaptive immune response as a neoadjuvant therapy for melanoma.

TNBC is an aggressive form of breast cancer, accounting for 10-15% of all cases, and is another cancer indication in need of more targeted and effective medicines. Patients have a poor prognosis with limited treatment options. While checkpoint inhibitor therapies including anti-PD-1 antibodies have improved outcomes in patients, only a small percentage respond to this treatment strategy. The second award will allow Strand to engineer synthetic self-replicating mRNA therapies expressing locally-acting cytokines with the goal of improving anti-PD-1 therapy responses.

"It is well known that cytokines can be utilized to achieve an anti-tumor effect in cancer patients. However, treatment strategies that involve cytokines can be highly toxic, and therefore, its efficacy can be limited. To that end, we can use our programmable, self-replicating mRNA therapeutic platform to localize cytokine expression that will potentially enable more precise and longer-lasting anti-cancer immune responses," said Jake Becraft, PhD, co-founder and CEO of Strand. "This generous support from NIH’s NCI will enable us to create synthetic mRNA-based therapeutics that can be safer and more effective than currently available treatment options for both melanoma and breast cancer patients."

Gamida Cell Announces the Date of Its Second Quarter 2021 Financial Results and Webcast

On August 4, 2021 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, reported that the company will host a conference call and live audio webcast on Wednesday, August 11, 2021, at 8:00 a.m. ET to review its second quarter 2021 financial results and provide an update on the company (Press release, Gamida Cell, AUG 4, 2021, View Source [SID1234585744]).

Management will discuss the company’s progress during the quarter, including advances in the development of omidubicel, which has the potential to be the first approved cell therapy for blood cancer patients in need of an allogeneic bone marrow transplant, following the planned BLA submission in the fourth quarter of 2021. Gamida Cell will also provide an update on its pipeline of NAM-enabled natural killer (NK) cell therapies, including GDA-201 and genetically-modified NK cell constructs. The Company is planning an IND submission to support the initiation of a Phase 1/2 clinical study of cryopreserved, off-the-shelf GDA-201 in patients with follicular and diffuse large b-cell lymphomas.

The webcast will be available on the "Investors & Media" section of the Gamida Cell website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 9949715. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.

Schrödinger and Zai Lab Announce a Global R&D Collaboration in Oncology

On August 4, 2021 Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, and Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, reported a global discovery, development and commercialization collaboration focused on a novel program in oncology targeting DNA damage response (Press release, Schrodinger, AUG 4, 2021, View Source [SID1234585743]).

"With an established track record of developing and commercializing therapeutics in oncology, Zai Lab is an ideal partner for Schrödinger on this project," said Karen Akinsanya, Ph.D., executive vice president, chief biomedical scientist and head of discovery R&D at Schrödinger. "Together, we will aim to accelerate and expand our focus on targeted DNA damage response inhibition, which is emerging as an important therapeutic strategy for a broad range of cancers. Additionally, the structure of this collaboration provides us with the opportunity to gain development and commercial expertise and the potential to participate more significantly in the downstream value of the program."

"We are pleased to be collaborating with Schrödinger, a recognized leader in physics-based computational drug discovery," said Alan Sandler, M.D., president and head of global development, oncology, at Zai Lab. "This program will complement our existing discovery efforts in the DNA damage response pathway in addition to potential combinatorial approaches within our pipeline, such as with the PARP inhibitor Zejula."

The research program will be conducted jointly by the Schrödinger and Zai Lab scientific teams. The companies will be responsible for their own research program expenses, and under the terms of the collaboration agreement, Zai Lab will make an upfront payment to Schrödinger to help fund Schrödinger’s share of research costs. Following the selection of a development candidate, Zai Lab will assume primary responsibility for global development, manufacturing and commercialization. The agreement provides Schrödinger co-development and co-commercialization rights in the U.S. If Schrödinger elects to co-fund clinical development of a product candidate under the collaboration, it will be entitled to 50 percent of the profits, if any, from the commercialization of such product candidate in the United States. Schrödinger will also be eligible to receive up to approximately $338 million in preclinical, clinical, regulatory and sales-based milestone payments. Additionally, Schrödinger is entitled to receive royalties on net sales outside the U.S.