On June 22, 2022 The Cancer Research Institute (CRI), a nonprofit organization dedicated to the discovery and development of powerful immunotherapies for all types of cancer, reported the newest cohort of scientists chosen for the CRI Lloyd J. Old STAR Program (Scientists Taking Risks) (Press release, Cancer Research Institute, JUN 22, 2022, View Source [SID1234616171]). Each STAR will receive a grant of $1.25 million payable over five years to carry out high-risk/high-reward research that has the potential to produce transformative leaps forward in tumor immunology. This long-term funding provides a degree of flexibility and freedom for CRI STARs to explore new and disruptive avenues of cancer research.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The competitive CRI Lloyd J. Old STAR program supports gifted, mid-career scientists working at the intersection of immunology, technology, and bioinformatics to identify specific molecular and genetic factors that influence patient responses to immunotherapy, discovering answers to the field’s key scientific questions to potentially effect a sea change in how cancer patients are diagnosed and treated," said Jill O’Donnell-Tormey, Ph.D., CEO and director of scientific affairs at the Cancer Research Institute, which now actively supports twenty-two STARs throughout the U.S. and Europe.

The announcement comes during the tenth annual Cancer Immunotherapy Month celebrations in June of scientists who are driving new and lifesaving advances in the immunological treatment and prevention of cancer. This year’s Cancer Research Institute Lloyd J. Old STARs include:

Iliyan D. Iliev, Ph.D., of Weill Cornell Medicine, who is breaking new ground in efforts to understand the role fungi play in cancer development and immunotherapy, characterizing how different fungal strains promote or inhibit cancer growth through interaction of their metabolites and toxins with the immune system, and determining how the presence of fungi within the tumor microenvironment and blood influences – and may even predict – patient responses to treatment with immunotherapy
Philip J. Kranzusch, Ph.D., of the Dana-Farber Cancer Institute and Harvard Medical School, who has discovered and is exploring thousands of previously uncharacterized signaling enzymes from the cGAS family involved in immune cell responses to threats, using biochemistry and structural biology to uncover the functions of these enzymes and their related cellular pathways in order to define at the molecular level how they are activated, potentially leading to new, more effective therapeutic strategies
Kole T. Roybal, Ph.D., of the University of California, San Francisco Helen Diller Family Comprehensive Cancer Center and Gladstone-UCSF Institute of Genomic Immunology, who has developed a synthetic biology approach to modifying immune cell receptor and signaling gene programs to create "smart cell" therapeutics with enhanced abilities to target tumors more precisely and more safely than current cell therapies, which have so far proven largely ineffective against solid tumors despite their successes in treating cancers of the blood
Brian Ruffell, Ph.D., of the H. Lee Moffitt Cancer Center and Research Institute, who aims to improve patient responses to immunotherapy by using CRISPR-Cas9 genetic screens to define specific molecular pathways involved in suppression of dendritic cells – key orchestrators of the immune response to cancer and other threats – in order to identify and validate targets of immunotherapy for preclinical development
Ansuman T. Satpathy, M.D., Ph.D., of Stanford University School of Medicine, Stanford Cancer Institute, and Gladstone-UCSF Institute of Genomic Immunology, who is using new genetic analysis technologies capable of scanning and profiling the entire genome of immune cells to understand how transcription and expression of specific genes affects immune cell behavior or leads to dysfunctions in specific cellular pathways that contribute to T cell exhaustion, and is developing and using tools from functional genomics and mass spectrometry to study fundamental properties of the immune system in search of new regulators of anti-tumor immune responses
Matthew H. Spitzer, Ph.D., of the University of California, San Francisco Helen Diller Family Comprehensive Cancer Center and Gladstone-UCSF Institute of Genomic Immunology, who is using cutting-edge experimental and computational technologies to explore the role of immune cells circulating outside tumors – rather than those within the tumor microenvironment – in conferring long-term protection against cancer and infection, leading potentially to the identification of therapeutic targets involved in tumor-mediated immune suppression throughout the body.
The Cancer Research Institute named this program in honor of Lloyd J. Old, M.D., the "Father of Modern Tumor Immunology," who served as CRI’s founding scientific and medical director from 1971 to 2011. A mentor to generations of immunologists and tumor immunologists who flourished under his guidance and went on to make significant contributions to the field, Dr. Old embodies the ideals of the STAR program, through which CRI identifies and funds high-impact scientists whose outstanding work has distinguished them as today’s visionaries in cancer immunology.

The following members of CRI’s Scientific Advisory Council leadership comprise the CRI Lloyd J. Old STAR Program Selection Committee:

Carl F. Nathan, M.D., (Committee Chair), R.A. Rees Pritchett Professor of Microbiology and Chair, Department of Microbiology and Immunology, Weill Cornell Medicine
James P. Allison, Ph.D., Regental Professor and Chair of Immunology; Olga and Keith Wiess Distinguished University Chair for Cancer Research; Executive Director of the Immunotherapy Platform; Deputy Director for Applied Research of Genitourinary Cancers; Director of the Parker Institute for Cancer Immunotherapy, University of Texas MD Anderson Cancer Center; and 2018 Nobel Laureate
Glenn Dranoff, M.D., Global Head of Immuno-Oncology, Novartis Institutes for Biomedical Research
Kunle Odunsi, M.D., Ph.D., FRCOG, FACOG, Director, University of Chicago Medicine Comprehensive Cancer Center; Dean of Oncology and Professor of Obstetrics and Gynecology, Division of Biological Sciences, University of Chicago
Ellen Puré, Ph.D., Professor of Pharmacology; Grace Lansing Lambert Professor of Biomedical Science and Chair, University of Pennsylvania School of Veterinary Medicine; Director, Penn Vet Cancer Center; and Member, Abramson Cancer Center, University of Pennsylvania
Robert D. Schreiber, Ph.D., Andrew M. and Jane M. Bursky Distinguished Professor, Pathology and Immunology; Interim Chief, Division of Immunobiology; Director, Center for Human Immunology and Immunotherapy Programs; Co-Leader, Tumor Immunology Program, Siteman Cancer Center, Washington University School of Medicine
E. John Wherry, Ph.D., Chair, Department of Systems Pharmacology & Translational Therapeutics; Richard and Barbara Schiffrin President’s Distinguished Professor; Director, Institute for Immunology; Co-Program Leader, Immunobiology Program, Abramson Cancer Center, and Co-Director, Parker Institute for Cancer Immunotherapy, University of Pennsylvania
Jedd D. Wolchok, M.D., Ph.D., Lloyd J. Old/Virginia and Daniel K. Ludwig Chair in Clinical Investigation; Chief, Immuno-Oncology Service, Human Oncology and Pathogenesis Program; Director, Parker Institute for Cancer Immunotherapy at MSK; and Associate Director, Ludwig Center for Cancer Immunotherapy, Memorial Sloan Kettering Cancer Center.
Applications to the next CRI Lloyd J. Old STAR Program funding round are due January 15, 2023. To learn more about the program, including eligibility and application instructions, go to cancerresearch.org/star.

On June 22, 2022, bluebird bio, Inc. (the "Company") reported that entered into an Equity Distribution Agreement (the "Equity Distribution Agreement") with Goldman Sachs & Co. LLC ("Goldman") to sell shares of the Company’s common stock, par value $0.01 per share (the "Common Stock"), with aggregate gross sales proceeds of up to $75.0 million, from time to time, through an "at the market" equity offering program under which Goldman will act as manager (Filing, 8-K, bluebird bio, JUN 22, 2022, View Source [SID1234616170]). The Equity Distribution Agreement also provides for the sale of shares to Goldman directly as principal, in which case the Company and Goldman will enter into a separate terms agreement ("Terms Agreement").

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the Equity Distribution Agreement, the Company will set the parameters for the sale of shares, including any price, time or size limits or other customary parameters or conditions. The Company intends to sell shares pursuant to the Equity Distribution Agreement from time to time in varying amounts, which may be limited, based upon factors including (among others) market conditions, trading liquidity, the trading price of the Company’s Common Stock, and determinations by the Company of its need for, and appropriate sources of, additional capital. Subject to the terms and conditions of the Equity Distribution Agreement, Goldman may sell the shares by any method permitted by law, including without limitation (i) by means of ordinary brokers’ transactions (whether or not solicited), (ii) to or through a market maker, (iii) directly on or through any national securities exchange or facility thereof, a trading facility of a national securities association, an alternative trading system, or any other market venue, (iv) in the over-the-counter market, (v) in privately negotiated transactions, or (vi) through a combination of any such methods. The Company will pay Goldman a commission equal to up to 3.0% of the gross proceeds of any Common Stock sold through Goldman under the Equity Distribution Agreement, and also has provided Goldman with customary representations, warranties, covenants and indemnification rights. The Equity Distribution Agreement may be terminated by the Company upon written notice to Goldman or by Goldman upon written notice to the Company. In the case of any purchase of shares by Goldman directly as principal pursuant to a Terms Agreement, such Terms Agreement may be terminated by Goldman upon notice to the Company under certain circumstances, including but not limited to the occurrence of a material adverse effect in the Company.

Any sales of shares under the Equity Distribution Agreement will be made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-236489) filed with the Securities and Exchange Commission (the "Commission") on February 18, 2020, which was automatically effective upon filing. The Company filed a prospectus supplement with the Commission on June 22, 2022 in connection with the offer and sale of the shares pursuant to the Equity Distribution Agreement.

The foregoing is only a brief description of the material terms of the Equity Distribution Agreement and is qualified in its entirety by reference to the full agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Latham & Watkins LLP, counsel to the Company, has issued an opinion to the Company, dated June 22, 2022, regarding the validity of the shares of Common Stock to be issued and sold pursuant to the Equity Distribution Agreement. A copy of the opinion is filed as Exhibit 5.1 to this Current Report on Form 8-K.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of any offer to buy the securities discussed herein, nor shall there be any offer, solicitation or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On June 22, 2022 Avid Bioservices, Inc. (NASDAQ:CDMO), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality services to biotechnology and pharmaceutical companies, reported that it will report financial results for the quarter and fiscal year ended April 30, 2022 on June 29, 2022 after market close and will host a conference call and webcast at 1:30 PM Pacific Time (4:30 PM Eastern Time) (Press release, Avid Bioservices, JUN 22, 2022, View Source [SID1234616169]). Members of Avid’s senior management will discuss financial results for the quarter and FY ended April 30, 2022 and review recent corporate developments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To listen to the live webcast, or access the archived webcast, please visit: View Source

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices call.

On June 22, 2022 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, reported that it has entered into a clinical trial collaboration and supply agreement in North America with Eli Lilly and Company (Lilly) to evaluate ficlatuzumab in combination with ERBITUX (cetuximab), an anti-EGFR antibody, in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) (Press release, AVEO, JUN 22, 2022, View Source [SID1234616168]). Ficlatuzumab is AVEO’s investigational potent humanized immunoglobulin G1 monoclonal antibody that targets hepatocyte growth factor.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This clinical trial collaboration and supply agreement with Lilly follows a similar engagement we entered into with Merck KGaA, Darmstadt, Germany earlier this year, both of which we believe serve as validation for our ficlatuzumab clinical development plan. We expect these collaborations will play an important role in the advancement of the combination of ficlatuzumab and cetuximab," said Michael Bailey, president and chief executive officer of AVEO. "We reported positive Phase 2 clinical data last year that show ficlatuzumab in combination with cetuximab has the potential to play a meaningful role in the treatment of patients with human papillomavirus (HPV) negative R/M HNSCC, which is associated with particularly poor outcomes. We continue to be in discussions with regulators on the final design of a potential pivotal study for this combination therapy, which we expect to commence in the first half of 2023."

Under the terms of the agreement, Lilly will provide cetuximab clinical drug supply in the U.S. and Canada for AVEO’s potential registrational study, which will assess ficlatuzumab with cetuximab in HPV negative R/M HNSCC. AVEO will serve as the study sponsor and will be responsible for trial execution.

In June 2021, AVEO announced positive results from a randomized Phase 2 study of ficlatuzumab alone or in combination with cetuximab in patients with pan-refractory metastatic HNSCC. Of note, patients with HPV negative disease, a subgroup normally associated with poorer outcomes, who received the ficlatuzumab and cetuximab combination demonstrated both a superior overall response rate, including two patients with complete responses, and median progression free survival superior to historical data for current standards of care. In September 2021, the FDA awarded Fast Track designation for the combination of ficlatuzumab and cetuximab in HPV negative relapsed/recurrent HNSCC. A copy of the presentation is available at www.aveooncology.com.

AVEO recently commenced manufacturing of ficlatuzumab clinical supply in the second quarter of 2022, with the potential registrational study expected to be initiated in the first half of 2023. AVEO expects to continue to discuss potential ficlatuzumab pivotal study designs with the FDA and to continue ongoing partnership dialogues.

About Ficlatuzumab

Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) immunoglobulin G1 (IgG1) inhibitory antibody that binds to the HGF ligand with high affinity and specificity. HGF is the natural ligand of c-Met and blocking HGF inhibits signaling through the HGF/c-Met signaling pathway. Ficlatuzumab is currently being evaluated in squamous cell carcinoma of the head and neck (HNSCC) and pancreatic cancer. The U.S. Food and Drug Administration designated as a Fast Track development program the investigation of ficlatuzumab and ERBITUX (cetuximab) for relapsed/recurrent HNSCC in September 2021.

On June 22, 2022 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported results from a retrospective, matched case control study (Press release, Aura Biosciences, JUN 22, 2022, View Source [SID1234616167]). This retrospective analysis assessed the visual acuity of patients following treatment with plaque radiotherapy compared with prospective data on visual acuity in subjects with early-stage choroidal melanoma treated with belzupacap sarotalocan by intravitreal administration in the Phase 1b/2 trial (NCT03052127).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"These results point to the high unmet medical need for a first line vision preserving therapy for the treatment of early-stage choroidal melanoma given the high levels of irreversible visual acuity loss with the current standard of care with radiotherapy," said Carol Shields, MD, Chief of the Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University. "Being able to treat the disease early, avoid radiotherapy and spare long-term vision loss in many patients, as well as potentially reducing the risk of metastatic disease, could represent a paradigm shift in our approach to the treatment of choroidal melanoma. This would be a significant improvement in the quality of life for patients with this life-threatening rare disease."

Results from the Retrospective Study

Study Design

This retrospective, matched case control study compared visual acuity outcomes for 43 patients from Aura’s Phase 1b/2 trial evaluating intravitreal administration of belzupacap sarotalocan in patients with early-stage choroidal melanoma (AU-011-101, NCT03052127) to 150 patients from the subject database of a previously completed and published study where patients with small choroidal melanoma had been treated with plaque radiotherapy (Shields, et al. "Visual Outcome and Millimeter Incremental Risk of Metastasis in 1780 Patients With Small Choroidal Melanoma Managed by Plaque Radiotherapy." JAMA Ophthalmology. September 27, 2018). Both cohorts of patients were at high risk for vision loss due to having the tumor edge within 3.0 mm of the fovea. The patients were matched for tumor height, tumor diameter, distance from the fovea and baseline visual acuity, which are among the core factors that impact visual acuity after treatment.

Key Findings:

The vision results of patients with early-stage choroidal melanoma treated with radiotherapy showed the long term, progressive and irreversible loss of visual acuity in patients where tumors were close to the fovea.

The loss of vision in radiotherapy patients was ≥3 lines in a majority of patients as early as 2 years and ≥6 lines as early as 3 years.

We believe the comparison of the belzupacap sarotalocan and radiotherapy results supports the potential benefit of a targeted treatment achieving a statistically significant difference in visual acuity preservation as soon as two years including for both logMAR (Logarithm of the Minimum Angle of Resolution) vision (p = 0.0094) and change in logMAR vision (p = 0.0323).

We believe the progressive loss of visual acuity with radiotherapy observed in this retrospective study underscores the urgent need for a vision preserving targeted therapy.

The findings of this retrospective study were consistent with published clinical data supporting the irreversible loss of visual acuity after treatment with radiotherapy.

"We are committed to developing the first potential targeted therapy for patients with early-stage choroidal melanoma. We believe the visual acuity results of the retrospective matched case control study are exciting because they support the high unmet medical need for a long-term vision preserving therapy," said Dr. Cadmus Rich, Chief Medical Officer and Head of R&D of Aura Biosciences. "Belzupacap sarotalocan is currently being evaluated in a Phase 2 dose escalation clinical trial (AU-011-202, NCT04417530) using suprachoroidal administration in patients with early-stage choroidal melanoma. We remain on track to initiate our pivotal trial by the end of 2022."

Study Limitations include the retrospective nature and utilizing a matched case control design. The mean follow-up for patients treated with belzupacap sarotalocan in this initial analysis was 15.6 months. Due to the retrospective nature of this analysis, it is hypothesis-generating; no formal conclusions can be drawn. Aura has also initiated a prospective matched case control study to further evaluate the long-term visual acuity results of belzupacap sarotalocan from the Phase 2 trial AU-011-202 using suprachoroidal administration versus radiotherapy.