On May 13, 2021 Interline Therapeutics, a Foresite Labs incubated company focused on systematically elucidating protein communities to define molecular mechanisms of disease, reported that the company has raised $92 million (Press release, Interline Therapeutics, MAY 13, 2021, View Source [SID1234627668]). Foresite Capital and ARCH Venture Partners co-led the financing, which will be used to expand the research platform and advance six preclinical therapeutic programs.

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Dysfunctional protein communities drive disease

Proteins have generally been studied as isolated entities, but in nature function in protein communities – interconnected networks of dynamic protein interactions. Medical researchers have been limited by an incomplete understanding of how these communities impact common diseases, lowering the likelihood of successful drug development.

Reshaping protein communities to treat common diseases

Interline Therapeutics uses genomics, proteomics, structural biology and computational chemistry to systematically map and modulate protein communities. Interline is leveraging recent advancements in these technologies, as well as collaborations with leading academic groups, to develop a precision medicine platform focused on three essential areas:

Genomics: Prioritize genetic variants that drive disease by altering protein communities
Communities: Identify the specific molecular mechanisms through which these variants change protein community dynamics, enabled by the application of machine learning
Modulators: Discover and characterize drugs that reshape these communities
The discovery platform will allow the company to identify new medicines targeting genetically validated signaling pathways and ensure that drug candidates comprehensively correct dysfunctional disease networks.

Interline was co-founded by CEO Zachary Sweeney, a scientist with a track record of growing and leading successful drug discovery groups. Company leaders bring decades of experience discovering innovative medicines at Amgen, Denali Therapeutics, Genentech, Novartis and Nurix. The team includes Nick Galli, Chief Operating Officer, Don Kirkpatrick, Chief Technology Officer, Mario Cardozo, Vice President Computational Chemistry and Cheminformatics, Anj Saha, Vice President Discovery Pharmacology and David Tully, Vice President Medicinal Chemistry.

"Biomedical research is newly enabled by advances in human genomic and proteomic technologies," said Zachary Sweeney, CEO. "We are excited to collaborate with leading research groups to develop a protein-focused roadmap for precision medicine."

The company will continue to collaborate with Foresite Labs in the fields of data science and genomics. Interline also launches with foundational collaborations with University of California San Francisco and Memorial Sloan Kettering Cancer Center, as well as an internationally recognized team of founding scientific advisors, including:

John Chodera, PhD, Associate Member and Laboratory Director, Sloan Kettering Institute, Memorial Sloan Kettering Cancer Center
Wade Harper, PhD, Chairman and Bert and Natalie Vallee Professor of Molecular Pathology and Cell Biology, Harvard Medical School
Nevan J. Krogan, PhD, Professor, Cellular and Molecular Pharmacology, UCSF, Director, Quantitative Biosciences Institutes, and Senior Investigator, Gladstone Institutes
Brenda Schulman, PhD, Director, Molecular Machines and Signaling, Max Planck Institute of Biochemistry
Mike Varney, PhD, Former Executive Vice President Research and Early Development of Genentech
"Interline has assembled a world-class set of scientific advisors and an outstanding leadership team," said Mike Varney, member of the company’s Board of Directors. "The company has made great progress toward mapping and understanding the perturbations in protein dynamics caused by genetic mutations, and leveraging these insights to correct the protein communities found in cancer and inflammation."

"By creating a platform to discover, understand and re-engineer protein interactions, we will find new approaches to treat debilitating diseases," commented Vikram Bajaj, PhD, co-founder and CEO of Foresite Labs. "Zach and the Interline team possess an incredible breadth of experience, and we are thrilled to help accelerate Interline’s growth."

Jay Parrish, PhD and Venture Partner at ARCH Venture Partners said, "Our investment in Interline Therapeutics reflects our commitment to their vision of protein-centric systems biology drug discovery. The platform allows for unique insights into mechanisms of serious illnesses with high unmet need, while delivering novel paths and high-impact therapeutics to tackle validated disease targets."

For more information about Interline Therapeutics, please visit www.interlinetx.com.

Dr. Chodera has served as a scientific advisor for and has financial interests in Interline Therapeutics, and has also provided consulting and advisory services to Foresite Labs. Memorial Sloan Kettering Cancer Center (MSK) has intellectual property rights and associated financial interests related to Interline Therapeutics by virtue of licensing agreements between MSK and Interline Therapeutics.

On May 13, 2021 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Decibel Therapeutics, MAY 13, 2021, View Source [SID1234585162]).

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"The start of 2021 marked a pivotal time for Decibel as we successfully closed our upsized IPO. With this strong financial foundation, we are in a position to further advance our exciting pipeline of clinical, preclinical and discovery programs with the overarching goal of bringing the privileges of hearing and balance to people in need. In early 2021, we announced encouraging preclinical results on our lead gene therapy program, DB-OTO, for the treatment of people with otoferlin deficiency. We also established a critical cGMP manufacturing and development relationship with Catalent," said Laurence Reid, Ph.D., Chief Executive Officer of Decibel. "Beyond DB-OTO, we remain encouraged by the progress in our gene therapy programs for congenital, monogenic hearing loss and look forward to announcing the program target for our AAV.104 program in 2021."

Company Highlights

Closed Second Tranche of Series D Financing and Upsized Initial Public Offering: In February 2021, Decibel completed its Series D financing, closing the second tranche and receiving net proceeds of $27.4 million. Additionally, Decibel completed its Initial Public Offering (IPO) of 7,662,000 shares of common stock at a public offering price of $18.00 per share. Net proceeds from the offering, after deducting underwriting discounts and offering expenses, were approximately $124.8 million.
Pipeline Progress

Gene Therapies for Congenital, Monogenic Hearing Loss

Continued Development of Lead Gene Therapy Program, DB-OTO, for Otoferlin (OTOF): In February 2021, Decibel established manufacturing capabilities for its lead gene therapy product candidate, DB-OTO. Under the new agreement, Catalent will provide Decibel with cGMP manufacturing and process and analytical development of DB-OTO.
Presented New Preclinical Data on DB-OTO and Surgical Approach at the 44th Annual Association for Research in Otolaryngology Conference (ARO) and the Annual Scientific and Technology Conference of the American Auditory Society: In the first quarter of 2021, Decibel presented new preclinical findings to support the development of DB-OTO. Presentations highlighted data demonstrating that the Company’s proprietary dual vector technology and cell-selective promoter enabled expression of OTOF in hair cells and durably restored hearing in mice and drove highly selective expression of a reporter gene in hair cells of non-human primates across the cochlear length.
On Track for DB-OTO Key Milestones in 2022: Decibel expects to submit an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) and/or a Clinical Trials Application (CTA) in Europe and initiate a Phase 1/2 clinical trial for DB-OTO in pediatric patients with congenital hearing loss in 2022.
Preclinical Pipeline Expansion Continues: Decibel expects to announce the program target for its AAV.104 discovery program in patients with autosomal recessive hearing disorders in 2021.
Gene Therapies for Hair Cell Regeneration

Preclinical Pipeline Expansion Continues: Decibel continues to advance DB-ATO and AAV.201, its gene therapy programs for regeneration of hair cells in the vestibule for the treatment of bilateral vestibulopathy, and its gene therapy program to regenerate hair cells in the cochlea for the treatment of sensorineural hearing loss. Based on findings from recently completed behavioral studies of DB-ATO, the Company did not see sufficient functional recovery to continue to move DB-ATO to development candidate in 2021. The Company plans to announce the program target for AAV.201 in 2022.
Otoprotection Therapeutic

Updated Timeline to Report Interim Results from Phase 1b Proof-of-Concept Trial of DB-020 for the Treatment of Cisplatin-Induced Hearing Loss: The reporting of interim results from the ongoing Phase 1b clinical trial of DB-020 in patients with cisplatin-induced hearing loss is now expected in the first half of 2022 due to continued impact of the COVID-19 pandemic on the pace of patient recruitment in the United States. Due to COVID-19 restrictions, sites in the United States have been delayed in recruiting, but are now open and actively recruiting for the trial, along with the active sites in Australia.
First Quarter 2021 Financial Results:

Cash Position: As of March 31, 2021, cash, cash equivalents and available-for-sale securities were $191.1 million, compared to $54.3 million as of December 31, 2020. The increase in cash, cash equivalents and available-for-sale securities was due to the sale of the Company’s Series D convertible preferred stock and common stock in the Company’s IPO completed in February 2021.
Research and Development Expenses: Research and development expenses were $6.0 million for the first quarter of 2021, compared to $7.4 million for the first quarter of 2020. The decrease in research and development expenses for the first quarter of 2021 was primarily due to $1.8 million decrease in personnel-related costs due to reduced headcount, driven primarily by a reduction-in-force conducted in January 2020 and a $0.8 million decrease in expenses incurred for our DB-020 program driven by decreased activity as a result of delays due to the COVID-19 pandemic, partially offset by an increase of $1.2 million in other indirect research and development expenses.
General and Administrative Expenses: General and administrative expenses were $4.9 million for the first quarter of 2021, compared to $4.2 million for the same period in 2020. The increase in general and administrative expenses for the first quarter of 2021 was primarily attributable to $1.0 million increase in professional fees, driven primarily by expenses related to consulting, accounting advisory and audit services incurred as a result of becoming a public company in February 2021.
Financial Guidance:

Based on its current operating and development plans, Decibel believes that its existing cash, cash equivalents and available-for-sale securities will fund its pipeline programs and operating expenses into 2024.

On May 13, 2021 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company developing tumor infiltrating lymphocytes, or TIL, therapies for the treatment of patients with cancer, reported its first quarter 2021 financial results and provided a corporate update (Press release, Instil Bio, MAY 13, 2021, View Source [SID1234583996]).

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"In March of 2021, Instil completed an initial public offering to support the development of our TIL therapies. We believe that our continued investment in cell manufacturing and process science will enable the development of our current and future product candidates, with a goal of providing broad patient access," said Bronson Crouch, Chief Executive Officer of Instil. "We recently presented clinical data from our compassionate use program at the AACR (Free AACR Whitepaper) conference and received orphan drug designation from the U.S. Food and Drug Administration for ITIL-168 in melanoma. We continue to advance ITIL-168 towards a potentially registration-enabling Phase 2 clinical trial in advanced melanoma, which we expect to initiate in the second half of this year."

First Quarter 2021 Highlights and Upcoming Anticipated Milestones

Corporate:

Completed Initial Public Offering: On March 23, 2021, Instil closed its initial public offering of 18,400,000 shares of common stock, including the full exercise of the underwriters’ option to purchase an additional 2,400,000 shares of common stock at the public offering price of $20.00 per share. The gross proceeds of the offering were $368 million, before underwriting discounts and commissions and other offering expenses payable by Instil. The Company’s common stock now trades on the Nasdaq Global Select Market under the symbol "TIL."
Clinical and Regulatory:

Orphan Drug Designation for ITIL-168: On April 27, 2021 Instil received orphan drug designation from the U.S. Food and Drug Administration for the treatment of melanoma stages IIB to IV for its ITIL-168 TIL product candidate.
American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting: Presented late-breaking e-Poster on clinical data from a compassionate use program for the treatment of metastatic melanoma at the AACR (Free AACR Whitepaper) virtual meeting April 10 – 15, 2021.
Upcoming Phase 2 Clinical Trial: Instil expects to initiate a Phase 2 clinical trial of ITIL-168 for the treatment of advanced melanoma and begin enrolling patients in the second half of 2021.
Manufacturing:

Facility Readiness for Clinical Trials: Manufacturing facilities in the United Kingdom are functional and ready to support clinical manufacturing for the upcoming ITIL-168 clinical trial, with additional capacity expected to come online later this year. Instil also expects U.S. clinical manufacturing to be online in the first half of 2022.
First Quarter 2021 Financial and Operating Results

As of March 31, 2021, cash and cash equivalents totaled $609.6 million, compared to $241.7 million as of December 31, 2020. The Company expects that its cash and cash equivalents as of March 31, 2021 will enable it to fund its operating plan into 2023.

Research and development expenses for the three months ended March 31, 2021 were $14.4 million, compared to $2.0 million for the same period in 2020.

General and administrative expenses for the three months ended March 31, 2021 were $9.0 million, compared to $1.9 million for the same period in 2020.

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Pulmatrix has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-K/A [Amend], Pulmatrix, 2021, MAY 14, 2021, View Source [SID1234580083]).

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