On May 17, 2021 Panolos Bioscience, a protein structure-based new drug development company, reported on the 17th that it has attracted 20 billion won in Series A investment (Press release, Panolos Bioscience, MAY 17, 2021, View Source [SID1234633687]).

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A total of five companies participated in the investment, including strategic investor OCI, Cloud Ivy Investment, UTC Investment, K-Clavis Investment, and JL Partners, and attracted a cumulative investment of 31.5 billion won in 19 months since its establishment in September 2019. .

Using this investment as a stepping stone, Panolos plans to enter phase 1 clinical trials in the first half of 2022 for PB101, a core pipeline that has completed the development of mass production processes with Samsung Biologics, develop additional pipelines, and expand manpower and facilities.

Panolos is developing new biotherapeutics by utilizing αART (Anti-angiogenesis-based Artifact Re-targeting Tri-specifics platform), a proprietary multi-specific drug generation platform. It can reduce the side effects of single-target protein therapeutics and is a platform with excellent potential for expanding new drug pipelines through multiple targeting.

‘PB101’, a next-generation anti-cancer drug candidate based on the αART platform, is an all-family of Vascular Endothelial Growth Factor (VEGF) (VEGF-A, VEGF-B, Placental Growth Factor) that is excessively produced around cancer cells. targets and inhibits the growth of cancer cells. Unlike conventional VEGF-inhibiting therapeutics that target only a portion of VEGF, it blocks all delivery pathways to reduce drug resistance and increase efficacy.

The αART platform has excellent productivity and stability, so it can be used as a multi-target protein platform to attach several verified active targets, which can be expanded to various therapeutic areas.

Panolos is actively expanding joint research and development using the αART platform. The company is conducting joint research with NeoImmuneTech, which develops next-generation immunotherapeutic drugs, TerraImmune, which develops autoimmune disease treatments, and Scripps Korea Antibody Research Institute.

Hyeseong Lim, CEO of Panolos, said, "Based on our expertise in protein structure analysis, we have conducted R&D with a focus on minimizing the probability of failure with a design that considers effectiveness, stability, and productivity from the candidate material development stage, and is exceptionally fast as a bio venture. "Through the development of PB101, we plan to prove the potential of the αART platform technology and expedite the expansion of the multi-target pipeline by expanding collaboration with our partners," he said.

Panolos was founded in September 2019 by CEO Lim, who has extensive experience in engineering and process development of protein therapeutics. Former Vice President of OCI Choi Soo-jin, who recently served as MD of the Ministry of Trade, Industry and Energy, joined as CEO, and Lim and CEO Lim switched to their own representative system. With the joining of CEO Choi, who has been active in the pharmaceutical industry and the government, it is expected that the company’s operations, including new drug development, will be on a growth track.

On May 17, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the patient’s body, reported a business and clinical progress update for the first quarter 2021 (Press release, Cue Biopharma, MAY 17, 2021, View Source [SID1234608279]).

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"During the first quarter of 2021 and early second quarter, we continued to make significant progress advancing the Phase 1a/1b monotherapy trial of CUE-101 and continued development of our expanding pipeline and technology platforms, as well as enhancing our capital resources," said Daniel Passeri, chief executive officer of Cue Biopharma. "Importantly, we recently reported a confirmed partial response (PR) in a patient from our ongoing Phase 1 monotherapy dose escalation trial of CUE-101 and look forward to providing further details as well as describing the development implications for CUE-101 and potential of the CUE-100 series and Immuno-STAT platform, during the quarterly update call."

Kerri-Ann Millar, chief financial officer of Cue Biopharma, added, "We finished the first quarter of 2021 in a solid financial position which was further strengthened by the deployment of our at-the-market (ATM) common stock facility in April that enabled us to boost our cash position by an additional $10.4 million giving us operational runway into the fourth quarter of 2022."

Recent News & Business Updates

Reported PR in one patient and stable disease (SD) in five patients, confirmed by RECIST criteria, providing evidence of single-agent clinical activity of CUE-101 in the ongoing Phase 1 monotherapy dose escalation trial in late stage second-line and beyond patients with HPV+ recurrent/metastatic head and neck cancer, as well as evidence of both tumor-specific CD8+ T cell expansion and dose-dependent increases in NK cells.
Extended cash runway with sales in April of an aggregate of $10.4 million shares of our common stock pursuant to our ATM equity offering sales agreement with Stifel. As of April 30, 2021, we sold a cumulative total of 2,099,700 shares of common stock for aggregate net proceeds of $32.7M, net of commissions paid, under the sales agreement.
Initiated Phase 1 dose escalation clinical trial of CUE-101 in combination with Merck’s KEYTRUDA, an anti-PD-1 biologic agent, as first-line therapy in patients with advanced HPV16+ head and neck cancer.
Appointed renowned experts Abul K. Abbas, M.D., distinguished professor in pathology and former chair of the department of pathology at the University of California, San Francisco (UCSF) and Michael Kalos, Ph.D., managing director of Next Pillar Consulting, LLC and former executive vice president and head of research and development at ArsenalBio, to our Scientific Advisory Board (SAB).
First-Quarter 2021 Financial Results

The Company reported collaboration revenue of approximately $1.6 million and $0.9 million for the three months ended March 31, 2021 and 2020, respectively.

Research and development expenses were $9.8 million and $9.9 million for the three months ended March 31, 2021 and 2020, respectively. The decrease in research and development expenses of $0.9 million was primarily due to a decrease in laboratory and drug substance manufacturing costs as the clinical supply for our lead drug candidate, CUE-101, was produced during 2020, as well as a reduction in clinical and travel related expenses.

General and administrative expenses were $4.3 million and $4.0 million for the three months ended March 31, 2021 and 2020, respectively. The increase in general and administrative expense of $0.3 million was primarily due to an increase in stock-based compensation expense and legal fees incurred in the first quarter of 2021 as compared to the same period in 2020.

On May 17, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, and Antengene Corporation, Ltd. (SEHK: 6996.HK), a leading clinical-stage R&D driven biopharmaceutical company focused on innovative medicines for oncology and other life-threatening diseases, reported an exclusive, worldwide license agreement for the development and commercialization of CB-708, Calithera’s small molecule inhibitor of CD73 (Press release, Calithera Biosciences, MAY 17, 2021, View Source [SID1234606789]).

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"This agreement validates the capabilities of our drug discovery engine and represents a significant milestone for our CD73 program," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "Antengene brings significant enthusiasm and proven global capabilities to the development and future commercialization of CB-708, a potential best-in-class oral small molecule CD73 inhibitor. This licensing agreement enables the continued advancement of this promising program, while allowing Calithera to focus our resources on our more advanced clinical programs evaluating telaglenastat in non-small cell lung cancer and CB-280 in cystic fibrosis."

CB-708 is a highly potent, selective, orally-bioavailable small molecule inhibitor of CD73. Preclinical data presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and the 2019 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting demonstrated that CB-708 has immune-mediated, single agent activity in syngeneic mouse tumor models. In preclinical studies, CB-708 was well-tolerated and showed enhanced anti-tumor activity when combined with either an anti-PD-L1 immunotherapy or with chemotherapeutic agents, such as oxaliplatin or doxorubicin. CB-708 has completed GLP toxicology studies and is poised to advance into clinical development.

"We are excited to continue the advancement of CB-708 through our deep experience in global clinical development and extensive track record in commercialization in major markets around the world," said Dr. Jay Mei, Founder and Chief Executive Officer of Antengene. "CB-708 is a highly differentiated oral small molecule CD73 inhibitor with best-in-class potential. Antengene will continue to complete the GMP manufacturing of CB-708 and advance it into clinical trials for the treatment of multiple cancers including solid tumors and hematologic malignancies. This agreement brings a great addition to our synergistic portfolio of 12 assets with combinatory potential, is a testament to our abilities in accelerating global development, and represents another step in realizing our mission of treating patients beyond borders."

Under the terms of the license agreement, Calithera will receive an upfront payment and potential development, regulatory and sales milestones of up to $255.0 million. Additionally, Calithera is eligible to receive tiered royalties on sales of the licensed product up to low double-digits. Antengene Investment Ltd, a wholly owned subsidiary of Antengene Corporation, will receive exclusive, worldwide rights to develop and commercialize CB-708.

On May 17 2021 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a biotech innovator and biologics contract manufacturing organization, reported its financial results for the fiscal quarter ended March 31, 2021 (Press release, iBioPharma, MAY 17, 2021, View Source [SID1234585484]).

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"Our focus on strategy execution was reflected in our third quarter results as we advanced our second-generation COVID-19 vaccine candidate, defended our intellectual property rights, and achieved strong year-over-year revenue growth while adding new development services clients," said Tom Isett, Chairman & CEO of iBio. "Also, more recently, we saw continued progress on new product and pipeline additions, including line extensions to our Bioanalytical Services offering, and a planned investment in the establishment of a new Drug Discovery team. Importantly, we believe that when our new discovery capabilities are installed, we will be able to more fully leverage the many ‘speed-to-clinic’ advantages conveyed by our proprietary FastPharming System."

Fiscal Third Quarter and Recent Business Developments:

Vaccines

In May 2021, iBio reported on development of IBIO-202, a subunit vaccine candidate that targets the nucleocapsid protein ("N protein") of SARS-CoV-2. Using its FastPharming System, iBio has successfully expressed N protein antigens and has initiated both intramuscular and intranasal preclinical studies to evaluate antigen-adjuvant combinations that may provide strong T-cell memory and immune responses. Initial results are expected in early Q1 FY2022.
The Company also announced that IBIO-201, its COVID-19 vaccine candidate combining antigens derived from the spike protein ("S protein") fused with its patented LicKM Immunostimulator, had completed IND-enabling toxicology studies, with no adverse effects observed at low or high doses.
In support of approval for production of its lead animal health product candidate, IBIO-400, the Company submitted an "Outline of Production" and facility documentation to the U.S. Department of Agriculture for review.
Therapeutics

Today, iBio announced its plans to establish drug discovery capabilities in the San Diego, CA, area, with an initial focus upon monoclonal antibodies for use in oncology.
The Company continued pre-clinical development of IBIO-100, with initiation of IND-enabling studies expected in FY 2022.
Contract Development and Manufacturing ("CDMO") Services

In May 2021, iBio announced that it concluded its lawsuit with Fraunhofer USA, Inc. ("Fraunhofer USA") as described in full detail in the Company’s Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission on May 4, 2021.
Today, iBio announced an expanded menu of Bioanalytical Services, including intact protein analysis, new proteomic assays and middle-down characterization for monoclonal antibodies. The Company’s Bioanalytical Services were previously available only to FastPharming Development and Manufacturing Services clients, but are now available to biologics developers using alternative protein expression systems.
Research & Bioprocess Products

iBio continues to make progress towards launching certain cytokines and growth factors as part of a new catalog of products for research and further manufacturing uses.
"We are excited about the advancement of a differentiated second-generation COVID-19 vaccine candidate," said Mr. Isett. "Additionally, we are pleased with the protection of – and compensation for – our IP in plant-based biologics, as we further develop our FastPharming Technologies. Moreover, we continue to see increased demand from new and existing customers for our CDMO Services, even while we are in the midst of our transformation."

With reference to the Company’s planned establishment of in-house drug discovery capabilities, Mr. Isett commented, "We believe that our investment in fast, translatable drug discovery activities will enable us to optimally leverage our FastPharming System to create a robust pipeline of truly innovative molecules and fast-followers, particularly in the field of oncology."

Fiscal Third Quarter and Recent Corporate Developments:

Fiscal year to-date, iBio increased staffing by approximately 21% to 57 employees.
During the fiscal third quarter, iBio further strengthened its leadership team with the additions of Dr. Martin B. Brenner as Chief Scientific Officer and Mr. Robert M. Lutz as Chief Financial & Business Officer, effective January 18 and March 4, 2021, respectively.
"The key additions of Martin and Rob – along with the recruitment of many talented new employees to our R&D and Operations functions – reflect the ongoing rapid and successful transformation of iBio," said Mr. Isett. "By further expanding the capabilities of our team this quarter, we delivered new pipeline candidates, new service products and continued to advance other key initiatives. Clearly, our ability to execute and deliver value to shareholders has been further elevated this quarter, and we expect that the investment in the new Drug Discovery Team will yield significant returns as we seek to make the FastPharming System the bioprocess platform-of-choice."

Financial Results:

For the fiscal quarter ended March 31, 2021, iBio reported revenues of approximately $0.8 million, an increase of $0.7 million from $0.1 million in the fiscal quarter ended March 31, 2020.

To further clarify the results of its operations for investors, from this quarter forward, iBio will include Cost of Goods Sold ("COGS") and Gross Profit line items in its financial statements. For the three-months ended March 31, 2021, iBio reported COGS of approximately $0.5 million and gross profit of $0.3 million, compared to COGS of $0.1 million and gross profit that was not significant for the three months ended March 31, 2020. Since iBio’s revenue is currently derived from a small number of contracts, and revenue recognition from development and manufacturing services is generally subject to volatility due to timing, the Company expects that gross profit and gross profit percentage may fluctuate significantly from quarter to quarter.

R&D expenses for the fiscal quarter ended March 31, 2021 were approximately $2.2 million, compared with approximately $1.1 million in the same period of 2020. The increase in R&D expense of approximately $1.1 million was primarily related to increases in personnel and other expenses to support the Company’s development of a portfolio of proprietary therapeutics and vaccines.

G&A expenses for the fiscal quarter ended March 31, 2021 were approximately $5.3 million, compared with approximately $3.0 million in the same period of 2020. The increase of approximately $2.3 million resulted primarily from increased headcount and increased operations to support the growth of the business.

Net loss attributable to iBio stockholders for the fiscal quarter ended March 31, 2021 was approximately $7.7 million, or $0.04 per share. This compared with a net loss of approximately $4.7 million, or $0.06 per share, in the same period of 2020.

iBio had $103.9 million in cash, cash equivalents and debt investments as of March 31, 2021. The Company further strengthened its financial position through the aforementioned settlement of litigation with Fraunhofer USA. The Company believes it will have sufficient resources to fund its planned operations at least through March 31, 2023, inclusive of its planned investment in the FastPharming Discovery Platform and potential in-licensing activities.

Webcast and Conference Call

iBio management will host a webcast and conference call at 8:00 a.m. Eastern Time today, May 17, 2021, to discuss these results and provide a corporate update.

The live and archived webcast may be accessed on the Company’s website at www.ibioinc.com under "News and Events" in the Investors section. The live call can be accessed by dialing (833) 672-0651 (domestic) or (929) 517-0227 (international) and referencing conference code: 3085726.

On May 17, 2021 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported that Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) has purchased the potential future milestones under the companies’ 2017 asset purchase agreement relating to VX-561 (deutivacaftor) for $32 million (Press release, Concert Pharmaceuticals, MAY 17, 2021, View Source [SID1234584685]).

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"This transaction provided an opportunity to secure non-dilutive capital and strengthens our balance sheet as we continue to advance CTP-543, our lead asset for alopecia areata, through its Phase 3 program," stated Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. "By receiving these proceeds, we now expect our cash, cash equivalents and investments to fund the Company into the second quarter of 2022."

Under the asset purchase agreement, Vertex acquired worldwide development and commercialization rights to VX-561 (formerly known as CTP-656) and other assets related to the treatment of cystic fibrosis. VX-561 is an investigational cystic fibrosis transmembrane conductance regulator (CFTR) potentiator that has the potential to be used as part of future once-daily combination regimens of CFTR modulators that treat the underlying cause of cystic fibrosis. In 2017, Concert received a one-time cash payment of $160 million upon closing the asset purchase, with the potential for $90 million in future milestones. Following receipt of the $32 million, no further milestone obligations remain.

Chestnut Securities, Inc. acted as exclusive financial advisor to Concert in this transaction.