On May 17, 2021 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported its financial results for the three months ended March 31, 2021 and provided a business update (Press release, Sonnet BioTherapeutics, MAY 17, 2021, View Source [SID1234580194]).

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"Over the course of the quarter, we have made several advancements across our pipeline products, most notably of which are the completion of non-human primate (NHP) toxicology study of SON-080 and the completion of a repeat dose study of SON-1010 in NHPs," commented Pankaj Mohan, Ph.D., Founder and CEO. "Additionally, we were thrilled to have our abstract detailing data from our NHP study of SON-1010 accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting."

FY 2021 Second Quarter and Recent Corporate Updates

Sonnet provided the following updates on its lead pipeline assets:

The Company successfully completed multiple NHP GLP toxicology studies with SON-1010 (FHAB-IL12) and is generating data to prepare an IND submission to initiate clinical studies in the second half of 2021.

Regarding SON-080, the Company intends to file a US IND to initiate a Phase 1b/2a pilot-scale efficacy study in the Chemotherapy-Induced Peripheral Neuropathy (CIPN) indication during the second half of 2021. Additionally, as part of the recently announced partnership with New Life Therapeutics, the companies intend to file an ex-US IND equivalent for a Phase 1b/2a pilot-scale efficacy study in Diabetic Peripheral Neuropathy (DPN) during the second half of 2021. Going forward, Sonnet will exclusively refer to the low-dose IL-6 programs, namely CIPN and DPN, using the SON-080 designation, the latter of which had previously been known as the SON-081 program.

The Company’s first bispecific candidate, SON-1210 (IL-FHAB-IL15), is undergoing cell line and process development activities. Sonnet expects completion of NHP studies in the second half of this year with an IND submission during the first half of 2022.

Sonnet has manufactured bi-specific preclinical constructs of SON-2014 (GMcSF-FHAB-IL18), as well as IL18-FHAB-IL12 and IL12-FHAB-GMcSF that are being evaluated for in vivo efficacy, biomarker profiles and fluorescence-activated cell sorting (FACS) assessment in single dose and multi-dose preclinical studies. The Company intends to initiate commercial cell line development necessary for future clinical studies, with an IND submission for SON-2014 targeted for the second half of 2022.

Sonnet has added key senior management hires of Richard Kenney, M.D. as Chief Medical Officer and Manuel Dafonseca as Head of Clinical Operations, as the Company prepares to advance its FHAB platform into its first clinical study.

"During the quarter, we were able to successfully draw from our at-the-market sales agreement with BTIG and bring in over $10 million of capital to the Company", commented Jay Cross, CFO. "This additional funding will enable us to continue driving our R&D activities forward and furthers our goal of bringing much need therapeutic advancements to patients."

FY 2021 Second Quarter Ended March 31, 2021 Financial Results

●As of March 31, 2021, Sonnet had $6.7 million cash on hand.
●As previously announced, on February 5, 2021, Sonnet entered into an at-the-market sales agreement with BTIG, LLC, for an aggregate offering of up to $15.9 million. Through March 31, 2021, the Company sold an aggregate of 4,021,561 shares for net proceeds of $10.2 million to Sonnet. The company has not sold shares though this facility since March 12, 2021.
●Research and development expenses were $3.8 million for the three months ended March 31, 2021, compared to $1.3 million for the three months ended March 31, 2020. The increase of $2.5 million was primarily due to increased expenditures for the development of the cell line for IL12-FHAB and IL12-FHAB-IL15

General and administrative expenses were $2.2 million for the three months ended March 31, 2021, compared to $1.3 million for the three months ended March 31, 2020. The increase of $1.0 million was primarily due to an increase in insurance expense of related to directors and officer’s insurance, and in increase in payroll and share-based compensation expense to support our expanded operations.

On May 17, 2021 Wugen reported that it is adding a new subset of NK cells to the cell therapy toolkit with its memory NK cell approach, which may lead to high antitumor efficacy without requiring a CAR or other modifications (Press release, Wugen, MAY 17, 2021, View Source [SID1234580426]).

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The company was formed in 2018 to develop off-the-shelf CAR T cell therapies, but broadened its scope to include memory NK cells after in-licensing the technology from Washington University in St. Louis last year.

Now, it has programs for both cell types running in parallel, with each expected to start clinical development next half.

Unmodified NK cells have historically fallen short on efficacy, and companies have increasingly turned to the addition of a tumor antigen-specific CAR to harness and concentrate activity against the tumor. CAR NK cells are attracting broad industry attention as clinical validation builds.

"NK cell platforms are now really coming to the fore in industry in terms of the realization that off-the-shelf, allogeneic NK cells will be competitive against CAR T cells," said Daniel Kemp, who joined Wugen as CEO this month after serving as VP and head of cell therapies BD & operations at Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK).

Wugen thinks its memory NK cells may attain high levels of efficacy without a CAR.

CMO Jan Davidson told BioCentury memory NK cells are a subset with an enhanced effector function. Specifically, they express more activating receptors and have fewer inhibitory signals. They also produce more cytotoxic effector molecules and cytokines to activate downstream components of the immune system, and they persist longer.

He added that most NK cell therapies aren’t enriched for the memory NK subpopulation because the subtype is formed through a process that naturally occurs in the tumor, but NK cell therapies are usually sourced from cord blood or induced pluripotent stem cells.

The company has an in vitro process for converting NK cells harvested from healthy donors into the memory phenotype using cytokines to drive them into a highly activated functional state.

The memory NK cells have been tested in investigator-initiated studies at Washington University in St. Louis in several acute myelogenous leukemia (AML) settings. Next, Wugen plans to begin a study in the relapsed/refractory population.

"We’re building on the existing data in AML, where there’s a high unmet need and the cells can be potentially curative. This is a quick path to develop this strategy and be able to help patients in short order, but after that, there are a lot of different opportunities," said Ryan Sullivan, VP and head of NK research at Wugen.

Davidson noted that the company has strong preclinical evidence of efficacy in solid tumors.

Kemp added that the company will explore engineered versions of the cells as well, "whether through CAR mechanisms or other types of modifications."

In solid tumors, Sullivan told BioCentury there’s an opportunity to combine the NK cells with mAbs that act via antibody-dependent cellular toxicity (ADCC) — a process that recruits NK cells to kill the antibody-bound tumor cells. Many cancer therapies including anti-CTLA-4 mAb Yervoy ipilimumab heavily rely on ADCC for therapeutic efficacy, and are less effective in patients with compromised innate immune systems.

"A lot of the patients who these mAbs are administered to have some level of immunosuppression, so there’s a poor response, but we’re providing the engine to potentiate the ADCC capability," said Sullivan.

Kemp noted Wugen is interested in building strategic relationships around the ADCC mechanism.

With its allogeneic CAR T cell platform, Wugen is first tackling T cell malignancies. The indication has proven challenging because when designed to hit a T cell target on malignant cells, the CAR Ts can destroy themselves through fratricide. Wugen is sidestepping fratricide by deleting CD7.

At least four companies have CAR T cell therapies in development to treat T cell cancers. Davidson and Sullivan aren’t aware of other companies developing memory NK cell therapy products.

In March, Wugen granted development, manufacturing and commercialization rights to Alpha Biopharma Inc. for its universal memory NK and CAR T cells for certain cancers in mainland China, Hong Kong, Macao, Taiwan and Singapore. The same month, it signed a deal with HCW Biologics Inc. to use its fusion molecules in the manufacturing of Wugen’s cell therapies.

The company raised $36 million in a series A round, and is currently raising a series B round.

On May 17, 2021 Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases, reported that members of its senior management team will participate in three upcoming virtual investor conferences (Press release, Cerecor, MAY 17, 2021, View Source [SID1234580115]).

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2021 RBC Capital Markets Global Healthcare Virtual Conference
Date: Tuesday, May 18, 2021
Time: 8:35 AM ET

Oppenheimer Rare & Orphan Disease Summit
Date: Friday, May 21, 2021
1×1 meetings only

Jefferies Virtual Healthcare Conference
Date: Wednesday, June 2, 2021
Time: 1:00 PM ET

A live webcast of the presentation at the 2021 RBC Capital Markets Global Healthcare Virtual Conference and the Jefferies Virtual Healthcare Conference can be accessed under the "News/Events" page in the Investors section of the Company’s website at www.cerecor.com.

On May 17, 2021 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Vaccinex, MAY 17, 2021, View Source [SID1234580155]).

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"During the first quarter and subsequent period, we achieved notable progress across our proprietary clinical programs in cancer and neurology as well as our technology partnerships," stated Maurice Zauderer, Ph.D., president and chief executive officer. "We were very pleased to announce the commencement of our Phase 2 clinical trial of pepinemab in combination with KEYTRUDA for front-line, recurrent or metastatic head and neck cancer, a solid tumor indication in which SEMA4D is highly expressed. This represents an expansion of our development pipeline and, together with the recently published results of our non-small cell lung cancer trial, we believe that pepinemab can be a valuable new addition to cancer immunotherapy.

"Continued analysis of the full data set from our Phase 2 SIGNAL trial in Huntington’s disease indicates that pepinemab can provide a cognitive benefit in this and potentially other neuroinflammatory and neurodegenerative indications with significant unmet medical needs. To that end, we remain on track to initiate a Phase 1/2a trial of pepinemab in Alzheimer’s disease by the end of the second quarter while we continue to engage in discussions with potential partners regarding a planned Phase 3 trial in Huntington’s disease.

"Finally, during the quarter we announced that we entered into a licensing agreement with Surface Oncology following on delivery and qualification of a fully human anti-CCR8 antibody. This is meaningful as we continue to leverage our proprietary ActivMab platform as a potential source of non-dilutive funding that can help advance our other programs."

Pepinemab Clinical Updates:

Head and Neck Cancer. Subsequent to the end of the first quarter, Vaccinex announced it initiated a Phase 2 clinical trial evaluating pepinemab in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for advanced, recurrent or metastatic head and neck cancer. Multiple prior studies suggest that inhibition of SEMA4D increases immune infiltration and alters the balance of cytotoxic and immunosuppressive cells in the tumor microenvironment. As SEMA4D is highly expressed in head and neck cancer, we believe there is a strong rationale for development in this indication.
The study is expected to enroll up to 65 subjects and key endpoints are expected to include objective response, duration of response, progression free survival and overall survival.

Alzheimer’s Disease. By the end of the second quarter, Vaccinex intends to initiate a Phase 1/2a clinical trial of pepinemab in Alzheimer’s disease, funded in part by a $750,000 development grant from the Alzheimer’s Association under the 2020 Part the Cloud Program, as well as a $3 million award from the Alzheimer’s Drug Discovery Foundation.
The awards are based in part on earlier findings that treatment with pepinemab prevented the characteristic loss of glucose transport in the brain during underlying Huntington’s disease progression as detected by conventional FDG-PET imaging. Uptake of glucose, the main source of energy in the brain, is also known to decline with underlying disease progression in Alzheimer’s disease, and multiple studies in Alzheimer’s disease have shown that decline in glucose transport correlates with cognitive decline. The randomized, placebo-controlled, multi-center study is anticipated to enroll 40 subjects for 12 months treatment duration.

Huntington’s disease. Based on analysis of the full data set from the Phase 2, double-blind, placebo-controlled SIGNAL trial of pepinemab in patients with early manifest Huntington’s disease (HD), Vaccinex determined that pepinemab appeared to confer cognitive benefit to patients as determined from results of the Huntington’s Disease Cognitive Assessment Battery (HD-CAB). As a result, Vaccinex believes that a phase 3 trial is warranted and is currently engaged in discussions of such a study with several potential pharmaceutical partners.
Other Trials. Pepinemab is also being evaluated in multiple investigator-sponsored trials (ISTs) being conducted by the Winship Cancer Institute of Emory University to evaluate pepinemab in combination with checkpoint inhibitors in short term "Window of Opportunity" studies in colorectal, pancreatic, and head and neck cancer and melanoma.
Other First Quarter and Recent Accomplishments:

Announced the publication of results from the CLASSICAL-Lung phase 1b/2 clinical trial in non-small cell lung cancer in the peer-reviewed journal Clinical Cancer Research. The publication presents data showing that pepinemab is clinically active when combined with BAVENCIO, a checkpoint inhibitor, and that the combination was well-tolerated with no major new safety signals identified. It was of particular interest that the combination appeared to extend treatment benefit to immunotherapy naïve patients whose tumors were PD- L1 negative or low, a patient population that has, in general, been less responsive to immunotherapy. Combination treatment also appeared to halt or reverse tumor progression (partial response or stable disease) in select patients with primary or acquired resistance to anti-PD-1/L1 therapy.
Entered into multi-project deals with two leading pharmaceutical companies focused on leveraging Vaccinex’s ActivMAb antibody discovery and novel viral display platform for drug discovery against difficult but important multi-pass membrane receptors such as GPCR and ion channels.
Announced that Surface Oncology will be exercising its option to license an anti-CCR8 antibody discovered using Vaccinex’s ActivMAb platform. The terms of agreement with Surface Oncology providedthat Surface Oncology pay technology access and licensing fees to Vaccinex in addition to providing research funding, and that Vaccinex will qualify for development milestone payments and royalties.
Raised $32 million in net proceeds through its existing open sale market agreement, or ATM, facility.
Upcoming Anticipated Milestone Dates:

Q2 2021 – Initiation of Alzheimer’s disease Phase 1/2a trial
Mid-2022 – Initial data from open label head and neck cancer trial
Late 2022/Early 2023 – Data from randomized Alzheimer’s trial
Financial Results for the Three Months Ended March 31, 2021:

Revenue. Revenue for the three months ended March 31, 2021 was $850,000. The Company’s revenues were generated from the licensing arrangement with Surface Oncology.

Research and Development Expenses. Research and development expenses for the three months ended March 31, 2021 were $5.5 million as compared to $5.4 million for the comparable period in 2020.

General and Administrative Expenses. General and administrative expenses for the three months ended March 31, 2021 were $1.6 million as compared to $1.8 million for the comparable period in 2020.

Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on March 31, 2021 were $29.4 million, as compared to $10.6 million as of December 31, 2020. The increase in cash was a result of $32 million in net proceeds raised by the Company through its ATM facility.

On May 17, 2021 Soteria Biotherapeutics, Inc. ("Soteria"), a privately-held, immuno-oncology company focused on developing a next generation of switchable bispecific T-cell engagers to treat patients with solid tumor cancers, reported a $42 million Series A financing led by Roche Venture Fund and 5AM Ventures with participation from other leading investors, including M Ventures, Novartis Venture Fund and Alexandria Venture Investments (Press release, Soteria Biotherapeutics, MAY 17, 2021, View Source [SID1234580173]).

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Soteria’s T-LITETM T-cell engagers are selectively switched on through oral administration of a small-molecule activator to modulate potent T-cell activity by controlling the timing, duration, and level of bispecific complex formation. This switchable activity enables precise on/off control over the timing and magnitude of T-cell redirection and cytotoxic activity. Unlike conventional T-cell engagers which lack a control switch and therefore are associated with significant side effects, Soteria’s T-LITE therapies are being designed to allow physicians to modulate T-cell activity to maximize efficacy while minimizing side effects.

"Soteria’s technology has the potential to revolutionize the T-cell engager field with its proprietary approach designed to control and target potent biologic immune activators to attack tumors," said Nisha Marathe, investment director at Roche Venture Fund. "Specifically, we believe the T-LITE technology is highly differentiated, where the potent activity of a T-cell engager can be selectively switched on by small-molecule activators to direct tumor cytotoxicity and reduce cytokine release syndrome, ultimately resulting in a therapy with potentially greater safety and efficacy."

"These funds will support the advancement of our technology and allow us to build a pipeline of T-LITE development candidates with potential in well validated cancer targets," said Kristine Ball, chief executive officer of Soteria. "We appreciate the confidence and vision this syndicate of premier investors has shown in our opportunity to disrupt the T-cell engager field and our potential to create differentiated, potent therapies against solid tumors."

Company Founders and Leadership
Soteria’s team of founders, management and board members brings together accomplished leaders from academia and the biopharma industry with successful track records discovering and developing therapeutics at companies such as Abgenix, Ascendis Pharma, AstraZeneca/Medimmune, Exelixis, Genentech/Roche, KAI (acquired by Amgen), Labrys (acquired by TEVA), Merck Research Laboratories, Novartis, Relypsa (acquired by Vifor) and Sunesis:

Kristine Ball, Chief Executive Officer and Member of the Board
Zachary Hill, PhD, Co-Founder and SVP, Chief Scientific Officer, and Member of the Board
Mohammad Tabrizi, PhD, VP Preclinical Development
Alex Martinko, PhD, Co-Founder and Senior Director of Protein Science
Jim Wells, PhD, Academic Co-founder, Chair of Scientific Advisory Board, and Professor of Pharmaceutical Chemistry at UC San Francisco
Steven P. James, Board Chair and Chief Executive Officer of Pionyr Immunotherapeutics
David Allison, PhD, Member of the Board and Partner at 5AM Ventures
Keno Gutierrez, PhD, Member of the Board and Vice President at M Ventures
Nisha Marathe, PhD, Member of the Board and Investment Director at Roche Venture Fund
David Morris, MD, Member of the Board and Operating Partner at Novartis Venture Fund
Momo Wu, PhD, Member of the Board and Portfolio Investment Manager at Emerson Collective