On March 24, 2022 Formosa Pharmaceuticals reported the approval of a resolution by the boards of directors of both Formosa Pharmaceuticals and EirGenix, Inc. for the co-development of anticancer ADC, TSY-0110 (EG12043) (Press release, Formosa Pharmaceuticals, MAR 24, 2022, View Source [SID1234630879]). This agreement strengthens the existing relationship between both companies and fortifies TSY-0110’s clinical development pathway and subsequent licensing prospects.

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TSY-0110 is a biosimilar of the antibody-drug conjugate, Kadcyla, which combines Herceptin with the cytotoxic payload, mertansine, to achieve an enhanced antitumor effect with manageable safety profile. Kadcyla, developed by Roche Pharmaceuticals, was first approved by the US FDA in 2013 for the treatment of HER2-positive metastatic breast cancer (MBC) and later gained additional approval for early breast cancer (EBC) in 2019. Kadcyla is currently utilized as a single-agent 2nd-line treatment for breast cancer and is being tested in numerous clinical trials as a combination agent with other biologics and chemotherapeutics. Kadcyla’s global sales from 2021 is approximately USD $2.1 billion and annual sales are expected to remain strong.

Per the terms of the agreement, Formosa Pharmaceuticals will receive upfront and milestone payments for a total of USD $30 million from EirGenix in exchange for profit-sharing rights to TSY-0110. Additionally, EirGenix is named the exclusive supplier of its Herceptin biosimilar (EG12014) as the key intermediate toward the manufacturing of TSY-0110. EirGenix, who recently completed a USD $110 million cash capital increase and $175 million private placement, submitted Marketing Authorization (MAA) and Biologics Licensing (BLA) Applications to the EMA (EU) and FDA (US), respectively, for EG12014 with marketing partner, Sandoz AG, in December, 2021.

Formosa Pharmaceuticals’ chairman and founder, Dr. CY Cheng, said, "We are pleased to broaden our relationship with EirGenix for the development of HER2-related cancer therapies and leverage their proven clinical development expertise. We look forward to sharing the commercial benefits."

On March 24, 2022 The publication is reported on a basis of the research using our Tribody technology (Press release, Chiome Bioscience, MAR 24, 2022, View Source [SID1234625712]). Tribody
tecnhology is one of our platform antibody engineering technologies that can generate multi-specific antibody applying for cancer immunotherapy. The research outcomes are published at International Journal of Molecular Sciences.

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This research is conducted in collaboration with Ceinge Biotecnologie Avanzate ("Ceinge"), a nonprofit consortium research organization in Italy. We constructed novel bi-specific tribodies targeting different molecules involved in immune checkpoints. The tribody exhibited the retained binding activity to each target, increased immuno-modulatory effect to induce lymphocyte activation, and enhanced in vitro cytotoxicity against tumor cells. Tribody format could also reduce the production costs. Also, the molecular size is well suited for both tumor penetration and an acceptable half-life. Tribody could offer useful therapeutic applications, particularly in monotherapy-resistant cancer patients.

Publication

T i t l e ： Novel Bi-Specific Immuno-Modulatory Tribodies Potentiate T Cell Activation and
Increase Anti-Tumor Efficacy

Authors ： Margherita Passariello, Asami Yoshioka, Kota Takahashi, Shu-ichi Hashimoto,
Rosa Rapuano Lembo, Lorenzo Manna, Koji Nakamura and Claudia De Lorenzo

Journal ： International Journal of Molecular Sciences
View Source

About TribodyTM

The Tribody technology enables the generation of multi-specific antibody products. This unique technology overcomes the key shortcomings of conventional mono- as well as of currently developed bi-specific antibody formats. Tribody enables creation of unique antibody by building multi-binding sites that bind to different antigen or epitope, which differentiate from conventional antibody. It is expected to generate antibodies against targets that could not be made into pharmaceuticals, and to generate antibodies that can be released from the combination drugs therapy.

On March 24, 2022 Yumanity Therapeutics (Nasdaq: YMTX), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative, disease-modifying therapies for neurodegenerative diseases, reported financial results for full-year ended December 31, 2021 and provided an overview of the Company’s recent corporate developments (Press release, Yumanity Therapeutics, MAR 24, 2022, View Source [SID1234615744]).

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"We continue to believe in the potential of YTX-7739, which may represent a major advancement in the treatment paradigm for Parkinson’s patients," said Richard Peters, M.D., Ph.D., President, Chief Executive Officer and Director of Yumanity. "As previously announced, to preserve capital and optimize shareholder value, we took several rapid steps recently including engaging H.C. Wainwright to evaluate strategic alternatives for the Company; implementing an aggressive restructuring of our workforce; retiring our venture debt with Hercules; and reducing our lease expenses."

Recent Corporate Developments

In February 2022, the Company announced its exploration of strategic alternatives to enhance shareholder value and engaged H.C. Wainwright as its exclusive financial advisor to assist in this process. The Company also announced a restructuring of the Company to preserve capital.
In February 2022, the Company collected a $5 million milestone payment from Merck & Co. for its ongoing research collaboration in ALS and frontotemporal lobar dementia. Yumanity is eligible to receive more than $500 million in future milestones and royalties under this research agreement.
In January 2022, the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on our multidose clinical trials of YTX-7739. The partial clinical hold suspends initiation of multiple dose clinical trials in the U.S. until the FDA’s concerns have been addressed. The FDA has not halted all clinical programming and is permitting our planned single dose formulation clinical trial to proceed. We anticipate working closely with the FDA to adequately address their concerns.
Announced successful Phase 1b clinical trial results for YTX-7739 in patients with Parkinson’s disease. YTX-7739 demonstrated target engagement in patients with mild-to-moderate disease, and was found to be generally well tolerated, demonstrating favorable pharmacokinetic/ pharmacodynamic (PK/PD) profiles and a safety profile with no serious adverse events. In a subset of patients studied, YTX-7739 demonstrated a statistically significant change compared to baseline in an exploratory measurement of quantitative electroencephalogram, suggestive of a potential improvement in synaptic function that may benefit Parkinson’s patients.
2021 Financial Highlights

Cash position: As of December 31, 2021, cash, cash equivalents and investments were $36.5 million, compared to $85.3 million as of December 31, 2020. The decrease was primarily due to spending on the clinical development of YTX-7739 and costs related to being a public company. The Company believes its cash, cash equivalents and marketable securities, including the $5 million milestone payment from Merck & Co., will not be sufficient to fund operating expenses and capital expenditure requirements for a period of twelve months.
Research and development expense (R&D): Research and development expense was $26.4 million compared to $22.3 million for the prior year. The increase in R&D expense was due to the costs associated with the YTX-7739 clinical program, the YTX-9184 preclinical program, and increased spending on early-stage discovery efforts.
General and administrative expense: General and administrative expense was $20.4 million compared to $11.9 million for the prior year. The increase was primarily attributable to increased professional services fees associated with operating as a public company.
Net loss: The Company reported a net loss of $39.5 million, or $3.84 per basic and diluted share, compared to a net loss of $50.8 million, or $21.57 per basic and diluted share for the prior year. The decrease was due to increased research and development expenses and increased general and administrative expenses offset by costs associated with a one-time in-process research and development assets acquired expense in 2020.

About YTX-7739
YTX-7739 is Yumanity Therapeutics’ proprietary lead small molecule investigational therapy designed to penetrate the blood-brain barrier and inhibit the activity of a novel target, stearoyl-CoA desaturase (SCD). SCD appears to play an important and previously unrecognized role in mitigating neurotoxicity arising from the effects of pathogenic alpha-synuclein protein aggregation and accumulation, which ultimately results in the death of neurons and the subsequent dysregulation of movement and cognition that afflicts patients living with these diseases. Through inhibition of SCD, YTX-7739 modulates an upstream process in the alpha-synuclein pathological cascade and has been shown to rescue or prevent toxicity in preclinical cellular and animal models. The company is assessing the potential utility of YTX-7739 as a disease modifying therapy for Parkinson’s disease.

About SCD
SCD is an enzyme that catalyzes fatty acid desaturation, the products of which are incorporated into phospholipids, triglycerides, or cholesterol esters. These classes of lipid molecules regulate multiple diverse cellular properties and processes, including membrane structure and function, vesicle and organelle trafficking, intracellular signaling and inflammation. SCD expression is regulated by a transcription factor known as SREBF1, which has been identified in human genome-wide association studies as a risk factor for Parkinson’s disease. In preclinical models, SCD inhibition appears to normalize the dynamic interaction of pathological alpha-synuclein with membranes, which improves neuronal function and reduces toxicity, leading to enhanced neuronal survival. Following the initial discovery of SCD’s role in synucleinopathy by Yumanity’s unbiased discovery engine, several prominent academic labs have independently focused on SCD as a promising upstream target for mitigating alpha-synuclein mediated neurodegeneration. Alpha-synuclein-dependent disruption of membrane-related biological pathways, such as vesicle trafficking, is closely linked to the formation of Lewy body protein/membrane aggregations a hallmark pathological feature of Parkinson’s disease, Lewy body dementia and other neurodegenerative diseases.

On March 24, 2022 LAVA Therapeutics N.V. (Nasdaq: LVTX), an immuno-oncology company focused on developing its proprietary Gammabody platform of bispecific gamma delta T cell engagers to transform the treatment of cancer, reported recent corporate highlights and financial results for the fourth quarter and year ended December 31, 2021 (Press release, Lava Therapeutics, MAR 24, 2022, View Source [SID1234611048]).

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"I am incredibly proud of our LAVA team and the steady advancements we’ve made in the continued development of our Gammabody pipeline, despite the challenging times of the last year," said Stephen Hurly, president and chief executive officer. "With the encouraging LAVA-051 initial safety and pharmacodynamic observations and the LAVA-1207 study now actively recruiting patients, we are focused on execution and delivering potential product and platform-validating milestones this year and preparing our early-stage Gammabody pipeline for the clinic. We remain focused on our mission to efficiently develop transformative treatments for those suffering from cancer."

Recent Business and Pipeline Highlights

LAVA-051 Shows Encouraging Initial Safety and Pharmacodynamic Observations: In March 2022, LAVA announced interim data from the first three single patient cohorts of the Phase 1 dose escalation portion of its Phase 1/2a clinical trial, which we believe demonstrated that the doses of LAVA-051 used in these initial cohorts were safe and well-tolerated with no dose limiting toxicities or cytokine release syndrome observed. Per the study protocol, the cohort three dose was 33-times that of the cohort one dose. Vg9Vd2 (Vgamma9 Vdelta2) T cell receptor occupancy of LAVA-051 increased with LAVA-051 dose increases and peripheral blood Vg9Vd2 T cells also expressed higher levels of activation markers after LAVA-051 dosing. One patient with chronic lymphocytic leukemia (CLL) experienced multiple enlarged tender diseased lymph nodes one week after first dosing that subsequently regressed, reminiscent of tumor flare. Dosing in the study is continuing, with subsequent cohorts planned to enroll at least three patients per cohort. Additional data from the Phase 1 dose escalation phase of the trial is expected in the second

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quarter of 2022 and data from the Phase 2a expansion cohorts are expected in the second half of 2022.

The Phase 1/2a clinical trial (NCT04887259) is currently evaluating LAVA-051 in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and multiple myeloma (MM). Later in the trial, LAVA will also include patients with acute myeloid leukemia (AML). The trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary antitumor activity of LAVA-051. In October 2021, the company announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to LAVA-051 for the treatment of CLL.

Enrollment in LAVA-1207 Phase 1/2a Trial Underway: In February 2022, LAVA announced it had initiated dosing in the Company’s open-label, multi-center, Phase 1/2a clinical trial evaluating LAVA-1207 in patients with metastatic castration-resistant prostate cancer (mCRPC) and enrollment is ongoing. LAVA-1207 is a Gammabody that conditionally activates Vg9Vd2 T cells upon crosslinking to prostate-specific membrane antigen (PSMA) to trigger the potent and preferential killing of PSMA-positive tumor cells. The trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary antitumor activity of LAVA-1207 in patients with mCRPC. The Phase 1 dose-escalation phase of the study will determine the recommended Phase 2 dose/schedule to be used in the subsequent Phase 2a expansion cohort to confirm safety and tolerability of LAVA-1207 in mCRPC patients. Data from the Phase 1 dose escalation phase of the trial are expected in the second half of 2022 and data from the Phase 2a expansion cohort are expected in the first half of 2023.

Early-Stage Pipeline Development: In addition to LAVA’s two lead programs, the Company is developing a portfolio of earlier stage GammabodyTM programs including LAVA-1223, a GammabodyTM directed at the epidermal growth factor receptor (EGFR) for the treatment of solid tumors, for which a clinical trial application (CTA) is planned for late 2022. There is potential for targeting several EGFR-expressing tumors with LAVA-1223, including: colorectal cancer, head and neck squamous cell carcinoma, non-small cell lung cancer and pancreatic cancer.

LAVA today announces the addition of LAVA-1266, a CD123 GammabodyTM, to its pipeline for the treatment of hematological malignancies. A CTA is planned for late 2023. CD123 is overexpressed in a wide range of hematological malignancies, including AML, B-cell acute lymphoblastic leukemia, hairy cell leukemia, Hodgkin lymphoma, blastic plasmacytoid dendritic cell neoplasm, B-cell chronic lymphoproliferative disorders and myelodysplastic syndrome.

Fourth Quarter and Annual Financial Results

●As of December 31, 2021, LAVA had cash, cash equivalents and investments totaling $133.2 million compared to cash and cash equivalents of $15.8 million as of December 31,

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2020. The increase was primarily attributable to proceeds from the Series C financing and subsequent IPO during the first quarter of 2021, partially offset by operating expenses.
●Research and license revenue was solely attributable to the company’s collaboration with Janssen Biotech, Inc. which was entered into in May 2020.
●Research and development expenses were $6.9 million and $37.2 million for the quarter and year ended December 31, 2021, respectively, compared to $5.2 million and $15.7 million for the quarter and year ended December 31, 2020. The increase for the quarter was primarily due to increases in clinical trial, headcount and other costs incurred in connection with advancing our lead GammabodyTM clinical candidates, LAVA-051 and LAVA-1207, into human clinical trials. The increase for the year also includes $14.4 million in license fees triggered by the IPO, most of which will be paid on the first and second anniversaries of our IPO and may be paid in either cash or common stock of the Company.

●General and administrative expenses were $3.9 million and $12.2 million for the quarter and year ended December 31, 2021, compared to general administrative expenses of $0.4 million and $2.7 million for the quarter and year ended December 31, 2020. The increases for the quarter and year were primarily due to increases in personnel-related costs, non-cash share-based compensation expense and additional insurance, professional and consultant fees incurred in connection with being a publicly traded company in the United States.
●Net losses were $9.9 million and $3.7 million, or $0.38 and $12.97 loss per share for the quarters ended December 31, 2021 and 2020, respectively and were $45.3 million and $15.5 million, or $2.30 and $38.85 loss per share for the years ended December 31, 2021 and 2020, respectively.

On March 24, 2022 IntelGenx Technologies Corp. (TSX:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") reported financial results for the three- and twelve-month periods ended December 31, 2021 (Press release, IntelGenx, MAR 24, 2022, View Source [SID1234610996]). All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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"2021 was a transformational year for IntelGenx, during which we achieved multiple corporate milestones, entered into important strategic partnerships and made significant progress across our various development programs," commented Dr. Horst G. Zerbe, CEO of IntelGenx. "We transitioned from a development-stage to a commercial-stage leader in pharmaceutical films with our first shipment of CBD Filmstrips to Heritage Cannabis; and graduated to the TSX, Canada’s most senior exchange. We entered into a strategic partnership and signed a second feasibility agreement with atai, solidifying our position in the burgeoning psychedelics space; established a commercial partnership for Tadalafil oral films in the U.S.; and partnered with an animal healthcare company to evaluate our VetaFilmTM platform. Further, our commercialization partner, Exeltis Healthcare S.L., launched our migraine treatment, RIZAPORT in Spain. On the heels of all of that, we were pleased to start 2022 with the resumption of our Phase 2a ‘BUENA’ clinical trial. I am thrilled with our team’s progress, which positions us for continued success this year and beyond."

2021 Fourth Quarter Financial Highlights:

Revenue was $494,000, compared to $790,000 in the 2020 fourth quarter.
Net comprehensive loss was $2.9 million, compared to $1.3 million in the 2020 fourth quarter.
Adjusted EBITDA loss was $2.3 million, compared to $0.8 million in Q4-2020.
2021 Full-Year Financial Highlights:

Revenue was $1.5 million, essentially unchanged from 2020.
Net comprehensive loss was $9.8 million, compared to $7.1 million in 2020.
Adjusted EBITDA loss was $7.1 million, compared to $5.3 million in 2020.
Recent Developments:

The Company’s wholly owned subsidiary, IntelGenx Corp., received a third term loan in the amount of $3.0 million pursuant to its amended and restated secured loan agreement with atai Life Sciences ("atai").
Resumed patient dosing in the ongoing Phase 2a ‘BUENA’ clinical trial in patients with mild to moderate Alzheimer’s Disease under a previously amended protocol using higher doses of Montelukast VersaFilm.
Initiated an arbitration proceeding against Tilray, Inc. related to an alleged breach of the parties’ 2018 license, development and supply agreement, as amended, for the co-development and commercialization of cannabis-infused VersaFilm products.
Graduated to the Toronto Stock Exchange.
Financial Results:

Total revenues for the three-month period ended December 31, 2021 amounted to $494,000, a decrease of $296,000, or 37%, compared to $790,000 for the three-month period ended December 31, 2020. The change is mainly attributable to a $425,000 decrease in revenues from licensing agreements, partially offset by increases in and R&D revenues of $94,000 and product revenues of $35,000. Operating costs and expenses were $3.0 million for the fourth quarter of 2021, versus $1.8 million for the corresponding three-month period of 2020. For Q4-2021, the Company had an operating loss of $2.5 million, compared to operating loss of $1.0 million for the comparable period of 2020. Net comprehensive loss was $2.9 million, or $0.02 per basic and diluted share, for the fourth quarter of 2021, compared to net comprehensive loss of $1.3 million, or $0.01 per basic and diluted share, for the comparable period of 2020.

Total revenues for the twelve-month period ended December 31, 2021 amounted to $1.5 million, essentially unchanged from the year ended December 31, 2020. Operating costs and expenses were $9.5 million for the full year 2021, versus $7.8 million for the corresponding twelve-month period of 2020. For the twelve-month period of 2021, the Company had an operating loss of $8.0 million, compared to an operating loss of $6.3 million for the comparable period of 2020. Net comprehensive loss was $9.9 million, or $0.07 per basic and diluted share, for the twelve-month period of 2021, compared to net comprehensive loss of $7.1 million, or $0.07 per basic and diluted share, for the comparable period of 2020.

As at December 31, 2021, the Company’s cash and short-term investments totalled $9.9 million, which did not include the $3.0 million secured loan granted to IntelGenx Corp. by atai in February 2022.

Annual Filings:

The Company’s annual report on Form 10-K and financial statements for the year ended December 31, 2021, as well as the 2022 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities today, March 24, 2022.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2021 fourth quarter and full year financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (888) 506-0058 (Canada and the United States) or (973) 528-0135 (International); access code 503612. The call will be also be webcast live and archived on the Company’s website at www.intelgenx.com under "Webcasts" in the Investors section.