On March 1, 2022 Hera BioLabs, an innovative service and technology provider with novel genetic engineering products, reported a collaboration with Charles River Laboratories, International Inc. for a global license agreement to commercialize Hera’s SRGTM rat (OncoRat) (Press release, Hera BioLabs, MAR 1, 2022, View Source [SID1234610113]). The SRG rat is the first highly immunocompromised rat model, validated for xenograft studies in oncology and infectious disease research applications.

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Under this new collaborative agreement, Charles River will breed, distribute, sell, and market the SRG rat directly to the preclinical research community, while Hera will focus on providing services utilizing the model.

Hera BioLabs CEO, Dr. Mike Schlosser, commented, "We are very pleased to be working with Charles River, a company known for delivering high quality products and services for drug discovery and development. Their confidence in Hera’s SRG rat as an emerging go-to model is evidenced by this collaboration and highlights the transformative technology offered by Hera. This agreement creates substantial opportunities for Hera BioLabs to grow our SRG rat franchise in conjunction with Charles River’s portfolio expansion, bringing high quality research models to investigators world-wide."

Colin Dunn, Corporate Senior Vice President of Charles River’s Research Model and Services, commented, "We are thrilled to add the SRG rat to our portfolio of research models, which will expand the availability and distribution of this impactful oncology model for preclinical research."

On February 28, 2022 Harbour BioMed ("HBM", HKEX: 02142) reported that, it has been approved by the Institutional Review Boards (the "IRBs") to commence phase I trial of its B7H4x4-1BB bispecific antibody (HBM7008) in Australia (Press release, Harbour BioMed, FEB 28, 2022, View Source [SID1234609083]). This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of HBM7008 in patients with solid tumors.

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HBM7008 is generated from our unique and innovative HBICE platform. It targets Tumor Associated Antigen (B7H4), mediated crosslinking T cell activation through 4-1BB. B7H4 is overexpressed on a variety of solid malignancies, including breast, ovarian, endometrial and non-small cell lung cancers. With its crosslinking dependent specificity on tumors and potent immune modulation activity, HBM7008 has shown excellent safety profile with strong anti-tumor efficacy in the pre-clinical study, including completed response observed in mouse tumor model.

"4-1BB is one of the most promising anti-tumor immune targets, providing new solutions for tumor treatment. Based on preclinical study data, we are highly confident in B7H4x4-1BB bispecific antibody. We will efficiently promote this clinical study to provide an novel, effective and safe treatment for patients, so that more tumor patients can benefit from the innovative therapeutic." said Dr. Xiaoxiang Chen, Chief Development Officer of Harbour BioMed.

About HBM7008

HBM7008 is a bispecific antibody targeting Tumor Associated Antigen B7H4x4-1BB that not only displays high potency in the T cell co-stimulation and tumor growth inhibition, and potentially may also translate to better safety due to its strict dependency of TAA-mediated crosslinking T cell activation. HBM7008 is one of the fully human bispecific antibodies developed from the HBICE platform of the Company. It is the only bispecific antibody against these two targets globally. Its unique specificity on tumors and immune modulation activity makes it a promising therapeutics in PD-L1 negative or PD-1/PD-L1 resistant patients. It also has the potential to avoid 4-1BB liver toxicity risk observed in other products with the benefit of its innovative biology mechanisms and bispecific design.

On February 28, 2022 Blueprint Medicines Corporation (NASDAQ: BPMC) and Proteovant Therapeutics reported a strategic collaboration to advance novel targeted protein degrader therapies to address important areas of medical need (Press release, Blueprint Medicines, FEB 28, 2022, View Source [SID1234609111]). Targeted protein degradation harnesses the body’s natural protein disposal system and offers the potential to develop new medicines that target historically difficult-to-drug proteins that play an important role in causing serious diseases.

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The collaboration will bring together Proteovant’s Artificial Intelligence (AI)-enhanced targeted protein degradation (TPD) platform and Blueprint Medicine’s precision medicine expertise to discover novel targeted protein degraders. The companies will jointly research important targets and advance up to two novel protein degrader therapies into development candidates. As a core part of the collaboration, Proteovant’s exclusive partner for TPD, VantAI, will deploy its leading AI technologies for degrader generation and optimization. Upon designation of a clinical development candidate, Blueprint Medicines has the exclusive option to develop and commercialize products resulting from the collaboration. Proteovant has the option to co-develop and co-commercialize the second of the two Blueprint Medicines-optioned programs in the U.S.

"At Blueprint Medicines, we strive to stay on the cutting edge by identifying emerging precision medicine technologies with potential to complement and further amplify our highly productive research platform," said Fouad Namouni, M.D., President of Research and Development at Blueprint Medicines. "Recent scientific advancements in the field of targeted protein degradation have revealed opportunities to expand our core kinase capabilities and explore new ways to treat difficult to drug and novel targets, as well as address on-target resistance mechanisms. This collaboration with Proteovant Therapeutics will enable us to expand our platform more quickly in our mission to improve outcomes for patients with cancer and blood disorders."

"Protein degradation is one of the most promising areas of drug discovery and presents us with the opportunity to discover potent, selective, well-tolerated and potentially more effective therapeutics that can reach previously undruggable targets," said Drew Fromkin, CEO, Proteovant Therapeutics. "We have created a powerful degrader discovery engine that harnesses the synergies of Proteovant’s deep drug hunting expertise with VantAI’s proprietary AI platform driven by its Protein Contact First approach. We are excited to bring our targeted protein degradation platform together with Blueprint Medicines’ vast precision therapy expertise to energize the fight against these dynamic and debilitating diseases."

Subject to the terms of the agreement, Proteovant will receive a $20 million upfront payment and will be eligible to receive up to an additional $632 million in potential research, development, regulatory and commercialization milestone payments plus tiered royalties from mid- to high-single digits on net sales on the first two program targets, subject to adjustment in specified circumstances. Of the total contingent payments, up to $105 million would be preclinical, clinical development and regulatory milestones and up to $527 million would be approval and sales milestones. Each company will be responsible for its own costs under the research plan. Should Proteovant opt in to the second program, the parties will split profits and losses of that program equally in the U.S. along with development costs and the milestone payments for the program will be reduced accordingly. Proteovant will be eligible to receive milestone payments and royalties on ex-U.S. sales. In addition, the partners may jointly extend the collaboration, with the same structure and financial terms, to two additional program targets through additional funding by Blueprint Medicines.

On February 28, 2022 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) reported financial results for the three months and full-year ended December 31, 2021 and provided an update on key milestones (Press release, Lexicon Pharmaceuticals, FEB 28, 2022, View Source [SID1234609127]).

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"We remain focused on advancing sotagliflozin for the millions of people suffering from heart failure and living with type 2 diabetes on a daily basis. We announced today that we voluntarily withdrew the sotagliflozin NDA to correct a technical issue that we recently identified, and we plan to promptly resubmit early in the second quarter of 2022," said Lonnel Coats, Lexicon’s chief executive officer. "In addition, we are looking forward to completing and announcing top-line results in the coming months from our two proof-of-concept Phase 2 studies of LX9211 in diabetic peripheral neuropathic pain and post-herpetic neuralgia."

Fourth Quarter Highlights

Sotagliflozin

Lexicon submitted a New Drug Application (NDA) to the FDA at the end of the fourth quarter of 2021 seeking approval for the marketing and sale of sotagliflozin, to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure irrespective of left ventricular ejection fraction. Today, Lexicon announced its voluntary withdrawal and planned near-term resubmission of the NDA to correct a technical issue with the submission recently identified by the company.
A new analysis evaluating the clinical benefit of sotagliflozin in heart failure and blood glucose control across the full range of kidney function was presented at the American Heart Association Scientific Sessions 2021. Sotagliflozin significantly reduced total cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure, as well as decreased hemoglobin A1c, across the full range of kidney function studied, including individuals with moderate-to-severe chronic kidney disease.
LX9211

Patient enrollment continued in two ongoing Phase 2 clinical studies of LX9211: RELIEF-DPN-1 for the treatment of diabetic peripheral neuropathic pain and RELIEF-PHN-1 for the treatment of post-herpetic neuralgia. Lexicon anticipates completing recruitment this week for RELIEF-DPN-1 and expects top-line results for the study by the end of the second quarter of 2022. Top-line results for RELIEF-PHN-1 are expected in the third quarter of 2022.
Fourth Quarter and Full-Year 2021 Financial Highlights

Unless otherwise stated, all comparisons are for the fourth quarter and full year of 2021 compared to the fourth quarter and full year of 2020.

Revenues: Revenues were negligible for the fourth quarters of 2021 and 2020. Full-year revenues were negligible in 2021 as compared to $24.0 million for 2020, primarily due to the absence of product revenues in 2021 as a result of Lexicon’s sale of its XERMELO product and related assets to TerSera Therapeutics LLC during the third quarter of 2020.

Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2021 increased to $16.5 million from $1.0 million for the corresponding period in 2020. The R&D expense in the fourth quarter of 2020 reflected a reduction in external clinical development cost estimates primarily related to sotagliflozin R&D expenses. Full-year R&D expenses decreased to $55.0 million in 2021 from $153.6 million in 2020, primarily due to lower sotagliflozin clinical external research expenses, partially offset by higher LX9211 clinical external research expenses.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the fourth quarter of 2021 increased to $8.8 million from $6.4 million for the corresponding period in 2020, primarily due to higher legal fees during the quarter. Full-year SG&A expenses for 2021 decreased to $32.3 million from $47.2 million, primarily due to lower salaries and benefits and marketing costs.

Gain on Sale of XERMELO: A gain of $132.6 million was recognized during 2020 from the sale of XERMELO and related assets to TerSera in September 2020.

Net Income (Loss): Net loss for the fourth quarter of 2021 was $25.6 million, or $0.17 per share, as compared to a net loss of $5.5 million, or $0.04 per share, in the corresponding period in 2020. For the fourth quarter of 2021 and 2020, net loss included non-cash, stock-based compensation expense of $2.2 million and $2.7 million, respectively. Net loss for the full-year was $87.8 million, or $0.60 per share, in 2021 as compared to a net loss of $58.6 million, or $0.53 per share, in 2020. For the full years of 2021 and 2020, net loss included non-cash, stock-based compensation expense of $10.6 million and $13.3 million, respectively.

Cash and Investments: As of December 31, 2021, Lexicon had $86.7 million in cash and investments, as compared to $152.3 million as of December 31, 2020.

Conference Call and Webcast Information

Lexicon management will hold a live conference call and webcast today at 8:00 am ET / 7:00 am CT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 8051406. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/investors. An archived version of the webcast will be available on the website for 14 days.

On February 28, 2022 PharmaMar Group (MSE: PHM) reported recurring revenue growth of 27% to €165 million (Press release, PharmaMar, FEB 28, 2022, View Source [SID1234609144]). These revenues are the sum of net sales plus royalties received for sales.

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The increase in recurring revenues in 2021 is due to the good performance of the oncology business. To year-end, oncology sales revenues totaled €119 million, an 18% increase compared with the sales recorded the previous year. Royalty revenues grew by 162% to €41 million1. This strong growth is mainly due to royalty revenues received from our partner in the United States, Jazz Pharmaceuticals, for sales of Zepzelca (lurbinectedin).

In the case of non-recurring revenues from licensing agreements, these mainly relate, in both 2020 and 2021, to the licensing agreement entered into with Jazz Pharmaceuticals, and total €65 million in 2021 and €140.3 million in 2020. License revenues in 2021 include the accrual of US$25 million (€22 million) from Jazz Pharmaceuticals for achieving certain commercial targets.

The difference in these revenue between years is due to the accounting recognition of the receivables collected in 2020 for the signing of the agreement with Jazz and for the approval of lurbinectedin in the US.

Eliminating the effect of the collections from the lurbinectedin license to Jazz Pharmaceuticals in both 2021 and 2020, PharmaMar Group’s operating profit in 2021 would have increased by 57% with respect to 2020.

In the molecular diagnostics segment, GENOMICA, reported net revenues of €5 million at the end of 2021, compared with €13 million in 2020. This difference was mainly due to lower revenues from Covid-19 tests, PCR, lateral flow and antibody tests, as a result of increased competition, which has led to a significant decrease in the prices of these tests.

In 2021, the Group generated operating cash of €26 million. It should be noted that this cash generation followed an investment of €72 million in R&D, an increase of 34% compared to the resources devoted to this, the previous year.

One of the PharmaMar Group’s most important clinical trials is LAGOON, which will evaluate lurbinectedin for treating patients with relapsed Small-Cell Lung Cancer which commenced in 2021.

If successful, LAGOON will serve as the confirmatory trial for lurbinectedin to secure full approval in the U.S. LAGOON will also be used as a registrational trial with the European Medicines Agency (EMA) to obtain marketing authorization in Europe.

PharmaMar Group increased its net cash position in 2021 to €167 million, from €163 million the previous year thus ending to December 31st, 2021 with cash and cash equivalents (cash and cash equivalents plus current and non-current financial investments) of €212 million and total debt of €45.5 million.

As a result, the PharmaMar Group reported net income of €93 million at the end of 2021.

The Board of Directors of Pharma Mar, S.A. will propose to the Shareholders’ Meeting that a dividend in cash of €0.65 gross per Pharma Mar, S.A. share be paid to shareholders against 2021 earnings, 8% higher than the dividend paid in the previous year.

Conference call on results for analysts and investors

PharmaMar will hold a conference call for analysts and investors on Tuesday, March 1st, 2022, at 13:00 (CET). The numbers to connect to the conference call are: +34 91 901 16 44 (from Spain), +1 646 664 1960 (from the US or Canada) or +44 20 3936 2999 (other countries). Participants’ access code: 146916. To view the webcast, please click on the following link: View Source

The teleconference and the recording of the webcast can be accessed on PharmaMar’s website by visiting the Events Calendar section of the Company’s website at www.pharmamar.com.