On December 20, 2024 Bio-Techne Corporation (NASDAQ: TECH) reported that Kim Kelderman, President and Chief Executive Officer, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2025, at 10:30 a.m. PST (Press release, Bio-Techne, DEC 20, 2024, View Source [SID1234649234]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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On December 19, 2024 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for NX-5948, a highly selective degrader of Bruton’s tyrosine kinase (BTK), for the treatment of adult patients with relapsed or refractory Waldenstrom’s macroglobulinemia (WM) after at least two lines of therapy, including a BTK inhibitor (Press release, Nurix Therapeutics, DEC 19, 2024, View Source [SID1234649216]).

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"Fast Track designation for NX-5948 is an important recognition of the unmet patient need in Waldenstrom’s macroglobulinemia, particularly in the growing number of patients whose cancer has progressed following BTK inhibitor therapy," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "This designation follows encouraging safety and efficacy data from our ongoing Phase 1 clinical trial, demonstrating early promise of clinical benefit with potential for durable outcomes. We continue to enroll Waldenstrom’s macroglobulinemia patients in the ongoing Phase 1b expansion cohort and anticipate sharing additional clinical data in 2025."

In addition to the Fast Track designation announced today for Waldenstrom’s macroglobulinemia, NX-5948 previously received Fast Track designation in January 2024 for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) after at least two lines of therapy, including a BTK inhibitor and a B-cell lymphoma 2 (BCL2) inhibitor. In November 2024, the European Medicines Agency (EMA) granted NX-5948 PRIME designation for the treatment of adult patients with relapsed or refractory CLL/SLL after at least a BTK inhibitor and a BCL2 inhibitor.

About Waldenstrom’s Macroglobulinemia

WM is a rare, slow growing type of non-Hodgkin’s lymphoma that is characterized by the replacement of normal bone marrow cells by malignant lymphocytic cells that produce monoclonal IgM. This replacement leads to anemia, bleeding, and impaired immune function, while the elevated IgM levels may cause neurologic symptoms. The incidence of Waldenstrom’s macroglobulinemia ranges from 0.361,2 to 0.573 per 100,000 people in the United States or approximately 1,200 to 1,900 annually. With a median disease duration approaching 10 years,4 approximately 12,000 to 19,000 patients are living with Waldenstrom’s macroglobulinemia in the United States. Recommended first-line treatments including chemoimmunotherapy and BTK inhibitor therapy. There are no therapies approved to treat WM patients after BTKi.

About Fast Track Designation

The FDA’s Fast Track designation is intended to facilitate and expedite the development and review of drug candidates to treat serious conditions and fulfill an unmet medical need. To qualify, available clinical and non-clinical data need to demonstrate a therapeutic candidate’s potential to address this unmet medical need. A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.

About PRIME Designation

The PRIME initiative, launched by the EMA in 2016, offers early, proactive and enhanced support to developers of promising medicines to optimize development plans and accelerate evaluation so these medicines can reach patients faster. To be eligible for PRIME, medicines must target an unmet medical need and show potential benefit for patients based on early clinical data.

About NX-5948

NX-5948 is an investigational, orally bioavailable, brain penetrant, small molecule degrader of BTK. NX-5948 is currently being evaluated in a Phase 1 clinical trial in patients with relapsed or refractory B cell malignancies. Nurix has previously reported that NX-5948 is highly potent against a range of tumor cell lines that are resistant to current BTK inhibitor therapies, an important consideration in heavily pretreated CLL/SLL patient populations. Additional information on the ongoing clinical trial can be accessed at clinicaltrials.gov (NCT05131022).

On December 19, 2024 Ottimo Pharma ("Ottimo"), a private biotech company pioneering bifunctional medicines to extend the lives of people living with cancer, reported the completion of a Series A financing round of over $140 million (Press release, Ottimo Pharma, DEC 19, 2024, View Source [SID1234649217]). The financing will accelerate the lead asset, Jankistomig, a first-in-class PD1/VEGFR2 bifunctional antibody for multiple solid tumor indications, in both IV and SC forms as well as a pipeline of follow-on bifunctional assets.

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The round was led by OrbiMed, Avoro Capital, Samsara BioCapital, and included blue chip investors RTW Investments, Decheng Capital, Janus Henderson Investors, J.P. Morgan Life Sciences Private Capital, Invus, and founding investor Medicxi. In connection with the financing Peter Thompson (OrbiMed), Mark Chin (Avoro Capital), and Srini Akkaraju (Samsara BioCapital) will join the Board of Directors.

Simultaneously, Ottimo has expanded its management team under the leadership of David Epstein, Chair and Chief Executive Officer. The Company announces the appointment of Rick Anderson as SVP Finance, Spencer Fisk as Chief Technical and Quality Officer, and Ling Zeng as General Counsel and EVP of Execution. Rick, Spencer, and Ling bring extensive pharma experience, having held senior roles at Seagen, Novartis, and Dicerna Pharmaceuticals.

Ottimo, co-founded by Medicxi and Jonny Finlay, emerged from stealth in October 2024. It is advancing IND-enabling studies for lead molecule Jankistomig, with a planned IND filing in late 2025.

Jankistomig is a first-in-class PD1/VEGFR2 bifunctional antibody that is differentiated from bispecific antibodies. It is exquisitely designed as a dual pathway, biparatopic single-agent IgG therapy, targeting immune checkpoint inhibition and angiogenesis in the treatment of cancer. This innovative approach aims to offer a wider therapeutic window regardless of tumor VEGF levels, with the potential to improve outcomes across multiple solid tumor indications. Jankistomig is expected to address a global oncology market valued at well over $50 billion.

David Epstein, Chair & Chief Executive Officer of Ottimo Pharma, said: "The successful completion of our Series A financing marks a milestone for Ottimo as we advance our goal to make first-in-class bifunctional medicines to extend the lives of people living with cancer. Jankistomig represents a significant breakthrough with its novel design and mechanism of action, and we are incredibly grateful to have the backing of such well-renowned healthcare investors. With the addition of Rick, Spencer, and Ling, we have assembled a proven leadership team to progress Ottimo to our first IND by late 2025."

Peter Thompson, General Partner at OrbiMed, Board Director of Ottimo Pharma, commented: "Ottimo’s unique approach has differentiated itself in the PD1/VEGF field. We are looking forward to working alongside this experienced team with their extensive track record to develop new cancer treatments with improved outcomes for patients."

Francesco De Rubertis, Co-Founder and Partner at Medicxi, Board Director of Ottimo Pharma added: "Ottimo has shown considerable progress with Jankistomig. As a co-founder of the Company, we are pleased to welcome top-tier investors including OrbiMed, Avoro Capital, and Samsara BioCapital to the syndicate as we advance the pipeline to address multiple solid tumor indications."

Fredric (Rick) Anderson has more than 30 years of leadership experience in strategic financial and operations management. Rick was the Vice President, Corporate Controller for Seagen Inc. from 2018, where he supported the Company’s growth and international expansion. He was a key member of the leadership team that led the $44 billion acquisition by Pfizer and supported the post-acquisition integration. Rick holds an MBA from the University of San Diego. He started his career as a CPA for Ernst & Young and later joined their mergers & acquisition group.

Spencer Fisk has more than 30 years of experience in manufacturing and CMC product development. Spencer joins Ottimo from National Resilience, Inc. where he transformed the R&D focus to deliver on disruptive approaches to accelerate multi-modality drug development. From 2018 to 2022, he served as the Chief Technical Operations Officer at Rubius Therapeutics. Before Rubius he held senior roles at Novartis AG where he led the team to the successful registration and launch of the first CAR-T cellular therapy product, Kymriah. Prior to Novartis, Spencer held various technical development and manufacturing roles at Merck, Genentech, Genencor, and Novo Nordisk.

Ling Zeng, Esq. was previously Chief Legal and Administrative Officer and a member of the executive leadership team of Omega Therapeutics. Prior to Omega, she was the Chief Legal Officer and Secretary of Dicerna Pharmaceuticals and played a critical role in executing the Company’s strategy including the $3.3 billion acquisition by Novo Nordisk in 2021. Before working in biotech companies, Ling was Deputy Head Legal, Group Mergers and Acquisitions, at Novartis AG, responsible for global transactions across the Novartis Group. From 2009 to 2017, Ling held various executive roles of increasing responsibility at Bausch Health Companies.

On December 19, 2024, Personalis, Inc. (the "Company") reported to have entered into an investment agreement (the "Investment Agreement") with Merck Sharp & Dohme LLC ("Merck") pursuant to which Merck has agreed to purchase from the Company 14,044,943 shares (the "Shares") of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), at a price per share of $3.56, representing the last reported closing price of the Common Stock on The Nasdaq Global Market on December 18, 2024, for gross proceeds to the Company of approximately $50.0 million (Filing, 8-K, Personalis, DEC 19, 2024, View Source [SID1234649218]). The closing is expected to occur on or about December 19, 2024 (the "Closing Date"). Pursuant to the terms of the Investment Agreement, the Company agreed to reserve $10.0 million of the proceeds to open an ISO-certified laboratory in a region outside of the United States, with such region mutually agreed upon by the Company and Merck.

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Pursuant to the terms of the Investment Agreement, Merck agreed to certain customary standstill restrictions that apply from the Closing Date until the earlier of (a) the second anniversary of the Closing Date and (b) the first time that Merck and its affiliates no longer own at least 50% of the Company’s shares owned by Merck immediately following the Closing Date (this clause (b), the "Investor Rights Period," and the earlier of clause (a) and (b), the "Standstill Period"). These standstill restrictions will lapse prior to the end of the Standstill Period if the Company publicly announces the entry into a definitive agreement providing for a change of control transaction. In addition, during the Investor Rights Period, the Company has agreed to provide Merck with certain information and strategic transaction notification rights, including to notify Merck in certain circumstances and subject to certain specified exceptions if (a) the Company receives a bona fide offer, indication of interest or proposal from a third party for a change of control transaction (a "Proposal") or (b) the Company’s board of directors commences a process for solicitation of offers or indications of interest for a change of control transaction (a "Sale Process"). Subject to specific exceptions, the Company agreed to provide Merck with a reasonable opportunity to respond to a Proposal or participate in a Sale Process in a similar manner to other participants. In addition, during the Investor Rights Period the Company agreed to provide Merck with the opportunity to participate pro rata in future equity or equity-linked offerings of the Company, subject to specified exceptions.

Merck also agreed to certain voting commitments under the Investment Agreement that, during the Standstill Period, require Merck to vote, subject to specified exceptions, any shares of Common Stock that Merck owns in accordance with the recommendations of the Company’s board of directors. Such voting commitments generally apply to director nominations for any meeting of the Company’s stockholders, amendments to the Company’s charter to increase the authorized shares of Common Stock, various compensation-related matters, and ratification of the Company’s auditors. Merck also agreed not to transfer (a) any Shares to any third party, subject to certain specified exceptions, for 90 days following the Closing Date or (b) at any time any Shares or other securities acquired under the Investment Agreement to certain restricted parties and activist investors specified in the Investment Agreement.

Pursuant to the terms of the Investment Agreement, the Company agreed to file a registration statement with the U.S. Securities and Exchange Commission within 30 calendar days of the date of sale of the Shares to register the Shares for resale.

The Investment Agreement contains customary representations, warranties and covenants that were made solely for the benefit of the parties to the Investment Agreement. Such representations, warranties and covenants (a) are intended as a way of allocating risk between the parties to the Investment Agreement and not as statements of fact, and (b) may apply standards of materiality in a way that is different from what may be viewed as material by stockholders of, or other investors in, the Company. Accordingly, the Investment Agreement is included with this filing only to provide investors with information regarding the terms of the transaction and not to provide investors with any other factual information regarding the Company. Investors should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company or any of its subsidiaries or affiliates. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Investment Agreement, which subsequent information may or may not be fully reflected in public disclosures.

The foregoing summary of the Investment Agreement is qualified in its entirety by reference to the full text of the Investment Agreement, a copy of which is attached to this report as Exhibit 4.1, which is incorporated herein by reference.

On December 19, 2024 PharmaMar (MSE: PHM) reported that the Phase III LAGOON clinical trial, which evaluates Zepzelca (lurbinectedin) for the treatment of patients with relapsed small cell lung cancer (SCLC), has achieved its recruitment target of 705 patients (Press release, PharmaMar, DEC 19, 2024, View Source [SID1234649219]).

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LAGOON is a randomized (1:1:1), multicenter, open-label Phase III clinical trial with three arms: in the first arm, patients receive lurbinectedin as monotherapy; in the second arm, lurbinectedin is administered in combination with irinotecan; and in the third arm, patients are treated with physician’s choice of topotecan or irinotecan. The study enrolled patients with SCLC whose disease has progressed after one prior line of platinum-based chemotherapy, with or without anti-PD-1 or anti-PD-L1 agents.

The primary objective of the trial is to evaluate overall survival (OS) and progression-free survival (PFS) is one of the secondary endpoints. Top-line results from the study are anticipated in the first quarter of 2026.

Lurbinectedin received accelerated approval from the FDA in June 2020 for the treatment of adult patients with metastatic SCLC whose disease has progressed during or after platinum-based chemotherapy. Since then, it has been approved in 17 territories, including recently in China, although in Europe it has only received approval in Switzerland.

Lurbinectedin is also being investigated in the Phase 3 IMforte clinical trial in combination with atezolizumab compared to atezolizumab alone when administered as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) following induction therapy with carboplatin, etoposide and atezolizumab. As previously announced in October 2024 by Jazz Pharmaceuticals and PharmaMar, the preliminary results from the IMforte trial demonstrated a statistically significant improvement in the primary endpoints of OS and PFS, as assessed by an independent review facility (IRF), for the combination compared to treatment with atezolizumab alone.

SCLC accounts for 15% of all lung cancer diagnoses and is among the most aggressive cancer types. It is characterized by its rapid growth, invasive nature, and early metastasis. Approximately 70% of cases are diagnosed at advanced stages. While the disease often initially responds well to treatment, it tends to recur frequently.