On August 18, 2023 Scholar Rock (NASDAQ: SRRK; "The Company"), a Phase 3, clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that the company granted inducement equity awards covering an aggregate of 150,938 shares of its common stock to 8 newly hired employees, consisting of inducement stock options to purchase an aggregate of 86,250 shares of common stock and inducement restricted stock units, ("RSUs"), covering an aggregate of 64,688 shares of its common stock (Press release, Scholar Rock, AUG 18, 2023, View Source [SID1234634582]).

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The awards are subject to all terms and conditions and other provisions set forth in the Company’s 2022 Inducement Equity Plan ("The Plan") and the award agreements thereunder.

The Plan, which was adopted by the Company’s board of directors on June 16, 2022, is used exclusively for the grant of equity awards to individuals who were not previously employees of Scholar Rock, or following a bona fide period of non-employment, as an inducement material to such individuals entering into employment with Scholar Rock, pursuant to Nasdaq Listing Rule 5635(c)(4).

The options have an exercise price of $7.12, which is equal to the closing price of Scholar Rock’s common stock on August 14, 2023. The stock option award will vest with respect to 25% of the shares of common stock underlying the award on the first anniversary of each employee’s start date, and the remaining 75% of the shares of common stock underlying the Stock Option Award will vest in 12 equal quarterly installments thereafter. Vesting for RSUs will be in four equal annual installments. All vesting related to inducement awards is subject to the employees’ continuing service at the Company through the applicable vesting date.

On August 18, 2023 Boston Immune Technologies and Therapeutics, Inc. (BITT), a clinical stage biotechnology company developing novel tumor necrosis factor superfamily receptor (TNFSR) antagonist antibodies, reported that the Food and Drug Administration (FDA) has cleared BITT’s Investigational New Drug application (IND) for a Phase I trial of BITT2101 (anti-TNFR2) in patients with relapsed or refractory Non-Hodgkin’s lymphomas (Press release, BITT, AUG 18, 2023, View Source [SID1234634581]).

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"We are excited to have approval to bring our lead antibody into clinical trials," said Russell LaMontagne, Co-Founder and Chief Executive Officer of BITT. "This is the first antibody from BITT’s TNF Superfamily platform to enter the clinic and the first opportunity to demonstrate the novelty and utility of our proprietary dominant antagonist antibodies."

BITT’s Phase I, first-in-human, multi-center trial will be an open-label study of escalating doses of BITT2101 in Non-Hodgkin’s lymphoma subgroups including cutaneous T cell lymphoma (CTCL), primary cutaneous peripheral T cell lymphoma (PTCL), adult T cell leukemia/lymphoma (ATLL), diffuse large B cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL).

"The elevated levels of soluble TNFR2 (sTNFR2) in these lymphoma subtypes suggest that TNFR2 may play a significant role in progression and response to first line therapy. As the escalation arm progresses, we are actively exploring validation of sTNFR2 in multiple cancers including solid tumors for potential expansion arms," added LaMontagne.

On August 18, 2023 Medivir reported Continued strong momentum and promising signs of patient benefit in the combination study with fostrox and Lenvima (Press release, Medivir, AUG 18, 2023, View Source;interim-report-january–june-2023-301904356.html [SID1234634506]).

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April – June
Financial summary for the quarter

Net turnover amounted to SEK 2.0 (0.5) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -26.3
(-21.5) million. Basic and diluted earnings per share amounted to SEK -0.47 (-0.42) and SEK -0.47 (-0.42) respectively.
Cash flow from operating activities amounted to SEK -17.9 (-17.6) million.
Cash and cash equivalents at the end of the period amounted to SEK 82.8 (162.8) million.
Significant events during the quarter

In April, new data were presented showing synergistic anti-tumor effect of fostrox in triple combination with anti-PD1 and Lenvima in non-clinical tumor models.
Medivir’s patent application for fostrox was approved by the patent authority in China.
January – June
Financial summary for the period

Net turnover amounted to SEK 2.4 (1.0) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -45.2
(-52.9) million. Basic and diluted earnings per share amounted to SEK -0.81 (-1.00) and SEK -0.81 (-1.00) respectively.
Cash flow from operating activities amounted to SEK -34.1 (-57.5) million.
Cash and cash equivalents at the end of the period amounted to SEK 82.8 (162.8) million.
Events after the end of the period

In August, Medivir’s Scientific Advisory Council was formed, consisting of five world-leading experts in liver cancer.
In August, the 15th patient was included in the phase 2a study with fostrox in combination with Lenvima, which shows promising tumor control and good tolerability.
Conference call for investors, analysts and the media
The Interim Report January – June 2023 will be presented by Medivir’s CEO, Jens Lindberg.

Time: Friday, August 18, 2023, at 14.00 (CET).

For dial-in numbers to the conference call, please see information on the website; www.medivir.com/investors/calendar

The conference call will also be streamed via a link on the website: www.medivir.com
The presentation will be available on Medivir’s website after completion of the conference.

On August 18, 2023 Akeso Inc. ("Akeso", 9926. HK) reported that the first patient has been dosed in a head-to-head phase III trial of ivonescimab, a potential first-in-class investigational PD-1/VEGF bi-specific antibody discovered by Akeso (Press release, Akeso Biopharma, AUG 18, 2023, View Source [SID1234634504]). The Phase III trial will evaluate the clinical efficacy and assess the safety of ivonescimab compared with tislelizumab in combination with chemotherapy as first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC).

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The international multicenter Phase III clinical trial of ivonescimab for this specific indication is currently ongoing. According to the latest clinical development plan for ivonescimab released by Summit Therapeutics, a partner of Akeso in the global development of ivonescimab, the international multicenter Phase III clinical study of ivonescimab in combination with chemotherapy versus pembrolizumab in combination with chemotherapy for first-line treatment of metastatic sq-NSCLC (HARMONi-3 ) is scheduled to dose the first patient in the second half of 2023.

The use of PD- (L)1 inhibitors in conjunction with chemotherapy is the current standard of care (SOC) for lung cancer worldwide, especially in the United States and China. However, despite this approach, there is still significant room for improvement in terms of prognosis, as there remains an extensive unmet need.

Currently, ivonescimab has been engaged in several Phase III head-to-head trials compared with standard of care PD-(L)1 inhibitors for lung cancer in developed countries worldwide, including China, the United States, Europe, and other developed countries. Akeso and Summit are determined and confident in pursuing stronger evidence-based medical research for ivonescimab, with a specific emphasis on the drug’s clinical value. These efforts aim to expedite the drug’s time to market and ensure its commercial success on a global scale.

Following an acceptance of marketing application for an indication of ivonescimab by the China CDE, four pivotal registrational Phase III clinical trials have been initiated/are being conducted worldwide, including three head-to-head trials with PD-1 monoclonal antibody as the positive control drug:

A Phase III study of ivonescimab monotherapy versus pembrolizumab monotherapy as first-line treatment for NSCLC patients with positive PD-L1 expression (AK112-303), which has been granted BTD in China.
An international multicenter Phase III study of Ivonescimab in combination with chemotherapy for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC progressing on third-generation EGFR-TKI therapy (HARMONi/AK112-301), which has been granted BTD in China.
A Phase III study in China for the first-line treatment of advanced squamous NSCLC with ivonescimab in combination with chemotherapy versus tislelizumab in combination with chemotherapy（AK112-306).
An international multicenter Phase III study of ivonescimab in combination with chemotherapy versus pembrolizumab monoclonal antibody in combination with chemotherapy as the first-line treatment for metastatic squamous NSCLC (HARMONi-3).
About Ivonescimab

Ivonescimab is a potential first-in-class investigational PD-1/VEGF bi-specific antibody discovered by Akeso and is believed to be the PD-1 / VEGF bispecific antibody that is most advanced in the clinic. Ivonescimab is currently developed by Akeso (known as AK112) in China and Australia and Summit (known as SMT112) in the United States, Canada, Europe, and Japan (Summit’s license territories). It combines the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab is currently engaged in multiple Phase III clinical trials worldwide.

On August 18, 2023 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for rare and ultra-rare diseases, reported the grant of 42,840 restricted stock units of the company’s common stock to 18 newly hired non-executive officers of the company (Press release, Ultragenyx Pharmaceutical, AUG 18, 2023, View Source [SID1234634502]). The awards were approved by the compensation committee of the company’s board of directors and granted under the Ultragenyx Employment Inducement Plan, with a grant date of August 16, 2023, as an inducement material to the new employees entering into employment with Ultragenyx in accordance with Nasdaq Listing Rule 5635(c)(4).

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The restricted stock units vest over four years, with 25% of the underlying shares vesting on each anniversary of the grant date, subject to the employee being continuously employed by the company as of such vesting dates.