On June 17, 2022 Melanoma Research Alliance’s reported that more than 900 people from over 100 firms from the leveraged finance and private equity communities came together for the Leveraged Finance Fights Melanoma (LFFM) benefit and cocktail party (Press release, Melanoma Research Alliance, JUN 17, 2022, View Source [SID1234616076]). Hosted at the Museum of Modern Art, the event raised a record breaking $3 million for the Melanoma Research Alliance’s (MRA) mission to advance the world’s most innovative and promising melanoma research.

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"Each year, I continue to be amazed by the community’s response to this event and the mission it supports," says LFFM co-founder and MRA board member Jeff Rowbottom. "LFFM has become a signature event for the finance industry, and it plays a critical role in advancing cancer research that is literally saving lives, including mine."

LFFM funding supports cutting-edge melanoma research that has helped patients with all types of cancer live longer, fuller lives. Treatments first pioneered in melanoma are now being used to treat patients with over 30 other cancer types.

LFFM was founded in 2011 by Jeff Rowbottom (Iron Park Capital) and Brendan Dillon (Veritas Capital) – both melanoma survivors. Since its founding, LFFM has raised more than $19 million for MRA, the largest nonprofit funder of melanoma research. Since its founding in 2007, MRA-funded investigators have been deeply involved in every breakthrough in melanoma research, including the approval of 15 new therapies.

The event was co-chaired by Clare Bailhé (MidCap Financial), Brendan Dillon (Veritas Capital), Kerry Dolan (Brinley Partners), Lee Grinberg (Elliott Management), Matt Manin (Apollo), George Mueller (KKR), Geoff Oltmans (Silver Lake), Kevin Pluff, Jeff Rowbottom (Iron Park Capital), Ian Schuman (Latham & Watkins), Cade Thompson (KKR), Trevor Watt (Hellman & Friedman), and Eric Wedel (Kirkland & Ellis).

Presenting sponsors of the event included Latham & Watkins, Kirkland & Ellis, Simpson Thacher & Bartlett, Fitch Ratings, Michael Milken, HPS Investment Partners, Apollo|Midcap, Iron Park Capital Management, Veritas Capital Management and White & Case. A full list of LFFM sponsors is included below.

"The leveraged finance and private equity communities are some of the biggest advocates for MRA and our mission to cure melanoma," says MRA CEO Marc Hurlbert, PhD. "The funds raised from this event will further accelerate the MRA research agenda and the continuation of faster cures, new treatments and lifesaving breakthroughs.

On June 17, 2022 Scholar Rock (NASDAQ: SRRK), 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 it has entered into a securities purchase agreement with certain institutional investors to sell, in a registered direct offering, 16,326,530 shares of common stock and, in lieu of common stock, pre-funded warrants to purchase 25,510,205 shares of common stock, and accompanying warrants to purchase 10,459,181 shares of common stock, at a price of $4.90 per share and accompanying warrant or $4.8999 per pre-funded warrant and accompanying warrant, for total gross proceeds of approximately $205 million, before deducting placement agent commissions and estimated offering expenses (Press release, Scholar Rock, JUN 17, 2022, View Source [SID1234616075]). The accompanying warrants will be immediately exercisable and expire on December 31, 2025 and have an exercise price of $7.35 per share. The offering is expected to close on June 22, 2022, subject to the satisfaction of customary closing conditions.

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Scholar Rock intends to use the net proceeds from the offering, together with existing cash, cash equivalents and investments, to advance its ongoing and future clinical programs (including the development of apitegromab in SMA through the anticipated Phase 3 SAPPHIRE topline data readout and SRK-181 in immuno-oncology), to further develop its technology platform and to continue to advance its preclinical pipeline, as well as other ongoing research and development activities and for general corporate purposes.

J.P. Morgan Securities LLC is acting as lead placement agent and Piper Sandler & Co. is acting as co-placement agent for the offering.

Investors in the offering include Invus, Polaris Partners, Redmile, Samsara BioCapital, and other institutional investors.

The securities were offered pursuant to an effective shelf registration statement on Form S-3, as amended (File No. 333-254057) that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on April 13, 2022. A final prospectus supplement, which contains additional information relating to the offering, will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement may be obtained, when available, from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at 866-803-9204, or by email at [email protected]; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, or by telephone at (800) 747-3924, or by email at [email protected].

Before investing in this offering, interested parties should read the prospectus supplement, the accompanying prospectus and the other documents that are incorporated by reference in such prospectus supplement and the accompanying prospectus in their entirety, which provide more information about Scholar Rock and the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On June 17, 2022 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company on a mission to deliver transformative therapies for rare cancers, reported the company has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for momelotinib, an ACVR1 / ALK2, JAK1 and JAK2 inhibitor in development for the treatment of myelofibrosis (Press release, Sierra Oncology, JUN 17, 2022, View Source [SID1234616074]).

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"Today is truly momentous for everyone at Sierra Oncology and the patients we serve. This team designed a targeted study to address the highest unmet need and delivered incredible results in the midst of a pandemic. We are thrilled to submit this NDA on behalf of myelofibrosis patients and look forward to working with the FDA over the coming months," said Stephen Dilly, MBBS, PhD, President and Chief Executive Officer of Sierra Oncology. "We are immensely grateful to the patients and investigators who participated in momelotinib trials over the years, making it possible to achieve this milestone."

The NDA submission is based on the results from several Phase 2 and Phase 3 studies, including the recently completed MOMENTUM study. As with all new drug applications, the company expects the FDA to respond as to whether this submission is accepted within 60 days. Assuming the submission is accepted and a subsequent approval is granted, commercial launch of momelotinib is anticipated in 2023.

About the Pivotal MOMENTUM Clinical Trial
MOMENTUM is a global, randomized, double-blind Phase 3 clinical trial of momelotinib versus danazol in patients with myelofibrosis who were symptomatic and anemic, and had been previously treated with an FDA-approved JAK inhibitor. The study was designed to evaluate the safety and efficacy of momelotinib for the treatment and reduction of the key hallmarks of disease: symptoms, blood transfusions (due to anemia) and splenomegaly (enlarged spleen). Results from the MOMENTUM study were presented at the 2022 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

The primary endpoint of the study is Total Symptom Score (TSS) reduction of >50% over the 28 days immediately prior to the end of Week 24 compared to baseline TSS, using the Myelofibrosis Symptom Assessment Form (MFSAF). Secondary endpoints included Transfusion Independence (TI) rate for >12 weeks immediately prior to the end of Week 24 with Hgb levels ≥ 8 g/dL, and Splenic Response Rate (SRR) based on splenic volume reduction of >35% at Week 24. The study enrolled 195 patients based on a planned 180 patients across 21 countries.

Danazol was selected as the treatment comparator given its use to ameliorate anemia in patients with myelofibrosis, as recommended by National Comprehensive Cancer Network (NCCN) and European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) guidelines. Patients were randomized 2:1 (MMB n = 130 and DAN n = 65) to receive either momelotinib or danazol. After 24 weeks of treatment, patients on danazol were allowed to crossover to receive momelotinib. Early cross-over to momelotinib was available for confirmed symptomatic splenic progression.

About Momelotinib
Momelotinib is a potent, selective and orally bioavailable ACVR1 / ALK2, JAK1, JAK2 inhibitor under investigation for the treatment of myelofibrosis in symptomatic, anemic patients previously treated with an approved JAK inhibitor. More than 1,200 subjects have received momelotinib since clinical studies began in 2009, including approximately 1,000 patients treated for myelofibrosis, several of whom remain on treatment for over 12 years. Momelotinib is the first and only JAK inhibitor to demonstrate positive data for all key hallmarks of the disease—symptoms, splenic response and anemia.

About Myelofibrosis
Myelofibrosis is a rare blood cancer that results from dysregulated JAK-STAT signaling and is characterized by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia. From prior studies with momelotinib, we know approximately half of myelofibrosis patients are moderately to severely anemic when eligible for JAK inhibitor treatment. Furthermore, currently approved JAK inhibitors only address symptoms and splenomegaly and are myelosuppressive. This can lead to worsening anemia, resulting in dose reductions that potentially reduce treatment effect.

On June 17, 2022 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported multiple presentations of data evaluating its first VDC, belzupacap sarotalocan (AU-011), for the first-line treatment of patients with early-stage choroidal melanoma (indeterminate lesions and small choroidal melanoma (CM)) (Press release, Aura Biosciences, JUN 17, 2022, View Source [SID1234616073]). The presentations include updated safety results from the Phase 2 trial using suprachoroidal (SC) administration, final safety and efficacy data from the Phase 1b/2 trial using intravitreal (IVT) administration as well as top-line data from the Retrospective Match Case Control study comparing the long-term visual acuity outcomes following treatment with belzupacap sarotalocan versus treatment with plaque brachytherapy, the current standard of care. The results will be presented at the International Society of Ocular Oncology (ISOO) 2022 Bi-Annual Meeting, the largest global ocular oncology meeting, being held June 17-21, 2022, in Leiden, the Netherlands.

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"The final safety and efficacy data from the Phase 1b/2 trial using IVT administration, along with the data from the ongoing Phase 2 trial using SC administration, continues to support the value of a vision preserving therapy for the first line treatment of patients with early-stage CM," said Dr. Cadmus Rich, Chief Medical Officer and Head of R&D of Aura Biosciences. "We remain on track with our Phase 2 SC study and we plan to finalize a decision on the route of administration and initiate our pivotal program before the end of the year. Aura is also excited to share the topline results of the retrospective matched case control study as well."

Details for ISOO 2022 presentations:

Title: A Phase 1b/2 trial of AU-011, a first-in-class targeted therapy for the treatment of choroidal melanoma via intravitreal administration
Presenter: Carol L. Shields, MD, Wills Eye Hospital and Cadmus C. Rich MD, Aura Biosciences
Session: S17 Other Intraocular Tumors
Date/Time: Monday, June 20, 2022 from 09:32 a.m. – 09:40 a.m. CEST

Title: A Phase 2 trial of a first-in-class targeted therapy for choroidal melanoma via suprachoroidal (SC) administration
Presenter: Ivana K. Kim, MD, Massachusetts Eye and Ear
Session: S13 Uveal Melanoma: Clinic and Case
Date/Time: Sunday, June 19, 2022 from 11:24 a.m. – 11:32 a.m. CEST

Industry Symposium: New Developments in AU-011, an Investigational Virus-Like Drug Conjugate (VDC) for the treatment of Ocular Cancer and Metastatic Disease
Presenter: Cadmus Rich, MD, Chief Medical Officer and Head of R&D Aura Biosciences
Date/Time: Sunday, June 19, 2022 from 12:30 p.m. – 01:15 p.m. CEST

On June 17, 2022 Hong Kong Science and Technology Parks Corporation (HKSTP) reported that it is partnering global research-driven biopharmaceutical leader, Boehringer Ingelheim Venture Fund Limited (BIVF) in a strategic co-incubation collaboration to promote and nurture startups on research and development for infectious diseases and immunology (Press release, Boehringer Ingelheim, JUN 17, 2022, View Source [SID1234616072]).

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HKSTP is dedicated to collaborating with sector leaders in building the strongest I&T eco-system to help startups via business development, mentorship and investment initiatives. In the last five years, the number of biotech companies at HKSTP have tripled from 50 to over 150, which has also synched with the Government’s strategic focus on biomedical technology with allocation of HK$10 billion to develop life and health technology as a key future growth sector for Hong Kong.

This partnership between HKSTP and BIVF marks a key milestone to drive the Hong Kong’s biomedical technology development. Both local and global qualified startups in infectious diseases and immunology can apply to the incubation programme to access the full capabilities of the HKSTP ecosystem and BIVF’s extensive biotech funding network. Incubatees can access one-on-one coaching and assessment to track key research milestones, while receiving expert guidance from HKSTP on commercialisation, manufacturing, scaling-up and marketing strategy to ensure successful innovation, plus vital funding opportunities and investment insight from BI.

Mr. Albert Wong, CEO of HKSTP, said: "Hong Kong is now Asia’s largest and the world’s second largest fundraising hub for biotech. As HKSTP marks our 20th year of propelling success and innovation, our mission is to drive the growth of biotech to another level with world class leaders like BIVF. We will maximise the GBA growth opportunities for high-potential tech talents and early-stage startups to ensure the region emerges as a global I&T powerhouse."

Dr. Grace Lau, Head of Institute for Translational Research of HKSTP, said: "Our partnership with BIVF, provides early-stage startups and promising university spinoffs with vital support at the most critical stage of their long and challenging biotech innovation journey. Incubatees will have access to our Incu-Bio Programme, with total incubatees doubling up in the last five years. The startups can also access funding support of up to HK$6 million, with financial subsidies and upfront grants to cover regulatory activities such as clinical trials."

"The world has faced growing public health challenges in recent years. As Boehringer Ingelheim’s strategic investment arm, BIVF focuses on the development of new science in areas with huge unmet medical needs such infectious diseases and immunology," said Dr. Frank Kalkbrenner, Global Head of the BIVF. "The co-incubation program jointly initiated by HKSTP and BIVF will enable us to identify more breakthrough technologies in the early stage of development. With the funding and infrastructure support offered by HKSTP and BI‘s expertise and experiences in the successful development of breakthrough mediactions for patients, we foster the startup companies and bridge the gap between science and industry for the local ecosystem. We look forward to developing together with HKSTP next-generation therapies in the fields of infectious diseases and immunology with long term partnerships."

"The innovation competency of biopharmaceuticals in Asia is rising quickly. To grab the opportunities in this market, Boehringer Ingelheim has set up the External Innovation Hub in China which brings our Research Beyond Borders, Business Development & Licensing and Venture Fund groups under one umbrella. Now we’re thrilled to see that the biopharmaceutical industry is picking up rapidly in the Guangdong–Hong Kong–Macau Greater Bay Area, it’s a great opportunity for us to partner with HKSTP to develop the local ecosystem, and further enhance China’s dual-circulation scheme. We hope to offer our continuous support to more home-grown innovations to be recognized on the global market and eventually benefit the patients worldwide." said Mr. Felix Gutsche, President & CEO, Boehringer Ingelheim China.

Programme incubatees will also benefit from HKSTP’s rapidly-growing biotech R&D capabilities including the HKSTP Institute for Translational Research (ITR), enabling biomedical startups to turn their innovative biomedical technologies to life-changing impact for patients and society. Also available to startups is HKSTP’s Incu-Bio program providing dedicated biotech mentorship, business matching, entrepreneur-in-residence, and access to R&D facilities and the Science Parks’ diverse talent pool.