On October 23, 2024 Alpha-9 Oncology Inc. (Alpha-9 or the Company), a clinical stage company developing radiopharmaceuticals to meaningfully improve the treatment of people living with cancer, reported an oversubscribed $175 million Series C financing to support the progression of its pipeline (Press release, Alpha9 Oncology, OCT 23, 2024, View Source [SID1234647328]). The financing was led by Lightspeed Venture Partners and Ascenta Capital. A selected syndicate of new investors – General Catalyst, a16z Bio + Health, RA Capital Management, Janus Henderson Investors, Delos Capital, Digitalis Ventures, Lumira Ventures and a healthcare fund managed by abrdn Inc. – joined the round, in addition to existing investors Frazier Life Sciences, Longitude Capital, Nextech Invest, BVF Partners LP, and Samsara BioCapital. Shelley Chu, head of Lightspeed Venture Partners’ healthcare team and Evan Rachlin, co-founder and managing partner of Ascenta Capital will join the Company’s Board of Directors.

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Alpha-9 has built a diversified portfolio of clinical and discovery assets across both validated and novel targets. The Series C will fund human studies for the clinical stage assets and advancement of discovery stage assets to clinic-ready development candidates. Furthermore, the Series C will fund expanded R&D capabilities and continued investment in CMC and supply chain.

"Over the last few years, Alpha-9 has built a leading radiopharmaceutical company with a deep pipeline and robust infrastructure," said Alpha-9 CEO, David Hirsch, MD, PhD. "The Series C is an exciting, significant milestone for us and will greatly accelerate our growth. We are thrilled to have the backing of a top-tier investor syndicate who share our belief in the potential of radiopharmaceuticals."

"Alpha-9 is developing a differentiated portfolio that includes multiple radiopharmaceuticals with first in-class and best-in-class potential," said Shelley Chu, head of Lightspeed Venture Partners’ healthcare team. "We are impressed with the team’s progress to date and are proud to support the advancement of these programs."

Alpha-9’s approach to designing bespoke molecules is systematic and data-driven. The Company has a differentiated toolbox of binders, linkers, chelators and radioisotopes – elements that each play an integral role in radiopharmaceutical development. Alpha-9 designs each component of the radiopharmaceutical for optimal selectivity, stability and payload delivery. The Alpha-9 approach is rigorous, fast and capital efficient, generating best-in-class compounds for rapid clinical development.

"We have been following this space for a long time. What differentiated Alpha-9 was its effective approach to molecule design as well as its thoughtful strategy on infrastructure expansion," said Evan Rachlin, MD, managing partner of Ascenta Capital. "We are pleased to support the Company’s continued progress as it strives to deliver on the promise of radiopharmaceuticals."

To support its endeavors, Alpha-9 has purpose-built research facilities in Vancouver, which were completed last year and have been operating at scale. These facilities help to accelerate drug development by streamlining discovery processes. Alpha-9 has also partnered with isotope suppliers and CDMOs to support its ongoing clinical trials. Alpha-9’s commitment to continue building robust infrastructure and world class capabilities underscores the company’s mission to provide effective treatments for patients worldwide.

On October 22, 2024 (the "Closing Date"), MEI Pharma, Inc., a Delaware corporation (the "Company"), and Aardvark Therapeutics, Inc., a Delaware corporation (the "Purchaser"), reported to have entered into an Asset Purchase Agreement (the "Asset Purchase Agreement"), pursuant to which the Company sold its rights, title and interest in and to certain assets related to ME-344 (the "Program Candidate"), including relevant intellectual property rights, technology and contracts (Filing, 8-K, MEI Pharma, OCT 22, 2024, View Source [SID1234647440]). Pursuant to the Asset Purchase Agreement, the Purchaser paid the Company an initial payment of $500,000 in cash plus the Reimbursement Amount (as defined in the Asset Purchase Agreement) at the closing of the transactions contemplated by the Asset Purchase Agreement (the "Closing") and may make payments up to $62 million after the Closing (the "Milestone Payments"), payable upon the achievement of certain milestones regulatory approval and sales related to the Program Candidate (the "Milestone Events"). The Purchaser also assumed certain liabilities of the Company arising after the Closing, including liabilities arising under the transferred contracts.

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The Asset Purchase Agreement and the transactions contemplated therein were approved by the board of directors of the Company. The Asset Purchase Agreement contains customary representations, warranties and covenants of each of the Company and the Purchaser. Subject to specified survival limitations, the representations and warranties contained in the Asset Purchase Agreement terminated immediately following the Closing.

Other than the Asset Purchase Agreement, there exists no material relationship between the Company, its affiliates or any of the Company’s directors and officers, on the one hand, and the Purchaser, on the other. The terms of the transaction were negotiated between the Company and the Purchaser on an arms-length basis.

The foregoing description of the Asset Purchase Agreement is qualified in its entirety by reference to the complete text of the Asset Purchase Agreement, which is attached as Exhibit 2.1 to this Current Report on Form 8-K and incorporated herein by reference.

The Asset Purchase Agreement contains representations and warranties that the parties made to, and are solely for the benefit of, each other. Investors and security holders should not rely on the representations and warranties as characterizations of the actual state of facts since they were made only as of the date of the Asset Purchase Agreement. Moreover, information concerning the subject matter of such representations and warranties might change after the date of the Asset Purchase Agreement, which subsequent information might or might not be fully reflected in public disclosures.

On October 22, 2024, vTv Therapeutics LLC ("vTv LLC"), a controlled subsidiary of vTv Therapeutics Inc. (the "Company"), reported to have received notice from OnKure Therapeutics, formerly Reneo Pharmaceuticals, Inc. ("OnKure"), of their intent to terminate the License Agreement between vTv LLC and Reneo Pharmaceuticals, Inc., dated December 21, 2017, as amended December 20, 2021 (the "Agreement") (Filing, 8-K, vTv Therapeutics, OCT 22, 2024, View Source [SID1234647426]). Under the Agreement, the Company had granted OnKure an exclusive, worldwide license to intellectual property pertaining to the Company’s peroxisome proliferator-activated receptor delta (ppar-δ) agonist program. In its notice, OnKure indicated that it had decided to discontinue development of the program. Under the Agreement, the termination will become effective as of January 20, 2025.

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On October 22, 2024 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported new positive survival data, outperforming patients, and survival rates in its Phase 2 metastatic breast cancer (MBC) study (Press release, BriaCell Therapeutics, OCT 22, 2024, View Source [SID1234647332]).

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In BriaCell’s Phase 2 clinical study, patients treated with the same Bria-IMT regimen formulation being used in the ongoing Phase 3 pivotal trial experienced a one-year survival rate of 55% (i.e. 55% of patients remain alive at least one year after starting on the study). This rate exceeds the survival data of the current standard of care for similar patients (see Table 1). Notably, 4 of 13 patients recruited in 2022 remain in survival follow-up as well, including:

Patient 01-009: Overall survival (OS) of 25 months has been reported in a patient who had failed 6 prior treatments prior to the BriaCell regimen. Stable disease and lymph node shrinkage has been recorded during 13 cycles of therapy.
Patient 07-001: OS of 24 months. She had stable disease and received 8 cycles of BriaCell’s therapy.
Patient 16-003: OS of 15 months and received 8 cycles of therapy with stable disease. Prior to the BriaCell regimen, she had 7 lines of therapy, which included the progression of disease while on the antibody-drug conjugate (ADC) Enhertu.
Patient 11-018: OS of 14 months. This previously-reported responder with 100% resolution of her brain metastasis has recently completed her 19th cycle of therapy.
"With over 40,000 deaths each year in the US alone, late-stage MBC remains an important unmet medical need for many patients and their families. Approved treatments are restricted by poor survival and harsh side effects," stated Adam M. Brufsky, MD, PhD, FACP, Professor of Medicine at the University of Pittsburgh School of Medicine and Medical Director of the Magee-Women’s Cancer Program. "We are impressed with BriaCell’s promising randomized Phase 2 survival data indicating robust survival and a preferred tolerability profile for Bria-IMT and look forward to seeing the data being replicated in BriaCell’s pivotal Phase 3 study."

"A number of patients with metastatic breast cancer have disease progression on currently approved drugs, including CPIs and ADCs, with limited overall survival," remarked Dr. Aditya Bardia, Program Director of Breast Medical Oncology at UCLA, who was not involved with the BriaCell Phase 2 clinical trial. "BriaCell’s clinical data is interesting and highlights the role of the combination of Bria-IMT with CPIs in MBC."

"Significant numbers of patients with metastatic breast cancer do not respond to currently approved drugs, including CPIs and ADCs, and have a very limited lifespan of weeks to a few months," said Dr. William V. Williams, BriaCell’s President and CEO. "BriaCell’s clinical data supports our hypothesis that our regimen has prolonged survival in patients with metastatic breast cancer who otherwise have not responded to currently available treatments. We look forward to further confirming these impressive data in our ongoing pivotal Phase 3 study, with interim results expected in the second half of 2025. Overall survival is the primary endpoint in our pivotal Phase 3 study."

Table 1: Comparable Analysis of 1 year survival for the BriaCell Phase 2 study

Reference Breast Cancer Type Median prior lines of therapy Median OS (months) Percent Survival at 1 year
Bria-IMT plus CPI All types
61% HR+
33% TNBC
6% HER2+ 6 13.4*
15.6** 55%
Cortes et al.1 All types
57% HR+
18-19% TNBC
18-20% HER2+ 4 9.1-9.3 ~38-40%
Kazmi et al.2 All types
51-52% HR+
25-29% TNBC
9-24% HER2+ 2 7.2-9.8 30-38%
Bardia et al.
(TPC arm)3 TNBC 2-3 6.9 ~23%
Rugo et al
(TPC arm)4

HR+ HER2- 2 11.2 47%
* Patients treated with the Phase 3 formulation
** Patients treated with the Phase 3 formulation since 2022

Cortes J, et al. Annals of Oncology 2018
Kazmi S, et al. Breast Cancer Res Treat. 2020
Bardia A, et al. J Clin Oncol. 2024
Rugo HS, et al. The Lancet. 2023
Abbreviations:
HR+: hormone receptor-positive
TNBC: Triple-negative breast cancer (lacks or has low levels of the estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2))
HER2+: Human epidermal growth factor receptor 2 positive
HR+ HER2-: hormone receptor-positive and human epidermal growth factor receptor 2 negative
TPC: Treatment of Physicians Choice

The Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients (median number of prior treatments = 6) who received the Bria-IMT regimen plus checkpoint inhibitor. Of these 54 patients, 37 were treated with the formulation currently being used in BriaCell’s ongoing pivotal Phase 3 study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612). Final median overall survival calculation for the Phase 2 study is pending, as many patients remain alive. No Bria-IMT related discontinuations have been reported to date.

On October 22, 2024 Scholar Rock Holding Corporation (Nasdaq: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, reported that on October 16, 2024, the underwriters of its previously announced underwritten public offering of common stock and pre-funded warrants, which closed on October 10, 2024, exercised their option in full to purchase an additional 1,592,920 shares at the public offering price of $28.25 per share, resulting in additional gross proceeds of approximately $45 million, before deducting underwriting discounts and commissions and offering expenses payable by Scholar Rock (Press release, Scholar Rock, OCT 22, 2024, View Source [SID1234647324]). The closing of the underwriters’ exercise of their option to purchase 1,592,920 additional shares occurred on October 18, 2024.

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J.P. Morgan Securities LLC, Jefferies and Piper Sandler & Co. acted as joint book-running managers for the offering. BMO Capital Markets Corp., Wedbush Securities Inc. and Raymond James & Associates, Inc. acted as co-managers for the offering.

An automatically effective shelf registration statement on Form S-3 relating to the offering of the shares of common stock and pre-funded warrants described above was filed with the Securities and Exchange Commission (SEC) on October 7, 2024. A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC on October 7, 2024, and are available on the SEC’s website located at www.sec.gov. The final prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC on October 9, 2023 and may be obtained by contacting: J.P. Morgan Securities LLC, c/o: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at 877-821-7388, or by email at [email protected]; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at 800-747-3924, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 that state or jurisdiction.