On September 14, 2023 Bristol Myers Squibb (NYSE: BMY) reported that it is holding a Research and Development (R&D) Day in New York to discuss the company’s R&D strategy and capabilities and to provide insight into its robust pipeline supporting long-term sustainable growth (Press release, Bristol-Myers Squibb, SEP 14, 2023, View Source [SID1234635160]).

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Members of the company’s leadership team will also highlight its differentiated research platforms and enhanced R&D framework, which are expected to drive top-tier productivity that delivers high quality early-stage candidates and meaningfully accelerates R&D timelines.

"We are seeing the impact of our focused efforts to strengthen our R&D engine and pipeline as we’ve executed against our priorities over the past four years," said Giovanni Caforio, M.D., board chair and CEO, Bristol Myers Squibb. "By combining the best assets, capabilities and platforms within our company, we are well-positioned to deliver more medicines to patients even faster in the future."

"Science and innovation derived from research and development are critical to the continued success of our company and represent the core of Bristol Myers Squibb’s vision to transform patients’ lives," said Chris Boerner, Ph.D., executive vice president and chief operating officer, Bristol Myers Squibb. "We are further enhancing our R&D engine to strengthen scientific leadership, accelerate our promising pipeline and drive increased productivity. This work is a key enabler of our goal of delivering long-term sustainable growth and ensuring we help more patients prevail over serious diseases."

Strengthening Scientific Leadership and Advancing Promising Pipeline

The company expects to double the number of registrational assets over the next 18 months from six to 12. Key pipeline updates for the newly anticipated registrational assets include:

CD19-directed NEX T cell therapy BMS-986353, expanding into clinical trials for immunologic diseases, including severe, refractory systemic lupus erythematosus.
Potential first cell therapy targeting GPRC5D, our CAR T BMS-986393, starting a registrational trial in relapsed/refractory multiple myeloma (RRMM).
BCMA x CD3 T-cell engager, alnuctumab, advancing into a Phase 3 trial for RRMM.
Potential first-in-class protein degrader, golcadomide, progressing into a Phase 3 trial in first-line large B-cell lymphoma.
The first asset from BMS’ novel ligand-directed protein degradation platform, androgen receptor degrader, moving into pivotal studies in metastatic castration-resistant prostate cancer.
Potential best-in-class BET inhibitor, BMS-986158, for myelofibrosis expecting proof-of-concept data.
This complements six assets already in registrational trials:

Repotrectinib, a potential best-in-class ROS1 inhibitor with a U.S. FDA PDUFA goal date of November 27, 2023.
Iberdomide and mezigdomide, protein degraders in registrational trials with first data expected in 2026.
Cendakimab, an anti-IL-13 asset in eosinophilic esophagitis.
BMS-986278, our first-in-class LPA1 antagonist, with potential to become the new standard of care in idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. Today, the company outlined Phase 3 trials in each disease that will evaluate both 60mg and 120mg doses of this potentially important medicine for patients.
Milvexian in secondary stroke prevention, acute coronary syndrome and atrial fibrillation, in collaboration with Janssen Pharmaceuticals Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
In addition to its growing registrational portfolio, the company has more than 25 indication expansion opportunities on the horizon and nine, high-potential early assets expected to advance in the pipeline. Taken together, this leads to increased depth across the company’s therapeutic areas, including oncology, hematology, immunology, cardiovascular and a growing presence in neuroscience.

"The work we’re undertaking to accelerate our clinical pipeline and extend scientific leadership across therapeutic areas make it an incredibly exciting time to be a part of this company and our R&D organization," said Samit Hirawat, M.D., executive vice president and chief medical officer, Drug Development, Bristol Myers Squibb. "Our integrated approach to R&D will allow us to maximize innovation and get more medicines to more patients faster."

Differentiated Research Platforms Support Long-Term Growth

The company is uniquely positioned with differentiated research platforms including Cell Therapy and Targeted Protein Degradation supporting its innovative work across therapeutic areas.

Building on our leadership in Cell Therapy

BMS is the only company with two cell therapies approved against two distinct targets, exhibiting growing leadership in the space with strong positioning at the center of the innovation ecosystem. The company is expanding manufacturing capacity, exploring innovative technologies such as dual-targeting CARs and allogenic approaches, advancing multiple next-generation assets including new targets. BMS is also rapidly expanding into immunology, including lupus and multiple sclerosis.

Expanding to new targets with Targeted Protein Degradation

The company has a strong legacy in the protein degradation field and has been advancing its pipeline with an expansive library of assets spanning molecular glues, ligand-directed degraders and antibody drug conjugates. With three assets in registrational trials, four others in the clinic and more than 15 being studied pre-clinically, this growing platform has potential across several diseases, and is positioned to deliver approximately four investigational new drugs (INDs) each year.

Enhancing R&D Productivity and Bringing Treatments to Patients Faster

The company is undertaking efforts to further increase and sustain the productivity of its R&D engine, enabling an approach to research and development that will allow it to identify higher-quality candidates with increased probability of making it to market. Moving forward, BMS is focused on three objectives for establishing and sustaining top-tier R&D productivity:

Driving toward approximately 10 INDs per year.
Increasing success rates from first-in-human to approval to approximately 20%.
Reducing research and drug development timelines to achieve a median of 6.5 years from first-in-human to approval.
"Bristol Myers Squibb is committed to harnessing our integrated R&D approach to deliver high-quality assets with an increased chance of success based on a deep understanding of causal human biology," said Robert Plenge, M.D., Ph.D., executive vice president and chief research officer. "Our research strategy will enable us to increase the number and quality of potentially transformational early-stage candidates, leveraging our differentiated research platforms, and accelerate the path from proof-of-concept to regulatory approval."

R&D Day takes place at 9 a.m. ET today and will be available via live webcast here.

On September 14, 2023 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that a patient with advanced inoperable pancreatic cancer has been treated in a clinical trial at Hadassah Medical Center in Jerusalem, Israel (Press release, Alpha Tau Medical, SEP 14, 2023, View Source [SID1234635159]). The trial is designed for a broad range of solid tumor patients who do not qualify for participation in other existing trials or who do not have other treatment options according to the treating physician.

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"We are dedicated to improving the lives and giving hope to cancer patients and their families, and we believe that Alpha DaRT has the potential to transform the treatment landscape for malignant tumors worldwide," said Alpha Tau CEO Uzi Sofer. "Treating this patient with advanced inoperable pancreatic cancer, who may not have had other life-saving options at this stage, is very encouraging as we continue to execute on our unwavering mission to reach those patients with high unmet need. We are pursuing our objective of establishing Alpha DaRT as a treatment option for this terrible illness with our ongoing studies of pancreatic cancer in Israel and Montreal."

"The Department of Gastroenterology of Hadassah University Medical Center, in conjunction with all our multidisciplinary partners, was privileged to utilize the groundbreaking Israeli technology of endoscopic ultrasound-guided implantable alpha radiation to treat a patient with pancreatic cancer," noted Dr. Harold Jacob, Head of the Advanced Endoscopic Unit, Hadassah Medical Center, who, together with Dr. Ari Benson and Dr. Julia Epstein, treated the patient. "The procedure was smooth, straightforward, and incredibly quick, thanks to the support of the Alpha Tau team. The Alpha DaRT treatment holds promise and gives hope for pancreatic cancer patients and their families."

"Pancreatic cancer is particularly devastating, with an estimated 5-year survival rate of less than 5%," commented Alpha Tau CMO Dr. Robert Den. "Alpha DaRT might offer hope to patients who otherwise may not have available efficacious treatments. I am heartened that we have been able to treat our first pancreatic cancer patient in Israel, and I look forward to gaining further insight into the safety and efficacy profile of Alpha DaRT from our ongoing studies."

On September 13, 2023 AimedBio reported to have received equity investment from the "Life Science Fund", an investment fund created by Samsung Biologics, Samsung C&T, and Samsung Bioepis.

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– It is Samsung’s fourth investment through the "Life Science Fund", but the first case as domestic investment.

– They will be collaborating on ADC toolbox co-development and CDO business of AMB001, a KDDF grant-receiving platform.

(Press release, AimedBio, SEP 13, 2023, View Source;s_keyword=&s_where=&start=10 [SID1234656920])

On September 13, 2023 ImmuneOnco Biopharmaceuticals reported the preclinical research results of IMM47 under the tittle of IMM47, a humanized monoclonal antibody that targets CD24, exhibits exceptional anti-tumor efficacy by blocking the CD24/Siglec-10 interaction and can be used as monotherapy or in combination with anti-PD1 antibodies for cancer immunotherapy " in the journal "Antibody Therapeutics" (Press release, ImmuneOnco Biopharma, SEP 13, 2023, View Source [SID1234655691]).

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CD24 widely expresses in a variety of solid tumors, including breast cancer, non-small cell lung cancer, colorectal cancer, hepatocellular carcinoma, renal cell carcinoma, and ovarian cancer. It is well accepted that CD24 is an important biomarker of poor prognosis in these cancers and focused in clinical R&D.

The paper explains the mechanism of IMM47 on destroying tumor cells and its powerful ability to inhibit tumor growth by a serial in vitro and in vivo experiments. With high specificity and binding ability to CD24 expressed on tumor cells, IMM47 can block immunosuppressive signals transmitted via the CD24/Siglec-10 pathway to macrophages, natural killer cells (NK) and T cells. With genetically engineered IgG1-Fc, IMM47 effectively activates macrophage and natural killer cell via powerful ADCP and ADCC. Li, song and Chen, Dianze share the first author. In the in vivo efficacy studies on model animals, IMM47 significantly increases the number of M1 macrophages in tumor tissues and downregulates CD24 expression in tumor cells, either alone or in combination with PD-1/PD-L1 immune checkpoint inhibitors and other drugs. By using both combinations, it also demonstrates encouraging abilities to inhibit tumor growth.

With these promising results, the IND application for IMM47 to treat solid tumors was accepted by the National Medical Products Administration (NMPA). It is also ready to submit the application to the U.S. Food and Drug Administration (FDA) in the near future.

The corresponding author, Dr. Tian, Wenzhi ( founder and chairman of ImmuneOnco), said: "I am very pleased to see the preclinical research results of our IMM47 published in Antibody Therapeutics. IMM47 is a humanized monoclonal antibody targeting CD24 for cancer therapy. The antibody screening for CD24 was quite challenge due to its small size of extracellular domain which exhibits weaker immunogenicity. We persevered through the accumulation of a lot of trivial work and finally got the IMM47 molecule with high affinity and specificity. IMM47 can specifically bind to CD24 and effectively activate macrophages and natural killer cell to regain immune response. Preclinical studies support the conclusion that IMM47 has powerful anti-tumor activity with great clinical value. We will quickly advance the clinical research of the IMM47 to benefit more subjects sooner."

On September 13, 2023 Titan Pharmaceuticals, Inc. ("Titan" or the "Company") reported to have entered into a Securities Purchase Agreement (the "Purchase Agreement") with The Sire Group Ltd. ("Sire Group" or the "Investor"), pursuant to which the Company has agreed to issue 950,000 shares of Series AA Convertible Preferred Stock, par value $0.001 per share (the "Series AA Preferred Stock") to the Investor at a price of $10.00 per share, for an aggregate purchase price of $9,500,000 (the "Private Placement"). The purchase price consists of (i) $5 million in cash at closing and (ii) $4.5 million in the form of a promissory note from Sire Group, personally guaranteed by a principal of Sire Group, due and payable on September 23, 2023, subject to two 10-day extensions which include additional payments of $50,000 for each extension. The terms, rights, obligations and preferences of the Series AA Preferred Stock are set forth in a Certificate of Designations, Preferences and Rights of Series AA Convertible Preferred Stock of the Company (the "Certificate of Designations"), filed with the Secretary of State of the State of Delaware on September 13, 2023. Copies of the form of Purchase Agreement and the Certificate of Designations are attached hereto as Exhibits 10.1 and 4.1, respectively, and are incorporated herein by reference.

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Under the Certificate of Designations, each share of Series AA Preferred Stock will be convertible, at the holder’s option at any time, into shares of the Company’s common stock at a conversion rate equal to the quotient of (i) the stated value of such share divided by (ii) the initial conversion price of $0.466, subject to specified adjustments as set forth in the Certificate of Designations. Based on the initial conversion rate, approximately 20,386,266 shares of the Company’s common stock would be issuable upon conversion of all the shares of Series AA Preferred Stock, when issued, assuming the absence of in-kind dividends. The Series AA Preferred Stock will contain limitations that prevent the Investor from acquiring the lower of either (i) the maximum percentage of common stock permissible under the rules and regulations of The Nasdaq Stock Market ("Nasdaq") without first obtaining shareholder approval or (ii) 19.99% of the Company’s outstanding common stock.

The holder of the Series AA Preferred Stock is entitled to receive dividends on shares of the Series AA Preferred Stock equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends actually paid on shares of the common stock. No other dividends will be paid on shares of the Series AA Preferred Stock. Any shares of Series AA Preferred Stock may, at the option of the holder, be converted at any time into that number of shares of common stock at the conversion price set forth above. The Series AA Preferred Stock does not have any voting rights. In the event of any liquidation, dissolution or winding up of the Company, the holder of the Series AA Preferred Stock will be entitled to receive out of the assets, whether capital or surplus, of the Company the same amount that a holder of common stock would receive if the Series AA Preferred Stock were fully converted to common stock, which amounts shall be paid pari passu with all holders of common stock. The foregoing description provides a summary of certain material terms of the Series AA Preferred Stock issued pursuant to the Purchase Agreement, as set forth in Certificate of Designations, which is filed as Exhibit 4.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The shares sold in the Private Placement do not involve a public offering and have not been registered under the Securities Act of 1933, as amended, in reliance on Regulation S thereunder.

Registration Rights Agreement

In connection with the Private Placement, the Company entered into a registration rights agreement with the Investor (the "Registration Rights Agreement") pursuant to which the Company has agreed to provide certain registration rights upon the occurrence of certain events set forth in the Registration Rights Agreement. The foregoing description of the Registration Rights Agreement does not purport to be complete and is qualified in its entirety by the full text of the Registration Rights Agreement, which is filed as Exhibit 10.2 to this Current Report on Form 8-K and is incorporated herein by reference.