On August 30, 2021 Catalent, Inc. (NYSE: CTLT), the leading global provider of development sciences and manufacturing platforms for medicines, including biotherapeutics; cell and gene therapies; and consumer health products, reported that it has reached an agreement to acquire Bettera Holdings, LLC, a major manufacturer in the high-growth gummy, soft chew, and lozenge segments of the nutritional supplements market, for $1 billion, subject to customary adjustments (Press release, Catalent, AUG 30, 2021, https://www.catalent.com/catalent-news/catalent-to-extend-leadership-in-rapidly-growing-nutraceuticals-market-with-proposed-1-billion-acquisition-of-bettera-a-leading-gummies-manufacturer/ [SID1234586999]). Currently a portfolio company of Highlander Partners, LP, Bettera will complement and accelerate the growth of Catalent’s global softgel and oral dose formulation and manufacturing business to provide consumer health innovators with unrivalled choice, formulation expertise, and high-quality, scalable manufacturing solutions to help bring new products to market.

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Bettera is a market leader with broad and difficult-to-replicate expertise in successfully developing and producing consumer-preferred products for nutraceutical, functional, and botanical ingredients, and has four production facilities in the U.S. The acquisition will enable Catalent to expand its current consumer health technology platform with a wider range of technologies and ready-to-market product libraries, as well as a variety of packaging options to meet customers’ branding needs. Bettera will complement and leverage Catalent’s network of consumer health manufacturing sites across North and South America, Europe, and Japan, offering formulation development, delivery and supply solutions to the global consumer health and beauty markets. The combination will unlock significant commercial synergies as Catalent brings the unique offerings of each company to their respective high-quality customer bases.

"As the leading global innovator of softgel and oral technologies, Catalent has a strong, long-standing presence in the rapidly expanding consumer health and nutraceutical marketplace. This acquisition allows us to significantly accelerate the growth of our consumer health business and offer customers access to the substantial potential in gummies, soft chews, and lozenges, which are experiencing double-digit growth," commented Dr. Aris Gennadios, President, Softgel and Oral Technologies, Catalent. "This acquisition is a key strategic move for Catalent’s Consumer Health business, where our leadership in manufacturing technologies and formulation can offer customers more product development opportunities and add manufacturing capacity in this dynamic and fast-growing segment."

"Bettera was established with a vision to serve the needs of consumers who want to experience the benefits of nutritional supplements through more enjoyable and convenient dose forms," stated Jeff L. Hull, President and CEO of Highlander Partners. "Catalent has long had a similar vision, combined with specialized expertise, a history of successful innovation, a wide range of offerings, and the resources to help Bettera continue to grow and meet customer and consumer needs. Together, Catalent Consumer Health and Bettera are well positioned to continue Bettera’s mission of serving consumers and participating in the long-term growth of the self-care market."

The acquisition is expected to close before the end of 2021, and includes the transfer of substantially all of the approximately 500 employees, and product development, manufacturing, and packaging assets of Bettera Holdings, headquartered in Plano, Texas, including its production facilities in California, Indiana, New Jersey, and Virginia.

The acquisition is subject to customary terms and closing conditions. Catalent will pay the purchase price for this all-cash acquisition at closing using a combination of cash on hand, existing credit facilities and, depending on market conditions, new debt financing. The closing of the acquisition is not contingent on any financing activity. Catalent intends to file a Current Report on Form 8-K with the Securities and Exchange Commission with further details concerning the acquisition.

Centerview Partners LLC is serving as financial advisor to Catalent, and Fried, Frank, Harris, Shriver & Jacobson LLP is serving as Catalent’s legal counsel.

On August 30, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that the U.S. Food and Drug Administration (FDA) has granted LP-184 Orphan Drug Designation (ODD) for the treatment of glioblastoma multiforme (GBM) and other malignant gliomas (Press release, Lantern Pharma, AUG 30, 2021, View Source;malignant-gliomas-301365111.html [SID1234587015]). This news follows the recent announcement of the FDA granting LP-184 ODD for the treatment of pancreatic cancer.

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LP-184 is a small molecule drug candidate and next generation alkylating agent that preferentially damages DNA in cancer cells that over-express certain biomarkers or that harbor mutations in DNA repair pathways. LP-184 is being developed for several targeted indications in cancer, including glioblastoma and pancreatic cancer.

GBM is a rare disease with an overall five-year survival rate of 5%. This means that only approximately 5 in 100 people survive GBM for five years and beyond. In 2020, 12,000 new GBM cases were diagnosed in the U.S. and more than 154,000 new cases were diagnosed worldwide. LP-184 acts by damaging DNA selectively in tumors that express high levels of the enzyme PTGR1. Analyses driven by RADR, Lantern’s proprietary machine learning-based artificial intelligence platform, have identified, in clinical databases, GBMs with elevated PTGR1 expression and harboring defects in DNA damage repair components as a targeted subset of genetically defined patients who could potentially benefit from LP-184-based therapy. According to market analysts at GlobalData, the global GBM market is expected to reach $1.8 billion USD in therapy sales and is growing at a CAGR of 12.8%.

"GBM represents an important, underserved clinical opportunity, with a significant unmet medical need," stated Panna Sharma, President & CEO of Lantern Pharma. "This second Orphan Drug Designation from the FDA for the LP-184 program marks another major milestone and is further validation of the power of our data-driven approach to oncology drug development, aimed at more targeted and effective oncology therapies."

"We recently reported positive preclinical data that demonstrated LP-184 inhibits tumor growth by greater than 106% and improved survival in animal models of GBM," continued Mr. Sharma. "This new data that we reported, in collaboration with the Kennedy Krieger Institute and Johns Hopkins, on the efficacy of LP-184 in GBM cell lines, in-vivo animal models, and in patient-derived neurospheres, validated in-silico predictions generated by our RADR A.I. platform. We believe LP-184’s ability to cross the blood-brain barrier, together with its anti-tumor efficacy and sensitivity correlations with relevant biomarkers, highlight LP-184’s potential to be used as both monotherapy as well as a synergistic agent in combination with other drugs to address the unmet needs in GBM and other aggressive central nervous system tumors."

"With our extended and expanded agreement with the Kennedy Krieger Institute and Johns Hopkins, we look forward to further advancing the potential of LP-184 as a new, potent treatment option for GBM, especially in areas of unmet clinical need, including MGMT-unmethylated, temozolomide (TMZ)-resistant GBMs, and also EGFR-aberrant or recurrent GBMs, all of which are often associated with poor prognosis and outcome for patients."

The FDA’s Office of Orphan Products Development grants orphan status to drugs intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. Orphan Drug Designation is designed to provide drug developers with various benefits to support the development of novel drugs, including market exclusivity for seven years upon FDA approval, eligibility for tax credits for qualified clinical trials, waiver of marketing registration application fees, reduced annual product fees, clinical protocol assistance and qualification for expedited development programs.

On August 30, 2021 Fresenius Medical Care, the world’s leading provider of products and services for individuals with renal diseases, reported that it is investing an additional USD 25 million in the U.S. medical company Humacyte, Inc (Press release, Fresenius, AUG 30, 2021, View Source [SID1234587000]). In connection with the merger of Humacyte with a special purpose acquisition company (SPAC), Fresenius Medical Care is increasing its position in the newly combined entity as the lead investor of a private investment in public equity (PIPE). Fresenius Medical Care acquired a stake in Humacyte in 2018 for USD 150 million and agreed then on a strategic partnership. The combined company, which will be called Humacyte, is listed and trades on the Nasdaq exchange under HUMA. Fresenius Medical Care’s original stake in Humacyte will be exchanged for shares in the combined company.

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Humacyte is developing implantable human acellular vessels for multiple vascular repair, reconstruction and replacement. These vessels are biologically produced blood vessels made from banked human smooth muscle cells; they are manufactured to be non-immunogenic and are to be available "off the shelf" when needed by a patient. Among numerous applications, the product is now being investigated in a clinical study for use as a vascular access for hemodialysis patients, and may prove more effective than conventional synthetic grafts and fistulas in reducing infection as well as central venous catheter use. Other possible applications include reconstruction and repair from traumatic injury, and for implants for various vascular diseases.

"Humacyte’s regenerative medicine technology has great potential in many areas of healthcare," said Franklin W. Maddux, MD, Global Chief Medical Officer of Fresenius Medical Care. "We are committed to helping Humacyte achieve market approvals with this renewed investment, to bring their technology into the mainstream of health delivery. This will bring benefits worldwide in the care of patients needing repair or reconstruction of the human vasculature. In this way, Fresenius Medical Care is consistently pursuing our strategic goal of driving medical progress with innovative therapeutic approaches, recognizing the powerful advances this represents in bringing regenerative medicine to people in need."

Humacyte and Fresenius Medical Care had already expanded their collaboration in June: In addition to the vascular access and peripheral arterial disease applications, Fresenius Medical Care was granted exclusive rights to market the human acellular vessel outside the United States, including enhancements and modifications for vascular trauma applications.

"Our partnership with Fresenius Medical Care has developed very positively over the last three years, and we are very pleased with the company’s renewed commitment to our shared goals," said Laura Niklason, MD, PhD, the Chief Executive Officer of Humacyte. "Our two teams have worked well to prepare for the commercialization of our human acellular vessels globally since the formation of the partnership, and we look forward to collaborating further to benefit patients and care providers, as well as the growth of our two companies."

The biotechnology-derived blood vessel is an investigational product and is currently subject to late-stage clinical trials in the United States and Europe. Humacyte plans to file for regulatory approval in both markets after their completion Fresenius Medical Care will support the approval processes and plans the introduction in other markets worldwide with Humacyte.

On August 30, 2021 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for P-BCMA-ALLO1, the Company’s first fully allogeneic CAR-T product candidate for patients with relapsed/refractory multiple myeloma (Press release, Poseida Therapeutics, AUG 30, 2021, View Source;investigational-new-drug-application-for-p-bcma-allo1-an-allogeneic-car-t-candidate-for-relapsedrefractory-multiple-myeloma-301364920.html [SID1234587017]).

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"We view a fully allogeneic CAR-T product candidate comprised of a high-percentage of desirable stem cell memory T cells (Tscm) as the ‘holy grail’ of cell therapy in oncology," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida Therapeutics. "P-BCMA-ALLO1 has a very high percentage of Tscm cells with the potential to demonstrate safety in line with our prior P-BCMA-101 autologous approach, allowing for fully-outpatient dosing. The increase in Tscm and a switch to an improved binder also gives P-BCMA-ALLO1 the potential for even better efficacy."

Poseida announces FDA clearance of IND for its first fully #allogeneic CAR-T therapy for patients with multiple myeloma.

"Notably, Poseida’s propriety booster molecule technology gives us the ability to produce up to hundreds of doses of P-BCMA-ALLO1 from a single manufacturing run, thereby dramatically reducing cost and further increasing accessibility for patients who desperately need better and safer cell therapies," Ostertag continued.

With the P-BCMA-ALLO1 IND now cleared, the Company is actively focused on opening clinical sites with the intention to begin dosing later this year. P-BCMA-ALLO1-101 is a Phase 1 study comprised of open-label, dose escalation, multiple cohorts of allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed/refractory multiple myeloma. This Phase 1 study follows a 3+3 design of dose-escalating cohorts. After a subject enrolls, allogeneic CAR-T cells will be administered as a single dose, following a standard chemotherapy-based conditioning regimen. Treated subjects will undergo serial measurements of safety, tolerability, and response. The study protocol allows for exploration of additional dosing regimens, including re-dosing, once initial safety has been established.

About P-BCMA-ALLO1
P-BCMA-ALLO1 is Poseida’s first fully allogeneic product candidate targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma. In in vitro and in vivo preclinical studies, P-BCMA-ALLO1 showed effective, targeted cancer cell killing and cytokine secretion, with similar or superior performance in anti-tumor efficacy compared to an autologous CAR-T therapy, P-BCMA-101. Inclusion of a proprietary "booster molecule" in the allogeneic manufacturing process further improved expansion of gene-edited cells and enabled production of hundreds of patient doses from a single manufacturing run, thereby reducing the manufacturing cost per dose into the same range as that of a monoclonal antibody.

On August 30, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that the U.S. Food and Drug Administration (FDA) has granted LP-184 Orphan Drug Designation (ODD) for the treatment of glioblastoma multiforme (GBM) and other malignant gliomas (Press release, Lantern Pharma, AUG 30, 2021, View Source [SID1234591495]). This news follows the recent announcement of the FDA granting LP-184 ODD for the treatment of pancreatic cancer.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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LP-184 is a small molecule drug candidate and next generation alkylating agent that preferentially damages DNA in cancer cells that over-express certain biomarkers or that harbor mutations in DNA repair pathways. LP-184 is being developed for several targeted indications in cancer, including glioblastoma and pancreatic cancer.

GBM is a rare disease with an overall five-year survival rate of 5%. This means that only approximately 5 in 100 people survive GBM for five years and beyond. In 2020, 12,000 new GBM cases were diagnosed in the U.S. and more than 154,000 new cases were diagnosed worldwide. LP-184 acts by damaging DNA selectively in tumors that express high levels of the enzyme PTGR1. Analyses driven by RADR, Lantern’s proprietary machine learning-based artificial intelligence platform, have identified, in clinical databases, GBMs with elevated PTGR1 expression and harboring defects in DNA damage repair components as a targeted subset of genetically defined patients who could potentially benefit from LP-184-based therapy. According to market analysts at GlobalData, the global GBM market is expected to reach $1.8 billion USD in therapy sales and is growing at a CAGR of 12.8%.

"GBM represents an important, underserved clinical opportunity, with a significant unmet medical need," stated Panna Sharma, President & CEO of Lantern Pharma. "This second Orphan Drug Designation from the FDA for the LP-184 program marks another major milestone and is further validation of the power of our data-driven approach to oncology drug development, aimed at more targeted and effective oncology therapies."

"We recently reported positive preclinical data that demonstrated LP-184 inhibits tumor growth by greater than 106% and improved survival in animal models of GBM," continued Mr. Sharma. "This new data that we reported, in collaboration with the Kennedy Krieger Institute and Johns Hopkins, on the efficacy of LP-184 in GBM cell lines, in-vivo animal models, and in patient-derived neurospheres, validated in-silico predictions generated by our RADR A.I. platform. We believe LP-184’s ability to cross the blood-brain barrier, together with its anti-tumor efficacy and sensitivity correlations with relevant biomarkers, highlight LP-184’s potential to be used as both monotherapy as well as a synergistic agent in combination with other drugs to address the unmet needs in GBM and other aggressive central nervous system tumors."

"With our extended and expanded agreement with the Kennedy Krieger Institute and Johns Hopkins, we look forward to further advancing the potential of LP-184 as a new, potent treatment option for GBM, especially in areas of unmet clinical need, including MGMT-unmethylated, temozolomide (TMZ)-resistant GBMs, and also EGFR-aberrant or recurrent GBMs, all of which are often associated with poor prognosis and outcome for patients."

The FDA’s Office of Orphan Products Development grants orphan status to drugs intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. Orphan Drug Designation is designed to provide drug developers with various benefits to support the development of novel drugs, including market exclusivity for seven years upon FDA approval, eligibility for tax credits for qualified clinical trials, waiver of marketing registration application fees, reduced annual product fees, clinical protocol assistance and qualification for expedited development programs.